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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 10:10:1.0.1.1.12.1.76.1 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | A | Subpart A—General | § 14.1 Scope of regulations. | NRC | [90 FR 54227, Nov. 26, 2025] | (a) The terms “Nuclear Regulatory Commission” and “NRC” as used in this part mean the agency established by section 201(a) of the Energy Reorganization Act of 1974, but do not include any contractor with the Nuclear Regulatory Commission. (b) The regulations in this part supplement the Department of Justice's regulations in 28 CFR parts 14 and 15. (c) These regulations apply to administrative claims under the Federal Tort Claims Act, as amended, asserted on or after the effective date of this rule, for money damages against the United States for damage to or loss of property or personal injury or death caused by the negligent or wrongful act or omission of any employee of the NRC while acting within the scope of his or her office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred. | ||||
| 10:10:1.0.1.1.12.1.76.2 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | A | Subpart A—General | § 14.3 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.2.76.1 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.11 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.2.76.2 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.13 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.2.76.3 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.15 Where to present a claim to NRC. | NRC | [47 FR 8983, Mar. 3, 1982, as amended at 51 FR 35999, Oct. 8, 1986] | A claimant shall mail or deliver the claim to the office of employment of the NRC employee whose negligent or wrongful act or omission is alleged to have caused the loss or injury. If the office of employment is not known, the claimant shall file the claim with the Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555. | ||||
| 10:10:1.0.1.1.12.2.76.4 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.17 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.2.76.5 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.19 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.2.76.6 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.21 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.2.76.7 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.23 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.2.76.8 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.25 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.2.76.9 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | B | Subpart B—Filing Procedures and Requirements | § 14.27 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.3.76.1 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | C | Subpart C—Commission Action and Authority | § 14.31 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.3.76.2 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | C | Subpart C—Commission Action and Authority | § 14.33 Officials authorized to act. | NRC | [51 FR 35999, Oct. 8, 1986] | The General Counsel or the General Counsel's designee shall exercise the authority to adjust, determine, compromise and settle a claim under the provisions of 28 U.S.C. 2672. | ||||
| 10:10:1.0.1.1.12.3.76.3 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | C | Subpart C—Commission Action and Authority | § 14.35 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.3.76.4 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | C | Subpart C—Commission Action and Authority | § 14.37 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.3.76.5 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | C | Subpart C—Commission Action and Authority | § 14.39 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.3.76.6 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | C | Subpart C—Commission Action and Authority | § 14.41 [Reserved] | NRC | ||||||
| 10:10:1.0.1.1.12.3.76.7 | 10 | Energy | I | 14 | PART 14—ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT | C | Subpart C—Commission Action and Authority | § 14.43 [Reserved] | NRC | ||||||
| 14:14:1.0.1.2.6.1.11.1 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | A | Subpart A—General Provisions | § 14.01 Purpose of these rules. | FAA | The Equal Access to Justice Act, 5 U.S.C. 504 (the Act), provides for the award of attorney fees and other expenses to eligible individuals and entities who are parties to certain administrative proceedings (adversary adjudications) before the Federal Aviation Administration (FAA). An eligible party may receive an award when it prevails over the FAA, unless the agency's position in the proceeding was substantially justified or special circumstances make an award unjust. The rules in this part describe the parties eligible for awards and the proceedings that are covered. They also explain how to apply for awards, and the procedures and standards that the FAA Decisionmaker will use to make them. As used hereinafter, the term “agency” applies to the FAA. | ||||
| 14:14:1.0.1.2.6.1.11.2 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | A | Subpart A—General Provisions | § 14.02 Proceedings covered. | FAA | [54 FR 46199, Nov. 1, 1989, as amended by Amdt. 14-03, 64 FR 32935, June 18, 1999] | (a) The Act applies to certain adversary adjudications conducted by the FAA under 49 CFR part 17 and the Acquisition Management System (AMS). These are adjudications under 5 U.S.C. 554, in which the position of the FAA is represented by an attorney or other representative who enters an appearance and participates in the proceeding. This subpart applies to proceedings under 49 U.S.C. 46301, 46302, and 46303 and to the Default Adjudicative Process under part 17 of this chapter and the AMS. (b) If a proceeding includes both matters covered by the Act and matters specifically excluded from coverage, any award made will include only fees and expenses related to covered issues. (c) Fees and other expenses may not be awarded to a party for any portion of the adversary adjudication in which such party has unreasonably protracted the proceedings. | |||
| 14:14:1.0.1.2.6.1.11.3 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | A | Subpart A—General Provisions | § 14.03 Eligibility of applicants. | FAA | [54 FR 46199, Nov. 1, 1989, as amended by Amdt. 14-03, 64 FR 32935, June 18, 1999] | (a) To be eligible for an award of attorney fees and other expenses under the Act, the applicant must be a party to the adversary adjudication for which it seeks an award. The term “party” is defined in 5 U.S.C. 504(b)(1)(B) and 5 U.S.C. 551(3). The applicant must show that it meets all conditions or eligibility set out in this subpart. (b) The types of eligible applicants are as follows: (1) An individual with a net worth of not more than $2 million at the time the adversary adjudication was initiated; (2) The sole owner of an unincorporated business who has a net worth of not more than $7 million, including both personal and business interests, and not more than 500 employees at the time the adversary adjudication was initiated; (3) A charitable or other tax-exempt organization described in section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)) with not more than 500 employees at the time the adversary adjudication was initiated; and (4) A cooperative association as defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a)) with not more than 500 employees at the time the adversary adjudication was initiated; and (5) Any other partnership, corporation, association, or public or private organization with a net worth of not more than $7 million and not more than 500 employees at the time the adversary adjudication was initiated. (c) For the purpose of eligibility, the net worth and number of employees of an applicant shall be determined as of the date the proceeding was initiated. (d) An applicant who owns an unincorporated business will be considered an “individual” rather than a “sole owner of an unincorporated business” if the issues on which the applicant prevails are related primarily to personal interests rather than to business interest. (e) The employees of an applicant include all persons who regularly perform services for remuneration for the applicant, under the applicant's direction and control. Part-time employees shall be included on a proportional basis. … | |||
| 14:14:1.0.1.2.6.1.11.4 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | A | Subpart A—General Provisions | § 14.04 Standards for awards. | FAA | (a) A prevailing applicant may receive an award for attorney fees and other expenses incurred in connection with a proceeding, or in a significant and discrete substantive portion of the proceeding, unless the position of the agency over which the applicant has prevailed was substantially justified. Whether or not the position of the FAA was substantially justified shall be determined on the basis of the record (including the record with respect to the action or failure to act by the agency upon which the civil action is based) which was made in the civil action for which fees and other expenses are sought. The burden of proof that an award should not be made to an eligible prevailing applicant is on the agency counsel, who may avoid an award by showing that the agency's position was reasonable in law and fact. (b) An award will be reduced or denied if the applicant has unduly or unreasonably protracted the proceeding or if special circumstances make the award sought unjust. | ||||
| 14:14:1.0.1.2.6.1.11.5 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | A | Subpart A—General Provisions | § 14.05 Allowance fees and expenses. | FAA | [Amdt. 13-18, 53 FR 34655, Sept. 7, 1988, as amended by Amdt. 14-1, 55 FR 15131, Apr. 20, 1990; Amdt. 14-03, 64 FR 32935, June 18, 1999] | (a) Awards will be based on rates customarily charged by persons engaged in the business of acting as attorneys, agents, and expert witnesses, even if the services were made available without charge or at a reduced rate to the applicant. (b) No award for the fee of an attorney or agent under this part may exceed $125 per hour, or such rate as prescribed by 5 U.S.C. 504. No award to compensate an expert witness may exceed the highest rate at which the agency pays expert witnesses. However, an award may also include the reasonable expenses of the attorney, agent, or witness as a separate item, if the attorney, agent, or witness ordinarily charges clients separately for such expenses. (c) In determining the reasonableness of the fee sought for an attorney, agent, or expert witness, the ALJ or adjudicative officer shall consider the following: (1) If the attorney, agent, or witness is in private practice, his or her customary fee for similar services, or if an employee of the applicant, the fully allocated cost of the services; (2) The prevailing rate for similar services in the community in which the attorney, agent, or witness ordinarily performs services; (3) The time actually spent in the representation of the applicant; (4) The time reasonably spent in light of the difficulty or complexity of the issues in the proceeding; and (5) Such other factors as may bear on the value of the services provided. (d) The reasonable cost of any study, analysis, engineering report, test, project, or similar matter prepared on behalf of a party may be awarded, to the extent that the charge for the service does not exceed the prevailing rate for similar services, and the study or other matter was necessary for preparation of the applicant's case. (e) Fees may be awarded only for work performed after the issuance of a complaint, or in the Default Adjudicative Process for a protest or contract dispute under part 17 of this chapter and the AMS. | |||
| 14:14:1.0.1.2.6.2.11.1 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | B | Subpart B—Information Required From Applicants | § 14.10 Contents of application. | FAA | (a) An application for an award of fees and expenses under the Act shall identify the applicant and the proceeding for which an award is sought. The application shall show that the applicant has prevailed and identify the position of the agency in the proceeding that the applicant alleges was not substantially justified. Unless the applicant is an individual, the application shall also state the number of employees of the applicant and describe briefly the type and purpose of its organization or business. (b) The application shall also include a statement that the applicant's net worth does not exceed $2 million (if an individual) or $7 million (for all other applicants, including their affiliates) at the time the adversary adjudication was initiated. However, an applicant may omit this statement if: (1) It attaches a copy of a ruling by the Internal Revenue Service that it qualifies as an organization described in section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)), or in the case of a tax-exempt organization not required to obtain a ruling from the Internal Revenue Service on its exempt status, a statement that describes the basis for the applicant's belief that it qualifies under such section; or (2) It states that it is a cooperative association as defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a)). (c) The application shall state the amount of fees and expenses for which an award is sought. (d) The application may also include any other matters that the applicant wishes this agency to consider in determining whether and in what amount an award should be made. (e) The application shall be signed by the applicant or an authorized officer or attorney for the applicant. It shall also contain or be accompanied by a written verification under oath or under penalty of perjury that the information provided in the application is true and correct. (f) If the applicant is a partnership, corporation, association, organization, or sole owner of an unincorporated busine… | ||||
| 14:14:1.0.1.2.6.2.11.2 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | B | Subpart B—Information Required From Applicants | § 14.11 Net worth exhibit. | FAA | [54 FR 46199, Nov. 1, 1989, as amended by Amdt. 14-03, 64 FR 32935, June 18, 1999] | (a) Each applicant except a qualified tax-exempt organization or cooperative association must provide with its application a detailed exhibit showing the net worth of the applicant and any affiliates when the proceeding was initiated. If any individual, corporation, or other entity directly or indirectly controls or owns a majority of the voting shares or other interest of the applicant, or if the applicant directly or indirectly owns or controls a majority of the voting shares or other interest of any corporation or other entity, the exhibit must include a showing of the net worth of all such affiliates or of the applicant including the affiliates. The exhibit may be in any form convenient to the applicant that provides full disclosure of the applicant's and its affiliates' assets and liabilities and is sufficient to determine whether the applicant qualifies under the standards in this part. The administrative law judge may require an applicant to file additional information to determine the eligibility for an award. (b) The net worth exhibit shall describe any transfers of assets from, or obligations incurred by, the applicant or any affiliate, occurring in the one-year period prior to the date on which the proceeding was initiated, that reduced the net worth of the applicant and its affiliates below the applicable net worth ceiling. If there were no such transactions, the applicant shall so state. (c) Ordinarily, the net worth exhibit will be included in the public record of the proceeding. However, an applicant that objects to public disclosure of the net worth exhibit, or any part of it, may submit that portion of the exhibit directly to the ALJ or adjudicative officer in a sealed envelope labeled “Confidential Financial Information,” accompanied by a motion to withhold the information. (1) The motion shall describe the information sought to be withheld and explain, in detail, why it should be exempt under applicable law or regulation, why public disclosure would adversely affect the applicant, and why di… | |||
| 14:14:1.0.1.2.6.2.11.3 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | B | Subpart B—Information Required From Applicants | § 14.12 Documentation of fees and expenses. | FAA | The application shall be accompanied by full documentation of the fees and expenses, including the cost of any study, analysis, engineering report, test, project or similar matter, for which an award is sought. A separate itemized statement shall be submitted for each professional firm or individual whose services are covered by the application, showing the hours spent in connection with the proceedings by each individual, a description of the specific services performed, the rate at which each fee has been computed, any expenses for which reimbursement is sought, the total amount claimed, and the total amount paid or payable by the applicant or by any other person or entity for the services provided. The administrative law judge may require the applicant to provide vouchers, receipts, or other substantiation for any expenses claimed. | ||||
| 14:14:1.0.1.2.6.3.11.1 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.20 When an application may be filed. | FAA | [54 FR 46199, Nov. 1, 1989, as amended by Amdt. 14-03, 64 FR 32936, June 18, 1999] | (a) An application may be filed whenever the applicant has prevailed in the proceeding, but in no case later than 30 days after the FAA Decisionmaker's final disposition of the proceeding, or service of the order of the Administrator in a proceeding under the AMS. (b) If review or reconsideration is sought or taken of a decision to which an applicant believes it has prevailed, proceedings for the award of fees shall be stayed pending final disposition of the underlying controversy. (c) For purposes of this part, final disposition means the later of: (1) Under part 17 of this chapter and the AMS, the date on which the order of the Administrator is served; (2) The date on which an unappealed initial decision becomes administratively final; (3) Issuance of an order disposing of any petitions for reconsideration of the FAA Decisionmaker's final order in the proceeding; (4) If no petition for reconsideration is filed, the last date on which such a petition could have been filed; or (5) Issuance of a final order or any other final resolution of a proceeding, such as a settlement or voluntary dismissal, which is not subject to a petition for reconsideration. | |||
| 14:14:1.0.1.2.6.3.11.10 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.29 Judicial review. | FAA | If an applicant is dissatisfied with the determination of fees and other expenses made under this subsection, pursuant 5 U.S.C. 504(c)(2), that applicant may, within thirty (30) days after the determination is made, appeal the determination to the court of the United States having jurisdiction to review the merits of the underlying decision of the FAA adversary adjudication. The court's determination on any appeal heard under this paragraph shall be based solely on the factual record made before the FAA. The court may modify the determination of fees and other expenses only if the court finds that the failure to make an award of fees and other expenses, or the calculation of the amount of the award, was unsupported by substantial evidence. | ||||
| 14:14:1.0.1.2.6.3.11.11 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.30 Payment of award. | FAA | An applicant seeking payment of an award shall submit to the disbursing official of the FAA a copy of the FAA Decisionmaker's final decision granting the award, accompanied by a statement that the applicant will not seek review of the decision in the United States courts. Applications for award grants in cases involving the FAA shall be sent to: The Office of Accounting and Audit, AAA-1, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591. The agency will pay the amount awarded to the applicant within 60 days, unless judicial review of the award or of the underlying decision of the adversary adjudication has been sought by the applicant or any other party to the proceeding. | ||||
| 14:14:1.0.1.2.6.3.11.2 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.21 Filing and service of documents. | FAA | [Doc. No. FAA-1998-4379, 64 FR 32936, June 18, 1999] | Any application for an award or other pleading or document related to an application shall be filed and served on all parties to the proceeding in the same manner as other pleadings in the proceeding, except as provided in § 14.11(b) for confidential financial information. Where the proceeding was held under part 17 of this chapter and the AMS, the application shall be filed with the FAA's attorney and with the Office of Dispute Resolution for Acquisition. | |||
| 14:14:1.0.1.2.6.3.11.3 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.22 Answer to application. | FAA | [54 FR 46199, Nov. 1, 1989, as amended by Amdt. 14-03, 64 FR 32936, June 18, 1999] | (a) Within 30 days after service of an application, counsel representing the agency against which an award is sought may file an answer to the application. Unless agency counsel requests an extension of time for filing or files a statement of intent to negotiate under paragraph (b) of the section, failure to file an answer within the 30-day period may be treated as a consent to the award requested. (b) If the FAA's counsel and the applicant believe that the issues in the fee application can be settled, they may jointly file a statement of their intent to negotiate a settlement. The filing of this statement shall extend the time for filing an answer for an additional 30 days, and further extensions may be granted by the ALJ or adjudicative officer upon request by the FAA's counsel and the applicant. (c) The answer shall explain in detail any objections to the award requested and identify the facts relied on in support of agency counsel's position. If the answer is based on any alleged facts not already in the record of the proceeding, agency counsel shall include with the answer either supporting affidavits or a request for further proceedings under § 14.26. | |||
| 14:14:1.0.1.2.6.3.11.4 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.23 Reply. | FAA | Within 15 days after service of an answer, the applicant may file a reply. If the reply is based on any alleged facts not already in the record of the proceeding, the applicant shall include with the reply either supporting affidavits or a request for further proceedings under § 14.26. | ||||
| 14:14:1.0.1.2.6.3.11.5 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.24 Comments by other parties. | FAA | [Doc. No. FAA-1998-4379, 64 FR 32936, June 18, 1999] | Any party to a proceeding other than the applicant and the FAA's counsel may file comments on an application within 30 days after it is served, or on an answer within 15 days after it is served. A commenting party may not participate further in proceedings on the application unless the ALJ or adjudicative officer determines that the public interest requires such participation in order to permit full exploration of matters raised in the comments. | |||
| 14:14:1.0.1.2.6.3.11.6 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.25 Settlement. | FAA | The applicant and agency counsel may agree on a proposed settlement of the award before final action on the application, either in connection with a settlement of the underlying proceeding, or after the underlying proceeding has been concluded. If a prevailing party and agency counsel agree on a proposed settlement of an award before an application has been filed, the application shall be filed with the proposed settlement. | ||||
| 14:14:1.0.1.2.6.3.11.7 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.26 Further proceedings. | FAA | [54 FR 46199, Nov. 1, 1989, as amended by Amdt. 14-03, 64 FR 32936, June 18, 1999] | (a) Ordinarily the determination of an award will be made on the basis of the written record; however, on request of either the applicant or agency counsel, or on his or her own initiative, the ALJ or adjudicative officer assigned to the matter may order further proceedings, such as an informal conference, oral argument, additional written submissions, or an evidentiary hearing. Such further proceedings shall be held only when necessary for full and fair resolution of the issues arising from the application and shall be conducted as promptly as possible. (b) A request that the administrative law judge order further proceedings under this section shall specifically identify the information sought or the disputed issues and shall explain why the additional proceedings are necessary to resolve the issues. | |||
| 14:14:1.0.1.2.6.3.11.8 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.27 Decision. | FAA | [Doc. No. FAA-1998-4379, 64 FR 32936, June 18, 1999] | (a) The ALJ shall issue an initial decision on the application within 60 days after completion of proceedings on the application. (b) An adjudicative officer in a proceeding under part 17 of this chapter and the AMS shall prepare a findings and recommendations for the Office of Dispute Resolution for Acquisition. (c) A decision under paragraph (a) or (b) of this section shall include written findings and conclusions on the applicant's eligibility and status as prevailing party and an explanation of the reasons for any difference between the amount requested and the amount awarded. The decision shall also include, if at issue, findings on whether the FAA's position was substantially justified, or whether special circumstances make an award unjust. | |||
| 14:14:1.0.1.2.6.3.11.9 | 14 | Aeronautics and Space | I | B | 14 | PART 14—RULES IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 | C | Subpart C—Procedures for Considering Applications | § 14.28 Review by FAA decisionmaker. | FAA | [Doc. No. FAA-1998-4379, 64 FR 32936, June 18, 1999, as amended at 70 FR 8238, Feb. 18, 2005] | (a) In proceedings other than those under part 17 of this chapter and the AMS, either the applicant or the FAA counsel may seek review of the initial decision on the fee application in accordance with subpart G of part 13 of this chapter, specifically § 13.233. Additionally, the FAA Decisionmaker may decide to review the decision on his/her own initiative. If neither the applicant nor the FAA's counsel seeks review within 30 days after the decision is issued, it shall become final. Whether to review a decision is a matter within the discretion of the FAA Decisionmaker. If review is taken, the FAA Decisionmaker will issue a final decision on the application or remand the application to the ALJ who issue the initial fee award determination for further proceedings. (b) In proceedings under part 17 of this chapter and the AMS, the adjudicative officer shall prepare findings and recommendations for the Office of Dispute Resolution for Acquisition with recommendations as to whether or not an award should be made, the amount of the award, and the reasons therefor. The Office of Dispute Resolution for Acquisition shall submit a recommended order to the Administrator after the completion of all submissions related to the EAJA application. Upon the Administrator's action, the order shall become final, and may be reviewed under 49 U.S.C. 46110. | |||
| 17:17:1.0.1.1.13.0.7.1 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.1 Scope. | CFTC | The rules of this part describe the circumstances under which persons may be denied, either temporarily or permanently, the privilege of appearing or practicing before the Commission as an attorney or accountant. An attorney may also be excluded from further participation in a particular adjudicatory proceeding in accordance with the provisions of § 10.11(b) of this chapter or from further participation in a particular investigatory proceeding in accordance with the provisions of § 11.7(c)(2) of this chapter. | |||||||
| 17:17:1.0.1.1.13.0.7.10 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.10 Reinstatement. | CFTC | Any person who is disqualified from appearing or practicing before the Commission under any of the provisions of this part may at any time file an application of reinstatement and the applicant may, in the Commission's discretion, be afforded a hearing on the application. However, denial of the privilege of appearing or practicing before the Commission shall continue unless and until the applicant has been reinstated by order of the Commission. | |||||||
| 17:17:1.0.1.1.13.0.7.2 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.2 Definitions of appearance and practice. | CFTC | (a) Appearance. For the purpose of this part, “appearance” refers to the representation of a person by another who appears in his behalf at any adjudicatory, investigatory or rulemaking proceeding conducted before the Commission, including but not limited to those proceedings encompassed in parts 10 through 13 of the Commission's rules. (b) Practice. For the purpose of this part, practicing before the Commission shall include but shall not be limited to: (1) The preparation of any statement, opinion or other paper by any attorney or accountant filed with or submitted to the Commission on behalf of another person in or in connection with any application, notification, report or other document; and (2) Transacting any other formal business with the Commission, on behalf of another person, in the capacity of an attorney or accountant. | |||||||
| 17:17:1.0.1.1.13.0.7.3 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.3 Hearings. | CFTC | Hearings required or permitted to be held under provisions of this part shall be held before an Administrative Law Judge, utilizing the procedures established in the rules of practice (part 10) for adjudicatory proceedings. Any proceeding brought under provisions of this part shall, unless otherwise determined by the Commission, be prosecuted by the General Counsel of the Commission or by such attorneys in his office as he may assign. | |||||||
| 17:17:1.0.1.1.13.0.7.4 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.4 Violation of Commodity Exchange Act. | CFTC | The Commission may deny, temporarily or permanently, the privilege of appearing or practicing before it in any way to any person who is found by the Commission, after notice of and opportunity for hearing in the matter, to have violated, caused, or aided and abetted any violation of the Commodity Exchange Act, as amended, 7 U.S.C. 1 et seq., or the rules and regulations adopted thereunder. | |||||||
| 17:17:1.0.1.1.13.0.7.5 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.5 Criminal conviction. | CFTC | Any person who after licensing or certification to practice his profession by any competent authority has been convicted of any felony or of a misdemeanor involving fraud or involving moral turpitude in matters related to the regulatory responsibilities of the Commission, and whose conviction has not been reversed by an appellate court, may not appear or practice before the Commission. A conviction within the meaning of this section shall be deemed to have occurred when the convicting court enters its judgment or order, regardless of whether an appeal is pending or could be taken, and includes a judgment on a plea of nolo contendere. | |||||||
| 17:17:1.0.1.1.13.0.7.6 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.6 Disbarment or suspension by licensing authority. | CFTC | Any attorney who has been suspended or disbarred by a Court of the United States or any state or territory or the District of Columbia and any person whose license to practice as an accountant has been revoked or suspended in any state or territory or the District of Columbia may not appear or practice before the Commission during the period when such suspension or revocation is in effect. A suspension or revocation shall be deemed to have occurred when the disbarring, suspending or revoking agency or tribunal enters its order, regardless of whether appeal is pending or could be taken, and includes a judgment or order on a plea of nolo contendere or the procedural equivalent of such a plea. For purposes of this section it shall be irrelevant that any attorney or accountant who has been suspended, disbarred, or otherwise disqualified from practice before a court or in a jurisdiction continues in professional good standing before other courts or in other jurisdictions. | |||||||
| 17:17:1.0.1.1.13.0.7.7 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.7 Finding of violation of Commodity Exchange Act or Federal securities laws in another proceeding. | CFTC | (a) Temporary suspension. The Commission, with due regard to the public interest, and without preliminary hearing, may by order temporarily suspend from appearing or practicing before it any person who, on or after the effective date of this rule has been by name: (1) Permanently enjoined by reason of his misconduct by any court of competent jurisdiction (i) whether by consent, default, upon summary judgment or after trial, in any action brought by the Commission based upon violations of any provision of the Commodity Exchange Act, as amended, or of the rules and regulations adopted thereunder, or (ii) after trial or upon summary judgment in any action brought by the U.S. Securities and Exchange Commission based upon any violation of the federal securities laws (15 U.S.C. 77a to 80b-20) or of rules and regulations adopted thereunder; (2) Found by any court of competent jurisdiction (whether by consent, default, upon summary judgment or after trial) in any action brought by the Commission to which he is a party, or found by the Commission (whether by consent, default, upon summary disposition or after hearing) in any administrative proceeding in which the Commission is a complainant and to which he is a party, to have committed, caused, or aided and abetted a violation of any provision of the Commodity Exchange Act, as amended, or of the rules and regulations promulgated under any of those statutes; (3) Found upon summary judgment or after trial by any court of competent jurisdiction in any action brought by the U.S. Securities and Exchange Commission to which he is a party, or found by the Securities and Exchange Commission, upon summary disposition or after hearing, in any administrative proceeding in which the Securities and Exchange Commission is a complainant and to which he is a party, to have committed, caused, or aided or abetted a violation of any provision of the federal securities laws (15 U.S.C. 77a to 80b-20) or of the rules and regulations adopted thereunder. (b) Petition to lift suspension. … | |||||||
| 17:17:1.0.1.1.13.0.7.8 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.8 Lack of requisite qualifications, character and integrity. | CFTC | [41 FR 28472, July 12, 1976, as amended at 80 FR 32857, June 10, 2015] | In addition to those matters specifically referred to in §§ 14.4 through 14.7, the Commission may, after notice and opportunity for hearing in the matter, deny, temporarily or permanently, the privilege of appearing or practicing before it to any person who is found by the Commission by a preponderance of the evidence: (a) Not to possess the requisite qualifications to represent others; or (b) To be lacking in character or integrity; or (c) To have engaged in unethical or improper professional conduct either in the course of any adjudicatory, investigative or rulemaking or other proceeding before the Commission or otherwise. With respect to the professional conduct of persons licensed to practice as accountants, “unethical or improper professional conduct” means: (1) Intentional or knowing conduct, including reckless conduct, that results in a violation of applicable professional principles or standards; or (2) Either of the following two types of negligent conduct: (i) A single instance of highly unreasonable conduct that results in a violation of applicable professional principles or standards in circumstances in which an accountant knows, or should know, that heightened scrutiny is warranted. (ii) Repeated instances of unreasonable conduct, each resulting in a violation of applicable professional principles or standards, which indicate a lack of competence to practice before the Commission. | ||||||
| 17:17:1.0.1.1.13.0.7.9 | 17 | Commodity and Securities Exchanges | I | 14 | PART 14—RULES RELATING TO SUSPENSION OR DISBARMENT FROM APPEARANCE AND PRACTICE | § 14.9 Duty to file information concerning adverse judicial or administrative action. | CFTC | [41 FR 28472, July 12, 1976, as amended at 60 FR 49335, Sept. 25, 1995; 89 FR 71809, Sept. 4, 2024] | Any person appearing or practicing before the Commission who has been the subject of a conviction, suspension, disbarment, revocation, injunction or finding of the kind described in §§ 14.5 through 14.7, unless based on action instituted by the Commission, shall promptly file a copy of the relevant order, judgment or decree with the Secretariat of the Commission at the Commission's Washington, DC headquarters, together with any related opinion or statement of the agency or tribunal involved. Any person who has been the subject of administrative or judicial action of the kind described in §§ 14.5 through 14.7 and who has not filed a copy of the order, judgment or decree within thirty days after its entry shall for that reason alone be disqualified from appearing or practicing before the Commission until such time as the appropriate filing shall be made, but neither the filing of these documents nor the failure of a person to file them shall in any way affect the operations of any other provision of this part. | ||||||
| 21:21:1.0.1.1.11.1.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | A | Subpart A—General Provisions | § 14.1 Scope. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 78 FR 17087, Mar. 20, 2013; 81 FR 45409, July 14, 2016] | (a) This part governs the procedures when any of the following applies: (1) The Commissioner concludes, as a matter of discretion, that it is in the public interest for a standing or ad hoc policy or technical public advisory committee ( advisory committee or committee ) to hold a public hearing and to review and make recommendations on any matter before FDA and for interested persons to present information and views at an oral public hearing before the advisory committee. (2) Under specific provisions in the FD&C Act or other sections of this chapter, a matter is subject to a hearing before an advisory committee. The specific provisions are— (i) Section 14.120 on review of a performance standard for an electronic product by the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC); (ii) Section 14.140 on review of the safety of color additives; (iii) Section 14.160 on review of the safety and effectiveness of human prescription drugs; (iv) Section 330.10 on review of the safety and effectiveness of over-the-counter drugs; (v) [Reserved] (vi) Part 860, on classification of devices; (vii) Section 514(b)(5) of the FD&C Act on establishment, amendment, or revocation of a device performance standard; (viii) Section 515 of the FD&C Act on review of device premarket approval applications and product development protocols; and (ix) Section 520(f) of the FD&C Act on review of device good manufacturing practice regulations. (3) A person who has a right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead under § 12.32 requests a hearing before an advisory committee, and the Commissioner, as a matter of discretion, accepts the request. (b) In determining whether a group is a public advisory committee as defined in § 10.3(a) and thus subject to this part and to the Federal advisory Committee Act, the following guidelines will be used: (1) An advisory committee may be a standing advisory committee or an ad hoc advisory committee. A… | |||
| 21:21:1.0.1.1.11.1.98.2 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | A | Subpart A—General Provisions | § 14.5 Purpose of proceedings before an advisory committee. | FDA | (a) An advisory committee is utilized to conduct public hearings on matters of importance that come before FDA, to review the issues involved, and to provide advice and recommendations to the Commissioner. (b) The Commissioner has sole discretion concerning action to be taken and policy to be expressed on any matter considered by an advisory committee. | ||||
| 21:21:1.0.1.1.11.1.98.3 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | A | Subpart A—General Provisions | § 14.7 Administrative remedies. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 55 FR 1404, Jan. 16, 1990; 85 FR 72906, Nov. 16, 2020] | A person who alleges noncompliance by the Commissioner or an advisory committee with any provision of this part or the Federal Advisory Committee Act may pursue the following administrative remedies: (a) If the person objects to any action, including a failure to act, other than denial of access to an advisory committee document, the person shall submit a petition in the form and in accordance with the requirements of § 10.30. The provisions of § 10.45 relating to exhaustion of administrative remedies are applicable. (1) If the person objects to past action, the person shall submit the petition within 30 days after the action objected to. If the Commissioner determines that there was noncompliance with any provision of this subpart or of the Federal Advisory Committee Act, the Commissioner will grant any appropriate relief and take appropriate steps to prevent its future recurrence. (2) If the person objects to proposed future action, the Commissioner will expedite the review of the petition and make a reasonable effort to render a decision before the action concerned in the petition. (3) If the person objects to action that is imminent or occurring and which could not reasonably have been anticipated, e.g., the closing of a portion of a meeting which is made known for the first time on the day of the meeting, the matter may be handled by an oral petition in lieu of a written petition. (b) If the person objects to a denial of access to an advisory committee document, administrative review is in accordance with the procedures established by the Department of Health and Human Services under 45 CFR 5.61—and 45 CFR 5.64. | |||
| 21:21:1.0.1.1.11.1.98.4 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | A | Subpart A—General Provisions | § 14.10 Applicability to Congress. | FDA | This part applies to Congress, individual Members of Congress, and other employees or representatives of Congress in the same way that they apply to any other member of the public, except that disclosure of advisory committee records to Congress is governed by § 20.87. | ||||
| 21:21:1.0.1.1.11.1.98.5 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | A | Subpart A—General Provisions | § 14.15 Committees working under a contract with FDA. | FDA | (a) FDA may enter into contracts with independent scientific or technical organizations to obtain advice and recommendations on particular matters, and these organizations may in turn undertake such work through existing or new committees. Whether a particular committee working under such a contract is an advisory committee subject to the Federal Advisory Committee Act and this subpart depends upon application of the criteria and principles in § 14.1(b). (b) The following minimum standards apply to any committee of an independent scientific or technical organization which is working under a contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory committee: (1) The committee shall give public notice of its meetings and agenda, and provide interested persons an opportunity to submit relevant information and views in writing at any time, and orally at specified times. The notice may be published in the Federal Register or disseminated by other reasonable means. It is in any event to be filed with the Dockets Management Staff not less than 15 days before the meeting. The time for oral presentations and the extent to which the committee meets in open session other than for such oral presentations is in the discretion of the committee. (2) Minutes of open sessions are to be maintained, with all written submissions attached which were made to the committee in open session. After approval, the minutes are to be forwarded to the Dockets Management Staff and placed on public display. The extent to which the committee maintains minutes of closed sessions is in the discretion of the committee. (3) In selecting the members of the committee, the organization involved is to apply the principles relating to conflicts of interest that FDA uses in establishing a public advisory committee. Those principles are set out or cross-referenced in this part and in part 19. Upon request, FDA will assist or provide guidance to any organization in meeting this requirement. | ||||
| 21:21:1.0.1.1.11.2.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.20 Notice of hearing before an advisory committee. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 47 FR 26375, June 1, 1982; 54 FR 9035, Mar. 3, 1989; 66 FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, 2001] | (a) Before the first of each month, and at least 15 days in advance of a meeting, the Commissioner will publish a notice in the Federal Register of all advisory committee meetings to be held during the month. Any advisory committee meetings for that month called after the publication of the general monthly notice are to be announced in the Federal Register on an individual basis at least 15 days in advance. The Commissioner may authorize an exception to these notice requirements in an emergency or for other reasons requiring an immediate meeting of an advisory committee, in which case public notice will be given at the earliest time and in the most accessible form feasible including, whenever possible, publication in the Federal Register. (b) The Federal Register notice will include— (1) The name of the committee; (2) The date, time, and place of the meeting; (3) The general function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an open or closed portion of the meeting; (5) If any portion of the meeting is closed, a statement of the time of the open and closed portions; (6) The nature of the subjects to be discussed during, and the reasons for closing, any closed portion of the meeting; (7) The time set aside for oral statements and other public participation; (8) The name, address, and telephone number of the advisory committee Designated Federal Officer and any other agency employee designated as responsible for the administrative support for the advisory committee; (9) A statement that written submissions may be made to the advisory committee through the Designated Federal Officer at any time, unless a cutoff date has been established under § 14.35(d)(2); (10) When a notice is published in the Federal Register less than 15 days before a meeting, an explanation for the lateness of the notice; and (c) If a public hearing before an advisory committee is used in lieu of a formal evidentiary public hearing under § 14.1(a)(3), an initial notice of he… | |||
| 21:21:1.0.1.1.11.2.98.10 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.39 Additional rules for a particular advisory committee. | FDA | (a) In addition to these rules, an advisory committee may, with the concurrence of the designated Federal employee, adopt additional rules which are not inconsistent with this subpart or with other legal requirements. (b) Any additional rules will be included in the minutes of the meeting when adopted and in the materials compiled under § 14.33 and will be available for public disclosure under § 14.65(c). | ||||
| 21:21:1.0.1.1.11.2.98.2 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.22 Meetings of an advisory committee. | FDA | [44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept. 12, 1983, as amended at 54 FR 9035, Mar. 3, 1989; 78 FR 17087, Mar. 20, 2013] | (a) No advisory committee may conduct a meeting except at the call or with the advance approval of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee. (1) If any matter is added to the agenda after its publication in the Federal Register under § 14.20(b)(4), an attempt is to be made to inform persons known to be interested in the matter, and the change is to be announced at the beginning of the open portion of the meeting. (2) The advisory committee meeting is to be conducted in accordance with the approved final agenda insofar as practical. (b) Advisory committee meetings will be held at places that are reasonably accessible to the public. All advisory committee meetings will be held in Washington, DC, or Rockville, MD, or the immediate vicinity, unless the Commissioner receives and approves a written request from the advisory committee for a different location. A different location may be approved when one or more of the following applies: (1) The total cost of the meeting to the Government will be reduced. (2) A substantial number of the committee members will be at the location at no expense to FDA for other reasons, e.g., for a meeting of a professional association. (3) It is a central location more readily accessible to committee members. (4) There is a need for increased participation available at that location. (5) The committee wishes to review work or facilities in a specific location. (6) The committee is concerned with matters that functionally or historically occur in some other location, e.g., the Science Advisory Board of the National Center for Toxicological Research will generally hold meetings in the Little Rock, AR, vicinity. (c) Advisory committee members may, with the approval of FDA, conduct onsite visits relevant to their work. (d) Unless the committee charter provides otherwise, a quorum for an advisory committee is a majority of the current voting members of the committee, exc… | |||
| 21:21:1.0.1.1.11.2.98.3 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.25 Portions of advisory committee meetings. | FDA | An advisory committee meeting has the following portions: (a) The open public hearing. Every committee meeting includes an open portion, which constitutes a public hearing during which interested persons may present relevant information or views orally or in writing. The hearing is conducted in accordance with § 14.29. (b) The open committee discussion. A committee discusses any matter pending before it in an open portion of its meeting unless the meeting has been closed for that matter under § 14.27. To the maximum extent feasible, consistent with the policy expressed in § 14.27, a committee conducts its discussion of pending matters in an open portion. No public participation is permissible during this portion of the meeting except with the consent of the committee Chairperson. (c) The closed presentation of data. Information prohibited from public disclosure under part 20 and the regulations referenced therein is presented to the committee in a closed portion of its meeting. However, if information is in the form of a summary that is not prohibited from public disclosure, the presentation is to be made in an open portion of a meeting. (d) The closed committee deliberations. Deliberations about matters before an advisory committee may be held in a closed portion of a meeting only upon an appropriate determination by the Commissioner under § 14.27. | ||||
| 21:21:1.0.1.1.11.2.98.4 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.27 Determination to close portions of advisory committee meetings. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000] | (a) No committee meeting may be entirely closed. A portion of a meeting may be closed only in accordance with a written determination by the Commissioner under this section. (b) The Designated Federal Officer or other designated agency employee shall prepare the initial request for a determination to close a portion of a meeting, specifying the matter(s) to be discussed during the closed portion and the reasons why the portion should be closed. The Commissioner, based upon this request and with the concurrence of the Chief Counsel, will determine whether to close a portion of a meeting. The reasons for closing a portion of a meeting will be announced in the Federal Register notice of the meeting under § 14.20 in accordance with the following rules: (1) Any determination to close a portion of a meeting restricts the closing to the shortest possible time consistent with the policy in this section. (2) A portion of a meeting may be closed only if the Commissioner determines that the closing is permitted under 5 U.S.C. 552b(c), and that the closing is necessary. (3) Portions of meetings may ordinarily be closed if they concern the review, discussion, and evaluation of drafts or regulations, guidance documents or similar preexisting internal agency documents, but only if their premature disclosure would significantly impede proposed agency action; review of trade secrets and confidential commercial or financial information; consideration of matters involving investigatory files compiled for law enforcement purposes; and review of matters, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. (4) Portions of meetings ordinarily may not be closed if they concern review, discussion, and evaluation of general preclinical and clinical test protocols and procedures for a class of drugs or devices; consideration of labeling requirements for a class of marketed drugs and devices; review of information on specific investigational or marketed drugs and devices that have previously b… | |||
| 21:21:1.0.1.1.11.2.98.5 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.29 Conduct of a hearing before an advisory committee. | FDA | (a) For each meeting, the open portion for public participation, which constitutes a public hearing under § 14.25(a), will be at least 1 hour, unless public participation does not last that long, and may last for whatever longer time the committee Chairperson determines will facilitate the work of the committee. The Federal Register notice published under § 14.20 will designate the time specifically reserved for the hearing, which is ordinarily the first portion of the meeting. Further public participation in any open portion of the meeting under § 14.25(b) is solely at the discretion of the Chairperson. (b) An interested person who wishes to be assured of the right to make an oral presentation at a meeting shall inform the Designated Federal Officer or other designated agency employee, orally or in writing, before the meeting. (1) The person shall state the general nature of the presentation and the approximate time desired. Whenever possible, all written information to be discussed by that person at the meeting should be furnished in advance to the Designated Federal Officer or other designated agency employee. This material may be distributed or mailed by FDA to the committee members in advance of the meeting if time permits, and otherwise will be distributed to the members when they arrive for the meeting. The mailing or distribution may be undertaken only by FDA unless FDA grants permission to a person to mail or distribute the material (2) Before the meeting, the Designated Federal Officer or other designated agency employee shall determine the amount of time allocated to each person for oral presentation and the time that the presentation is to begin. Each person will be so informed in writing, if time permits, or by telephone. FDA may require persons with common interests to make joint presentations. (c) The Chairperson of the committee shall preside at the meeting in accordance with § 14.30 and be accompanied by other committee members, who serve as a panel in conducting the hearing portion of the … | ||||
| 21:21:1.0.1.1.11.2.98.6 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.30 Chairperson of an advisory committee. | FDA | (a) The advisory committee Chairperson has the authority to conduct hearings and meetings, including the authority to adjourn a hearing or meeting if the Chairperson determines that adjournment is in the public interest, to discontinue discussion of a matter, to conclude the open portion of a meeting, or to take any other action to further a fair and expeditious hearing or meeting. (b) If the Chairperson is not a full-time employee of FDA, the Designated Federal Officer or other designated agency employee, or alternate, is to be the designated Federal employee who is assigned to the advisory committee. The designated Federal employee is also authorized to adjourn a hearing or meeting if the employee determines adjournment to be in the public interest. | ||||
| 21:21:1.0.1.1.11.2.98.7 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.31 Consultation by an advisory committee with other persons. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990] | (a) A committee may confer with any person who may have information or views relevant to any matter pending before the committee. (b) An interested person may submit to the committee a written request that it confer with specific persons about any matter pending before the committee. The request is to contain adequate justification. The committee may, in its discretion, grant the request. (c) A committee may confer with a person who is not a Federal Government executive branch employee only during the open portions of a meeting. The person may, however, submit views in writing to the committee as part of the administrative record under § 14.70. The person may participate at the closed portions of a meeting only if appointed as a special Government employee by the Commissioner as provided in paragraph (e) of this section. This paragraph (c) is not intended to bar the testimony of a person during a closed portion of a meeting about matters prohibited from public disclosure under §§ 14.25(c) and 14.27(c). (d) To prevent inadvertent violation of Federal conflict of interest laws and laws prohibiting disclosure of trade secrets (18 U.S.C. 208, 21 U.S.C. 331(j), 18 U.S.C. 1905), Federal executive branch employees who are not employees of the Department may not confer, testify, or otherwise participate (other than as observers) at any portion of an advisory committee meeting unless they are appointed as special Government employees by the Commissioner under paragraph (e) of this section. this paragraph does not apply to Federal executive branch employees who are appointed as members of TEPRSSC, as provided in § 14.127. (e) The Commissioner may appoint persons as special Government employees to be consultants to an advisory committee. Consultants may be appointed to provide expertise, generally concerning a highly technical matter, not readily available from the members of the committee. Consultants may be either from outside the Government or from agencies other than the Food and Drug Administration. Reports, data, … | |||
| 21:21:1.0.1.1.11.2.98.8 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.33 Compilation of materials for members of an advisory committee. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000] | The Commissioner shall prepare and provide to all committee members a compilation of materials bearing upon members' duties and responsibilities, including— (a) All applicable conflict of interest laws and regulations and a summary of their principal provisions; (b) All applicable laws and regulations relating to trade secrets and confidential commercial or financial information that may not be disclosed publicly and a summary of their principal provisions; (c) All applicable laws, regulations, and guidance documents relating to the subject matter covered by the advisory committee and a summary of their principal provisions; (d) All applicable laws, regulations, including the regulations in part 20 of this chapter, advisory committee charters, Federal Register notices, curricula vitae, rules adopted by the advisory committee, and other material relating to the formation, composition, and operation of the advisory committee, and a summary of their principal provisions; (e) Instructions on whom to contact when questions arise; and (f) Other material relating to FDA and the subject matter covered by the committee which may facilitate the work of the committee. | |||
| 21:21:1.0.1.1.11.2.98.9 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | B | Subpart B—Meeting Procedures | § 14.35 Written submissions to an advisory committee. | FDA | (a) Ten copies of written submissions to a committee are to be sent to the Designated Federal Officer unless an applicable Federal Register notice or other regulations in this chapter specify otherwise. Submissions are subject to the provisions of § 10.20, except that it is not necessary to send copies to the Dockets Management Staff. (b) At the request of a committee, or on the Commissioner's own initiative, the Commissioner may issue in the Federal Register a notice requesting the submission to the committee of written information and views pertinent to a matter being reviewed by the committee. The notice may specify the manner in which the submission should be made. (c) At the request of a committee, or on the Commissioner's own initiative, the Commissioner may at any time request the applicant or sponsor of an application or petition about a specific product on which action is pending before FDA, and is being reviewed by an advisory committee, to present or discuss safety, effectiveness, or other data concerning the product during a regularly scheduled meeting of the committee. The request may be for an oral presentation or for a concise, well-organized written summary of pertinent information for review by the committee members before the meeting, or both. Unless specified otherwise, one copy of the written summary along with a proposed agenda outlining the topics to be covered and identifying the participating industry staff members or consultants that will present each topic is to be submitted to the Designated Federal Officer or other designated agency employee at least 3 weeks before the meeting. (d) An interested person may submit to a committee written information or views on any matter being reviewed. Voluminous data is to be accompanied by a summary. A submission is to be made to the Designated Federal Officer and not directly to a committee member. (1) FDA will distribute submissions to each member, either by mail or at the next meeting. Submissions will be considered by the committee in its… | ||||
| 21:21:1.0.1.1.11.3.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | C | Subpart C—Establishment of Advisory Committees | § 14.40 Establishment and renewal of advisory committees. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990] | (a) An advisory committee may be established or renewed whenever it is necessary or appropriate for the committee to hold a public hearing and to review and make recommendations on any matter pending before FDA. Except for committees established by statute, before a committee is established or renewed it must first be approved by the Department pursuant to 45 CFR part 11 and by the General Services Administration. (b) When an advisory committee is established or renewed, the Commissioner will issue a Federal Register notice certifying that the establishment or renewal is in the public interest and stating the structure, function, and purposes of the committee and, if it is a standing advisory committee, shall amend § 14.100 to add it to the list of standing advisory committees. A notice of establishment will be published at least 15 days before the filing of the advisory committee charter under paragraph (c) of this section. A notice of renewal does not require the 15-day notice. (c) No committee may meet or take action until its charter is prepared and filed as required by section 9(c) of the Federal Advisory Committee Act. This requirement is to be met by an advisory committee utilized by FDA, even though it is not established by the agency, prior to utilization. (d) The regulations of the Department cited in paragraph (a) of this section provide that the charter of a parent committee may incorporate information concerning activities of a subgroup. In such instances, a subgroup will not be established as a committee distinct from the parent committee. However, a subgroup will be established as a separate committee when the charter of the parent committee does not incorporate the activities of the subgroup, or when the subgroup includes members who are not all drawn from the parent committee. (e) An advisory committee not required to be established by law will be established or utilized only if it is in the public interest and only if its functions cannot reasonably be performed by other existing advisory … | |||
| 21:21:1.0.1.1.11.3.98.2 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | C | Subpart C—Establishment of Advisory Committees | § 14.55 Termination of advisory committees. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 75 FR 73953, Nov. 30, 2010; 78 FR 17087, Mar. 20, 2013] | (a) Except as provided in paragraph (c) of this section, a standing advisory committee is terminated when it is no longer needed, or not later than 2 years after its date of establishment unless it is renewed for an additional 2-year period. A committee may be renewed for as many 2-year periods as the public interest requires. The requirements for establishment of a committee under § 14.40 also apply to its renewal. (b) FDA will issue a Federal Register notice announcing the reasons for terminating a committee and, if it is a standing committee, amending § 14.100 to delete it from the list. (c) TEPRSSC is a permanent statutory advisory committee established by section 358(f)(1)(A) of the Public Health Service Act, as added by the Radiation Control for Health and Safety Act of 1968, transferred to the FD&C Act (21 U.S.C. 360kk(f)(1)(A)), and is not subject to termination and renewal under paragraph (a) of this section, except that a new charter is prepared and filed at the end of each 2-year period as provided in § 14.40(c). Also, the statutory medical device classification panels established under section 513(b)(1) of the FD&C Act (21 U.S.C. 360c(b)(1)) and part 860, and the statutory medical device good manufacturing practice advisory committees established under section 520(f)(3) of the FD&C Act (21 U.S.C. 360j(f)(3)), are specifically exempted from the normal 2-year duration period. (d) Color additive advisory committees are required to be established under the circumstances specified in sections 721(b)(5)(C) and (D) of the FD&C Act (21 U.S.C. 379e(b)(5)(C) and (D)). A color additive advisory committee is subject to the termination and renewal requirements of the Federal Advisory Committee Act and of this part. (e) The Tobacco Products Scientific Advisory Committee is a permanent statutory advisory committee established by section 917 of the Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387q) (Pub. L. 111-31) and is not subject to termination and renewal under paragraph (a) of this section… | |||
| 21:21:1.0.1.1.11.4.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | D | Subpart D—Records of Meetings and Hearings Before Advisory Committees | § 14.60 Minutes and reports of advisory committee meetings. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 45 FR 85725, Dec. 30, 1980] | (a) The Designated Federal Officer or other designated agency employee prepares detailed minutes of all advisory committee meetings, except that less detailed minutes may be prepared for open portions of meetings which under § 14.61, must be transcribed or recorded by the agency. Their accuracy is approved by the committee and certified by the Chairperson. The approval and certification may be accomplished by mail or by telephone. (b) The minutes include the following: (1) The time and place of the meeting. (2) The members, committee staff, and agency employees present, and the names and affiliations or interests of public participants. (3) A copy of or reference to all written information made available for consideration by the committee at the proceedings. (4) A complete and accurate description of matters discussed and conclusions reached. A description is to be kept separately for the following portions of the meeting to facilitate their public disclosure: The open portions specified in § 14.25 (a) and (b), any closed portion during which a presentation is made under § 14.25(c), and any closed deliberative portion under § 14.25(d). The minutes of a closed deliberative portion of a meeting may not refer to members by name, except upon their request, or to data or information described in § 14.75(b). Any inadvertent references that occur are to be deleted before public disclosure. (5) A copy of or reference to all reports received, issued, or approved by the committee. (6) The extent to which the meeting was open to the public. (7) The extent of public participation, including a list of members of the public who presented oral or written statements. (c) For a meeting that has a closed portion, either (1) the minutes of the closed portion are available for public disclosure under § 14.75(a)(6)(i), or (2) if under § 14.75(a)(6)(ii) they are not promptly available, the Designated Federal Officer or other designated agency employee shall prepare a brief summary of the matters considered in an informative m… | |||
| 21:21:1.0.1.1.11.4.98.2 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | D | Subpart D—Records of Meetings and Hearings Before Advisory Committees | § 14.61 Transcripts of advisory committee meetings. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 68 FR 25285, May 12, 2003] | (a) The agency will arrange for a transcript or recording to be made for each portion of a meeting. (b) A transcript or recording of an open portion of a meeting made by FDA is to be included in the record of the committee proceedings. (c) A transcript or recording of any closed portion of a meeting made by FDA will not be included in the administrative record of the committee proceedings. The transcript or recording will be retained as confidential by FDA, and will not be discarded or erased. (d) Any transcript or recording of a meeting or portion thereof which is publicly available under this section will be available at actual cost of duplication, which will be, where applicable, the fees established in § 20.45. FDA may furnish the requested transcript or recording for copying to a private contractor who shall charge directly for the cost of copying under § 20.53. (e) A person attending any open portion of a meeting may, consistent with the orderly conduct of the meeting, record or otherwise take a transcript of the meeting. This transcription will not be part of the administrative record. (f) Only FDA may make a transcript or recording of a closed portion of a meeting. | |||
| 21:21:1.0.1.1.11.4.98.3 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | D | Subpart D—Records of Meetings and Hearings Before Advisory Committees | § 14.65 Public inquiries and requests for advisory committee records. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 76 FR 31469, June 1, 2011; 78 FR 17087, Mar. 20, 2013; 79 FR 68114, Nov. 14, 2014] | (a) Public inquiries on general committee matters, except requests for records, are to be directed to the Committee Management Officer in the Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993. (b) Public inquiries on matters relating to a specific committee, except requests for records, are to be directed to the Designated Federal Officer or the designated agency employee listed in the Federal Register notices published under § 14.20. (c) Requests for public advisory committee records, including minutes, are to be made, to FDA's Division of Freedom of Information (the Freedom of Information Staff's address is available on the agency's web site at http://www.fda.gov ) under § 20.40 and the related provisions of part 20. | |||
| 21:21:1.0.1.1.11.4.98.4 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | D | Subpart D—Records of Meetings and Hearings Before Advisory Committees | § 14.70 Administrative record of a public hearing before an advisory committee. | FDA | (a) Advice or recommendations of an advisory committee may be given only on matters covered in the administrative record of the committee's proceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1) Any transcript or recording of an open portion of a meeting. (2) The minutes of all portions of all meetings, after any deletions under § 14.60(b)(4). (3) All written submissions to and information considered by the committee. (4) All reports made by the committee. (5) Any reports prepared by a consultant under § 14.31(e). (b) The record of the proceeding is closed at the time the advisory committee renders its advice or recommendations or at any earlier time specified by the committee or in other sections in this chapter. | ||||
| 21:21:1.0.1.1.11.4.98.5 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | D | Subpart D—Records of Meetings and Hearings Before Advisory Committees | § 14.75 Examination of administrative record and other advisory committee records. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989] | (a) The administrative record and other committee records are available for public disclosure under part 20, except as provided in paragraph (b) of this section, at the following times: (1) The written information for consideration by the committee at any meeting: at the same time it is made available to the committee. (2) The transcript or recording of any open portion of a meeting: as soon as it is available. (3) The minutes of any open portion of a meeting: after they have been approved by the committee and certified by the Chairperson. (4) The brief summary of any closed portion of a meeting prepared under § 14.60(c): as soon as it is available. (5) All written information or views submitted to the committee at an open portion of a meeting: as soon as they are submitted. (6) The minutes or portions thereof of a closed portion of a meeting— (i) For a matter not directed to be maintained as confidential under § 14.22(i)(2): After they have been approved by the committee and certified by the Chairperson; and (ii) For a matter directed to be maintained as confidential under § 14.22(i)(2): After the advice or report of the committee relevant to those minutes or portions thereof is acted upon by the Commissioner, or upon a determination by the Commissioner that such minutes or portions thereof may be made available for public disclosure without undue interference with agency or advisory committee operations. (7) Formal advice or a report of the committee: After it has been acted upon, i.e., approved, disapproved, or rejected as inadequate, by the Commissioner, or upon a determination by the Commissioner that such formal advice or report may be made available for public disclosure without undue interference with agency or committee operations. Such formal advice or report may be retained as confidential while it is under active advisement. (8) Any other committee records relating to the matter, except transcripts and recordings of closed portions of meetings: After the advice or report of the committee rel… | |||
| 21:21:1.0.1.1.11.5.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | E | Subpart E—Members of Advisory Committees | § 14.80 Qualifications for members of standing policy and technical advisory committees. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988; 54 FR 9035, Mar. 3, 1989] | (a) Members of a policy advisory committee— (1) Shall have diverse interests, education, training, and experience; specific technical expertise is not a requirement; (2) Are subject to the conflict of interest laws and regulations either as special Government employees or as members of the uniformed services, including the Commissioned Corps of the Public Health Service (the Commissioner has determined that, because members representing particular interests, e.g., a representative of labor, industry, consumers, or agriculture, are included on advisory committees specifically for the purpose of representing these interests, any financial interest covered by 18 U.S.C. 208(a) in the class which the member represents is irrelevant to the services which the Government expects from them and thus is hereby exempted under 18 U.S.C. 208(b) as too remote and inconsequential to affect the integrity of their services); and (3) Shall be voting members. (b) Technical advisory committee. (1) Voting members of technical advisory committees— (i) Shall have expertise in the subject matter with which the committee is concerned and have diverse professional education, training, and experience so that the committee will reflect a balanced composition of sufficient scientific expertise to handle the problems that come before it; and (ii) Except for members of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC), are subject to the conflict of interest laws and regulations either as special Government employees or as members of the uniformed services, including the Commissioned Corps of the Public Health Service. (2) The Commissioner shall, when required by statute, and may when not required by statute, provide for nonvoting members of a technical advisory committee to serve as representatives of and liaison with interested organizations. Nonvoting members— (i) Shall be selected by the interested organizations, as provided in § 14.84; technical expertise in the subject matter with which the committe… | |||
| 21:21:1.0.1.1.11.5.98.2 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | E | Subpart E—Members of Advisory Committees | § 14.82 Nominations of voting members of standing advisory committees. | FDA | (a) The Commissioner will publish one or more notices in the Federal Register each year requesting nominations for voting members of all existing standing advisory committees. The notice will invite the submission of nominations for voting members from both individuals and organizations. (b) The notice announcing the establishment of a new committee under § 14.40(b) will invite the submission of nominations for voting members. (c) A person may nominate one or more qualified persons to an advisory committee. Nominations will specify the advisory committee for which the nominee is recommended and will include a complete curriculum vitae of the nominee. Nominations are to state that the nominee is aware of the nomination, is willing to serve as a member of the advisory committee, and appears to have no conflict of interest that would preclude membership. (d) Voting members serve as individuals and not as representatives of any group or organization which nominated them or with which they may be affiliated. | ||||
| 21:21:1.0.1.1.11.5.98.3 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | E | Subpart E—Members of Advisory Committees | § 14.84 Nominations and selection of nonvoting members of standing technical advisory committees. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 75 FR 15342, Mar. 29, 2010] | (a) This section applies when the Commissioner concludes that a technical advisory committee should include nonvoting members to represent and serve as a liaison with interested individuals and organizations. (b) Except when the Commissioner concludes otherwise, nonvoting members of a technical advisory committee are selected in accordance with paragraphs (c) and (d) of this section and are normally limited to one person selected by consumer groups and organizations and one person selected by industry groups and organizations. (c) To select a nonvoting member to represent consumer interests, except as provided in paragraph (c)(5) of this section, the Commissioner publishes a notice in the Federal Register requesting nominations for each specific committee, or subcommittee, for which nonvoting members are to be appointed. (1) A period of 30 days will be permitted for submission of nominations for that committee or subcommittee. Interested persons may nominate one or more qualified persons to represent consumer interests. Although nominations from individuals will be accepted, individuals are encouraged to submit their nominations through consumer organizations as defined in paragraph (c)(3) of this section. Nominations of qualified persons for general consideration as nonvoting members of unspecified advisory committees or subcommittees may be made at any time. All nominations are to be submitted in writing to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 1503, Silver Spring, MD 20993. (2) A complete curriculum vitae of any nominee is to be included. Nominations must state that the nominee is aware of the nomination, is willing to serve as a member of an advisory committee, and appears to have no conflict of interest. The nomination must state whether a nominee is interested only in a particular advisory committee or subcommittee, or whether the nominee is interested in becoming a member of any advisory committee or subcommittee. Nomi… | |||
| 21:21:1.0.1.1.11.5.98.4 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | E | Subpart E—Members of Advisory Committees | § 14.86 Rights and responsibilities of nonvoting members of advisory committees. | FDA | (a) A nonvoting member of an advisory committee selected to represent and serve as a liaison with interested individuals, associations, and organizations has the same rights as any other committee member except that— (1) A nonvoting member may vote only on procedural matters such as additional rules adopted under § 14.39(a), approval of minutes under § 14.60(a), decisions on transcripts under § 14.61(b), and future meeting dates; (2) A nonvoting member who is a representative of industry interest may have access to data and information that constitute a trade secret or confidential commercial or financial information as defined in § 20.61 only if the person has been appointed as a special Government employee under § 14.80(b). (b) A nonvoting member of an advisory committee is subject to, and shall abide by, all rules and regulations adopted by FDA and the committee. (c) It is the responsibility of the nonvoting consumer and industry members of an advisory committee to represent the consumer and industry interests in all deliberations. (1) A nonvoting member does not represent any particular organization or group, but rather represents all interested persons within the class which the member is selected to represent. Accordingly, an interested person within the class represented by that nonvoting member may, upon request, have access to all written statements or oral briefings concerning the committee prepared by the nonvoting member for distribution to any person outside the committee. When documents are prepared with non-Government funds, persons desiring copies may be required to pay a reasonable fee to cover printing and similar costs. (2) The nonvoting member reviews all official committee minutes to assure their completeness and accuracy. (3) The nonvoting member acts as a liaison between the committee and the interested persons whom that member represents, and transmits requests for information from the committee and relevant information and views to the committee. The nonvoting member takes the init… | ||||
| 21:21:1.0.1.1.11.5.98.5 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | E | Subpart E—Members of Advisory Committees | § 14.90 Ad hoc advisory committee members. | FDA | In selecting members of an ad hoc advisory committee, the Commissioner may use the procedures in §§ 14.82 and 14.84 or any other procedure deemed appropriate. | ||||
| 21:21:1.0.1.1.11.5.98.6 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | E | Subpart E—Members of Advisory Committees | § 14.95 Compensation of advisory committee members. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988] | (a)(1) Except as provided in paragraphs (a) (2) and (3) of this section, all voting advisory committee members shall, and nonvoting members may, be appointed as special Government employees and receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsistence, unless such compensation and reimbursement are waived. (2) Members of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) are not appointed as special Government employees. Any member of TEPRSSC who is not a Federal employee or member of the uniformed services, including the Commissioned Corps of the Public Health Service, shall receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsistence, unless such compensation and reimbursement are waived. (3) Voting and nonvoting advisory committee members who are members of the uniformed services, including the Commissioned Corps of the Public Health Service, provide service on Food and Drug Administration advisory committees as part of their assigned functions, are not appointed as special government employees, but are reimbursed by the Food and Drug Administration for travel expenses. (b) Notwithstanding the member's primary residence, an advisory committee member, while attending meetings of the full committee or a subcommittee, will be paid whether the meetings are held in the Washington, DC, area or elsewhere. (c) A committee member who participates in any agency-directed assignment will be paid at an hourly rate when doing assigned work at home, a place of business, or in an FDA facility located within the member's commuting area, and at a daily rate when required to travel outside of that commuting area to perform the assignment. A committee member will not be paid for time spent on normal preparation for a committee meeting. (1) An agency-directed assignment is an assignment that meets the following criteria: (i) An activity that requires undertaking a definitive study. The activity must produ… | |||
| 21:21:1.0.1.1.11.6.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | F | Subpart F—Standing Advisory Committees | § 14.100 List of standing advisory committees. | FDA | [54 FR 9036, Mar. 3, 1989] | Standing advisory committees and the dates of their establishment are as follows: (a) Office of the Commissioner —(1) Science Board to the Food and Drug Administration. (i) Date established: June 26, 1992. (ii) Function: The board shall provide advice primarily to the agency's Senior Science Advisor and, as needed, to the Commissioner and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community in industry and academia. Additionally, the board will provide advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science; on formulating an appropriate research agenda; and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs. (2) Pediatric Advisory Committee. (i) Date established: June 18, 2004. (ii) Function: Advises on pediatric therapeutics, pediatric research, and other matters involving pediatrics for which the Food and Drug Administration has regulatory responsibility. (3) Risk Communication Advisory Committee. (i) Date rechartered: July 9, 2009. (ii) Function: The committee reviews and evaluates strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. The committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities. It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products. (4) Tobacco Products Scientific Advisory Committee. (i) Date Established: August 12, 2009. (ii) Function: The committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information, and r… | |||
| 21:21:1.0.1.1.11.7.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | G | Subpart G—Technical Electronic Products Radiation Safety Standards Committee | § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013] | The Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC), consisting of 15 members, is established in accordance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360kk(f)(1)(A)) to provide consultation before the Commissioner prescribes any performance standard for an electronic product. | |||
| 21:21:1.0.1.1.11.7.98.2 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | G | Subpart G—Technical Electronic Products Radiation Safety Standards Committee | § 14.122 Functions of TEPRSSC. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013] | (a) In performing its function of advising the Commissioner, TEPRSSC— (1) May propose electronic product radiation safety standards to the Commissioner for consideration; (2) Provides consultation to the Commissioner on all performance standards proposed for consideration under 21 U.S.C. 360kk; and (3) May make recommendations to the Commissioner on any other matters it deems necessary or appropriate in fulfilling the purposes of the act. (b) Responsibility for action on performance standards under 21 U.S.C. 360kk rests with the Commissioner, after receiving the advice of TEPRSSC. | |||
| 21:21:1.0.1.1.11.7.98.3 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | G | Subpart G—Technical Electronic Products Radiation Safety Standards Committee | § 14.125 Procedures of TEPRSSC. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989; 78 FR 17087, Mar. 20, 2013] | (a) When the Commissioner is considering promulgation of a performance standard for an electronic product, or an amendment of an existing standard, before issuing a proposed regulation in the Federal Register the Commissioner will submit to TEPRSSC the proposed standard or amendment under consideration, together with other relevant information to aid TEPRSSC in its deliberations. (b) The agenda and other material to be considered at any meeting will be sent to members whenever possible at least 2 weeks before the meeting. (c) Ten members constitute a quorum, provided at least three members are present from each group specified in 21 U.S.C. 360kk(f)(1)(A) and in § 14.127(a), i.e., Government, industry, and the public. (d) The Chairperson of TEPRSSC will ordinarily submit a report to the Commissioner of the committee's consideration of any proposed performance standard for an electronic product within 60 days after consideration. If the Chairperson believes that more time is needed, the Chairperson will inform the Director of the Center for Devices and Radiological Health in writing, in which case an additional 30 days will be allowed to make the report. (e) Sections 14.1 through 14.7 apply to TEPRSSC, except where other provisions are specifically included in §§ 14.120 through 14.130. | |||
| 21:21:1.0.1.1.11.7.98.4 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | G | Subpart G—Technical Electronic Products Radiation Safety Standards Committee | § 14.127 Membership of TEPRSSC. | FDA | (a) The Commissioner will appoint the members after consultation with public and private organizations concerned with the technical aspect of electronic product radiation safety. TEPRSSC consists of 15 members, each of whom is technically qualified by training and experienced in one or more fields of science or engineering applicable to electronic product radiation safety, as follows: (1) Five members selected from government agencies, including State and Federal Governments. (2) Five members selected from the affected industries after consultation with industry representatives. (3) Five members selected from the general public, of whom at least one shall be a representative of organized labor. (b) The Commissioner will appoint a committee member as Chairperson of TEPRSSC. (c) Appointments of members are for a term of 3 years or as specified by the Commissioner. (1) The Chairperson is appointed for a term concurrent with the Chairperson's term as a member of TEPRSSC. If the Chairpersonship becomes vacant without adequate notice, the Designated Federal Officer may appoint a committee member as temporary Chairperson pending appointment of a new Chairperson by the Commissioner. (2) Members may not be reappointed for a second consecutive full term. (d) A person otherwise qualified for membership is not eligible for selection as a member of TEPRSSC from Government agencies or the general public if the Commissioner determines that the person does not meet the requirements of the conflict of interest laws and regulations. (e) Retention of membership is conditioned upon the following: (1) Continued status as a member of the group from which the member was selected as specified in paragraph (a) of this section. (2) Absence of any conflict of interest during the term of membership as specified in paragraph (d) of this section. (3) Active participation in TEPRSSC activities. (f) Appointment as a member of TEPRSSC is conditioned on certification that the prospective member: (1) Agrees to the procedures and crit… | ||||
| 21:21:1.0.1.1.11.7.98.5 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | G | Subpart G—Technical Electronic Products Radiation Safety Standards Committee | § 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013] | (a) In accordance with 21 U.S.C. 360kk(f)(1)(B), all proceedings of TEPRSSC are recorded, and the record of each proceeding is available for public inspection. (b) All proceedings of TEPRSSC are open except when the Commissioner has determined, under § 14.27, that a portion of a meeting may be closed. | |||
| 21:21:1.0.1.1.11.8.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | H | Subpart H—Color Additive Advisory Committees | § 14.140 Establishment of a color additive advisory committee. | FDA | The Commissioner will establish a color additive advisory committee under the following circumstances: (a) The Commissioner concludes, as a matter of discretion, that it would be in the public interest for a color additive advisory committee to review and make recommendations about the safety of a color additive on which important issues are pending before FDA and for interested persons to present information and views at an oral public hearing before a color additive advisory committee. (b) There is an issue arising under section 721(b)(5)(B) of the FD&C Act concerning the safety of a color additive, including its potential or actual carcinogenicity, that requires the exercise of scientific judgment and a person who would be adversely affected by the issuance, amendment, or repeal of a regulation listing a color additive requests that the matter, or the Commissioner as a matter of discretion determines that the matter should, be referred to a color additive advisory committee. (1) Paragraph (b) does not apply to any issue arising under the transitional provisions in section 203 of the Color Additive Amendments of 1960 relating to provisional listing of commercially established colors. A color additive advisory committee to consider any such matter will be established under paragraph (a) of this section. (2) A request for establishment of a color additive advisory committee is to be made in accordance with § 10.30. The Commissioner may deny any petition if inadequate grounds are stated for establishing a color additive advisory committee. A request for establishment of a color additive advisory committee may not rest on mere allegations or denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires scientific judgment and justifies a hearing before a color additive advisory committee. When it conclusively appears from the request for a color additive advisory committee that the matter is premature or that it does not involve an issue arising under sec… | ||||
| 21:21:1.0.1.1.11.8.98.2 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | H | Subpart H—Color Additive Advisory Committees | § 14.142 Functions of a color additive advisory committee. | FDA | (a) A color additive advisory committee reviews all available information relating to the matter referred to it, including all information contained in any pertinent color additive petition and in FDA files. All information reviewed is placed on public display and is available for review at the office of the Dockets Management Staff. (b) The Commissioner specifies to the color additive advisory committee, in writing, the issues on which review and recommendations are requested. (c) The date of the first meeting of a color additive advisory committee, following receipt of the administrative record by each of the committee members, is designated as the beginning of the period allowed for consideration of the matter by the committee. Within 60 days after the first meeting, unless the time is extended as provided in paragraph (d) of this section, the Chairperson of the committee shall certify to the Commissioner the report containing the recommendations of the committee, including any minority report. The report states the recommendations of the committee and the reasons or basis for them. The report includes copies of all material considered by the committee in addition to the administrative record furnished to it. (d) If the Chairperson concludes that the color additive advisory committee needs additional time, the Chairperson shall so inform the Commissioner in writing and may certify the report of the committee to the Commissioner within 90 days instead of 60 days. (e) More than one matter may be handled concurrently by a color additive advisory committee. | ||||
| 21:21:1.0.1.1.11.8.98.3 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | H | Subpart H—Color Additive Advisory Committees | § 14.145 Procedures of a color additive advisory committee. | FDA | (a) A color additive advisory committee is subject to all the requirements of the Federal Advisory Committee Act and this part. (b) All interested persons have a right to consult with the color additive advisory committee reviewing a matter and to submit information and views to a color additive advisory committee, in accordance with the procedures in this part. | ||||
| 21:21:1.0.1.1.11.8.98.4 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | H | Subpart H—Color Additive Advisory Committees | § 14.147 Membership of a color additive advisory committee. | FDA | (a) The members of a color additive advisory committee are selected in the following manner: (1) If a color additive advisory committee is established for purposes that do not include review of an issue arising under section 721(b)(5)(B) of the act, or is established on the initiative of the Commissioner, the Commissioner may use the procedure in paragraph (a)(2) of this section to select the members or may use an existing standing advisory committee listed in § 14.100, or may establish a new advisory committee under this subpart. Once the Commissioner has established a color additive advisory committee under this paragraph and has referred to it a matter relating to a color additive, no interested person may subsequently request that an additional or different color additive advisory committee be established to review and make recommendations about that color additive. (2) If the Commissioner established a color additive advisory committee to review an issue arising under section 721(b)(5)(B) of the FD&C Act on the request of an interested person, it shall be established under the following requirements: (i) Except as provided in paragraph (a)(2) (ii) and (iii) of this section, the Commissioner will request the National Academy of Sciences to select the members of a color additive advisory committee from among experts qualified in the subject matter to be reviewed by the committee, and of adequately diversified professional backgrounds. The Commissioner will appoint one of the members as the Chairperson. (ii) If the National Academy of Sciences is unable or refuses to select the members of a color additive advisory committee, the Commissioner will select the members. (iii) If the Commissioner and the requesting party agree, section 721(b)(5)(D) of the FD&C Act may be waived and the matter may be referred to any standing advisory committee listed in § 14.100 or to any advisory committee established under any other procedure that is mutually agreeable. Once the Commissioner has established a color additive ad… | ||||
| 21:21:1.0.1.1.11.8.98.5 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | H | Subpart H—Color Additive Advisory Committees | § 14.155 Fees and compensation pertaining to a color additive advisory committee. | FDA | (a) When a matter is referred to a color additive advisory committee, all related costs, including personal compensation of committee members, travel, materials, and other costs, are borne by the person requesting the referral, such costs to be assessed on the basis of actual cost to the government. The compensation of such costs includes personal compensation of committee members at a rate not to exceed $128.80 per member per day. (b) In the case of a request for referral to a color additive advisory committee, a special advance deposit is to be made in the amount of $2,500. Where required, further advances in increments of $2,500 each are to be made upon request of the Commissioner. All deposits for referrals to a color additive advisory committee in excess of actual expenses will be refunded to the depositor. (c) All deposits and fees required by this section are to be paid by money order, bank draft, or certified check drawn to the order of the Food and Drug Administration, collectible at par in Washington, DC. All deposits and fees are to be forwarded to the Associate Commissioner for Management and Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, and after appropriate record of them is made, they will be transmitted to the Treasurer of the United States for deposit in the special account “Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration.” (d) The Commissioner may waive or refund such fees in whole or in part when, in the Commissioner's judgment, such action will promote the public interest. Any person who believes that payment of these fees will be a hardship may petition the Commissioner under § 10.30 to waive or refund the fees. | ||||
| 21:21:1.0.1.1.11.9.98.1 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | I | Subpart I—Advisory Committees for Human Prescription Drugs | § 14.160 Establishment of standing technical advisory committees for human prescription drugs. | FDA | The standing technical advisory committees for human prescription drugs are established to advise the Commissioner: (a) Generally on the safety and effectiveness, including the labeling and advertising, and regulatory control of the human prescription drugs falling within the pharmacologic class covered by the advisory committee and on the scientific standards appropriate for a determination of safety and effectiveness in that class of drugs. (b) Specifically on any particular matter involving a human prescription drug pending before FDA, including whether the available information is adequate to support a determination that— (1) A particular IND study may properly be conducted; (2) A particular drug meets the statutory standard for proof of safety and effectiveness necessary for approval or continued approval for marketing; or (3) A particular drug is properly classified as a new drug, an old drug, or a banned drug. | ||||
| 21:21:1.0.1.1.11.9.98.2 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | I | Subpart I—Advisory Committees for Human Prescription Drugs | § 14.171 Utilization of an advisory committee on the initiative of FDA. | FDA | [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989] | (a) Any matter involving a human prescription drug under review within the agency may, in the discretion of the Commissioner, be the subject of a public hearing and continuing or periodic review by the appropriate standing technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda of the committee are based upon the priorities of the various matters pending before the agency which fall within the pharmacologic class covered by that committee. (b) High priority for such hearing and review by the appropriate standing technical advisory committee for human prescription drugs are given to the following types of human prescription drugs: (1) Investigational drugs which are potential therapeutic advances over currently marketed products from the standpoint of safety or effectiveness, or which pose significant safety hazards, or which present narrow benefit-risk considerations requiring a close judgmental decision on approval for marketing, or which have a novel delivery system or formulation, or which are the subject of major scientific or public controversy, or which may be subject to special regulatory requirements such as a limitation on clinical trials, a patient followup requirement, postmarketing Phase IV studies, distributional controls, or boxed warnings. (2) Marketed drugs for which an important new use has been discovered or which pose newly discovered safety hazards, or which are the subject of major scientific or public controversy, or which may be subject to important regulatory actions such as withdrawal of approval for marketing, boxed warnings, distributional controls, or newly required scientific studies. (c) The committee may request the Commissioner for an opportunity to hold a public hearing and to review any matter involving a human prescription drug which falls within the pharmacologic class covered by the committee. The Commissioner may, after consulting with the committee on such request, grant or deny the request in light of the priorities of … | |||
| 21:21:1.0.1.1.11.9.98.3 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | I | Subpart I—Advisory Committees for Human Prescription Drugs | § 14.172 Utilization of an advisory committee at the request of an interested person. | FDA | Any interested person may request, under § 10.30, that a specific matter relating to a particular human prescription drug be submitted to an appropriate advisory committee for a hearing and review and recommendations. The request must demonstrate the importance of the matter and the reasons why it should be submitted for a hearing at that time. The Commissioner may grant or deny the request. | ||||
| 21:21:1.0.1.1.11.9.98.4 | 21 | Food and Drugs | I | A | 14 | PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE | I | Subpart I—Advisory Committees for Human Prescription Drugs | § 14.174 Advice and recommendations in writing. | FDA | Advice and recommendations given by a committee on a specific drug or a class of drugs are ordinarily in the form of a written report. The report may consist of the approved minutes of the meeting or a separate written report. The report responds to the specific issues or questions which the Commissioner has addressed to the advisory committee, and states the basis of the advice and recommendations of the committee. | ||||
| 24:24:1.1.1.1.11.1.25.1 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.50 Definitions. | HUD | [52 FR 27126, July 17, 1987, as amended at 72 FR 53877, Sept. 20, 2007; 87 FR 8196, Feb. 14, 2022] | Act. The Equal Access to Justice Act, 5 U.S.C. 504, title II of Pub. L. 96-481, as amended by Pub. L. 99-80. Adjudicative officer. The Administrative Law Judge, Administrative Judge of the HUD Office of Hearings and Appeals, or other officer designated by the Secretary, who presided at the adversary adjudication. Adversary adjudication. (a) An adjudication under 5 U.S.C. 554 in which the position of the United States is represented by counsel or otherwise, but not including an adjudication for the purpose of establishing or fixing a rate or for the purpose of granting or renewing a license; and (b) Appeals of decisions of contracting officers made pursuant to section 6 of the Contract Disputes Act of 1978 (41 U.S.C. 605) before agency boards of contract appeals as provided in section 8 of that Act (41 U.S.C. 607). Agency counsel (a) When the position of the Department is being represented, the attorney or attorneys designated by the Department's General Counsel to represent the Department in a proceeding covered by this part, and (b) When the position of another agency of the United States is being represented, the representative as designated by that agency. Department. The Department of Housing and Urban Development, or the organizational unit within the Department responsible for conducting an adversary adjudication subject to this part. Proceeding. An adversary adjudication as defined above. Secretary. The Secretary of Housing and Urban Development. | |||||
| 24:24:1.1.1.1.11.1.25.10 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.140 Awards against other agencies. | HUD | If an applicant is entitled to an award because it prevails over another agency of the United States that participates in a proceeding before the Department and takes a position that is not substantially justified, the award or an appropriate portion of the award shall be made against that agency. | ||||||
| 24:24:1.1.1.1.11.1.25.2 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.100 Time computation. | HUD | Time periods stated in this part shall be computed in accordance with the Department's rules with respect to computation of time which apply to the underlying proceeding. | ||||||
| 24:24:1.1.1.1.11.1.25.3 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.105 Purpose of these rules. | HUD | The Act provides for the award of attorney fees and other expenses to eligible individuals and entities who are parties to certain administrative proceedings ( adversary adjudications ) before the Department. An eligible party may receive an award when it prevails over an agency, unless the agency's position was substantially justified or special circumstances make an award unjust. The rules in this part described the parties eligible for awards and the proceedings that are covered. They also explain how to apply for awards and the procedures and standards that the Department will use to make them. | ||||||
| 24:24:1.1.1.1.11.1.25.4 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.110 When the Act applies. | HUD | The Act applies to any adversary adjudication pending or commenced before this Department on or after August 5, 1985. It also applies to any adversary adjudication commenced on or after October 1, 1984, and finally disposed of before August 5, 1985, provided that an application for fees and expenses, as described in subpart B of these rules, has been filed with the Department no later than 30 days after August 5, 1985, and to any adversary adjudication pending on or commenced on or after October 1, 1981, in which an application for fees and other expenses was timely filed and was dismissed for lack of jurisdiction. | ||||||
| 24:24:1.1.1.1.11.1.25.5 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.115 Proceedings covered. | HUD | [52 FR 27126, July 17, 1987, as amended at 54 FR 3283, Jan. 23, 1989; 85 FR 61562, Sept. 29, 2020] | (a) The proceedings to which this part applies are adversary adjudications conducted by the Department under: (1) The Interstate Land Sales Full Disclosure Act, as amended, 15 U.S.C. 1701 et seq., pursuant to 15 U.S.C. 1715 and 24 CFR part 1720; (2) Section 602 of the Civil Rights Act of 1964, 42 U.S.C. 2000d-1, and 24 CFR parts 1 and 2; (3) Section 505(a) of the Rehabilitation Act of 1973, as amended, 29 U.S.C. 794a, 28 CFR part 41, and any applicable HUD regulations; (4) Section 305(a) of the Age Discrimination Act of 1975, 42 U.S.C. 6104(a), 45 CFR part 90 and any applicable HUD regulations; (5) [Reserved] (6) Debt Collection Act of 1982 (Salary Offset), 5 U.S.C. 5514, and 24 CFR 17.125-.140; (7) Manufactured Home Construction and Safety Standards Act of 1974, 42 U.S.C. 5401 et seq., and 24 CFR part 3280; (8) Section 111 of title I of the Housing and Community Development Act of 1974, 42 U.S.C. 5311, and 24 CFR 570.913; (9) Appeals of decisions of contracting officers made pursuant to section 6 of the Contract Disputes Act of 1978 (41 U.S.C. 605) before the HUD Board of Contract Appeals as provided in section 8 of that Act (41 U.S.C. 607); or (10) Title VIII of the Civil Rights Act of 1968 (42 U.S.C. 3600-3620) and 24 CFR part 104. (b) The Department's failure to identify a type of proceeding as an adversary adjudication shall not preclude the filing of an application by a party who believes the proceeding is covered by the Act; whether the proceeding is covered will then be an issue for resolution in proceedings on the application. (c) If a proceeding includes both matters covered by the Act and matters specifically excluded from coverage, any award made will include only fees and expenses related to covered issues. | |||||
| 24:24:1.1.1.1.11.1.25.6 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.120 Eligibility of applicants. | HUD | (a) To be eligible for an award of attorney fees and other expenses under the Act, the applicant must be a party to the adversary adjudication for which it seeks an award. The term party is defined in 5 U.S.C. 551(3). The applicant must show that it meets all conditions of eligibility set out in this subpart and in subpart B. (b) The types of eligible applicants are as follows: (1) An individual with a net worth of not more than $2 million; (2) The sole owner of an unincorporated business who has a net worth of not more than $7 million, including both personal and business interests, and not more than 500 employees; (3) A charitable or other tax-exempt organization described in section 501(c)(3) of the Internal Revenue Code, 26 U.S.C. 501(c)(3), with not more than 500 employees; (4) A cooperative association as defined in section 15(a) of the Agricultural Marketing Act, 12 U.S.C. 1141j(a), with not more than 500 employees; or (5) Any other partnership, corporation, association, unit of local government, or organization with a net worth of not more than $7 million and not more than 500 employees. (c) For the purpose of eligibility, the net worth and number of employees of an applicant shall be determined as of the date the proceeding was initiated. For the purpose of eligibility of applicants before the HUD Board of Contract Appeals, the net worth and number of employees of an applicant shall be determined as of the date the applicant filed its appeal under 41 U.S.C. 606. (d) An applicant who owns an unincorporated business will be considered as an individual rather than a sole owner of an unincorporated business if the issues on which the application prevails are related primarily to personal interests rather than to business interests. (e) The employees of an applicant include all persons who regularly perform services for remuneration for the applicant, under the applicant's direction and control. Part-time employees shall be included on a proportional basis. (f) The net worth and number of empl… | ||||||
| 24:24:1.1.1.1.11.1.25.7 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.125 Standards for awards. | HUD | (a) A prevailing applicant may receive an award for fees and expenses incurred in connection with a proceeding, or in a significant and discrete substantive portion of the proceeding, unless the position of the agency over which the applicant has prevailed was substantially justified. The position of the agency includes, in addition to the position taken by the agency in the adversary adjudication, the action or failure to act by the agency upon which the adversary adjudication is based. The burden of proof that an award should not be made to an ineligible prevailing applicant because the agency's position was substantially justified is on the agency counsel, who may avoid an award by showing that its position was reasonable in law and fact. (b) An award will be reduced or denied if the applicant has unduly or unreasonably protracted the proceeding, if the applicant has falsified the application (including documentation) or net worth exhibit or if special circumstances make the award sought unjust. | ||||||
| 24:24:1.1.1.1.11.1.25.8 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.130 Allowable fees and expenses. | HUD | (a) No award for the fee of an attorney or agent under these rules may exceed $75.00 per hour. However, an award may also include the reasonable expenses of the attorney, agent or witness as a separate item, if the attorney, agent or witness ordinarily charges clients separately for such expenses. (b) In determining the reasonableness of the fee sought for an attorney, agent or expert witness, the adjudicative officer shall consider the following: (1) If the attorney, agent or witness is in private practice, his or her customary fee for similar services, or, if an employee of the applicant, the fully allocated cost of the services; (2) The prevailing rate for the kind and quality of services furnished in the community in which the attorney, agent or witness ordinarily performs services; (3) The time actually spent in the representation of the applicant; (4) The time reasonably spent in the light of the difficulty or complexity of the issues in the proceeding; and (5) Such other factors as may bear on the value of the services provided. (c) The reasonable cost of any study, analysis, engineering report, test, project, or similar matter prepared on behalf of a party may be awarded, to the extent that the charge for the services does not exceed the prevailing rate for similar services, and the study or other matter was necessary for preparation of the applicant's case. | ||||||
| 24:24:1.1.1.1.11.1.25.9 | 24 | Housing and Urban Development | 14 | PART 14—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN ADMINISTRATIVE PROCEEDINGS | A | Subpart A—General Provisions | § 14.135 Rulemaking on maximum rates for attorney fees. | HUD | Any person may file with the Department a petition for rulemaking to increase the maximum rate for attorney fees as provided in 5 U.S.C. 504(b)(1)(A)(ii), in accordance with 24 CFR part 10. The petition should identify the rate the petitioner believes the Department should establish and the types of proceedings in which the rate should be used. It should also explain fully the reasons why the higher rate is warranted. The Department will respond to the petition in accordance with 24 CFR 10.20(b). |
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title_name TEXT,
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