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

(c) Evidence. The presiding officer shall admit only evidence that is relevant, material, reliable, and not unduly repetitious.

Opinion

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

(e) Documents to be filed. The presiding officer shall file as exhibits copies of the following documents:

(1) The proposal to issue, amend, or repeal a regulation as published in the FEDERAL REGISTER, described in § 2.66(a).

(2) The order of the Commissioner as published in the FEDERAL REGISTER, described in § 2.66(c).

(3) The notice of receipt of objections as published in the FEDERAL REGISTER, described in § 2.67(e).

(4) The notice of public hearing as published in the FEDERAL REGISTER, described in § 2.69.

(5) The prehearing order, if any, as described in § 2.76.

(6) Any other document necessary to show the basis for the hearing. § 2.82 Inspection of documents.

All documents constituting the record bearing on the matter or matters in controversy, and not entitled to protection under section 301(j) of the act, accumulated up to the start of the hearing shall be open for inspection by interested persons during office hours in the office of the hearing clerk.

§ 2.84 Affidavits.

Upon a showing of their relevancy, materiality, and competency, affidavits may be marked as exhibits at the prehearing conference. Every interested person shall be permitted to examine all affidavits that have been so filed and to file counteraffidavits with the presiding officer, within a period of time to be fixed by the presiding officer, not more than 15 days following the close of the hearing. Subject to the provisions of section 7(c) of the Administrative Procedure Act (5 U.S.C. 1006), these affidavits may be admitted into evidence. If so admitted, the Commissioner and presiding officer will consider the lack of opportunity for cross-examination in determining the weight to be attached to statements made in the form of affildavits.

Where official notice is taken or is to be taken of a material fact not appearing in the evidence of record, any party, on timely request, shall be afforded opportunity to show the contrary.

§ 2.88 Offer of proof.

An offer of proof made in connection with an objection taken to any ruling of the presiding officer rejecting or excluding proffered oral testimony shall consist of a statement of the substance of the evidence which counsel contends would be adduced by such testimony; and, if the excluded evidence consists of evidence in documentary or written form, a copy of such evidence shall be marked for identification and shall accompany the record as the offer of proof.

$2.89 Appeal from ruling of presiding officer.

Rulings of the presiding officer may not be appealed to the Commissioner prior to his consideration of the entire proceeding, except with the consent of the presiding officer and where he certifies on the record or in writing that the allowance of an interlocutory appeal is clearly necessary to prevent exceptional delay, expense, or prejudice to any party, or substantial detriment to the public interest. If an appeal is allowed, any party may file a brief with the Commissioner within such period that the presiding officer directs. No oral argument will be heard unless the Commissioner directs otherwise.

§ 2.90

THE RECORD

Official transcript; indexing of record.

(a) Official transcript. Testimony given at a public hearing shall be reported verbatim. The Department will make provision 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 transcript of the testimony and exhibits taken at the hearing or of any part thereof shall be entitled to the same upon application to the official reporter and upon payment of the costs thereof.

(b) Indexing of record. (1) Whenever it appears to the presiding officer that the record of hearing will be of such length that an index to the record will permit a more orderly presentation of the evidence and reduce delay, the presiding officer shall require counsel for the parties to prepare a daily topical index which will be available to the presiding officer and all parties. Preparation of such an index shall be apportioned among all counsel present in such manner as appears just and proper in the circumstances.

(2) The index should include each topic of testimony upon which evidence is taken, the name of each witness testifying upon the topic, the page of the record at which each portion of his testimony appeared, and the number of each exhibit relating to the topic. The index should also contain the name of each witness, followed by the topics upon which he testified and the page of the record at which such testimony appears.

All written statements, charts, tabulations, reports, documents, and similar data offered in evidence at the hearing shall be marked for identification, and upon a showing satisfactory to the presiding officer of the authenticity, relevancy, materiality, and reliability, shall be received in evidence, subject to section 7(c) of the Administrative Procedure Act (5 U.S.C. 1006(c)). Exhibits shall be submitted in quintuplicate. In case the required number of copies are not made available, the presiding officer shall exercise his discretion in determining whether the exhibit will be read in evidence or whether additional copies will be required to be submitted within a time to be specified by the presiding officer. Where relevant and material matter offered into evidence is embraced in a report or document containing immaterial and irrelevant matter, such immaterial and irrelevant matter will be excluded and will be segregated, insofar as practicable, subject to the direction of the presiding officer.

At the close of the hearing, the presiding officer shall afford witnesses and their counsel time (not longer than 30 days, except in unusual cases) in which to submit written proposed corrections of the transcript, pointing out errors that may have been made in transcribing the testimony. The presiding officer shall promptly thereafter order such corrections made as in his judgment are required to make the transcript conform to the testimony.

§ 2.94 Record for decision.

The transcript of testimony and exhibits together with any written arguments that may have been filed in the proceeding, including rulings, shall constitute the exclusive record for decision.

50-041-71-5

BRIEFS, REQUESTS FOR FINDINGS, DECISIONS, EXCEPTIONS, ORAL ARGUMENT; FINAL ORDER

§ 2.95 Briefs.

The time for filing briefs and reply briefs (if permitted) with the presiding officer shall be fixed by him. The person submitting a brief shall file five copies with the hearing clerk. Briefs shall include a statement of position on each issue as supported by the evidence of record, together with specific and complete citations of the pages of the transcript and exhibits, together with citations of authorities relied upon. Briefs shall contain proposed findings of fact and conclusions of law when requested by the presiding officer. § 2.96

Decisions.

As soon as practicable after the time for filing of briefs has expired, the presiding officer shall prepare a report and shall certify the record together with his report to the Commissioner. § 2.97 Tentative order.

(a) As soon as practicable thereafter the Commissioner shall prepare and cause to be published in the FEDERAL REGISTER his tentative order, including detailed findings of fact and conclusions upon which it is based.

(b) The tentative order shall specify a reasonable time (ordinarily not to exceed 60 days), within which any party of record may file exceptions to the proposed order. The exceptions shall point out with particularity the alleged errors in said order and shall contain a specific reference to the pages of the transcript of the testimony or to exhibits on which exceptions are based. Such exceptions may be accompanied by a memorandum or brief in support thereof and if oral argument on the exceptions is desired, such a request shall be made with the exceptions. The Commissioner will grant or deny oral argument in his discretion. § 2.98 Final order.

As soon as practicable after the time for filing exceptions has passed, the Commissioner shall cause to be published in the FEDERAL REGISTER his final order in the proceeding, which shall set forth detailed findings of fact and conclusions upon which the order is based. This

§ 2.104 Ex parte communications.

If any official of the Food and Drug Administration is contacted by any individual in private or public life concerning any matter which is the subject of a public hearing, the official who is contacted shall prepare a memorandum setting forth the substance of the conversation and shall file this memorandum in the appropriate public docket file.

Subpart G-Public Information § 2.115 Fee schedule for searching, supplying, and certifying records.

(a) Certain routine information is provided to the general public at no charge; however, special informational services involving more than routine investigation and allocation of staff time are subject to fees as necessary to recover costs to the Government.

(b) Charges for special services regarding Food and Drug Administration records are as follows:

(1) Search for records: $3 per hour. (2) Reproduction, duplication, or copying of records: 25 cents per page.

(3) Reproduction, duplication, or copying of microfilm: 50 cents per microfilm frame and 50 cents per microfiche.

(4) Certification or authentication of records: $5 per certification.

(5) Forwarding material to destinafees will be charged on an actual cost tion: Postage, insurance, and special basis.

(c) These charges are in agreement with charges for similar services by the Department of Health, Education, and Welfare as published in the FEDERAL REGISTER of May 6, 1969 (34 F.R. 7348). (d) This schedule does not apply to official records and information provided under § 4.1 of this chapter. [35 F.R. 7299, May 9, 1970]

Subpart H-Delegations of Authority

§ 2.120 Delegations from the Secretary and Assistant Secretary.

for

(a) The Assistant Secretary Health and Scientific Affairs has redelegated to the Commissioner of Food and Drugs with authority to redelegate (35 F.R. 606, 3000) all authority delegated to him by the Secretary of Health, Education, and Welfare as follows:

(1) Functions vested in the Secretary and the Department of Health, Education, and Welfare under the Federal Food, Drug, and Cosmetic Act as amended (21 U.S.C. 301 et seq.), the Filled Milk Act (21 U.S.C. 61-63), the Federal Import Milk Act (21 U.S.C. 141 et seq.), the Tea Importation Act (21 U.S.C. 41 et seq.), the Federal Caustic Poison Act (44 Stat. 1406), the Federal Hazardous Substances Act as amended (15 U.S.C. 1261 et seq.), the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), and the Flammable Fabrics Act (15 U.S.C. 1201), pursuant to section 12 of Reorganization Plan No. IV and Reorganization Plan No. 1 of 1953, including authority to administer oaths vested in the Secretary of Agriculture by 7 U.S.C. 2217.

(2) Functions vested in the Secretary by amendments to the foregoing statutes subsequent to Reorganization Plan No. 1 of 1953.

(3) Functions pertaining to sections 301, 311, 314, and 361 of the Public Health Service Act (42 U.S.C. 241, 243, 246, and 264) that relate to pesticides, product safety, interstate travel sanitation, milk and food service sanitation, shellfish sanitation, and poison control.

(4) Functions under Executive Order 11490, section 1103(5), and those portions of sections 1103 (1), (3), and (4), 3001 (2) and (3), 3002 (1), (2), and (3), and 3004 that relate to food, drugs, and biologicals. In the performance of these emergency functions, the Commissioner shall coordinate his activities with the Administrator, Health Services and Mental Health Administration, in order that preemergency plans shall be developed in consonance with postattack organizational plans and structure of the Department for the Emergency Health Service.

(5) Function of issuing all regulations of the Food and Drug Administration. The reservation of authority contained in Chapter 1A (formerly 2-000) of the Department Organization Manual shall not apply.

(6) Function of authorizing and approving miscellaneous and emergency expenses of enforcement activities vested in the Secretary.

(b) The Assistant General Counsel in charge of the Division of Food, Drug, and Environmental Health has been authorized to report apparent violations to the Department of Justice for the institution of criminal proceedings, pursuant to section 305 of the Federal Food, Drug, and Cosmetic Act, section 4 of the Federal Import Milk Act, section 9(b) of the Federal Caustic Poison Act, and section 4 of the Federal Hazardous Substances Act.

(c) The Assistant Secretary for Administration has redelegated (34 F.R. 18049, 35 F.R. 607) to the Commissioner of Food and Drugs, with authority to redelegate, the authority: To certify true copies of any books, records, papers, or other documents on file within the Department, or extracts from such; to certify that true copies are true copies of the entire file of the Department; to certify the complete original record or to certify the nonexistence of records on file within the Department; and to cause the Seal of the Department to be affixed to such certifications and to agreements, awards, citations, diplomas, and similar documents.

[35 F.R. 14768, Sept. 23, 1970]

§ 2.121 Redelegations of authority from the Commissioner to other officers of the Administration.

Final authority of the Commissioner of Food and Drugs is redelegated as set forth in this section. Further redelegation of the authority vested herein is not authorized. Authority redelegated herein to a position by title may be exercised by a person officially designated to serve in such position in an acting capacity or on a temporary basis, unless prohibited by a restriction written into the document designating him as "acting" or unless not legally permissible.

(a) General delegation of authority. The Deputy Commissioner of Food and Drugs and the Associate Commissioner for Compliance are authorized to perform all the functions of the Commissioner of Food and Drugs.

(b) Delegations regarding authorization to hold informal hearings. The Directors of Bureaus, Regional Food and Drug Directors, and Deputy Regional Food and Drug Directors are authorized to designate officials to hold informal hearings under sections 305, 404(b), and 801(a) of the Federal Food, Drug, and Cosmetic Act, sections 7 and 14 of the Federal Hazardous Substances Act, and section 5 of the Federal Import Milk Act. Officials so designated are delegated authority contemplated by section 1 of the Act of January 31, 1925 (Ch. 124, 43 Stat. 803); sections 12 to 15 of Reorganization Plan No. IV, effective June 30, 1940; Reorganization Plan No. 1 of 1953, effective April 11, 1953; and section 556 (c) of Title 5 U.S.C. (80 Stat. 386), to administer to or take from any person an oath, affirmation, affidavit, or deposition for use in any prosecution or proceeding under or in enforcement of any law as cited in this section.

(c) Delegations regarding authorization to request samples of imports. The Regional Food and Drug Directors and Deputy Regional food and Drug Directors are authorized to designate officials who may request, pursuant to section 801(a) of the Federal Food, Drug, and Cosmetic Act and section 14 of the Federal Hazardous Substances Act, from the Secretary of the Treasury samples of foods, drugs, devices, cosmetics, or hazardous substances imported, or offered for import, in order to determine whether such articles are in compliance with those acts.

(d) Certification of true copies and use of Department seal. (1) The Assistant Commissioner for Administration is delegated the authority to certify true copies of any books, records, papers, or other documents, or extracts from such, or to certify the nonexistence of records on file within the Food and Drug Administration, and to cause the seal of the Department of Health, Education, and Welfare to be affixed to such certifications, as well as to agreements, awards, citations, diplomas, and similar documents.

(2) The following officials are delegated the authority to certify true copies of any books, records, papers, or other documents, or extracts from such, or to certify the nonexistence of records on file within the Food and Drug Administration, and to cause the seal of the Department of Health, Education, and Welfare to be affixed to such certifications: (i) Food and Drug Administration Information Center Officer.

(ii) [Reserved]

(iii) In the Bureau of Regulatory Compliance: Director, Deputy Director; Director. Division of Case Guidance; and Deputy Director, Division of Case Guidance.

(e) Delegations regarding disclosure of official records. The Director of the Bureau of Regulatory Compliance and the Director of the Division of Case Supervision of that Bureau are authorized to make determinations to disclose official records and information in accordance with § 4.1 of this chapter.

(f) Delegations regarding certification of color additives. The Director of the Bureau of Science and the Director of the Division of Colors and Cosmetics of that Bureau are authorized to certify batches of color additives for use in food, drugs, or cosmetics, pursuant to section 706 of the Federal Food, Drug, and Cosmetic Act.

(g) [Reserved]

(h) Delegations regarding certification of insulin. The Director of the Office of Certification Services, a unit within the Office of the Associate Commissioner for Compliance, is authorized to exercise the functions and duties of the Commissioner under the regulations insofar as such duties and functions involve the certification of batches of drugs containing insulin as contemplated by § 164.3 (a) and (c) of this chapter or approval of the use of materials as contemplated by § 164.2 (j) and (k) of this chapter.