cfr_sections
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47 rows where part_number = 114 sorted by section_id
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| 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 |
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| 21:21:2.0.1.1.14.1.1.1 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | A | Subpart A—General Provisions | § 114.3 Definitions. | FDA | [44 FR 16235, Mar. 16, 1979, as amended at 61 FR 14245, Apr. 1, 1996] | For the purposes of this part, the following definitions apply. (a) Acid foods means foods that have a natural pH of 4.6 or below. (b) Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (a w ) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, “pickles” or “pickled ______.” Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and nonstandardized food dressings and condiment sauces) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this part. (c) Lot means the product produced during a period indicated by a specific code. (d) Low-acid foods means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (a w ) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods. (e) Scheduled process means the process selected by a processor as adequate for use under the conditions of manufacture for a food in achieving and maintaining a food that will not permit the growth of microorganisms having public health significance. It includes control of pH and other critical factors equivalent to the process established by a competent processing authority. (f) Shall is used to state mandatory requirements. (g) Should is used to state recommended or advisory procedures or to identify recommended equipment. (h) Water activity (a w ) is a measure of the free moisture in a product and is the quotient of the water vapor press… | |||
| 21:21:2.0.1.1.14.1.1.2 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | A | Subpart A—General Provisions | § 114.5 Current good manufacturing practice. | FDA | [80 FR 56144, Sept. 17, 2015] | The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in parts 110 and 117 of this chapter, apply in determining whether an article of acidified food is adulterated: (a) Within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it has been manufactured under such conditions that it is unfit for food; or (b) Within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. | |||
| 21:21:2.0.1.1.14.1.1.3 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | A | Subpart A—General Provisions | § 114.10 Personnel. | FDA | All operators of processing and packaging systems shall be under the operating supervisions of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food-protection principles, personal hygiene and plant sanitation practices, pH controls and critical factors in acidification, and who has been identified by that school as having satisfactorily completed the prescribed course of instruction. The Commissioner will consider students who have satisfactorily completed the required portions of the courses presented under § 108.35 and part 113 of this chapter before March 16, 1979, to be in compliance with the requirement of this section. | ||||
| 21:21:2.0.1.1.14.3.1.1 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | E | Subpart E—Production and Process Controls | § 114.80 Processes and controls. | FDA | (a) Processing operations. The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard. (1) Acidified foods shall be so manufactured, processed, and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. Manufacturing shall be in accordance with the scheduled process. Acidified foods shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. Permitted preservatives may be used to inhibit reproduction of microorganisms of nonhealth significance (in lieu of thermal processing). (2) Sufficient control, including frequent testing and recording of results, shall be exercised so that the finished equilibrium pH values for acidified foods are not higher than 4.6. Measurement of acidity of foods in-process may be made by potentiometric methods, titratable acidity, or colorimetric methods. If the finished equilibrium pH of the food is above 4.0, the measurement of the finished equilibrium pH shall be by a potentiometric method, and the in-process measurements by titration or colorimetry shall be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, then the measurement of acidity of the final product may be made by any suitable method. Special care should be taken when food ingredients have been subjected to lye, lime, or similar high pH materials. (3) Procedures for acidification to attain acceptable equilibrium pH levels in the final food include, but are not limited to, the following: (i) Blanching of the food ingredients in acidified aqueous solutions. (ii) Immersion of the blanched food in acid solutions. Although immersion of food in an acid solution is a sa… | ||||
| 21:21:2.0.1.1.14.3.1.2 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | E | Subpart E—Production and Process Controls | § 114.83 Establishing scheduled processes. | FDA | The scheduled process shall be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods. | ||||
| 21:21:2.0.1.1.14.3.1.3 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | E | Subpart E—Production and Process Controls | § 114.89 Deviations from scheduled processes. | FDA | Whenever any process operation deviates from the scheduled process for any acidified food and/or the equilibrium pH of the finished product is higher than 4.6, the commercial processor of the acidified food shall either: (a) Fully reprocess that portion of the food by a process established by a competent processing authority as adequate to ensure a safe product; (b) thermally process it as a low-acid food under part 113 of this chapter; or (c) set aside that portion of the food involved for further evaluation as to any potential public health significance. The evaluation shall be made by a competent processing authority and shall be in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health. Unless the evaluation demonstrates that the food has undergone a process that has rendered it safe, the food set aside shall either be fully reprocessed to render it safe, or be destroyed. A record shall be made of the procedures used in the evaluation and the results. Either upon completion of full reprocessing and the attainment of a safe food, or after the determination that no significant potential for public health hazard exists, that portion of the food involved may be shipped in normal distribution. Otherwise, the portion of the food involved shall be destroyed. | ||||
| 21:21:2.0.1.1.14.3.1.4 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | E | Subpart E—Production and Process Controls | § 114.90 Methodology. | FDA | [44 FR 16235, Mar. 16, 1979, as amended at 47 FR 11822, Mar. 19, 1982; 49 FR 5609, Feb. 14, 1984; 54 FR 24892, June 12, 1989; 63 FR 14035, Mar. 24, 1998] | Methods that may be used to determine pH or acidity for acidified foods include, but are not limited to, the following: (a) Potentiometric method for the determination of pH —(1) Principles. The term “pH” is used to designate the intensity or degree of acidity. The value of pH, the logarithm of the reciprocal of the hydrogen ion concentration in solution, is determined by measuring the difference in potential between two electrodes immersed in a sample solution. A suitable system consists of a potentiometer, a glass electrode, and a reference electrode. A precise pH determination can be made by making an electromotive force (emf) measurement of a standard buffer solution whose pH is known, and then comparing that measurement to an emf measurement of a sample of the solution to be tested. (2) Instruments. The primary instrument for use in pH determination is the pH meter or potentiometer. For most work, an instrument with a direct-reading pH scale is necessary. Battery and line-operated instruments are available commercially. If the line voltage is unstable, line-operated instruments should be fitted with voltage regulators to eliminate drifting of meter-scale readings. Batteries should be checked frequently to ensure proper operation of battery operated instruments. An instrument using an expanded unit scale or a digital readout system is preferred since it allows more precise measurements. (3) Electrodes. The typical pH meter is equipped with a glass membrane electrode and a reference electrode or a single probe combination electrode. Various types of electrodes designed for specific uses are available. The most commonly used reference electrode is the calomel electrode, which incorporates a salt bridge filled with saturated potassium chloride solution. (i) Care and use of electrodes. Calomel electrodes should be kept filled with saturated potassium chloride solution or other solution specified by the manufacturer because they may become damaged if they are allowed to dry out. For best results, elec… | |||
| 21:21:2.0.1.1.14.4.1.1 | 21 | Food and Drugs | I | B | 114 | PART 114—ACIDIFIED FOODS | F | Subpart F—Records and Reports | § 114.100 Records. | FDA | [44 FR 16235, Mar. 16, 1979, as amended at 65 FR 56479, Sept. 19, 2000] | (a) Records shall be maintained of examinations of raw materials, packaging materials, and finished products, and of suppliers' guarantees or certifications that verify compliance with Food and Drug Administration regulations and guidance documents or action levels. (b) Processing and production records showing adherence to scheduled processes, including records of pH measurements and other critical factors intended to ensure a safe product, shall be maintained and shall contain sufficient additional information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production. (c) All departures from scheduled processes having a possible bearing on public health or the safety of the food shall be noted and the affected portion of the product identified; these departures shall be recorded and made the subject of a separate file (or log identifying the appropriate data) delineating them, the action taken to rectify them, and the disposition of the portion of the product involved. (d) Records shall be maintained identifying initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use. (e) Copies of all records provided for in paragraphs (b), (c), and (d) of this section shall be retained at the processing plant or other reasonably accessible location for a period of 3 years from the date of manufacture. | |||
| 33:33:1.0.1.10.59.0.26.1 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.01 Purpose. | USCG | [USCG-2008-0179, 73 FR 35012, June 19, 2008, as amended by USCG-2013-0397, 78 FR 39174, July 1, 2013] | (a) The purpose of the rules and regulations in this subchapter is to implement certain laws and set forth the requirements for: (1) Locations and clearances of bridges and causeways over the navigable waters; (2) Administration of the alteration of unreasonably obstructive bridges; and (3) Regulation of drawbridge operation. (b) The rules and regulations in this subchapter also describe the procedures, practices, and instructions, which are applicable to the public subject to certain laws governing bridges and causeways over the navigable waters of the United States. | |||||
| 33:33:1.0.1.10.59.0.26.2 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.05 Definitions. | USCG | [USCG-2012-0306, 77 FR 37313, June 21, 2012, as amended by USCG-2020-0304, 85 FR 58278, Sept. 18, 2020] | The following definitions apply to this subchapter: Approved means approved by the Commandant unless otherwise stated. Bridge means a structure erected across navigable waters of the United States, and includes causeways, approaches, fenders, and other appurtenances thereto. Coast Guard District Commander or District Commander means an officer of the Coast Guard designated as such by the Commandant to command all Coast Guard activities within his or her district. (See part 3 of this chapter for descriptions of Coast Guard Districts.) Commandant means Commandant, U.S. Coast Guard, Department of Homeland Security, Washington, DC 20593. Deputy Commandant for Operations means the officer of the Coast Guard designated by the Commandant as the staff officer in charge of “Operations” (DCO), U.S. Coast Guard Headquarters. District Office or Coast Guard District Office means the Office of the Commander of a Coast Guard District. Headquarters or Coast Guard Headquarters means the Office of the Commandant, U.S. Coast Guard, Department of Homeland Security, Washington, DC 20593-7000. Permit means the license permitting construction of bridges and approaches thereto in or over navigable waters of the United States, issued under the rules and regulations in this subchapter. Secretary means the Secretary of Homeland Security or any person to whom he or she has delegated his or her authority in the matter concerned. United States Coast Guard or Coast Guard means the organization or agency established by the Act of January 28, 1915, as amended (14 U.S.C. 101). | |||||
| 33:33:1.0.1.10.59.0.26.3 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.10 General policies on issuance of permits and drawbridge operation regulations. | USCG | [CGD 82-006, 47 FR 36640, Aug. 23, 1982, as amended by USCG-2000-7223, 65 FR 40056, June 29, 2000; USCG-2013-0397, 78 FR 39174, July 1, 2013] | The several bridge laws referenced in the Authority for part 114, are intended to prevent any interference with navigable waters of the United States whether by bridges, dams, dikes or other obstructions to navigation except by express permission of the United States. The decision as to whether a bridge permit or a drawbridge operation regulation will be issued or promulgated must rest primarily upon the effect of the proposed action on navigation to assure that the action provides for the reasonable needs of navigation after full consideration of the effect of the proposed action on the human environment. The Coast Guard is not responsible for any other permits that the applicant may need from other federal, state, or local agencies and issuance of a bridge permit does not affect flood control projects or other governmental programs. | |||||
| 33:33:1.0.1.10.59.0.26.4 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.20 Departure from permit plans. | USCG | [CGFR 67-46, 32 FR 17769, Dec. 12, 1967, as amended by USCG-2012-0306, 77 FR 37314, June 21, 2012] | (a) If the final inspection shows a minor departure from the authorized plans which does not materially affect navigation, the permittee will be required to furnish as-built plans showing the work as actually constructed but no further action will be taken by the Coast Guard. (b) It is not the practice of the Coast Guard to issue letters certifying that completed work conforms to that which was authorized. That question is a matter of fact to be determined in case of controversy by the usual rules of court procedure. | |||||
| 33:33:1.0.1.10.59.0.26.5 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.25 Work constructed without prior authority. | USCG | [CGD 80-099, 46 FR 38354, July 27, 1981, as amended by USCG-2013-0397, 78 FR 39174, July 1, 2013; USCG-2020-0304, 85 FR 58278, Sept. 18, 2020] | The Commandant or District Commander will approve plans and issue permits authorizing bridges across navigable waters, in cases where the application therefor is submitted after the commencement or completion of the bridges subject to the following rules: Approval will be limited to those cases where the necessary primary authority, State or Federal as the case may be, validly existed, when the work was innocently constructed, and where the work will not unreasonably interfere with navigation. Upon issuance of the permit, applicant will be informed that the law contemplates prior approval and that in the future plans must be submitted in ample time for their consideration by the Commandant or District Commander before construction is begun. | |||||
| 33:33:1.0.1.10.59.0.26.6 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.30 Revocation. | USCG | [CGD 82-006, 47 FR 36640, Aug. 23, 1982] | Permits may be revoked by the issuing official for failure on the part of the permittee to comply with any of the conditions therein, or where the structures or other work constitute an unreasonable obstruction to navigation or to operations of the United States in the interest of navigation or flood control. | |||||
| 33:33:1.0.1.10.59.0.26.7 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.40 Violations of law. | USCG | [CGD 82-102, 47 FR 54299, Dec. 2, 1982, as amended by USCG-2001-9286, 66 FR 33641, June 25, 2001] | The Coast Guard has the authority and responsibility for enforcement of the applicable provisions of law for the protection and preservation of navigable waters. It is the policy of the Coast Guard to secure compliance with these provisions of law short of legal proceedings. As a general principle, no action is taken when the violation is minor, unintentional, or accidental and the party responsible corrects the violation. It is the policy of the Coast Guard to implement civil or criminal proceedings in all other circumstances. These proceedings are in subpart 1.07 of Part 1 of this chapter. | |||||
| 33:33:1.0.1.10.59.0.26.8 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.45 Applications, extensions of time. | USCG | [CGD 76-144, 42 FR 28882, June 6, 1977] | Extensions of time to commence or complete construction of a bridge or remove a bridge that has been replaced as an element of a permitted bridge project must be submitted to, and received by the District Commander at least 30 days before the existing permit expires to allow the permit to remain in effect until the final agency action is taken. | |||||
| 33:33:1.0.1.10.59.0.26.9 | 33 | Navigation and Navigable Waters | I | J | 114 | PART 114—GENERAL | § 114.50 Right of appeal. | USCG | [CGD 80-099, 46 FR 38354, July 27, 1981] | A District Commander's decision to deny a bridge permit application or an application for drawbridge operation regulations may be appealed to the Commandant, U.S. Coast Guard. The appeal must be submitted in writing to the Commandant (CG-BRG), Attn: Office of Bridge Programs, U.S. Coast Guard Stop 7418, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7418 or HQS-SMB-CG-BRG@uscg.mil , within 60 days of the District Commander's decision. The Commandant will take action on the appeal within 90 days of its receipt. | |||||
| 46:46:4.0.1.4.18.0.45.1 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.100 Purpose. | USCG | [USCG-2012-0196, 81 FR 48267, July 22, 2016] | The purpose of this subchapter is to implement applicable sections of Subtitle II of Title 46, United States Code, which require the inspection and certification of small passenger vessels. The regulations in this subchapter (parts 114 through 122) have preemptive effect over State or local regulations within the same fields. | |||||
| 46:46:4.0.1.4.18.0.45.10 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.600 Incorporation by reference. | USCG | [USCG-2012-0196, 81 FR 48268, July 22, 2016] | (a) Certain material is incorporated by reference into this subchapter 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 Coast Guard must publish a 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 U.S. Coast Guard, Office of Operating and Environmental Standards (CG-OES), 2703 Martin Luther King Jr. Avenue SE., Stop 7509, Washington, DC 20593-7509, and is available from the sources listed below. It 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) American Boat and Yacht Council (ABYC), 613 Third Street, Suite 10, Annapolis, MD 21403, 410-990-4460, http://www.abycinc.org . (1) A-1-93—Marine Liquefied Petroleum Gas (LPG) Systems, IBR approved for § 121.240(a), (c), (d), and (g). (2) A-3-93—Galley Stoves, IBR approved for § 121.200. (3) A-7-70—Boat Heating Systems, IBR approved for § 121.200. (4) A-22-93—Marine Compressed Natural Gas (CNG) Systems, IBR approved for § 121.240(b) through (e). (5) H-25-94—Portable Gasoline Fuel Systems for Flammable Liquids, IBR approved for § 119.458(b). (6) P-1-93—Installation of Exhaust Systems for Propulsion and Auxiliary Engines, IBR approved for §§ 116.405, 119.425(c) and 119.430(k). (c) American Bureau of Shipping (ABS), ABS Plaza, 16855 Northchase Drive, Houston, TX 77060, 281-877-5800, http://ww2.eagle.org . (1) Rules for Building and Classing Aluminum Vessels, 1975, IBR approved for § 116.300(b). (2) Rules for Building and Classing Steel Vessels, 1995, IBR approved for §§ 119.410 and 120.360(a). (3) Rules for Building and Classing Steel Vessels Under 61 Meters (200 Feet) in Length, 1983, IBR approved for § 116.300(a) and (b… | |||||
| 46:46:4.0.1.4.18.0.45.11 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.800 Approved equipment and material. | USCG | [CGD 85-080, 61 FR 885, Jan. 10, 1996, as amended at 62 FR 51348, Sept. 30, 1997] | (a) Equipment and material that is required by this subchapter to be approved or of an approved type, must have been manufactured and approved in accordance with the design and testing requirements in subchapter Q (Equipment, Construction, and Materials: Specifications and Approval) of this chapter or as otherwise specified by the Commandant. (b) Coast Guard publication COMDTINST M16714.3 (Series) “Equipment Lists, Items Approved, Certificated or Accepted under Marine Inspection and Navigation Laws,” lists approved equipment by type and manufacturer. COMDTINST M16714.3 (Series) may be obtained from New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. | |||||
| 46:46:4.0.1.4.18.0.45.12 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.900 OMB control numbers. | USCG | [CGD 85-080, 61 FR 885, Jan. 10, 1996, as amended by USCG-2004-18884, 69 FR 58348, Sept. 30, 2004] | (a) Purpose. This section lists the control numbers assigned to information collection and recordkeeping requirements in this subchapter by the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et. seq. ). The Coast Guard intends that this section comply with the requirements of 44 U.S.C. 3507(f), which requires that agencies display a current control number assigned by the Director of OMB for each approved agency information collection requirement. (b) Display. | |||||
| 46:46:4.0.1.4.18.0.45.2 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.110 General applicability. | USCG | [CGD 85-080, 61 FR 885, Jan. 10, 1996, as amended at 62 FR 51347, Sept. 30, 1997; USCG-2008-1107, 74 FR 63664, Dec. 4, 2009; 86 FR 73170, Dec. 27, 2021; 87 FR 3449, Jan. 24, 2022] | (a) Except as in paragraph (b) of this section, this subchapter applies to each vessel of less than 100 gross tons that carries more than 150 passengers, or has overnight accommodations for more than 49 passengers, and that— (1) Carries at least one passenger for hire; (2) Is chartered with or without a crew provided or specified by the owner or the owner's representative; or (3) If a submersible vessel, carries at least one passenger for hire; or (4) Is a ferry carrying more than 150 passengers, or having overnight accommodations for more than 49 passengers. For a vessel of less than 100 gross tons that carries 150 or less passengers or has overnight accommodations for 49 or less passengers, see subchapter T of this chapter. (b) This subchapter does not apply to: (1) A vessel operating exclusively on inland waters that are not navigable waters of the United States; (2) An oceanographic research vessel; (3) A boat forming part of a vessel's lifesaving equipment and that is not used for carrying passengers except in emergencies or during emergency drills; (4) A vessel of a foreign country that is a party to the International Convention for the Safety of Life at Sea, 1974, as amended (SOLAS), to which the United States Government is currently a party, and which has on board a current valid SOLAS Passenger Ship Safety Certificate; or (5) A vessel of a foreign country, whose government has inspection laws approximating those of the United States and which by its laws accords similar privileges to vessels of the United States, which has on board a current valid certificate of inspection, permitting the carrying of passengers, issued by its government. (c) Unless otherwise provided, an existing vessel that is not required to comply with a requirement in this subchapter may comply with the regulation that was applicable to the vessel on March 10, 1996. (d) A vessel required by this subchapter to meet applicable sections of subchapter H shall follow the phase-in schedule for certain equipment and requirement… | |||||
| 46:46:4.0.1.4.18.0.45.3 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.112 Specific applicability for individual parts. | USCG | At the beginning of certain parts of this subchapter, a more specific application is given for all or particular portions of that part. This application sets forth the type, size, service, or age of a vessel to which certain portions of that part apply or particular dates by which an existing vessel must comply with certain portions of that part. | ||||||
| 46:46:4.0.1.4.18.0.45.4 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.120 Vessels on an international voyage. | USCG | A mechanically propelled vessel that carries more than 12 passengers on an international voyage must comply with the applicable requirements of SOLAS as well as this subchapter. | ||||||
| 46:46:4.0.1.4.18.0.45.5 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.122 Load lines. | USCG | A vessel of 24 meters (79 feet) in length or more, the keel of which was laid or that was at a similar stage of construction on or after July 21, 1968, and that is on a voyage other than a domestic voyage is subject to load line assignment, certification, and marking in subchapter E (Load Lines) of this chapter. | ||||||
| 46:46:4.0.1.4.18.0.45.6 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.400 Definitions of terms used in this subchapter. | USCG | [CGD 85-080, 61 FR 887, Jan. 10, 1996] | (a) Terms used in this subchapter are defined in paragraph (b) of this section. The number in parenthesis after certain terms describing areas on a vessel refers to the applicable column and row number where that area is listed in Tables 116.415 (b) and (c) of part 116 of this subchapter. (b) General terms: Accommodation space (5, 6, or 7 depending on size, fire load, and furnishings) means a space that does not contain any cooking appliance other than a microwave oven or other low heat (maximum heating element temperature less than 121 °C (250 °F)) appliance used as a— (1) Public space; (2) Hall; (3) Dining room and messroom; (4) Lounge or cafe; (5) Public sales room; (6) Overnight accommodation space; (7) Barber shop or beauty parlor; (8) Office or conference room; (9) Medical treatment room or dispensary; or (10) Game or hobby room. Adequate hull protection system means a method of protecting the vessel's hull from corrosion. It includes, as a minimum, either hull coatings and a cathodic protection (CP) system consisting of sacrificial anodes, or an impressed current CP system. Alternative Hull Examination (AHE) Program means a program in which an eligible vessel may receive an initial and subsequent credit hull examination through a combination of underwater surveys, internal examinations, and annual hull condition assessments. Anniversary date means the day and the month of each year, which corresponds to the date of expiration of the Certificate of Inspection. Approval series means the first six digits of a number assigned by the Coast Guard to approved equipment. Where approval is based on a subpart of subchapter Q of this chapter, the approval series corresponds to the number of the subpart. A listing of current and formerly approved equipment and materials may be found on the Internet at: http://cgmix.uscg.mil/equipment. Area of refuge means an area that is separated from the effects of fire and flooding where passengers and crew can gather to await disembarking in the event of fi… | |||||
| 46:46:4.0.1.4.18.0.45.7 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.540 Equivalents. | USCG | [CGD 85-080, 61 FR 885, Jan. 10, 1996, as amended at 62 FR 51348, Sept. 30, 1997] | (a) The Commandant may approve any arrangement, fitting, appliance, apparatus, equipment, calculation, information, or test which provides a level of safety equivalent to that established by specific provisions of this subchapter. Requests for approval must be submitted to the Marine Safety Center. If necessary, the Marine Safety Center may require engineering evaluations and tests to demonstrate the equivalence of the substitute. (b) The Commandant may accept compliance by a high speed craft with the provisions of the International Maritime Organization (IMO) “Code of Safety for High Speed Craft” as an equivalent to compliance with applicable requirements of this subchapter. Requests for a determination of equivalency for a particular vessel must be submitted to the Marine Safety Center. (c) The Commandant may approve a novel lifesaving appliance or arrangement as an equivalent if it has performance characteristics at least equivalent to the appliance or arrangement required under this part, and: (1) Is evaluated and tested under IMO Resolution A.520(13), “Code of Practice for the Evaluation, Testing and Acceptance of Prototype Novel Life-Saving Appliances and Arrangements”; or (2) Has successfully undergone an evaluation and tests that are substantially equivalent to those recommendations. | |||||
| 46:46:4.0.1.4.18.0.45.8 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.550 Special consideration. | USCG | In applying the provisions of this subchapter, the OCMI may give special consideration to authorizing departures from the specific requirements when unusual circumstances or arrangements warrant such departures and an equivalent level of safety is provided. The OCMI of each marine inspection zone in which a vessel operates must approve any special consideration granted to the vessel. | ||||||
| 46:46:4.0.1.4.18.0.45.9 | 46 | Shipping | I | K | 114 | PART 114—GENERAL PROVISIONS | § 114.560 Appeals. | USCG | Any person directly affected by a decision or action taken under this subchapter, by or on behalf of the Coast Guard, may appeal therefrom in accordance with § 1.03 in subchapter A of this chapter. | ||||||
| 9:9:1.0.1.5.52.0.83.1 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.1 Applicability. | APHIS | [52 FR 11026, Apr. 7, 1987, as amended at 56 FR 66784, Dec. 26, 1991] | Unless exempted by regulation or otherwise authorized by the Administrator, all biological products prepared, sold, bartered or exchanged, shipped or delivered for shipment in or from the United States, the District of Columbia, any Territory of the United States, or any place under the jurisdiction of the United States shall be prepared in accordance with the regulations in this part. The licensee or permittee shall adopt and enforce all necessary measures and shall comply with all directions the Administrator prescribes for carrying out such regulations. | |||||
| 9:9:1.0.1.5.52.0.83.10 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.10 Antibiotics as preservatives. | APHIS | [39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991] | Antibiotics are authorized for use as preservatives for biological products if used within the limitations as to kinds and amounts prescribed in this section. (a) When an antibiotic or combination of antibiotics, with or without a fungistat is to be used in the preparation of a biological product, the kind(s) and amount(s) of each shall be specified in the outline for such product in such a way that the concentration in the final product may be calculated. Except as may be approved by the Administrator, only those individual antibiotics or combinations of antibiotics listed in paragraphs (b) and (c) of this section shall be used. (b) Permitted individual antibiotics: (1) The antibiotic level of a specified individual antibiotic in one ml. of a biological product, when prepared as recommended for use, shall not exceed the amounts listed in this paragraph: Provided, That in the case a desiccated biological product is to be used with an indefinite quantity of water or other menstruum, the determination shall be based on 30 ml. per 1,000 dose vial or equivalent. (2) Except as prescribed in paragraph (c) of this section, only one antibiotic shall be used as a preservative in a biological product. The kind and maximum amount per ml. of such antibiotic shall be restricted to: (c) Permitted combinations: (1) Penicillin and streptomycin. (2) Either amphotericin B or nystatin, but not both, may be used with one of the other antibiotics listed in paragraph (b) of this section, or with a combination of penicillin and streptomycin, or with a combination of polymyxin B and neomycin. (3) The maximum amount of each antibiotic in a combination shall be the amount prescribed for such antibiotic in paragraph (b) of this section. (d) Antibiotics used in virus seed stock purification are not restricted as to kind or amounts provided carryover into the final product is controlled and specified in outlines of production. | |||||
| 9:9:1.0.1.5.52.0.83.11 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.11 Storage and handling. | APHIS | [81 FR 59436, Aug. 30, 2016] | Biological products at licensed establishments must be protected at all times against improper storage and handling. Completed product must be kept under refrigeration at 35 to 46 °F (2 to 8 °C), unless the inherent nature of the product makes storage at different temperatures advisable, in which case, the proper storage temperature must be specified in the filed Outline of Production. All biological products to be shipped or delivered must be securely packed. | |||||
| 9:9:1.0.1.5.52.0.83.12 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.12 Expiration date required for a serial. | APHIS | [83 FR 11143, Mar. 14, 2018] | Unless otherwise provided for in a Standard Requirement or filed Outline of Production, each serial or subserial of a biological product prepared in a licensed establishment shall be given an expiration date according to the dating period of the product when computed from a date no later than the date of the initiation of the first potency test of the serial or subserial. A licensed biological product shall be considered worthless under the Virus-Serum-Toxin Act after the expiration date appearing on the label. | |||||
| 9:9:1.0.1.5.52.0.83.13 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.13 Determination of the dating period of a product. | APHIS | [83 FR 11143, Mar. 14, 2018] | The following requirements do not apply to those biological products used for diagnostic purposes. (a) Stability criteria. Stability criteria include the specifications for potency at release, potency throughout the dating period, and the length of the dating period. (b) Stability study requirement. The dating period of each fraction of each product shall be confirmed by conducting a stability study. (c) Licensure prior to completion of a stability study. Prior to licensure, the licensee shall propose a dating period for the product based on preliminary information available about the stability of each of its fractions. If the preliminary stability information is acceptable, the product may be licensed with the provision that the proposed dating period must be confirmed by conducting a real-time stability study with a stability-indicating potency assay that can detect changes over time in the potency of the product. (d) Use of stability-indicating assay. Stability studies must be conducted with a stability-indicating assay, with the following exceptions: (1) If the potency test specified in the filed Outline of Production of a licensed product is the one stated in the regulations, that potency test may be used in place of a stability-indicating assay for that fraction. (2) If the initial confirmation of dating study of a product in development on April 13, 2018 has an approved potency assay, that assay may be used. (e) Number of serials. At least three production serials of the product shall be selected for testing in the stability study. (f) Testing sequences —(1) Initial test. The first test in the sequence shall be as close as practical to the day of filling into final containers or the date of final formulation if the potency of the product is tested in bulk form. (2) Subsequent testing for in vitro assays. (i) One test every 3 months during the first year of storage; (ii) One test every 6 months during the second year of storage; and (iii) One test annually thereafter throughout the… | |||||
| 9:9:1.0.1.5.52.0.83.14 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.14 Extension of expiration date for a serial or subserial. | APHIS | [50 FR 24903, June 14, 1985, as amended at 56 FR 66784, Dec. 26, 1991] | (a) Unless otherwise provided for in a filed Outline of Production for the product, the expiration date shall not be extended: (1) If all fractions of the product are not evaluated for potency by tests designated in the filed Outline of Production for such product in accordance with § 113.4(b) of this subchapter. (2) For any serial or portion of any serial which has left licensed premises: Provided, That product which has been shipped from one licensed premises to another licensed premises shall be exempt from this requirement. (3) For a serial or portion of a serial if the expiration date has been extended previously, unless otherwise authorized in accordance with § 114.1. (b) An extension of the expiration date may be granted by Animal and Plant Health Inspection Service if a request from the licensee is substantiated by valid test data which demonstrate the potency of the product meets or exceeds the requirements for release. The new expiration date shall be calculated from the date the latest satisfactory potency test was initiated. The extension of the expiration date shall not exceed the maximum dating allowed in the filed Outline of Production. (1) Serials are approved for redating under the condition that Animal and Plant Health Inspection Service may require the firm to retest the redated serial for potency during the extended dating period and if found unsatisfactory require it be removed from the market by the licensee. (2) [Reserved] | |||||
| 9:9:1.0.1.5.52.0.83.15 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.15 Disposal of unsatisfactory products and byproducts. | APHIS | [41 FR 44687, Oct. 12, 1976, as amended at 56 FR 66784, Dec. 26, 1991] | All biological products found to be unsatisfactory for marketing, all biological products which have become worthless subsequent to the expiration date, all refuse, other materials deemed unsatisfactory for production purposes, all carcasses (part or whole) of production or test animals, and any undesirable byproducts of manufacture shall be disposed of as may be required by the Administrator. | |||||
| 9:9:1.0.1.5.52.0.83.16 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.16 Producing subsidiaries. | APHIS | [40 FR 46093, Oct. 6, 1975] | A serial or subserial of a biological product may be produced jointly by a licensee and one or more subsidiaries, or by two or more subsidiaries. The exact amount of each serial or subserial credited to each participating producer shall be determined at the time of labeling and packaging and shall be noted in the records for such serial or subserial. | |||||
| 9:9:1.0.1.5.52.0.83.17 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.17 Rebottling of biological products. | APHIS | [39 FR 16869, May 10, 1974, as amended at 56 FR 66784, Dec. 26, 1991] | The Administrator may authorize the rebottling of a completed product in liquid form subject to the conditions prescribed in this section. (a) All or part of a serial which has not left the licensed establishment may be aseptically returned to the mixing tank, thoroughly mixed, and rebottled in new final containers. (b) The rebottled product shall be adequately identified by serial number or subserial number, as the case may be. (c) Required purity tests for final container samples of the product shall be conducted on new samples selected from the rebottled product (serial or subserials). Rebottled product found to be unsatisfactory by such tests shall not be released. (d) New test samples from each serial or subserial and copies of test reports of all tests conducted on the rebottled product shall be submitted to Animal and Plant Health Inspection Service. (e) The licensee shall not release the rebottled product unless notified by Animal and Plant Health Inspection Service that such product is eligible for release. Production records shall show the results of all tests conducted and shall accurately reflect the actions taken. | |||||
| 9:9:1.0.1.5.52.0.83.18 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.18 Reprocessing of biological products. | APHIS | [50 FR 24904, June 15, 1985, as amended at 56 FR 66784, Dec. 26, 1991] | The Administrator may authorize a licensee to reprocess a serial of completed product subject to the conditions prescribed in this section. (a) Reprocessing shall not include any method or procedure which would be deleterious to the product. (b) All appropriate tests for purity, safety, potency, and efficacy for the product shall be conducted on the reprocessed product. A serial found unsatisfactory by a required test shall not be released. (c) The reprocessed serial shall be identified by a new serial number and the records for the serial shall accurately reflect the action taken. (d) Test samples of the reprocessed serial and test reports for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The licensee shall not release the serial until notified by Animal and Plant Health Inspection Service that the serial is eligible for release. | |||||
| 9:9:1.0.1.5.52.0.83.2 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.2 Products not prepared under license. | APHIS | [39 FR 16869, May 10, 1974, as amended at 60 FR 48021, Sept. 21, 1995] | (a) When an establishment license is issued, if biological products which were not prepared in compliance with the regulations are in the establishment, such products shall not be shipped or delivered for shipment or otherwise dealt with as having been prepared under such regulations. (b) Except as provided in 9 CFR part 103, a biological product shall not be prepared in a licensed establishment unless the person to whom the establishment license is issued holds an unexpired, unsuspended, and unrevoked product license issued by the Administrator to prepare such biological product, or unless the products prepared are subject to the provisions of § 107.2 of this subchapter. (c) A biological product produced in a USDA-licensed establishment shall be produced under a U.S. Veterinary Biological Product License or a license granted by a State under § 107.2 (referred to as a State biological product license and the products prepared pursuant thereto as State-licensed biological products, including autogenous biologics), but not under both a U.S. Veterinary Biological Product License and a State biological product license. Before a U.S. Veterinary Biological Product License (including a conditional license) is issued, the licensee shall relinquish its State license for that product: Provided, That autogenous biologics shall not be subject to this provision when they are prepared in accordance with the provisions of paragraph (c)(5) of this section. (1) State-licensed biological products (including autogenous biologics) shall only be distributed or shipped intrastate, must not bear a U.S. Veterinary Biologics Establishment License Number, and must not otherwise be represented in any manner as having met the requirements for a U.S. Veterinary Biological Product license. Labeling of State- and USDA-licensed biological products produced in the same establishment must be distinctly different in color and design. (2) All biological products in USDA-licensed establishments, whether licensed by USDA or by the State, shall … | |||||
| 9:9:1.0.1.5.52.0.83.3 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.3 Separation of establishments. | APHIS | [39 FR 16869, May 10, 1974, as amended at 40 FR 46093, Oct. 6, 1975; 49 FR 45846, Nov. 21, 1984; 56 FR 66784, Dec. 26, 1991] | (a) Each licensed establishment shall be separate and distinct from any other establishment in which a biological product is prepared. (b) No biological products authorized to be prepared in a licensed establishment shall be prepared in whole or in part by another licensed establishment except as provided in paragraphs (c) and (d) of this section. (c) When a partially prepared biological product cannot be completed at a licensed establishment due to failure of essential equipment, the Administrator may authorize the use of similar equipment at another licensed establishment: Provided, That, such authorization shall be limited to the duration of the emergency and to the phase of production affected by the equipment failure. (d) Partially prepared products or serials of completed products for further manufacture may be moved from one licensed establishment to another licensed establishment, imported under the provisions of § 104.5, or moved from a licensed establishment for purpose of being exported under conditions prescribed in an Outline of Production filed with Animal and Plant Health Inspection Service. Licensed products or products imported for distribution and sale may be prepared and recommended for final use, for further manufacturing purposes, or both. All serials shall be subject to the requirements for testing and release specified in § 113.5 or § 113.10 and to the requirements for identification specified in § 114.4. | |||||
| 9:9:1.0.1.5.52.0.83.4 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.4 Identification of biological products. | APHIS | Suitable tags or labels of a distinct design shall be used for identifying all ingredients used in the preparation of biological products, all component parts to be combined to form a biological product, all biological products while in the course of preparation and all completed biological products held in storage at licensed establishments: Provided, That, if such ingredients, components, or biological products are not so identified, they shall be disposed of as provided in § 114.15. | ||||||
| 9:9:1.0.1.5.52.0.83.5 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.5 Micro-organisms used as seed. | APHIS | [39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991] | Micro-organisms used in the preparation of biological products at licensed establishments shall be free from the causative agents of other diseases or conditions. A complete record of such micro-organisms shall be kept currently correct and a list submitted to Animal and Plant Health Inspection Service upon request of the Administrator. | |||||
| 9:9:1.0.1.5.52.0.83.6 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.6 Mixing biological products. | APHIS | Each biological product, when in liquid form, shall be mixed thoroughly in a single container. During bottling operations, the product shall be constantly mixed sufficient to maintain physical uniformity of the entire fill. A serial number, with any other markings that may be necessary for ready identification of the serial, shall be applied to identify it with the records of preparation and labeling. | ||||||
| 9:9:1.0.1.5.52.0.83.7 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.7 Personnel at licensed establishments. | APHIS | [39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991] | (a) Each licensee shall designate a person(s) to make all official contacts with Animal and Plant Health Inspection Service on matters pertaining to the preparation of biological products under the Virus-Serum-Toxin Act. The licensee shall file three copies of biographical summary with Animal and Plant Health Inspection Service for such designated person and for each person responsible for any phase of preparation of a biological product. (b) All personnel employed in the preparation of biological products at a licensed establishment shall be competent in good laboratory techniques through education or training, or both, so as to consistently prepare high quality products. (c) All biological products prepared at licensed establishments shall be prepared and handled with due sanitary precautions. Good sanitary measures shall be practiced at all times by all personnel involved in such preparation and handling of biological products. (1) The clothing worn by persons while preparing biological products shall be clean. All persons, immediately before entering laboratory rooms of a licensed establishment, shall change their outer clothing or effectively cover the same with gowns or other satisfactory clean garments. (2) Unsanitary practices such as, but not limited to, eating, smoking, or expectorating on the floors or otherwise creating a nuisance in any room, compartment, or place in which biological products are prepared, handled, or stored at licensed establishments are prohibited. | |||||
| 9:9:1.0.1.5.52.0.83.8 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.8 Outline of Production required. | APHIS | [39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, 1991; 75 FR 20773, Apr. 21, 2010] | An Outline of Production shall be on file with Animal and Plant Health Inspection Service for each licensed biological product or for each biological product authorized to be imported into the United States for Distribution and Sale. Preparation of a biological product in a licensed establishment shall be in accordance with the Outline of Production for such product filed with Animal and Plant Health Inspection Service as provided in this section, but subject to changes as may be required under § 114.8(f). (a) The Outline of Production shall be prepared as prescribed in § 114.9 and submitted to Animal and Plant Health Inspection Service for filing. When objectionable features, if any, are corrected and no further exceptions are taken by Animal and Plant Health Inspection Service to an Outline of Production for a biological product, such Outline of Production shall be approved for filing. (b) Each page shall be stamped as filed on the date such action was taken in the bottom right hand corner. Although the filed outline may be referred to as an approved outline, approval for filing constitutes no endorsement by Animal and Plant Health Inspection Service of such biological product or the methods and procedures used to prepare such biological product. (c) One copy of the Outline of Production shall be retained by the Animal and Plant Health Inspection Service and one copy returned to the licensee or permittee. (d) Each licensee shall review each Outline of Production for accuracy and sufficiency not less frequently than once a year. Revisions necessary to bring an Outline of Production into compliance with the regulations shall be submitted to Animal and Plant Health Inspection Service. (e) When a list of licensed products to be continued in production at a licensed establishment is requested by the Administrator in accordance with § 102.5(d) of this subchapter, the licensee shall supplement the list with information for each product as follows: (1) The Outline of Production currently being used shall be ident… | |||||
| 9:9:1.0.1.5.52.0.83.9 | 9 | Animals and Animal Products | I | E | 114 | PART 114—PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS | § 114.9 Outline of Production guidelines. | APHIS | [39 FR 16869, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 20124, May 2, 1991; 56 FR 66784, Dec. 26, 1991; 75 FR 20773, Apr. 21, 2010] | Each Outline of Production shall be prepared in accordance with the applicable directions provided in this section. (a) General requirements. (1) All copies of each Outline of Production or special outline or revised pages of either shall be prepared on heavy paper (8.5″ × 11″) of a type receptive to permanent stamp ink. (2) The name of the biological product (or component), the establishment license number, and the date prepared shall appear on a front cover page and each page of the Outline of Production or special outline. The name of the licensee (or foreign manufacturer) shall appear on the front cover page. (3) The pages shall be numbered in the upper center. At least 1 1/2 inch margin shall be left at the top of the first page and a 2 inch margin at the bottom of each page for the Animal and Plant Health Inspection Service stamp. (4) Amended pages shall be numbered the same as those being superseded. They shall bear the date prepared and refer to the date on the pages being superseded. If one replacement page supersedes more than one page, the new page shall indicate same, but if several replacement pages are added to supersede one page, the page number followed by letters shall be used. (5) The last page of both copies of either a new or a completely rewritten Outline of Production and each page revised separately shall be signed in the lower left corner by the authorized representative of the licensee (or foreign producer). Stamped or facsimile signatures are not acceptable. (6) A summary of changes shall appear on an attached page and refer to each page, paragraph, or subparagraph being changed. (7) Transmittal forms shall be used for the original and subsequent revisions. Transmittal forms are available on the Internet at ( http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml ). (b) Special outline. An outline describing the preparation of a component of a biological product or an operation performed in the preparation of a biological product may be required if such specia… |
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