PROCEDURE AT HEARING § 1.705 Appearances. 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. (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, (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 satisfiled that the witness is properly qualified. (e) Affidavits, if relevant and material, shall be received and marked as exhibits, provided they are filed 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. 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. 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. PART 2-ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Sec. 2.90 2.91 2.101 Subparts A-G-[Reserved] Direct delegations from the Secretary. Subparts I-L-[Reserved] Subpart M-Organization Washington headquarters. 2.102 Food and Drug Division, Office of the General Counsel, Department of Health, Education, and Welfare. 2.103 Field 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-G-[Reserved] Subpart H-Delegations of Authority §2.90 Direct delegations from the Secretary. (a) The Secretary has delegated to the Commissioner (25 F.R. 8625) all the functions vested by Congress in the Secretary and the Department under the Federal Food, Drug, and Cosmetic Act, the Federal Caustic Poison Act, the Federal Hazardous Substances Labeling Act, the Import Milk Act, the Filled Milk Act, and the Tea Importation Act. (b) The Secretary has redelegated to the Commissioner certain civil defense responsibilities delegated to the Secretary by Executive Order 11001 (27 F.R. 1534), sections 3 (b), (d), (e), 6, 7, 9, and 12 that relate to food, drugs, and biologicals. In the performance of his emergency functions, the Commissioner shall coordinate his activities with the Surgeon General, Public Health Service, in order that preemergency plans shall be developed in consonance with postattack organizational plans and structure of the Department for the Emergency Health Service. (c) The Assistant General Counsel in charge of the Food and Drug Division has been authorized to accept services of process pursuant to sections 408 (i) (1), 409, 505 (h), 507, 701 (f) (1), and 706 of the Federal Food, Drug, and Cosmetic Act, and sections 8 and 9 of the Hazardous Substances Labeling Act, and 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 Hazardous Substances Labeling Act. [29 F.R. 471, Jan. 18, 1964] § 2.91 Redelegations of authority from the Commissioner to other officers of the Administration. Final authority of the Commissioner of Food and Drugs is delegated as set forth in this section. Unless otherwise specified, final authority is retained by the Commissioner of Food and Drugs. (a) General delegation of authority. The Deputy Commissioner of Food and Drugs, the Assistant Commissioner for Planning, and the Assistant Commissioner for Operations are authorized to perform all the functions of the Commissioner of Food and Drugs. (b) Designations to hold informal hearings in districts. (1) The Director of the Bureau of Regulatory Compliance is authorized to designate officers and employees 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 Labeling Act, and section 5 of the Federal Import Milk Act. These employees are delegated authority contemplated by section 1, 43 Stat. 803 (5 U.S.C. 521), section 13 of Reorganization Plan No. 1 of 1953, and section 7(b) of the Administrative Procedure Act (sec. 7(b), 60 Stat. 241; 5 U.S.C. 1006) to administer to or take from any person an oath, affirmation, affidavit, or deposition for use in any prosecution or proceeding under or in the enforcement of any law cited in this paragraph. (2) Duly appointed and authorized inspectors of the Food and Drug Administration and all officers and employees of the Food and Drug Administration who have been issued the official credentials denominated as Form FD-200A entitled "Identification Record," which bears the description and photograph of the bearer, his signature, identification number, and the date of issuance, and Form FD-200B entitled "Specification of General Authority," which contains the name of and describes the general authority of the bearer, and the signature of the Commissioner of Food and Drugs: (i) Have been designated by the Commissioner of Food and Drugs to conduct examinations, inspections, and investigations; to collect and obtain samples; to have access to and to copy and verify records; and to supervise compliance operations, for the enforcement of the Federal Food, Drug, and Cosmetic Act, the Federal Tea Importation Act, the Federal Import Milk Act, Federal Filled Milk Act, Federal Caustic Poison Act, and Federal Hazardous Substances Labeling Act. (ii) Have been designated by the Commissioner of Food and Drugs to administer oaths and affirmations, under the Act of January 31, 1925, Chapter 124, section 1, 43 Stat. 803 (5 U.S.C. 521) and sections 12 to 15 of Reorganization Plan No. IV, effective June 30, 1940, and Reorganization Plan No. 1 of 1953, sections 1 to 9, effective April 11, 1953. (3) Duly appointed and authorized inspectors of the Food and Drug Administration and all officers and employees of the Food and Drug Administration who have been issued the official credential denominated as Form FD-200C entitled "Specification of Special Authority," bearing the signature of the Commissioner of Food and Drugs and containing authorization to copy or verify sections 505 (i) and (j) and 507(d) and (g) records and reports, have been designated as officers and employees having the authority to request and the allthority to have access to and copy and verify records and reports required by sections 505(i) and (j) and 507(d) and (g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335(1) and (j), 357(d) and (g)). (4) The official credentials denominated as Form FD-200A, Form FD-200B, and Form FD-200C, described in subparagraphs (2) and (3) of this paragraph are all superimposed with the seal of the Department of Health, Education, and Welfare, with blue imprint. (c) Authorization of officials to request samples of imports. The Director of the Bureau of Regulatory Compliance may authorize officials to request, pursuant to section 801(a) of the Federal Food, Drug, and Cosmetic Act, and section 14 of the Federal Hazardous Substances Labeling 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. The Director of the Bureau of Regulatory Compliance may certify true copies of documents and cause the seal of the Department of Health, Education, and Welfare to be affixed to such copies. (e) Delegation 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. (f) Delegation regarding certification of color additives. The Director of the Bureau of Scientific Standards and Evaluation and the Director of the Division of Color Certification and Evaluation 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) Delegations regarding food additives, food standards, pesticides, and color additives-(1) Food additives. The Assistant Commissioner for Regulations and/or the Assistant Commissioner for Operations are authorized to publish notices of the filing of food additive petitions and notices of withdrawal of food additive petitions, pursuant to section 409 (b) and (c) (1) of the Federal Food, Drug, and Cosmetic Act. The Assistant (2) Foods standards. Commissioner for Regulations and/or the Assistant Commissioner for Operations are authorized to publish notices of the filing of food standards petitions and notices of withdrawal of food standards petitions, pursuant to section 701(e) of the Federal Food, Drug, and Cosmetic Act. (3) Pesticides. The Assistant Commissioner for Regulations and/or the Assistant Commissioner for Operations are authorized to publish notices of the filing of pesticide petitions and notices of withdrawal of pesticide petitions, pursuant to section 408 (d) (1) of the Federal Food, Drug, and Cosmetic Act. (4) Color additives. The Assistant Commissioner for Regulations and/or the Assistant Commissioner for Operations are authorized to publish notices of the filing of color additive petitions and notices of withdrawal of color additive petitions, pursuant to section 706(b) (5) (C) of the Federal Food, Drug, and Cosmetic Act. (h) Delegations regarding certification of insulin. The Director of the Bureau of Scientific Standards and Evaluation and the Director of the Division of Antibiotics and Insulin Certification are 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. (i) Delegations regarding certification of antibiotic drugs. The Director of the Bureau of Scientific Standards and Evaluation and the Director of the Division of Antibiotics and Insulin Certification are authorized to certify or reject batches of antibiotic drugs, or any derivative of these drugs, pursuant to section 507(a) of the Federal Food, Drug, and Cosmetic Act. (j) Delegations regarding approved new-drug applications. The Assistant Commissioners for Regulations and Operations are authorized to notify applicants of approved new-drug applications pursuant to § 130.10 of this chapter. (k) Delegations regarding approved new-drug application supplements involving only changes in manufacturing processes or controls. The Director of the Bureau of Medicine, the Director of the Division of New Drugs, and the Director of the Bureau of Veterinary Medicine are authorized to notify applicants of supplements to approved new-drug applications involving only changes in manufacturing processes or controls pursuant to § 130.9 of this chapter. (Sec. 3(a) (1), 60 Stat. 238; 5 U.S.C. 1002) [29 F.R. 471, Jan. 18, 1964, as amended at 30 F.R. 9574, July 31, 1965] Subparts I-L-[Reserved] Subpart M-Organization § 2.101 Washington headquarters.1 The central organization of the Food and Drug Administration consists of: OFFICE OF THE COMMISSIONER Commissioner of Food and Drugs. Deputy Commissioner of Food and Drugs. Special Assistant for National Advisory Council and Special Projects. Associate Commissioner of Food and Drugs. Assistant Commissioner for Regulations. BUREAU OF DRUG ABUSE CONTROL Division of Antibiotic Drugs. BUREAU OF VETERINARY MEDICINE Division of Food Standards and Additives. Division of Color Certification and Evaluation. 1 Current locations and addresses of these units may be obtained from the Office of Public Information, Room 3807, 200 C Street SW., Washington, D.C., 20204. |