who requests the part of sample shall specify the amount desired. A request from an owner shall be accompanied by a showing of ownership, and a request from an attorney or agent by a showing of authority from such person or owner to receive the part of sample. When two or more requests for parts of the same sample are received the requests shall be complied with in the order in which they were received so long as any part of the sample remains available therefor. (d) When an official sample of a food, drug, or cosmetic is the basis of a notice given under section 305 of the act, or of a case under the act, and the person to whom the notice was given, or any person who is a party to the case, has no right under paragraph (c) of this section to a part of the sample, such person or his attorney or agent may obtain a part of the sample upon request accompanied by a written waiver of right under such paragraph (c) from each person named on the label of the article and owner thereof, who has not exercised his right under such paragraph (c). The operation of this paragraph shall be subject to the exceptions, terms, and conditions prescribed in paragraph (c) of this section. (e) The Food and Drug Administration is authorized to destroy: (1) Any official sample when it determines that no analysis of such sample will be made; (2) Any official sample or part thereof when it determines that no notice under section 305 of the act, and no case under the act, is or will be based on such sample; (3) Any official sample or part thereof when the sample was the basis of a notice under section 305 of the act, and when, after opportunity for presentation of views following such notice, it determines that no other such notice, and no case under the act, is or will be based on such sample; (4) Any official sample or part thereof when the sample was the basis of a case under the act which has gone to final judgment, and when it determines that no other such case is or will be based on such sample; (5) Any official sample or part thereof if the article is perishable; Subparts A-E-[Reserved] Subpart F-Public Hearings AUTHORITY: The provisions of this Subpart F also issued under sec. 8(a) (2), 74 Stat. 374; 15 U.S.C. 1262. SOURCE: The provisions of this Subpart F appear at 31 F.R. 3003, Feb. 22, 1966, unless otherwise noted. § 2.48 Purpose of holding public hearings. Procedure for the issuance, amendment, or repeal of regulations under sections 401 (definitions and standards for food), 403 (j) (foods for special dietary uses), 404(a) (emergency permit control for the interstate shipment of certain classes of food), 406 (tolerances for poisonous ingredients in food), 501 (b) (tests and methods of assay for drugs described in official compendia), 502(d) (habitforming drugs), 502(h) (drugs liable to deterioration), 502(n) (drug advertisements), 506(c) (insulin), and 706 (color additives listing and certification) of the Federal Food, Drug, and Cosmetic Act, sections 4 and 5 of the Fair Packaging and Labeling Act, and sections 2(q) (1) (B) and 3(a) (2) of the Federal Hazardous Substances Act is described in section 701(e) (1) of the Federal Food, Drug, and Cosmetic Act. Public hearings contemplated by this Subpart F arise only through the rulemaking provisions cited above and in section 507(f) of the Federal Food, Drug, and Cosmetic Act, and will be granted only where adverse effect and/or reasonable grounds can be shown. Hearings will be limited to the issues raised by the objections filed within the statutory time limits, or extended as specified in the order of the Commissioner. [31 F.R. 3003, Feb. 22, 1966, as amended at 31 FR. 16564, Dec. 28, 1966, 32 F.R. 6839, May 4, 1967; 33 F.R. 15652, Oct. 23, 1968; 33 F.R. 19800, Dec. 27, 1968; 34 F.R. 6238, Apr. 8, 1969] As used in this Subpart F the following terms shall have the meanings specified: (a) The term "act" means the Federal Food, Drug, and Cosmetic Act. (b) The term "Department" means the U.S. Department of Health, Education, and Welfare. (c) The term "Secretary" means the Secretary of Health, Education, and Welfare. (d) The term "Commissioner" means the Commissioner of Food and Drugs, Food and Drug Administration. (e) The term "person" includes an individual, partnership, corporation, and association. (f) The term "presiding officer" means the Commissioner or a hearing examiner appointed as provided in the Administrative Procedure Act (60 Stat. 235; 5 U.S.C. 1001 et seq.). (g) The term "Hearing Clerk" means the hearing clerk of the Department. (h) The term "FEDERAL REGISTER" means the publication provided for by the Federal Register Act of July 26, 1935, and acts supplementary thereto and amendatory thereof (44 U.S.C. 301-314). (i) The term "proceeding" means any action taken pursuant to sections 507(f) and 701(e) (1) of the act for the issuance, amendment, or repeal of any regulation issued pursuant to sections 201(v) (2) (C) and (3), 401, 403(j), 404(a), 406, 501(b), 502 (d), (h), and (n), 506(c), 507, and 706 (b), (c), and (d) of the act, and sections 4 and 5 of the Fair Packaging and Labeling Act, and sections 2(q) (1) (B) and 3(a)(2) of the Federal Hazardous Substances Act. (j) The term "hearing" means any hearing held pursuant to sections 507(f) and 701(e) (3) of the act. (k) Any term not defined in this section shall have the definition set forth in section 201 of the act, and Part 1 of this chapter. [31 F.R. 3003, Feb. 22, 1966, as amended at 34 F.R. 6238, Apr. 8, 1969] § 2.53 Filing; address; hours; papers to be filed. Documents required or permitted to be filed in, and correspondence relating to, proceedings governed by the regulations in this Subpart F shall be filed with the 66-041-72- -5 Hearing Clerk, Room 5440, Department of Health, Education, and Welfare, Washington, D.C., 20201. This Office is open Monday through Friday from 9 a.m. to 5:30 p.m., eastern standard or daylight saving time, whichever is effective in the District of Columbia at the time, except on national legal holidays. § 2.54 Inspection of records. Subject to the provisions of law restricting public disclosure of information, all documents filed in the docket in any proceeding may be inspected and copied in the office of the Hearing Clerk. § 2.55 Information; special instructions. Information regarding procedure under these rules and instructions supplementing these rules in special instances will be furnished on application to the Hearing Clerk. § 2.56 Use of gender and number. Words importing the singular number may extend and be applied to the plural. Words importing the masculine gender may be applied to the feminine gender. § 2.57 Waiver, suspension, amendment of rules. The Commissioner or the presiding officer (with respect to matters pending before him) may modify or waive any rule in this Subpart F, by announcement at the hearing or by notice in advance of the hearing, if he determines that no party will be unduly prejudiced and the ends of justice will thereby be served. APPEARANCE, PRACTICE, AND BURDEN OF PROOF § 2.58 Appearance. Any interested person may appear in person or by or with counsel or other duly qualified representative in any proceeding or hearing and may be heard with respect to matters relevant to the issues under consideration. § 2.59 Authority for representation. Any individual acting in a representative capacity in any proceeding may be required by the Commissioner or the presiding officer to show his authority to act in such capacity. § 2.60 Written appearance. Any interested person desiring to appear at any hearing or prehearing conference shall, within the time specified in the notice of hearing, file with the presiding officer a written notice of appearance as specified in § 2.64 setting forth his name, address, and interest. If any interested person desires to be heard through a representative, such person or such representative shall file with the presiding officer a written appearance setting forth the name, address, and employment of such person. The written notice of appearance shall conform to the form set forth in § 2.64. Any person or representative shall state with particularity in the notice of appearance his interest in the proceeding and shall set forth the objection or issue concerning which such person desires to be heard. Practice before the Commissioner shall comprehend all matters connected with any proceeding or hearing conducted pursuant to section 507(f) and section 701 of the act (21 U.S.C. 371). [31 F.R. 3003, Feb. 22, 1966, as amended at 34 F.R. 6238, Apr. 8, 1969] § 2.62 Conduct at hearings. Disrespectful, disorderly, or contumacious language or contemptuous conduct, refusal to comply with directions, continued use of dilatory tactics, or refusal to adhere to reasonable standards of orderly and ethical conduct, at any hearing before the Commissioner or a presiding officer, shall constitute grounds for immediate exclusion from the hearing. § 2.63 Burden of proof. (a) At any hearing held as provided in section 701 of the act, the originator of the proposal or petition for the issuance, amendment, or repeal of any regulation contemplated under section 701(e) (1) of the act, shall be, within the meaning of section 7(c) of the Administrative Procedure Act (5 U.S.C. 1006 (c)), the proponent of the rule or order, and accordingly shall have the burden of proof. (b) Any adversely affected person filing an objection pursuant to section 701(e) (2) of the act, which objection proposes the substitution of a new provision for that provision objected to, shall have the burden of proof in relation to the new provision so proposed. (Signature of authorized FILING PETITIONS, PUBLICATION OF PROPOS- Procedure for filing petitions. (a) Petitions for the issuance, amendment, or repeal of any regulation subject to the provisions of section 507(f) and 701(e) of the act (except petitions filed under sections 506(c) and 706 of the act, which shall conform to the requirements and procedures of sections 506 and 706 of the act and the sections promulgated thereunder (21 CFR Parts 164 and 8, respectively)), shall be submitted in quintuplicate to the Commissioner. If any part of the material submitted is in a foreign language it shall be accompanied by an accurate and complete English translation. The petition shall state the petitioner's mailing address to which a copy of the notice contemplated by section 701(e) (2) of the act may be sent. (b) Petitions shall include the following data and be submitted in the following form: this petition pursuant to section 507(f) or 701 (e) (1) (B) of the Federal Food, Drug, and Cosmetic Act with respect to the issuance (amendment or repeal) of a regulation under (the blank to be filled in with the appropriate section of the Federal Food, Drug, and Cosmetic Act: sections 401, 403 (j), 404(a), 406, 501 (b), 502 (d), (h), or (n), or 507 (f); or with section 5 of the Fair Packaging and Labeling Act or sections 2(q) (1) (B) and 3(a) (2) of the Federal Hazardous Substances Act). Attached hereto, in quintuplicate and constituting a part of this petition, are the following: (A) The proposed regulation in the form proposed by the petitioner. (B) A statement of the grounds upon which the petitioner relies for the issuance (amendment or repeal) of the regulation. (Such grounds shall include a reasonably precise statement of the facts relied upon by the petitioner. If it appears that reasonable grounds for the action proposed are not stated in the petition, the petition will be denied.) (C) If the petition seeks the amendment or repeal of an existing regulation, a reference to the section of Title 21, Chapter I, of the Code of Federal Regulations where it appears. resentative, or (if a corporation) by an authorized official. All petitions shall be submitted in quintuplicate. A single copy will not be accepted for filing. (c) The Commissioner shall notify the petitioner promptly after its receipt of acceptance or nonacceptance of a petition, and if not accepted the reason therefor. A petition shall not be accepted for filing if any of the data prescribed in paragraph (b) of this section are lacking or are not set forth so as to be readily understood. If petitioner desires, he may supplement a deficient petition after notification of deficiency. The proposal contained in any petition filed with the Commissioner for the issuance, amendment, or repeal of any regulation subject to the provisions of sections 507(f) and 701(e) of the act, and any proposal initiated by the Commissioner under section 701(e) (1) (A) shall be published in the FEDERAL REGISTER as provided in § 2.66. [31 F.R. 3003, Feb. 22, 1966, as amended at 31 FR. 16564, Dec. 28, 1966, 32 F.R. 6839, May 4, 1967; 33 F.R. 15652, Oct. 23, 1968; 33 F.R. 19000, Dec. 27, 1968; 34 F.R. 6238, Apr. 8, 1969] § 2.66 Proposals and petitions. (a) The Commissioner, under the authority delegated to him by the Secretary (21 CFR 2.120), on his own initiative or upon petition filed with him by any interested person stating reasonable grounds therefor, shall publish in the FEDERAL REGISTER any proposal or petition to issue, amend, or repeal any regulation contemplated under the following sections of the act: Sections 401, 403 (j), 404 (a), 406, 501(b), 502 (d), (h), and (n), 506(c), 507(f), 706 (b) and (c); and sections 4 and 5 of the Fair Packaging and Labeling Act, and sections 2 (q) (1) (B) and 3(a) (2) of the Federal Hazardous Substances Act. (b) Such published notice will provide for a time period of not less than 30 days within which all interested persons may present their views and comments thereon in writing. (c) As soon as practicable after the expiration of the time for filing views and comments the Commissioner shall publish in the FEDERAL REGISTER his order acting upon such proposal or petition. Except as provided in § 2.67, this order |