Subparts A-E-[Reserved]

Subpart F-Public Hearings AUTHORITY: The provisions of this Subpart F also issued under sec. 3(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 201(v) (2) (C) and (3) (procedure for listing habit-forming drugs and drugs having a potential for abuse), 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) (habit-forming 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 section 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 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 F.R. 16564, Dec. 28, 1966, 32 F.R. 6839, May 4, 1967]

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 section 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), 706(b), (c), and (d), and sections 4 and 5 of the Fair Packaging and Labeling Act, and section 3(a) (2) of the Federal Hazardous Substances Act.

(j) The term "hearing" means any hearing held pursuant to section 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 31 F.R. 16564, Dec. 28, 1966, 32 F.R. 6839, May 4, 1967]

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.

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. § 2.64 Form of written appearance.

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

FOOD AND DRUG ADMINISTRATION

In the matter of:

(Identify the matter in which the appearance is being filed, as set forth in the notice of hearing.)

(Signature of authorized counsel or representative)

FILING PETITIONS, PUBLICATION OF PROPOSALS AND PETITIONS, FILING OBJECTIONS AND REQUESTS FOR HEARINGS

§ 2.65 Procedure for filing petitions.

(a) Petitions for the issuance, amendment, or repeal of any regulation subject to the provisions of section 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:

(Date)

COMMISSIONER OF FOOD AND DRUGS, Department of Health, Education, and Welfare,

Washington, D.C., 20204.

DEAR SIR: The undersigned

--, submits this petition pursuant to section 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 201(v) (2) (C) or (3), 401, 403(j), 404(a), 406, 501(b), 502 (d), (h), or (n); or with section 5 of the Fair Packaging and Labeling Act or section 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.

Very truly yours,

This petition must be signed by the petitioner or by his attorney or authorized representative, 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 section 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 F.R. 16564, Dec. 28, 1966, 32 F.R. 6839, May 4, 1967]

§ 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 201(v) (2) (C) and (3), 401, 403(j), 404(a), 406, 501(b), 502 (d), (h), and (n), 506(c), 706 (b) and (c); and sections 4 and 5 of the Fair Packaging and Labeling Act, and section 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 shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under this section.

[31 F.R. 3003, Feb. 22, 1966, as amended at 31 F.R. 4201, Mar. 10, 1966; 31 F.R. 16564, Dec. 28, 1966; 32 F.R. 6839, May 4, 1967] § 2.67 Objections to the Commissioner's order and requests for hearings.

(a) on or before the 30th day after the date of the publication of the Commissioner's order in the FEDERAL REGISTER as specified in § 2.66 (c), any person who will be adversely affected by such

order, if placed in effect, may submit objections thereto to the Commissioner and request a public hearing on the stated objections.

(b) These objections shall be accepted for filing only when they comply with all the following provisions:

(1) Objections shall be received by the Hearing Clerk if postmarked on or before the 30th day after the date of publication of the Commissioner's order in the FEDERAL REGISTER.

(2) Each objection to a provision of the Commissioner's order shall be separately numbered.

(3) Objections must establish that the objector will be adversely affected by the order.

(4) Objections must specify with particularity the provisions of the order to which objection is taken.

(5) Objections must be supported by reasonable grounds which, if true, are adequate to justify the relief sought.

(c) If the statement of objections is not accepted for filing because of failure to comply with paragraph (b) of this section, the Commissioner shall so inform the objector and state the reasons for refusing to file the objections.

(d) If objections to the Commissioner's order issued pursuant to a petition are filed by a person other than the petitioner, the Food and Drug Administration shall mail a copy of the objections to the petitioner at the address given in the petition. Petitioner shall have 2 weeks from the date of receipt of the objections to make written reply.

(e) As soon as practicable after the time for filing objections has expired, the Commissioner shall publish a notice in the FEDERAL REGISTER Specifying those parts of the order that have been stayed by the filing of objections or, if no objections have been filed, stating that fact.

PUBLIC HEARINGS AND NOTICE THEREOF

§ 2.68 Hearings under section 701(e) of the act.

(a) Under the authority delegated to him by the Secretary (21 CFR 2.120), the Commissioner on his own initiative or upon a petition of any interested person adversely affected stating reasonable ground therefor, shall hold a public hearing for the purpose of receiving evidence relevant and material to the