unless the chief of district is in full agreement with the action.

§ 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 $6.20 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 $7.68 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.

(Sec. 801, 52 Stat. 1058 as amended; 21 U.S.C. 381) [20 FR. 9539, Dec. 20, 1955, as amended at 27 F.R. 6753, July 17, 1962]

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 in

troduced 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 estab

lish 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 decom. posed 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 un

der 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. 371, 372)

RULES OF PRACTICE FOR HEARINGS AUTHORITY: §§ 1.701 to 1.715 issued under sec. 701, 52 Stat. 1055, as amended; 21 U. S. C. 371.

As used in §§ 1.701-1.715:

(a) The term "act" means the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938 (52 Stat. 1040, as amended; 21 U. S. C. 301-392).

(b) The term "Department" means the Department of Health, Education, and Welfare of the United States.

(c) The term "Secretary" means the Secretary of Health, Education, and Welfare.

(d) 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 (49 Stat. 500, 50 Stat. 304, sec. 202, 53 Stat. 1435, 56 Stat. 1045, 61 Stat. 451; 44 U. S. C. Chapter 8B).

(e) The term "person" includes an individual, partnership, corporation, and association.

(f) The term "hearing clerk" means the hearing clerk of the Department.

HEARINGS AND NOTICE THEREOF

§ 1.702 Hearings under section 701(e) of the act, except hearings with reference to regulations under section 404(a) of the act.

The Secretary, on his own initiative or upon an application of any interested industry or substantial portion thereof stating reasonable grounds therefor, shall hold a public hearing upon a proposal to issue, amend, or repeal any regulation contemplated by any of the following sections of the act: 401, 403 (j), 406 (a) and (b), 501(b), 502 (d), (h), 504, and 604.

§ 1.703 Notice of hearing.

The Secretary shall give notice of the hearing by filing the same with the Archivist of the United States for publication in the FEDERAL REGISTER. The notice shall set forth the proposal in general terms and shall specify the time, which shall not be less than 30 days after the date of the notice, and the place for the public hearing.

§ 1.704 Designation and powers of presiding officer.

(a) Each such hearing shall be conducted by a presiding officer, who shall be the Secretary or such officer or employee of the Secretary as the Department may designate for the purpose. Any such designation may be made or revoked by the Secretary at any time. Such hearing shall be conducted in an informal but orderly manner in accordance with the rules in §§ 1.701-1.715, and, where such rules are inapplicable or incomplete, in accordance with the directions of the presiding officer. The presiding officer shall have power to administer oaths, examine witnesses, and receive evidence, and to rule upon the admissibility of evidence and other matters that arise in the course of the hearing, but, except where the presiding officer is the Secretary, shall have no power to decide any motion which involves final determination of the merits of the proceeding.

(b) The hearing shall be held at the time and place set forth in the notice of the hearing, but may at such time and place be continued from day to day and adjourned to a later day or to a different place, within the city designated in the notice, without notice other than the announcement thereof by the presiding officer at the hearing.

At the hearing, any interested person shall be given an opportunity to appear, either in person or through his authorized representative, and to be heard with respect to matters relevant and material to the proposal. Any interested person who desires to be heard in person at any hearing under the rules in §§ 1.701-1.715 shall file with the presiding officer a written appearance setting forth his name, address and occupation. If such 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 authority for such representative and the names, addresses, and occupations of such person and such representative. Any such person or such representative shall give such other information respecting his appearance as the presiding officer may request. All present at the hearing shall conform to all reasonable standards of orderly and ethical conduct.

§ 1.706 Order of procedure.

(a) The presiding officer shall have noted on the record his designation as presiding officer and the notice of the hearing as filed with the Archivist of the United States. This shall be done by filing as an exhibit for the record a copy of the FEDERAL REGISTER containing such designation and such notice. If the designation has not been published in the FEDERAL REGISTER, the presiding officer shall file as an exhibit the order of the Secretary designating him to preside.

(b) To promote orderliness and clarity of the record, evidence shall be received with respect to the subject matter of the hearing in the following order, except as the presiding officer otherwise may permit:

(1) Evidence with respect to the proposal in general, including such matters as its historical background, the reason for the proposal, and its probable effect. No evidence shall be introduced at this stage of the hearing as to any specific provision of the proposal.

(2) Evidence with respect to specific terms of the proposal, which shall be read and considered section by section in a sequence to be determined by the presiding officer. Suggestions to add to, delete, or alter any portions of a given

(a) Each witness shall, before proceeding to testify, be sworn or make affirmation.

(b) When necessary in order to prevent undue prolongation of the hearing, the presiding officer may limit the number of times any witness may testify to the same matter or the repetitious examination and cross-examination of witnesses, or the amount of corroborative or cumulative evidence.

(c) The presiding officer shall admit only relevant and material evidence.

(d) Opinion evidence shall be admitted when the presiding officer is satisfied that the witness is properly qualified.

(e) Affidavits, if relevant and material, shall be received and marked as exhibits, provided they are filled with the presiding officer on or before the date of the opening of the hearing. Every interested person shall be permitted to examine all affidavits which have been so filed and to file counter-affidavits with the presiding officer, within a period of time, to be fixed by the presiding officer, not more than 5 days following the close of the hearing. In any event, the Secretary will consider the lack of opportunity for cross-examination in determining the weight to be attached to statements made in the form of affidavits.

(f) If any person objects to the admission or rejection of any evidence, or other limitation of the scope of any examination or cross-examination, he shall state briefly the grounds of such objection, and the transcript shall not include argument or debate thereon except as ordered by the presiding officer. Any such objection shall be made before the presiding officer in order subsequently to be relied upon in the proceeding. A ruling of the presiding officer on any such objection shall be a part of the transcript, together with such offer of proof as has been made.

(g) Samples may be displayed at the hearing and may be described for purposes of the record but shall not be admitted in evidence as exhibits.

§ 1.708 Transcript of the testimony.

Testimony given at a hearing shall be reported verbatim. All written statements, charts, tabulations, and similar data offered in evidence at the hearing shall be marked for identification and, upon a showing satisfactory to the presiding officer of their authenticity, relevancy, and materiality, shall be received and marked as exhibits in evidence. Such exhibits (including affidavits) shall, if practicable, be submitted in quintuplicate and in documentary form. In case the required number of copies are not made available, the presiding officer shall exercise his discretion as to whether said exhibit shall when practicable be read in evidence or whether additional copies shall be required to be submitted within a time to be specified by the presiding officer. Where the testimony of a witness refers to a statute, or to a report or document, the presiding officer shall, after inquiry relating to the identification of such statute, report, or document, determine whether the same shall be produced at the hearing and physically be made a part of the evidence as an exhibit or whether it shall be incorporated into the evidence by reference. Where relevant and material matter offered in evidence is embraced in a report or document containing immaterial and irrelevant matter, such immaterial and irrelevant matter shall be excluded and shall be segregated insofar as practicable, subject to the direction of the presiding officer.

§ 1.709

Oral and written arguments.

(a) Unless the presiding officer shall issue an announcement at the hearing authorizing oral argument before him, it shall not be permitted.

(b) The presiding officer shall announce at the hearing a reasonable period within which interested persons may file written arguments based solely upon the evidence received at the hearing, citing the page or pages of the transcript of the testimony where such evidence occurs.

§ 1.710 Filing the record of the hearing.

As soon as practicable after the close of the hearing, the complete record of the

hearing shall be filed in the office of the hearing clerk. The record of the hearing shall include the transcript of the testimony, including any exhibits and together with any written arguments that may have been filed with the presiding officer.

§ 1.711 Copies of the record of the hearing.

The Department will make provisions for a stenographic record of the testimony and for such copies of the transcript thereof as it requires for its own purposes. Any person desiring a copy of the record of the hearing or of any part thereof shall be entitled to the same upon application to the hearing clerk and upon payment of the costs thereof. Suggested corrections to transcripts of the testimony shall be considered only if offered within a period (to be fixed by the presiding officer) of not more than 3 days following the completion of the testimony, for which purpose the record shall be kept open for such additional period. The presiding officer shall have authority to act upon such suggested corrections. ISSUANCE OF ORDER

The Secretary, within a reasonable time after the filing of the record of the hearing, will issue his proposed order, which shall be served upon the interested persons whose appearances were entered at the hearing by publication in the FEDERAL REGISTER or by mailing a copy of the proposed order to each of such persons by registered mail: Provided, however, That if, after examination of the record of the hearing, the Secretary finds that no controversy with respect to the subject of the hearing exists between the persons who appeared thereat, and that such action will promote the purposes of the act, the Secretary will issue a final order in lieu of issuing a proposed order in accordance with this section.

§ 1.713 Exceptions.

Within a reasonable time, which shall be specified in the proposed order but shall not exceed 20 days from the time of the issuance of such order, any interested person whose appearance was filed at the hearing may file exceptions to the proposed order. The exceptions shall point out with particularity the alleged errors in said proposed order, and shall contain a specific reference to the page

of the transcript of the testimony or to the exhibit on which each exception is based. Such exceptions may be accompanied by a memorandum or brief in support thereof.

§ 1.714 Final order.

The Secretary thereafter will issue his final order. A duplicate original thereof shall thereupon be filed with the Archivist of the United States and published in the FEDERAL REGISTER. A duplicate original thereof shall also be filed with the hearing clerk for public inspection.

PUBLIC NOTICE OF REGULATIONS

§ 1.715 Public notice of regulations.

Public notice of the issuance of the foregoing rules of practice for hearings in §§ 1.701-1.714 shall be given by publishing the same in the FEDERAL REGISTER.