section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 21:21:2.0.1.1.6.1.1.1,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",A,Subpart A—General Provisions,,§ 106.1 Status and applicability of the regulations in part 106.,FDA,,,,"(a) The criteria set forth in subparts B, C, and D of this part prescribe the steps that manufacturers shall take under section 412(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b)(2) and (b)(3)) in processing infant formula. If the processing of the formula does not comply with any regulation in subparts B, C, or D of this part, the formula will be deemed to be adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. (b) The criteria set forth in subpart E of this part prescribe the requirements for quality factors that infant formula shall meet under section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the formula fails to comply with any regulation in subpart E of this part, it will be deemed to be adulterated under section 412(a)(2) of the Federal Food, Drug, and Cosmetic Act. (c) The criteria set forth in subpart F of this part prescribe records requirements for quality factors under section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act and for good manufacturing practices and quality control procedures, including distribution and audit records, under section 412(b)(2). If an infant formula manufacturer fails to comply with the quality factor record requirements in subpart F of this part with respect to an infant formula, the formula will be deemed to be adulterated under section 412(a)(2) of the Federal Food, Drug, and Cosmetic Act. If an infant formula manufacturer fails to comply with the good manufacturing practices or quality control procedures record requirements in subpart F of this part with respect to an infant formula, the infant formula will be deemed to be adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. The criteria set forth in subpart F of this part also implement record retention requirements under section 412(b)(4) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart F of this part is a violation of section 301(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(e)). (d) The criteria set forth in subpart G of this part describe, in part, certain good manufacturing practices, quality control procedures, and quality factor records requirements under section 412(b)(1) and (b)(2) of the Federal Food, Drug and Cosmetic Act. If an infant formula manufacturer fails to comply with such records requirements with respect to an infant formula, the infant formula will be deemed to be adulterated under section 412(a)(2) or (a)(3) of the Federal Food, Drug, and Cosmetic Act, as applicable. The criteria set forth in subpart G of this part also describe the circumstances in which an infant formula manufacturer is required to register with, submit to, or notify the Food and Drug Administration, and the content of a registration, submission, or notification, under section 412(c), (d), and (e) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart G of this part is a violation of section 301(s) of the Federal Food, Drug, and Cosmetic Act." 21:21:2.0.1.1.6.1.1.2,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",A,Subpart A—General Provisions,,§ 106.3 Definitions.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33070, June 10, 2014]","The definitions in this section and the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) shall apply to infant formula requirements in 21 CFR parts 106 and 107 of this chapter. Eligible infant formula means an infant formula that could be lawfully distributed in the United States on December 8, 2014. Final product stage means the point in the manufacturing process, before distribution of an infant formula, at which the infant formula is homogeneous and is not subject to further degradation due to processing. Indicator nutrient means a nutrient whose concentration is measured during the manufacture of an infant formula to confirm complete addition and uniform distribution of a premix or other substance of which the indicator nutrient is a part. Infant means a person not more than 12 months of age. Infant formula means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk. In-process production aggregate means a combination of ingredients at any point in the manufacturing process before packaging. Major change in an infant formula means any new formulation, or any change of ingredients or processes where experience or theory would predict a possible significant adverse impact on levels of nutrients or bioavailability of nutrients, or any change that causes an infant formula to differ fundamentally in processing or in composition from any previous formulation produced by the manufacturer. Examples of infant formulas deemed to differ fundamentally in processing or in composition include: (1) Any infant formula produced by a manufacturer who is entering the U.S. market; (2) Any infant formula powder processed and distributed by a manufacturer who previously only produced liquids (or vice versa); (3) Any infant formula having a significant revision, addition, or substitution of a macronutrient (i.e., protein, fat, or carbohydrate), with which the manufacturer has not had previous experience; (4) Any infant formula manufactured on a new processing line or in a new plant; (5) Any infant formula manufactured containing a new constituent not listed in section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)), such as taurine or L-carnitine; (6) Any infant formula processed by a manufacturer on new equipment that utilizes a new technology or principle (e.g., from terminal sterilization to aseptic processing); or (7) An infant formula for which there has been a fundamental change in the type of packaging used (e.g., changing from metal cans to plastic pouches). Manufacturer means a person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages or labels the product in a container for distribution. The term “manufacturer” does not include a person who prepares, reconstitutes, or mixes infant formula exclusively for an infant under his/her direct care or the direct care of the institution employing such person. Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. New infant formula means: (1) An infant formula manufactured by a person that has not previously manufactured an infant formula, and (2) An infant formula manufactured by a person that has previously manufactured infant formula and in which there is a major change in processing or formulation from a current or any previous formulation produced by such manufacturer, or which has not previously been the subject of a submission under section 412(c) of the Federal Food, Drug, and Cosmetic Act for the U.S. market. Nutrient means any vitamin, mineral, or other substance or ingredient that is required in accordance with the “Nutrients” table set out in section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act or by regulations issued under section 412(i)(2) or that is identified as essential for infants by the Food and Nutrition Board of the Institute of Medicine through its development of a Dietary Reference Intake, or that has been identified as essential for infants by the Food and Drug Administration through a Federal Register publication. Nutrient premix means a combination of ingredients containing two or more nutrients received from a supplier or prepared by an infant formula manufacturer. Production aggregate means a quantity of product, or, in the case of an infant formula produced by continuous process, a specific identified amount produced in a unit of time, that is intended to have uniform composition, character, and quality, within specified limits, and is produced according to a master manufacturing order. Production unit means a specific quantity of an infant formula produced during a single cycle of manufacture that has uniform composition, character, and quality, within specified limits. Production unit number or production aggregate number means any distinctive combination of letters, numbers, symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a production aggregate or a production unit of infant formula can be determined. Quality factors means those factors necessary to demonstrate the safety of the infant formula and the bioavailability of its nutrients, as prepared for market and when fed as the sole source of nutrition, to ensure the healthy growth of infants. Representative sample means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled. Shall is used to state mandatory requirements." 21:21:2.0.1.1.6.2.1.1,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.5 Current good manufacturing practice.,FDA,,,,"(a) The regulations set forth in this subpart define the minimum current good manufacturing practices that are to be used in, and the facilities or controls that are to be used for, the manufacture, processing, packing, or holding of an infant formula. Compliance with these provisions is necessary to ensure that such infant formula provides the nutrients required under § 107.100 of this chapter and is manufactured in a manner designed to prevent its adulteration. A liquid infant formula that is a thermally processed low-acid food packaged in a hermetically sealed container is also subject to the regulations in part 113 of this chapter, and an infant formula that is an acidified food, as defined in § 114.3(b) of this chapter, is also subject to the regulations in part 114 of this chapter. (b) The failure to comply with any regulation in this subpart in the manufacture, processing, packing, or holding of an infant formula shall render such infant formula adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)(3)); the failure to comply with any regulation in part 113 of this chapter in the manufacture, processing, packing, or holding of a liquid infant formula shall render such infant formula adulterated under section 412(a)(3); and the failure to comply with any regulation in part 114 of this chapter in the manufacture, processing, packing, or holding of an infant formula that is an acidified food shall render such infant formula adulterated under section 412(a)(3)." 21:21:2.0.1.1.6.2.1.10,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.60 Controls to prevent adulteration during packaging and labeling of infant formula.,FDA,,,,"(a) A manufacturer shall examine packaged and labeled infant formula during finishing operations to ensure that all containers and packages in the production aggregate have the correct label, the correct use-by date, and the correct code established under § 106.80. (b) Labels shall be designed, printed, and applied so that the labels remain legible and attached during the conditions of processing, storage, handling, distribution, and use. (c) Packaging used to hold multiple containers of an infant formula product shall be labeled as follows: (1) Where all containers are the same infant formula product and all bear the same code established under § 106.80, the packaging label shall include the product name, the name of the manufacturer, distributor, or shipper, and the code established under § 106.80. (2) Where the containers are not the same infant formula product or do not all bear the same code established under § 106.80, the packaging label shall: (i) Include the product name of each product, the name of the manufacturer, distributor, or shipper of each product, the code established under § 106.80 for each product, and a “use by” date that is no later than the “use by” date of the container exhibiting the closest “use by” date applied to satisfy the requirement of § 107.20(c) of this chapter; or (ii) Include a unique identification number assigned by the packager, provided that the distributor of the package maintains a record linked to such unique number that identifies the product name of each product, the name of the manufacturer, distributor, or shipper of each product, the code established under § 106.80 for each product, and the “use by” date for each product applied to satisfy the requirement of § 107.20(c) of this chapter." 21:21:2.0.1.1.6.2.1.11,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.70 Controls on the release of finished infant formula.,FDA,,,,"(a) A manufacturer shall control under a quarantine system designed to prevent use or distribution of each production aggregate of infant formula until it determines that the production aggregate meets all of the manufacturer's specifications, including those adopted to meet the standards of § 106.55 on microbiological contamination and of § 106.91(a) on quality control procedures, or until the documented review of the failure to meet any of the manufacturer's specifications finds that the failure does not result in, or could not lead to, adulteration of the product. (b) Any production aggregate of infant formula that fails to meet any of the manufacturer's specifications shall be quarantined under a system designed to prevent its use in the manufacture of infant formula or its distribution until an individual qualified by education, training, or experience has conducted a documented review and has made and documented a material disposition decision to reject the infant formula; to reprocess or otherwise recondition the infant formula; or to approve and release the infant formula. Any production aggregate of infant formula that is reprocessed or otherwise reconditioned shall be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether it may be released for use or distribution. (c) Any rejected infant formula shall be clearly identified as having been rejected for use and shall be controlled under a quarantine system designed to prevent its release or distribution. (d) A production aggregate of infant formula, including a reprocessed or reconditioned production aggregate, that does not meet the nutrient requirements of section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) or that has not been manufactured, packaged, labeled, and held under conditions to prevent adulteration under sections 402(a)(1) through (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4)) shall not be approved and released for distribution." 21:21:2.0.1.1.6.2.1.12,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.80 Traceability.,FDA,,,,"Each production aggregate of infant formula shall be coded with a sequential number that identifies the product and the establishment where the product was packed and that permits tracing of all stages of manufacture of that production aggregate, including the year, the days of the year, and the period during those days that the product was packed, and the receipt and handling of raw materials used." 21:21:2.0.1.1.6.2.1.13,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.90 Audits of current good manufacturing practice.,FDA,,,,"(a) A manufacturer of an infant formula, or an agent of such manufacturer, shall conduct regularly scheduled audits to determine whether the manufacturer has complied with the current good manufacturing practice regulations in this subpart. Such audits shall be conducted at a frequency that is required to ensure compliance with such regulations. (b) The audits required by paragraph (a) of this section shall be performed by an individual or a team of individuals who, as a result of education, training, or experience, is knowledgeable in all aspects of infant formula production and of the Agency's regulations concerning current good manufacturing practice that such individual or team is responsible for auditing. This individual or team of individuals shall have no direct responsibility for the matters that such individual or team is auditing and shall have no direct interest in the outcome of the audit." 21:21:2.0.1.1.6.2.1.2,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.6 Production and in-process control system.,FDA,,,,"(a) A manufacturer shall conform to the requirements of this subpart by implementing a system of production and in-process controls. This production and in-process control system shall cover all stages of processing, from the receipt and acceptance of the raw materials, ingredients, and components through the storage and distribution of the finished product and shall be designed to ensure that all the requirements of this subpart are met. (b) The production and in-process control system shall be set out in a written plan or set of procedures that is designed to ensure that an infant formula is manufactured in a manner that will prevent adulteration of the infant formula. (c) At any point, step, or stage in the production process where control is necessary to prevent adulteration, a manufacturer shall: (1) Establish specifications to be met; (2) Monitor the production and in-process control point, step, or stage; (3) Establish a corrective action plan for use when a specification established in accordance with paragraph (c)(1) of this section is not met; (4) Review the results of the monitoring required by paragraph (c)(2) of this section, and review and evaluate the public health significance of any deviation from specifications that have been established in accordance with paragraph (c)(1) of this section. For any specification established in accordance with paragraph (c)(1) of this section that a manufacturer fails to meet, an individual qualified by education, training, or experience shall conduct a documented review and shall make a material disposition decision to reject the affected article, to reprocess or otherwise recondition the affected article, or to approve and release the article for use or distribution; and (5) Establish recordkeeping procedures, in accordance with § 106.100(e)(3), that ensure that compliance with the requirements of this section is documented. (d) Any article that fails to meet a specification established in accordance with paragraph (c)(1) of this section shall be controlled under a quarantine system designed to prevent its use pending the completion of a documented review and material disposition decision." 21:21:2.0.1.1.6.2.1.3,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.10 Controls to prevent adulteration by workers.,FDA,,,,"(a) A manufacturer shall employ sufficient personnel, qualified by education, training, or experience, to perform all operations, including all required recordkeeping, in the manufacture, processing, packing, and holding of each infant formula and to supervise such operations to ensure that the operations are correctly and fully performed. (b) Personnel working directly with infant formula, infant formula raw materials, infant formula packaging, or infant formula equipment or utensil contact surfaces shall practice good personal hygiene to protect the infant formula against contamination. Good personal hygiene includes: (1) Wearing clean outer garments and, as necessary, protective apparel such as head, face, hand, and arm coverings; and (2) Washing hands thoroughly in a hand washing facility with soap and running water at a suitable temperature before starting work, after each absence from the work station, and at any other time when the hands may become soiled or contaminated. (c) Any person who reports that he or she has, or appears by medical examination or supervisory observation to have, an illness, open lesion (including boils, sores, or infected wounds), or any other source of microbial contamination that creates a reasonable possibility that the safety of an infant formula may be adversely affected, shall be excluded from direct contact with ingredients, containers, closures, in-process materials, equipment, utensils, and infant formula product until the condition is corrected or determined by competent medical personnel not to jeopardize the safety of the infant formula." 21:21:2.0.1.1.6.2.1.4,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.20 Controls to prevent adulteration caused by facilities.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33070, June 10, 2014]","(a) Buildings used in the manufacture, processing, packing, or holding of infant formula shall be maintained in a clean and sanitary condition and shall have space for the separation of incompatible operations, such as the handling of raw materials, the manufacture of the product, and packaging and labeling operations. (b) Separate areas or another system of separation, such as a computerized inventory control, a written card system, or an automated system of segregation, shall be used for holding raw materials, in-process materials, and final infant formula product at the following times: (1) Pending release for use in infant formula production or pending release of the final product; (2) After rejection for use in, or as, infant formula; and (3) After release for use in infant formula production or after release of the final product. (c) Lighting shall allow easy identification of raw materials, packaging, labeling, in-process materials, and finished products that have been released for use in infant formula production and shall permit the easy reading of instruments and controls necessary in processing, packaging, and laboratory analysis. Any lighting fixtures directly over or adjacent to exposed raw materials, in-process materials, or bulk (unpackaged) finished product shall be protected to prevent glass from contaminating the product in the event of breakage. (d) A manufacturer shall provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate the infant formula; and shall minimize the potential for contamination of raw materials, in-process materials, final product infant formula, packing materials, and infant formula-contact surfaces, through the use of appropriate measures, which may include the use of air filtration. (e) All rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents shall be stored and used in a manner that protects against contamination of infant formula. (f) Potable water used in the manufacture of infant formula shall meet the standards prescribed in the Environmental Protection Agency's (EPA's) Primary Drinking Water regulations in 40 CFR part 141, except that the water used in infant formula manufacturing shall not be fluoridated or shall be defluoridated to a level as low as possible prior to use. (1) The water shall be supplied under continuous positive pressure in a plumbing system that is free of defects that could contaminate an infant formula. (2) A manufacturer shall test representative samples of the potable water drawn at a point in the system at which the water is in the same condition that it will be when it is used in infant formula manufacturing. (3) A manufacturer shall conduct the tests required by paragraph (f)(2) of this section with sufficient frequency to ensure that the water meets the EPA's Primary Drinking Water Regulations but shall not conduct these tests less frequently than annually for chemical contaminants, every 4 years for radiological contaminants, and weekly for bacteriological contaminants. (4) A manufacturer shall make and retain records, in accordance with § 106.100(f)(1), of the frequency and results of testing of the water used in the production of infant formula. (g) There shall be no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for infant formula manufacturing. (h) Only culinary steam shall be used at all direct infant formula product contact points. Culinary steam shall be in compliance with the 3-A Sanitary Standards, No. 60903, which is incorporated by reference at § 106.160. Boiler water additives in the steam shall be used in accordance with § 173.310 of this chapter. (i) Each infant formula manufacturing site shall provide its employees with readily accessible toilet facilities and hand washing facilities that include hot and cold water, soap or detergent, single-service towels or air dryers in toilet facilities. These facilities shall be maintained in good repair and in a sanitary condition at all times. These facilities shall provide for proper disposal of the sewage. Doors to the toilet facility shall not open into areas where infant formula, ingredients, containers, or closures are processed, handled, or stored, except where alternate means have been taken to protect against contamination." 21:21:2.0.1.1.6.2.1.5,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.30 Controls to prevent adulteration caused by equipment or utensils.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]","(a) A manufacturer shall ensure that equipment and utensils used in the manufacture, processing, packing, or holding of an infant formula are of appropriate design and are installed to facilitate their intended function and their cleaning and maintenance. (b) A manufacturer shall ensure that equipment and utensils used in the manufacture, processing, packing, or holding of an infant formula are constructed so that surfaces that contact ingredients, in-process materials, or infant formula are made of nontoxic materials and are not reactive or absorptive. A manufacturer shall ensure that such equipment and utensils are designed to be easily cleanable and to withstand the environment of their intended use and that all surfaces that contact ingredients, in-process materials, or infant formula are cleaned and sanitized, as necessary, and are maintained to protect infant formula from being contaminated by any source. All sanitizing agents used on such equipment and utensils that are regulated as pesticide chemicals under 21 U.S.C. 346a(a) shall comply with the Environmental Protection Agency's regulations established under such section, and all other such sanitizers shall comply with all applicable Food and Drug Administration laws and regulations. (c) A manufacturer shall ensure that any substance, such as a lubricant or a coolant, that is required for operation of infant formula manufacturing equipment and which would render the infant formula adulterated if such substance were to come in contact with the formula, does not come in contact with formula ingredients, containers, closures, in-process materials, or with infant formula product during the manufacture of an infant formula. (d) A manufacturer shall ensure that each instrument used for measuring, regulating, or controlling mixing time and speed, temperature, pressure, moisture, water activity, or other parameter at any point, step, or stage where control is necessary to prevent adulteration of an infant formula during processing is accurate, easily read, properly maintained, and present in sufficient number for its intended use. (1) The instruments and controls shall be calibrated against a known reference standard at the time of or before first use and thereafter at routine intervals, as specified in writing by the manufacturer of the instrument or control, or as otherwise deemed necessary to ensure the accuracy of the instrument or control. The known reference standard shall be certified for accuracy at the intervals specified in writing by the manufacturer of the instrument or control, or at routine intervals otherwise deemed necessary to ensure the accuracy of the instrument or control. A manufacturer shall make and retain records of the calibration activities in accordance with § 106.100(f)(2). (2) Instruments and controls that cannot be adjusted to agree with the reference standard shall be repaired or replaced. (3) If calibration of an instrument shows a failure to meet a specification for a point where control is deemed necessary to prevent adulteration of infant formula product, a written evaluation of all affected product, and of any actions that need to be taken with respect to that product, shall be made, in accordance with § 106.100(f)(2). (e) The following provisions apply to thermal processing and cold storage of infant formulas: (1) Equipment and procedures for thermal processing of infant formula packaged in hermetically sealed containers shall conform to the requirements in 21 CFR parts 108 and 113. (2)(i) Except as provided in paragraph (e)(2)(ii) of this section, a manufacturer shall maintain all areas of cold storage at a temperature of 40 °F (4.4 °C) or below. (ii) A manufacturer may maintain a cold storage area for an in-process infant formula or for a final infant formula at a temperature not to exceed 45 °F (7.2 °C) for a defined period of time provided that the manufacturer has scientific data and other information to demonstrate that the time and temperature conditions of such storage are sufficient to ensure that there is no significant growth of microorganisms of public health significance during the period of storage of the in-process or final infant formula product. (3)(i) Cold storage compartments and thermal processing equipment shall be equipped with easily readable, accurate temperature-indicating devices. (ii) A manufacturer shall ensure that the temperature of each cold storage compartment is maintained by: (A) Monitoring the temperature of the cold storage compartment on a temperature-indicating device and recording this temperature in a record with such frequency as is necessary to ensure that temperature control is maintained; (B) Equipping the cold storage compartment with one or more temperature-recording devices that will reflect, on a continuing basis, the true temperature, within the compartment; (C) Equipping the cold storage compartment with a high temperature alarm that has been validated to function properly and recording the temperature in a record with such frequency as is necessary to ensure that temperature control is maintained; or (D) Equipping the cold storage compartment with a maximum-indicating thermometer that has been validated to function properly and recording this temperature in a record with such frequency as is necessary to ensure that temperature control is maintained. (iii) A manufacturer shall, in accordance with § 106.100(f)(3), make and retain records of the temperatures recorded in compliance with § 106.30(e)(3)(ii). (4) When a manufacturer uses a temperature-recording device for a cold storage compartment, such device shall not read lower than the reference temperature-indicating device. (5) A manufacturer shall monitor the temperature in thermal processing equipment at points where temperature control is necessary to prevent adulteration. Such monitoring shall be at such frequency as is required by regulation or is necessary to ensure that temperature control is maintained. (f) A manufacturer shall ensure that equipment and utensils used in the manufacture of infant formula are cleaned, sanitized, and maintained at regular intervals to prevent adulteration of the infant formula. (1) An individual qualified by education, training, or experience to conduct such a review shall review all cleaning, sanitizing, and maintenance to ensure that it has been satisfactorily completed. (2) A manufacturer shall make and retain records on equipment cleaning, sanitizing, and maintenance, in accordance with § 106.100(f)(4). (g) A manufacturer shall ensure that compressed air or other gases that are mechanically introduced into infant formula, that are used to clean any equipment, or that come into contact with any other surface that contacts ingredients, in-process materials, or infant formula product are treated in such a way that their use will not contaminate the infant formula with unlawful or other chemical, physical, or microbiological contaminants. When compressed gases are used at product filling machines to replace air removed from the headspace of containers, a manufacturer shall install, as close as practical to the end of the gas line that feeds gas into the space, a filter capable of retaining particles 0.5 micrometer or smaller." 21:21:2.0.1.1.6.2.1.6,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.35 Controls to prevent adulteration due to automatic (mechanical or electronic) equipment.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]","(a) For the purposes of this section: (1) “Hardware” means all automatic equipment, including mechanical and electronic equipment (such as computers), that is used in production or quality control of infant formula. (2) “Software” means any programs, procedures, rules, and associated documentation used in the operation of a system. (3) “System” means a collection of components (including software and hardware) organized to accomplish a specific function or set of functions in a specified environment. (4) “Validation” means establishing documented evidence that provides a high degree of assurance that a system will consistently produce a product meeting its predetermined specifications and quality characteristics. Validation can be accomplished through any suitable means, such as verification studies or modeling. (b) All systems shall be designed, installed, tested, and maintained in a manner that will ensure that they are capable of performing their intended function and of producing or analyzing infant formula in accordance with this subpart and subpart C of this part. (1) A manufacturer shall ensure, at any point, step, or stage where control is necessary to prevent adulteration of the infant formula, that all hardware is routinely inspected and checked according to written procedures and that hardware that is capable of being calibrated is routinely calibrated according to written procedures. (2) A manufacturer shall check and document the accuracy of input into, and output generated by, any system used in the production or quality control of an infant formula to ensure that the infant formula is not adulterated. The degree and frequency of input/output verification shall be based on the complexity and reliability of the system and the level of risk associated with the safe operation of the system. (3) A manufacturer shall ensure that each system is validated prior to the release for distribution of any infant formula manufactured using the system. (4) A manufacturer shall ensure that any system that is modified is revalidated following the modification and prior to the release for distribution of any infant formula manufactured using the modified system. All modifications to software shall be made by a designated individual and shall be checked by the infant formula manufacturer to ensure that infant formula that is produced or analyzed using the modified software complies with this subpart and with subpart C of this part. (c) A manufacturer shall make and retain records, in accordance with § 106.100(f)(5), concerning mechanical or electronic equipment." 21:21:2.0.1.1.6.2.1.7,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,"§ 106.40 Controls to prevent adulteration caused by ingredients, containers, and closures.",FDA,,,,"(a) The only substances that may be used in an infant formula are substances that are safe and suitable for use in infant formula under the applicable food safety provisions of the Federal Food, Drug, and Cosmetic Act; that is, a substance is used in accordance with the Agency's food additive regulations, is generally recognized as safe (GRAS) for such use, or is authorized by a prior sanction. (b) Infant formula containers and closures shall not be reactive or absorptive so as to affect the safety of the infant formula. The following substances may be used as packaging material that comes in contact with an infant formula: (1) A food additive that is the subject of a regulation issued under section 409(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(c)) and is used consistent with the conditions of use of that regulation; (2) A food contact substance that is the subject of an effective notification under section 409(h) of the Federal Food, Drug, and Cosmetic Act and is used consistent with the conditions of use in that notification; (3) A substance that is exempt from regulation as a food additive under § 170.39 of this chapter and its use conforms to the use identified in the exemption letter; (4) A substance that is generally recognized as safe for use in or on infant formula or for use in infant formula packaging; (5) A substance the use of which is authorized by a prior sanction from the Food and Drug Administration or from the U.S. Department of Agriculture; and (6) A substance that is not a food additive within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)) because the substance is not reasonably expected to become a component of food or otherwise affect the characteristics of food. (c) Ingredients, containers, and closures used in the manufacture of infant formula shall be identified with a lot number to be used in recording their disposition. (d) A manufacturer shall develop written specifications for ingredients, containers, and closures used in manufacturing infant formula and shall develop and follow written procedures to determine whether all ingredients, containers, and closures meet these specifications. When any specification is not met, an individual qualified by education, training, or experience shall conduct a documented review, shall determine whether a failure to meet such a specification could result in an adulterated infant formula, and shall make and document a material disposition decision to reject the ingredient, container, or closure or the affected infant formula; to reprocess or otherwise recondition the ingredient, container, or closure or the affected infant formula; or to approve and release the ingredient, container, or closure or the affected infant formula for use. (e) Ingredients, containers, and closures shall be stored in separate areas or separated by a system of segregation, such as a computerized inventory control, a written card system, or an automated system of segregation, clearly designated for materials pending release for use; materials released for use; or materials rejected for use in infant formula production. (1) Any lot of an ingredient, a container, or a closure that does not meet the manufacturer's specifications shall be quarantined under a system designed to prevent its use in the manufacture of infant formula until an individual qualified by education, training, or experience has conducted a documented review, has determined whether such failure could result in an adulterated infant formula, and has made and documented a material disposition decision to reject the ingredient, container, closure, or the affected infant formula; to reprocess or otherwise recondition the ingredient, container, closure, or the affected infant formula; or to approve and release the ingredient, container, closure, or the affected infant formula for use. (2) Any ingredient, container, or closure that has been reprocessed or otherwise reconditioned shall be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether it may be released for use. (3) A manufacturer shall not reprocess or otherwise recondition an ingredient, container, or closure rejected because it is contaminated with microorganisms of public health significance or other contaminants, such as heavy metals. (f) If an ingredient, container, or closure that complies with a manufacturer's specifications, or that has been released for use following a material review and disposition decision, is subsequently exposed to air, heat, or other conditions that may adversely affect it, or if a manufacturer reasonably believes that an ingredient, container, or closure that complies with a manufacturer's specifications, or that has been released for use following a material review and disposition decision, has been exposed to air, heat, or other conditions that may adversely affect it, the ingredient, container, or closure shall be quarantined under a system designed to prevent its use in the manufacture of infant formula until an individual qualified by education, training, or experience has conducted a documented review and has made and documented a material disposition decision to reject the ingredient, container, or closure; to reprocess or otherwise recondition the ingredient, container, or closure; or to approve and release the ingredient, container, or closure for use. (1) Any ingredient, container, or closure that is reprocessed or otherwise reconditioned shall be retested or reexamined and be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether the ingredient, container, or closure should be rejected, further reprocessed or otherwise further reconditioned, or approved and released for use. (2) Any rejected ingredient, container, or closure shall be clearly identified as having been rejected for use in infant formula manufacturing or processing operations and shall be controlled under a quarantine system designed to prevent its use in infant formula manufacturing or processing operations. (3) Any ingredient, container, or closure that has not been manufactured, packaged, labeled, or held under conditions to prevent adulteration under section 402(a)(1) through (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4)) shall not be approved and released for use. (g) A manufacturer shall make and retain records, in accordance with § 106.100(f)(6), on the ingredients, containers, and closures used in the manufacture of infant formula." 21:21:2.0.1.1.6.2.1.8,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.50 Controls to prevent adulteration during manufacturing.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]","(a) A manufacturer shall prepare and follow a written master manufacturing order that establishes controls and procedures for the production of an infant formula. (1) The manufacturer shall make and retain records, in accordance with § 106.100(e), that include complete information relating to the production and control of the production aggregate. An individual qualified by education, training, or experience shall conduct an investigation of any deviations from the master manufacturing order and document any corrective action taken. (2) Changes made to the master manufacturing order shall be reviewed and approved by a responsible official and include an evaluation of the effect of the change on the nutrient content and the suitability of the formula for infants. (b) A manufacturer shall establish controls to ensure that each raw or in-process ingredient required by the master manufacturing order is examined by one person and checked by a second person or system. This checking shall ensure that the correct ingredient is added during the manufacturing process, that the ingredient has been released for use in infant formula, and that the correct weight or measure of the ingredient is added to the production unit. (c) A manufacturer shall establish a system of identification for the contents of all compounding and storage containers, processing lines, and major equipment used during the manufacture of a production aggregate of an infant formula. The system shall permit the identification of the processing stage and the unique identification number for the particular production unit or production aggregate of infant formula. (d) A manufacturer shall establish controls to ensure that the nutrient levels required by § 107.100 of this chapter are maintained in the formula, and that the formula is not contaminated with microorganisms or other contaminants. Such controls shall include: (1) The mixing time; the speed, temperature, and flow rate of product; and other critical parameters necessary to ensure the addition of required ingredients to, and the homogeneity of, the formula; (2) The spray-drying process for powdered infant formula, including the filtering of the intake air before heating, to prevent microbial and other contamination; (3) The removal of air from the finished product to ensure that nutrient deterioration does not occur; (4) Ensuring that each container of finished product is properly sealed. Such controls shall involve use of established procedures, specifications, and intervals of examination that are designed by qualified individuals and are sufficient to: (i) Detect visible closure or seal defects, and (ii) Determine closure strength through destructive testing. A manufacturer of a liquid infant formula that is a thermally processed low-acid food packaged in a hermetically sealed container shall perform such closure integrity testing in accordance with § 113.60(a) of this chapter. (e) A manufacturer shall establish controls that ensure that the equipment used at points where control is deemed necessary to prevent adulteration is monitored, so that personnel will be alerted to malfunctions. (f) A manufacturer shall establish controls for in-process material as follows: (1) For any specification established in accordance with § 106.6(c)(1) that a manufacturer fails to meet for in-process material, an individual qualified by education, training, or experience shall conduct a documented review and shall make a material disposition decision to reject the affected in-process material, to reprocess or otherwise recondition the affected in-process material, or to approve and release the affected in-process material for use or distribution; (2) Pending a documented review and material disposition decision, any in-process material that fails to meet any specification established in accordance with § 106.6(c)(1) shall be clearly identified as such and shall be controlled under a quarantine system designed to prevent its use in manufacturing or processing operations until completion of the documented review and material disposition decision; (3) Any in-process material that has been reprocessed or otherwise reconditioned shall be the subject of a documented review and material disposition decision by an individual qualified by education, training, or experience to determine whether it may be released for use; and (4) Any rejected in-process material shall be clearly identified as having been rejected for use in infant formula and shall be controlled under a quarantine system designed to prevent its use in infant formula manufacturing or processing operations." 21:21:2.0.1.1.6.2.1.9,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",B,Subpart B—Current Good Manufacturing Practice,,§ 106.55 Controls to prevent adulteration from microorganisms.,FDA,,,,"(a) A manufacturer of infant formula shall establish a system of process controls covering all stages of processing that is designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. (b) A manufacturer of liquid infant formula shall comply, as appropriate, with the procedures specified in part 113 of this chapter for thermally processed low-acid foods packaged in hermetically sealed containers and part 114 of this chapter for acidified foods. (c) A manufacturer of powdered infant formula shall test representative samples of each production aggregate of powdered infant formula at the final product stage, before distribution, to ensure that each production aggregate meets the microbiological quality standards in the table in paragraph (e) of this section. (d) A manufacturer shall make and retain records, in accordance with § 106.100(e)(5)(ii) and (f)(7), on the testing of infant formulas for microorganisms. (e) A powdered infant formula that contains any microorganism that exceeds the M value listed for that microorganism in the table in paragraph (e) of this section shall be deemed adulterated under sections 402(a)(1), 402(a)(4), and 412(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)(3)). The Food and Drug Administration will determine compliance with the M values listed below using the latest edition of the Bacteriological Analytical Manual (BAM) ( http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm ) (accessed April 8, 2013). 1 Number of samples. 2 None detected." 21:21:2.0.1.1.6.3.1.1,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",C,Subpart C—Quality Control Procedures,,§ 106.91 General quality control.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]","(a) During manufacture, a manufacturer shall test each production aggregate for nutrients as follows: (1) Each nutrient premix used in the manufacture of an infant formula shall be tested for each nutrient (required under § 107.100 of this chapter or otherwise added by the manufacturer) that the manufacturer is relying on the premix to provide, to ensure that the premix is in compliance with the manufacturer's specifications; (2) During the manufacturing process, after the addition of the premix, or at the final product stage but before distribution, each production aggregate of infant formula shall be tested for at least one indicator nutrient for each of the nutrient premixes used in the infant formula to confirm that the nutrients supplied by each of the premixes are present, in the proper concentration, in the production aggregate of infant formula. (3) At the final product stage, before distribution of an infant formula, each production aggregate shall be tested for vitamins A, C, E, and thiamin. (4) During the manufacturing process or at the final product stage, before distribution, each production aggregate shall be tested for all nutrients required to be included in such formula under § 107.100 of this chapter for which testing is not conducted for compliance with paragraphs (a)(1) or (a)(3) of this section and for any nutrient added by the manufacturer for which testing is not conducted for compliance with paragraph (a)(1) of this section. (b) A manufacturer shall test each production aggregate of finished product for nutrients as follows: (1)(i) For an infant formula that is a new infant formula the manufacturer shall collect, from each manufacturing site and at the final product stage, a representative sample of the first production aggregate of packaged, finished formula in each physical form (powder, ready-to-feed, or concentrate) and evaluate the levels of all nutrients required under § 107.100 of this chapter and all other nutrients added by the manufacturer. The manufacturer shall repeat such testing every 4 months thereafter throughout the shelf life of the product. (ii) The Food and Drug Administration will exempt the manufacturer from the requirements of paragraph (b)(1)(i) of this section if the manufacturer of a new infant formula requests an exemption and provides analytical data, as required under § 106.120(b)(7), that demonstrates that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data. A manufacturer exempt from the requirements of paragraph (b)(1)(i) of this section would be required to test the first production aggregate according to the requirements of § 106.91(b)(2). (2) The manufacturer shall collect, from each manufacturing site and at the final product stage, a representative sample of each subsequent production aggregate of packaged, finished formula in each physical form (powder, ready-to-feed, or concentrate) and evaluate the levels of all nutrients required under § 107.100 of this chapter and all other nutrients added by the manufacturer. The manufacturer shall repeat such testing at the end of the shelf life of the product. (3) If the results of the testing required by paragraph (b)(1) of this section do not substantiate the shelf life of the infant formula, the manufacturer shall address, as appropriate, all production aggregates of formula released and pending release for distribution that are implicated by the testing results, such as by conducting the testing required by paragraph (b)(1) of this section on a subsequently produced production aggregate to substantiate the shelf life of the infant formula or revising the use by date for such product so that such date is substantiated by the stability testing results. (4) If results of the testing required by paragraph (b)(2) of this section show that any required nutrient is not present in the production aggregate of infant formula at the level required by § 107.100 of this chapter or that any nutrient added by the manufacturer is not present at the level declared on the label of the production aggregate of infant formula, the manufacturer shall: (i) Investigate the cause of such variance in the level of any required or added nutrient; (ii) Evaluate the significance, if any, of the results for other production aggregates of the same formula that have been released for distribution; (iii) Address, as appropriate, all production aggregates of formula released and pending release for distribution that are implicated by the testing results; and (iv) Determine whether it is necessary to conduct the testing required by paragraph (b)(1) of this section. (5) The testing required by paragraphs (b)(1) and (b)(2) of this section is not required to evaluate the level of minerals present in the infant formula. (c) All quality control testing shall be conducted using appropriate, scientifically valid test methods. (d) A manufacturer shall make and retain quality control records in accordance with § 106.100(e)(5)(i)." 21:21:2.0.1.1.6.3.1.2,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",C,Subpart C—Quality Control Procedures,,§ 106.92 Audits of quality control procedures.,FDA,,,,"(a) A manufacturer of an infant formula, or an agent of such a manufacturer, shall conduct regularly scheduled audits to determine whether the manufacturer has complied with the requirements for quality control procedures that are necessary to ensure that an infant formula provides nutrients in accordance with section 412(b) and (i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b) and (i)) and is manufactured in a manner designed to prevent adulteration of the infant formula under section 412(a)(1) and (a)(3) of the Federal Food, Drug, and Cosmetic Act. Such audits shall be conducted at a frequency that is required to ensure compliance with the requirements for quality control procedures. (b) The audits required by paragraph (a) of this section shall be performed by an individual or a team of individuals who, as a result of education, training, or experience, is knowledgeable in all aspects of infant formula production and of the regulations concerning quality control procedures that such individual or team is responsible for auditing. This individual or team of individuals shall have no direct responsibility for the matters that such individual or team is auditing and shall have no direct interest in the outcome of the audit." 21:21:2.0.1.1.6.4.1.1,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",D,Subpart D—Conduct of Audits,,§ 106.94 Audit plans and procedures.,FDA,,,,"(a) A manufacturer shall develop and follow a written audit plan that is available at the manufacturing facility for Food and Drug Administration inspection. (b) The audit plan shall include audit procedures that set out the methods the manufacturer uses to determine whether the facility is operating in accordance with current good manufacturing practice, with the quality control procedures that are necessary to ensure that an infant formula provides nutrients in accordance with sections 412(b) and (i) of the Federal Food, Drug, and Cosmetic Act, and in a manner designed to prevent adulteration of the infant formula. (c) The audit procedures shall include: (1) An evaluation of the production and in-process control system established under § 106.6(b) by: (i) Observing the production of infant formula and comparing the observed process to the written production and in-process control plan required under § 106.6(b); (ii) Reviewing records of the monitoring of points, steps, or stages where control is deemed necessary to prevent adulteration; and (iii) Reviewing records of how deviations from any specification at points, steps, or stages where control is deemed necessary to prevent adulteration were handled; and (2) A review of a representative sample of all records maintained in accordance with § 106.100(e) and (f)." 21:21:2.0.1.1.6.5.1.1,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",E,Subpart E—Quality Factors for Infant Formulas,,§ 106.96 Requirements for quality factors for infant formulas.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]","The regulations set forth in this subpart define the minimum requirements for quality factors for infant formulas: (a) An infant formula shall meet the quality factor of normal physical growth. (b) A manufacturer of an infant formula that is not an eligible infant formula shall demonstrate that a formula supports normal physical growth in infants when fed as a sole source of nutrition by conducting, in accordance with good clinical practice, an adequate and well-controlled growth monitoring study of the infant formula that: (1) Is no less than 15 weeks in duration, enrolling infants no more than 2 weeks old at time of entry into the study; (2) Includes the collection and maintenance of data on formula intake and anthropometric measures of physical growth, including body weight, recumbent length, head circumference, average daily weight increment, and average daily recumbent length increment; (3) Includes anthropometric measurements made at the beginning and end of the study, and at least four additional measurements made at intermediate time points with three of the six total measurements made within the first 4 weeks of the study and three measurements made at approximately 4-week intervals over the remaining 11 weeks of the study; (4) Compares the anthropometric data for the test group to a concurrent control group or groups at each time point and compares the anthropometric data for each infant (body weight for age, body length for age, head circumference for age, and weight for length) in the test group and the control group to the 2009 CDC growth charts, which are incorporated by reference at § 106.160; and (5) Compares the data on formula intake of the test group with a concurrent control group or groups and a scientifically appropriate reference. (c) The Food and Drug Administration will exempt a manufacturer from the requirements of paragraph (b) of this section, if: (1) The manufacturer requests an exemption and provides assurances, as required under § 106.121(b), that the changes made by the manufacturer to an existing infant formula are limited to changing the type of packaging of an existing infant formula (e.g., changing from metal cans to plastic pouches); or (2) The manufacturer requests an exemption and provides assurances, as required under § 106.121, which demonstrate that: (i) An alternative method or study design that is based on sound scientific principles is available to show that the formula supports normal physical growth in infants when the formula is fed as the sole source of nutrition; (ii) The change made by the manufacturer to an existing formula does not affect the ability of the formula to support normal physical growth; or (iii) The manufacturer markets a formulation in more than one form (e.g., liquid and powdered forms) and the quality factor requirements are met by the form of the formula that is processed using the method that has the greatest potential for adversely affecting nutrient content and bioavailability. (d) A manufacturer of a new infant formula that is not an eligible infant formula shall, in accordance with § 106.100(p)(1), make and retain records demonstrating that the formula meets the quality factor of normal physical growth. (e) An infant formula shall meet the quality factor of sufficient biological quality of protein. (f) A manufacturer of an infant formula that is not an eligible infant formula shall demonstrate that a formula meets the quality factor of sufficient biological quality of protein by establishing the biological quality of the protein in the infant formula when fed as the sole source of nutrition using an appropriate modification of the Protein Efficiency Ratio (PER) rat bioassay described in the “Official Methods of Analysis of AOAC International,” 18th ed., sections 45.3.04 and 45.3.05, “AOAC Official Method 960.48 Protein Efficiency Ratio Rat Bioassay,” which is incorporated by reference at § 106.160. The PER rat bioassay shall be conducted on a formula and the results evaluated prior to the initiation of a growth monitoring study of the formula that is required under paragraph (b) of this section. (g) The Food and Drug Administration will exempt a manufacturer from the requirements of paragraph (f) of this section, if: (1) The manufacturer requests an exemption and provides assurances as required under § 106.121(g) that the changes made by the manufacturer to an existing infant formula are limited to changing the type of packaging of an existing infant formula (e.g., changing from metal cans to plastic pouches); or (2) The manufacturer requests an exemption and provides assurances, as required under § 106.121(h), that demonstrate that the change made by the manufacturer to an existing formula does not affect the bioavailability of the protein. (3) The manufacturer requests an exemption and provides assurances, as required under § 106.121(i), that demonstrate that an alternative method to the PER that is based on sound scientific principles is available to demonstrate that the formula supports the quality factor for the biological quality of the protein. (h) A manufacturer of a new infant formula that is not an eligible infant formula shall, in accordance with § 106.100(q), make and retain records demonstrating that the formula meets the quality factor of sufficient biological quality of protein. (i) The following provisions for requirements for quality factors apply only to an “eligible infant formula” as defined in § 106.3: (1) An eligible infant formula that fulfills one or more of the following criteria meets the quality factor of normal physical growth: (i) The scientific evidence on such infant formula meets the requirements of paragraph (b) of this section that apply to infant formula that is not an eligible infant formula; (ii) The scientific evidence on such infant formula meets the following provisions: (A) The evidence is an adequate and well-controlled growth study, conducted in accordance with good clinical practice, to determine whether an infant formula supports normal physical growth in infants when the formula is fed as the sole source of nutrition; (B) The growth study is no less than 4 months in duration, enrolling infants no more than 1 month old at time of entry into the study; (C) The growth study collects from the study subjects data on anthropometric measures of physical growth, including body weight, recumbent length, head circumference, and average daily weight increment, and plots the data on the following charts from “Physical Growth: National Center for Health Statistics Percentiles” for body weight, body length, and head circumference, which are incorporated by reference at § 106.160: ( 1 ) Figure 1. Length by age percentiles for girls aged birth-36 months (p. 609); ( 2 ) Figure 2. Length by age percentiles for boys aged birth-36 months (p. 610); ( 3 ) Figure 3. Weight by age percentiles for girls aged birth-36 months (p. 611); ( 4 ) Figure 4. Weight by age percentiles for boys aged birth-36 months (p. 612); ( 5 ) Figure 5. Head circumference by age percentiles for girls aged birth-36 months (p. 613); ( 6 ) Figure 6. Weight by length percentiles for girls aged birth-36 months (p. 613); ( 7 ) Figure 7. Head circumference by age percentiles for boys aged birth-36 months (p. 614); and ( 8 ) Figure 8. Weight by length percentiles for boys aged birth-36 months (p. 614); and (D) The growth study collects anthropometric measurements at the beginning of the growth study, at 2 weeks, at 4 weeks, at least monthly thereafter, and at the conclusion of the study; or (iii) The scientific evidence on such infant formula otherwise demonstrates that such formula supports normal physical growth. (2) An eligible infant formula that fulfills one or more of the following criteria meets the quality factor of sufficient biological quality of the protein: (i) The scientific evidence on such infant formula meets the requirements of paragraph (f) of this section that apply to infant formula that is not an eligible infant formula; (ii) The scientific evidence on such infant formula is a study that establishes the biological quality of the protein in an infant formula by demonstrating that the protein source supports adequate growth using the Protein Efficiency Ratio (PER) rat bioassay described in sections 45.3.04 and 45.3.05 of the “Official Methods of Analysis of the Association of Official Analytical Chemists,” 16th ed., which are incorporated by reference at § 106.160; or (iii) The scientific evidence on such infant formula otherwise demonstrates that the protein in such infant formula is of sufficient biological quality. (3) The manufacturer of an eligible infant formula may, not later than November 12, 2015, submit a petition to the Food and Drug Administration under § 10.30 of this chapter that: (i) Demonstrates that such formula fulfills one or more of the criteria in paragraph (i)(1) of this section; or (ii) Demonstrates that such formula fulfills one or more of the criteria in paragraph (i)(2) of this section. (4) A petition filed under paragraph (i)(3) of this section shall address only one infant formula formulation and shall contain all data and information relied upon by the manufacturer to demonstrate that such formulation fulfills one or more of the criteria in paragraph (i)(1) or in paragraph (i)(2) of this section. A manufacturer may combine petitions submitted under paragraphs (i)(3)(i) and (i)(3)(ii) of this section that relate to the same formulation. (5) The manufacturer of each eligible infant formula shall make and retain, in accordance with § 106.100(p)(2), records to demonstrate that such formula supports normal physical growth in infants when fed as the sole source of nutrition and shall make and retain, in accordance with § 106.100(q)(2), records to demonstrate that that the protein in such infant formula is of sufficient biological quality. The records required by this paragraph shall include all relevant scientific data and information and a narrative explanation of why the data and information demonstrate that the formula supports normal physical growth and a narrative explanation of why the data and information demonstrate that the protein in such infant formula is of sufficient biological quality." 21:21:2.0.1.1.6.6.1.1,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",F,Subpart F—Records and Reports,,§ 106.100 Records.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014; 80 FR 56144, Sept. 17, 2015]","(a) Every manufacturer of infant formula shall maintain the records specified in this regulation in order to permit the Food and Drug Administration to determine whether each manufacturer is in compliance with section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a)). (b) The manufacturer shall maintain all records that pertain to food-packaging materials subject to § 174.5 of this chapter and that bear on whether such materials would cause an infant formula to be adulterated within the meaning of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(2)(C)). (c) The manufacturer shall maintain all records that pertain to nutrient premix testing that it generates or receives. Such records shall include, but are not limited to: (1) Any results of testing conducted to ensure that each nutrient premix is in compliance with the premix certificate and guarantee and specifications that have been provided to the manufacturer by the premix supplier, including tests conducted when nutrients exceed their expiration date or shelf life (retest date). (2) All certificates and guarantees given by premix suppliers concerning the nutrients required by section 412(i) of the Federal Food, Drug, and Cosmetic Act and § 107.100 of this chapter. (d) The premix supplier shall maintain the results of all testing conducted to provide all certificates and guarantees concerning nutrient premixes for infant formulas. Such records shall include but are not limited to: (1) The results of tests conducted to determine the purity of each nutrient required by section 412(i) of the Federal Food, Drug, and Cosmetic Act or § 107.100 of this chapter and any other nutrient listed in the certificate and guarantee; (2) The weight of each nutrient added; (3) The results of any quantitative tests conducted to determine the amount of each nutrient certified or guaranteed; and (4) The results of any quantitative tests conducted to identify the nutrient levels present when nutrient premixes exceed their expiration date or shelf life (retest date). (e) For each production aggregate of infant formula, a manufacturer shall prepare and maintain records that include complete information relating to the production and control of the production aggregate. These records shall include: (1) The master manufacturing order. The master manufacturing order shall include: (i) The significant steps in the production of the production aggregate and the date on which each significant step occurred; (ii) For a manufacturing facility that has more than one set of equipment or more than one processing line, the identity of equipment and processing lines for which the manufacturer has identified points, steps, or stages in the production process where control is necessary to prevent adulteration; (iii) The identity of each lot of ingredients, containers, and closures used in producing the production aggregate of formula; (iv) The amount of each ingredient to be added to the production aggregate of infant formula and a check (verification) that the correct amount was added; and (v) A copy of each infant formula label used on a finished production aggregate of infant formula and the results of examinations conducted during the finishing operations to provide assurance that the containers and packages have the correct label. (2) Any deviations from the master manufacturing order and any corrective actions taken because of the deviations. (3) Documentation, in accordance with § 106.6(c), of the monitoring at any point, step, or stage in the manufacturer 's production process where control is deemed necessary to prevent adulteration. These records shall include: (i) A list of the specifications established at each point, step, or stage in the production process where control is deemed necessary to prevent adulteration, in accordance with § 106.6(c)(1), including documentation of the scientific basis for each specification; (ii) The actual values obtained during the monitoring operation, any deviations from established specifications, and any corrective actions taken; and (iii) Identification of the person monitoring each point, step, or stage in the production process where control is deemed necessary to prevent adulteration. (4) The conclusions and followup, along with the identity of the individual qualified by education, training, or experience who investigated: (i) Any deviation from the master manufacturing order and any corrective actions taken; (ii) A finding that a production aggregate or any of its ingredients failed to meet the infant formula manufacturer's specifications; and (iii) A failure to meet any specification at any point, step, or stage in the production process where control is deemed necessary to prevent adulteration. (5) The results of all testing performed on the production aggregate of infant formula, including testing on the in-process production aggregate, at the final product stage, and on finished product throughout the shelf life of the product. The results recorded shall include: (i) The results of all quality control testing conducted in accordance with § 106.91(a) and (b) to verify that each nutrient required by § 107.100 of this chapter is present in each production aggregate of infant formula at the level required by § 107.100 of this chapter, and that all other nutrients added by the manufacturer are present at the appropriate level. The record of the results of the quality control testing shall include: (A) A summary document identifying the stages of the manufacturing process at which the nutrient analysis for each required nutrient is conducted as required under § 106.91(a); and (B) A summary document on the stability testing program conducted under § 106.91(b), including the nutrients tested and the frequency of nutrient testing throughout the shelf life of the product. (ii) For powdered infant formula, the results of any testing conducted in accordance with § 106.55(c) to verify compliance with the microbiological quality standards in § 106.55(e). (f) A manufacturer shall make and retain all records described in subparts B and C of this part, including: (1) Records, in accordance with § 106.20(f)(4), of the frequency and results of testing of the water used in the production of infant formula; (2) Records, in accordance with § 106.30(d), of accuracy checks of instruments and controls. A certification of accuracy of any known reference standard used and a history of recertification shall be maintained. At a minimum, such records shall specify the instrument or control being checked, the date of the accuracy check, the standard used, the calibration method used, the results found, any actions taken if the instrument is found to be out of calibration, and the initials or name of the individual performing the test. If calibration of an instrument shows that a specification at a point, step, or stage in the production process where control is deemed necessary to prevent adulteration has not been met, a written evaluation of all affected product, and any actions that need to be taken with respect to that product, shall be made. (3) Records, in accordance with § 106.30(e)(3)(iii). (4) Records, in accordance with § 106.30(f), on equipment cleaning, sanitizing, and maintenance that show the date and time of such cleaning, sanitizing, and maintenance and the production aggregate number of each infant formula processed between equipment startup and shutdown for cleaning, sanitizing, and maintenance. The person performing and checking the cleaning, sanitizing, and maintenance shall date and sign or initial the record indicating that the work was performed. (5) Records, in accordance with § 106.35(c), on all mechanical and electronic equipment used in the production or quality control of infant formula. These records shall include: (i) A list of all systems used with a description of the computer files and the defined capabilities and inherent limitations of each system; (ii) A copy of all software used; (iii) Records that document installation, calibration, testing or validation, and maintenance of the systems used; (iv) A list of all persons authorized to create or modify software; (v) Records that document modifications to software, including the identity of the person who modified the software; (vi) Records that document retesting or revalidation of modified systems; and (vii) A backup file of data entered into a computer or related system. The backup file shall consist of a hard copy or alternative system, such as duplicate electronic records, tapes, or microfilm, designed to ensure that backup data are exact and complete, and that they are secure from alteration, inadvertent erasures, or loss. (6) Records, in accordance with § 106.40(g), on ingredients, containers, and closures used in the manufacture of infant formula. These records shall include: (i) The identity and quantity of each lot of ingredients, containers, and closures; (ii) The name of the supplier; (iii) The supplier's lot numbers; (iv) The name and location of the manufacturer of the ingredient, container, or closure, if different from the supplier; (v) The date of receipt; (vi) The receiving code as specified; and (vii) The results of any test or examination (including retesting and reexamination) performed on the ingredients, containers, or closures and the conclusions derived there from and the disposition of all ingredients, containers, or closures. (7) A full description of the methodology used to test powdered infant formula to verify compliance with the microbiological quality standards of § 106.55(c) and the methodology used to do quality control testing, in accordance with § 106.91(a). (g) A manufacturer shall maintain all records pertaining to distribution of the infant formula, including records that show that formula produced for export only is exported. Such records shall include all information and data necessary to effect and monitor recalls of the manufacturer's infant formula products in accordance with subpart E of part 107 of this chapter. (h) The manufacturer shall maintain all records pertaining to the microbiological quality and purity of raw materials and finished powdered infant formula. (i) [Reserved] (j) The manufacturer shall make and retain records pertaining to regularly scheduled audits, including the audit plans and procedures, the findings of the audit, and a listing of any changes made in response to these findings. The manufacturer shall make readily available for authorized inspection the audit plans and procedures and a statement of assurance that the regularly scheduled audits are being conducted. The findings of the audit and any changes made in response to these findings shall be maintained for the time period required under paragraph (n) of this section, but need not be made available to the Food and Drug Administration. (k) The manufacturer shall maintain procedures describing how all written and oral complaints regarding infant formula will be handled. The manufacturer shall follow these procedures and shall include in them provisions for the review of any complaint involving an infant formula and for determining the need for an investigation of the possible existence of a hazard to health. (1) For purposes of this section, every manufacturer shall interpret a “complaint” as any communication that contains any allegation, written or oral, expressing dissatisfaction with a product for any reason, including concerns about the possible existence of a hazard to health and about appearance, taste, odor, and quality. Correspondence about prices, package size or shape, or other matters that could not possibly reveal the existence of a hazard to health shall not, for compliance purposes, be considered a complaint and therefore need not be made available to a Food and Drug Administration investigator. (2) When a complaint shows that a hazard to health possibly exists, the manufacturer shall conduct an investigation into the validity of the complaint. Where such an investigation is conducted, the manufacturer shall include in its file on the complaint the determination as to whether a hazard to health exists and the basis for that determination. No investigation is necessary when the manufacturer determines that there is no possibility of a hazard to health. When no investigation is necessary, the manufacturer shall include in the record the reason that an investigation was found to be unnecessary and the name of the responsible person making that determination. (3) When there is a reasonable possibility of a causal relationship between the consumption of an infant formula and an infant's death, the manufacturer shall, within 15 days of receiving such information, conduct an investigation and notify the Agency as required in § 106.150. (4) The manufacturer shall maintain in designated files all records pertaining to the complaints it receives. The manufacturer shall separate the files into two classes: (i) Those complaints that allege that the infant became ill from consuming the product or required treatment by a physician or health care provider and (ii) Those complaints that may involve a possible existence of a hazard to health but do not refer to an infant becoming ill or the need for treatment by physician or a health care provider. (5) The manufacturer shall include in a complaint file the following information concerning the complaint: (i) The name of the infant formula; (ii) The production aggregate number; (iii) The name of complainant; (iv) A copy of the complaint or a memo of the telephone conversation or meeting and all correspondence with the complainant; (v) By reference or copy, all the associated manufacturing records and complaint investigation records needed to evaluate the complaint. When copies of such records are not maintained in the complaint file, they must be available within 24 hours when requested by a Food and Drug Administration official. (vi) All actions taken to followup on the complaint; and (vii) All findings and evaluations of the complaint. (6) The manufacturer should maintain the files regarding infant formula complaints at the establishment where the infant formula was manufactured, processed, or packed. When the manufacturer wishes to maintain all consumer complaints for the entire firm at one location other than at the facility where an infant formula was manufactured, processed, or packed, the manufacturer may do so as long as all records required by this section are available within 24 hours of request for inspection at that facility. However, all records of consumer complaints, including summaries, any reports, and any files, maintained at the manufacturing facility or at any other facility shall be made available to investigators for review and copying upon request. (l) The manufacturer shall make readily available for authorized inspection all records required under this part or copies of such records. Records shall be available at any reasonable time at the establishment where the activities described in such records occurred. (Infant formula complaint files may be maintained at one facility, as provided in paragraph (k)(6) of this section, if all required records are readily available at that facility.) These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by electronic means shall be considered as meeting the requirements of this paragraph. (m) A manufacturer shall maintain all records required under this part in a manner that ensures that both the manufacturer and the Food and Drug Administration can be provided with access to such records within 24 hours. The manufacturer may maintain the records required under this part as original records, as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records, or as electronic records. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available. All electronic records maintained under this part shall comply with part 11 of this chapter. (n) Production control, product testing, testing results, complaints, and distribution records necessary to verify compliance with parts 106, 107, 109, 110, 113, and 117 of this chapter, or with other appropriate regulations, shall be retained for 1 year after the expiration of the shelf life of the infant formula or 3 years from the date of manufacture, whichever is greater. (o) The manufacturer shall maintain quality control records that contain sufficient information to permit a public health evaluation of any production aggregate of infant formula. (p) A manufacturer shall make and retain records that demonstrate that the formula meets the quality factor of normal physical growth. (1) For an infant formula that is not an eligible infant formula, in accordance with § 106.96(d), these records shall include: (i) Records demonstrating compliance with the requirements in § 106.96(b), including records made in compliance with § 106.121; or (ii) Records demonstrating satisfaction of an applicable exemption under § 106.96(c), including records made in compliance with § 106.121. (2) For an eligible infant formula, in accordance with § 106.96(i)(5), these records shall include records demonstrating that the formula fulfills one or more of the criteria listed in § 106.96(i)(1). (q) A manufacturer shall make and retain records that demonstrate that a formula meets the quality factor of sufficient biological quality of protein. (1) For an infant formula that is not an eligible infant formula, in accordance with § 106.96(h), these records shall include: (i) Records demonstrating compliance with the requirements in § 106.96(f), including records made in compliance with § 106.121; or (ii) Records demonstrating satisfaction of an applicable exemption under § 106.96(g), including records made in compliance with § 106.121. (2) For an eligible infant formula, in accordance with § 106.96(i)(5), these records shall include records demonstrating that the formula fulfills one or more of the criteria listed in § 106.96(i)(2). (r) The failure to comply with the records requirements in this section applicable to the quality factors shall render the formula adulterated under section 412(a)(2) of the Federal Food, Drug, and Cosmetic Act. The failure to comply with the records requirements in this section applicable to the good manufacturing practices and quality control procedures, including distribution and audit records requirements, with respect to an infant formula shall render the formula adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. A failure to retain or make available records applicable to the quality factor requirements, quality control procedures, or current good manufacturing practices requirements in compliance with paragraph (l), (m), or (n) of this section with respect to a formula shall render the formula adulterated under section 412(a)(2) or (a)(3) of the Federal Food, Drug, and Cosmetic Act, as applicable." 21:21:2.0.1.1.6.7.1.1,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",G,"Subpart G—Registration, Submission, and Notification Requirements",,§ 106.110 New infant formula registration.,FDA,,,,"(a) Before a new infant formula may be introduced or delivered for introduction into interstate commerce, including a new infant formula for export only, the manufacturer of the formula shall register with the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, Infant Formula and Medical Foods Staff (HFS-850), 5001 Campus Dr., College Park, MD 20740-3835. (b) The new infant formula registration shall include: (1) The name of the new infant formula; (2) The name of the manufacturer; (3) The street address of the place of business of the manufacturer; and (4) The name and street address of each establishment at which the manufacturer intends to manufacture such new infant formula." 21:21:2.0.1.1.6.7.1.2,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",G,"Subpart G—Registration, Submission, and Notification Requirements",,§ 106.120 New infant formula submission.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014]","(a) At least 90 days before a new infant formula is introduced or delivered for introduction into interstate commerce, a manufacturer shall submit notice of its intent to do so to the Food and Drug Administration at the address given in § 106.110(a). An original and two paper copies of such notice of intent shall be submitted, unless the notice is submitted in conformance with part 11 of this chapter, in which case a single copy shall be sufficient. (b) The new infant formula submission shall include: (1) The name and description of the physical form (e.g., powder, ready-to feed, or concentrate) of the infant formula; (2) An explanation of why the formula is a new infant formula; (3) The quantitative formulation of each form of the infant formula that is the subject of the notice in units per volume or units per weight for liquid formulas, specified either as sold or as fed, and units per dry weight for powdered formulas, and the weight of powder to be reconstituted with a specified volume of water, and, when applicable, a description of any reformulation of the infant formula, including a listing of each new or changed ingredient and a discussion of the effect of such changes on the nutrient levels in the formulation; (4) A description, when applicable, of any change in processing of the infant formula. Such description shall identify the specific change in processing, including side-by-side, detailed schematic diagrams comparing the new processing to the previous processing and processing times and temperatures; (5) Assurance that the infant formula will not be marketed unless the formula meets the requirements for quality factors of section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b)(1)) and the nutrient content requirements of section 412(i) of the Federal Food, Drug, and Cosmetic Act. (i) Assurance that the formula meets the requirements for quality factors, which are set forth in § 106.96, shall be provided by a submission that complies with § 106.121; (ii) Assurance that the formula complies with the nutrient content requirements, which are set forth in § 107.100 of this chapter, shall be provided by a statement that the formula will not be marketed unless it meets the nutrient requirements of § 107.100 of this chapter, as demonstrated by testing required under subpart C of this part; and (6) Assurance that the processing of the infant formula complies with section 412(b)(2) of the Federal Food, Drug, and Cosmetic Act. Such assurance shall include: (i) A statement that the formula will be produced in accordance with subparts B and C of this part; and (ii) The basis on which each ingredient meets the requirements of § 106.40(a), e.g. that it is an approved food additive, that it is authorized by a prior sanction, or that it is generally recognized as safe (GRAS) for its intended use. Any claim that an ingredient is GRAS shall be supported by a citation to the Agency's regulations or by an explanation, including a list of published studies and a copy of those publications, for why, based on the published studies, there is general recognition of the safety of the use of the ingredient in infant formula. (7) If the manufacturer is requesting an exemption under § 106.91(b)(1)(ii), the manufacturer shall include the scientific evidence that the manufacturer is relying on to demonstrate that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data. (c) For a new infant formula for export only, a manufacturer may submit, in lieu of the information required under paragraphs (b)(5) and (b)(6) of this section, a statement certifying that the infant formula meets the specifications of the foreign purchaser, the infant formula does not conflict with the laws of the country to which it is intended for export, the infant formula is labeled on the outside of the shipping package to indicate that it is intended for export only, and the infant formula will not be sold or offered for sale in domestic commerce. Such manufacturer shall also submit a statement certifying that it has adequate controls in place to ensure that such formula is actually exported. (d) The submission will not constitute notice under section 412 of the Federal Food, Drug, and Cosmetic Act unless it complies fully with paragraph (b) of this section, as applicable, and the information that it contains is set forth in a manner that is readily understandable. The Agency will notify the manufacturer if the notice is not complete because it does not meet the requirements in section 412(c) and (d) of the Federal Food, Drug, and Cosmetic Act. (e) If a new infant formula submission contains all the information required by paragraph (b) of this section, as applicable, the Food and Drug Administration will acknowledge its receipt and notify the manufacturer of the date of receipt. The date that the Agency receives a new infant formula submission that is complete is the filing date for such submission. The manufacturer shall not market the new infant formula before the date that is 90 days after the filing date. If the information in the submission does not provide the assurances required under section 412(d)(1) of the Federal Food, Drug, and Cosmetic Act and the regulations of this chapter, the Food and Drug Administration will so notify the manufacturer before the expiration of the 90th day. (f) If the manufacturer provides additional information in support of a new infant formula submission, the Agency will determine whether the additional information is a substantive amendment to the new infant formula submission. If the Agency determines that the new submission is a substantive amendment, the Food and Drug Administration will assign the new infant formula submission a new filing date. The Food and Drug Administration will acknowledge receipt of the additional information and, when applicable, notify the manufacturer of the new filing date, which is the date of receipt by the Food and Drug Administration of the information that constitutes the substantive amendment to the new infant formula submission. (g) Submissions relating to exempt infant formulas are subject to the provisions of § 107.50 of this chapter." 21:21:2.0.1.1.6.7.1.3,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",G,"Subpart G—Registration, Submission, and Notification Requirements",,§ 106.121 Quality factor assurances for infant formulas.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014]","To provide assurance that an infant formula meets the requirements for quality factors set forth in § 106.96, the manufacturer shall submit the following data and information: (a) Unless the manufacturer of a new infant formula can claim an exemption under § 106.96(c)(1) or (c)(2), the following assurances shall be provided to ensure that the requirements of § 106.96(a) and (b) have been met: (1) An explanation, in narrative form, setting forth how requirements for quality factors in § 106.96(b) have been met; (2) Records that contain the information required by § 106.96(b) to be collected during the study for each infant enrolled in the study. The records shall be identified by subject number, age, feeding group, gender, and study day of collection. (3) Data, which shall include: (i) Statistical evaluation for all measurements, including group means, group standard deviations, and measures of statistical significance for all measurements for each feeding group at the beginning of the study and at every point where measurements were made throughout the study, and (ii) Calculations of the statistical power of the study before study initiation and at study completion. (4) A report on attrition and on all occurrences of adverse events during the study, which shall include: (i) Identification of the infant by subject number and feeding group and a complete description of the adverse event, including comparisons of the frequency and nature of occurrence in each feeding group and information on the health of the infant during the course of the study, including the occurrence and duration of any illness; (ii) A clinical assessment by a health care provider of the infant's health during each suspected adverse event; and (iii) A list of all subjects who did not complete the study, including the subject number and the reason that each subject did not complete the study. (b) If the manufacturer is requesting an exemption from the growth monitoring study requirements under § 106.96(c)(1), the manufacturer shall include a detailed description of the change made by the manufacturer to an existing infant formula and an explanation of why the change made by the manufacturer to an existing infant formula satisfies the criteria of § 106.96(c)(1). (c) If the manufacturer is requesting an exemption under § 106.96(c)(2)(i), the manufacturer shall include a detailed description of the alternative method or alternative study design, an explanation of why the method or study design is based on sound scientific principles, and data that demonstrate that the formula supports normal physical growth in infants when the formula is fed as the sole source of nutrition. (d) If the manufacturer is requesting an exemption under § 106.96(c)(2)(ii), the manufacturer shall include a detailed description of the change and an explanation of why the change made by the manufacturer to an existing infant formula does not the affect the ability of the formula to support normal physical growth. (e) If the manufacturer is requesting an exemption under § 106.96(c)(2)(iii), the manufacturer shall include a detailed description of the two formulations and an explanation of why the quality factor requirement of normal physical growth is met by the form of the formula that is processed using the method that has the greatest potential for adversely affecting nutrient content and bioavailability. (f) Unless the manufacturer of a new infant formula is requesting an exemption under § 106.96(g), the results of the Protein Efficiency Ratio bioassay shall be provided in accordance with § 106.96(f). (g) If the manufacturer is requesting an exemption under § 106.96(g)(1), the manufacturer shall include a detailed description of the change made by the manufacturer to an existing infant formula and an explanation of why the change made by the manufacturer to an existing infant formula satisfies the criteria listed in § 106.96(g)(1). (h) If the manufacturer is requesting an exemption under § 106.96(g)(2), the manufacturer shall include a detailed description of the change and an explanation of why the change made by the manufacturer to an existing infant formula does not affect the bioavailability of the protein. (i) If the manufacturer is requesting an exemption under § 106.96(g)(3), the manufacturer shall include a detailed explanation of the alternative method, an explanation of why the method is based on sound scientific principles, and the data that demonstrate that the quality factor for the biological quality of the protein has been met. (j) A statement certifying that the manufacturer has collected and considered all information and data concerning the ability of the infant formula to meet the requirements for quality factors and that the manufacturer is not aware of any information or data that would show that the formula does not meet the requirements for quality factors." 21:21:2.0.1.1.6.7.1.4,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",G,"Subpart G—Registration, Submission, and Notification Requirements",,§ 106.130 Verification submission.,FDA,,,,"(a) A manufacturer shall, after the first production and before the introduction into interstate commerce of a new infant formula (except for a new infant formula that is for export only for which a submission is received in compliance with § 106.120(c)), verify in a written submission to the Food and Drug Administration at the address given in § 106.110(a) that the infant formula complies with the requirements of the Federal Food, Drug, and Cosmetic Act and is not adulterated. (b) The verification submission shall include the following information: (1) The name of the new infant formula; the filing date for the new infant formula submission, in accordance with § 106.120, for the subject formula; and the identification number assigned by the Agency to the new infant formula submission: (2) A statement that the infant formula to be introduced into interstate commerce is the same as the infant formula that was the subject of the new infant formula notification and for which the manufacturer provided assurances in accordance with the requirements of § 106.120; (3) A summary of test results of the level of each nutrient required by § 107.100 of this chapter and any nutrient added by the manufacturer in the formula, presented in units per 100 kilocalories at the final product stage. (4) A certification that the manufacturer has established current good manufacturing practices, including quality control procedures and in-process controls, and testing required by current good manufacturing practice, designed to prevent adulteration of this formula in accordance with subparts B and C of this part. (c) The submission shall not constitute written verification under section 412(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)(2)) when any data prescribed in paragraph (b) of this section are lacking or are not set forth so as to be readily understood. In such circumstances, the Agency will notify the manufacturer that the notice is not adequate." 21:21:2.0.1.1.6.7.1.5,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",G,"Subpart G—Registration, Submission, and Notification Requirements",,§ 106.140 Submission concerning a change in infant formula that may adulterate the product.,FDA,,,,"(a) When a manufacturer makes a change in the formulation or processing of the formula that may affect whether the formula is adulterated under section 412(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)), the manufacturer shall, before the first processing of such formula, make a submission to the Food and Drug Administration at the address given in § 106.110(a). An original and two copies shall be submitted. (b) The submission shall include: (1) The name and physical form of the infant formula (i.e., powder, ready-to-feed, or concentrate); (2)(i) An explanation of why the change in formulation or processing may affect whether the formula is adulterated; and (ii) What steps will be taken to ensure that, before the formula is introduced into interstate commerce, the formula will not be adulterated; and (3) A statement that the submission complies with § 106.120(b)(3), (b)(4), (b)(5), and (b)(6). When appropriate, a statement to the effect that the information required by § 106.120(b)(3), (b)(4), (b)(5), or (b)(6) has been provided to the Agency previously and has not been affected by the changes that are the subject of the current submission, together with the identification number assigned by the Agency to the relevant infant formula submission, may be provided in lieu of such statement. (c) The submission shall not constitute notice under section 412 of the Federal Food, Drug, and Cosmetic Act unless it complies fully with paragraph (b) of this section, and the information that it contains is set forth in a manner that is readily understandable. The Agency will notify the manufacturer if the notice is not adequate because it does not meet the requirements of section 412(d)(3) of the Federal Food, Drug, and Cosmetic Act." 21:21:2.0.1.1.6.7.1.6,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",G,"Subpart G—Registration, Submission, and Notification Requirements",,§ 106.150 Notification of an adulterated or misbranded infant formula.,FDA,,,"[79 FR 8059, Feb. 10, 2014, as amended at 88 FR 17718, Mar. 24, 2023]","(a) A manufacturer shall promptly notify the Food and Drug Administration in accordance with paragraph (b) of this section when the manufacturer has knowledge (that is, actual knowledge that the manufacturer had, or the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care) that reasonably supports the conclusion that an infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer: (1) May not provide the nutrients required by section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) or by regulations issued under section 412(i)(2); or (2) May be otherwise adulterated or misbranded. (b) The notification made according to paragraph (a) of this section shall be made by telephone, to the Director of the appropriate Food and Drug Administration district office. After normal business hours (8 a.m. to 4:30 p.m.), the Food and Drug Administration's emergency number, 1-866-300-4374 shall be used. The manufacturer shall promptly send written confirmation of the notification to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement (HFS-605), Recall Coordinator, 5001 Campus Dr., College Park, MD 20740, and to the appropriate Food and Drug Administration district office." 21:21:2.0.1.1.6.7.1.7,21,Food and Drugs,I,B,106,"PART 106—INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS",G,"Subpart G—Registration, Submission, and Notification Requirements",,§ 106.160 Incorporation by reference.,FDA,,,,"(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, the Food and Drug Administration must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the Food and Drug Administration library at 10903 New Hampshire Ave., Building 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, and is available from the sources listed below. This material is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) 3-A Sanitary Standards, Inc., 6888 Elm St., Suite 2D, McLean, VA 22101-3829, 703-790-0295, and may be ordered online at http://www.3-a.org/ : (1) 3-A Sanitary Standards, No. 609-03: A Method of Producing Culinary Steam, adopted November 21, 2004, into § 106.20(h). (2) [Reserved] (c) American Society for Nutrition, 9650 Rockville Pike, Bethesda, MD 20814-3998, 301-634-7279, http://www.nutrition.org : (1) Physical growth: National Center for Health Statistics percentiles, Hamill, P.V.V., T.A. Drizd, C.L. Johnson, R.B. Reed, A.F. Roche, and W.M. Moore, American Journal of Clinical Nutrition, vol. 32, pp. 607-614, dated March 1979, into § 106.96(i)(1)(ii)(c). (2) [Reserved] (d) AOAC International, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, 301-924-7078: (1) Official Methods of Analysis of AOAC International, 16th ed., dated 1995, into § 106.96(i)(2)(ii): (i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency Ratio Rat Bioassay, and (ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency Ratio Calculation Method. (2) Official Methods of Analysis of AOAC International, 18th ed., dated 2005, into § 106.96(f): (i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency Ratio Rat Bioassay, and (ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency Ratio Calculation Method. (e) Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333, 1-800-232-4636, http://www.cdc.gov/growthcharts/who_charts.htm. (1) Birth to 24 months: Boys Head circumference-for-age and Weight-for-length percentiles, dated November 1, 2009, into § 106.96(b)(4). (2) Birth to 24 months: Boys Length-for-age and Weight-for-age percentiles, dated November 1, 2009, into § 106.96(b)(4). (3) Birth to 24 months: Girls Head circumference-for-age and Weight-for-length percentiles, dated November 1, 2009, into § 106.96(b)(4). (4) Birth to 24 months: Girls Length-for-age and Weight-for-age percentiles, dated November 1, 2009, into § 106.96(b)(4)." 28:28:2.0.1.1.45.0.31.1,28,Judicial Administration,I,,106,PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021,,,,§ 106.1 Authority.,DOJ,,,"[A.G. Order No. 5922-2024, 89 FR 28636, Apr. 19, 2024; 89 FR 36671, May 3, 2024]","(a) Under section 3 of the HAVANA Act of 2021, Public Law 117-46, 135 Stat. 391 (2021) (codified at 22 U.S.C. 2680b(i)), the Attorney General or other agency heads may provide a payment to a covered employee or covered dependent who experiences a qualifying injury to the brain on or after January 1, 2016. The authority to provide such payments is at the discretion of the Attorney General or the Attorney General's designees. (b) These regulations are issued in accordance with 22 U.S.C. 2680b(i)(4) and apply to covered employees (current and former employees) and covered dependents." 28:28:2.0.1.1.45.0.31.2,28,Judicial Administration,I,,106,PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021,,,,§ 106.2 Definitions.,DOJ,,,,"For purposes of this part, the following definitions apply: (a) Covered employee. (1) A current or former employee of the Department who, on or after January 1, 2016, became injured by reason of a qualifying injury while they were employed by the Department. (2) The following are considered covered employees for the purposes of this rule: Department of Justice employees as defined in 5 U.S.C. 2105, including employees on Limited Non-Career Appointments, employees on Temporary Appointments, personnel hired on Personal Services Contracts, and students providing volunteer services under 5 U.S.C. 3111. (3) The following are not considered employees of the Department for purposes of this rule: employees or retired employees who were employed by other agencies at the time of the injury. (b) Covered dependent. A family member, as defined in paragraph (c) of this section, of a current or former employee of the Department who, on or after January 1, 2016, became injured by reason of a qualifying injury while their relative was an employee of the Department in a position listed in paragraph (a)(2) of this section. (c) Family member. For purposes of determining who is a “covered dependent,” a family member is defined as follows: (1) Children who at the time of the injury are unmarried and under 21 years of age or, regardless of age, are unmarried and due to mental or physical limitations are incapable of self-support. The term “children” includes natural offspring; stepchildren; adopted children; those under permanent legal guardianship, or comparable permanent custody arrangement, of the employee, spouse, or domestic partner as defined in 5 CFR 875.101 when dependent upon and normally residing with the guardian or custodial party; and U.S. citizen children placed for adoption if a U.S. court grants temporary guardianship of the child to the employee and specifically authorizes the child to reside with the employee in the country of assignment before the adoption is finalized; (2) Parents (including stepparents and legally adoptive parents) of the employee or of the spouse or of the domestic partner as defined in 5 CFR 875.101, when normally residing with the employee at the time of the injury; (3) Sisters and brothers (including stepsisters or stepbrothers, or adoptive sisters or brothers) of the employee or the spouse when at the time of the injury such sisters and brothers are at least 51 percent dependent on the employee or spouse for support, unmarried and under 21 years of age, or, regardless of age, are physically or mentally incapable of self-support; and (4) Spouse or domestic partner at the time of the injury. (d) Qualifying injury to the brain. (1) An injury to the brain that occurred in connection with war, insurgency, hostile act, terrorist activity, or other incidents designated under 22 U.S.C. 2680b, and that was not the result of the willful misconduct of the covered employee or covered dependent. (2) The individual must have: (i) An acute injury to the brain such as a concussion, a penetrating injury, or an injury as the consequence of an event that leads to permanent alterations in brain function where such alterations are demonstrated by confirming correlative findings on imaging studies (including computed tomography scan (CT) or magnetic resonance imaging scan (MRI)), or electroencephalogram (EEG); (ii) A medical diagnosis of a traumatic brain injury that required active medical treatment for 12 months or more; or (iii) Acute onset of new, persistent, disabling neurologic symptoms, as demonstrated by confirming correlative findings on imaging studies (including CT or MRI), EEG, physical exam, or other appropriate testing, that required active medical treatment for 12 months or more. (e) Other incident. A new onset of physical manifestations that cannot otherwise be readily explained and that is designated under 22 U.S.C. 2680b." 28:28:2.0.1.1.45.0.31.3,28,Judicial Administration,I,,106,PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021,,,,§ 106.3 Eligibility for payments by the Department of Justice.,DOJ,,,,"(a) The Department may, in its discretion, provide a payment to an employee, covered dependent, or former employee if that person suffered a qualifying injury to the brain that was assessed and diagnosed in person by a physician who is currently a neurologist certified by the American Board of Psychology and Neurology (ABPN) or a physician certified by the American Osteopathic Board of Neurology and Psychiatry (AOBNP), the American Board of Physical Medicine and Rehabilitation (ABPMR), or the American Osteopathic Board of Physical Medicine and Rehabilitation (AOBPMR); occurred on or after January 1, 2016; and, for an employee or former employee, occurred while the employee or former employee was a covered employee of the Department or, for a covered dependent, occurred while the covered dependent's relative was an employee of the Department in a position listed in § 106.2(a)(2). (b) Payment for a qualifying injury to the brain will be a non-taxable, one-time lump sum payment, unless a second payment is authorized under paragraph (d) of this section. (c) The amount of the payment is at the Department's discretion. The Department will determine the amount paid to each eligible person based on the following factors: (1) The responses on the “Eligibility Questionnaire for HAVANA Act Payments” form; and (2) Whether the Department of Labor (Office of Workers' Compensation Programs) has determined that the applicant has no reemployment potential, or the Social Security Administration has approved the applicant for Social Security Disability Insurance or Supplemental Security Income benefits, or the applicant's ABPN-certified neurologist or the applicant's AOBNP-, ABPMR-, or AOBPMR-certified physician has certified that the individual requires a full-time caregiver for activities of daily living, as defined by the Katz Index of Independence in Activities of Daily Living. (d) The award thresholds are based on Level III of the Executive Schedule: Base will be 75 percent of Level III pay, and Base+ will be 100 percent of Level III pay. If the applicant meets any of the criteria listed in paragraph (c)(2) of this section, the applicant will be eligible to receive a Base+ payment. Applicants whose board-certified physician (as described in paragraph (a) of this section) confirms that the definition of “qualifying injury to the brain” has been met, but who have not met any of the criteria listed in paragraph (c)(2) of this section, will be eligible to receive a Base payment. If an applicant who received a Base payment later meets any of the criteria listed in paragraph (c)(2) of this section, the applicant may apply for an additional payment that will be the difference between the Base and Base+ payment." 28:28:2.0.1.1.45.0.31.4,28,Judicial Administration,I,,106,PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021,,,,§ 106.4 Consultation.,DOJ,,,,"When a covered employee or covered dependent seeks payment for an incident that occurred overseas under Chief of Mission security responsibility, the Department will coordinate with the Department of State as appropriate in evaluating whether the incident is an “other incident” under the HAVANA Act or should be so designated." 28:28:2.0.1.1.45.0.31.5,28,Judicial Administration,I,,106,PART 106—IMPLEMENTATION OF THE HAVANA ACT OF 2021,,,,§ 106.5 Procedures.,DOJ,,,,"(a) Application. (1) A covered employee or covered dependent may apply for a HAVANA Act payment if the covered individual has sustained a qualifying injury to the brain on or after January 1, 2016. To apply for the benefit, the applicant must submit the “Eligibility Questionnaire for HAVANA Act Payments” claim form to the appropriate email address or fax number set forth in this paragraph (a). The claim form must be completed by a person eligible to file a claim under the HAVANA Act or by that person's legal guardian and must be signed by a currently certified physician as listed in § 106.3(a) of this part. The claim form must be emailed or faxed to the following address: HRD_AHI_QUESTIONNAIR@FBI.GOV or fax number (202) 323-9420 (covered FBI employees and dependents) or HavanaActClaims@usdoj.gov or fax number (202) 616-3200 (covered DOJ employees and dependents). (2) The applicant must furnish additional documentation upon request. (3) Copies of the claim form, as well as the regulations and other information, may be obtained by requesting the document or publications via an email to HRD_AHI_QUESTIONNAIR@FBI.GOV (covered FBI employees and dependents) or HavanaActClaims@usdoj.gov (covered DOJ employees and dependents). (b) Review. For FBI covered employees and dependents, the Human Resources Division (HRD) of the FBI is responsible for reviewing the applications to determine their completeness. For other DOJ covered employees and dependents, the Justice Management Division (JMD) is responsible for reviewing the applications to determine their completeness. (c) Other incident. The Department will determine whether a covered employee or covered dependent has a qualifying injury to the brain as set forth in § 106.2, and whether the incident causing the injury was in connection with war, insurgency, hostile act, or terrorist activity. The Department will as appropriate or necessary make a recommendation to the Secretary of State that the incident should be deemed an “other incident designated by the Secretary of State” for purposes of 22 U.S.C. 2680b(i)(1)(D) (cross-referencing subparagraph 2680b(e)(4)); or, for incidents affecting employees or dependents who are not under the security responsibility of the Secretary of State, the Department will as appropriate or necessary designate such incidents, under authority set forth in 22 U.S.C. 2680b(j). (d) Decisions. For FBI covered employees and covered dependents, the Executive Assistant Director, Human Resources Branch, FBI, in their discretion may approve payments under the HAVANA Act. For all other Departmental covered employees and covered dependents, the Deputy Assistant Attorney General, Human Resources and Administration, JMD, in their discretion may approve payments under the HAVANA Act. (e) Appeals. In the event of a decision to deny an application for payment under the HAVANA Act, the Department will notify the applicant in writing. Applicants may direct an appeal to the Assistant Attorney General for Administration within 60 days of the date of the notification of the denial. However, decisions concerning the amount paid are not subject to appeal. The Department will notify the applicant in writing of the decision on appeal." 33:33:1.0.1.8.55.1.26.1,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.100 Definitions.,USCG,,,,"Except as specifically stated in this subpart, the definitions in part 101 of this subchapter apply to this part." 33:33:1.0.1.8.55.1.26.10,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.145 Right to appeal.,USCG,,,,"Any person directly affected by a decision or action taken under this part, by or on behalf of the Coast Guard, may appeal as described in § 101.420 of this subchapter." 33:33:1.0.1.8.55.1.26.2,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.105 Applicability.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended by USCG-2006-24196, 72 FR 55048, Sept. 28, 2007]","(a) The requirements in this part apply to owners and operators of any fixed or floating facility, including MODUs not subject to part 104 of this subchapter, operating on the Outer Continental Shelf (OCS) of the United States for the purposes of engaging in the exploration, development, or production of oil, natural gas, or mineral resources that are regulated by 33 CFR subchapter N, that meet the following operating conditions: (1) Hosts more than 150 persons for 12 hours or more in each 24-hour period continuously for 30 days or more; (2) Produces greater than 100,000 barrels of oil per day; or (3) Produces greater than 200 million cubic feet of natural gas per day. (b) The TWIC requirements found in this part do not apply to mariners employed aboard vessels moored at U.S. OCS facilities only when they are working immediately adjacent to their vessels in the conduct of vessel activities." 33:33:1.0.1.8.55.1.26.3,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.110 Compliance dates.,USCG,,,"[USCG-2007-28915, 81 FR 57713, Aug. 23, 2016]","(a) OCS facility owners or operators must submit to the cognizant District Commander for each OCS facility— (1) The Facility Security Plan described in subpart D of this part for review and approval; or (2) If intending to operate under an approved Alternative Security Program, a letter signed by the OCS facility owner or operator stating which approved Alternative Security Program the owner or operator intends to use. (b) OCS facilities built on or after July 1, 2004 must submit a Facility Security Plan for approval 60 days prior to beginning operations." 33:33:1.0.1.8.55.1.26.4,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.115 Compliance documentation.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2007-28915, 81 FR 57713, Aug. 23, 2016]","Each OCS facility owner or operator subject to this part must ensure that copies of the following documentation are available at the OCS facility and are made available to the Coast Guard upon request: (a) The approved Facility Security Plan (FSP) and any approved revisions or amendments thereto, and a letter of approval from the cognizant District Commander dated within the last 5 years; (b) The FSP submitted for approval and current written acknowledgment from the cognizant District Commander, stating that the Coast Guard is currently reviewing the FSP submitted for approval and that the OCS facility may continue to operate so long as the OCS facility remains in compliance with the submitted FSP; or (c) For OCS facilities operating under a Coast Guard-approved Alternative Security Program as provided in § 106.135, a copy of the Alternative Security Program the OCS facility is using, including a facility specific security assessment report generated under the Alternative Security Program, as specified in § 101.120(b)(3) of this subchapter, and a letter signed by the OCS facility owner or operator, stating which Alternative Security Program the OCS facility is using and certifying that the OCS facility is in full compliance with that program." 33:33:1.0.1.8.55.1.26.5,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.120 Noncompliance.,USCG,,,"[USCG-2003-14759, 68 FR 60558, Oct. 22, 2003]","When an OCS facility must temporarily deviate from the requirements of this part, the OCS facility owner or operator must notify the cognizant District Commander, and either suspend operations or request and receive permission from the District Commander to continue operating." 33:33:1.0.1.8.55.1.26.6,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.125 Waivers.,USCG,,,,"Any OCS facility owner or operator may apply for a waiver of any requirement of this part that the OCS facility owner or operator considers unnecessary in light of the nature or operating conditions of the OCS facility. A request for a waiver must be submitted in writing with justification to the cognizant District Commander. The cognizant District Commander may require the OCS facility owner or operator to provide additional data for use in determining the validity of the requested waiver. The cognizant District Commander may grant a waiver, in writing, with or without conditions only if the waiver will not reduce the overall security of the OCS facility, its personnel, or visiting vessels." 33:33:1.0.1.8.55.1.26.7,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.130 Equivalents.,USCG,,,,"For any measure required by this part, the OCS facility owner or operator may propose an equivalent, as provided in § 101.130 of this subchapter." 33:33:1.0.1.8.55.1.26.8,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.135 Alternative Security Program.,USCG,,,,"An OCS facility owner or operator may use an Alternative Security Program approved under § 101.120 of this subchapter if: (a) The Alternative Security Program is appropriate to that OCS facility; (b) The OCS facility does not serve vessels on international voyages; and (c) The Alternative Security Program is implemented in its entirety." 33:33:1.0.1.8.55.1.26.9,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,A,Subpart A—General,,§ 106.140 Maritime Security (MARSEC) Directive.,USCG,,,,All OCS facility owners or operators subject to this part must comply with any instructions contained in a MARSEC Directive issued under § 101.405 of this subchapter. 33:33:1.0.1.8.55.2.26.1,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.200 Owner or operator.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2006-24196, 72 FR 3585, Jan. 25, 2007; USCG-2007-28915, 81 FR 57713, Aug. 23, 2016]","(a) Each OCS facility owner or operator must ensure that the OCS facility operates in compliance with the requirements of this part. (b) For each OCS facility, the OCS facility owner or operator must: (1) Define the security organizational structure for each OCS facility and provide each person exercising security duties or responsibilities within that structure the support needed to fulfill those obligations; (2) Designate in writing, by name or title, a Company Security Officer (CSO) and a Facility Security Officer (FSO) for each OCS facility and identify how those officers can be contacted at any time; (3) Ensure that a Facility Security Assessment (FSA) is conducted; (4) Ensure the development and submission for approval of a Facility Security Plan (FSP); (5) Ensure that the OCS facility operates in compliance with the approved FSP; (6) Ensure that the TWIC Program is properly implemented as set forth in this subchapter, including: (i) Ensuring that only individuals who hold a TWIC and are authorized to be in the secure area are permitted to escort; and (ii) Identifying what action is to be taken by an escort, or other authorized individual, should individuals under escort engage in activities other than those for which escorted access was granted. (7) Ensure that adequate coordination of security issues takes place between OCS facilities and vessels, including the execution of a Declaration of Security (DoS) as required by this part; (8) Ensure, within 12 hours of notification of an increase in MARSEC level, implementation of the additional security measures required by the FSP for the new MARSEC level; (9) Ensure all breaches of security and security incidents are reported in accordance with the requirements in part 101 of this subchapter; (10) Ensure consistency between security requirements and safety requirements; (11) Inform OCS facility personnel of their responsibility to apply for and maintain a TWIC, including the deadlines and methods for such applications, and of their obligation to inform TSA of any event that would render them ineligible for a TWIC, or which would invalidate their existing TWIC; (12) Ensure that protocols consistent with § 101.550 of this subchapter, for dealing with individuals requiring access who report a lost, damaged, or stolen TWIC, or who have applied for and not yet received a TWIC, are in place; and (13) If applicable, ensure that protocols consistent with § 106.262 of this part, for dealing with newly hired employees who have applied for and not yet received a TWIC, are in place." 33:33:1.0.1.8.55.2.26.10,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.245 Procedures for interfacing with vessels.,USCG,,,,The OCS facility owner or operator must ensure that there are measures for interfacing with vessels at all MARSEC Levels. 33:33:1.0.1.8.55.2.26.11,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.250 Declaration of Security (DoS).,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended at 68 FR 60558, Oct. 22, 2003]","(a) Each OCS facility owner or operator must ensure procedures are established for requesting a DoS and for handling DoS requests from vessels. (b) At MARSEC Level 1, owners or operators of OCS facilities interfacing with a manned vessel carrying Certain Dangerous Cargoes, in bulk, must: (1) Prior to the arrival of a vessel to the OCS facility, ensure the Facility Security Officer (FSO) and Master, Vessel Security Officer (VSO), or their designated representatives coordinate security needs and procedures, and agree upon the contents of a DoS for the period of time the vessel is at the OCS facility; and (2) Upon the arrival of the vessel at the OCS facility, the FSO and Master, VSO, or their designated representatives, must sign the written DoS. (c) Neither the OCS facility nor the vessel may embark or disembark personnel, or transfer stores or industrial supplies until the DoS has been signed. (d) At MARSEC Levels 2 and 3, the FSOs of OCS facilities interfacing with manned vessels subject to part 104 of this chapter, or their designated representatives, must sign and implement DoSs as required in paragraphs (b)(1) and (b)(2) of this section. (e) At MARSEC Levels 1 and 2, FSOs of OCS facilities that frequently interface with the same vessel may implement a continuing DoS for multiple visits, provided that: (1) The DoS is valid for a specific MARSEC Level; (2) The effective period at MARSEC Level 1 does not exceed 90 days; and (3) The effective period at MARSEC Level 2 does not exceed 30 days. (f) When the MARSEC Level increases beyond that contained in the DoS, the continuing DoS is void and a new DoS must be executed in accordance with this section." 33:33:1.0.1.8.55.2.26.12,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.255 Security systems and equipment maintenance.,USCG,,,,"(a) Security systems and equipment must be in good working order and inspected, tested, calibrated, and maintained according to manufacturers' recommendations. (b) Security systems must be regularly tested in accordance with the manufacturers' recommendations; noted deficiencies corrected promptly; and the results recorded as required in § 106.230(b)(5) of this part. (c) The Facility Security Plan (FSP) must include procedures for identifying and responding to security system and equipment failures or malfunctions." 33:33:1.0.1.8.55.2.26.13,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.258 Risk Group classification for OCS facilities.,USCG,,,"[USCG-2007-28915, 81 FR 57713, Aug. 23, 2016]","For the purposes of this subchapter, no OCS facilities are considered Risk Group A." 33:33:1.0.1.8.55.2.26.14,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.260 Security measures for access control.,USCG,,,"[USCG-2006-24196, 72 FR 3586, Jan. 25, 2007, as amended by USCG-2007-28915, 81 FR 57713, Aug. 23, 2016]","(a) General. The OCS facility owner or operator must ensure the implementation of security measures to: (1) Deter the unauthorized introduction of dangerous substances and devices, including any device intended to damage or destroy persons, vessels, or the OCS facility; (2) Secure dangerous substances and devices that are authorized by the OCS facility owner or operator to be on board; (3) Control access to the OCS facility; and (4) Prevent an unescorted individual from entering the OCS facility unless the individual holds a duly issued TWIC and is authorized to be on the OCS facility. (b) The OCS facility owner or operator must ensure that the following are specified: (1) All locations providing means of access to the OCS facility where access restrictions or prohibitions are applied for each security level to prevent unauthorized access, including those points where TWIC access control procedures will be applied; (2) The identification of the types of restriction or prohibition to be applied and the means of enforcing them; (3) The means used to establish the identity of individuals not in possession of a TWIC and the means by which they will be allowed access to the OCS facility; and (4) Procedures for identifying authorized and unauthorized persons at any MARSEC level. (c) The OCS facility owner or operator must establish in the approved Facility Security Plan (FSP) the frequency of application of any access controls, particularly if they are to be applied on a random or occasional basis. (d) MARSEC Level 1. The OCS facility owner or operator must ensure the following security measures are implemented at the facility: (1) Implement TWIC as set out in subpart E of part 101 of this subchapter and in accordance with the OCS facility's assigned Risk Group, as set out in § 106.258. (2) Screen persons and personal effects going aboard the OCS facility for dangerous substances and devices at the rate specified in the approved FSP; (3) Conspicuously post signs that describe security measures currently in effect and clearly stating that: (i) Boarding an OCS facility is deemed valid consent to screening or inspection; and (ii) Failure to consent or submit to screening or inspection will result in denial or revocation of authorization to be on board; (4) Check the identification of any person seeking to board the OCS facility, including OCS facility employees, passengers and crews of vessels interfacing with the OCS facility, vendors, and visitors and ensure that non-TWIC holders are denied unescorted access to the OCS facility; (5) Deny or revoke a person's authorization to be on board if the person is unable or unwilling, upon the request of OCS facility personnel or a law enforcement officer, to establish his or her identity in accordance with this part or to account for his or her presence on board. Any such incident must be reported in compliance with this part; (6) Deter unauthorized access to the OCS facility; (7) Identify access points that must be secured or attended to deter unauthorized access; (8) Lock or otherwise prevent access to unattended spaces that adjoin areas to which OCS facility personnel and visitors have access; (9) Ensure OCS facility personnel are not required to engage in or be subjected to screening, of the person or of personal effects, by other OCS facility personnel, unless security clearly requires it; (10) Provide a designated secure area on board, or in liaison with a vessel interfacing with the OCS facility, for conducting inspections and screening of people and their personal effects; and (11) Respond to the presence of unauthorized persons on board. (e) MARSEC Level 2. In addition to the security measures required for MARSEC Level 1 in this section, at MARSEC Level 2, the OCS facility owner or operator must ensure the implementation of additional security measures, as specified for MARSEC Level 2 in the approved FSP. These additional security measures may include: (1) Increasing the frequency and detail of screening of people and personal effects embarking onto the OCS facility as specified for MARSEC Level 2 in the approved FSP; (2) Assigning additional personnel to patrol deck areas during periods of reduced OCS facility operations to deter unauthorized access; (3) Limiting the number of access points to the OCS facility by closing and securing some access points; (4) Deterring waterside access to the OCS facility, which may include, providing boat patrols; or (5) Implementing additional electronic TWIC inspection requirements, as required by § 106.258, and by subpart E of part 101 of this subchapter. (f) MARSEC Level 3. In addition to the security measures required for MARSEC Level 1 and MARSEC Level 2, at MARSEC level 3, the facility owner or operator must ensure the implementation of additional security measures, as specified for MARSEC Level 3 in their approved FSP. The additional security measures may include: (1) Screening all persons and personal effects for dangerous substances and devices; (2) Being prepared to cooperate with responders; (3) Limiting access to the OCS facility to a single, controlled access point; (4) Granting access to only those responding to the security incident or threat thereof; (5) Suspending embarkation and/or disembarkation of personnel; (6) Suspending the loading of stores or industrial supplies; (7) Evacuating the OCS facility; (8) Preparing for a full or partial search of the OCS facility; or (9) Implementing additional electronic TWIC inspection requirements, as required by § 106.258, and by subpart E of part 101 of this subchapter." 33:33:1.0.1.8.55.2.26.15,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.262 Security measures for newly-hired employees.,USCG,,,"[USCG-2006-24196, 72 FR 3587, Jan. 25, 2007, as amended by USCG-2007-28915, 81 FR 57713, Aug. 23, 2016; USCG-2022-0323, 88 FR 10029, Feb. 16, 2023]","(a) Newly-hired OCS facility employees may be granted entry to secure areas of the OCS facility for up to 30 consecutive calendar days prior to receiving their TWIC provided all of the requirements in paragraph (b) of this section are met, and provided that the new hire is accompanied by an individual with a TWIC while within the secure areas of the OCS facility. If TSA does not act upon a TWIC application within 30 days, the cognizant Coast Guard COTP may further extend access to secure areas for another 30 days. The Coast Guard will determine whether, in particular circumstances, certain practices meet the condition of a new hire being accompanied by another individual with a TWIC. (b) Newly-hired OCS facility employees may be granted the access provided for in paragraph (a) of this section if: (1) The new hire has applied for a TWIC in accordance with 49 CFR part 1572 by completing the full enrollment process, paying the user fee, and is not currently engaged in a waiver or appeal process. The OCS facility owner or operator or Facility Security Officer (FSO) must have th enew hire sign a statement affirming this, and must retain the signed statement until the new hire receives a TWIC; (2) The OCS facility owner or operator or the FSO enters the following information on the new hire into the Coast Guard's Homeport Web site ( https://homeport.uscg.mil ): (i) Full legal name, including middle name if one exists; (ii) Date of birth; (iii) Social security number (optional); (iv) Employer name and 24 hour contact information; and (v) Date of TWIC enrollment. (3) The new hire presents an identification credential that meets the requirements of § 101.515 of this subchapter; (4) There are no other circumstances that would cause reasonable suspicion regarding the new hire's ability to obtain a TWIC, and the OCS facility owner or operator or FSO have not been informed by the cognizant COTP that the individual poses a security threat; and (5) There would be an adverse impact to OCS facility operations if the new hire is not allowed access. (c) This section does not apply to any individual being hired as a Company Security Officer or FSO, or any individual being hired to perform OCS facility security duties. (d) The new hire may not begin working at the OCS facility under the provisions of this section until the owner, operator, or FSO receives notification, via Homeport or some other means, the new hire has passed an initial name check." 33:33:1.0.1.8.55.2.26.16,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.265 Security measures for restricted areas.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003]","(a) General. The OCS facility owner or operator must ensure the designation of restricted areas in order to: (1) Prevent or deter unauthorized access; (2) Protect persons authorized to be in the OCS facility; (3) Protect the OCS facility; (4) Protect vessels using and serving the OCS facility; (5) Protect sensitive security areas within the OCS facility; (6) Protect security and surveillance equipment and systems; and (7) Protect stores and industrial supplies from tampering. (b) Designation of restricted areas. The OCS facility owner or operator must ensure restricted areas are designated within the OCS facility. They must also ensure that all restricted areas are clearly marked and indicate that access to the area is restricted and that unauthorized presence within the area constitutes a breach of security. The OCS facility owner or operator may designate the entire OCS facility as a restricted area. Restricted areas must include, as appropriate: (1) Areas containing sensitive security information; (2) Areas containing security and surveillance equipment and systems and their controls, and lighting system controls; and (3) Areas containing critical OCS facility infrastructure equipment, including: (i) Water supplies; (ii) Telecommunications; (iii) Power distribution system; (iv) Access points for ventilation and air-conditioning systems; (v) Manufacturing areas and control rooms; (vi) Areas designated for loading, unloading or storage of stores and industrial supplies; and (vii) Areas containing hazardous materials. (c) The OCS facility owner or operator must ensure that the Facility Security Plan (FSP) includes measures for restricted areas to: (1) Identify which OCS facility personnel are authorized to have access; (2) Determine which persons other than OCS facility personnel are authorized to have access; (3) Determine the conditions under which that access may take place; (4) Define the extent of any restricted area; and (5) Define the times when access restrictions apply. (d) MARSEC Level 1. At MARSEC Level 1, the OCS facility owner or operator must ensure the implementation of security measures to prevent unauthorized access or activities within the area. These security measures may include: (1) Restricting access to only authorized personnel; (2) Securing all access points not actively used and providing physical barriers to impede movement through the remaining access points; (3) Verifying the identification and authorization of all persons seeking entry; (4) Using security personnel, automatic intrusion detection devices, surveillance equipment, or surveillance systems to detect unauthorized entry to or movement within restricted areas; or (5) Designating temporary restricted areas to accommodate OCS facility operations. If temporary restricted areas are designated, the FSP must include security requirements to conduct a security sweep of the designated temporary restricted areas both before and after the area has been established. (e) MARSEC Level 2. In addition to the security measures required for MARSEC Level 1 in this section, at MARSEC Level 2, the OCS facility owner or operator must also ensure the implementation of additional security measures, as specified for MARSEC Level 2 in their approved FSP. These additional security measures may include: (1) Enhancing the effectiveness of the barriers surrounding restricted areas, for example, by the use of patrols or automatic intrusion detection devices; (2) Reducing the number of access points to restricted areas, and enhancing the controls applied at the remaining accesses; (3) Further restricting access to the restricted areas and movements and storage within them; (4) Using continuously monitored and recorded surveillance equipment; (5) Increasing the number and frequency of patrols, including the use of waterborne patrols; or (6) Restricting access to areas adjacent to the restricted areas. (f) MARSEC Level 3. In addition to the security measures required for MARSEC Level 1 and MARSEC Level 2, at MARSEC Level 3, the OCS facility owner or operator must ensure the implementation of additional security measures, as specified for MARSEC Level 3 in their approved FSP. These additional security measures may include: (1) Restricting access to additional areas; (2) Prohibiting access to restricted areas; or (3) Searching restricted areas as part of a security sweep of all or part of the OCS facility." 33:33:1.0.1.8.55.2.26.17,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.270 Security measures for delivery of stores and industrial supplies.,USCG,,,,"(a) General. The OCS facility owner or operator must ensure that security measures relating to the delivery of stores or industrial supplies to the OCS facility are implemented to: (1) Check stores or industrial supplies for package integrity; (2) Prevent stores or industrial supplies from being accepted without inspection; (3) Deter tampering; and (4) Prevent stores and industrial supplies from being accepted unless ordered. For any vessels that routinely use an OCS facility, an OCS facility owner or operator may establish and implement standing arrangements between the OCS facility, its suppliers, and any vessel delivering stores or industrial supplies regarding notification and the timing of deliveries and their documentation. (b) MARSEC Level 1. At MARSEC Level 1, the OCS facility owner or operator must ensure the implementation of measures to: (1) Inspect stores or industrial supplies before being accepted; and (2) Check that stores or industrial supplies match the order prior to being brought on board. (c) MARSEC Level 2. In addition to the security measures required for MARSEC Level 1 in this section, at MARSEC Level 2, the OCS facility owner or operator must also ensure the implementation of additional security measures, as specified for MARSEC Level 2 in the approved Facility Security Plan (FSP). These additional security measures may include: (1) Intensifying inspection of the stores or industrial supplies during delivery; or (2) Checking stores or industrial supplies prior to receiving them on board. (d) MARSEC Level 3. In addition to the security measures for MARSEC Level 1 and MARSEC Level 2, at MARSEC Level 3, the OCS facility owner or operator must ensure the implementation of additional security measures, as specified for MARSEC Level 3 in the approved FSP. These additional security measures may include: (1) Checking all OCS facility stores or industrial supplies more extensively; (2) Restricting or suspending delivery of stores or industrial supplies; or (3) Refusing to accept stores or industrial supplies on board." 33:33:1.0.1.8.55.2.26.18,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.275 Security measures for monitoring.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended at 68 FR 60558, Oct. 22, 2003]","(a) General. (1) The OCS facility owner or operator must ensure the implementation of security measures in this section and have the capability to continuously monitor, through a combination of lighting, watchkeepers, security guards, deck watches, waterborne patrols, automatic intrusion-detection devices, or surveillance equipment as specified in their approved Facility Security Plan (FSP), the: (i) OCS facility; (ii) Restricted areas on board the OCS facility; and (iii) The area surrounding the OCS facility. (2) The following must be considered when establishing the appropriate level and location of lighting: (i) OCS facility personnel should be able to detect activities on and around OCS facilities; (ii) Coverage should facilitate personnel identification at access points; and (iii) Lighting effects, such as glare, and their impact on safety, navigation, and other security activities. (b) MARSEC Level 1. At MARSEC Level 1, the OCS facility owner or operator must ensure the implementation of security measures, which may be implemented in coordination with a vessel interfacing with the OCS facility, to: (1) Monitor the OCS facility, particularly OCS facility access points and restricted areas; (2) Be able to conduct emergency searches of the OCS facility; (3) Ensure that equipment or system failures or malfunctions are identified and corrected; (4) Ensure that any automatic intrusion detection device, sets off an audible or visual alarm, or both, at a location that is continuously attended or monitored; and (5) Light deck and OCS facility access points during the period between sunset and sunrise and periods of limited visibility sufficiently to allow visual identification of persons seeking access to the OCS facility. (c) MARSEC Level 2. In addition to the security measures required for MARSEC Level 1 in this section, at MARSEC Level 2, the OCS facility owner or operator must also ensure the implementation of additional security measures, as specified for MARSEC Level 2 in the approved FSP. These additional security measures may include: (1) Increasing the frequency and detail of security patrols; (2) Using (if not already in use) or increasing the use of security and surveillance equipment; (3) Assigning additional personnel as security lookouts; or (4) Coordinating with boat patrols, when provided. (d) MARSEC Level 3. In addition to the security measures for MARSEC Level 1 and MARSEC Level 2, at MARSEC Level 3, the OCS facility owner or operator must ensure the implementation of additional security measures, as specified for MARSEC Level 3 in the approved FSP. These additional security measures may include: (1) Cooperating with responders; (2) Switching on all lights; (3) Switching on all surveillance equipment capable of recording activities on, or in the vicinity of, the OCS facility; (4) Maximizing the length of time such surveillance equipment (if not already in use) can continue to record; or (5) Preparing for underwater inspection of the OCS facility." 33:33:1.0.1.8.55.2.26.19,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.280 Security incident procedures.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003]","For each MARSEC Level, the OCS facility owner or operator must ensure the Facility Security Officer (FSO) and OCS facility security personnel are able to: (a) Respond to security threats or breaches of security and maintain critical OCS facility and OCS facility-to-vessel interface operations; (b) Deny access to the OCS facility, except to those responding to an emergency; (c) Evacuate the OCS facility in case of security threats or breaches of security; and (d) Report security incidents as required in § 101.305 of this subchapter; (e) Brief all OCS facility personnel on possible threats and the need for vigilance, soliciting their assistance in reporting suspicious persons, objects, or activities; and (f) Secure non-critical operations in order to focus response on critical operations." 33:33:1.0.1.8.55.2.26.2,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.205 Company Security Officer (CSO).,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2006-24196, 72 FR 3585, Jan. 25, 2007]","(a) General. (1) An OCS facility owner or operator may designate a single CSO for all its OCS facilities to which this part applies, or may designate more than one CSO, in which case the owner or operator must clearly identify the OCS facilities for which each CSO is responsible. (2) A CSO may perform other duties within the owner's or operator's organization, including the duties of a Facility Security Officer, provided he or she is able to perform the duties and responsibilities required of the CSO. (3) The CSO may delegate duties required by this part, but remains responsible for the performance of those duties. (4) The CSO must maintain a TWIC. (b) Qualifications. The CSO must have general knowledge, through training or equivalent job experience, in the following: (1) Security administration and organization of the OCS facility; (2) OCS facility and vessel operations and conditions; (3) OCS facility and vessel security measures including the meaning and consequential requirements of the different MARSEC Levels; (4) Emergency preparedness and response and contingency planning; (5) Security equipment and systems and their operational limitations; (6) Methods of conducting audits, inspection, control, and monitoring; and (7) Techniques for security training and education, including security measures and procedures. (c) In addition to the knowledge and training in paragraph (b) of this section, the CSO must have general knowledge, through training or equivalent job experience, in the following, as appropriate: (1) Relevant international conventions, codes, and recommendations; (2) Relevant government legislation and regulations; (3) Responsibilities and functions of other security organizations; (4) Methodology of Facility Security Assessment. (5) Methods of OCS facility security surveys and inspections; (6) Handling sensitive security information (SSI) and security related communications; (7) Knowledge of current security threats and patterns; (8) Recognition and detection of dangerous substances and devices; (9) Recognition of characteristics and behavioral patterns of persons who are likely to threaten security; (10) Techniques used to circumvent security measures; (11) Methods of physical screening and non-intrusive inspections; and (12) Conducting and assessing security drills and exercises. (13) Knowledge of TWIC requirements. (d) Responsibilities. In addition to any other duties required by this part, for each OCS facility for which the CSO is responsible, the CSO must: (1) Keep the OCS facility apprised of potential threats or other information relevant to its security; (2) Ensure that a Facility Security Assessment (FSA) is carried out in compliance with this part; (3) Ensure that a Facility Security Plan (FSP) is developed, approved, maintained, and implemented in compliance with this part; (4) Ensure that the FSP is modified when necessary to comply with this part; (5) Ensure that OCS facility security activities are audited in compliance with this part; (6) Ensure the timely correction of problems identified by audits or inspections; (7) Enhance security awareness and vigilance within the owner's or operator's organization; (8) Ensure relevant personnel receive adequate security training in compliance with this part; (9) Ensure communication and cooperation between the OCS facility and vessels that interface with it, in compliance with this part; (10) Ensure consistency between security requirements and safety requirements in compliance with this part; (11) Ensure that if a common FSP is prepared for more than one similar OCS facility, the FSP reflects any OCS facility specific characteristics; and (12) Ensure compliance with an Alternative Security Program or equivalents approved under this subchapter, if appropriate. (13) Ensure the TWIC program is being properly implemented." 33:33:1.0.1.8.55.2.26.3,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.210 OCS Facility Security Officer (FSO).,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended by USCG-2006-24196, 72 FR 3585, Jan. 25, 2007]","(a) General. (1) The FSO may perform other duties within the owner's or operator's organization, provided he or she is able to perform the duties and responsibilities required of the FSO of each such OCS facility. (2) The same person may serve as the FSO for more than one OCS facility, provided the facilities are within a reasonable proximity to each other. If a person serves as the FSO for more than one OCS facility, the name of each OCS facility for which he or she is the FSO must be listed in the Facility Security Plan (FSP) of each OCS facility for which he or she is the FSO. (3) The FSO may assign security duties to other OCS facility personnel; however, the FSO remains responsible for these duties. (4) The FSO must maintain a TWIC. (b) Qualifications. The FSO must have general knowledge, through training or equivalent job experience, in the following: (1) Those items listed in § 106.205(b), and as appropriate § 106.205(c), of this part; (2) OCS facility layout; (3) The FSP and related procedures; and (4) Operation, testing and maintenance of security equipment and systems. (c) Responsibilities. In addition to any other responsibilities specified elsewhere in this part, the FSO must, for each OCS facility for which he or she has been designated: (1) Regularly inspect the OCS facility to ensure that security measures are maintained in compliance with this part; (2) Ensure the maintenance of and supervision of the implementation of the FSP, and any amendments to the FSP, in compliance with this part; (3) Ensure the coordination and handling of stores and industrial supplies in compliance with this part; (4) Where applicable, propose modifications to the FSP to the Company Security Officer (CSO); (5) Ensure that any problems identified during audits or inspections are reported to the CSO, and promptly implement any corrective actions; (6) Ensure security awareness and vigilance on board the OCS facility; (7) Ensure adequate security training for OCS facility personnel in compliance with this part; (8) Ensure the reporting and recording of all security incidents in compliance with this part; (9) Ensure the coordinated implementation of the FSP with the CSO; (10) Ensure that security equipment is properly operated, tested, calibrated and maintained in compliance with this part; (11) Ensure consistency between security requirements and the proper treatment of OCS facility personnel affected by those requirements; (12) Ensure that occurrences that threaten the security of the OCS facility are recorded and reported to the CSO; (13) Ensure that when changes in the MARSEC Level are attained they are recorded and reported to the CSO, OCS facility owner or operator, and the cognizant District Commander; and (14) Have prompt access to a copy of the FSA, along with an approved copy of the FSP. (15) Ensure the TWIC program is properly implemented." 33:33:1.0.1.8.55.2.26.4,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.215 Company or OCS facility personnel with security duties.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended by USCG-2006-24196, 72 FR 3586, Jan. 25, 2007]","Company and OCS facility personnel responsible for security duties must maintain a TWIC, and must have knowledge, through training or equivalent job experience, in the following, as appropriate: (a) Knowledge of current and anticipated security threats and patterns. (b) Recognition and detection of dangerous substances and devices; (c) Recognition of characteristics and behavioral patterns of persons who are likely to threaten security; (d) Recognition of techniques used to circumvent security measures; (e) Security related communications; (f) Knowledge of emergency procedures and contingency plans; (g) Operation of security equipment and systems; (h) Testing, calibration, and maintenance of security equipment and systems; (i) Inspection, control, and monitoring techniques; (j) Methods of physical screenings of persons, personal effects, stores and industrial supplies; (k) Familiarity with all relevant aspects of the TWIC program and how to carry them out; (l) Relevant provisions of the Facility Security Plan (FSP); and (m) The meaning and the consequential requirements of the different MARSEC Levels." 33:33:1.0.1.8.55.2.26.5,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.220 Security training for all other OCS facility personnel.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2006-24196, 72 FR 3586, Jan. 25, 2007]","All other OCS facility personnel, including contractors, whether part-time, full-time, temporary, or permanent, must have knowledge, through training or equivalent job experience, of the following, as appropriate: (a) Relevant provisions of the Facility Security Plan (FSP); (b) The meaning and the consequential requirements of the different MARSEC Levels including emergency procedures and contingency plans; (c) Recognition and detection of dangerous substances and devices; (d) Recognition of characteristics and behavioral patterns of persons who are likely to threaten security; and (e) Recognition of techniques used to circumvent security measures. (f) Familiarity with all relevant aspects of the TWIC program and how to carry them out." 33:33:1.0.1.8.55.2.26.6,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.225 Drill and exercise requirements.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003]","(a) General. (1) Drills and exercises must test the proficiency of facility personnel in assigned security duties at all MARSEC Levels and the effective implementation of the Facility Security Plan (FSP). They must enable the Facility Security Officer (FSO) to identify any related security deficiencies that need to be addressed. (2) A drill or exercise required by this section may be satisfied with the implementation of security measures required by the FSP as the result of an increase in the MARSEC Level, provided the FSO reports attainment to the cognizant District Commander. (b) Drills. (1) From the date of the FSP approval, the FSO must ensure that at least one security drill is conducted every 3 months. Security drills may be held in conjunction with non-security drills, where appropriate. (2) Drills must test individual elements of the FSP, including response to security threats and incidents. Drills should take into account the types of operations of the OCS facility, OCS facility personnel changes, the types of vessels calling at the OCS facility, and other relevant circumstances. Examples of drills include unauthorized entry to a restricted area, response to alarms, and notification of appropriate authorities. (3) If a vessel is conducting operations with the OCS facility on the date the OCS facility has planned to conduct any drills, the OCS facility may include, but cannot require, the vessel or vessel personnel to participate in the OCS facility's scheduled drill. (c) Exercises. (1) From the date of the FSP approval, exercises must be conducted at least once each calendar year, with no more than 18 months between exercises. (2) Exercises may be: (i) Full scale or live; (ii) Tabletop simulation; (iii) Combined with other appropriate exercises held; or (iv) A combination of the elements in paragraphs (c)(2)(i) through (iii) of this section. (3) Exercises may be facility-specific or part of a cooperative exercise program. (4) Each exercise must test communication and notification procedures, and elements of coordination, resource availability, and response. (5) Exercises are a full test of the Facility Security Plan and must include substantial and active participation of relevant company and OCS facility personnel, and may include governmental authorities and vessels depending on the scope and the nature of the exercise." 33:33:1.0.1.8.55.2.26.7,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.230 OCS facility recordkeeping requirements.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003]","(a) Unless otherwise specified in this section, the Facility Security Officer (FSO) must keep records of the activities as set out in paragraph (b) of this section for at least 2 years and make them available to the Coast Guard upon request. (b) Records required by this section may be kept in electronic format. If kept in an electronic format, they must be protected against unauthorized access, deletion, destruction, amendment, and disclosure. The following records must be kept: (1) Training. For training under § 106.215, the date of each session, duration of session, a description of the training, and a list of attendees; (2) Drills and exercises. For each drill or exercise, the date held, a description of the drill or exercise, a list of participants, and any best practices or lessons learned which may improve the FSP; (3) Incidents and breaches of security. Date and time of occurrence, location within the OCS facility, a description of the incident or breach, the identity of the individual to whom it was reported, and a description of the response; (4) Changes in MARSEC Levels. Date and time of the notification received, and the time of compliance with additional requirements; (5) Maintenance, calibration, and testing of security equipment. For each occurrence of maintenance, calibration, and testing, record the date and time, and the specific security equipment involved; (6) Security threats. Date and time of occurrence, how the threat was communicated, who received or identified the threat, a description of the threat, to whom it was reported, and a description of the response; (7) Declaration of Security (DoS). A copy of each DoS for at least 90 days after the end of its effective period; and (8) Annual audit of the Facility Security Plan (FSP). For each annual audit, a letter certified by the FSO stating the date the audit was conducted." 33:33:1.0.1.8.55.2.26.8,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.235 Maritime Security (MARSEC) Level coordination and implementation.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003]","(a) The OCS facility owner or operator must ensure the OCS facility operates in compliance with the security requirements in this part for the MARSEC Level in effect for the OCS facility. (b) When notified of an increase in the MARSEC Level, the OCS facility owner or operator must ensure: (1) Vessels conducting operations with the OCS facility and vessels scheduled to arrive at the OCS facility within 96 hours of the MARSEC Level change are notified of the new MARSEC Level and the Declaration of Security (DoS), if applicable, is revised as necessary; (2) The OCS facility complies with the required additional security measures within 12 hours; and (3) The OCS facility reports compliance or noncompliance to the cognizant District Commander. (c) For MARSEC Levels 2 and 3, the Facility Security Officer (FSO) must inform all OCS facility personnel about identified threats, emphasize reporting procedures, and stress the need for increased vigilance. (d) An OCS facility owner or operator whose facility is not in compliance with the requirements of this section must so inform the cognizant District Commander and obtain approval prior to interfacing with another vessel or prior to continuing operations." 33:33:1.0.1.8.55.2.26.9,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,B,Subpart B—Outer Continental Shelf (OCS) Facility Security Requirements,,§ 106.240 Communications.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003]","(a) The Facility Security Officer (FSO) must have a means to effectively notify OCS facility personnel of changes in security conditions at the OCS facility. (b) Communication systems and procedures must allow effective and continuous communications between the OCS facility security personnel, vessels interfacing with the OCS facility, the cognizant District Commander, and national and local authorities with security responsibilities. (c) Facility communications systems must have a backup means for both internal and external communications." 33:33:1.0.1.8.55.3.26.1,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,C,Subpart C—Outer Continental Shelf (OCS) Facility Security Assessment (FSA),,§ 106.300 General.,USCG,,,,"(a) The Facility Security Assessment (FSA) is a written document that is based on the collection of background information, the completion of an on-scene survey and an analysis of that information. (b) A single FSA may be performed and applied to more than one OCS facility to the extent they share physical characteristics, location, and operations. (c) Third parties may be used in any aspect of the FSA if they have the appropriate skills and if the Company Security Officer (CSO) reviews and accepts their work. (d) Those involved in a FSA must be able to draw upon expert assistance in the following areas, as appropriate: (1) Knowledge of current and anticipated security threats and patterns; (2) Recognition and detection of dangerous substances and devices; (3) Recognition of characteristics and behavioral patterns of persons who are likely to threaten security; (4) Recognition of techniques used to circumvent security measures; (5) Methods used to cause a security incident; (6) Effects of dangerous substances and devices on structures and essential services; (7) OCS facility security requirements; (8) OCS facility and vessel interface business practices; (9) Contingency planning, emergency preparedness and response; (10) Physical security requirements; (11) Radio and telecommunications systems, including computer systems and networks; (12) Marine or civil engineering; and (13) OCS facility and vessel operations." 33:33:1.0.1.8.55.3.26.2,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,C,Subpart C—Outer Continental Shelf (OCS) Facility Security Assessment (FSA),,§ 106.305 Facility Security Assessment (FSA) requirements.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended at 68 FR 60558, Oct. 22, 2003]","(a) Background. The OCS facility owner or operator must ensure that the following background information, if applicable, is provided to the person or persons who will conduct the assessment: (1) The general layout of the OCS facility, including: (i) The location of each access point to the OCS facility; (ii) The number, reliability, and security duties of OCS facility personnel; (iii) Security doors, barriers, and lighting; (iv) The location of restricted areas; (v) The emergency and stand-by equipment available to maintain essential services; (vi) The essential maintenance equipment and storage areas; (vii) Location of escape and evacuation routes and assembly stations; and (viii) Existing security and safety equipment for protection of personnel; (2) Response procedures for fire or other emergency conditions; (3) Procedures for monitoring OCS facility and vessel personnel; (4) Procedures for controlling keys and other access prevention systems; (5) Response capability for security incidents; (6) Threat assessments, including the purpose and methodology of the assessment, for the OCS facility's location; (7) Previous reports on security needs; and (8) Any other existing security procedures and systems, equipment, communications, and OCS facility personnel. (b) On-scene survey. The OCS facility owner or operator must ensure that an on-scene survey of each OCS facility is conducted. The on-scene survey examines and evaluates existing OCS facility protective measures, procedures, and operations to verify or collect the information required in paragraph (a) of this section. (c) Analysis and recommendations. In conducting the FSA, the OCS owner or operator must ensure that the Company Security Officer (CSO) analyzes the OCS facility background information and the on-scene survey, and considering the requirements of this part, provides recommendations to establish and prioritize the security measures that should be included in the FSP. The analysis must consider: (1) Each vulnerability found during the on-scene survey, including but not limited to: (i) Access to the OCS facility; (ii) Structural integrity of the OCS facility; (iii) Existing security measures and procedures, including identification systems; (iv) Existing security measures and procedures relating to essential services; (v) Measures to protect radio and telecommunication equipment, including computer systems and networks; (vi) Existing agreements with private security companies; (vii) Any conflicting policies between safety and security measures and procedures; (viii) Any conflicting OCS facility operations and security duty assignments; (ix) Any deficiencies identified during daily operations or training and drills; and (x) Any deficiencies identified following security incidents or alerts, the report of security concerns, the exercise of control measures, or audits. (2) Possible security threats, including but not limited to: (i) Damage to or destruction of the OCS facility or of a vessel adjacent to the OCS facility; (ii) Smuggling dangerous substances and devices; (iii) Use of a vessel interfacing with the OCS facility to carry those intending to cause a security incident and their equipment; (iv) Use of a vessel interfacing with the OCS facility as a weapon or as a means to cause damage or destruction; and (v) Effects of a nuclear, biological, radiological, explosive, or chemical attack to the OCS facility's shoreside support system; (3) Threat assessments by Government agencies; (4) Vulnerabilities, including human factors, in the OCS facility's infrastructure, policies and procedures; (5) Any particular aspects of the OCS facility, including the vessels that interface with the OCS facility, which make it likely to be the target of an attack; (6) Likely consequences, in terms of loss of life, damage to property, or economic disruption, of an attack on or at the OCS facility; and (7) Locations where access restrictions or prohibitions will be applied for each MARSEC Level. (d) FSA Report. (1) The OCS facility owner or operator must ensure that a written FSA report is prepared and included as a part of the FSP. The report must contain: (i) A summary of how the on-scene survey was conducted; (ii) A description of existing security measures, including inspection, control and monitoring equipment, personnel identification documents and communication, alarm, lighting, access control, and similar systems; (iii) A description of each vulnerability found during the on-scene survey; (iv) A description of security measures that could be used to address each vulnerability; (v) A list of the key OCS facility operations that are important to protect; and (vi) A list of identified weaknesses, including human factors, in the infrastructure, policies, and procedures of the OCS facility. (2) A FSA report must describe the following elements within the OCS facility: (i) Physical security; (ii) Structural integrity; (iii) Personnel protection systems; (iv) Procedural policies; (v) Radio and telecommunication systems, including computer systems and networks; and (vi) Essential services. (3) The FSA report must list the persons, activities, services, and operations that are important to protect, in each of the following categories: (i) OCS facility personnel; (ii) Visitors, vendors, repair technicians, vessel personnel, etc.; (iii) OCS facility stores; (iv) Any security communication and surveillance systems; and (v) Any other security systems, if any. (4) The FSA report must account for any vulnerabilities in the following areas: (i) Conflicts between safety and security measures; (ii) Conflicts between personnel duties and security assignments; (iii) The impact of watch-keeping duties and risk of fatigue on personnel alertness and performance; (iv) Security training deficiencies; and (v) Security equipment and systems, including communication systems. (5) The FSA report must discuss and evaluate key OCS facility measures and operations, including— (i) Ensuring performance of all security duties; (ii) Controlling access to the OCS facility through the use of identification systems or otherwise; (iii) Controlling the embarkation of OCS facility personnel and other persons and their effects (including personal effects and baggage, whether accompanied or unaccompanied); (iv) Supervising the delivery of stores and industrial supplies; (v) Monitoring restricted areas to ensure that only authorized persons have access; (vi) Monitoring deck areas and areas surrounding the OCS facility; and (vii) The ready availability of security communications, information, and equipment. (e) The FSA, FSA report, and FSP must be protected from unauthorized access or disclosure." 33:33:1.0.1.8.55.3.26.3,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,C,Subpart C—Outer Continental Shelf (OCS) Facility Security Assessment (FSA),,§ 106.310 Submission requirements.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003]","(a) A completed FSA report must be submitted with the Facility Security Plan (FSP) required in § 106.410 of this part. (b) An OCS facility owner or operator may generate and submit a report that contains the FSA for more than one OCS facility subject to this part, to the extent that they share similarities in physical characteristics, location and operations. (c) The FSA must be reviewed and validated, and the FSA report must be updated each time the FSP is submitted for reapproval or revisions." 33:33:1.0.1.8.55.4.26.1,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,D,Subpart D—Outer Continental Shelf (OCS) Facility Security Plan (FSP),,§ 106.400 General.,USCG,,,,"(a) The OCS facility owner or operator must ensure the FSO develops and implements a Facility Security Plan (FSP) for each OCS facility for which he or she is designated as FSO. The FSP: (1) Must identify the FSO by name or position and provide 24-hour contact information; (2) Must be written in English; (3) Must address each vulnerability identified in the Facility Security Assessment (FSA); (4) Must describe security measures for each MARSEC Level; and (5) May cover more than one OCS facility to the extent that they share similarities in physical characteristics and operations, if authorized and approved by the cognizant District Commander. (b) The FSP must be submitted for approval to the cognizant District Commander in a written or electronic format in a manner prescribed by the cognizant District Commander. (c) The FSP is sensitive security information and must be protected in accordance with 49 CFR part 1520. (d) If the FSP is kept in an electronic format, procedures must be in place to prevent its unauthorized deletion, destruction, or amendment." 33:33:1.0.1.8.55.4.26.2,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,D,Subpart D—Outer Continental Shelf (OCS) Facility Security Plan (FSP),,§ 106.405 Format and content of the Facility Security Plan (FSP).,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003; 68 FR 41917, July 16, 2003, as amended by USCG-2006-24196, 72 FR 3587, Jan. 25, 2007; USCG-2007-28915, 81 FR 57713, Aug. 23, 2016]","(a) An OCS facility owner or operator must ensure that the FSP consists of the individual sections listed in this paragraph (a). If the FSP does not follow the order as it appears in this paragraph, the OCS facility owner or operator must ensure that the FSP contains an index identifying the location of each of the following sections: (1) Security organization of the OCS facility; (2) Personnel training; (3) Drills and exercises; (4) Records and documentation; (5) Response to change in MARSEC Level; (6) Procedures for interfacing with vessels; (7) Declaration of Security (DoS); (8) Communications; (9) Security systems and equipment maintenance; (10) Security measures for access control, including the OCS facility's TWIC Program; (11) Security measures for restricted areas; (12) Security measures for delivery of stores and industrial supplies; (13) Security measures for monitoring; (14) Security incident procedures; (15) Audits and FSP amendments; and (16) Facility Security Assessment (FSA) report. (b) The FSP must describe in detail how the requirements of subpart B of this part will be met." 33:33:1.0.1.8.55.4.26.3,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,D,Subpart D—Outer Continental Shelf (OCS) Facility Security Plan (FSP),,§ 106.410 Submission and approval.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60558, Oct. 22, 2003; USCG-2013-0397, 78 FR 39173, July 1, 2013; USCG-2007-28915, 81 FR 57713, Aug. 23, 2016]","(a) The owner or operator of each OCS facility currently in operation must either— (1) Submit one copy of the Facility Security Plan (FSP) for review and approval to the cognizant District Commander and a letter certifying that the FSP meets the applicable requirements of this part; or (2) If intending to operate under an Approved Alternative Security Program, submit a letter signed by the OCS facility owner or operator stating which approved Alternative Security Program the owner or operator intends to use. (b) Owners or operators of OCS facilities not in service on or before December 31, 2003, must comply with the requirements in paragraph (a) of this section 60 days prior to beginning operations. (c) The cognizant District Commander will examine each submission for compliance with this part and either: (1) Approve it and specify any conditions of approval, returning to the submitter a letter stating its acceptance and any conditions; (2) Return it for revision, returning a copy to the submitter with brief descriptions of the required revisions; or (3) Disapprove it, returning a copy to the submitter with a brief statement of the reasons for disapproval. (d) An FSP may be submitted and approved to cover more than one OCS facility where they share similarities in physical characteristics, location, and operations. (e) Each OCS facility owner or operator that submits one FSP to cover two or more OCS facilities of similar design, location, and operation must address OCS facility-specific information that includes the physical and operational characteristics of each OCS facility. (f) An FSP that is approved by the cognizant District Commander is valid for 5 years from the date of its approval. The cognizant District Commander will issue an approval letter, as indicated in § 106.115 of this part." 33:33:1.0.1.8.55.4.26.4,33,Navigation and Navigable Waters,I,H,106,PART 106—MARINE SECURITY: OUTER CONTINENTAL SHELF (OCS) FACILITIES,D,Subpart D—Outer Continental Shelf (OCS) Facility Security Plan (FSP),,§ 106.415 Amendment and audit.,USCG,,,"[USCG-2003-14759, 68 FR 39345, July 1, 2003, as amended at 68 FR 60559, Oct. 22, 2003]","(a) Amendments. (1) Amendments to a Facility Security Plan (FSP) that are approved by the cognizant District Commander may be initiated by: (i) The OCS facility owner or operator; or (ii) The cognizant District Commander, upon a determination that an amendment is needed to maintain the OCS facility's security. The cognizant District Commander will give the OCS facility owner or operator written notice and request that the OCS facility owner or operator propose amendments addressing any matters specified in the notice. The OCS facility owner or operator will have at least 60 days to submit its proposed amendments. Until amendments are approved, the OCS facility owner or operator shall ensure temporary security measures are implemented to the satisfaction of the cognizant District Commander. (2) Proposed amendments must be sent to the cognizant District Commander. If initiated by the OCS facility owner or operator, the proposed amendment must be submitted at least 30 days before the amendment is to take effect unless the cognizant District Commander allows a shorter period. The cognizant District Commander will approve or disapprove the proposed amendment in accordance with § 106.410 of this subpart. (3) Nothing in this section should be construed as limiting the OCS facility owner or operator from the timely implementation of such additional security measures not enumerated in the approved FSP as necessary to address exigent security situations. In such cases, the owner or operator must notify the cognizant District Commander by the most rapid means practicable as to the nature of the additional measures, the circumstances that prompted these additional measures, and the period of time these additional measures are expected to be in place. (4) If the owner or operator has changed, the Facility Security Officer (FSO) must amend the Facility Security Plan (FSP) to include the name and contact information of the new OCS facility owner(s) or operator(s) and submit the affected portion of the FSP for review and approval in accordance with § 106.410 of this subpart. (b) Audits. (1) The FSO must ensure an audit of the FSP is performed annually, beginning no later than one year from the initial date of approval and attach a letter to the FSP certifying that the FSP meets the applicable requirements of this part. (2) If there is a change in ownership or operations of the OCS facility, or if there have been modifications to the OCS facility, the FSP must be audited including but not limited to physical structure, emergency response procedures, security measures, or operations. (3) Auditing the FSP as a result of modifications to the OCS facility may be limited to those sections of the FSP affected by the OCS facility modifications. (4) Unless impracticable due to the size and nature of the company or the OCS facility, personnel conducting internal audits of the security measures specified in the FSP or evaluating its implementation must: (i) Have knowledge of methods of conducting audits and inspections, and control and monitoring techniques; (ii) Not have regularly assigned security duties; and (iii) Be independent of any security measures being audited. (5) If the results of an audit require an amendment of either the Facility Security Assessment (FSA) or FSP, the FSO must submit, in accordance with § 106.410 of this subpart, the amendments to the cognizant District Commander for review and approval no later than 30 days after completion of the audit and a letter certifying that the amended FSP meets the applicable requirements of this part." 34:34:1.2.1.1.5.1.113.1,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.1 Purpose.,ED,,,"[89 FR 33882, Apr. 29, 2024]","The purpose of this part is to effectuate Title IX, which is designed to eliminate (with certain exceptions) discrimination on the basis of sex in any education program or activity receiving Federal financial assistance, whether or not such program or activity is offered or sponsored by an educational institution as defined in this part. This part is also intended to effectuate section 844 of the Education Amendments of 1974, Public Law 93-380, 88 Stat. 484." 34:34:1.2.1.1.5.1.113.2,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.2 Definitions.,ED,,,"[89 FR 33832, Apr. 29, 2024]","As used in this part, the term: Administrative law judge means a person appointed by the reviewing authority to preside over a hearing held under § 106.81. Administratively separate unit means a school, department, or college of an educational institution (other than a local educational agency), admission to which is independent of admission to any other component of such institution. Admission means selection for part-time, full-time, special, associate, transfer, exchange, or any other enrollment, membership, or matriculation in or at an education program or activity operated by a recipient. Applicant, as used in the definition of educational institution in this section and as used in § 106.4, means one who submits an application, request, or plan required to be approved by a Department official, or by a recipient, as a condition to becoming a recipient. Assistant Secretary means the Assistant Secretary for Civil Rights of the Department. Complainant means: (1) A student or employee who is alleged to have been subjected to conduct that could constitute sex discrimination under Title IX or this part; or (2) A person other than a student or employee who is alleged to have been subjected to conduct that could constitute sex discrimination under Title IX or this part and who was participating or attempting to participate in the recipient's education program or activity at the time of the alleged sex discrimination. Complaint means an oral or written request to the recipient that objectively can be understood as a request for the recipient to investigate and make a determination about alleged discrimination under Title IX or this part. Confidential employee means: (1) An employee of a recipient whose communications are privileged or confidential under Federal or State law. The employee's confidential status, for purposes of this part, is only with respect to information received while the employee is functioning within the scope of their duties to which privilege or confidentiality applies; (2) An employee of a recipient whom the recipient has designated as confidential under this part for the purpose of providing services to persons related to sex discrimination. If the employee also has a duty not associated with providing those services, the employee's confidential status is only with respect to information received about sex discrimination in connection with providing those services; or (3) An employee of a postsecondary institution who is conducting an Institutional Review Board-approved human-subjects research study designed to gather information about sex discrimination—but the employee's confidential status is only with respect to information received while conducting the study. Department means the Department of Education. Disciplinary sanctions means consequences imposed on a respondent following a determination under Title IX that the respondent violated the recipient's prohibition on sex discrimination. Educational institution means a local educational agency (LEA) as defined by section 8101 of the Elementary and Secondary Education Act of 1965, as amended by the Every Student Succeeds Act (20 U.S.C. 7801(30)), a preschool, a private elementary or secondary school, or an applicant or recipient that is an institution of graduate higher education, an institution of undergraduate higher education, an institution of professional education, or an institution of vocational education. Elementary school means elementary school as defined by section 8101 of the Elementary and Secondary Education Act of 1965, as amended by the Every Student Succeeds Act (20 U.S.C. 7801(19)), and a public or private preschool. Federal financial assistance means any of the following, when authorized or extended under a law administered by the Department: (1) A grant or loan of Federal financial assistance, including funds made available for: (i) The acquisition, construction, renovation, restoration, or repair of a building or facility or any portion thereof; and (ii) Scholarships, loans, grants, wages, or other funds extended to any entity for payment to or on behalf of students admitted to that entity, or extended directly to such students for payment to that entity. (2) A grant of Federal real or personal property or any interest therein, including surplus property, and the proceeds of the sale or transfer of such property, if the Federal share of the fair market value of the property is not, upon such sale or transfer, properly accounted for to the Federal Government. (3) Provision of the services of Federal personnel. (4) Sale or lease of Federal property or any interest therein at nominal consideration, or at consideration reduced for the purpose of assisting the recipient or in recognition of public interest to be served thereby, or permission to use Federal property or any interest therein without consideration. (5) Any other contract, agreement, or arrangement which has as one of its purposes the provision of assistance to any education program or activity, except a contract of insurance or guaranty. Institution of graduate higher education means an institution which: (1) Offers academic study beyond the bachelor of arts or bachelor of science degree, whether or not leading to a certificate of any higher degree in the liberal arts and sciences; or (2) Awards any degree in a professional field beyond the first professional degree (regardless of whether the first professional degree in such field is awarded by an institution of undergraduate higher education or professional education); or (3) Awards no degree and offers no further academic study, but operates ordinarily for the purpose of facilitating research by persons who have received the highest graduate degree in any field of study. Institution of professional education means an institution (except any institution of undergraduate higher education) which offers a program of academic study that leads to a first professional degree in a field for which there is a national specialized accrediting agency recognized by the Secretary. Institution of undergraduate higher education means: (1) An institution offering at least two but less than four years of college level study beyond the high school level, leading to a diploma or an associate degree, or wholly or principally creditable toward a baccalaureate degree; or (2) An institution offering academic study leading to a baccalaureate degree; or (3) An agency or body which certifies credentials or offers degrees, but which may or may not offer academic study. Institution of vocational education means a school or institution (except an institution of professional or graduate or undergraduate higher education) which has as its primary purpose preparation of students to pursue a technical, skilled, or semiskilled occupation or trade, or to pursue study in a technical field, whether or not the school or institution offers certificates, diplomas, or degrees and whether or not it offers fulltime study. Parental status, as used in §§ 106.21(c)(2)(i), 106.37(a)(3), 106.40(a), and 106.57(a)(1), means the status of a person who, with respect to another person who is under the age of 18 or who is 18 or older but is incapable of self-care because of a physical or mental disability, is: (1) A biological parent; (2) An adoptive parent; (3) A foster parent; (4) A stepparent; (5) A legal custodian or guardian; (6) In loco parentis with respect to such a person; or (7) Actively seeking legal custody, guardianship, visitation, or adoption of such a person. Party means a complainant or respondent. Peer retaliation means retaliation by a student against another student. Postsecondary institution means an institution of graduate higher education, an institution of undergraduate higher education, an institution of professional education, or an institution of vocational education that serves postsecondary school students. Pregnancy or related conditions means: (1) Pregnancy, childbirth, termination of pregnancy, or lactation; (2) Medical conditions related to pregnancy, childbirth, termination of pregnancy, or lactation; or (3) Recovery from pregnancy, childbirth, termination of pregnancy, lactation, or related medical conditions. Program or activity and program means all of the operations of— (1)(i) A department, agency, special purpose district, or other instrumentality of a State or local government; or (ii) The entity of a State or local government that distributes such assistance and each such department or agency (and each other State or local government entity) to which the assistance is extended, in the case of assistance to a State or local government; (2)(i) A college, university, or other postsecondary institution, or a public system of higher education; or (ii) A local educational agency (as defined in 20 U.S.C. 8801), system of vocational education, or other school system; (3)(i) An entire corporation, partnership, other private organization, or an entire sole proprietorship— (A) If assistance is extended to such corporation, partnership, private organization, or sole proprietorship as a whole; or (B) Which is principally engaged in the business of providing education, health care, housing, social services, or parks and recreation; or (ii) The entire plant or other comparable, geographically separate facility to which Federal financial assistance is extended, in the case of any other corporation, partnership, private organization, or sole proprietorship; or (4) Any other entity that is established by two or more of the entities described in paragraph (1), (2), or (3) of this definition, any part of which is extended Federal financial assistance. Recipient means any State or political subdivision thereof, or any instrumentality of a State or political subdivision thereof, any public or private agency, institution, or organization, or other entity, or any person, to whom Federal financial assistance is extended directly or through another recipient and which operates an education program or activity which receives such assistance, including any subunit, successor, assignee, or transferee thereof. Relevant means related to the allegations of sex discrimination under investigation as part of the grievance procedures under § 106.45, and if applicable § 106.46. Questions are relevant when they seek evidence that may aid in showing whether the alleged sex discrimination occurred, and evidence is relevant when it may aid a decisionmaker in determining whether the alleged sex discrimination occurred. Remedies means measures provided, as appropriate, to a complainant or any other person the recipient identifies as having had their equal access to the recipient's education program or activity limited or denied by sex discrimination. These measures are provided to restore or preserve that person's access to the recipient's education program or activity after a recipient determines that sex discrimination occurred. Respondent means a person who is alleged to have violated the recipient's prohibition on sex discrimination. Retaliation means intimidation, threats, coercion, or discrimination against any person by the recipient, a student, or an employee or other person authorized by the recipient to provide aid, benefit, or service under the recipient's education program or activity, for the purpose of interfering with any right or privilege secured by Title IX or this part, or because the person has reported information, made a complaint, testified, assisted, or participated or refused to participate in any manner in an investigation, proceeding, or hearing under this part, including in an informal resolution process under § 106.44(k), in grievance procedures under § 106.45, and if applicable § 106.46, and in any other actions taken by a recipient under § 106.44(f)(1). Nothing in this definition or this part precludes a recipient from requiring an employee or other person authorized by a recipient to provide aid, benefit, or service under the recipient's education program or activity to participate as a witness in, or otherwise assist with, an investigation, proceeding, or hearing under this part. Reviewing authority means that component of the Department delegated authority by the Secretary to appoint, and to review the decisions of, administrative law judges in cases arising under this part. Secondary school means secondary school as defined by section 8101 of the Elementary and Secondary Education Act of 1965, as amended by the Every Student Succeeds Act (20 U.S.C. 7801(45)), and an institution of vocational education that serves secondary school students. Secretary means the Secretary of Education. Sex-based harassment prohibited by this part is a form of sex discrimination and means sexual harassment and other harassment on the basis of sex, including on the bases described in § 106.10, that is: (1) Quid pro quo harassment. An employee, agent, or other person authorized by the recipient to provide an aid, benefit, or service under the recipient's education program or activity explicitly or impliedly conditioning the provision of such an aid, benefit, or service on a person's participation in unwelcome sexual conduct; (2) Hostile environment harassment. Unwelcome sex-based conduct that, based on the totality of the circumstances, is subjectively and objectively offensive and is so severe or pervasive that it limits or denies a person's ability to participate in or benefit from the recipient's education program or activity ( i.e., creates a hostile environment). Whether a hostile environment has been created is a fact-specific inquiry that includes consideration of the following: (i) The degree to which the conduct affected the complainant's ability to access the recipient's education program or activity; (ii) The type, frequency, and duration of the conduct; (iii) The parties' ages, roles within the recipient's education program or activity, previous interactions, and other factors about each party that may be relevant to evaluating the effects of the conduct; (iv) The location of the conduct and the context in which the conduct occurred; and (v) Other sex-based harassment in the recipient's education program or activity; or (3) Specific offenses. (i) Sexual assault meaning an offense classified as a forcible or nonforcible sex offense under the uniform crime reporting system of the Federal Bureau of Investigation; (ii) Dating violence meaning violence committed by a person: (A) Who is or has been in a social relationship of a romantic or intimate nature with the victim; and (B) Where the existence of such a relationship shall be determined based on a consideration of the following factors: ( 1 ) The length of the relationship; ( 2 ) The type of relationship; and ( 3 ) The frequency of interaction between the persons involved in the relationship; (iii) Domestic violence meaning felony or misdemeanor crimes committed by a person who: (A) Is a current or former spouse or intimate partner of the victim under the family or domestic violence laws of the jurisdiction of the recipient, or a person similarly situated to a spouse of the victim; (B) Is cohabitating, or has cohabitated, with the victim as a spouse or intimate partner; (C) Shares a child in common with the victim; or (D) Commits acts against a youth or adult victim who is protected from those acts under the family or domestic violence laws of the jurisdiction; or (iv) Stalking meaning engaging in a course of conduct directed at a specific person that would cause a reasonable person to: (A) Fear for the person's safety or the safety of others; or (B) Suffer substantial emotional distress. Note 1 to the definition of sex-based harassment: The Assistant Secretary will not require a recipient to adopt a particular definition of consent, where that term is applicable with respect to sex-based harassment. Student means a person who has gained admission. Student with a disability means a student who is an individual with a disability as defined in the Rehabilitation Act of 1973, as amended, 29 U.S.C. 705(9)(B), (20)(B), or a child with a disability as defined in the Individuals with Disabilities Education Act, 20 U.S.C. 1401(3). Supportive measures means individualized measures offered as appropriate, as reasonably available, without unreasonably burdening a complainant or respondent, not for punitive or disciplinary reasons, and without fee or charge to the complainant or respondent to: (1) Restore or preserve that party's access to the recipient's education program or activity, including measures that are designed to protect the safety of the parties or the recipient's educational environment; or (2) Provide support during the recipient's grievance procedures under § 106.45, and if applicable § 106.46, or during the informal resolution process under § 106.44(k). Title IX means Title IX of the Education Amendments of 1972 (Pub. L. 92-318; 20 U.S.C. 1681, 1682, 1683, 1685, 1686, 1687, 1688, 1689), as amended." 34:34:1.2.1.1.5.1.113.3,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.3 Remedial and affirmative action and self-evaluation.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30572, 30579, May 19, 2020; 89 FR 33885, Apr. 29, 2024]","(a) Remedial action. If the Assistant Secretary finds that a recipient has discriminated against persons on the basis of sex in an education program or activity under this part, or otherwise violated this part, such recipient must take such remedial action as the Assistant Secretary deems necessary to remedy the violation, consistent with 20 U.S.C. 1682. (b) Affirmative action. In the absence of a finding of discrimination on the basis of sex in an education program or activity, a recipient may take affirmative action to overcome the effects of conditions which resulted in limited participation therein by persons of a particular sex. Nothing herein shall be interpreted to alter any affirmative action obligations which a recipient may have under Executive Order 11246." 34:34:1.2.1.1.5.1.113.4,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.4 Assurance required.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 45 FR 86298, Dec. 30, 1980; 65 FR 68056, Nov. 13, 2000; 85 FR 30579, May 19, 2020]","(a) General. Every application for Federal financial assistance shall as condition of its approval contain or be accompanied by an assurance from the applicant or recipient, satisfactory to the Assistant Secretary, that the education program or activity operated by the applicant or recipient and to which this part applies will be operated in compliance with this part. An assurance of compliance with this part shall not be satisfactory to the Assistant Secretary if the applicant or recipient to whom such assurance applies fails to commit itself to take whatever remedial action is necessary in accordance with § 106.3(a) to eliminate existing discrimination on the basis of sex or to eliminate the effects of past discrimination whether occurring prior or subsequent to the submission to the Assistant Secretary of such assurance. (b) Duration of obligation. (1) In the case of Federal financial assistance extended to provide real property or structures thereon, such assurance shall obligate the recipient or, in the case of a subsequent transfer, the transferee, for the period during which the real property or structures are used to provide an education program or activity. (2) In the case of Federal financial assistance extended to provide personal property, such assurance shall obligate the recipient for the period during which it retains ownership or possession of the property. (3) In all other cases such assurance shall obligate the recipient for the period during which Federal financial assistance is extended. (c) Form. The Director will specify the form of the assurances required by paragraph (a) of this section and the extent to which such assurances will be required of the applicant's or recipient's subgrantees, contractors, subcontractors, transferees, or successors in interest." 34:34:1.2.1.1.5.1.113.5,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.5 Transfers of property.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020]","If a recipient sells or otherwise transfers property financed in whole or in part with Federal financial assistance to a transferee which operates any education program or activity, and the Federal share of the fair market value of the property is not upon such sale or transfer properly accounted for to the Federal Government both the transferor and the transferee shall be deemed to be recipients, subject to the provisions of subpart B of this part." 34:34:1.2.1.1.5.1.113.6,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.6 Effect of other requirements and preservation of rights.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 65 FR 68056, Nov. 13, 2000; 85 FR 30573, 30579, May 19, 2020; 89 FR 33885, Apr. 29, 2024]","(a) Effect of other Federal provisions. The obligations imposed by this part are independent of, and do not alter, obligations not to discriminate on the basis of sex imposed by Executive Order 11246, as amended; sections 704 and 855 of the Public Health Service Act (42 U.S.C. 292d and 298b-2); Title VII of the Civil Rights Act of 1964 (42 U.S.C. 2000e et seq. ); the Equal Pay Act (29 U.S.C. 206 and 206(d)); and any other Act of Congress or Federal regulation. (b) Effect of State or local law or other requirements. The obligation to comply with Title IX and this part is not obviated or alleviated by any State or local law or other requirement that conflicts with Title IX or this part. (c) Effect of rules or regulations of private organizations. The obligation to comply with this part is not obviated or alleviated by any rule or regulation of any organization, club, athletic or other league, or association which would render any applicant or student ineligible to participate or limit the eligibility or participation of any applicant or student, on the basis of sex, in any education program or activity operated by a recipient and which receives Federal financial assistance. (d) Constitutional protections. Nothing in this part requires a recipient to: (1) Restrict any rights that would otherwise be protected from government action by the First Amendment of the U.S. Constitution; (2) Deprive a person of any rights that would otherwise be protected from government action under the Due Process Clauses of the Fifth and Fourteenth Amendments of the U.S. Constitution; or (3) Restrict any other rights guaranteed against government action by the U.S. Constitution. (e) Effect of Section 444 of General Education Provisions Act (GEPA)/Family Educational Rights and Privacy Act (FERPA). The obligation to comply with Title IX and this part is not obviated or alleviated by FERPA, 20 U.S.C. 1232g, or its implementing regulations, 34 CFR part 99. (f) Title VII of the Civil Rights Act of 1964. Nothing in this part may be read in derogation of any individual's rights under title VII of the Civil Rights Act of 1964, 42 U.S.C. 2000e et seq. or any regulations promulgated thereunder. (g) Exercise of rights by parents, guardians, or other authorized legal representatives. Nothing in Title IX or this part may be read in derogation of any legal right of a parent, guardian, or other authorized legal representative to act on behalf of a complainant, respondent, or other person, subject to paragraph (e) of this section, including but not limited to making a complaint through the recipient's grievance procedures for complaints of sex discrimination." 34:34:1.2.1.1.5.1.113.7,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.7 Effect of employment opportunities.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19 2020]",The obligation to comply with this part is not obviated or alleviated because employment opportunities in any occupation or profession are or may be more limited for members of one sex than for members of the other sex. 34:34:1.2.1.1.5.1.113.8,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.8 Designation of coordinator; nondiscrimination policy; grievance procedures; notice of nondiscrimination; training; students with disabilities; and recordkeeping.,ED,,,"[89 FR 33885, Apr. 29, 2024]","(a) Designation of a Title IX Coordinator. (1) Title IX Coordinator. Each recipient mustdesignate and authorize at least one employee, referred to herein as a Title IX Coordinator, to coordinate its efforts to comply with its responsibilities under Title IX and this part. If a recipient has more than one Title IX Coordinator, it must designate one of its Title IX Coordinators to retain ultimate oversight over those responsibilities and ensure the recipient's consistent compliance with its responsibilities under Title IX and this part. (2) Delegation to designees. As appropriate, a recipient may delegate, or permit a Title IX Coordinator to delegate, specific duties to one or more designees. (b) Adoption, publication, and implementation of nondiscrimination policy and grievance procedures. (1) Nondiscrimination policy. Each recipient must adopt, publish, and implement a policy stating that the recipient does not discriminate on the basis of sex and prohibits sex discrimination in any education program or activity that it operates, as required by Title IX and this part, including in admission (unless subpart C of this part does not apply) and employment. (2) Grievance procedures. A recipient must adopt, publish, and implement grievance procedures consistent with the requirements of § 106.45, and if applicable § 106.46, that provide for the prompt and equitable resolution of complaints made by students, employees, or other individuals who are participating or attempting to participate in the recipient's education program or activity, or by the Title IX Coordinator, alleging any action that would be prohibited by Title IX or this part. (c) Notice of nondiscrimination. A recipient must provide a notice of nondiscrimination to students; parents, guardians, or other authorized legal representatives of elementary school and secondary school students; employees; applicants for admission and employment; and all unions and professional organizations holding collective bargaining or professional agreements with the recipient. (1) Contents of notice of nondiscrimination. (i) The notice of nondiscrimination must include the following elements: (A) A statement that the recipient does not discriminate on the basis of sex and prohibits sex discrimination in any education program or activity that it operates, as required by Title IX and this part, including in admission (unless subpart C of this part does not apply) and employment; (B) A statement that inquiries about the application of Title IX and this part to the recipient may be referred to the recipient's Title IX Coordinator, the Office for Civil Rights, or both; (C) The name or title, office address, email address, and telephone number of the recipient's Title IX Coordinator; (D) How to locate the recipient's nondiscrimination policy under paragraph (b)(1) of this section; and the recipient's grievance procedures under paragraph (b)(2) of this section; and (E) How to report information about conduct that may constitute sex discrimination under Title IX; and how to make a complaint of sex discrimination under this part. (ii) Nothing in this part prevents a recipient from including in its notice of nondiscrimination information about any exceptions or exemptions applicable to the recipient under Title IX. (2) Publication of notice of nondiscrimination. (i) Each recipient must prominently include all elements of its notice of nondiscrimination set out in paragraphs (c)(1)(i)(A) through (E) of this section on its website and in each handbook, catalog, announcement, bulletin, and application form that it makes available to persons entitled to notice under paragraph (c) of this section, or which are otherwise used in connection with the recruitment of students or employees. (ii) If necessary, due to the format or size of any publication under paragraph (c)(2)(i) of this section, the recipient may instead include in those publications a statement that the recipient prohibits sex discrimination in any education program or activity that it operates and that individuals may report concerns or questions to the Title IX Coordinator, and provide the location of the notice on the recipient's website. (iii) A recipient must not use or distribute a publication stating that the recipient treats applicants, students, or employees differently on the basis of sex, except as such treatment is permitted by Title IX or this part. (d) Training. The recipient must ensure that the persons described in paragraphs (d)(1) through (4) of this section receive training related to their duties under Title IX promptly upon hiring or change of position that alters their duties under Title IX or this part, and annually thereafter. This training must not rely on sex stereotypes. (1) All employees. All employees must be trained on: (i) The recipient's obligation to address sex discrimination in its education program or activity; (ii) The scope of conduct that constitutes sex discrimination under Title IX and this part, including the definition of sex-based harassment; and (iii) All applicable notification and information requirements under §§ 106.40(b)(2) and 106.44. (2) Investigators, decisionmakers, and other persons who are responsible for implementing the recipient's grievance procedures or have the authority to modify or terminate supportive measures. In addition to the training requirements in paragraph (d)(1) of this section, all investigators, decisionmakers, and other persons who are responsible for implementing the recipient's grievance procedures or have the authority to modify or terminate supportive measures under § 106.44(g)(4) must be trained on the following topics to the extent related to their responsibilities: (i) The recipient's obligations under § 106.44; (ii) The recipient's grievance procedures under § 106.45, and if applicable § 106.46; (iii) How to serve impartially, including by avoiding prejudgment of the facts at issue, conflicts of interest, and bias; and (iv) The meaning and application of the term “relevant” in relation to questions and evidence, and the types of evidence that are impermissible regardless of relevance under § 106.45, and if applicable § 106.46. (3) Facilitators of informal resolution process. In addition to the training requirements in paragraph (d)(1) of this section, all facilitators of an informal resolution process under § 106.44(k) must be trained on the rules and practices associated with the recipient's informal resolution process and on how to serve impartially, including by avoiding conflicts of interest and bias. (4) Title IX Coordinator and designees. In addition to the training requirements in paragraphs (d)(1) through (3) of this section, the Title IX Coordinator and any designees under paragraph (a) of this section must be trained on their specific responsibilities under paragraph (a) of this section, §§ 106.40(b)(3), 106.44(f) and (g), the recipient's recordkeeping system and the requirements of paragraph (f) of this section, and any other training necessary to coordinate the recipient's compliance with Title IX. (e) Students with disabilities. If a complainant or respondent is an elementary or secondary student with a disability, the recipient must require the Title IX Coordinator to consult with one or more members, as appropriate, of the student's Individualized Education Program (IEP) team, 34 CFR 300.321, if any, or one or more members, as appropriate, of the group of persons responsible for the student's placement decision under 34 CFR 104.35(c), if any, to determine how to comply with the requirements of the Individuals with Disabilities Education Act, 20 U.S.C. 1400 et seq., and Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794, throughout the recipient's implementation of grievance procedures under § 106.45. If a complainant or respondent is a postsecondary student with a disability, the Title IX Coordinator may consult, as appropriate, with the individual or office that the recipient has designated to provide support to students with disabilities to determine how to comply with Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794. (f) Recordkeeping. A recipient must maintain for a period of at least seven years: (1) For each complaint of sex discrimination, records documenting the informal resolution process under § 106.44(k) or the grievance procedures under § 106.45, and if applicable § 106.46, and the resulting outcome. (2) For each notification the Title IX Coordinator receives of information about conduct that reasonably may constitute sex discrimination under Title IX or this part, including notifications under § 106.44(c)(1) or (2), records documenting the actions the recipient took to meet its obligations under § 106.44. (3) All materials used to provide training under paragraph (d) of this section. A recipient must make these training materials available upon request for inspection by members of the public." 34:34:1.2.1.1.5.1.113.9,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,A,Subpart A—Introduction,,§ 106.9 Severability.,ED,,,"[85 FR 30573, May 19, 2020]","If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby." 34:34:1.2.1.1.5.2.113.1,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,B,Subpart B—Coverage,,§ 106.10 Scope.,ED,,,"[89 FR 33886, Apr. 29, 2024]","Discrimination on the basis of sex includes discrimination on the basis of sex stereotypes, sex characteristics, pregnancy or related conditions, sexual orientation, and gender identity." 34:34:1.2.1.1.5.2.113.2,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,B,Subpart B—Coverage,,§ 106.11 Application.,ED,,,"[89 FR 33886, Apr. 29, 2024]","Except as provided in this subpart, this part applies to every recipient and to all sex discrimination occurring under a recipient's education program or activity in the United States. For purposes of this section, conduct that occurs under a recipient's education program or activity includes but is not limited to conduct that occurs in a building owned or controlled by a student organization that is officially recognized by a postsecondary institution, and conduct that is subject to the recipient's disciplinary authority. A recipient has an obligation to address a sex-based hostile environment under its education program or activity, even when some conduct alleged to be contributing to the hostile environment occurred outside the recipient's education program or activity or outside the United States." 34:34:1.2.1.1.5.2.113.3,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,B,Subpart B—Coverage,,§ 106.12 Educational institutions controlled by religious organizations.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30573, 30579, May 19, 2020; 85 FR 59980, Sept. 23, 2020]","(a) Application. This part does not apply to an educational institution which is controlled by a religious organization to the extent application of this part would not be consistent with the religious tenets of such organization. (b) Assurance of exemption. An educational institution that seeks assurance of the exemption set forth in paragraph (a) of this section may do so by submitting in writing to the Assistant Secretary a statement by the highest ranking official of the institution, identifying the provisions of this part that conflict with a specific tenet of the religious organization. An institution is not required to seek assurance from the Assistant Secretary in order to assert such an exemption. In the event the Department notifies an institution that it is under investigation for noncompliance with this part and the institution wishes to assert an exemption set forth in paragraph (a) of this section, the institution may at that time raise its exemption by submitting in writing to the Assistant Secretary a statement by the highest ranking official of the institution, identifying the provisions of this part which conflict with a specific tenet of the religious organization, whether or not the institution had previously sought assurance of an exemption from the Assistant Secretary. (c) Eligibility. Any of the following in paragraphs (c)(1) through (6) of this section shall be sufficient to establish that an educational institution is controlled by a religious organization, as contemplated under paragraph (a) of this section, and is therefore eligible to assert a religious exemption to the extent application of this part would not be consistent with its religious tenets: (1) That the educational institution is a school or department of divinity. (2) That the educational institution requires its faculty, students, or employees to be members of, or otherwise engage in religious practices of, or espouse a personal belief in, the religion of the organization by which it claims to be controlled. (3) That the educational institution, in its charter or catalog, or other official publication, contains an explicit statement that it is controlled by a religious organization or an organ thereof, or is committed to the doctrines or practices of a particular religion, and the members of its governing body are appointed by the controlling religious organization or an organ thereof, and it receives a significant amount of financial support from the controlling religious organization or an organ thereof. (4) That the educational institution has a doctrinal statement or a statement of religious practices, along with a statement that members of the institution community must engage in the religious practices of, or espouse a personal belief in, the religion, its practices, or the doctrinal statement or statement of religious practices. (5) That the educational institution has a published institutional mission that is approved by the governing body of an educational institution and that includes, refers to, or is predicated upon religious tenets, beliefs, or teachings. (6) Other evidence sufficient to establish that an educational institution is controlled by a religious organization, pursuant to 20 U.S.C. 1681(a)(3). (d) Severability. If any provision of this section or its application to any person, act, or practice is held invalid, the remainder of this section or the application of its provisions to any person, act, or practice shall not be affected thereby." 34:34:1.2.1.1.5.2.113.4,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,B,Subpart B—Coverage,,§ 106.13 Military and merchant marine educational institutions.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020]",This part does not apply to an educational institution whose primary purpose is the training of individuals for a military service of the United States or for the merchant marine. 34:34:1.2.1.1.5.2.113.5,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,B,Subpart B—Coverage,,§ 106.14 Membership practices of certain organizations.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020]","(a) Social fraternities and sororities. This part does not apply to the membership practices of social fraternities and sororities which are exempt from taxation under section 501(a) of the Internal Revenue Code of 1954, the active membership of which consists primarily of students in attendance at institutions of higher education. (b) YMCA, YWCA, Girl Scouts, Boy Scouts and Camp Fire Girls. This part does not apply to the membership practices of the Young Men's Christian Association, the Young Women's Christian Association, the Girl Scouts, the Boy Scouts and Camp Fire Girls. (c) Voluntary youth service organizations. This part does not apply to the membership practices of voluntary youth service organizations which are exempt from taxation under section 501(a) of the Internal Revenue Code of 1954 and the membership of which has been traditionally limited to members of one sex and principally to persons of less than nineteen years of age." 34:34:1.2.1.1.5.2.113.6,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,B,Subpart B—Coverage,,§ 106.15 Admissions.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 45 FR 86298, Dec. 30, 1980; 85 FR 30579, May 19, 2020; 89 FR 33886, Apr. 29, 2024]","(a) Admissions to educational institutions prior to June 24, 1973, are not covered by this part. (b) Administratively separate units. For purposes only of this section and subpart C, each administratively separate unit shall be deemed to be an educational institution. (c) Application of subpart C. Except as provided in paragraphs (d) and (e) of this section, subpart C applies to each recipient. A recipient to which subpart C applies shall not discriminate on the basis of sex in admission or recruitment in violation of that subpart. (d) Educational institutions. Except as provided in paragraph (e) of this section as to recipients which are educational institutions, subpart C applies only to institutions of vocational education, professional education, graduate higher education, and public institutions of undergraduate higher education. (e) Public institutions of undergraduate higher education. Subpart C does not apply to any public institution of undergraduate higher education which traditionally and continually from its establishment has had a policy of admitting only students of one sex." 34:34:1.2.1.1.5.2.113.7,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,B,Subpart B—Coverage,,§ 106.16 Severability.,ED,,,"[85 FR 30573, May 19, 2020. Redesignated at 89 FR 33886, Apr.29, 2024]","If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby." 34:34:1.2.1.1.5.3.113.1,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,C,Subpart C—Discrimination on the Basis of Sex in Admission and Recruitment Prohibited,,§ 106.21 Admission.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020; 89 FR 33886, Apr. 29, 2024]","(a) Status generally. No person shall, on the basis of sex, be denied admission, or be subjected to discrimination in admission, by any recipient to which this subpart applies. (b) Specific prohibitions. (1) In determining whether a person satisfies any policy or criterion for admission, or in making any offer of admission, a recipient to which this subpart applies shall not: (i) Give preference to one person over another on the basis of sex, by ranking applicants separately on such basis, or otherwise; (ii) Apply numerical limitations upon the number or proportion of persons of either sex who may be admitted; or (iii) Otherwise treat one individual differently from another on the basis of sex. (2) A recipient shall not administer or operate any test or other criterion for admission which has a disproportionately adverse effect on persons on the basis of sex unless the use of such test or criterion is shown to predict validly success in the education program or activity in question and alternative tests or criteria which do not have such a disproportionately adverse effect are shown to be unavailable. (c) Parental, family, or marital status; pregnancy or related conditions. In determining whether a person satisfies any policy or criterion for admission, or in making any offer of admission, a recipient to which this subpart applies: (1) Must treat pregnancy or related conditions in the same manner and under the same policies as any other temporary medical conditions; and (2) Must not: (i) Adopt or implement any policy, practice, or procedure concerning the current, potential, or past parental, family, or marital status of a student or applicant that treats persons differently on the basis of sex; (ii) Discriminate against any person on the basis of current, potential, or past pregnancy or related conditions, or adopt or implement any policy, practice, or procedure that so discriminates; and (iii) Make a pre-admission inquiry as to the marital status of an applicant for admission, including whether such applicant is “Miss or Mrs.” A recipient may ask an applicant to self-identify their sex, but only if this question is asked of all applicants and if the response is not used as a basis for discrimination prohibited by this part." 34:34:1.2.1.1.5.3.113.2,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,C,Subpart C—Discrimination on the Basis of Sex in Admission and Recruitment Prohibited,,§ 106.22 Preference in admission.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020]","A recipient to which this subpart applies shall not give preference to applicants for admission, on the basis of attendance at any educational institution or other school or entity which admits as students only or predominantly members of one sex, if the giving of such preference has the effect of discriminating on the basis of sex in violation of this subpart." 34:34:1.2.1.1.5.3.113.3,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,C,Subpart C—Discrimination on the Basis of Sex in Admission and Recruitment Prohibited,,§ 106.23 Recruitment.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020]","(a) Nondiscriminatory recruitment. A recipient to which this subpart applies shall not discriminate on the basis of sex in the recruitment and admission of students. A recipient may be required to undertake additional recruitment efforts for one sex as remedial action pursuant to § 106.3(a), and may choose to undertake such efforts as affirmative action pursuant to § 106.3(b). (b) Recruitment at certain institutions. A recipient to which this subpart applies shall not recruit primarily or exclusively at educational institutions, schools or entities which admit as students only or predominantly members of one sex, if such actions have the effect of discriminating on the basis of sex in violation of this subpart." 34:34:1.2.1.1.5.3.113.4,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,C,Subpart C—Discrimination on the Basis of Sex in Admission and Recruitment Prohibited,,§ 106.24 Severability.,ED,,,"[85 FR 30574, May 19, 2020]","If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby." 34:34:1.2.1.1.5.4.113.1,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.31 Education programs or activities.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 47 FR 32527, July 28, 1982; 65 FR 68056, Nov. 13, 2000; 85 FR 30579, May 19, 2020; 89 FR 33887, Apr. 29, 2024]","(a) General. (1) Except as provided elsewhere in this part, no person shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or otherwise be subjected to discrimination under any academic, extracurricular, research, occupational training, or other education program or activity operated by a recipient that receives Federal financial assistance. (2) In the limited circumstances in which Title IX or this part permits different treatment or separation on the basis of sex, a recipient must not carry out such different treatment or separation in a manner that discriminates on the basis of sex by subjecting a person to more than de minimis harm, except as permitted by 20 U.S.C. 1681(a)(1) through (9) and the corresponding regulations §§ 106.12 through 106.15, 20 U.S.C. 1686 and its corresponding regulation § 106.32(b)(1), or § 106.41(b). Adopting a policy or engaging in a practice that prevents a person from participating in an education program or activity consistent with the person's gender identity subjects a person to more than de minimis harm on the basis of sex. (3) This subpart does not apply to actions of a recipient in connection with admission of its students to an education program or activity of: (i) A recipient to which subpart C does not apply; or (ii) An entity, not a recipient, to which subpart C would not apply if the entity were a recipient. (b) Specific prohibitions. Except as provided in this subpart, in providing any aid, benefit, or service to a student, a recipient shall not, on the basis of sex: (1) Treat one person differently from another in determining whether such person satisfies any requirement or condition for the provision of such aid, benefit, or service; (2) Provide different aid, benefits, or services or provide aid, benefits, or services in a different manner; (3) Deny any person any such aid, benefit, or service; (4) Subject any person to separate or different rules of behavior, sanctions, or other treatment; (5) Apply any rule concerning the domicile or residence of a student or applicant, including eligibility for in-state fees and tuition; (6) Aid or perpetuate discrimination against any person by providing significant assistance to any agency, organization, or person which discriminates on the basis of sex in providing any aid, benefit or service to students or employees; (7) Otherwise limit any person in the enjoyment of any right, privilege, advantage, or opportunity. (c) Assistance administered by a recipient educational institution to study at a foreign institution. A recipient educational institution may administer or assist in the administration of scholarships, fellowships, or other awards established by foreign or domestic wills, trusts, or similar legal instruments, or by acts of foreign governments and restricted to members of one sex, which are designed to provide opportunities to study abroad, and which are awarded to students who are already matriculating at or who are graduates of the recipient institution; Provided, a recipient educational institution which administers or assists in the administration of such scholarships, fellowships, or other awards which are restricted to members of one sex provides, or otherwise makes available reasonable opportunities for similar studies for members of the other sex. Such opportunities may be derived from either domestic or foreign sources. (d) Aid, benefits or services not provided by recipient. (1) This paragraph applies to any recipient which requires participation by any applicant, student, or employee in any education program or activity not operated wholly by such recipient, or which facilitates, permits, or considers such participation as part of or equivalent to an education program or activity operated by such recipient, including participation in educational consortia and cooperative employment and student-teaching assignments. (2) Such recipient: (i) Shall develop and implement a procedure designed to assure itself that the operator or sponsor of such other education program or activity takes no action affecting any applicant, student, or employee of such recipient which this part would prohibit such recipient from taking; and (ii) Shall not facilitate, require, permit, or consider such participation if such action occurs." 34:34:1.2.1.1.5.4.113.10,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,"§ 106.40 Parental, family, or marital status; pregnancy or related conditions.",ED,,,"[89 FR 33887, Apr. 29, 2024]","(a) Status generally. A recipient must not adopt or implement any policy, practice, or procedure concerning a student's current, potential, or past parental, family, or marital status that treats students differently on the basis of sex. (b) Pregnancy or related conditions. (1) Nondiscrimination. A recipient must not discriminate in its education program or activity against any student based on the student's current, potential, or past pregnancy or related conditions. A recipient does not engage in prohibited discrimination when it allows a student, based on pregnancy or related conditions, to voluntarily participate in a separate portion of its education program or activity provided the recipient ensures that the separate portion is comparable to that offered to students who are not pregnant and do not have related conditions. (2) Responsibility to provide Title IX Coordinator contact and other information. A recipient must ensure that when a student, or a person who has a legal right to act on behalf of the student, informs any employee of the student's pregnancy or related conditions, unless the employee reasonably believes that the Title IX Coordinator has been notified, the employee promptly provides that person with the Title IX Coordinator's contact information and informs that person that the Title IX Coordinator can coordinate specific actions to prevent sex discrimination and ensure the student's equal access to the recipient's education program or activity. (3) Specific actions to prevent discrimination and ensure equal access. A recipient must take specific actions under paragraphs (b)(3)(i) through (vi) of this section to promptly and effectively prevent sex discrimination and ensure equal access to the recipient's education program or activity once the student, or a person who has a legal right to act on behalf of the student, notifies the Title IX Coordinator of the student's pregnancy or related conditions. The Title IX Coordinator must coordinate these actions. (i) Responsibility to provide information about recipient obligations. The recipient must inform the student, and if applicable, the person who notified the Title IX Coordinator of the student's pregnancy or related conditions and has a legal right to act on behalf of the student, of the recipient's obligations under paragraphs (b)(1) through (5) of this section and § 106.44(j) and provide the recipient's notice of nondiscrimination under § 106.8(c)(1). (ii) Reasonable modifications. (A) The recipient must make reasonable modifications to the recipient's policies, practices, or procedures as necessary to prevent sex discrimination and ensure equal access to the recipient's education program or activity. Each reasonable modification must be based on the student's individualized needs. In determining what modifications are required under this paragraph, the recipient must consult with the student. A modification that a recipient can demonstrate would fundamentally alter the nature of its education program or activity is not a reasonable modification. (B) The student has discretion to accept or decline each reasonable modification offered by the recipient. If a student accepts a recipient's offered reasonable modification, the recipient must implement it. (C) Reasonable modifications may include, but are not limited to, breaks during class to express breast milk, breastfeed, or attend to health needs associated with pregnancy or related conditions, including eating, drinking, or using the restroom; intermittent absences to attend medical appointments; access to online or homebound education; changes in schedule or course sequence; extensions of time for coursework and rescheduling of tests and examinations; allowing a student to sit or stand, or carry or keep water nearby; counseling; changes in physical space or supplies (for example, access to a larger desk or a footrest); elevator access; or other changes to policies, practices, or procedures. (iii) Voluntary access to separate and comparable portion of program or activity. The recipient must allow the student to voluntarily access any separate and comparable portion of the recipient's education program or activity under paragraph (b)(1) of this section. (iv) Voluntary leaves of absence. The recipient must allow the student to voluntarily take a leave of absence from the recipient's education program or activity to cover, at minimum, the period of time deemed medically necessary by the student's licensed healthcare provider. To the extent that a student qualifies for leave under a leave policy maintained by a recipient that allows a greater period of time than the medically necessary period, the recipient must permit the student to take voluntary leave under that policy instead if the student so chooses. When the student returns to the recipient's education program or activity, the student must be reinstated to the academic status and, as practicable, to the extracurricular status that the student held when the voluntary leave began. (v) Lactation space. The recipient must ensure that the student can access a lactation space, which must be a space other than a bathroom, that is clean, shielded from view, free from intrusion from others, and may be used by a student for expressing breast milk or breastfeeding as needed. (vi) Limitation on supporting documentation. A recipient must not require supporting documentation under paragraphs (b)(3)(ii) through (v) unless the documentation is necessary and reasonable for the recipient to determine the reasonable modifications to make or whether to take additional specific actions under paragraphs (b)(3)(ii) through (v). Examples of situations when requiring supporting documentation is not necessary and reasonable include, but are not limited to, when the student's need for a specific action under paragraphs (b)(3)(ii) through (v) is obvious, such as when a student who is pregnant needs a bigger uniform; when the student has previously provided the recipient with sufficient supporting documentation; when the reasonable modification because of pregnancy or related conditions at issue is allowing a student to carry or keep water nearby and drink, use a bigger desk, sit or stand, or take breaks to eat, drink, or use the restroom; when the student has lactation needs; or when the specific action under paragraphs (b)(3)(ii) through (v) is available to students for reasons other than pregnancy or related conditions without submitting supporting documentation. (4) Comparable treatment to other temporary medical conditions. To the extent consistent with paragraph (b)(3) of this section, a recipient must treat pregnancy or related conditions in the same manner and under the same policies as any other temporary medical conditions with respect to any medical or hospital benefit, service, plan, or policy the recipient administers, operates, offers, or participates in with respect to students admitted to the recipient's education program or activity. (5) Certification to participate. A recipient must not require a student who is pregnant or has related conditions to provide certification from a healthcare provider or any other person that the student is physically able to participate in the recipient's class, program, or extracurricular activity unless: (i) The certified level of physical ability or health is necessary for participation in the class, program, or extracurricular activity; (ii) The recipient requires such certification of all students participating in the class, program, or extracurricular activity; and (iii) The information obtained is not used as a basis for discrimination prohibited by this part." 34:34:1.2.1.1.5.4.113.11,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.41 Athletics.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020; 89 FR 33888, Apr. 29, 2024]","(a) General. No person shall, on the basis of sex, be excluded from participation in, be denied the benefits of, be treated differently from another person or otherwise be discriminated against in any interscholastic, intercollegiate, club or intramural athletics offered by a recipient, and no recipient shall provide any such athletics separately on such basis. (b) Separate teams. Notwithstanding the requirements of paragraph (a) of this section, a recipient may operate or sponsor separate teams for members of each sex where selection for such teams is based upon competitive skill or the activity involved is a contact sport. However, where a recipient operates or sponsors a team in a particular sport for members of one sex but operates or sponsors no such team for members of the other sex, and athletic opportunities for members of that sex have previously been limited, members of the excluded sex must be allowed to try-out for the team offered unless the sport involved is a contact sport. For the purposes of this part, contact sports include boxing, wrestling, rugby, ice hockey, football, basketball and other sports the purpose or major activity of which involves bodily contact. (c) Equal opportunity. A recipient which operates or sponsors interscholastic, intercollegiate, club or intramural athletics shall provide equal athletic opportunity for members of both sexes. In determining whether equal opportunities are available the Director will consider, among other factors: (1) Whether the selection of sports and levels of competition effectively accommodate the interests and abilities of members of both sexes; (2) The provision of equipment and supplies; (3) Scheduling of games and practice time; (4) Travel and per diem allowance; (5) Opportunity to receive coaching and academic tutoring; (6) Assignment and compensation of coaches and tutors; (7) Provision of locker rooms, practice and competitive facilities; (8) Provision of medical and training facilities and services; (9) Provision of housing and dining facilities and services; (10) Publicity. Unequal aggregate expenditures for members of each sex or unequal expenditures for male and female teams if a recipient operates or sponsors separate teams will not constitute noncompliance with this section, but the Assistant Secretary may consider the failure to provide necessary funds for teams for one sex in assessing equality of opportunity for members of each sex." 34:34:1.2.1.1.5.4.113.12,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.42 Textbooks and curricular material.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020]",Nothing in this regulation shall be interpreted as requiring or prohibiting or abridging in any way the use of particular textbooks or curricular materials. 34:34:1.2.1.1.5.4.113.13,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.43 Standards for measuring skill or progress in physical education classes.,ED,,,"[71 FR 62543, Oct. 25, 2006, as amended at 85 FR 30579, May 19, 2020]","If use of a single standard of measuring skill or progress in physical education classes has an adverse effect on members of one sex, the recipient shall use appropriate standards that do not have that effect." 34:34:1.2.1.1.5.4.113.14,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.44 Recipient's response to sex discrimination.,ED,,,"[89 FR 33888, Apr. 29, 2024]","(a) General. (1) A recipient with knowledge of conduct that reasonably may constitute sex discrimination in its education program or activity must respond promptly and effectively; and (2) A recipient must also comply with this section to address sex discrimination in its education program or activity. (b) Barriers to reporting. A recipient must require its Title IX Coordinator to: (1) Monitor the recipient's education program or activity for barriers to reporting information about conduct that reasonably may constitute sex discrimination under Title IX or this part; and (2) Take steps reasonably calculated to address such barriers. (c) Notification requirements. (1) An elementary school or secondary school recipient must require all of its employees who are not confidential employees to notify the Title IX Coordinator when the employee has information about conduct that reasonably may constitute sex discrimination under Title IX or this part. (2) All other recipients must, at a minimum, require: (i) Any employee who is not a confidential employee and who either has authority to institute corrective measures on behalf of the recipient or has responsibility for administrative leadership, teaching, or advising in the recipient's education program or activity to notify the Title IX Coordinator when the employee has information about conduct that reasonably may constitute sex discrimination under Title IX or this part; and (ii) All other employees who are not confidential employees and not covered by paragraph (c)(2)(i) of this section to either: (A) Notify the Title IX Coordinator when the employee has information about conduct that reasonably may constitute sex discrimination under Title IX or this part; or (B) Provide the contact information of the Title IX Coordinator and information about how to make a complaint of sex discrimination to any person who provides the employee with information about conduct that reasonably may constitute sex discrimination under Title IX or this part. (3) A postsecondary institution must reasonably determine and specify whether and under what circumstances a person who is both a student and an employee is subject to the requirements of paragraph (c)(2) of this section. (4) The requirements of paragraphs (c)(1) and (2) of this section do not apply to an employee who has personally been subject to conduct that reasonably may constitute sex discrimination under Title IX or this part. (d) Confidential employee requirements. (1) A recipient must notify all participants in the recipient's education program or activity of how to contact its confidential employees, if any, excluding any employee whose confidential status is only with respect to their conducting an Institutional Review Board-approved human-subjects research study designed to gather information about sex discrimination as set out in the definition of confidential employee in § 106.2. (2) A recipient must require a confidential employee to explain to any person who informs the confidential employee of conduct that reasonably may constitute sex discrimination under Title IX or this part: (i) The employee's status as confidential for purposes of this part, including the circumstances in which the employee is not required to notify the Title IX Coordinator about conduct that reasonably may constitute sex discrimination; (ii) How to contact the recipient's Title IX Coordinator and how to make a complaint of sex discrimination; and (iii) That the Title IX Coordinator may be able to offer and coordinate supportive measures, as well as initiate an informal resolution process or an investigation under the grievance procedures. (e) Public awareness events. When a postsecondary institution's Title IX Coordinator is notified of information about conduct that reasonably may constitute sex-based harassment under Title IX or this part that was provided by a person during a public event to raise awareness about sex-based harassment that was held on the postsecondary institution's campus or through an online platform sponsored by a postsecondary institution, the postsecondary institution is not obligated to act in response to the information, unless it indicates an imminent and serious threat to the health or safety of a complainant, any students, employees, or other persons. However, in all cases the postsecondary institution must use this information to inform its efforts to prevent sex-based harassment, including by providing tailored training to address alleged sex-based harassment in a particular part of its education program or activity or at a specific location when information indicates there may be multiple incidents of sex-based harassment. Nothing in Title IX or this part obligates a postsecondary institution to require its Title IX Coordinator or any other employee to attend such public awareness events. (f) Title IX Coordinator requirements. The Title IX Coordinator is responsible for coordinating the recipient's compliance with its obligations under Title IX and this part. (1) A recipient must require its Title IX Coordinator, when notified of conduct that reasonably may constitute sex discrimination under Title IX or this part, to take the following actions to promptly and effectively end any sex discrimination in its education program or activity, prevent its recurrence, and remedy its effects: (i) Treat the complainant and respondent equitably; (ii) Offer and coordinate supportive measures under paragraph (g) of this section, as appropriate, for the complainant. In addition, if the recipient has initiated grievance procedures under § 106.45, and if applicable § 106.46, or offered an informal resolution process under paragraph (k) of this section to the respondent, offer and coordinate supportive measures under paragraph (g) of this section, as appropriate, for the respondent; (iii)(A) Notify the complainant or, if the complainant is unknown, the individual who reported the conduct, of the grievance procedures under § 106.45, and if applicable § 106.46, and the informal resolution process under paragraph (k) of this section, if available and appropriate; and (B) If a complaint is made, notify the respondent of the grievance procedures under § 106.45, and if applicable § 106.46, and the informal resolution process under paragraph (k) of this section, if available and appropriate; (iv) In response to a complaint, initiate the grievance procedures under § 106.45, and if applicable § 106.46, or the informal resolution process under paragraph (k) of this section, if available and appropriate and requested by all parties; (v) In the absence of a complaint or the withdrawal of any or all of the allegations in a complaint, and in the absence or termination of an informal resolution process, determine whether to initiate a complaint of sex discrimination that complies with the grievance procedures under § 106.45, and if applicable § 106.46. (A) To make this fact-specific determination, the Title IX Coordinator must consider, at a minimum, the following factors: ( 1 ) The complainant's request not to proceed with initiation of a complaint; ( 2 ) The complainant's reasonable safety concerns regarding initiation of a complaint; ( 3 ) The risk that additional acts of sex discrimination would occur if a complaint is not initiated; ( 4 ) The severity of the alleged sex discrimination, including whether the discrimination, if established, would require the removal of a respondent from campus or imposition of another disciplinary sanction to end the discrimination and prevent its recurrence; ( 5 ) The age and relationship of the parties, including whether the respondent is an employee of the recipient; ( 6 ) The scope of the alleged sex discrimination, including information suggesting a pattern, ongoing sex discrimination, or sex discrimination alleged to have impacted multiple individuals; ( 7 ) The availability of evidence to assist a decisionmaker in determining whether sex discrimination occurred; and ( 8 ) Whether the recipient could end the alleged sex discrimination and prevent its recurrence without initiating its grievance procedures under § 106.45, and if applicable § 106.46. (B) If, after considering these and other relevant factors, the Title IX Coordinator determines that the conduct as alleged presents an imminent and serious threat to the health or safety of the complainant or other person, or that the conduct as alleged prevents the recipient from ensuring equal access on the basis of sex to its education program or activity, the Title IX Coordinator may initiate a complaint. (vi) If initiating a complaint under paragraph (f)(1)(v) of this section, notify the complainant prior to doing so and appropriately address reasonable concerns about the complainant's safety or the safety of others, including by providing supportive measures consistent with paragraph (g) of this section; and (vii) Regardless of whether a complaint is initiated, take other appropriate prompt and effective steps, in addition to steps necessary to effectuate the remedies provided to an individual complainant, if any, to ensure that sex discrimination does not continue or recur within the recipient's education program or activity. (2) A Title IX Coordinator is not required to comply with paragraphs (f)(1)(i) through (vii) of this section upon being notified of conduct that may constitute sex discrimination if the Title IX Coordinator reasonably determines that the conduct as alleged could not constitute sex discrimination under Title IX or this part. (g) Supportive measures. Under paragraph (f) of this section, a recipient must offer and coordinate supportive measures, as appropriate, as described in paragraphs (g)(1) through (6) of this section. For allegations of sex discrimination other than sex-based harassment or retaliation, a recipient's provision of supportive measures does not require the recipient, its employee, or any other person authorized to provide aid, benefit, or service on the recipient's behalf to alter the alleged discriminatory conduct for the purpose of providing a supportive measure. (1) Supportive measures may vary depending on what the recipient deems to be reasonably available. These measures may include but are not limited to: counseling; extensions of deadlines and other course-related adjustments; campus escort services; increased security and monitoring of certain areas of the campus; restrictions on contact applied to one or more parties; leaves of absence; changes in class, work, housing, or extracurricular or any other activity, regardless of whether there is or is not a comparable alternative; and training and education programs related to sex-based harassment. (2) Supportive measures must not unreasonably burden either party and must be designed to protect the safety of the parties or the recipient's educational environment, or to provide support during the recipient's grievance procedures under § 106.45, and if applicable § 106.46, or during the informal resolution process under § 106.44(k). A recipient must not impose such measures for punitive or disciplinary reasons. (3) A recipient may, as appropriate, modify or terminate supportive measures at the conclusion of the grievance procedures under § 106.45, and if applicable § 106.46, or at the conclusion of the informal resolution process under paragraph (k) of this section, or the recipient may continue them beyond that point. (4) A recipient must provide a complainant or respondent with a timely opportunity to seek, from an appropriate and impartial employee, modification or reversal of the recipient's decision to provide, deny, modify, or terminate supportive measures applicable to them. The impartial employee must be someone other than the employee who made the challenged decision and must have authority to modify or reverse the decision, if the impartial employee determines that the decision to provide, deny, modify, or terminate the supportive measure was inconsistent with the definition of supportive measures in § 106.2. A recipient must also provide a party with the opportunity to seek additional modification or termination of a supportive measure applicable to them if circumstances change materially. (5) A recipient must not disclose information about any supportive measures to persons other than the person to whom they apply, including informing one party of supportive measures provided to another party, unless necessary to provide the supportive measure or restore or preserve a party's access to the education program or activity, or when an exception in § 106.44(j)(1) through (5) applies. (6)(i) If the complainant or respondent is an elementary or secondary student with a disability, the recipient must require the Title IX Coordinator to consult with one or more members, as appropriate, of the student's Individualized Education Program (IEP) team, 34 CFR 300.321, if any, or one or more members, as appropriate, of the group of persons responsible for the student's placement decision under 34 CFR 104.35(c), if any, to determine how to comply with the requirements of the Individuals with Disabilities Education Act, 20 U.S.C. 1400 et seq., and Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794, in the implementation of supportive measures. (ii) If the complainant or respondent is a postsecondary student with a disability, the Title IX Coordinator may consult, as appropriate, with the individual or office that the recipient has designated to provide support to students with disabilities to determine how to comply with Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794, in the implementation of supportive measures. (h) Emergency removal. Nothing in this part precludes a recipient from removing a respondent from the recipient's education program or activity on an emergency basis, provided that the recipient undertakes an individualized safety and risk analysis, determines that an imminent and serious threat to the health or safety of a complainant or any students, employees, or other persons arising from the allegations of sex discrimination justifies removal, and provides the respondent with notice and an opportunity to challenge the decision immediately following the removal. This provision must not be construed to modify any rights under the Individuals with Disabilities Education Act, 20 U.S.C. 1400 et seq., Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794, or the Americans with Disabilities Act of 1990, 42 U.S.C. 12101 et seq. (i) Administrative leave. Nothing in this part precludes a recipient from placing an employee respondent on administrative leave from employment responsibilities during the pendency of the recipient's grievance procedures. This provision must not be construed to modify any rights under Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794, or the Americans with Disabilities Act of 1990, 42 U.S.C. 12101 et seq. (j) Prohibited disclosures of personally identifiable information. A recipient must not disclose personally identifiable information obtained in the course of complying with this part, except in the following circumstances: (1) When the recipient has obtained prior written consent from a person with the legal right to consent to the disclosure; (2) When the information is disclosed to a parent, guardian, or other authorized legal representative with the legal right to receive disclosures on behalf of the person whose personally identifiable information is at issue; (3) To carry out the purposes of this part, including action taken to address conduct that reasonably may constitute sex discrimination under Title IX in the recipient's education program or activity; (4) As required by Federal law, Federal regulations, or the terms and conditions of a Federal award, including a grant award or other funding agreement; or (5) To the extent such disclosures are not otherwise in conflict with Title IX or this part, when required by State or local law or when permitted under FERPA, 20 U.S.C. 1232g, or its implementing regulations, 34 CFR part 99. (k) Discretion to offer informal resolution in some circumstances. (1) At any time prior to determining whether sex discrimination occurred under § 106.45, and if applicable § 106.46, a recipient may offer to a complainant and respondent an informal resolution process, unless the complaint includes allegations that an employee engaged in sex-based harassment of an elementary school or secondary school student or such a process would conflict with Federal, State or local law. A recipient that provides the parties an informal resolution process must, to the extent necessary, also require its Title IX Coordinator to take other appropriate prompt and effective steps to ensure that sex discrimination does not continue or recur within the recipient's education program or activity. (i) Subject to the limitations in paragraph (k)(1) of this section, a recipient has discretion to determine whether it is appropriate to offer an informal resolution process when it receives information about conduct that reasonably may constitute sex discrimination under Title IX or this part or when a complaint of sex discrimination is made, and may decline to offer informal resolution despite one or more of the parties' wishes. (ii) In addition to the limitations in paragraph (k)(1) of this section, circumstances when a recipient may decline to allow informal resolution include but are not limited to when the recipient determines that the alleged conduct would present a future risk of harm to others. (2) A recipient must not require or pressure the parties to participate in an informal resolution process. The recipient must obtain the parties' voluntary consent to the informal resolution process and must not require waiver of the right to an investigation and determination of a complaint as a condition of enrollment or continuing enrollment, or employment or continuing employment, or exercise of any other right. (3) Before initiation of an informal resolution process, the recipient must provide to the parties notice that explains: (i) The allegations; (ii) The requirements of the informal resolution process; (iii) That, prior to agreeing to a resolution, any party has the right to withdraw from the informal resolution process and to initiate or resume the recipient's grievance procedures; (iv) That the parties' agreement to a resolution at the conclusion of the informal resolution process would preclude the parties from initiating or resuming grievance procedures arising from the same allegations; (v) The potential terms that may be requested or offered in an informal resolution agreement, including notice that an informal resolution agreement is binding only on the parties; and (vi) What information the recipient will maintain and whether and how the recipient could disclose such information for use in grievance procedures under § 106.45, and if applicable § 106.46, if grievance procedures are initiated or resumed. (4) The facilitator for the informal resolution process must not be the same person as the investigator or the decisionmaker in the recipient's grievance procedures. Any person designated by a recipient to facilitate an informal resolution process must not have a conflict of interest or bias for or against complainants or respondents generally or an individual complainant or respondent. Any person facilitating informal resolution must receive training under § 106.8(d)(3). (5) Potential terms that may be included in an informal resolution agreement include but are not limited to: (i) Restrictions on contact; and (ii) Restrictions on the respondent's participation in one or more of the recipient's programs or activities or attendance at specific events, including restrictions the recipient could have imposed as remedies or disciplinary sanctions had the recipient determined at the conclusion of the recipient's grievance procedures that sex discrimination occurred." 34:34:1.2.1.1.5.4.113.15,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.45 Grievance procedures for the prompt and equitable resolution of complaints of sex discrimination.,ED,,,"[89 FR 33891, Apr. 29, 2024]","(a)(1) General. A recipient's grievance procedures for the prompt and equitable resolution of complaints of sex discrimination must be in writing and include provisions that incorporate the requirements of this section. The requirements related to a respondent apply only to sex discrimination complaints alleging that a person violated the recipient's prohibition on sex discrimination. When a sex discrimination complaint alleges that a recipient's policy or practice discriminates on the basis of sex, the recipient is not considered a respondent. (2) Complaint. The following persons have a right to make a complaint of sex discrimination, including complaints of sex-based harassment, requesting that the recipient investigate and make a determination about alleged discrimination under Title IX or this part: (i) A complainant; (ii) A parent, guardian, or other authorized legal representative with the legal right to act on behalf of a complainant; (iii) The Title IX Coordinator, after making the determination specified in § 106.44(f)(1)(v); (iv) With respect to complaints of sex discrimination other than sex-based harassment, in addition to the persons listed in paragraphs (a)(2)(i) through (iii) of this section, (A) Any student or employee; or (B) Any person other than a student or employee who was participating or attempting to participate in the recipient's education program or activity at the time of the alleged sex discrimination. (b) Basic requirements for grievance procedures. A recipient's grievance procedures must: (1) Treat complainants and respondents equitably; (2) Require that any person designated as a Title IX Coordinator, investigator, or decisionmaker not have a conflict of interest or bias for or against complainants or respondents generally or an individual complainant or respondent. The decisionmaker may be the same person as the Title IX Coordinator or investigator; (3) Include a presumption that the respondent is not responsible for the alleged sex discrimination until a determination is made at the conclusion of the recipient's grievance procedures for complaints of sex discrimination; (4) Establish reasonably prompt timeframes for the major stages of the grievance procedures, including a process that allows for the reasonable extension of timeframes on a case-by-case basis for good cause with notice to the parties that includes the reason for the delay. Major stages include, for example, evaluation ( i.e., the recipient's decision whether to dismiss or investigate a complaint of sex discrimination); investigation; determination; and appeal, if any; (5) Require the recipient to take reasonable steps to protect the privacy of the parties and witnesses during the pendency of a recipient's grievance procedures, provided that the steps do not restrict the ability of the parties to: obtain and present evidence, including by speaking to witnesses, subject to § 106.71; consult with their family members, confidential resources, or advisors; or otherwise prepare for or participate in the grievance procedures; (6) Require an objective evaluation of all evidence that is relevant, as defined in § 106.2, and not otherwise impermissible under paragraph (b)(7) of this section—including both inculpatory and exculpatory evidence—and provide that credibility determinations must not be based on a person's status as a complainant, respondent, or witness; (7) Exclude the following types of evidence, and questions seeking that evidence, as impermissible ( i.e., must not be accessed or considered, except by the recipient to determine whether an exception in paragraphs (i) through (iii) applies; must not be disclosed; and must not otherwise be used), regardless of whether they are relevant: (i) Evidence that is protected under a privilege as recognized by Federal or State law or evidence provided to a confidential employee, unless the person to whom the privilege or confidentiality is owed has voluntarily waived the privilege or confidentiality; (ii) A party's or witness's records that are made or maintained by a physician, psychologist, or other recognized professional or paraprofessional in connection with the provision of treatment to the party or witness, unless the recipient obtains that party's or witness's voluntary, written consent for use in the recipient's grievance procedures; and (iii) Evidence that relates to the complainant's sexual interests or prior sexual conduct, unless evidence about the complainant's prior sexual conduct is offered to prove that someone other than the respondent committed the alleged conduct or is evidence about specific incidents of the complainant's prior sexual conduct with the respondent that is offered to prove consent to the alleged sex-based harassment. The fact of prior consensual sexual conduct between the complainant and respondent does not by itself demonstrate or imply the complainant's consent to the alleged sex-based harassment or preclude determination that sex-based harassment occurred; and (8) If a recipient adopts grievance procedures that apply to the resolution of some, but not all, complaints articulate consistent principles for how the recipient will determine which procedures apply. (c) Notice of allegations. Upon initiation of the recipient's grievance procedures, a recipient must provide notice of the allegations to the parties whose identities are known. (1) The notice must include: (i) The recipient's grievance procedures under this section, and if applicable § 106.46, and any informal resolution process under § 106.44(k); (ii) Sufficient information available at the time to allow the parties to respond to the allegations. Sufficient information includes the identities of the parties involved in the incident(s), the conduct alleged to constitute sex discrimination under Title IX or this part, and the date(s) and location(s) of the alleged incident(s), to the extent that information is available to the recipient; (iii) A statement that retaliation is prohibited; and (iv) A statement that the parties are entitled to an equal opportunity to access the relevant and not otherwise impermissible evidence or an accurate description of this evidence as set out in paragraph (f)(4) of this section; and if the recipient provides a description of the evidence, the parties are entitled to an equal opportunity to access to the relevant and not otherwise impermissible evidence upon the request of any party. (2) If, in the course of an investigation, the recipient decides to investigate additional allegations of sex discrimination by the respondent toward the complainant that are not included in the notice provided under paragraph (c) of this section or that are included in a complaint that is consolidated under paragraph (e) of this section, the recipient must provide notice of the additional allegations to the parties whose identities are known. (d) Dismissal of a complaint. (1) A recipient may dismiss a complaint of sex discrimination made through its grievance procedures under this section, and if applicable § 106.46, for any of the following reasons: (i) The recipient is unable to identify the respondent after taking reasonable steps to do so; (ii) The respondent is not participating in the recipient's education program or activity and is not employed by the recipient; (iii) The complainant voluntarily withdraws any or all of the allegations in the complaint, the Title IX Coordinator declines to initiate a complaint under § 106.44(f)(1)(v), and the recipient determines that, without the complainant's withdrawn allegations, the conduct that remains alleged in the complaint, if any, would not constitute sex discrimination under Title IX or this part even if proven; or (iv) The recipient determines the conduct alleged in the complaint, even if proven, would not constitute sex discrimination under Title IX or this part. Prior to dismissing the complaint under this paragraph, the recipient must make reasonable efforts to clarify the allegations with the complainant. (2) Upon dismissal, a recipient must promptly notify the complainant of the basis for the dismissal. If the dismissal occurs after the respondent has been notified of the allegations, then the recipient must also notify the respondent of the dismissal and the basis for the dismissal promptly following notification to the complainant, or simultaneously if notification is in writing. (3) A recipient must notify the complainant that a dismissal may be appealed and provide the complainant with an opportunity to appeal the dismissal of a complaint on the bases set out in § 106.46(i)(1). If the dismissal occurs after the respondent has been notified of the allegations, then the recipient must also notify the respondent that the dismissal may be appealed on the bases set out in § 106.46(i)(1). If the dismissal is appealed, the recipient must: (i) Notify the parties of any appeal, including notice of the allegations consistent with paragraph (c) of this section if notice was not previously provided to the respondent; (ii) Implement appeal procedures equally for the parties; (iii) Ensure that the decisionmaker for the appeal did not take part in an investigation of the allegations or dismissal of the complaint; (iv) Ensure that the decisionmaker for the appeal has been trained as set out in § 106.8(d)(2); (v) Provide the parties a reasonable and equal opportunity to make a statement in support of, or challenging, the outcome; and (vi) Notify the parties of the result of the appeal and the rationale for the result. (4) A recipient that dismisses a complaint must, at a minimum: (i) Offer supportive measures to the complainant as appropriate under § 106.44(g); (ii) For dismissals under paragraph (d)(1)(iii) or (iv) of this section in which the respondent has been notified of the allegations, offer supportive measures to the respondent as appropriate under § 106.44(g); and (iii) Require its Title IX Coordinator to take other appropriate prompt and effective steps to ensure that sex discrimination does not continue or recur within the recipient's education program or activity under § 106.44(f)(1)(vii). (e) Consolidation of complaints. A recipient may consolidate complaints of sex discrimination against more than one respondent, or by more than one complainant against one or more respondents, or by one party against another party, when the allegations of sex discrimination arise out of the same facts or circumstances. If one of the complaints to be consolidated is a complaint of sex-based harassment involving a student complainant or student respondent at a postsecondary institution, the grievance procedures for investigating and resolving the consolidated complaint must comply with the requirements of § 106.46 in addition to the requirements of this section. When more than one complainant or more than one respondent is involved, references in this section and in § 106.46 to a party, complainant, or respondent include the plural, as applicable. (f) Complaint investigation. A recipient must provide for adequate, reliable, and impartial investigation of complaints. To do so, the recipient must: (1) Ensure that the burden is on the recipient—not on the parties—to conduct an investigation that gathers sufficient evidence to determine whether sex discrimination occurred; (2) Provide an equal opportunity for the parties to present fact witnesses and other inculpatory and exculpatory evidence that are relevant and not otherwise impermissible; (3) Review all evidence gathered through the investigation and determine what evidence is relevant and what evidence is impermissible regardless of relevance, consistent with § 106.2 and with paragraph (b)(7) of this section; and (4) Provide each party with an equal opportunity to access the evidence that is relevant to the allegations of sex discrimination and not otherwise impermissible, consistent with § 106.2 and with paragraph (b)(7) of this section, in the following manner: (i) A recipient must provide an equal opportunity to access either the relevant and not otherwise impermissible evidence, or an accurate description of this evidence. If the recipient provides a description of the evidence, it must further provide the parties with an equal opportunity to access the relevant and not otherwise impermissible evidence upon the request of any party; (ii) A recipient must provide a reasonable opportunity to respond to the evidence or to the accurate description of the evidence described in paragraph (f)(4)(i) of this section; and (iii) A recipient must take reasonable steps to prevent and address the parties' unauthorized disclosure of information and evidence obtained solely through the grievance procedures. For purposes of this paragraph, disclosures of such information and evidence for purposes of administrative proceedings or litigation related to the complaint of sex discrimination are authorized. (g) Questioning parties and witnesses to aid in evaluating allegations and assessing credibility. A recipient must provide a process that enables the decisionmaker to question parties and witnesses to adequately assess a party's or witness's credibility to the extent credibility is both in dispute and relevant to evaluating one or more allegations of sex discrimination. (h) Determination whether sex discrimination occurred. Following an investigation and evaluation of all relevant and not otherwise impermissible evidence under paragraphs (f) and (g) of this section, the recipient must: (1) Use the preponderance of the evidence standard of proof to determine whether sex discrimination occurred, unless the recipient uses the clear and convincing evidence standard of proof in all other comparable proceedings, including proceedings relating to other discrimination complaints, in which case the recipient may elect to use that standard of proof in determining whether sex discrimination occurred. Both standards of proof require the decisionmaker to evaluate relevant and not otherwise impermissible evidence for its persuasiveness; if the decisionmaker is not persuaded under the applicable standard by the evidence that sex discrimination occurred, whatever the quantity of the evidence is, the decisionmaker must not determine that sex discrimination occurred. (2) Notify the parties in writing of the determination whether sex discrimination occurred under Title IX or this part including the rationale for such determination, and the procedures and permissible bases for the complainant and respondent to appeal, if applicable; (3) If there is a determination that sex discrimination occurred, as appropriate, require the Title IX Coordinator to coordinate the provision and implementation of remedies to a complainant and other persons the recipient identifies as having had equal access to the recipient's education program or activity limited or denied by sex discrimination, coordinate the imposition of any disciplinary sanctions on a respondent, including notification to the complainant of any such disciplinary sanctions, and require the Title IX Coordinator to take other appropriate prompt and effective steps to ensure that sex discrimination does not continue or recur within the recipient's education program or activity under § 106.44(f)(1)(vii). A recipient may not impose discipline on a respondent for sex discrimination prohibited by Title IX unless there is a determination at the conclusion of the recipient's grievance procedures that the respondent engaged in prohibited sex discrimination; (4) Comply with § 106.45, and if applicable § 106.46, before the imposition of any disciplinary sanctions against a respondent; and (5) Not discipline a party, witness, or others participating in a recipient's grievance procedures for making a false statement or for engaging in consensual sexual conduct based solely on the recipient's determination whether sex discrimination occurred. (i) Appeals. In addition to an appeal of a dismissal consistent with paragraph (d)(3) of this section, a recipient must offer the parties an appeal process that, at a minimum, is the same as it offers in all other comparable proceedings, if any, including proceedings relating to other discrimination complaints. For a complaint of sex-based harassment involving a student complainant or student respondent, a postsecondary institution must also offer an appeal on the bases set out in § 106.46(i)(1). (j) Additional provisions. If a recipient adopts additional provisions as part of its grievance procedures for handling complaints of sex discrimination, including sex-based harassment, such additional provisions must apply equally to the parties. (k) Informal resolution. In lieu of resolving a complaint through the recipient's grievance procedures, the parties may instead elect to participate in an informal resolution process under § 106.44(k) if provided by the recipient consistent with that paragraph. (l) Provisions limited to sex-based harassment complaints. For complaints alleging sex-based harassment, the grievance procedures must: (1) Describe the range of supportive measures available to complainants and respondents under § 106.44(g); and (2) List, or describe the range of, the possible disciplinary sanctions that the recipient may impose and remedies that the recipient may provide following a determination that sex-based harassment occurred." 34:34:1.2.1.1.5.4.113.16,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.46 Grievance procedures for the prompt and equitable resolution of complaints of sex-based harassment involving student complainants or student respondents at postsecondary institutions.,ED,,,"[89 FR 33893, Apr. 29, 2024]","(a) General. A postsecondary institution's written grievance procedures for prompt and equitable resolution of complaints of sex-based harassment involving a student complainant or student respondent must include provisions that incorporate the requirements of § 106.45 and this section. (b) Student employees. When a complainant or respondent is both a student and an employee of a postsecondary institution, the postsecondary institution must make a fact-specific inquiry to determine whether the requirements of this section apply. In making this determination, a postsecondary institution must, at a minimum, consider whether the party's primary relationship with the postsecondary institution is to receive an education and whether the alleged sex-based harassment occurred while the party was performing employment-related work. (c) Written notice of allegations. Upon the initiation of the postsecondary institution's sex-based harassment grievance procedures under this section, a postsecondary institution must provide written notice to the parties whose identities are known with sufficient time for the parties to prepare a response before any initial interview. (1) The written notice must include all information required under § 106.45(c)(1)(i) through (iii) and also inform the parties that: (i) The respondent is presumed not responsible for the alleged sex-based harassment until a determination is made at the conclusion of the grievance procedures under this section and that prior to the determination, the parties will have an opportunity to present relevant and not otherwise impermissible evidence to a trained, impartial decisionmaker; (ii) They may have an advisor of their choice to serve in the role set out in paragraph (e)(2) of this section, and that the advisor may be, but is not required to be, an attorney; (iii) They are entitled to an equal opportunity to access the relevant and not otherwise impermissible evidence or an investigative report that accurately summarizes this evidence as set out in paragraph (e)(6) of this section; and if the postsecondary institution provides access to an investigative report, the parties are entitled to an equal opportunity to access to the relevant and not otherwise impermissible evidence upon the request of any party; and (iv) If applicable, the postsecondary institution's code of conduct prohibits knowingly making false statements or knowingly submitting false information during the grievance procedure. (2) If, in the course of an investigation, the recipient decides to investigate additional allegations of sex-based harassment by the respondent toward the complainant that are not included in the written notice provided under paragraph (c) of this section or that are included in a complaint that is consolidated under § 106.45(e), the recipient must provide written notice of the additional allegations to the parties whose identities are known. (3) To the extent the postsecondary institution has reasonable concerns for the safety of any person as a result of providing this notice, the postsecondary institution may reasonably delay providing written notice of the allegations in order to address the safety concern appropriately. Reasonable concerns must be based on individualized safety and risk analysis and not on mere speculation or stereotypes. (d) Dismissal of a complaint. When dismissing a complaint alleging sex-based harassment involving a student complainant or a student respondent, a postsecondary institution must: (1) Provide the parties, simultaneously, with written notice of the dismissal and the basis for the dismissal, if dismissing a complaint under any of the bases in § 106.45(d)(1), except if the dismissal occurs before the respondent has been notified of the allegations, in which case the recipient must provide such written notice only to the complainant; and (2) Obtain the complainant's withdrawal in writing if dismissing a complaint based on the complainant's voluntary withdrawal of the complaint or allegations under § 106.45(d)(1)(iii). (e) Complaint investigation. When investigating a complaint alleging sex-based harassment and throughout the postsecondary institution's grievance procedures for complaints of sex-based harassment involving a student complainant or a student respondent, a postsecondary institution: (1) Must provide, to a party whose participation is invited or expected, written notice of the date, time, location, participants, and purpose of all meetings or proceedings with sufficient time for the party to prepare to participate; (2) Must provide the parties with the same opportunities to be accompanied to any meeting or proceeding by the advisor of their choice, who may be, but is not required to be, an attorney, and not limit the choice or presence of the advisor for the complainant or respondent in any meeting or proceeding; however, the postsecondary institution may establish restrictions regarding the extent to which the advisor may participate in the grievance procedures, as long as the restrictions apply equally to the parties; (3) Must provide the parties with the same opportunities, if any, to have persons other than the advisor of the parties' choice present during any meeting or proceeding; (4) Has discretion to determine whether the parties may present expert witnesses as long as the determination applies equally to the parties; (5) Must allow for the reasonable extension of timeframes on a case-by-case basis for good cause with written notice to the parties that includes the reason for the delay; and (6) Must provide each party and the party's advisor, if any, with an equal opportunity to access the evidence that is relevant to the allegations of sex-based harassment and not otherwise impermissible, consistent with §§ 106.2 and 106.45(b)(7), in the following manner: (i) A postsecondary institution must provide an equal opportunity to access either the relevant and not otherwise impermissible evidence, or the same written investigative report that accurately summarizes this evidence. If the postsecondary institution provides access to an investigative report, it must further provide the parties with an equal opportunity to access the relevant and not otherwise impermissible evidence upon the request of any party; (ii) A postsecondary institution must provide the parties with a reasonable opportunity to review and respond to the evidence or the investigative report described in paragraph (e)(6)(i) of this section prior to the determination whether sex-based harassment occurred. If a postsecondary institution conducts a live hearing as part of its grievance procedures, it must provide this opportunity to review the evidence in advance of the live hearing; it is at the postsecondary institution's discretion whether to provide this opportunity to respond prior to the live hearing, during the live hearing, or both prior to and during the live hearing; (iii) A postsecondary institution must take reasonable steps to prevent and address the parties' and their advisors' unauthorized disclosure of information and evidence obtained solely through the sex-based harassment grievance procedures. For purposes of this paragraph, disclosures of such information and evidence for purposes of administrative proceedings or litigation related to the complaint of sex-based harassment are authorized; and (iv) Compliance with paragraph (e)(6) of this section satisfies the requirements of § 106.45(f)(4). (f) Questioning parties and witnesses to aid in evaluating allegations and assessing credibility. (1) Process for questioning parties and witnesses. A postsecondary institution must provide a process as specified in this subpart that enables the decisionmaker to question parties and witnesses to adequately assess a party's or witness's credibility to the extent credibility is both in dispute and relevant to evaluating one or more allegations of sex-based harassment. Questioning of the parties and witnesses must take place consistent with the following provisions before determining whether sex-based harassment occurred: (i) When a postsecondary institution chooses not to conduct a live hearing under paragraph (g) of this section, the process for proposing and asking relevant and not otherwise impermissible questions and follow-up questions of parties and witnesses under §§ 106.2 and 106.45(b)(7), including questions challenging credibility, must: (A) Allow the investigator or decisionmaker to ask such questions during individual meetings with a party or witness; (B) Allow each party to propose such questions that the party wants asked of any party or witness and have those questions asked by the investigator or decisionmaker during one or more individual meetings, including follow-up meetings, with a party or witness, subject to the requirements in paragraph (f)(3) of this section; and (C) Provide each party with an audio or audiovisual recording or transcript with enough time for the party to have a reasonable opportunity to propose follow-up questions. (ii) When a postsecondary institution chooses to conduct a live hearing under paragraph (g) of this section, the process for proposing and asking relevant and not otherwise impermissible questions and follow-up questions of parties and witnesses under §§ 106.2 and 106.45(b)(7), including questions challenging credibility, must allow the decisionmaker to ask such questions, and either: (A) Allow each party to propose such questions that the party wants asked of any party or witness and have those questions asked by the decisionmaker, subject to the requirements under paragraph (f)(3) of this section; or (B) Allow each party's advisor to ask any party or witness such questions, subject to the requirements under paragraph (f)(3) of this section. Such questioning must never be conducted by a party personally. If a postsecondary institution permits advisor-conducted questioning and a party does not have an advisor to ask questions on their behalf, the postsecondary institution must provide the party with an advisor of the postsecondary institution's choice, without charge to the party, for the purpose of advisor-conducted questioning. In those instances, the postsecondary institution must not appoint a confidential employee and may appoint, but is not required to appoint, an attorney to serve as an advisor. (2) Compliance with § 106.45(g). Compliance with paragraph (f)(1)(i) or (ii) of this section satisfies the requirements of § 106.45(g). (3) Procedures for the decisionmaker to evaluate the questions and limitations on questions. The decisionmaker must determine whether a proposed question is relevant under § 106.2 and not otherwise impermissible under § 106.45(b)(7), prior to the question being posed, and must explain any decision to exclude a question as not relevant or otherwise impermissible. If a decisionmaker determines that a party's question is relevant and not otherwise impermissible, then the question must be asked except that a postsecondary institution must not permit questions that are unclear or harassing of the party or witness being questioned. The decisionmaker must give a party an opportunity to clarify or revise a question that the decisionmaker has determined is unclear or harassing and, if the party sufficiently clarifies or revises a question to satisfy the terms of this paragraph, the question must be asked. A postsecondary institution may also adopt and apply other reasonable rules regarding decorum, provided they apply equally to the parties. (4) Refusal to respond to questions and inferences based on refusal to respond to questions. A decisionmaker may choose to place less or no weight upon statements by a party or witness who refuses to respond to questions deemed relevant and not impermissible. The decisionmaker must not draw an inference about whether sex-based harassment occurred based solely on a party's or witness's refusal to respond to such questions. (g) Live hearing procedures. A postsecondary institution's sex-based harassment grievance procedures may, but need not, provide for a live hearing. If a postsecondary institution chooses to conduct a live hearing, it may conduct the live hearing with the parties physically present in the same geographic location. At the postsecondary institution's discretion the institution may, or upon the request of either party it must, conduct the live hearing with the parties physically present in separate locations, with technology enabling the decisionmaker and parties to simultaneously see and hear the party or the witness while that person is speaking. A postsecondary institution must create an audio or audiovisual recording or transcript, of any live hearing and make it available to the parties for inspection and review. (h) Written determination whether sex-based harassment occurred. The postsecondary institution must provide the determination whether sex-based harassment occurred in writing to the parties simultaneously. (1) The written determination must include: (i) A description of the alleged sex-based harassment; (ii) Information about the policies and procedures that the postsecondary institution used to evaluate the allegations; (iii) The decisionmaker's evaluation of the relevant and not otherwise impermissible evidence and determination whether sex-based harassment occurred; (iv) When the decisionmaker finds that sex-based harassment occurred, any disciplinary sanctions the postsecondary institution will impose on the respondent, whether remedies other than the imposition of disciplinary sanctions will be provided by the postsecondary institution to the complainant, and, to the extent appropriate, other students identified by the postsecondary institution to be experiencing the effects of the sex-based harassment; and (v) The postsecondary institution's procedures for the complainant and respondent to appeal. (2) The determination regarding responsibility becomes final either on the date that the postsecondary institution provides the parties with the written determination of the result of any appeal, or, if no party appeals, the date on which an appeal would no longer be considered timely. (i) Appeals. (1) A postsecondary institution must offer the parties an appeal from a determination whether sex-based harassment occurred, and from a postsecondary institution's dismissal of a complaint or any allegations therein, on the following bases: (i) Procedural irregularity that would change the outcome; (ii) New evidence that would change the outcome and that was not reasonably available when the determination whether sex-based harassment occurred or dismissal was made; and (iii) The Title IX Coordinator, investigator, or decisionmaker had a conflict of interest or bias for or against complainants or respondents generally or the individual complainant or respondent that would change the outcome. (2) A postsecondary institution may offer an appeal to the parties on additional bases, so long as the procedures and additional bases for appeal are equally available to all parties. (3) As to all appeals, the postsecondary institution must comply with the requirements in § 106.45(d)(3)(i), (v), and (vi) in writing. (j) Informal resolution. If a postsecondary institution offers or provides the parties to the grievance procedures under § 106.45 and under this section with an informal resolution process under § 106.44(k), the postsecondary institution must inform the parties in writing of the offer and their rights and responsibilities in the informal resolution process and otherwise comply with the provisions of § 106.44(k)(3) in writing." 34:34:1.2.1.1.5.4.113.17,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.47 Assistant Secretary review of sex-based harassment complaints.,ED,,,"[89 FR 33895, Apr. 29, 2024]","The Assistant Secretary will not deem a recipient to have violated this part solely because the Assistant Secretary would have reached a different determination in a particular complaint alleging sex-based harassment than a recipient reached under § 106.45, and if applicable § 106.46, based on the Assistant Secretary's independent weighing of the evidence." 34:34:1.2.1.1.5.4.113.18,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.48 Severability.,ED,,,"[85 FR 30578, May 19, 2020. Redesignated at 89 FR 33893, Apr. 29, 2024]","If any provision of this subpart or its application to any person, act, or practice is held invalid, the remainder of the subpart or the application of its provisions to any person, act, or practice shall not be affected thereby." 34:34:1.2.1.1.5.4.113.2,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.32 Housing.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020]","(a) Generally. A recipient shall not, on the basis of sex, apply different rules or regulations, impose different fees or requirements, or offer different services or benefits related to housing, except as provided in this section (including housing provided only to married students). (b) Housing provided by recipient. (1) A recipient may provide separate housing on the basis of sex. (2) Housing provided by a recipient to students of one sex, when compared to that provided to students of the other sex, shall be as a whole: (i) Proportionate in quantity to the number of students of that sex applying for such housing; and (ii) Comparable in quality and cost to the student. (c) Other housing. (1) A recipient shall not, on the basis of sex, administer different policies or practices concerning occupancy by its students of housing other than provided by such recipient. (2) A recipient which, through solicitation, listing, approval of housing, or otherwise, assists any agency, organization, or person in making housing available to any of its students, shall take such reasonable action as may be necessary to assure itself that such housing as is provided to students of one sex, when compared to that provided to students of the other sex, is as a whole: (i) Proportionate in quantity and (ii) Comparable in quality and cost to the student. A recipient may render such assistance to any agency, organization, or person which provides all or part of such housing to students only of one sex." 34:34:1.2.1.1.5.4.113.3,34,Education,I,,106,PART 106—NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE,D,Subpart D—Discrimination on the Basis of Sex in Education Programs or Activities Prohibited,,§ 106.33 Comparable facilities.,ED,,,"[45 FR 30955, May 9, 1980, as amended at 85 FR 30579, May 19, 2020]","A recipient may provide separate toilet, locker room, and shower facilities on the basis of sex, but such facilities provided for students of one sex shall be comparable to such facilities provided for students of the other sex."