mony shall be confined to matters relevant to the admissibility of the article, and may be introduced orally or in writing.

(b) If such owner or consignee submits or indicates his intention to submit an application for authorization to relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug, device, or cosmetic, such testimony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing, the district director shall specify a time limit, reasonable in the light of the circumstances, for filing such application. (20 F.R. 9538, Dec. 20, 1955, as amended at 31 F.R. 8521, June 18, 1966]

§ 1.319

Application for authorization. Application for authorization to relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug, device or cosmetic may be filed only by the owner or consignee, and shall:

(a) Contain detailed proposals for bringing the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic.

(b) Specify the time and place where such operations will be carried out and the approximate time for their completion.

[20 F.R. 9538, Dec. 20, 1955]

§ 1.320 Granting of authorization.

(a) When authorization contemplated by § 1.319 is granted, the district director shall notify the applicant in writing, specifying:

(1) The procedure to be followed;

(2) The disposition of the rejected articles or portions thereof;

(3) That the operations are to be carried out under the supervision of an officer of the Food and Drug Administration or the Bureau of Customs, as the case may be;

(4) A time limit, reasonable in the light of the circumstances, for completion of the operations; and

may grant such additional time as he deems necessary.

(c) An authorization may be amended upon a showing of reasonable grounds therefor and the filling of an amended application for authorization with the district director.

(d) If ownership of an article covered by an authorization changes before the operations specified in the authorization have been completed, the original owner will be held responsible, unless the new owner has executed a bond and obtained a new authorization. Any authorization granted under this section shall supersede and nullify any previously granted authorization with respect to the article. [20 F.R. 9538, Dec. 20, 1955 as amended at 31 F.R. 8521, June 18, 1966]

(a) The bonds required under section 801(b) of the act may be executed by the owner or consignee on the appropriate form of a customs single-entry or term bond, containing a condition for the redelivery of the merchandise or any part thereof upon demand of the collector of customs and containing a provision for > the performance of conditions as may legally be imposed for the relabeling or other action necessary to bring the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic, in such manner as is prescribed for such bond in the customs regulations in force on the date of request for authorization. The bond shall be filed with the collector of customs.

(b) The collector of customs may cancel the liability for liquidated damages incurred under the above-mentioned provisions of such a bond, if he receives an application for relief therefrom, upon the payment of a lesser amount or upon such other terms and conditions as shall be deemed appropriate under the law and in view of the circumstances, but the collector shall not act under this regulation in any case unless the district director is in full agreement with the action.

[20 F.R. 9539, Dec. 20, 1955 as amended at 31 F.R. 8521, June 18, 1966]

§ 1.322 Costs chargeable in connection with relabeling and reconditioning inadmissible imports.

The cost of supervising the relabeling or other action in connection with an import of food, drugs, devices,

or

cosmetics which fails to comply with the Federal Food, Drug, and Cosmetic Act shall be paid by the owner or consignee who files an application requesting such action and executes a bond, pursuant to section 801 (b) of the act, as amended. The cost of such supervision shall include, but not be restricted to, the following:

(a) Travel expenses of the supervising officer.

(b) Per diem in lieu of subsistence of the supervising officer when away from his home station, as provided by law.

(c) Services of the supervising officer, to be calculated at a flat rate of $8 per hour (which shall include administrative expense), except that such services performed by a customs officer and subject to the provisions of the Act of February 13, 1911, as amended (sec. 5, 36 Stat. 901 as amended; 19 U.S.C. 267), shall be calculated as provided in that act.

(d) Services of analyst, to be calculated at a flat rate of $10 per hour (which shall include the use of the chemical laboratories and equipment of the Food and Drug Administration).

(e) The minimum charge for services of supervising officers and of analysts shall be not less than the charge for 1 hour, and time after the first hour shall be computed in multiples of 1 hour, disregarding fractional parts less than 1⁄2 hour.

[20 F.R. 9539, Dec. 20, 1955, as amended at 30 F.R. 5507, Apr. 17, 1965]

ADMINISTRATIVE

§ 1.700 Examinations and investigations; samples.

(a) (1) When any officer or employee of the Department collects a sample of a food, drug, or cosmetic for analysis under the act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Department indicating that the shipment or other lot of the article from which such sample was collected was introduced or delivered for introduction into interstate commerce, or was in or was received in interstate commerce, or was manufactured within a Territory. Only samples so designated by an officer or employee of the Department shall be considered to be official samples.

(2) For the purpose of determining whether or not a sample is collected for

analysis, the term "analysis" includes examinations and tests.

(3) The owner of a food, drug, or cosmetic of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected.

(b) When an officer or employee of the Department collects an official sample of a food, drug, or cosmetic for analysis under the act, he shall collect at least twice the quantity estimated by him to be sufficient for analysis, unless:

(1) The amount of the article available and reasonably accessible for sampling is less than twice the quantity so estimated;

(2) The cost of twice the quantity so estimated exceeds $10;

(3) The article is perishable;

(4) The sample is collected from a shipment or other lot which is being imported or offered for import into the United States;

(5) The sample is collected from a person named on the label of the article, or his agent, and such person is also the owner of the article;

(6) The sample is collected from the owner of the article, or his agent, and such article bears no label or, if it bears a label, no person is named thereon; or

(7) The analysis consists principally of rapid analytical procedures, organoleptic examination, or other field inspection examinations or tests, made at the place where the sample is collected or in a mobile or temporary laboratory. In addition to the quantity of sample prescribed above the officer or employee shall, if practicable, collect as part of the sample such further amount of the article as he estimates to be sufficient for use as exhibits in the trial of any case that may arise under the act based on the sample.

(c) After the Food and Drug Administration has completed such analysis of an official sample of a food, drug, or cosmetic as it determines, in the course of analysis and interpretation of analytical results, to be adequate to establish the respects, if any, in which the article is adulterated or misbranded within the meaning of the act, or otherwise subject to the prohibitions of the act, and has reserved an amount of the article it estimates to be adequate for use as exhibits in the trial of any case that may arise under the act based on the sample, a part of the sample, if any

remains available, shall be provided for analysis, upon written request, by any person named on the label of the article, or the owner thereof, or the attorney or agent of such person or owner, except when:

(1) After collection, the sample or remaining part thereof has become decomposed or otherwise unfit for analysis, or

(2) The request is not made within a reasonable time before the trial of any case under the act, based on the sample to which such person or owner is a party. The person, owner, attorney, or agent 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;

(6) Any official sample or part thereof when, after collection, such sample or part has become decomposed or otherwise unfit for analysis;

(7) That part of any official sample which is in excess of three times the quantity it estimates to be sufficient for analysis.

(Secs. 701, 702, 52 Stat. 1055, as amended; 1056, as amended; 21 U.S.C. 871, 372) [20 F.R. 9539, Dec. 20, 1955]

2.173 2.175

Food, Drug, and Environmental Health Division, Office of the General Counsel, Department of Health, Education, and Welfare.

Regional Offices.

District Offices.

AUTHORITY: The provisions of this Part 2 issued under sec. 10, 29 Stat. 607, as amended 41 Stat. 712; sec. 4, 49 Stat. 885; sec. 701, 52 Stat. 1055, as amended; sec. 10, 74 Stat. 378; 21 U.S.C. 50, 64, 371; 15 U.S.C. 1269, unless otherwise noted.

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 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 F.R. 16564, Dec. 28, 1966, 32 FR. 6839,

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 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 pro