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 21:21:1.0.1.1.23.1.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,A,Subpart A—General Provisions,,§ 58.1 Scope.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999]","(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted." 21:21:1.0.1.1.23.1.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,A,Subpart A—General Provisions,,§ 58.3 Definitions.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 54 FR 9039, Mar. 3, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729, May 21, 2002]","As used in this part, the following terms shall have the meanings specified: (a) Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)). (b) Test article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354-360F of the Public Health Service Act. (c) Control article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any article other than a test article, feed, or water that is administered to the test system in the course of a nonclinical laboratory study for the purpose of establishing a basis for comparison with the test article. (d) Nonclinical laboratory study means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article. (e) Application for research or marketing permit includes: (1) A color additive petition, described in part 71. (2) A food additive petition, described in parts 171 and 571. (3) Data and information regarding a substance submitted as part of the procedures for establishing that a substance is generally recognized as safe for use, which use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§ 170.35 and 570.35. (4) Data and information regarding a food additive submitted as part of the procedures regarding food additives permitted to be used on an interim basis pending additional study, described in § 180.1. (5) An investigational new drug application, described in part 312 of this chapter. (6) A new drug application, described in part 314. (7) Data and information regarding an over-the-counter drug for human use, submitted as part of the procedures for classifying such drugs as generally recognized as safe and effective and not misbranded, described in part 330. (8) Data and information about a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in parts 109 and 509. (9) [Reserved] (10) A Notice of Claimed Investigational Exemption for a New Animal Drug, described in part 511. (11) A new animal drug application, described in part 514. (12) [Reserved] (13) An application for a biologics license, described in part 601 of this chapter. (14) An application for an investigational device exemption, described in part 812. (15) An Application for Premarket Approval of a Medical Device, described in section 515 of the act. (16) A Product Development Protocol for a Medical Device, described in section 515 of the act. (17) Data and information regarding a medical device submitted as part of the procedures for classifying such devices, described in part 860. (18) Data and information regarding a medical device submitted as part of the procedures for establishing, amending, or repealing a performance standard for such devices, described in part 861. (19) Data and information regarding an electronic product submitted as part of the procedures for obtaining an exemption from notification of a radiation safety defect or failure of compliance with a radiation safety performance standard, described in subpart D of part 1003. (20) Data and information regarding an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for such product, described in section 358 of the Public Health Service Act. (21) Data and information regarding an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard as described in § 1010.4. (22) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from any electronic product performance standard, as described in § 1010.5. (23) A premarket notification for a food contact substance, described in part 170, subpart D, of this chapter. (f) Sponsor means: (1) A person who initiates and supports, by provision of financial or other resources, a nonclinical laboratory study; (2) A person who submits a nonclinical study to the Food and Drug Administration in support of an application for a research or marketing permit; or (3) A testing facility, if it both initiates and actually conducts the study. (g) Testing facility means a person who actually conducts a nonclinical laboratory study, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies. (h) Person includes an individual, partnership, corporation, association, scientific or academic establishment, government agency, or organizational unit thereof, and any other legal entity. (i) Test system means any animal, plant, microorganism, or subparts thereof to which the test or control article is administered or added for study. Test system also includes appropriate groups or components of the system not treated with the test or control articles. (j) Specimen means any material derived from a test system for examination or analysis. (k) Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments. (l) Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies. (m) Study director means the individual responsible for the overall conduct of a nonclinical laboratory study. (n) Batch means a specific quantity or lot of a test or control article that has been characterized according to § 58.105(a). (o) Study initiation date means the date the protocol is signed by the study director. (p) Study completion date means the date the final report is signed by the study director." 21:21:1.0.1.1.23.1.98.3,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,A,Subpart A—General Provisions,,§ 58.10 Applicability to studies performed under grants and contracts.,FDA,,,,"When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part." 21:21:1.0.1.1.23.1.98.4,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,A,Subpart A—General Provisions,,§ 58.15 Inspection of a testing facility.,FDA,,,,"(a) A testing facility shall permit an authorized employee of the Food and Drug Administration, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens required to be maintained regarding studies within the scope of this part. The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken. (b) The Food and Drug Administration will not consider a nonclinical laboratory study in support of an application for a research or marketing permit if the testing facility refuses to permit inspection. The determination that a nonclinical laboratory study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to the Food and Drug Administration." 21:21:1.0.1.1.23.10.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.200 Purpose.,FDA,,,,"(a) The purposes of disqualification are: (1) To permit the exclusion from consideration of completed studies that were conducted by a testing facility which has failed to comply with the requirements of the good laboratory practice regulations until it can be adequately demonstrated that such noncompliance did not occur during, or did not affect the validity or acceptability of data generated by, a particular study; and (2) To exclude from consideration all studies completed after the date of disqualification until the facility can satisfy the Commissioner that it will conduct studies in compliance with such regulations. (b) The determination that a nonclinical laboratory study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration." 21:21:1.0.1.1.23.10.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.202 Grounds for disqualification.,FDA,,,,"The Commissioner may disqualify a testing facility upon finding all of the following: (a) The testing facility failed to comply with one or more of the regulations set forth in this part (or any other regulations regarding such facilities in this chapter); (b) The noncompliance adversely affected the validity of the nonclinical laboratory studies; and (c) Other lesser regulatory actions (e.g., warnings or rejection of individual studies) have not been or will probably not be adequate to achieve compliance with the good laboratory practice regulations." 21:21:1.0.1.1.23.10.98.3,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.204 Notice of and opportunity for hearing on proposed disqualification.,FDA,,,,"(a) Whenever the Commissioner has information indicating that grounds exist under § 58.202 which in his opinion justify disqualification of a testing facility, he may issue to the testing facility a written notice proposing that the facility be disqualified. (b) A hearing on the disqualification shall be conducted in accordance with the requirements for a regulatory hearing set forth in part 16 of this chapter." 21:21:1.0.1.1.23.10.98.4,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.206 Final order on disqualification.,FDA,,,,"(a) If the Commissioner, after the regulatory hearing, or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, makes the findings required in § 58.202, he shall issue a final order disqualifying the facility. Such order shall include a statement of the basis for that determination. Upon issuing a final order, the Commissioner shall notify (with a copy of the order) the testing facility of the action. (b) If the Commissioner, after a regulatory hearing or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, does not make the findings required in § 58.202, he shall issue a final order terminating the disqualification proceeding. Such order shall include a statement of the basis for that determination. Upon issuing a final order the Commissioner shall notify the testing facility and provide a copy of the order." 21:21:1.0.1.1.23.10.98.5,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.210 Actions upon disqualification.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 59 FR 13200, Mar. 21, 1994]","(a) Once a testing facility has been disqualified, each application for a research or marketing permit, whether approved or not, containing or relying upon any nonclinical laboratory study conducted by the disqualified testing facility may be examined to determine whether such study was or would be essential to a decision. If it is determined that a study was or would be essential, the Food and Drug Administration shall also determine whether the study is acceptable, notwithstanding the disqualification of the facility. Any study done by a testing facility before or after disqualification may be presumed to be unacceptable, and the person relying on the study may be required to establish that the study was not affected by the circumstances that led to the disqualification, e.g., by submitting validating information. If the study is then determined to be unacceptable, such data will be eliminated from consideration in support of the application; and such elimination may serve as new information justifying the termination or withdrawal of approval of the application. (b) No nonclinical laboratory study begun by a testing facility after the date of the facility's disqualification shall be considered in support of any application for a research or marketing permit, unless the facility has been reinstated under § 58.219. The determination that a study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration." 21:21:1.0.1.1.23.10.98.6,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.213 Public disclosure of information regarding disqualification.,FDA,,,,"(a) Upon issuance of a final order disqualifying a testing facility under § 58.206(a), the Commissioner may notify all or any interested persons. Such notice may be given at the discretion of the Commissioner whenever he believes that such disclosure would further the public interest or would promote compliance with the good laboratory practice regulations set forth in this part. Such notice, if given, shall include a copy of the final order issued under § 58.206(a) and shall state that the disqualification constitutes a determination by the Food and Drug Administration that nonclinical laboratory studies performed by the facility will not be considered by the Food and Drug Administration in support of any application for a research or marketing permit. If such notice is sent to another Federal Government agency, the Food and Drug Administration will recommend that the agency also consider whether or not it should accept nonclinical laboratory studies performed by the testing facility. If such notice is sent to any other person, it shall state that it is given because of the relationship between the testing facility and the person being notified and that the Food and Drug Administration is not advising or recommending that any action be taken by the person notified. (b) A determination that a testing facility has been disqualified and the administrative record regarding such determination are disclosable to the public under part 20 of this chapter." 21:21:1.0.1.1.23.10.98.7,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.215 Alternative or additional actions to disqualification.,FDA,,,,"(a) Disqualification of a testing facility under this subpart is independent of, and neither in lieu of nor a precondition to, other proceedings or actions authorized by the act. The Food and Drug Administration may, at any time, institute against a testing facility and/or against the sponsor of a nonclinical laboratory study that has been submitted to the Food and Drug Administration any appropriate judicial proceedings (civil or criminal) and any other appropriate regulatory action, in addition to or in lieu of, and prior to, simultaneously with, or subsequent to, disqualification. The Food and Drug Administration may also refer the matter to another Federal, State, or local government law enforcement or regulatory agency for such action as that agency deems appropriate. (b) The Food and Drug Administration may refuse to consider any particular nonclinical laboratory study in support of an application for a research or marketing permit, if it finds that the study was not conducted in accordance with the good laboratory practice regulations set forth in this part, without disqualifying the testing facility that conducted the study or undertaking other regulatory action." 21:21:1.0.1.1.23.10.98.8,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.217 Suspension or termination of a testing facility by a sponsor.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 50 FR 8995, Mar. 6, 1985]","Termination of a testing facility by a sponsor is independent of, and neither in lieu of nor a precondition to, proceedings or actions authorized by this subpart. If a sponsor terminates or suspends a testing facility from further participation in a nonclinical laboratory study that is being conducted as part of any application for a research or marketing permit that has been submitted to any Center of the Food and Drug Administration (whether approved or not), it shall notify that Center in writing within 15 working days of the action; the notice shall include a statement of the reasons for such action. Suspension or termination of a testing facility by a sponsor does not relieve it of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration." 21:21:1.0.1.1.23.10.98.9,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,K,Subpart K—Disqualification of Testing Facilities,,§ 58.219 Reinstatement of a disqualified testing facility.,FDA,,,,"A testing facility that has been disqualified may be reinstated as an acceptable source of nonclinical laboratory studies to be submitted to the Food and Drug Administration if the Commissioner determines, upon an evaluation of the submission of the testing facility, that the facility can adequately assure that it will conduct future nonclinical laboratory studies in compliance with the good laboratory practice regulations set forth in this part and, if any studies are currently being conducted, that the quality and integrity of such studies have not been seriously compromised. A disqualified testing facility that wishes to be so reinstated shall present in writing to the Commissioner reasons why it believes it should be reinstated and a detailed description of the corrective actions it has taken or intends to take to assure that the acts or omissions which led to its disqualification will not recur. The Commissioner may condition reinstatement upon the testing facility being found in compliance with the good laboratory practice regulations upon an inspection. If a testing facility is reinstated, the Commissioner shall so notify the testing facility and all organizations and persons who were notified, under § 58.213 of the disqualification of the testing facility. A determination that a testing facility has been reinstated is disclosable to the public under part 20 of this chapter." 21:21:1.0.1.1.23.2.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,B,Subpart B—Organization and Personnel,,§ 58.29 Personnel.,FDA,,,,"(a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. (d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems. (e) Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles. (f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems, test and control articles and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a nonclinical laboratory study." 21:21:1.0.1.1.23.2.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,B,Subpart B—Organization and Personnel,,§ 58.31 Testing facility management.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]","For each nonclinical laboratory study, testing facility management shall: (a) Designate a study director as described in § 58.33, before the study is initiated. (b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study. (c) Assure that there is a quality assurance unit as described in § 58.35. (d) Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. (e) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled. (f) Assure that personnel clearly understand the functions they are to perform. (g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented." 21:21:1.0.1.1.23.2.98.3,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,B,Subpart B—Organization and Personnel,,§ 58.33 Study director.,FDA,,,"[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. 23, 1979]","For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that: (a) The protocol, including any change, is approved as provided by § 58.120 and is followed. (b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. (c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented. (d) Test systems are as specified in the protocol. (e) All applicable good laboratory practice regulations are followed. (f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study." 21:21:1.0.1.1.23.2.98.4,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,B,Subpart B—Organization and Personnel,,§ 58.35 Quality assurance unit.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]","(a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. (b) The quality assurance unit shall: (1) Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. (2) Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible. (3) Inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. Any problems found during the course of an inspection which are likely to affect study integrity shall be brought to the attention of the study director and management immediately. (4) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. (5) Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. (6) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study. (7) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director. (c) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees of the Food and Drug Administration. (d) A designated representative of the Food and Drug Administration shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed-up in accordance with this paragraph." 21:21:1.0.1.1.23.3.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,C,Subpart C—Facilities,,§ 58.41 General.,FDA,,,"[52 FR 33780, Sept. 4, 1987]",Each testing facility shall be of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. It shall be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study. 21:21:1.0.1.1.23.3.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,C,Subpart C—Facilities,,§ 58.43 Animal care facilities.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]","(a) A testing facility shall have a sufficient number of animal rooms or areas, as needed, to assure proper: (1) Separation of species or test systems, (2) isolation of individual projects, (3) quarantine of animals, and (4) routine or specialized housing of animals. (b) A testing facility shall have a number of animal rooms or areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test and control articles known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents. (c) Separate areas shall be provided, as appropriate, for the diagnosis, treatment, and control of laboratory animal diseases. These areas shall provide effective isolation for the housing of animals either known or suspected of being diseased, or of being carriers of disease, from other animals. (d) When animals are housed, facilities shall exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from the testing facility. Disposal facilities shall be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination." 21:21:1.0.1.1.23.3.98.3,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,C,Subpart C—Facilities,,§ 58.45 Animal supply facilities.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]","There shall be storage areas, as needed, for feed, bedding, supplies, and equipment. Storage areas for feed and bedding shall be separated from areas housing the test systems and shall be protected against infestation or contamination. Perishable supplies shall be preserved by appropriate means." 21:21:1.0.1.1.23.3.98.4,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,C,Subpart C—Facilities,,§ 58.47 Facilities for handling test and control articles.,FDA,,,,"(a) As necessary to prevent contamination or mixups, there shall be separate areas for: (1) Receipt and storage of the test and control articles. (2) Mixing of the test and control articles with a carrier, e.g., feed. (3) Storage of the test and control article mixtures. (b) Storage areas for the test and/or control article and test and control mixtures shall be separate from areas housing the test systems and shall be adequate to preserve the identity, strength, purity, and stability of the articles and mixtures." 21:21:1.0.1.1.23.3.98.5,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,C,Subpart C—Facilities,,§ 58.49 Laboratory operation areas.,FDA,,,"[52 FR 33780, Sept. 4, 1987]","Separate laboratory space shall be provided, as needed, for the performance of the routine and specialized procedures required by nonclinical laboratory studies." 21:21:1.0.1.1.23.3.98.6,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,C,Subpart C—Facilities,,§ 58.51 Specimen and data storage facilities.,FDA,,,,"Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies." 21:21:1.0.1.1.23.4.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,D,Subpart D—Equipment,,§ 58.61 Equipment design.,FDA,,,"[52 FR 33780, Sept. 4, 1987]","Equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control shall be of appropriate design and adequate capacity to function according to the protocol and shall be suitably located for operation, inspection, cleaning, and maintenance." 21:21:1.0.1.1.23.4.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,D,Subpart D—Equipment,,§ 58.63 Maintenance and calibration of equipment.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]","(a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, or assessment of data shall be adequately tested, calibrated and/or standardized. (b) The written standard operating procedures required under § 58.81(b)(11) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation. (c) Written records shall be maintained of all inspection, maintenance, testing, calibrating and/or standardizing operations. These records, containing the date of the operation, shall describe whether the maintenance operations were routine and followed the written standard operating procedures. Written records shall be kept of nonroutine repairs performed on equipment as a result of failure and malfunction. Such records shall document the nature of the defect, how and when the defect was discovered, and any remedial action taken in response to the defect." 21:21:1.0.1.1.23.5.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,E,Subpart E—Testing Facilities Operation,,§ 58.81 Standard operating procedures.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]","(a) A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management. (b) Standard operating procedures shall be established for, but not limited to, the following: (1) Animal room preparation. (2) Animal care. (3) Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles. (4) Test system observations. (5) Laboratory tests. (6) Handling of animals found moribund or dead during study. (7) Necropsy of animals or postmortem examination of animals. (8) Collection and identification of specimens. (9) Histopathology. (10) Data handling, storage, and retrieval. (11) Maintenance and calibration of equipment. (12) Transfer, proper placement, and identification of animals. (c) Each laboratory area shall have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Published literature may be used as a supplement to standard operating procedures. (d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained." 21:21:1.0.1.1.23.5.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,E,Subpart E—Testing Facilities Operation,,§ 58.83 Reagents and solutions.,FDA,,,,"All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Deteriorated or outdated reagents and solutions shall not be used." 21:21:1.0.1.1.23.5.98.3,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,E,Subpart E—Testing Facilities Operation,,§ 58.90 Animal care.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987; 54 FR 15924, Apr. 20, 1989; 56 FR 32088, July 15, 1991; 67 FR 9585, Mar. 4, 2002]","(a) There shall be standard operating procedures for the housing, feeding, handling, and care of animals. (b) All newly received animals from outside sources shall be isolated and their health status shall be evaluated in accordance with acceptable veterinary medical practice. (c) At the initiation of a nonclinical laboratory study, animals shall be free of any disease or condition that might interfere with the purpose or conduct of the study. If, during the course of the study, the animals contract such a disease or condition, the diseased animals shall be isolated, if necessary. These animals may be treated for disease or signs of disease provided that such treatment does not interfere with the study. The diagnosis, authorizations of treatment, description of treatment, and each date of treatment shall be documented and shall be retained. (d) Warm-blooded animals, excluding suckling rodents, used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require the animals to be removed from and returned to their home cages for any reason (e.g., cage cleaning, treatment, etc.), shall receive appropriate identification. All information needed to specifically identify each animal within an animal-housing unit shall appear on the outside of that unit. (e) Animals of different species shall be housed in separate rooms when necessary. Animals of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to control or test articles or animal mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification shall be made. (f) Animal cages, racks and accessory equipment shall be cleaned and sanitized at appropriate intervals. (g) Feed and water used for the animals shall be analyzed periodically to ensure that contaminants known to be capable of interfering with the study and reasonably expected to be present in such feed or water are not present at levels above those specified in the protocol. Documentation of such analyses shall be maintained as raw data. (h) Bedding used in animal cages or pens shall not interfere with the purpose or conduct of the study and shall be changed as often as necessary to keep the animals dry and clean. (i) If any pest control materials are used, the use shall be documented. Cleaning and pest control materials that interfere with the study shall not be used." 21:21:1.0.1.1.23.6.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,F,Subpart F—Test and Control Articles,,§ 58.105 Test and control article characterization.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]","(a) The identity, strength, purity, and composition or other characteristics which will appropriately define the test or control article shall be determined for each batch and shall be documented. Methods of synthesis, fabrication, or derivation of the test and control articles shall be documented by the sponsor or the testing facility. In those cases where marketed products are used as control articles, such products will be characterized by their labeling. (b) The stability of each test or control article shall be determined by the testing facility or by the sponsor either: (1) Before study initiation, or (2) concomitantly according to written standard operating procedures, which provide for periodic analysis of each batch. (c) Each storage container for a test or control article shall be labeled by name, chemical abstract number or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test or control article. Storage containers shall be assigned to a particular test article for the duration of the study. (d) For studies of more than 4 weeks' duration, reserve samples from each batch of test and control articles shall be retained for the period of time provided by § 58.195." 21:21:1.0.1.1.23.6.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,F,Subpart F—Test and Control Articles,,§ 58.107 Test and control article handling.,FDA,,,,"Procedures shall be established for a system for the handling of the test and control articles to ensure that: (a) There is proper storage. (b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage. (c) Proper identification is maintained throughout the distribution process. (d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned." 21:21:1.0.1.1.23.6.98.3,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,F,Subpart F—Test and Control Articles,,§ 58.113 Mixtures of articles with carriers.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 45 FR 24865, Apr. 11, 1980; 52 FR 33781, Sept. 4, 1987]","(a) For each test or control article that is mixed with a carrier, tests by appropriate analytical methods shall be conducted: (1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test or control article in the mixture. (2) To determine the stability of the test and control articles in the mixture as required by the conditions of the study either: (i) Before study initiation, or (ii) Concomitantly according to written standard operating procedures which provide for periodic analysis of the test and control articles in the mixture. (b) [Reserved] (c) Where any of the components of the test or control article carrier mixture has an expiration date, that date shall be clearly shown on the container. If more than one component has an expiration date, the earliest date shall be shown." 21:21:1.0.1.1.23.7.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,G,Subpart G—Protocol for and Conduct of a Nonclinical Laboratory Study,,§ 58.120 Protocol.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]","(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following information: (1) A descriptive title and statement of the purpose of the study. (2) Identification of the test and control articles by name, chemical abstract number, or code number. (3) The name of the sponsor and the name and address of the testing facility at which the study is being conducted. (4) The number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system. (5) The procedure for identification of the test system. (6) A description of the experimental design, including the methods for the control of bias. (7) A description and/or identification of the diet used in the study as well as solvents, emulsifiers, and/or other materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications. (8) Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units, of the test or control article to be administered and the method and frequency of administration. (9) The type and frequency of tests, analyses, and measurements to be made. (10) The records to be maintained. (11) The date of approval of the protocol by the sponsor and the dated signature of the study director. (12) A statement of the proposed statistical methods to be used. (b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the protocol." 21:21:1.0.1.1.23.7.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,G,Subpart G—Protocol for and Conduct of a Nonclinical Laboratory Study,,§ 58.130 Conduct of a nonclinical laboratory study.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]","(a) The nonclinical laboratory study shall be conducted in accordance with the protocol. (b) The test systems shall be monitored in conformity with the protocol. (c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data. (d) Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that specimen histopathologically. (e) All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified." 21:21:1.0.1.1.23.9.98.1,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,J,Subpart J—Records and Reports,,§ 58.185 Reporting of nonclinical laboratory study results.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987]","(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following: (1) Name and address of the facility performing the study and the dates on which the study was initiated and completed. (2) Objectives and procedures stated in the approved protocol, including any changes in the original protocol. (3) Statistical methods employed for analyzing the data. (4) The test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics. (5) Stability of the test and control articles under the conditions of administration. (6) A description of the methods used. (7) A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification. (8) A description of the dosage, dosage regimen, route of administration, and duration. (9) A description of all circumstances that may have affected the quality or integrity of the data. (10) The name of the study director, the names of other scientists or professionals, and the names of all supervisory personnel, involved in the study. (11) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis. (12) The signed and dated reports of each of the individual scientists or other professionals involved in the study. (13) The locations where all specimens, raw data, and the final report are to be stored. (14) The statement prepared and signed by the quality assurance unit as described in § 58.35(b)(7). (b) The final report shall be signed and dated by the study director. (c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible." 21:21:1.0.1.1.23.9.98.2,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,J,Subpart J—Records and Reports,,§ 58.190 Storage and retrieval of records and data.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4, 2002]","(a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained. (b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations. (c) An individual shall be identified as responsible for the archives. (d) Only authorized personnel shall enter the archives. (e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval." 21:21:1.0.1.1.23.9.98.3,21,Food and Drugs,I,A,58,PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES,J,Subpart J—Records and Reports,,§ 58.195 Retention of records.,FDA,,,"[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33781, Sept. 4, 1987; 54 FR 9039, Mar. 3, 1989]","(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter. (b) Except as provided in paragraph (c) of this section, documentation records, raw data and specimens pertaining to a nonclinical laboratory study and required to be made by this part shall be retained in the archive(s) for whichever of the following periods is shortest: (1) A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drug Administration. This requirement does not apply to studies supporting investigational new drug applications (IND's) or applications for investigational device exemptions (IDE's), records of which shall be governed by the provisions of paragraph (b)(2) of this section. (2) A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to the Food and Drug Administration in support of an application for a research or marketing permit. (3) In other situations (e.g., where the nonclinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued. (c) Wet specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids), samples of test or control articles, and specially prepared material, which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. In no case shall retention be required for longer periods than those set forth in paragraphs (a) and (b) of this section. (d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by § 58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of this section. (e) Summaries of training and experience and job descriptions required to be maintained by § 58.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraphs (a) and (b) of this section. (f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 58.63(b) and (c), shall be retained for the length of time specified in paragraph (b) of this section. (g) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. (h) If a facility conducting nonclinical testing goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The Food and Drug Administration shall be notified in writing of such a transfer." 24:24:1.1.1.1.32.1.59.1,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,A,"Subpart A—Purpose, Legal Authority, Federal Laws and Authorities",,§ 58.1 Purpose and applicability.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 68 FR 56127, Sept. 29, 2003; 89 FR 20056, Mar. 20, 2024]","(a) Purpose. This part provides instructions and guidance to recipients of HUD assistance and other responsible entities for conducting an environmental review for a particular project or activity and for obtaining approval of a Request for Release of Funds. (b) Applicability. This part applies to activities and projects where specific statutory authority exists for recipients or other responsible entities to assume environmental responsibilities. Programs and activities subject to this part include: (1) Community Development Block Grant programs authorized by Title I of the Housing and Community Development Act of 1974, in accordance with section 104(g) (42 U.S.C. 5304(g)); (2) [Reserved] (3)(i) Grants to states and units of general local government under the Emergency Shelter Grant Program, Supportive Housing Program (and its predecessors, the Supportive Housing Demonstration Program (both Transitional Housing and Permanent Housing for Homeless Persons with Disabilities) and Supplemental Assistance for Facilities to Assist the Homeless), Shelter Plus Care Program, Safe Havens for Homeless Individuals Demonstration Program, and Rural Homeless Housing Assistance, authorized by Title IV of the McKinney-Vento Homeless Assistance Act, in accordance with section 443 (42 U.S.C. 11402); (ii) Grants beginning with Fiscal Year 2001 to private non-profit organizations and housing agencies under the Supportive Housing Program and Shelter Plus Care Program authorized by Title IV of the McKinney-Vento Homeless Assistance Act, in accordance with section 443 (42 U.S.C. 11402); (4) The HOME Investment Partnerships Program authorized by Title II of the Cranston-Gonzalez National Affordable Housing Act (NAHA), in accordance with section 288 (42 U.S.C. 12838); (5) Grants to States and units of general local government for abatement of lead-based paint and lead dust hazards pursuant to Title II of the Departments of Veterans Affairs and Housing and Urban Development and Independent Agencies Appropriations Act, 1992, and grants for lead-based paint hazard reduction under section 1011 of the Housing and Community Development Act of 1992, in accordance with section 1011(o) (42 U.S.C. 4852(o)); (6)(i) Public Housing Programs under Title I of the United States Housing Act of 1937, including HOPE VI grants authorized under section 24 of the Act for Fiscal Year 2000 and later, in accordance with section 26 (42 U.S.C. 1437x); (ii) Grants for the revitalization of severely distressed public housing (HOPE VI) for Fiscal Year 1999 and prior years, in accordance with Title II of the Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations Act, 1999 (Pub. L. 105-276, approved October 21, 1998); and (iii) Assistance administered by a public housing agency under section 8 of the United States Housing Act of 1937, except for assistance provided under part 886 of this title, in accordance with section 26 (42 U.S.C. 1437x); (7) Special Projects appropriated under an appropriation act for HUD, such as special projects under the heading “Annual Contributions for Assisted Housing” in Title II of various Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations Acts, in accordance with section 305(c) of the Multifamily Housing Property Disposition Reform Act of 1994 (42 U.S.C. 3547); (8) The FHA Multifamily Housing Finance Agency Pilot Program under section 542(c) of the Housing and Community Development Act of 1992, in accordance with section 542(c)(9)(12 U.S.C. 1707 note); (9) The Self-Help Homeownership Opportunity Program under section 11 of the Housing Opportunity Program Extension Act of 1996 (Pub. L. 104-120, 110 Stat. 834), in accordance with section 11(m)); (10) Assistance provided under the Native American Housing Assistance and Self-Determination Act of 1996 (NAHASDA), in accordance with: (i) Section 105 for Indian Housing Block Grants and Federal Guarantees or Financing for Tribal Housing Authorities (25 U.S.C. 4115 and 4226); and (ii) Section 806 for Native Hawaiian Housing Block Grants (25 U.S.C. 4226); (11) Indian Housing Loan Guarantees authorized by section 184 of the Housing and Community Development Act of 1992 on trust land and on fee land within an Indian reservation, and on fee land owned by the Indian Tribe outside of the Tribe's Indian reservation boundaries, in accordance with section 184(k) (12 U.S.C. 1715z-13a(k)); and (12) Grants for Housing Opportunities for Persons with AIDS (HOPWA) under the AIDS Housing Opportunity Act, as follows: competitive grants beginning with Fiscal Year 2001 and all formula grants, in accordance with section 856(h) (42 U.S.C. 12905(h)); all grants for Fiscal Year 1999 and prior years, in accordance with section 207(c) of the Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations Act, 1999 (Pub. L. 105-276, approved October 21, 1998). (c) When HUD assistance is used to help fund a revolving loan fund that is administered by a recipient or another party, the activities initially receiving assistance from the fund are subject to the requirements in this part. Future activities receiving assistance from the revolving loan fund, after the fund has received loan repayments, are subject to the environmental review requirements if the rules of the HUD program that initially provided assistance to the fund continue to treat the activities as subject to the Federal requirements. If the HUD program treats the activities as not being subject to any Federal requirements, then the activities cease to become Federally-funded activities and the provisions of this part do not apply. (d) To the extent permitted by applicable laws and the applicable regulations of the Council on Environmental Quality, the Assistant Secretary for Community Planning and Development may, for good cause and with appropriate conditions, approve waivers and exceptions or establish criteria for exceptions from the requirements of this part." 24:24:1.1.1.1.32.1.59.2,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,A,"Subpart A—Purpose, Legal Authority, Federal Laws and Authorities",,"§ 58.2 Terms, abbreviations and definitions.",HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 68 FR 56128, Sept. 29, 2003]","(a) For the purposes of this part, the following definitions supplement the uniform terminology provided in 40 CFR part 1508: (1) Activity means an action that a grantee or recipient puts forth as part of an assisted project, regardless of whether its cost is to be borne by the HUD assistance or is an eligible expense under the HUD assistance program. (2) Certifying Officer means the official who is authorized to execute the Request for Release of Funds and Certification and has the legal capacity to carry out the responsibilities of § 58.13. (3) Extraordinary Circumstances means a situation in which an environmental assessment (EA) or environmental impact statement (EIS) is not normally required, but due to unusual conditions, an EA or EIS is appropriate. Indicators of unusual conditions are: (i) Actions that are unique or without precedent; (ii) Actions that are substantially similar to those that normally require an EIS; (iii) Actions that are likely to alter existing HUD policy or HUD mandates; or (iv) Actions that, due to unusual physical conditions on the site or in the vicinity, have the potential for a significant impact on the environment or in which the environment could have a significant impact on users of the facility. (4) Project means an activity, or a group of integrally related activities, designed by the recipient to accomplish, in whole or in part, a specific objective. (5) Recipient means any of the following entities, when they are eligible recipients or grantees under a program listed in § 58.1(b): (i) A State that does not distribute HUD assistance under the program to a unit of general local government; (ii) Guam, the Northern Mariana Islands, the Virgin Islands, American Samoa, and Palau; (iii) A unit of general local government; (iv) An Indian tribe; (v) With respect to Public Housing Programs under § 58.1(b)(6)(i), fiscal year 1999 and prior HOPE VI grants under § 58.1(b)(6)(ii) or Section 8 assistance under § 58.1(b)(6)(iii), a public housing agency; (vi) Any direct grantee of HUD for a special project under § 58.1(b)(7); (vii) With respect to the FHA Multifamily Housing Finance Agency Program under 58.1(b)(8), a qualified housing finance agency; (viii) With respect to the Self-Help Homeownership Opportunity Program under § 58.1(b)(9), any direct grantee of HUD. (ix)(A) With respect to NAHASDA assistance under § 58.1(b)(10), the Indian tribe or the Department of Hawaiian Home Lands; and (B) With respect to the Section 184 Indian Housing Loan Guarantee program under § 58.1(b)(11), the Indian tribe. (x) With respect to the Shelter Plus Care and Supportive Housing Programs under § 58.1(b)(3)(ii), nonprofit organizations and other entities. (6) Release of funds. In the case of the FHA Multifamily Housing Finance Agency Program under § 58.1(b)(8), Release of Funds, as used in this part, refers to HUD issuance of a firm approval letter, and Request for Release of Funds refers to a recipient's request for a firm approval letter. In the case of the Section 184 Indian Housing Loan Guarantee program under § 58.1(b)(11), Release of Funds refers to HUD's issuance of a commitment to guarantee a loan, or if there is no commitment, HUD's issuance of a certificate of guarantee. (7) Responsible Entity. Responsible Entity means: (i) With respect to environmental responsibilities under programs listed in § 58.1(b)(1), (2), (3)(i), (4), and (5), a recipient under the program. (ii) With respect to environmental responsibilities under the programs listed in § 58.1(b)(3)(ii) and (6) through (12), a state, unit of general local government, Indian tribe or Alaska Native Village, or the Department of Hawaiian Home Lands, when it is the recipient under the program. Under the Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4101 et seq. ) listed in § 58.1(b)(10)(i), the Indian tribe is the responsible entity whether or not a Tribally Designated Housing Entity is authorized to receive grant amounts on behalf of the tribe. The Indian tribe is also the responsible entity under the Section 184 Indian Housing Loan Guarantee program listed in § 58.1(b)(11). Regional Corporations in Alaska are considered Indian tribes in this part. Non-recipient responsible entities are designated as follows: (A) For qualified housing finance agencies, the State or a unit of general local government, Indian tribe or Alaska native village whose jurisdiction contains the project site; (B) For public housing agencies, the unit of general local government within which the project is located that exercises land use responsibility, or if HUD determines this infeasible, the county, or if HUD determines this infeasible, the State; (C) For non-profit organizations and other entities, the unit of general local government, Indian tribe or Alaska native village within which the project is located that exercises land use responsibility, or if HUD determines this infeasible, the county, or if HUD determines this infeasible, the State; (8) Unit Density refers to a change in the number of dwelling units. Where a threshold is identified as a percentage change in density that triggers review requirements, no distinction is made between an increase or a decrease in density. (9) Tiering means the evaluation of an action or an activity at various points in the development process as a proposal or event becomes ripe for an Environment Assessment or Review. (10) Vacant Building means a habitable structure that has been vacant for more than one year. (b) The following abbreviations are used throughout this part: (1) CDBG—Community Development Block Grant; (2) CEQ—Council on Environmental Quality; (3) EA—Environmental Assessment; (4) EIS—Environmental Impact Statement; (5) EPA—Environmental Protection Agency; (6) ERR—Environmental Review Record; (7) FONSI—Finding of No Significant Impact; (8) HUD—Department of Housing and Urban Development; (9) NAHA—Cranston-Gonzalez National Affordable Housing Act of 1990; (10) NEPA—National Environmental Policy Act of 1969, as amended; (11) NOI/EIS—Notice of Intent to Prepare an EIS; (12) NOI/RROF—Notice of Intent to Request Release of Funds; (13) ROD—Record of Decision; (14) ROF—Release of Funds; and (15) RROF—Request for Release of Funds." 24:24:1.1.1.1.32.1.59.3,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,A,"Subpart A—Purpose, Legal Authority, Federal Laws and Authorities",,§ 58.4 Assumption authority.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 68 FR 56128, Sept. 29, 2003]","(a) Assumption authority for responsible entities: General. Responsible entities shall assume the responsibility for environmental review, decision-making, and action that would otherwise apply to HUD under NEPA and other provisions of law that further the purposes of NEPA, as specified in § 58.5. Responsible entities that receive assistance directly from HUD assume these responsibilities by execution of a grant agreement with HUD and/or a legally binding document such as the certification contained on HUD Form 7015.15, certifying to the assumption of environmental responsibilities. When a State distributes funds to a responsible entity, the State must provide for appropriate procedures by which these responsible entities will evidence their assumption of environmental responsibilities. (b) Particular responsibilities of the States. (1) States are recipients for purposes of directly undertaking a State project and must assume the environmental review responsibilities for the State's activities and those of any non-governmental entity that may participate in the project. In this case, the State must submit the certification and RROF to HUD for approval. (2) States must exercise HUD's responsibilities in accordance with § 58.18, with respect to approval of a unit of local government's environmental certification and RROF for a HUD assisted project funded through the state. Approval by the state of a unit of local government's certification and RROF satisfies the Secretary's responsibilities under NEPA and the related laws cited in § 58.5. (c) Particular responsibilities of Indian tribes. An Indian tribe may, but is not required to, assume responsibilities for environmental review, decision-making and action for programs authorized by the Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4101 et seq. ) (other than title VIII) or section 184 of the Housing and Community Development Act of 1992 (12 U.S.C. 1715z-13a). The tribe must make a separate decision regarding assumption of responsibilities for each of these Acts and communicate that decision in writing to HUD. If the tribe assumes these responsibilities, the requirements of this part shall apply. If a tribe formally declines assumption of these responsibilities, they are retained by HUD and the provisions of part 50 of this title apply." 24:24:1.1.1.1.32.1.59.4,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,A,"Subpart A—Purpose, Legal Authority, Federal Laws and Authorities",,§ 58.5 Related Federal laws and authorities.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 68 FR 56128, Sept. 29, 2003; 78 FR 68734, Nov. 15, 2013; 89 FR 30913, Apr. 23, 2024]","In accordance with the provisions of law cited in § 58.1(b), the responsible entity must assume responsibilities for environmental review, decision-making and action that would apply to HUD under the following specified laws and authorities. The responsible entity must certify that it has complied with the requirements that would apply to HUD under these laws and authorities and must consider the criteria, standards, policies and regulations of these laws and authorities. (a) Historic properties. (1) The National Historic Preservation Act of 1966 (16 U.S.C. 470 et seq. ), particularly sections 106 and 110 (16 U.S.C. 470 and 470h-2). (2) Executive Order 11593, Protection and Enhancement of the Cultural Environment, May 13, 1971 (36 FR 8921), 3 CFR 1971-1975 Comp., p. 559, particularly section 2(c). (3) Federal historic preservation regulations as follows: (i) 36 CFR part 800 with respect to HUD programs other than Urban Development Action Grants (UDAG); and (ii) 36 CFR part 801 with respect to UDAG. (4) The Reservoir Salvage Act of 1960 as amended by the Archeological and Historic Preservation Act of 1974 (16 U.S.C. 469 et seq. ), particularly section 3 (16 U.S.C. 469a-1). (b) Floodplain management and wetland protection. (1) Executive Order 11988, Floodplain Management, as amended by Executive Order 13690, February 4, 2015 (3 CFR, 2016 Comp., p. 268), as implemented in HUD regulations at 24 CFR part 55, particularly section 2(a) of Executive Order 11988, as amended. (2) Executive Order 11990, Protection of Wetlands, May 24, 1977 (42 FR 26961), 3 CFR, 1977 Comp., p. 121, as interpreted in HUD regulations at 24 CFR part 55, particularly sections 2 and 5 of the order. (c) Coastal Zone Management. The Coastal Zone Management Act of 1972 (16 U.S.C. 1451 et seq. ), as amended, particularly section 307(c) and (d) (16 U.S.C. 1456(c) and (d)). (d) Sole source aquifers. (1) The Safe Drinking Water Act of 1974 (42 U.S.C. 201, 300(f) et seq., and 21 U.S.C. 349) as amended; particularly section 1424(e)(42 U.S.C. 300h-3(e)). (2) Sole Source Aquifers (Environmental Protection Agency—40 CFR part 149). (e) Endangered species. The Endangered Species Act of 1973 (16 U.S.C. 1531 et seq. ) as amended, particularly section 7 (16 U.S.C. 1536). (f) Wild and scenic rivers. The Wild and Scenic Rivers Act of 1968 (16 U.S.C. 1271 et seq. ) as amended, particularly section 7(b) and (c) (16 U.S.C. 1278(b) and (c)). (g) Air quality. (1) The Clean Air Act (42 U.S.C. 7401 et. seq. ) as amended; particularly section 176(c) and (d) (42 U.S.C. 7506(c) and (d)). (2) Determining Conformity of Federal Actions to State or Federal Implementation Plans (Environmental Protection Agency—40 CFR parts 6, 51, and 93). (h) Farmlands protection. (1) Farmland Protection Policy Act of 1981 (7 U.S.C. 4201 et seq. ) particularly sections 1540(b) and 1541 (7 U.S.C. 4201(b) and 4202). (2) Farmland Protection Policy (Department of Agriculture—7 CFR part 658). (i) HUD environmental standards. (1) Applicable criteria and standards specified in part 51 of this title, other than the runway clear zone notification requirement in § 51.303(a)(3). (2)(i) Also, it is HUD policy that all properties that are being proposed for use in HUD programs be free of hazardous materials, contamination, toxic chemicals and gases, and radioactive substances, where a hazard could affect the health and safety of occupants or conflict with the intended utilization of the property. (ii) The environmental review of multifamily housing with five or more dwelling units (including leasing), or non-residential property, must include the evaluation of previous uses of the site or other evidence of contamination on or near the site, to ensure that the occupants of proposed sites are not adversely affected by any of the hazards listed in paragraph (i)(2)(i) of this section. (iii) Particular attention should be given to any proposed site on or in the general proximity of such areas as dumps, landfills, industrial sites, or other locations that contain, or may have contained, hazardous wastes. (iv) The responsible entity shall use current techniques by qualified professionals to undertake investigations determined necessary. (j) Environmental justice. Executive Order 12898—Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, February 11, 1994 (59 FR 7629), 3 CFR, 1994 Comp. p. 859." 24:24:1.1.1.1.32.1.59.5,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,A,"Subpart A—Purpose, Legal Authority, Federal Laws and Authorities",,§ 58.6 Other requirements.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 63 FR 15271, Mar. 30, 1998; 78 FR 68734, Nov. 15, 2013]","In addition to the duties under the laws and authorities specified in § 58.5 for assumption by the responsible entity under the laws cited in § 58.1(b), the responsible entity must comply with the following requirements. Applicability of the following requirements does not trigger the certification and release of funds procedure under this part or preclude exemption of an activity under § 58.34(a)(12) and/or the applicability of § 58.35(b). However, the responsible entity remains responsible for addressing the following requirements in its ERR and meeting these requirements, where applicable, regardless of whether the activity is exempt under § 58.34 or categorically excluded under § 58.35(a) or (b). (a)(1) Under the Flood Disaster Protection Act of 1973, as amended (42 U.S.C. 4001-4128), Federal financial assistance for acquisition and construction purposes (including rehabilitation) may not be used in an area identified by the Federal Emergency Management Agency (FEMA) as having special flood hazards, unless: (i) The community in which the area is situated is participating in the National Flood Insurance Program (see 44 CFR parts 59 through 79), or less than one year has passed since the FEMA notification regarding such hazards; and (ii) Where the community is participating in the National Flood Insurance Program, flood insurance protection is to be obtained as a condition of the approval of financial assistance to the property owner. (2) Where the community is participating in the National Flood Insurance Program and the recipient provides financial assistance for acquisition or construction purposes (including rehabilitation) for property located in an area identified by FEMA as having special flood hazards, the responsible entity is responsible for assuring that flood insurance under the National Flood Insurance Program is obtained and maintained. (3) Paragraph (a) of this section does not apply to Federal formula grants made to a State. (4) Flood insurance requirements cannot be fulfilled by self-insurance except as authorized by law for assistance to state-owned projects within states approved by the Federal Insurance Administrator consistent with 44 CFR 75.11. (b) Under section 582 of the National Flood Insurance Reform Act of 1994, 42 U.S.C. 5154a, HUD disaster assistance that is made available in a special flood hazard area may not be used to make a payment (including any loan assistance payment) to a person for repair, replacement or restoration for flood damage to any personal, residential or commercial property if: (1) The person had previously received Federal flood disaster assistance conditioned on obtaining and maintaining flood insurance; and (2) The person failed to obtain and maintain flood insurance. (c) Pursuant to the Coastal Barrier Resources Act, as amended by the Coastal Barrier Improvement Act of 1990 (16 U.S.C. 3501), HUD assistance may not be used for most activities proposed in the Coastal Barrier Resources System. (d) In all cases involving HUD assistance, subsidy, or insurance for the purchase or sale of an existing property in a Runway Clear Zone or Clear Zone, as defined in 24 CFR part 51, the responsible entity shall advise the buyer that the property is in a runway clear zone or clear zone, what the implications of such a location are, and that there is a possibility that the property may, at a later date, be acquired by the airport operator. The buyer must sign a statement acknowledging receipt of this information." 24:24:1.1.1.1.32.2.59.1,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,B,Subpart B—General Policy: Responsibilities of Responsible Entities,,§ 58.10 Basic environmental responsibility.,HUD,,,"[68 FR 56128, Sept. 29, 2003]","In accordance with the provisions of law cited in § 58.1(b), except as otherwise provided in § 58.4(c), the responsible entity must assume the environmental responsibilities for projects under programs cited in § 58.1(b). In doing so, the responsible entity must comply with the provisions of NEPA and the CEQ regulations contained in 40 CFR parts 1500 through 1508, including the requirements set forth in this part." 24:24:1.1.1.1.32.2.59.2,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,B,Subpart B—General Policy: Responsibilities of Responsible Entities,,§ 58.11 Legal capacity and performance.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 68 FR 56129, Sept. 29, 2003]","(a) A responsible entity which believes that it does not have the legal capacity to carry out the environmental responsibilities required by this part must contact the appropriate local HUD Office or the State for further instructions. Determinations of legal capacity will be made on a case-by-case basis. (b) If a public housing, special project, HOPWA, Supportive Housing, Shelter Plus Care, or Self-Help Homeownership Opportunity recipient that is not a responsible entity objects to the non-recipient responsible entity conducting the environmental review on the basis of performance, timing, or compatibility of objectives, HUD will review the facts to determine who will perform the environmental review. (c) At any time, HUD may reject the use of a responsible entity to conduct the environmental review in a particular case on the basis of performance, timing or compatibility of objectives, or in accordance with § 58.77(d)(1). (d) If a responsible entity, other than a recipient, objects to performing an environmental review, or if HUD determines that the responsible entity should not perform the environmental review, HUD may designate another responsible entity to conduct the review in accordance with this part or may itself conduct the environmental review in accordance with the provisions of 24 CFR part 50." 24:24:1.1.1.1.32.2.59.3,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,B,Subpart B—General Policy: Responsibilities of Responsible Entities,,§ 58.12 Technical and administrative capacity.,HUD,,,,The responsible entity must develop the technical and administrative capability necessary to comply with 40 CFR parts 1500 through 1508 and the requirements of this part. 24:24:1.1.1.1.32.2.59.4,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,B,Subpart B—General Policy: Responsibilities of Responsible Entities,,§ 58.13 Responsibilities of the certifying officer.,HUD,,,,"Under the terms of the certification required by § 58.71, a responsible entity's certifying officer is the “responsible Federal official” as that term is used in section 102 of NEPA and in statutory provisions cited in § 58.1(b). The Certifying Officer is therefore responsible for all the requirements of section 102 of NEPA and the related provisions in 40 CFR parts 1500 through 1508, and 24 CFR part 58, including the related Federal authorities listed in § 58.5. The Certifying Officer must also: (a) Represent the responsible entity and be subject to the jurisdiction of the Federal courts. The Certifying Officer will not be represented by the Department of Justice in court; and (b) Ensure that the responsible entity reviews and comments on all EISs prepared for Federal projects that may have an impact on the recipient's program." 24:24:1.1.1.1.32.2.59.5,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,B,Subpart B—General Policy: Responsibilities of Responsible Entities,,"§ 58.14 Interaction with State, Federal and non-Federal entities.",HUD,,,"[63 FR 15271, Mar. 30, 1998]","A responsible entity shall consult with appropriate environmental agencies, State, Federal and non-Federal entities and the public in the preparation of an EIS, EA or other environmental reviews undertaken under the related laws and authorities cited in § 58.5 and § 58.6. The responsible entity must also cooperate with other agencies to reduce duplication between NEPA and comparable environmental review requirements of the State (see 40 CFR 1506.2 (b) and (c)). The responsible entity must prepare its EAs and EISs so that they comply with the environmental review requirements of both Federal and State laws unless otherwise specified or provided by law. State, Federal and local agencies may participate or act in a joint lead or cooperating agency capacity in the preparation of joint EISs or joint environmental assessments (see 40 CFR 1501.5(b) and 1501.6). A single EIS or EA may be prepared and adopted by multiple users to the extent that the review addresses the relevant environmental issues and there is a written agreement between the cooperating agencies which sets forth the coordinated and overall responsibilities." 24:24:1.1.1.1.32.2.59.6,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,B,Subpart B—General Policy: Responsibilities of Responsible Entities,,§ 58.15 Tiering.,HUD,,,,"Responsible entities may tier their environmental reviews and assessments to eliminate repetitive discussions of the same issues at subsequent levels of review. Tiering is appropriate when there is a requirement to evaluate a policy or proposal in the early stages of development or when site-specific analysis or mitigation is not currently feasible and a more narrow or focused analysis is better done at a later date. The site specific review need only reference or summarize the issues addressed in the broader review. The broader review should identify and evaluate those issues ripe for decision and exclude those issues not relevant to the policy, program or project under consideration. The broader review should also establish the policy, standard or process to be followed in the site specific review. The Finding of No Significant Impact (FONSI) with respect to the broader assessment shall include a summary of the assessment and identify the significant issues to be considered in site specific reviews. Subsequent site-specific reviews will not require notices or a Request for Release of Funds unless the Certifying Officer determines that there are unanticipated impacts or impacts not adequately addressed in the prior review. A tiering approach can be used for meeting environmental review requirements in areas designated for special focus in local Consolidated Plans. Local and State Governments are encouraged to use the Consolidated Plan process to facilitate environmental reviews." 24:24:1.1.1.1.32.2.59.7,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,B,Subpart B—General Policy: Responsibilities of Responsible Entities,,§ 58.17 [Reserved],HUD,,,, 24:24:1.1.1.1.32.2.59.8,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,B,Subpart B—General Policy: Responsibilities of Responsible Entities,,§ 58.18 Responsibilities of States assuming HUD environmental responsibilities.,HUD,,,"[68 FR 56129, Sept. 29, 2003]","States that elect to administer a HUD program shall ensure that the program complies with the provisions of this part. The state must: (a) Designate the state agency or agencies that will be responsible for carrying out the requirements and administrative responsibilities set forth in subpart H of this part and which will: (1) Develop a monitoring and enforcement program for post-review actions on environmental reviews and monitor compliance with any environmental conditions included in the award. (2) Receive public notices, RROFs, and certifications from recipients pursuant to §§ 58.70 and 58.71; accept objections from the public and from other agencies (§ 58.73); and perform other related responsibilities regarding releases of funds. (b) Fulfill the state role in subpart H relative to the time period set for the receipt and disposition of comments, objections and appeals (if any) on particular projects." 24:24:1.1.1.1.32.3.59.1,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,C,Subpart C—General Policy: Environmental Review Procedures,,§ 58.21 Time periods.,HUD,,,,All time periods in this part shall be counted in calendar days. The first day of a time period begins at 12:01 a.m. local time on the day following the publication or the mailing and posting date of the notice which initiates the time period. 24:24:1.1.1.1.32.3.59.2,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,C,Subpart C—General Policy: Environmental Review Procedures,,§ 58.22 Limitations on activities pending clearance.,HUD,,,"[68 FR 56129, Sept. 29, 2003]","(a) Neither a recipient nor any participant in the development process, including public or private nonprofit or for-profit entities, or any of their contractors, may commit HUD assistance under a program listed in § 58.1(b) on an activity or project until HUD or the state has approved the recipient's RROF and the related certification from the responsible entity. In addition, until the RROF and the related certification have been approved, neither a recipient nor any participant in the development process may commit non-HUD funds on or undertake an activity or project under a program listed in § 58.1(b) if the activity or project would have an adverse environmental impact or limit the choice of reasonable alternatives. (b) If a project or activity is exempt under § 58.34, or is categorically excluded (except in extraordinary circumstances) under § 58.35(b), no RROF is required and the recipient may undertake the activity immediately after the responsible entity has documented its determination as required in § 58.34(b) and § 58.35(d), but the recipient must comply with applicable requirements under § 58.6. (c) If a recipient is considering an application from a prospective subrecipient or beneficiary and is aware that the prospective subrecipient or beneficiary is about to take an action within the jurisdiction of the recipient that is prohibited by paragraph (a) of this section, then the recipient will take appropriate action to ensure that the objectives and procedures of NEPA are achieved. (d) An option agreement on a proposed site or property is allowable prior to the completion of the environmental review if the option agreement is subject to a determination by the recipient on the desirability of the property for the project as a result of the completion of the environmental review in accordance with this part and the cost of the option is a nominal portion of the purchase price. There is no constraint on the purchase of an option by third parties that have not been selected for HUD funding, have no responsibility for the environmental review and have no say in the approval or disapproval of the project. (e) Self-Help Homeownership Opportunity Program (SHOP). In accordance with section 11(d)(2)(A) of the Housing Opportunity Program Extension Act of 1996 (42 U.S.C. 12805 note), an organization, consortium, or affiliate receiving assistance under the SHOP program may advance nongrant funds to acquire land prior to completion of an environmental review and approval of a Request for Release of Funds (RROF) and certification, notwithstanding paragraph (a) of this section. Any advances to acquire land prior to approval of the RROF and certification are made at the risk of the organization, consortium, or affiliate and reimbursement for such advances may depend on the result of the environmental review. This authorization is limited to the SHOP program only and all other forms of HUD assistance are subject to the limitations in paragraph (a) of this section. (f) Relocation. Funds may be committed for relocation assistance before the approval of the RROF and related certification for the project provided that the relocation assistance is required by 24 CFR part 42." 24:24:1.1.1.1.32.3.59.3,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,C,Subpart C—General Policy: Environmental Review Procedures,,§ 58.23 Financial assistance for environmental review.,HUD,,,,"The costs of environmental reviews, including costs incurred in complying with any of the related laws and authorities cited in § 58.5 and § 58.6, are eligible costs to the extent allowable under the HUD assistance program regulations." 24:24:1.1.1.1.32.4.59.1,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,D,"Subpart D—Environmental Review Process: Documentation, Range of Activities, Project Aggregation and Classification",,§ 58.30 Environmental review process.,HUD,,,,"(a) The environmental review process consists of all the actions that a responsible entity must take to determine compliance with this part. The environmental review process includes all the compliance actions needed for other activities and projects that are not assisted by HUD but are aggregated by the responsible entity in accordance with § 58.32. (b) The environmental review process should begin as soon as a recipient determines the projected use of HUD assistance." 24:24:1.1.1.1.32.4.59.2,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,D,"Subpart D—Environmental Review Process: Documentation, Range of Activities, Project Aggregation and Classification",,§ 58.32 Project aggregation.,HUD,,,,"(a) A responsible entity must group together and evaluate as a single project all individual activities which are related either on a geographical or functional basis, or are logical parts of a composite of contemplated actions. (b) In deciding the most appropriate basis for aggregation when evaluating activities under more than one program, the responsible entity may choose: functional aggregation when a specific type of activity (e.g., water improvements) is to take place in several separate locales or jurisdictions; geographic aggregation when a mix of dissimilar but related activities is to be concentrated in a fairly specific project area (e.g., a combination of water, sewer and street improvements and economic development activities); or a combination of aggregation approaches, which, for various project locations, considers the impacts arising from each functional activity and its interrelationship with other activities. (c) The purpose of project aggregation is to group together related activities so that the responsible entity can: (1) Address adequately and analyze, in a single environmental review, the separate and combined impacts of activities that are similar, connected and closely related, or that are dependent upon other activities and actions. (See 40 CFR 1508.25(a)). (2) Consider reasonable alternative courses of action. (3) Schedule the activities to resolve conflicts or mitigate the individual, combined and/or cumulative effects. (4) Prescribe mitigation measures and safeguards including project alternatives and modifications to individual activities. (d) Multi-year project aggregation —(1) Release of funds. When a recipient's planning and program development provide for activities to be implemented over two or more years, the responsible entity's environmental review should consider the relationship among all component activities of the multi-year project regardless of the source of funds and address and evaluate their cumulative environmental effects. The estimated range of the aggregated activities and the estimated cost of the total project must be listed and described by the responsible entity in the environmental review and included in the RROF. The release of funds will cover the entire project period. (2) When one or more of the conditions described in § 58.47 exists, the recipient or other responsible entity must re-evaluate the environmental review." 24:24:1.1.1.1.32.4.59.3,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,D,"Subpart D—Environmental Review Process: Documentation, Range of Activities, Project Aggregation and Classification",,§ 58.33 Emergencies.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 68 FR 56129, Sept. 29, 2003]","(a) In the cases of emergency, disaster or imminent threat to health and safety which warrant the taking of an action with significant environmental impact, the provisions of 40 CFR 1506.11 shall apply. (b) If funds are needed on an emergency basis and adherence to separate comment periods would prevent the giving of assistance during a Presidentially declared disaster, or during a local emergency that has been declared by the chief elected official of the responsible entity who has proclaimed that there is an immediate need for public action to protect the public safety, the combined Notice of FONSI and Notice of Intent to Request Release of Funds (NOI/RROF) may be disseminated and/or published simultaneously with the submission of the RROF. The combined Notice of FONSI and NOI/RROF shall state that the funds are needed on an emergency basis due to a declared disaster and that the comment periods have been combined. The Notice shall also invite commenters to submit their comments to both HUD and the responsible entity issuing the notice to ensure that these comments will receive full consideration." 24:24:1.1.1.1.32.4.59.4,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,D,"Subpart D—Environmental Review Process: Documentation, Range of Activities, Project Aggregation and Classification",,§ 58.34 Exempt activities.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 63 FR 15271, Mar. 30, 1998]","(a) Except for the applicable requirements of § 58.6, the responsible entity does not have to comply with the requirements of this part or undertake any environmental review, consultation or other action under NEPA and the other provisions of law or authorities cited in § 58.5 for the activities exempt by this section or projects consisting solely of the following exempt activities: (1) Environmental and other studies, resource identification and the development of plans and strategies; (2) Information and financial services; (3) Administrative and management activities; (4) Public services that will not have a physical impact or result in any physical changes, including but not limited to services concerned with employment, crime prevention, child care, health, drug abuse, education, counseling, energy conservation and welfare or recreational needs; (5) Inspections and testing of properties for hazards or defects; (6) Purchase of insurance; (7) Purchase of tools; (8) Engineering or design costs; (9) Technical assistance and training; (10) Assistance for temporary or permanent improvements that do not alter environmental conditions and are limited to protection, repair, or restoration activities necessary only to control or arrest the effects from disasters or imminent threats to public safety including those resulting from physical deterioration; (11) Payment of principal and interest on loans made or obligations guaranteed by HUD; (12) Any of the categorical exclusions listed in § 58.35(a) provided that there are no circumstances which require compliance with any other Federal laws and authorities cited in § 58.5. (b) A recipient does not have to submit an RROF and certification, and no further approval from HUD or the State will be needed by the recipient for the drawdown of funds to carry out exempt activities and projects. However, the responsible entity must document in writing its determination that each activity or project is exempt and meets the conditions specified for such exemption under this section." 24:24:1.1.1.1.32.4.59.5,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,D,"Subpart D—Environmental Review Process: Documentation, Range of Activities, Project Aggregation and Classification",,§ 58.35 Categorical exclusions.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 63 FR 15272, Mar. 30, 1998; 68 FR 56129, Sept. 29, 2003; 78 FR 68734, Nov. 15, 2013; 89 FR 20056, Mar. 20, 2024]","Categorical exclusion refers to a category of activities for which no environmental impact statement or environmental assessment and finding of no significant impact under NEPA is required, except in extraordinary circumstances (see § 58.2(a)(3)) in which a normally excluded activity may have a significant impact. Compliance with the other applicable Federal environmental laws and authorities listed in § 58.5 is required for any categorical exclusion listed in paragraph (a) of this section. (a) Categorical exclusions subject to § 58.5. The following activities are categorically excluded under NEPA, but may be subject to review under authorities listed in § 58.5: (1) Acquisition, repair, improvement, reconstruction, or rehabilitation of public facilities and improvements (other than buildings) when the facilities and improvements are in place and will be retained in the same use without change in size or capacity of more than 20 percent (e.g., replacement of water or sewer lines, reconstruction of curbs and sidewalks, repaving of streets). (2) Special projects directed to the removal of material and architectural barriers that restrict the mobility of and accessibility to elderly and handicapped persons. (3) Rehabilitation of buildings and improvements when the following conditions are met: (i) In the case of a building for residential use (with one to four units), the density is not increased beyond four units, and the land use is not changed; (ii) In the case of multifamily residential buildings: (A) Unit density is not changed more than 20 percent; (B) The project does not involve changes in land use from residential to non-residential; and (C) The estimated cost of rehabilitation is less than 75 percent of the total estimated cost of replacement after rehabilitation. (iii) In the case of non-residential structures, including commercial, industrial, and public buildings: (A) The facilities and improvements are in place and will not be changed in size or capacity by more than 20 percent; and (B) The activity does not involve a change in land use, such as from non-residential to residential, commercial to industrial, or from one industrial use to another. (4)(i) An individual action on up to four dwelling units where there is a maximum of four units on any one site. The units can be four one-unit buildings or one four-unit building or any combination in between; or (ii) An individual action on a project of five or more housing units developed on scattered sites when the sites are more than 2,000 feet apart and there are not more than four housing units on any one site. (iii) Paragraphs (a)(4)(i) and (ii) of this section do not apply to rehabilitation of a building for residential use (with one to four units) (see paragraph (a)(3)(i) of this section). (5) Acquisition (including leasing) or disposition of, or equity loans on an existing structure, or acquisition (including leasing) of vacant land provided that the structure or land acquired, financed, or disposed of will be retained for the same use. (6) Combinations of the above activities. (b) Categorical exclusions not subject to § 58.5. The Department has determined that the following categorically excluded activities would not alter any conditions that would require a review or compliance determination under the Federal laws and authorities cited in § 58.5. When the following kinds of activities are undertaken, the responsible entity does not have to publish a NOI/RROF or execute a certification and the recipient does not have to submit a RROF to HUD (or the State) except in the circumstances described in paragraph (c) of this section. Following the award of the assistance, no further approval from HUD or the State will be needed with respect to environmental requirements, except where paragraph (c) of this section applies. The recipient remains responsible for carrying out any applicable requirements under § 58.6. (1) Tenant-based rental assistance; (2) Supportive services including, but not limited to, health care, housing services, permanent housing placement, day care, nutritional services, short-term payments for rent/mortgage/utility costs, and assistance in gaining access to local, State, and Federal government benefits and services; (3) Operating costs including maintenance, security, operation, utilities, furnishings, equipment, supplies, staff training and recruitment and other incidental costs; (4) Economic development activities, including but not limited to, equipment purchase, inventory financing, interest subsidy, operating expenses and similar costs not associated with construction or expansion of existing operations; (5) Activities to assist homebuyers to purchase existing dwelling units or dwelling units under construction, including closing costs and down payment assistance, interest buydowns, and similar activities that result in the transfer of title. (6) Affordable housing pre-development costs including legal, consulting, developer and other costs related to obtaining site options, project financing, administrative costs and fees for loan commitments, zoning approvals, and other related activities which do not have a physical impact. (7) Approval of supplemental assistance (including insurance or guarantee) to a project previously approved under this part, if the approval is made by the same responsible entity that conducted the environmental review on the original project and re-evaluation of the environmental findings is not required under § 58.47. (8) HUD's guarantee of loans for one- to-four family dwellings on trust land and on fee land within an Indian reservation and on fee land owned by the Indian Tribe outside the Tribe's Indian Reservation boundaries, under the Direct Guarantee procedure for the Section 184 Indian Housing loan guarantee program without any review or approval of the application for the loan guarantee by HUD or the responsible entity or approval of the loan guarantee by HUD before the execution of the contract for construction or rehabilitation and the loan closing. (c) Circumstances requiring NEPA review. If a responsible entity determines that an activity or project identified in paragraph (a) or (b) of this section, because of extraordinary circumstances and conditions at or affecting the location of the activity or project, may have a significant environmental effect, it shall comply with all the requirements of this part. (d) The Environmental Review Record (ERR) must contain a well organized written record of the process and determinations made under this section." 24:24:1.1.1.1.32.4.59.6,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,D,"Subpart D—Environmental Review Process: Documentation, Range of Activities, Project Aggregation and Classification",,§ 58.36 Environmental assessments.,HUD,,,,"If a project is not exempt or categorically excluded under §§ 58.34 and 58.35, the responsible entity must prepare an EA in accordance with subpart E of this part. If it is evident without preparing an EA that an EIS is required under § 58.37, the responsible entity should proceed directly to an EIS." 24:24:1.1.1.1.32.4.59.7,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,D,"Subpart D—Environmental Review Process: Documentation, Range of Activities, Project Aggregation and Classification",,§ 58.37 Environmental impact statement determinations.,HUD,,,,"(a) An EIS is required when the project is determined to have a potentially significant impact on the human environment. (b) An EIS is required under any of the following circumstances, except as provided in paragraph (c) of this section: (1) The project would provide a site or sites for, or result in the construction of, hospitals or nursing homes containing a total of 2,500 or more beds. (2) The project would remove, demolish, convert or substantially rehabilitate 2,500 or more existing housing units (but not including rehabilitation projects categorically excluded under § 58.35), or would result in the construction or installation of 2,500 or more housing units, or would provide sites for 2,500 or more housing units. (3) The project would provide enough additional water and sewer capacity to support 2,500 or more additional housing units. The project does not have to be specifically intended for residential use nor does it have to be totally new construction. If the project is designed to provide upgraded service to existing development as well as to serve new development, only that portion of the increased capacity which is intended to serve new development should be counted. (c) If, on the basis of an EA, a responsible entity determines that the thresholds in paragraph (b) of this section are the sole reason for the EIS, the responsible entity may prepare a FONSI pursuant to 40 CFR 1501.4. In such cases, the FONSI must be made available for public review for at least 30 days before the responsible entity makes the final determination whether to prepare an EIS. (d) Notwithstanding paragraphs (a) through (c) of this section, an EIS is not required where § 58.53 is applicable. (e) Recommended EIS Format. The responsible entity must use the EIS format recommended by the CEQ regulations (40 CFR 1502.10) unless a determination is made on a particular project that there is a compelling reason to do otherwise. In such a case, the EIS format must meet the minimum requirements prescribed in 40 CFR 1502.10." 24:24:1.1.1.1.32.4.59.8,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,D,"Subpart D—Environmental Review Process: Documentation, Range of Activities, Project Aggregation and Classification",,§ 58.38 Environmental review record.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 79 FR 49229, Aug. 20, 2014]","The responsible entity must maintain a written record of the environmental review undertaken under this part for each project. This document will be designated the “Environmental Review Record” (ERR) and shall be available for public review. The Departmental Environmental Clearance Officer (DECO) shall establish a prescribed format that the responsible entity shall use to prepare the ERR. The DECO may prescribe alternative formats as necessary to meet specific program needs. (a) ERR Documents. The ERR shall contain all the environmental review documents, public notices and written determinations or environmental findings required by this part as evidence of review, decisionmaking and actions pertaining to a particular project of a recipient. The document shall: (1) Describe the project and the activities that the recipient has determined to be part of the project; (2) Evaluate the effects of the project or the activities on the human environment; (3) Document compliance with applicable statutes and authorities, in particular those cited in § 58.5 and 58.6; and (4) Record the written determinations and other review findings required by this part (e.g., exempt and categorically excluded projects determinations, findings of no significant impact). (b) Other documents and information. The ERR shall also contain verifiable source documents and relevant base data used or cited in EAs, EISs or other project review documents. These documents may be incorporated by reference into the ERR provided that each source document is identified and available for inspection by interested parties. Proprietary material and special studies prepared for the recipient that are not otherwise generally available for public review shall not be incorporated by reference but shall be included in the ERR." 24:24:1.1.1.1.32.5.59.1,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,E,Subpart E—Environmental Review Process: Environmental Assessments (EA's),,§ 58.40 Preparing the environmental assessment.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 79 FR 49229, Aug. 20, 2014]","The DECO shall establish a prescribed format that the responsible entity shall use to prepare the EA. The DECO may prescribe alternative formats as necessary to meet specific program needs. In preparing an EA for a particular proposed project or other action, the responsible entity must: (a) Determine existing conditions and describe the character, features and resources of the project area and its surroundings; identify the trends that are likely to continue in the absence of the project. (b) Identify all potential environmental impacts, whether beneficial or adverse, and the conditions that would change as a result of the project. (c) Identify, analyze and evaluate all impacts to determine the significance of their effects on the human environment and whether the project will require further compliance under related laws and authorities cited in § 58.5 and § 58.6. (d) Examine and recommend feasible ways in which the project or external factors relating to the project could be modified in order to eliminate or minimize adverse environmental impacts. (e) Discuss the need for the proposal, appropriate alternatives where the proposal involves unresolved conflicts concerning alternative uses of available resources, the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted. (f) Complete all environmental review requirements necessary for the project's compliance with applicable authorities cited in §§ 58.5 and 58.6. (g) Based on steps set forth in paragraph (a) through (f) of this section, make one of the following findings: (1) A Finding of No Significant Impact (FONSI), in which the responsible entity determines that the project is not an action that will result in a significant impact on the quality of the human environment. The responsible entity may then proceed to § 58.43. (2) A finding of significant impact, in which the project is deemed to be an action which may significantly affect the quality of the human environment. The responsible entity must then proceed with its environmental review under subpart F or G of this part." 24:24:1.1.1.1.32.5.59.2,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,E,Subpart E—Environmental Review Process: Environmental Assessments (EA's),,§ 58.43 Dissemination and/or publication of the findings of no significant impact.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 89 FR 30913, Apr. 23, 2024]","(a) If the responsible entity makes a finding of no significant impact, it must prepare a FONSI notice, using the current HUD-recommended format or an equivalent format. As a minimum, the responsible entity must send the FONSI notice to individuals and groups known to be interested in the activities, to the local news media, to the appropriate Tribal, Federal, State, and local agencies to the Regional Offices of the Environmental Protection Agency having jurisdiction and to the HUD Field Office (or the State where applicable). The responsible entity may also publish the FONSI notice in a newspaper of general circulation in the affected community or on an appropriate Government website that is accessible to individuals with disabilities and provides meaningful access for individuals with Limited English Proficiency. If the notice is not published, it must also be prominently displayed in public buildings, such as the local Post Office and within the project area or in accordance with procedures established as part of the citizen participation process. (b) The responsible entity may disseminate or publish a FONSI notice at the same time it disseminates or publishes the NOI/RROF required by § 58.70. If the notices are released as a combined notice, the combined notice shall: (1) Clearly indicate that it is intended to meet two separate procedural requirements; and (2) Advise the public to specify in their comments which “notice” their comments address. (c) The responsible entity must consider the comments and make modifications, if appropriate, in response to the comments, before it completes its environmental certification and before the recipient submits its RROF. If funds will be used in Presidentially declared disaster areas, modifications resulting from public comment, if appropriate, must be made before proceeding with the expenditure of funds." 24:24:1.1.1.1.32.5.59.3,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,E,Subpart E—Environmental Review Process: Environmental Assessments (EA's),,§ 58.45 Public comment periods.,HUD,,,"[68 FR 56130, Sept. 29, 2003, as amended at 89 FR 30913, Apr. 23, 2024]","Required notices must afford the public the following minimum comment periods, counted in accordance with § 58.21:" 24:24:1.1.1.1.32.5.59.4,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,E,Subpart E—Environmental Review Process: Environmental Assessments (EA's),,§ 58.46 Time delays for exceptional circumstances.,HUD,,,,"The responsible entity must make the FONSI available for public comments for 30 days before the recipient files the RROF when: (a) There is a considerable interest or controversy concerning the project; (b) The proposed project is similar to other projects that normally require the preparation of an EIS; or (c) The project is unique and without precedent." 24:24:1.1.1.1.32.5.59.5,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,E,Subpart E—Environmental Review Process: Environmental Assessments (EA's),,§ 58.47 Re-evaluation of environmental assessments and other environmental findings.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 63 FR 15272, Mar. 30, 1998]","(a) A responsible entity must re-evaluate its environmental findings to determine if the original findings are still valid, when: (1) The recipient proposes substantial changes in the nature, magnitude or extent of the project, including adding new activities not anticipated in the original scope of the project; (2) There are new circumstances and environmental conditions which may affect the project or have a bearing on its impact, such as concealed or unexpected conditions discovered during the implementation of the project or activity which is proposed to be continued; or (3) The recipient proposes the selection of an alternative not in the original finding. (b)(1) If the original findings are still valid but the data or conditions upon which they were based have changed, the responsible entity must affirm the original findings and update its ERR by including this re-evaluation and its determination based on its findings. Under these circumstances, if a FONSI notice has already been published, no further publication of a FONSI notice is required. (2) If the responsible entity determines that the original findings are no longer valid, it must prepare an EA or an EIS if its evaluation indicates potentially significant impacts. (3) Where the recipient is not the responsible entity, the recipient must inform the responsible entity promptly of any proposed substantial changes under paragraph (a)(1) of this section, new circumstances or environmental conditions under paragraph (a)(2) of this section, or any proposals to select a different alternative under paragraph (a)(3) of this section, and must then permit the responsible entity to re-evaluate the findings before proceeding." 24:24:1.1.1.1.32.6.59.1,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,F,Subpart F—Environmental Review Process: Environmental Impact Statement Determinations,,§ 58.52 Adoption of other agencies' EISs.,HUD,,,,"The responsible entity may adopt a draft or final EIS prepared by another agency provided that the EIS was prepared in accordance with 40 CFR parts 1500 through 1508. If the responsible entity adopts an EIS prepared by another agency, the procedure in 40 CFR 1506.3 shall be followed. An adopted EIS may have to be revised and modified to adapt it to the particular environmental conditions and circumstances of the project if these are different from the project reviewed in the EIS. In such cases the responsible entity must prepare, circulate, and file a supplemental draft EIS in the manner prescribed in § 58.60(d) and otherwise comply with the clearance and time requirements of the EIS process, except that scoping requirements under 40 CFR 1501.7 shall not apply. The agency that prepared the original EIS should be informed that the responsible entity intends to amend and adopt the EIS. The responsible entity may adopt an EIS when it acts as a cooperating agency in its preparation under 40 CFR 1506.3. The responsible entity is not required to re-circulate or file the EIS, but must complete the clearance process for the RROF. The decision to adopt an EIS shall be made a part of the project ERR." 24:24:1.1.1.1.32.6.59.2,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,F,Subpart F—Environmental Review Process: Environmental Impact Statement Determinations,,§ 58.53 Use of prior environmental impact statements.,HUD,,,,"Where any final EIS has been listed in the Federal Register for a project pursuant to this part, or where an areawide or similar broad scale final EIS has been issued and the EIS anticipated a subsequent project requiring an environmental clearance, then no new EIS is required for the subsequent project if all the following conditions are met: (a) The ERR contains a decision based on a finding pursuant to § 58.40 that the proposed project is not a new major Federal action significantly affecting the quality of the human environment. The decision shall include: (1) References to the prior EIS and its evaluation of the environmental factors affecting the proposed subsequent action subject to NEPA; (2) An evaluation of any environmental factors which may not have been previously assessed, or which may have significantly changed; (3) An analysis showing that the proposed project is consistent with the location, use, and density assumptions for the site and with the timing and capacity of the circulation, utility, and other supporting infrastructure assumptions in the prior EIS; (4) Documentation showing that where the previous EIS called for mitigating measures or other corrective action, these are completed to the extent reasonable given the current state of development. (b) The prior final EIS has been filed within five (5) years, and updated as follows: (1) The EIS has been updated to reflect any significant revisions made to the assumptions under which the original EIS was prepared; (2) The EIS has been updated to reflect new environmental issues and data or legislation and implementing regulations which may have significant environmental impact on the project area covered by the prior EIS. (c) There is no litigation pending in connection with the prior EIS, and no final judicial finding of inadequacy of the prior EIS has been made." 24:24:1.1.1.1.32.7.59.1,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,G,"Subpart G—Environmental Review Process: Procedures for Draft, Final and Supplemental Environmental Impact Statements",,§ 58.55 Notice of intent to prepare an EIS.,HUD,,,,"As soon as practicable after the responsible entity decides to prepare an EIS, it must publish a NOI/EIS, using the HUD recommended format and disseminate it in the same manner as required by 40 CFR parts 1500 through 1508." 24:24:1.1.1.1.32.7.59.2,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,G,"Subpart G—Environmental Review Process: Procedures for Draft, Final and Supplemental Environmental Impact Statements",,§ 58.56 Scoping process.,HUD,,,,The determination on whether or not to hold a scoping meeting will depend on the same circumstances and factors as for the holding of public hearings under § 58.59. The responsible entity must wait at least 15 days after disseminating or publishing the NOI/EIS before holding a scoping meeting. 24:24:1.1.1.1.32.7.59.3,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,G,"Subpart G—Environmental Review Process: Procedures for Draft, Final and Supplemental Environmental Impact Statements",,§ 58.57 Lead agency designation.,HUD,,,,"If there are several agencies ready to assume the lead role, the responsible entity must make its decision based on the criteria in 40 CFR 1501.5(c). If the responsible entity and a Federal agency are unable to reach agreement, then the responsible entity must notify HUD (or the State, where applicable). HUD (or the State) will assist in obtaining a determination based on the procedure set forth in 40 CFR 1501.5(e)." 24:24:1.1.1.1.32.7.59.4,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,G,"Subpart G—Environmental Review Process: Procedures for Draft, Final and Supplemental Environmental Impact Statements",,§ 58.59 Public hearings and meetings.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 89 FR 30913, Apr. 23, 2024]","(a) Factors to consider. In determining whether or not to hold public hearings in accordance with 40 CFR 1506.6, the responsible entity must consider the following factors: (1) The magnitude of the project in terms of economic costs, the geographic area involved, and the uniqueness or size of commitment of resources involved. (2) The degree of interest in or controversy concerning the project. (3) The complexity of the issues and the likelihood that information will be presented at the hearing which will be of assistance to the responsible entity. (4) The extent to which public involvement has been achieved through other means. (b) Procedure. All public hearings must be preceded by a notice of public hearing, which must be published in the local news media or on an appropriate government website that is accessible to individuals with disabilities and provides meaningful access for individuals with Limited English Proficiency 15 days before the hearing date. The Notice must: (1) State the date, time, place, and purpose of the hearing or meeting. (2) Describe the project, its estimated costs, and the project area. (3) State that persons desiring to be heard on environmental issues will be afforded the opportunity to be heard. (4) State the responsible entity's name and address and the name and address of its Certifying Officer. (5) State what documents are available, where they can be obtained, and any charges that may apply." 24:24:1.1.1.1.32.7.59.5,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,G,"Subpart G—Environmental Review Process: Procedures for Draft, Final and Supplemental Environmental Impact Statements",,§ 58.60 Preparation and filing of environmental impact statements.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 63 FR 15272, Mar. 30, 1998]","(a) The responsible entity must prepare the draft environmental impact statement (DEIS) and the final environmental impact statements (FEIS) using the current HUD recommended format or its equivalent. (b) The responsible entity must file and distribute the (DEIS) and the (FEIS) in the following manner: (1) Five copies to EPA Headquarters; (2) Five copies to EPA Regional Office; (3) Copies made available in the responsible entity's and the recipient's office; (4) Copies or summaries made available to persons who request them; and (5) FEIS only—one copy to State, HUD Field Office, and HUD Headquarters library. (c) The responsible entity may request waivers from the time requirements specified for the draft and final EIS as prescribed in 40 CFR 1506.6. (d) When substantial changes are proposed in a project or when significant new circumstances or information becomes available during an environmental review, the recipient may prepare a supplemental EIS as prescribed in 40 CFR 1502.9. (e) The responsible entity must prepare a Record of Decision (ROD) as prescribed in 40 CFR 1505.2." 24:24:1.1.1.1.32.8.59.1,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,H,Subpart H—Release of Funds for Particular Projects,,§ 58.70 Notice of intent to request release of funds.,HUD,,,,The NOI/RROF must be disseminated and/or published in the manner prescribed by § 58.43 and § 58.45 before the certification is signed by the responsible entity. 24:24:1.1.1.1.32.8.59.2,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,H,Subpart H—Release of Funds for Particular Projects,,§ 58.71 Request for release of funds and certification.,HUD,,,,"(a) The RROF and certification shall be sent to the appropriate HUD Field Office (or the State, if applicable), except as provided in paragraph (b) of this section. This request shall be executed by the Certifying Officer. The request shall describe the specific project and activities covered by the request and contain the certification required under the applicable statute cited in § 58.1(b). The RROF and certification must be in a form specified by HUD. (b) When the responsible entity is conducting an environmental review on behalf of a recipient, as provided for in § 58.10, the recipient must provide the responsible entity with all available project and environmental information and refrain from undertaking any physical activities or choice limiting actions until HUD (or the State, if applicable) has approved its request for release of funds. The certification form executed by the responsible entity's certifying officer shall be sent to the recipient that is to receive the assistance along with a description of any special environmental conditions that must be adhered to in carrying out the project. The recipient is to submit the RROF and the certification of the responsible entity to HUD (or the State, if applicable) requesting the release of funds. The recipient must agree to abide by the special conditions, procedures and requirements of the environmental review, and to advise the responsible entity of any proposed change in the scope of the project or any change in environmental conditions. (c) If the responsible entity determines that some of the activities are exempt under applicable provisions of this part, the responsible entity shall advise the recipient that it may commit funds for these activities as soon as programmatic authorization is received. This finding shall be documented in the ERR maintained by the responsible entity and in the recipient's project files." 24:24:1.1.1.1.32.8.59.3,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,H,Subpart H—Release of Funds for Particular Projects,,§ 58.72 HUD or State actions on RROFs and certifications.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 68 FR 56130, Sept. 29, 2003]","The actions which HUD (or a State) may take with respect to a recipient's environmental certification and RROF are as follows: (a) In the absence of any receipt of objection to the contrary, except as provided in paragraph (b) of this section, HUD (or the State) will assume the validity of the certification and RROF and will approve these documents after expiration of the 15-day period prescribed by statute. (b) HUD (or the state) may disapprove a certification and RROF if it has knowledge that the responsible entity or other participants in the development process have not complied with the items in § 58.75, or that the RROF and certification are inaccurate. (c) In cases in which HUD has approved a certification and RROF but subsequently learns (e.g., through monitoring) that the recipient violated § 58.22 or the recipient or responsible entity otherwise failed to comply with a clearly applicable environmental authority, HUD shall impose appropriate remedies and sanctions in accord with the law and regulations for the program under which the violation was found." 24:24:1.1.1.1.32.8.59.4,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,H,Subpart H—Release of Funds for Particular Projects,,§ 58.73 Objections to release of funds.,HUD,,,,"HUD (or the State) will not approve the ROF for any project before 15 calendar days have elapsed from the time of receipt of the RROF and the certification or from the time specified in the notice published pursuant to § 58.70, whichever is later. Any person or agency may object to a recipient's RROF and the related certification. However, the objections must meet the conditions and procedures set forth in subpart H of this part. HUD (or the State) can refuse the RROF and certification on any grounds set forth in § 58.75. All decisions by HUD (or the State) regarding the RROF and the certification shall be final." 24:24:1.1.1.1.32.8.59.5,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,H,Subpart H—Release of Funds for Particular Projects,,§ 58.74 Time for objecting.,HUD,,,,"All objections must be received by HUD (or the State) within 15 days from the time HUD (or the State) receives the recipient's RROF and the related certification, or within the time period specified in the notice, whichever is later." 24:24:1.1.1.1.32.8.59.6,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,H,Subpart H—Release of Funds for Particular Projects,,§ 58.75 Permissible bases for objections.,HUD,,,"[61 FR 19122, Apr. 30, 1996, as amended at 68 FR 56130, Sept. 29, 2003]","HUD (or the State), will consider objections claiming a responsible entity's noncompliance with this part based only on any of the following grounds: (a) The certification was not in fact executed by the responsible entity's Certifying Officer. (b) The responsible entity has failed to make one of the two findings pursuant to § 58.40 or to make the written determination required by § 58.35, § 58.47 or § 58.53 for the project, as applicable. (c) The responsible entity has omitted one or more of the steps set forth at subpart E of this part for the preparation, publication and completion of an EA. (d) The responsible entity has omitted one or more of the steps set forth at subparts F and G of this part for the conduct, preparation, publication and completion of an EIS. (e) The recipient or other participants in the development process have committed funds, incurred costs or undertaken activities not authorized by this part before release of funds and approval of the environmental certification by HUD (or the state). (f) Another Federal agency acting pursuant to 40 CFR part 1504 has submitted a written finding that the project is unsatisfactory from the standpoint of environmental quality." 24:24:1.1.1.1.32.8.59.7,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,H,Subpart H—Release of Funds for Particular Projects,,§ 58.76 Procedure for objections.,HUD,,,,"A person or agency objecting to a responsible entity's RROF and certification shall submit objections in writing to HUD (or the State). The objections shall: (a) Include the name, address and telephone number of the person or agency submitting the objection, and be signed by the person or authorized official of an agency. (b) Be dated when signed. (c) Describe the basis for objection and the facts or legal authority supporting the objection. (d) State when a copy of the objection was mailed or delivered to the responsible entity's Certifying Officer." 24:24:1.1.1.1.32.8.59.8,24,Housing and Urban Development,,,58,PART 58—ENVIRONMENTAL REVIEW PROCEDURES FOR ENTITIES ASSUMING HUD ENVIRONMENTAL RESPONSIBILITIES,H,Subpart H—Release of Funds for Particular Projects,,§ 58.77 Effect of approval of certification.,HUD,,,,"(a) Responsibilities of HUD and States. HUD's (or, where applicable, the State's) approval of the certification shall be deemed to satisfy the responsibilities of the Secretary under NEPA and related provisions of law cited at § 58.5 insofar as those responsibilities relate to the release of funds as authorized by the applicable provisions of law cited in § 58.1(b). (b) Public and agency redress. Persons and agencies seeking redress in relation to environmental reviews covered by an approved certification shall deal with the responsible entity and not with HUD. It is HUD's policy to refer all inquiries and complaints to the responsible entity and its Certifying Officer. Similarly, the State (where applicable) may direct persons and agencies seeking redress in relation to environmental reviews covered by an approved certification to deal with the responsible entity, and not the State, and may refer inquiries and complaints to the responsible entity and its Certifying Officer. Remedies for noncompliance are set forth in program regulations. (c) Implementation of environmental review decisions. Projects of a recipient will require post-review monitoring and other inspection and enforcement actions by the recipient and the State or HUD (using procedures provided for in program regulations) to assure that decisions adopted through the environmental review process are carried out during project development and implementation. (d) Responsibility for monitoring and training. (1) At least once every three years, HUD intends to conduct in-depth monitoring and exercise quality control (through training and consultation) over the environmental activities performed by responsible entities under this part. Limited monitoring of these environmental activities will be conducted during each program monitoring site visit. If through limited or in-depth monitoring of these environmental activities or by other means, HUD becomes aware of any environmental deficiencies, HUD may take one or more of the following actions: (i) In the case of problems found during limited monitoring, HUD may schedule in-depth monitoring at an earlier date or may schedule in-depth monitoring more frequently; (ii) HUD may require attendance by staff of the responsible entity at HUD-sponsored or approved training, which will be provided periodically at various locations around the country; (iii) HUD may refuse to accept the certifications of environmental compliance on subsequent grants; (iv) HUD may suspend or terminate the responsible entity's assumption of the environmental review responsibility; (v) HUD may initiate sanctions, corrective actions, or other remedies specified in program regulations or agreements or contracts with the recipient. (2) HUD's responsibilities and action under paragraph (d)(1) of this section shall not be construed to limit or reduce any responsibility assumed by a responsible entity with respect to any particular release of funds under this part. Whether or not HUD takes action under paragraph (d)(1) of this section, the Certifying Officer remains the responsible Federal official under § 58.13 with respect to projects and activities for which the Certifying Officer has submitted a certification under this part." 28:28:2.0.1.1.15.0.1.1,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.1 Authorization to establish panels of private trustees.,DOJ,,,"[Order No. 921-80, 45 FR 82631, Dec. 16, 1980, as amended at 62 FR 30183, June 2, 1997]","(a) Each U.S. Trustee is authorized to establish a panel of private trustees (the “panel”) pursuant to 28 U.S.C. 586(a)(1). (b) Each U.S. Trustee is authorized, with the approval of the Director, Executive Office for United States Trustees (the “Director”) to increase or decrease the total membership of the panel. In addition, each U.S. Trustee, with the approval of the Director, is authorized to institute a system of rotation of membership or the like to achieve diversity of experience, geographical distribution or other characteristics among the persons on the panel." 28:28:2.0.1.1.15.0.1.10,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.12 Definitions.,DOJ,,,"[78 FR 16150, Mar. 14, 2013]","(a) The following definitions apply to §§ 58.12 through and including 58.24 of this Part and the applications and other materials agencies submit in an effort to establish they meet the requirements necessary to become an approved nonprofit budget and credit counseling agency. (b) These terms shall have these meanings: (1) The term “accreditation” means the recognition or endorsement that an accrediting organization bestows upon an agency because the accrediting organization has determined the agency meets or exceeds all the accrediting organization's standards; (2) The term “accrediting organization” means either an entity that provides accreditation to agencies or provides certification to counselors, provided, however, that an accrediting organization shall: (i) Not be an agency or affiliate of any agency; and (ii) Be deemed acceptable by the United States Trustee; (3) The term “adequate counseling” means the actual receipt by a client from an approved agency of all counseling services, and all other applicable services, rights, and protections specified in: (i) 11 U.S.C. 109(h); (ii) 11 U.S.C. 111; and (iii) This part; (4) The term “affiliate of an agency” includes: (i) Every entity that is an affiliate of the agency, as the term “affiliate” is defined in 11 U.S.C. 101(2), except that the word “agency” shall be substituted for the word “debtor” in 11 U.S.C. 101(2); (ii) Each of an agency's officers and each of an agency's directors; and (iii) Every relative of an agency's officers and every relative of an agency's directors; (5) The term “agency” and the term “budget and credit counseling agency” shall each mean a nonprofit organization that is applying under this part for United States Trustee approval to be included on a publicly available list in one or more United States district courts, as authorized by 11 U.S.C. 111(a)(1), and shall also mean, whenever appropriate, an approved agency; (6) The term “application” means the application and related forms, including appendices, approved by the Office of Management and Budget as form EOUST-CC1, Application for Approval as a Nonprofit Budget and Credit Counseling Agency, as it shall be amended from time to time; (7) The term “approved agency” means an agency currently approved by a United States Trustee under 11 U.S.C. 111 as an approved nonprofit budget and credit counseling agency eligible to be included on one or more lists maintained under 11 U.S.C. 111(a)(1); (8) The term “approved list” means the list of agencies currently approved by a United States Trustee under 11 U.S.C. 111, as currently published on the United States Trustee Program's Internet site, which is located on the United States Department of Justice's Internet site; (9) The term “audited financial statements” means financial reports audited by independent certified public accountants in accordance with generally accepted accounting principles as defined by the American Institute of Certified Public Accountants; (10) The term “certificate” means the certificate identified in 11 U.S.C. 521(b)(1) that an approved agency shall provide to a client after the client completes counseling services; (11) The term “client” means an individual who both seeks and receives (or sought and received) counseling services from an approved agency; (12) The term “counseling services” means all counseling required by 11 U.S.C. 109(h) and 111, and this part including, without limitation, services that are typically of at least 60 minutes in duration and that shall at a minimum include: (i) Performing on behalf of, and providing to, each client a written analysis of that client's current financial condition, which analysis shall include a budget analysis, consideration of all alternatives to resolve a client's credit problems, discussion of the factors that caused such financial condition, and identification of all methods by which the client can develop a plan to respond to the financial problems without incurring negative amortization of debt; and (ii) Providing each client the opportunity to have the agency negotiate an alternative payment schedule with regard to each unsecured consumer debt under terms as set forth in 11 U.S.C. 502(k) or, if the client accepts this option and the agency is unable to provide this service, the agency shall refer the client to another approved agency in the appropriate federal judicial district that provides it; (13) The term “counselor certification” means certification of a counselor by an accrediting organization because the accrediting organization has determined the counselor meets or exceeds all the accrediting organization's standards for counseling services or related areas, such as personal finance, budgeting, or credit or debt management; (14) The term “criminal background check” means a report generated by a state law enforcement authority disclosing the entire state criminal history record, if any, of the counselor for whom the criminal background check is sought, for every state where the counselor has resided or worked during any part of the immediately preceding five years. If a criminal background check is not available for, or is not authorized by state law in, each of the states where the counselor has resided or worked during any part of the immediately preceding five years, the agency shall instead obtain at least every five years a sworn statement from each counselor attesting to whether the counselor has been convicted of a felony, or a crime involving fraud, dishonesty, or false statements; (15) The term “debt repayment plan” means any written document suggested, drafted, or reviewed by an approved agency that either proposes or implements any mechanism by which a client would make payments to any creditor or creditors if, during the time any such payments are being made, that creditor or those creditors would forbear from collecting or otherwise enforcing their claim or claims against the client; provided, however, that any such written document shall not constitute a debt repayment plan if the client would incur a negative amortization of debt under it; (16) The term “Director” means the person designated or acting as the Director of the Executive Office for United States Trustees; (17) The term “entity” shall have the meaning given that term in 11 U.S.C. 101(15); (18) The term “fair share” means payments by a creditor to an approved agency for administering a debt repayment plan; (19) The terms “fee” and “fee policy” each mean the aggregate of all fees, contributions, and payments an approved agency charges clients for providing counseling services; “fee policy” shall also mean the objective criteria the agency uses in determining whether to waive or reduce any fee, contribution, or payment; (20) The term “final decision” means the written determination issued by the Director based upon the review of the United States Trustee's decision either to deny an agency's application or to remove an agency from the approved list; (21) The term “financial benefit” means any interest equated with money or its equivalent, including, but not limited to, stocks, bonds, other investments, income, goods, services, or receivables; (22) The term “governmental unit” shall have the meaning given that term in 11 U.S.C. 101(27); (23) The term “independent contractor” means a person or entity who provides any goods or services to an approved agency other than as an employee and as to whom the approved agency does not: (i) Direct or control the means or methods of delivery of the goods or services being provided; (ii) Make financial decisions concerning the business aspects of the goods or services being provided; and (iii) Have any common employees; (24) The term “languages offered” means every language other than English in which an approved agency provides counseling services; (25) The term “legal advice” shall have the meaning given that term in 11 U.S.C. 110(e)(2); (26) The term “limited English proficiency” refers to individuals who: (i) Do not speak English as their primary language; and (ii) Have a limited ability to read, write, speak, or understand English; (27) The term “material change” means, alternatively, any change: (i) In the name, structure, principal contact, management, counselors, physical location, counseling services, fee policy, language services, or method of delivery of an approved agency; or (ii) That renders inapplicable, inaccurate, incomplete, or misleading any statement an agency or approved agency previously made: (A) In its application or related materials; or (B) To the United States Trustee; (28) The term “method of delivery” means one or more of the three methods by which an approved agency can provide some component of counseling services to its clients, including: (i) “In person” delivery, which applies when a client primarily receives counseling services at a physical location with a credit counselor physically present in that location, and with the credit counselor providing oral and/or written communication to the client at the facility; (ii) “Telephone” delivery, which applies when a client primarily receives counseling services by telephone; and (iii) “Internet” delivery, which applies when a client primarily receives counseling services through an Internet Web site; (29) The term “nonprofit” means, alternatively: (i) An entity validly organized as a not-for-profit entity under applicable state or federal law, if that entity operates as a not-for-profit entity in full compliance with all applicable state and federal laws; or (ii) A qualifying governmental unit; (30) The term “notice” in § 58.24 means the written communication from the United States Trustee to an agency that its application to become an approved agency has been denied or to an approved agency that it is being removed from the approved list; (31) The term “potential client” means an individual who seeks, but does not receive, counseling services from an approved agency. (32) The term “qualifying government unit” means any governmental unit that, were it not a governmental unit, would qualify for tax-exempt status under 26 U.S.C. 501(c)(3), or would qualify as a nonprofit entity under applicable state law; (33) The term “referral fees” means money or any other valuable consideration paid or transferred between an approved agency and another entity in return for that entity, directly or indirectly, identifying, referring, securing, or in any other way encouraging any client or potential client to receive counseling services from the approved agency; provided, however, that “referral fees” shall not include fees paid to the agency under a fair share agreement; (34) The term “relative” shall have the meaning given that term in 11 U.S.C. 101(45); (35) The term “request for review” means the written communication from an agency to the Director seeking review of the United States Trustee's decision either to deny the agency's application or to remove the agency from the approved list; (36) The term “state” means state, commonwealth, district, or territory of the United States; (37) The term “tax waiver” means a document sufficient to permit the Internal Revenue Service to release directly to the United States Trustee information about an agency; (38) The term “trust account” means an account with a federally insured depository institution that is separated and segregated from operating accounts, which an approved agency shall maintain in its fiduciary capacity for the purpose of receiving and holding client funds entrusted to the approved agency; and (39) The term “United States Trustee” means, alternatively: (i) The Executive Office for United States Trustees; (ii) A United States Trustee appointed under 28 U.S.C. 581; (iii) A person acting as a United States Trustee; (iv) An employee of a United States Trustee; or (v) Any other entity authorized by the Attorney General to act on behalf of the United States under this part." 28:28:2.0.1.1.15.0.1.11,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.13 Procedures all agencies shall follow when applying to become approved agencies.,DOJ,,,"[78 FR 16150, Mar. 14, 2013]","(a) An agency applying to become an approved agency shall obtain an application, including appendices, from the United States Trustee. (b) The agency shall complete the application, including its appendices, and attach the required supporting documents requested in the application. (c) The agency shall submit the original of the completed application, including completed appendices and the required supporting documents, to the United States Trustee at the address specified on the application form. (d) The application shall be signed by an agency representative who is authorized under applicable law to sign on behalf of the applying agency. (e) The signed application, completed appendices, and required supporting documents shall be accompanied by a writing, signed by the signatory of the application and executed on behalf of the signatory and the agency, certifying the application does not: (1) Falsify, conceal, or cover up by any trick, scheme or device a material fact; (2) Make any materially false, fictitious, or fraudulent statement or representation; or (3) Make or use any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry. (f) The United States Trustee shall not consider an application, and it may be returned if: (1) It is incomplete; (2) It fails to include the completed appendices or all of the required supporting documents; or (3) It is not accompanied by the certification identified in paragraph (e) of this section. (g) The United States Trustee shall not consider an application on behalf of an agency, and it shall be returned if: (1) It is submitted by any entity other than the agency; or (2) Either the application or the accompanying certification is executed by any entity other than an agency representative who is authorized under applicable law to sign on behalf of the agency. (h) By the act of submitting an application, an agency consents to the release and disclosure of its name, contact information, and non-confidential business information relating to the services it provides on the approved list should its application be approved." 28:28:2.0.1.1.15.0.1.12,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.14 Automatic expiration of agencies' status as approved agencies.,DOJ,,,"[78 FR 16150, Mar. 14, 2013]","(a) Except as provided in § 58.15(c), if an approved agency was not an approved agency immediately prior to the date it last obtained approval to be an approved agency, such an approved agency shall cease to be an approved agency six months from the date on which it was approved unless the United States Trustee approves an additional one year period. (b) Except as provided in § 58.15(c), if an approved agency was an approved agency immediately prior to the date it last obtained approval to be an approved agency, such an agency shall cease to be an approved agency one year from the date on which it was last approved to be an approved agency unless the United States Trustee approves an additional one year period." 28:28:2.0.1.1.15.0.1.13,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.15 Procedures all approved agencies shall follow when applying for approval to act as an approved agency for an additional one year period.,DOJ,,,"[78 FR 16152, Mar. 14, 2013]","(a) To be considered for approval to act as an approved agency for an additional one year term, an approved agency shall reapply by complying with all the requirements specified for agencies under 11 U.S.C. 109(h) and 111, and under this part. (b) Such an agency shall apply no later than 45 days prior to the expiration of its six month probationary period or annual period to be considered for approval for an additional one year period, unless a written extension is granted by the United States Trustee. (c) An approved agency that has complied with all prerequisites for applying to act as an approved agency for an additional one year period may continue to operate as an approved agency while its application is under review by the United States Trustee, so long as either the application for an additional one year period is timely submitted, or an agency receives a written extension from the United States Trustee." 28:28:2.0.1.1.15.0.1.14,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.16 Renewal for an additional one year period.,DOJ,,,"[78 FR 16152, Mar. 14, 2013]","If an approved agency's application for an additional one year period is approved, such renewal period shall begin to run from the later of: (a) The day after the expiration date of the immediately preceding approval period; or (b) The actual date of approval of such renewal by the United States Trustee." 28:28:2.0.1.1.15.0.1.15,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.17 Mandatory duty of approved agencies to notify United States Trustees of material changes.,DOJ,,,"[78 FR 16152, Mar. 14, 2013]","(a) An approved agency shall immediately notify the United States Trustee in writing of any material change. (b) An approved agency shall immediately notify the United States Trustee in writing of any failure by the approved agency to comply with any standard or requirement specified in 11 U.S.C. 109(h) or 111, this part, or the terms under which the United States Trustee approved it to act as an approved agency. (c) An approved agency shall immediately notify the United States Trustee in writing of any of the following events: (1) Notification by the Internal Revenue Service or by a state or local taxing authority that the approved agency has been selected for audit or examination regarding its tax-exempt status, or any notification of a compliance check by the Internal Revenue Service or by a state or local taxing authority; (2) Revocation or termination of the approved agency's tax-exempt status by any governmental unit or by any judicial officer; (3) Cessation of business by the approved agency or by any office of the agency, or withdrawal from any federal judicial district(s) where the approved agency is approved; (4) Any investigation of, or any administrative or judicial action brought against, the approved agency by any governmental unit; (5) Termination or cancellation of any surety bond or fidelity insurance; (6) Any administrative or judicial action brought by any entity that seeks recovery against a surety bond or fidelity insurance; (7) Any action by a governmental unit or a court to suspend or revoke the approved agency's articles of incorporation, or any license held by the approved agency, or any authorization necessary to engage in business; (8) A suspension, or action to suspend, any accreditation held by the approved agency, or any withdrawal by the approved agency of any application for accreditation, or any denial of any application of the approved agency for accreditation; (9) A change in the approved agency's nonprofit status under any applicable law; (10) Any change in the banks or financial institutions used by the agency; and (11) [Reserved] (d) An agency shall notify the United States Trustee in writing if any of the changes identified in paragraphs (a) through (c) of this section occur while its application to become an approved agency is pending before the United States Trustee. (e) An approved agency whose name or other information appears incorrectly on the approved list shall immediately submit a written request to the United States Trustee asking that the information be corrected." 28:28:2.0.1.1.15.0.1.16,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.18 Mandatory duty of approved agencies to obtain prior consent of the United States Trustee before taking certain actions.,DOJ,,,"[78 FR 16153, Mar. 14, 2013]","(a) By accepting the designation to act as an approved agency, an agency agrees to obtain approval from the United States Trustee, prior to making any of the following changes: (1) Cancellation or change in the amount of the surety bond or employee fidelity bond or insurance; (2) The engagement of an independent contractor to provide counseling services or to have access to, possession of, or control over client funds; (3) Any increase in the fees, contributions, or payments received from clients for counseling services or a change in the agency's fee policy; (4) Expansion into additional federal judicial districts; (5) Any changes to the method of delivery the approved agency employs to provide counseling services; or (6) Any changes in the approved agency's counseling services. (b) An agency applying to become an approved agency shall also obtain approval from the United States Trustee before taking any action specified in paragraph (a) of this section. It shall do so by submitting an amended application. The agency's amended application shall be accompanied by a contemporaneously executed writing, signed by the signatory of the application, that makes the certifications specified in § 58.13(e). (c) An approved agency shall not transfer or assign its United States Trustee approval to act as an approved agency." 28:28:2.0.1.1.15.0.1.17,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.19 Continuing requirements for becoming and remaining approved agencies.,DOJ,,,"[78 FR 16153, Mar. 14, 2013]","(a) To become an approved agency, an agency must affirmatively establish, to the satisfaction of the United States Trustee, that the agency at the time of approval: (1) Satisfies every requirement of this part; and (2) Provides adequate counseling to its clients. (b) To remain an approved agency, an approved agency shall affirmatively establish, to the satisfaction of the United States Trustee, that the approved agency: (1) Has satisfied every requirement of this part; (2) Has provided adequate counseling to its clients; and (3) Would continue to satisfy both paragraphs (b)(1) and (2) of this section in the future." 28:28:2.0.1.1.15.0.1.18,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.20 Minimum qualifications agencies shall meet to become and remain approved agencies.,DOJ,,,"[78 FR 16153, Mar. 14, 2013]","To meet the minimum qualifications set forth in § 58.19, and in addition to the other requirements set forth in this part, agencies and approved agencies shall comply with paragraphs (a) through (p) of this section on a continuing basis: (a) Compliance with all laws. An agency shall comply with all applicable laws and regulations of the United States and each state in which the agency provides counseling services including, without limitation, all laws governing licensing and registration. (b) Prohibition on legal advice. An agency shall not provide legal advice. (c) Structure and organization. An agency shall: (1) Be lawfully organized and operated as a nonprofit entity; and (2) Have a board of directors, the majority of which: (i) Are not relatives; (ii) Are not employed by such agency; and (iii) Will not directly or indirectly benefit financially from the outcome of the counseling services provided by such agency. (d) Ethical standards. An agency shall: (1) Not engage in any conduct or transaction, other than counseling services, that generates a direct or indirect financial benefit for any member of the board of directors or trustees, officer, supervisor, or any relative thereof; (2) Ensure no member of the board of directors or trustees, officer, or supervisor receives any commissions, incentives, bonuses, or benefits (monetary or non-monetary) of any kind that are directly or indirectly based on the financial or legal decisions any client makes after requesting counseling services; (3) Ensure no member of the board of directors or trustees, officer or supervisor is a relative of an employee of the United States Trustee, a trustee appointed under 28 U.S.C. 586(a)(1) or (b) for any federal judicial district where the agency is providing or is applying to provide counseling services, a federal judge in any federal judicial district where the agency is providing or is applying to provide counseling services, a federal court employee in any federal judicial district where the agency is providing or is applying to provide counseling services, or a certified public accountant that audits the agency's trust account; (4) Not enter into any referral agreement or receive any financial benefit that involves the agency paying to or receiving from any entity or person referral fees for the referral of clients to or by the agency, except payments under a fair share agreement; (5) Not enter into agreements involving counseling services that create a conflict of interest; and (6) Not provide counseling services to a client with whom the agency has a lender-borrower relationship. (e) Use of credit counselors. An agency shall have a credit counselor provide the counseling services to each of the agency's clients. The credit counselor shall interact with the client regarding the accuracy of the information obtained from the client and the alternatives available to the client for dealing with his or her current financial situation, including the plan developed to address such financial situation. (f) Credit counselor training, certification and experience. An agency shall: (1) Use only counselors who possess adequate experience providing credit counseling, which shall mean that each counselor either: (i) Holds a counselor certification and who has complied with all continuing education requirements necessary to maintain his or her counselor certification; or (ii) Has successfully completed a course of study and worked a minimum of six months in a related area such as personal finance, budgeting, or credit or debt management. A course of study shall include training in counseling skills, personal finance, budgeting, or credit or debt management. A counselor shall also receive annual continuing education in the areas of counseling skills, personal finance, budgeting, or credit or debt management; (2) Demonstrate adequate experience, background, and quality in providing credit counseling, which shall mean that, at a minimum, the agency shall either: (i) Have experience in providing credit counseling for the two years immediately preceding the relevant application date; or (ii) For each office providing counseling services, employ at least one supervisor who has met the qualifications in paragraph (f)(2)(i) of this section for no fewer than two of the five years preceding the relevant application date; (3) If offering any component of counseling services by a telephone or Internet method of delivery, use only counselors who, in addition to all other requirements, demonstrate sufficient experience and proficiency in providing such counseling services by those methods of delivery, including proficiency in employing verification procedures to ensure the person receiving the counseling services is the client, and to determine whether the client has completely received counseling services. (g) No variation in services. An agency shall ensure that the type and quality of services do not vary based on a client's decision whether to obtain a certificate in lieu of other options that may or may not be suggested by the agency. (h) Use of the telephone and the Internet to deliver a component of client services. An agency shall: (1) Not provide any client diminished counseling services because the client receives any portion of those counseling services by telephone or Internet; (2) Confirm the identity of the client before receiving counseling services by telephone or Internet by: (i) Obtaining one or more unique personal identifiers from the client and assigning an individual access code, user ID, or password at the time of enrollment; and (ii) Requiring the client to provide the appropriate access code, user ID, or password, and also one or more of the unique personal identifiers during the course of delivery of the counseling services. (i) Services to hearing and hearing-impaired clients and potential clients. An agency shall furnish toll-free telephone numbers for both hearing and hearing-impaired clients and potential clients whenever telephone communication is required. The agency shall provide telephone amplification, sign language services, or other communication methods for hearing-impaired clients or potential clients. (j) [Reserved] (k) Services to clients and potential clients with special needs. An agency that provides any portion of its counseling in person shall comply with all federal, state and local laws governing facility accessibility. An agency shall also provide or arrange for communication assistance for clients or potential clients with special needs who have difficulty making their service needs known. (l) Mandatory disclosures to clients and potential clients. Prior to providing any information to or obtaining any information from a client or potential client, and prior to rendering any counseling service, an agency shall disclose: (1) The agency's fee policy, including any fees associated with generation of the certificate; (2) The agency's policies enabling clients to obtain counseling services for free or at reduced rates based upon the client's lack of ability to pay. To the extent an agency publishes information concerning its fees on the Internet, such fee information must include the agency's policies enabling clients to obtain counseling for free or at reduced rates based upon the client's lack of ability to pay; (3) The agency's policy to provide free bilingual counseling services or professional interpreter assistance to any limited English proficient client; (4) The agency's funding sources; (5) The counselors' qualifications; (6) The potential impacts on credit reports of all alternatives the agency may discuss with the client; (7) The agency's policy prohibiting it from paying or receiving referral fees for the referral of clients, except under a fair share agreement; (8) The agency's obligation to provide a certificate to the client promptly upon the completion of counseling services; (9) A statement that the client has the opportunity to negotiate an alternative payment schedule with regard to each unsecured consumer debt under terms as set forth in 11 U.S.C. 502(k), and a statement whether or not the agency will provide this service. If the agency does not provide this service, it shall disclose that it may refer the client to another approved agency, and shall disclose that clients may incur additional fees in connection with such a referral; (10) The fact that the agency might disclose client information to the United States Trustee in connection with the United States Trustee's oversight of the agency, or during the investigation of complaints, during on-site visits, or during quality of service reviews; (11) The fact that the United States Trustee has reviewed only the agency's credit counseling services (and, if applicable, its services as a provider of a personal financial management instructional course pursuant to 11 U.S.C. 111(d)), and the fact that the United States Trustee has neither reviewed nor approved any other services the agency provides to clients; and (12) The fact that a client will receive a certificate only if the client completes counseling services. (m) Complaint Procedures. An agency shall employ complaint procedures that adequately respond to clients' concerns. (n) Background checks. An agency shall: (1) Conduct a criminal background check at least every five years for each person providing credit counseling, and (2) Not employ anyone as a counselor who has been convicted of any felony, or any crime involving fraud, dishonesty, or false statements, unless the United States Trustee determines circumstances warrant a waiver of this prohibition against employment. (o) Agency records. An agency shall prepare and retain records that enable the United States Trustee to evaluate whether the agency is providing adequate counseling and acting in compliance with all applicable laws and this part. All records, including documents bearing original signatures, shall be maintained in either hard copy form or electronically in a format widely available commercially. Records that the agency shall prepare and retain for a minimum of two years, and permit review by the United States Trustee upon request, shall include: (1) Upon the filing of an application for probationary approval, all information requested by the United States Trustee as an estimate, projected to the end of the probationary period, in the form requested by the United States Trustee; (2) After probationary or annual approval, and for so long as the agency remains on the approved list, semi-annual reports of historical data (for the periods ending June 30 and December 31 of each year), of the type and in the form requested by the United States Trustee; these reports shall be submitted within 30 days of the end of the applicable periods specified in this paragraph; (3) Annual audited financial statements, including the audited balance sheet, statement of income and retained earnings, and statement of changes in financial condition; (4) Books, accounts, and records to provide a clear and readily understandable record of all business conducted by the agency, including, without limitation, copies of all correspondence with or on behalf of the client, including the contract between the agency and the client and any amendments thereto; (5) Records concerning the delivery of services to clients and potential clients with limited English proficiency and special needs, and to hearing-impaired clients and potential clients, including records: (i) Of the number of such clients and potential clients, and the methods of delivery used with respect to such clients and potential clients; (ii) Of which languages are offered or requested and the type of language support used or requested by such clients or potential clients (e.g., bilingual instructor, in-person or telephone interpreter, translated web instruction); (iii) Detailing the agency's provision of services to such clients and potential clients; and (iv) Supporting any justification if the agency did not provide services to such potential clients, including the number of potential clients not served, the languages involved, and the number of referrals provided; (6) Records concerning the delivery of counseling services to clients for free or at reduced rates based upon the client's lack of ability to pay, including records of the number of clients for whom the agency waived all of its fees under § 58.21(b)(1)(i), the number of clients for whom the agency waived all or part of its fees under § 58.21(b)(1)(ii), and the number of clients for whom the agency voluntarily waived all or part of its fees under § 58.21(c); (7) Records of complaints and the agency's responses thereto; (8) Records that enable the agency to verify the authenticity of certificates their clients file in bankruptcy cases; and (9) Records that enable the agency to issue replacement certificates. (p) Additional minimum requirements. An agency shall: (1) Provide records to the United States Trustee upon request; (2) Cooperate with the United States Trustee by allowing scheduled and unscheduled on-site visits, complaint investigations, or other reviews of the agency's qualifications to be an approved agency; (3) Cooperate with the United States Trustee by promptly responding to questions or inquiries from the United States Trustee; (4) Assist the United States Trustee in identifying and investigating suspected fraud and abuse by any party participating in the credit counseling or bankruptcy process; (5) Not exclude any client or creditor from a debt repayment plan because the creditor declines to make a fair share contribution to the agency; (6) Take no action that would limit, inhibit, or prevent a client from bringing an action or claim for damages against an agency, as provided in 11 U.S.C. 111(g)(2); (7) Refer clients and prospective clients for counseling services only to agencies that have been approved by a United States Trustee to provide such services; (8) Comply with the United States Trustee's directions on approved advertising, including without limitation those set forth in Appendix A to the application; (9) Not disclose or provide to a credit reporting agency any information concerning whether a client has received or sought instruction concerning credit counseling or personal financial management from an agency; (10) Not expose the client to commercial advertising as part of or during the client's receipt of any counseling services, and never market or sell financial products or services during the counseling session provided, however, this provision does not prohibit an agency from generally discussing all available financial products and services; (11) Not sell information about any client or potential client to any third party without the client or potential client's prior written permission; (12) If the agency is tax-exempt, submit a completed and signed tax waiver permitting and directing the Internal Revenue Service to provide the United States Trustee with access to the Internal Revenue Service's files relating to the agency; (13) Comply with the requirements elsewhere in this part concerning fees for credit counseling services and fee waiver policies; and (14) Comply with the requirements elsewhere in this part concerning certificates." 28:28:2.0.1.1.15.0.1.19,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.21 Minimum requirements to become and remain approved agencies relating to fees.,DOJ,,,"[78 FR 16153, Mar. 14, 2013]","(a) If a fee for, or relating to, credit counseling services is charged by an agency, such fee shall be reasonable: (1) A fee of $50 or less for credit counseling services is presumed to be reasonable and an agency need not obtain prior approval of the United States Trustee to charge such a fee; (2) A fee exceeding $50 for credit counseling services is not presumed to be reasonable and an agency must obtain prior approval from the United States Trustee to charge such a fee. The agency bears the burden of establishing that its proposed fee is reasonable. At a minimum, the agency must demonstrate that its cost for delivering such services justify the fee. An agency that previously received permission to charge a higher fee need not reapply for permission to charge that fee during the agency's annual review. Any new requests for permission to charge more than previously approved, however, must be submitted to EOUST for approval; and (3) The United States Trustee shall review the amount of the fee set forth in paragraphs (a)(1) and (2) of this section one year after the effective date of this part and then periodically, but not less frequently than every four years, to determine the reasonableness of the fee. Fee amounts and any revisions thereto shall be determined by current costs, using a method of analysis consistent with widely accepted accounting principles and practices, and calculated in accordance with the provisions of federal law as applicable. Fee amounts and any revisions thereto shall be published in the Federal Register. (b)(1) An agency shall waive the fee in whole or in part whenever a client demonstrates a lack of ability to pay the fee. (i) A client presumptively lacks the ability to pay the fee if the client's household current income is less than 150 percent of the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2), as adjusted from time to time, for a household or family of the size involved in the fee determination. (ii) The presumption shall be rebutted, and the agency may charge the client a reduced fee, if the agency determines, based on income information the client submits in connection with counseling services, that the client is able to pay the fee in a reduced amount. Nothing in this section requires an agency to charge a fee to clients whose household income exceeds the amount set forth in paragraph (b)(1)(i) of this section, or who are able to demonstrate ability to pay based on income as described in this section. (iii) An agency shall disclose its fee policy, including the criteria on which it relies in determining a client's eligibility for reduced fees, and the agency's policy for collecting fees pursuant to paragraph (b)(1)(ii) of this section, in accordance with § 58.20(l)(2). (2) The United States Trustee shall review the basis for the mandatory fee waiver policy set forth in paragraph (b)(1) of this section one year after the effective date of this part and then periodically, but not less frequently than every four years, to determine the impact of that fee waiver policy on clients and agencies. Any revisions to the mandatory fee waiver policy set forth in paragraph (b)(1) of this section shall be published in the Federal Register. (c) Notwithstanding the requirements of paragraph (b) of this section, an agency may also waive fees based upon other considerations, including, but not limited to: (1) The client's net worth; (2) The percentage of the client's income from government assistance programs; (3) Whether the client is receiving pro bono legal services in connection with a filed or anticipated bankruptcy case; or (4) If the combined current monthly income, as defined in 11 U.S.C. 101(10A), of the client and his or her spouse, when multiplied times twelve, is equal to or less than the amounts set forth in 11 U.S.C. 707(b)(7). (d) An agency shall not require a client to purchase counseling services in connection with the purchase of any other service offered by the agency." 28:28:2.0.1.1.15.0.1.2,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.2 Authorization to appoint standing trustees.,DOJ,,,"[51 FR 44288, Dec. 9, 1986]","Each U.S. Trustee is authorized, subject to the approval of the Deputy Attorney General, or his delegate, to appoint and remove one or more standing trustees to serve in cases under chapters 12 and 13 of title 11, U.S. Code." 28:28:2.0.1.1.15.0.1.20,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.22 Minimum requirements to become and remain approved agencies relating to certificates.,DOJ,,,"[78 FR 16153, Mar. 14, 2013]","(a) An approved agency shall send a certificate only to the client who took and completed the counseling services, except that an approved agency shall instead send a certificate to the attorney of a client who took and completed counseling services if the client specifically directs the agency to do so. In the case of Internet counseling and automated telephone counseling, counseling is not complete until the client has engaged in interaction with a counselor, whether by electronic mail, live chat, or telephone, following the automated portion of the counseling session. (b) An approved agency shall attach to the certificate the client's debt repayment plan (if any). (c) An approved agency shall send a certificate to a client no later than one business day after the client completed counseling services. If a client has completed counseling services, an agency may not withhold certificate issuance for any reason. An agency may not consider counseling services incomplete based solely on the client's failure to pay the fee. (d) If an approved agency provides other financial counseling in addition to counseling services, and such other financial counseling satisfies the requirements for counseling services specified in 11 U.S.C. 109(h) and 111, and this part, a person completing such other financial counseling is a client and the approved agency shall send a certificate to the client no later than one business day after the client's request. The approved agency shall not charge the client any additional fee except any separate fee charged for the issuance of the certificate, in accordance with § 58.20(l)(1). (e) An approved agency shall issue certificates only in the form approved by the United States Trustee, and shall generate the form using the Certificate Generating System maintained by the United States Trustee, except under exigent circumstances with notice to the United States Trustee. (f) An approved agency shall have sufficient computer capabilities to issue certificates from the United States Trustee's Certificate Generating System. (g) An approved agency shall issue a certificate to each client who completes counseling services. Spouses receiving counseling services jointly shall each receive a certificate. (h) An approved agency shall issue a replacement certificate to a client who requests one. (i) An approved agency shall not file certificates with the court. (j) Only an authorized officer, supervisor or employee of an approved agency shall issue a certificate, and an approved agency shall not transfer or delegate authority to issue certificates to any other entity. (k) An approved agency shall implement internal controls sufficient to prevent unauthorized issuance of certificates. (l) An approved agency shall ensure the signature affixed to a certificate is that of an officer, supervisor or employee authorized to issue the certificate, in accordance with paragraph (j) of this section, which signature shall be either: (1) An original signature; or (2) In a format approved for electronic filing with the court (most typically in the form/s/name of counselor). (m) An approved agency shall affix to the certificate the exact name under which the approved agency is incorporated or organized. (n) An approved agency shall identify on the certificate: (1) The specific federal judicial district requested by the client; (2) Whether counseling services were provided in person, by telephone or via the Internet; (3) The date and time (including the time zone) on which counseling services were completed by the client; and (4) The name of the counselor that provided the counseling services. (o) An approved agency shall affix the client's full, accurate name to the certificate. If the counseling services are obtained by a client through a duly authorized representative, the certificate also shall set forth the name of the legal representative and legal capacity of that representative. (p) If an individual enters into a debt repayment plan after completing credit counseling, upon the client's request after the completion or termination of the debt repayment plan, the approved agency shall: (1) Provide such additional credit counseling as is necessary at such time to comply with the requirements specified in 11 U.S.C. 109(h) and 111, and this part, including reviewing the client's current financial condition and counseling the client regarding the alternatives to resolve the client's credit problems; (2) Send a certificate to the client no later than one business day after the client completed such additional counseling; and (3) Not charge the client any additional fee except any separate fee charged for the issuance of the certificate, in accordance with § 58.20(l)(1)." 28:28:2.0.1.1.15.0.1.21,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.23 Minimum financial requirements and bonding and insurance requirements for agencies offering debt repayment plans.,DOJ,,,"[78 FR 16153, Mar. 14, 2013]","If an agency offers or has offered debt repayment plans, an agency shall possess adequate financial resources to provide continuing support services for such plans over the life of any debt repayment plan, and provide for the safekeeping of client funds, which shall include: (a) Depositing all client funds into a deposit account, held in trust, at a federally insured depository institution. Each such trust account shall be established in a fiduciary capacity and shall be in full compliance with federal law such that each client's funds shall be protected by federal deposit insurance up to the maximum amount allowable by federal law. (b) Keeping and maintaining books, accounts, and records to provide a clear and readily understandable record of all business conducted by the agency, including without limitation, all of the following: (1) Separate files for each client's account that include copies of all correspondence with or on behalf of the client, including: (i) All agreements with all entities, including the contract between the agency and the client and any amendments thereto; (ii) The analysis of the client's budget; (iii) Correspondence between the agency and the client's creditors; (iv) The notice given to creditors of any debt repayment plan; and (v) All written statements of account provided to the client and subsidiary ledgers concerning any debt repayment plan; (2) A trust account general ledger reflecting all deposits to and disbursements from all trust accounts, which shall be kept current at all times; (3) A reconciliation of the trust accounts, prepared at least once a month; and (4) An operating account general ledger reflecting all of the agency's financial transactions involving the agency's operating account, which shall be kept current at least on a monthly basis. (c) Allowing an independent certified public accounting firm to audit the trust accounts annually in accordance with generally accepted accounting principles as defined by the American Institute of Certified Public Accountants and any Statement of Work prepared by the United States Trustee, which audit shall include: (1) A report of all trust account activity including: (i) The balance of each trust account at the beginning and end of the period; (ii) The total of all receipts from clients and disbursements to creditors during the reporting period; (iii) The total of all disbursements to the agency; and (iv) The reconciliation of each trust account; (2) A report of all exceptions (e.g., discrepancies, irregularities, and errors) found, regardless of materiality; and (3) An evaluation of the agency's trust account internal controls and its computer operations to determine whether it provides a reasonable assurance that the trust funds are safeguarded against loss from unauthorized use or disposition. (d) Obtaining a surety bond payable to the United States, as follows: (1) Subject to the minimum amount of $5,000, the amount of such surety bond shall be the lesser of: (i) Two percent of the agency's disbursements made during the twelve months immediately prior to submission of the application from all trust accounts attributable to the federal judicial districts (or, if not feasible to determine, the states) in which the agency seeks approval from the United States Trustee; or (ii) Equal to the average daily balance maintained for the six months immediately prior to submission of the application in all trust accounts attributable to the federal judicial districts (or, if not feasible to determine, the states) in which the agency seeks approval from the United States Trustee; (2) The agency may receive an offset or credit against the surety bond amount determined under paragraph (d)(1) of this section if: (i) The agency has previously obtained a surety bond, or similar cash, securities, insurance (other than employee fidelity insurance), or letter of credit in compliance with the licensing requirements of the state in which the agency seeks approval from the United States Trustee; (ii) Such surety bond, or similar cash, securities, insurance (other than employee fidelity insurance), or letter of credit provides protection for the clients of the agency; (iii) Such surety bond, or similar cash, securities, insurance (other than employee fidelity insurance), or letter of credit, is written in favor of the state or the appropriate state agency; and (iv) The amount of the offset or credit shall be the lesser of: (A) The principal amount of such surety bond, or similar cash, securities, insurance (other than employee fidelity insurance), or letter of credit; or (B) The surety bond amount determined under paragraph (d)(1) of this section; (3) If an agency has contracted with an independent contractor to administer any part of its debt repayment plans: (i) Except as provided in paragraphs (d)(3)(ii) and (d)(3)(iii) of this section, the independent contractor shall: (A) Be an approved agency; or (B) If the independent contractor is not an approved agency, then the independent contractor shall: ( 1 ) Be specifically covered under the agency's surety bond required under paragraph (d)(1) of this section; or ( 2 ) Have a surety bond that meets the requirements of paragraph (d)(1) of this section; and ( 3 ) Agree in writing to allow the United States Trustee to audit the independent contractor's trust accounts for the debt repayment plans administered on behalf of the agency and to review the independent contractor's internal controls and administrative procedures; (ii) If the independent contractor holds funds for transmission for five days or less, then the amount of the required surety bond under paragraph (d)(3)(i)(B) of this section shall be $500,000; (iii) If the independent contractor performs only electronic fund transfers on the agency's behalf, then the independent contractor need not satisfy the requirements of paragraph (d)(3)(i) of this section during such time as the independent contractor is authorized by the National Automated Clearing House Association to participate in the Automated Clearing House system. (e) Obtaining either adequate employee bonding or fidelity insurance, as follows: (1) Subject to the minimum amount set forth below, the amount of such bonding or fidelity insurance shall be 50 percent of the surety bond amount calculated under paragraph (d)(1) of this section, prior to any offset or credit that the agency may receive under paragraph (d)(2) of this section; provided, however, that at a minimum, the employee bond or fidelity insurance must be $5,000; (2) An agency may receive an offset or credit against the employee bond or fidelity insurance amount determined under paragraph (e)(1) of this section if: (i) The agency has previously obtained an employee bond or fidelity insurance in compliance with the requirements of a state in which the agency seeks approval from the United States Trustee; and (ii) The deductible does not exceed a reasonable amount considering the financial resources of the agency; and (iii) The amount of the offset or credit shall be the lesser of: (A) The principal amount of such employee bond or fidelity insurance; or (B) The employee bond or fidelity insurance amount determined under paragraph (e)(1) of this section. (f) An agency that ceases to offer debt repayment plans to individuals who receive counseling from such agency pursuant to 11 U.S.C. 109(h) shall, concerning any debt repayment plans it services that remain in existence with respect to such individuals as of the date it ceases to offer debt repayment plans to new clients, continue to comply with all of the requirements of this section. (1) The agency may seek a waiver of the bonding and insurance requirements set forth in paragraphs (d) and (e) of this section if: (i) The agency has in effect, as of the date it ceases to offer debt repayment plans, a written agreement to transfer all such debt repayment plans to another approved agency for servicing, provided that: (A) Transfers to another approved agency pursuant to such agreements must be completed within 60 days of the date the agency ceases to offer debt repayment plans to individuals who receive counseling from such agency pursuant to 11 U.S.C. § 109(h); and (B) The agency provides written notice to clients whose debt repayment plans it intends to transfer within the time described in paragraph (f)(1)(i)(A) of this section, identifying the approved agency to which the clients' plans will be transferred, any fees associated with servicing by the approved agency, and any fees associated with the transfer; or (ii) In the reasonable determination of the United States Trustee, taking into account the facts and circumstances surrounding the agency's business and the terms of the bond, compliance with the bonding and insurance requirements set forth in paragraphs (d) and (e) of this section would impose an undue hardship on the agency." 28:28:2.0.1.1.15.0.1.22,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.24 Procedures for obtaining final agency action on United States Trustees' decisions to deny agencies' applications and to remove approved agencies from the approved list.,DOJ,,,"[78 FR 16153, Mar. 14, 2013]","(a) The United States Trustee shall remove an approved agency from the approved list whenever an approved agency requests its removal in writing. (b) The United States Trustee may issue a decision to remove an approved agency from the approved list, and thereby terminate the approved agency's authorization to provide counseling services, at any time. (c) The United States Trustee may issue a decision to deny an agency's application or to remove an agency from the approved list whenever the United States Trustee determines that the agency has failed to comply with the standards or requirements specified in 11 U.S.C. 109(h) or 111, this part, or the terms under which the United States Trustee designated it to act as an approved agency, including, but not limited to, finding any of the following: (1) The agency is not employing adequate procedures for safekeeping of client funds or paying client funds, which could result in a loss to a client; (2) The agency's surety bond has been canceled; (3) Any entity has revoked the agency's nonprofit status, even if that revocation is subject to further administrative or judicial litigation, review or appeal; (4) Any entity has suspended or revoked the agency's license to do business in any jurisdiction; or (5) Any United States district court has removed the agency under 11 U.S.C. § 111(e). (d) If the Internal Revenue Service revokes an agency's tax exempt status, the United States Trustee shall promptly commence an investigation to determine whether any of the factors set forth in paragraphs (c)(1) through (5) of this section exist. (e) The United States Trustee shall provide to the agency in writing a notice of any decision either to: (1) Deny the agency's application; or (2) Remove the agency from the approved list. (f) The notice shall state the reason(s) for the decision and shall reference any documents or communications relied upon in reaching the denial or removal decision. To the extent authorized by law, the United States Trustee shall provide to the agency copies of any such documents that were not supplied to the United States Trustee by the agency. The notice shall be sent to the agency by overnight courier, for delivery the next business day. (g) Except as provided in paragraph (i) of this section, the notice shall advise the agency that the denial or removal decision shall become final agency action, and unreviewable, unless the agency submits in writing a request for review by the Director no later than 21 calendar days from the date of the notice to the agency. (h) Except as provided in paragraph (i) of this section, the decision to deny an agency's application or remove an agency from the approved list shall take effect upon: (1) The expiration of the agency's time to seek review from the Director, if the agency fails to timely seek review of a denial or removal decision; or (2) The issuance by the Director of a final decision, if the agency timely seeks such review. (i) The United States Trustee may provide that a decision to remove an agency from the approved list is effective immediately and deny the agency the right to provide counseling services whenever the United States Trustee finds any of the factors set forth in paragraphs (c)(1) through (5) of this section. (j) An agency's request for review shall be in writing and shall fully describe why the agency disagrees with the denial or removal decision, and shall be accompanied by all documents and materials the agency wants the Director to consider in reviewing the denial or removal decision. The agency shall send the original and one copy of the request for review, including all accompanying documents and materials, to the Office of the Director by overnight courier, for delivery the next business day. To be timely, a request for review shall be received at the Office of the Director no later than 21 calendar days from the date of the notice to the agency. (k) The United States Trustee shall have 21 calendar days from the date of the agency's request for review to submit to the Director a written response regarding the matters raised in the agency's request for review. The United States Trustee shall provide a copy of this response to the agency by overnight courier, for delivery the next business day. (l) The Director may seek additional information from any party in the manner and to the extent the Director deems appropriate. (m) In reviewing the decision to deny an agency's application or remove an agency from the approved list, the Director shall determine: (1) Whether the denial or removal decision is supported by the record; and (2) Whether the denial or removal decision constitutes an appropriate exercise of discretion. (n) Except as provided in paragraph (o) of this section, the Director shall issue a final decision no later than 60 calendar days from the receipt of the agency's request for review, unless the agency agrees to a longer period of time or the Director extends the deadline. The Director's final decision on the agency's request for review shall constitute final agency action. (o) Whenever the United States Trustee provides under paragraph (i) of this section that a decision to remove an agency from the approved list is effective immediately, the Director shall issue a written decision no later than 15 calendar days from the receipt of the agency's request for review, unless the agency agrees to a longer period of time. The decision shall: (1) Be limited to deciding whether the determination that the removal decision should take effect immediately was supported by the record and an appropriate exercise of discretion; (2) Constitute final agency action only on the issue of whether the removal decision should take effect immediately; and (3) Not constitute final agency action on the ultimate issue of whether the agency should be removed from the approved list; after issuing the decision, the Director shall issue a final decision by the deadline set forth in paragraph (n) of this section. (p) In reaching a decision under paragraphs (n) and (o) of this section, the Director may specify a person to act as a reviewing official. The reviewing official's duties shall be specified by the Director on a case-by-case basis, and may include reviewing the record, obtaining additional information from the participants, providing the Director with written recommendations, and such other duties as the Director shall prescribe in a particular case. (q) An agency that files a request for review shall bear its own costs and expenses, including counsel fees. (r) When a decision to remove an agency from the approved list takes effect, the agency shall: (1) Immediately cease providing counseling services to clients and shall not provide counseling services to potential clients; (2) No later than three business days after the date of removal, send all certificates to all clients who completed counseling services prior to the agency's removal from the approved list; (3) No later than three business days after the date of removal, return all fees to clients and potential clients who had paid for counseling services, but had not completely received them; and (4) Transfer any debt repayment plans that the agency is administering to another approved agency. (s) An agency must exhaust all administrative remedies before seeking redress in any court of competent jurisdiction." 28:28:2.0.1.1.15.0.1.23,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.25 Definitions.,DOJ,,,"[78 FR 16170, Mar. 14, 2013]","(a) The following definitions apply to §§ 58.25 through and including 58.36 of this part, as well as the applications and other materials providers submit in an effort to establish they meet the requirements necessary to become an approved provider of a personal financial management instructional course. (b) These terms shall have these meanings: (1) The term “accreditation” means the recognition or endorsement that an accrediting organization bestows upon a provider because the accrediting organization has determined the provider meets or exceeds all the accrediting organization's standards; (2) The term “accrediting organization” means either an entity that provides accreditation to providers or provides certification to instructors, provided, however, that an accrediting organization shall: (i) Not be a provider or affiliate of any provider; and (ii) Be deemed acceptable by the United States Trustee; (3) The term “affiliate” means: (i) Every entity that is an affiliate of the provider, as the term “affiliate” is defined in 11 U.S.C. 101(2), except that the word “provider” shall be substituted for the word “debtor” in 11 U.S.C. 101(2); (ii) Each of a provider's officers and each of a provider's directors; and (iii) Every relative of a provider's officers and every relative of a provider's directors; (4) The term “application” means the application and related forms, including appendices, approved by the Office of Management and Budget as form EOUST-DE1, Application for Approval as a Provider of a Personal Financial Management Instructional Course, as it shall be amended from time to time; (5) The term “approved list” means the list of providers currently approved by a United States Trustee under 11 U.S.C. 111 as currently published on the United States Trustee Program's Internet site, which is located on the United States Department of Justice's Internet site; (6) The term “approved provider” means a provider currently approved by a United States Trustee under 11 U.S.C. 111 as an approved provider of a personal financial management instructional course eligible to be included on one or more lists maintained under 11 U.S.C. 111(a)(1); (7) The term “certificate” means the document an approved provider shall provide to a debtor after the debtor completes an instructional course, if the approved provider does not notify the appropriate bankruptcy court in accordance with the Federal Rules of Bankruptcy Procedure that a debtor has completed the instructional course; (8) The term “debtor” shall have the meaning given that term in 11 U.S.C. 101(13), to the extent that individual has sought an instructional course from an approved provider; (9) The term “Director” means the person designated or acting as the Director of the Executive Office for United States Trustees; (10) The term “effective instruction” means the actual receipt of an instructional course by a debtor from an approved provider, and all other applicable services, rights, and protections specified in: (i) 11 U.S.C. 111; and (ii) this part; (11) The term “entity” shall have the meaning given that term in 11 U.S.C. 101(15); (12) The terms “fee” and “fee policy” each mean the aggregate of all fees an approved provider charges debtors for providing an instructional course, including the fees for any materials; “fee policy” shall also mean the objective criteria the provider uses in determining whether to waive or reduce any fee, contribution, or payment; (13) The term “final decision” means the written determination issued by the Director based upon the review of the United States Trustee's decision either to deny a provider's application or to remove an approved provider from the approved list; (14) The term “financial benefit” means any interest equated with money or its equivalent, including, but not limited to, stocks, bonds, other investments, income, goods, services, or receivables; (15) The term “governmental unit” shall have the meaning given that term in 11 U.S.C. 101(27); (16) The term “independent contractor” means a person or entity who provides any goods or services to an approved provider other than as an employee and as to whom the approved provider does not: (i) Direct or control the means or methods of delivery of the goods or services being provided; (ii) Make financial decisions concerning the business aspects of the goods or services being provided; and (iii) Have any common employees; (17) The term “instructional course” means a course in personal financial management that is approved by the United States Trustee under 11 U.S.C. 111 and this part, including the learning materials and methodologies in § 58.33(f), which is to be taken and completed by the debtor after the filing of a bankruptcy petition and before receiving a discharge under 11 U.S.C. 727(a)(11), 1141(d)(3) or 1328(g)(1); (18) The term “instructor” means an individual who teaches, presents or explains substantive instructional course materials to debtors, whether provided in person, by telephone, or through the Internet; (19) The term “languages offered” means every language other than English in which an approved provider offers an instructional course; (20) The term “legal advice” shall have the meaning given that term in 11 U.S.C. 110(e)(2); (21) The term “limited English proficiency” refers to individuals who: (i) Do not speak English as their primary language; and (ii) Have a limited ability to read, write, speak, or understand English; (22) The term “material change” means, alternatively, any change: (i) In the name, structure, principal contact, management, instructors, physical location, instructional course, fee policy, language services, or method of delivery of an approved provider; or (ii) That renders inapplicable, inaccurate, incomplete, or misleading any statement a provider previously made: (A) In its application or related materials; or (B) To the United States Trustee; (23) The term “method of delivery” means one or more of the three methods by which an approved provider can provide some component of an instructional course to debtors, including: (i) “In person” delivery, which applies when a debtor primarily receives an instructional course at a physical location with an instructor physically present in that location, and with the instructor providing oral and/or written communication to the debtor at the facility; (ii) “Telephone” delivery, which applies when a debtor primarily receives an instructional course by telephone; and (iii) “Internet” delivery, which applies when a debtor primarily receives an instructional course through an Internet Web site; (24) The term “notice” in § 58.36 means the written communication from the United States Trustee to a provider that its application to become an approved provider has been denied or to an approved provider that it is being removed from the approved list; (25) The term “provider” shall mean any entity that is applying under this part for United States Trustee approval to be included on a publicly available list in one or more United States district courts, as authorized by 11 U.S.C. 111(a)(1), and shall also mean, whenever appropriate, an approved provider; (26) The term “referral fees” means money or any other valuable consideration paid or transferred between an approved provider and another entity in return for that entity, directly or indirectly, identifying, referring, securing, or in any other way encouraging any debtor to receive an instructional course from the approved provider; (27) The term “relative” shall have the meaning given that term in 11 U.S.C. 101(45); (28) The term “request for review” means the written communication from a provider to the Director seeking review of the United States Trustee's decision either to deny the provider's application or to remove the provider from the approved list; (29) The term “state” means state, commonwealth, district, or territory of the United States; (30) The term “United States Trustee” means, alternatively: (i) The Executive Office for United States Trustees; (ii) A United States Trustee appointed under 28 U.S.C. 581; (iii) A person acting as a United States Trustee; (iv) An employee of a United States Trustee; or (v) Any other entity authorized by the Attorney General to act on behalf of the United States under this part." 28:28:2.0.1.1.15.0.1.24,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.26 Procedures all providers shall follow when applying to become approved providers.,DOJ,,,"[78 FR 16170, Mar. 14, 2013]","(a) A provider applying to become an approved provider shall obtain an application, including appendices, from the United States Trustee. (b) The provider shall complete the application, including its appendices, and attach the required supporting documents requested in the application. (c) The provider shall submit the original of the completed application, including completed appendices and the required supporting documents, to the United States Trustee at the address specified on the application form. (d) The application shall be signed by a representative of the provider who is authorized under applicable law to sign on behalf of the applying provider. (e) The signed application, completed appendices, and required supporting documents shall be accompanied by a writing, signed by the signatory of the application and executed on behalf of the signatory and the provider, certifying the application does not: (1) Falsify, conceal, or cover up by any trick, scheme or device a material fact; (2) Make any materially false, fictitious, or fraudulent statement or representation; or (3) Make or use any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry. (f) The United States Trustee shall not consider an application, and it may be returned if: (1) It is incomplete; (2) It fails to include the completed appendices or all of the required supporting documents; or (3) It is not accompanied by the certification identified in the preceding subsection. (g) The United States Trustee shall not consider an application on behalf of a provider, and it shall be returned if: (1) It is submitted by any entity other than the provider; or (2) Either the application or the accompanying certification is executed by any entity other than a representative of the provider who is authorized under applicable law to sign on behalf of the provider. (h) By the act of submitting an application, a provider consents to the release and disclosure of its name, contact information, and non-confidential business information relating to the services it provides on the approved list should its application be approved." 28:28:2.0.1.1.15.0.1.25,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.27 Automatic expiration of providers' status as approved providers.,DOJ,,,"[78 FR 16170, Mar. 14, 2013]","(a) Except as provided in § 58.28(c), if an approved provider was not an approved provider immediately prior to the date it last obtained approval to be an approved provider, such an approved provider shall cease to be an approved provider six months from the date on which it was approved unless the United States Trustee approves an additional one year period. (b) Except as provided in § 58.28(c), if an approved provider was an approved provider immediately prior to the date it last obtained approval to be an approved provider, such a provider shall cease to be an approved provider one year from the date on which it was last approved to be an approved provider unless the United States Trustee approves an additional one year period." 28:28:2.0.1.1.15.0.1.26,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.28 Procedures all approved providers shall follow when applying for approval to act as an approved provider for an additional one year period.,DOJ,,,"[78 FR 16172, Mar. 14, 2013]","(a) To be considered for approval to act as an approved provider for an additional one year term, an approved provider shall reapply by complying with all the requirements specified for providers under 11 U.S.C. 111, and under this part. (b) Such a provider shall apply no later than 45 days prior to the expiration of its six month probationary period or annual period to be considered for approval for an additional one year period, unless a written extension is granted by the United States Trustee. (c) An approved provider that has complied with all prerequisites for applying to act as an approved provider for an additional one year period may continue to operate as an approved provider while its application is under review by the United States Trustee, so long as either the application for an additional one year period is timely submitted, or a provider receives a written extension from the United States Trustee." 28:28:2.0.1.1.15.0.1.27,28,Judicial Administration,I,,58,PART 58—REGULATIONS RELATING TO THE BANKRUPTCY REFORM ACTS OF 1978 AND 1994,,,,§ 58.29 Renewal for an additional one year period.,DOJ,,,"[78 FR 16172, Mar. 14, 2013]","If an approved provider's application for an additional one year period is approved, such renewal period shall begin to run from the later of: (a) The day after the expiration date of the immediately preceding approval period; or (b) The actual date of approval of such renewal by the United States Trustee."