result in recommendations for regulatory decisions under the Federal Food, Drug, and Cosmetic Act and which are concerned with matters listed in 5 U.S.C. 552(b) (4), (5), and (7);

(iii) Meetings held for the sole purpose of considering and formulating advice which the comittee will give or any final report it will render, Provided:

(a) The meetings will involve solely the internal expression of views and judgments of the members and it is essential to close the meeting or portions thereof to protect the free exchange of such views and avoid undue interference with agency or committee operations, and such views if reduced to writing would be protected from mandatory disclosure under section 552(b) (5) of title 5 U.S.C.;

(b) The meeting is closed for the shortest time necessary, summarizing the work of the committee during the closed session, and a report, prepared by the executive secretary will be made available promptly to the public.

(c) When feasible, the public is given a timely opportunity to present relevant information and views to the committee; and

(d) Concurrence for closing the meetings for such purpose is obtained from the Office of the General Counsel and the Office of Public Affairs.

(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 Health has redelegated to the Commissioner of Food and Drugs, with authority to redelegate, the authority delegated to him by the Assistant Secretary for Administration and Management: 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 FR 14768, Sept. 23, 1970, as amended at 38 FR 6668, Mar. 12, 1973; 38 FR 17212, June 29, 1973; 38 FR 33593, Dec. 6, 1973; 39 FR 2479, Jan. 22, 1974; 39 FR 9657, Mar. 13, 1974]

§ 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) Genera' deiegation 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 hearings and review boards. (1) The Directors and Deputy Director of Bureaus, the Associate Director for Regulatory and Administrative Management of the Bureau of Biologics, Regional Food and Drug Directors, and Deputy Regional Food and Drug Directors are authorized to designate officials to hold informal hearings which relate to their assigned functions under section 305, 404(b), and 801(a) of the Federal Food, Drug, and Cosmetic Act, section 6 of the Fair Packaging and Labeling Act, section 9(b) of the Federal Caustic Poison Act, and section 5 of the Federal Import Milk Act. Officials so designated are delegated authority vested in the Secretary of Agriculture by 7 U.S.C.2217 (43 Stat. 803) to administer or to 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.

(2) The Director of the Bureau of Biologics and the Associate Director for Regulatory and Administrative Management of that Bureau are authorized to appoint review boards as provided by § 601.41 of this chapter (21 CFR 601.41). (3) The Director and Deputy Director of the Bureau of Radiological Health are authorized to hold hearings under sec

tion 360(a) of the Public Health Service Act, and to designate officials to hold informal hearings under section 360(a) of the act.

(c) Delegations regarding imports. (1) The Regional Food and Drug Directors and Deputy Regional Food and Drug Directors are authorized to designate officials who may request, under section 801(a) of the Federal Food, Drug, and Cosmetic Act, from the Secretary of the Treasury samples of foods, drugs, devices, or cosmetics imported, or offered for import, in order to determine whether such articles are in compliance with the act.

(2) The Director and Deputy Director of the Bureau of Radiological Health, and the Director of the Division of Compliance of that Bureau are authorized to request, under section 360(a) of the Public Health Service Act, from the Secretary of the Treasury samples of electronic products imported or offered for import in order to determine whether such articles are in compliance with that act.

(3) The Director and Deputy Director of the Bureau of Radiological Health, and the Director of the Division of Compliance of that Bureau may, under section 360B(b) of the Public Health Service Act, exempt persons from issuing a certification as required by section 358 (h) of the act, for electronic products imported into the United States for testing, evaluation, demonstration, or training, which will not be introduced into commerce and upon completion of their function, will be destroyed or exported in accord with Bureau of Customs regulations.

(d) Delegations regarding certification of true copies and use of Department seal. (1) The following officials are authorized to certify true copies of or extracts from any books, records, papers, or other documents on file within the Food and Drug Administration, to certify that copies are true copies of the entire file, to certify the complete original record, or to certify the nonexistence of records on file within the Administration, and to cause the seal of the Department to be affixed to such certifications.

(1) Associate and Deputy Associate Commissioners.

(ii) Assistant and Deputy Assistant Commissioners.

(iii) Director of the Executive Secretariat.

(iv) Director and Deputy Director of the Office of Legislative Services.

(v) The FDA Regulations Officer and the Federal Register Liaison Officer and their alternates of the Office of the Associate Commissioner for Compliance.

(vi) Directors and Deputy Directors of Bureaus and Executive Director and Deputy Executive Director of Regional Operations.

(vii) Assistant Director for Planning and Analysis of the Bureau of Drugs, the Director and Deputy Director of the Office of Compliance of that Bureau, and the Director of the Division of Case Guidance of that Office and Bureau.

(viii) Associate Director for Management of the Bureau of Foods, the Director and Associate Director of the Office of Compliance of that Bureau, the Director of the Division of Regulatory Guidance of that Office and Bureau, the Director of the Division of Food Technology of the Office of Technology of that Bureau, and the Director of the Division of Food Service of the Office of Nutrition and Consumer Sciences of that Bureau.

(ix) Associate Director for Regulatory and Administrative Management of the Bureau of Biologics.

(x) Director and Deputy Director of the Division of Compliance of the Bureau of Veterinary Medicine.

(xi) Associate Director for Administration of the Bureau of Radiological Health, and the Director of the Division of Compliance of that Bureau.

(2) The following officials are authorized to cause the seal of the Department to be affixed to agreements, awards, citations, diplomas, and similar documents.

(i) Associate and Deputy Associate Commissioners.

(ii) The Director of the Division of Personnel Management of the Office of the Associate Commissioner for Administration and the Chief of the Staff Development and Training Branch of that Division and Office.

(3) The Federal Register Writer and his alternates of the Office of the Associate Commissioner for Compliance are authorized to certify true copies of FEDERAL REGISTER documents.

(e) Delegations regarding disclosure of official records. (1) The following officials are authorized to make determinations to disclose official records and information in accordance with § 4.1 of this chapter:

(i) The Director and Deputy Director of the Bureau of Drugs, the Director and Deputy Director of the Office of Compliance of that Bureau, and the Director and Deputy Director of the Division of Regulatory Operations of the Office of Compliance of that Bureau.

(ii) The Director and Deputy Director of the Bureau of Foods, the Director and Associate Director of the Office of Compliance of that Bureau, and the Director of the Division of Regulatory Guidance of the Office of Compliance of that Bureau.

(iii) The Director and Deputy Director of the Bureau of Veterinary Medicine and the Director and Deputy Director of the Division of Compliance of that Bureau.

(iv) The Director and Deputy Director, Bureau of Radiological Health, the Director of the Division of Electronic Products, and the Director of the Office of Criteria and Standards of that Bureau.

(v) The Director and Deputy Director of the Bureau of Biologics, the Associate Director for Regulatory and Administrative Management, and the Director of the Office of Compliance of that Bureau.

(2) The Chief of the Drug Registration Section of the Division of Regulatory Operations, Office of Compliance, Bureau of Drugs, is authorized to sign affidavits regarding the presence or absence of records of Registration of Drug Establishments.

(3) The Chief of the Records Section of the Administrative Services Branch, Division of General Services, Office of the Associate Commissioner for Administration, is authorized to sign affidavits regarding the presence or absence of records in the files of that section.

(f) Delegations regarding certification of color additives. The Director and Deputy Director of the Bureau of Foods, the Director and Deputy Director of the Office of Technology of that Bureau, and the Director and Deputy Director of the Division of Color Technology of that Office and Bureau are authorized to certify batches of color additives for use in foods, 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 and Deputy Director of the Bureau of Drugs, the Director of the Office of Scientific Evalua

tion of that Bureau, the Deputy Director for Medical Affairs of that Office and Bureau, the Director and Deputy Director of the Division of Anti-Infective Drug Products of that Office and Bureau, and the Chief of the Certification Services Staff and the Chief of the Certifiable Drug Review Staff of that Division, Office, and Bureau are authorized to certify or reject batches of drugs containing insulin, pursuant to section 506(a) of the Federal Food, Drug, and Cosmetic Act.

(1) Delegations regarding certification of antibiotic drugs. The Director and Deputy Director of the Bureau of Drugs, the Director of the Office of Scientific Evaluation of that Bureau, the Deputy Director for Medical Affairs of that Office and Bureau, the Director and Deputy Director of the Division of Anti-Infective Drug Products of that Office and Bureau, and the Chief of the Certification Services Staff and the Chief of the Certifiable Drug Review Staff of that Division, Office, and Bureau 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 animal drug applications and approved new animal drug application supplements for new animal drugs. The Director of the Bureau of Veterinary Medicine is authorized to perform all the functions of the Commissioner of Food and Drugs with regard to the approval of new animal drug applications, and new animal drug application supplements, for new animal drugs submitted pursuant to section 512 of the Federal Food, Drug, and Cosmetic Act. The Director of the Division of Veterinary Medical Review of the Bureau of Veterinary Medicine is authorized to perform the functions of the Commissioner with regard to the approval of applications for animal feeds containing new animal drugs.

(k) Delegations regarding approval of new-drug applications and new-drug application supplements for drugs for human use. (1) The Director and Deputy Director of the Bureau of Drugs, and the Director of the Office of Scientific Evaluation and the Director of the Drug Efficacy Study Implementation Project Office of that Bureau are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to the approval of new-drug applications

and new-drug application supplements which are for drugs for human use and have been submitted pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act.

(2) The Directors of Divisions in the Office of Scientific Evaluation and the Drug Efficacy Study Implementation Project Office of the Bureau of Drugs are authorized to perform all the functions of the Commissioner with regard to the approval of new-drug application supplements which are for drugs for human use and have been submitted pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act.

(1) Delegations regarding issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and new drug application supplements for drugs for human use. The Director of the Bureau of Drugs is authorized to issue notices of an opportunity for a hearing on proposals to refuse approval or to withdraw approval of new drug applications and new drug application supplements for drugs for human use submitted pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act and to issue notices of withdrawal of approval when opportunity for hearing has been waived.

(m) [Reserved]

(n) Delegation regarding designation of official master and working standards for antibiotic drugs. The Director and Deputy Director of the Bureau of Drugs, the Director of the Office of Pharmaceutical Research and Testing of that Bureau, and the Director of the National Center for Antibiotic Analysis of that Office and Bureau are authorized to designate official Food and Drug Administration master and working standards for antibiotic drugs under § 145.3 of this chapter.

(0) Delegations regarding emergency functions. Each Regional Food and Drug Director is authorized, during any period when normal channels of direction are disrupted between the Food and Drug Administration headquarters and his region, to fully represent the Food and Drug Administration within his region in consonance with the Department of Health, Education, and Welfare regional emergency plans and to exercise the authority of the Commissioner for supervision of and direction to all Food and Drug Administration activities and use of resources within his region for con

tinuity and for Federal Emergency Health Service operations. These same officials are authorized to provide in Regional Emergency Plans for the delegation of Food and Drug Administration regional authorities to heads of field activities when such activities are cut off from national and regional headquarters.

(p) Delegations regarding enforcement activities. (1) Duly appointed and authorized inspectors, officers, and employees of the Food and Drug Administration who have been issued the Food and Drug Administration official credentials consisting of FD Form 200a entitled "Identification Record" and FD Form 200b entitled "Specification of General Authority" are designated by the Commissioner of Food and Drugs:

(1) 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 Fair Packaging and Labeling Act, the Federal Caustic Poison Act, the Import Milk Act, the Filled Milk Act, the Tea Importation Act, and section 361 of the Public Health Service Act.

(ii) To administer oaths and affirmations under 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; and Reorganization Plan No. 1 of 1953, effective April 11, 1953.

(2) Duly appointed and authorized inspectors, officers, and employees of the Food and Drug Administration who have been issued the Food and Drug Administration official credentials consisting of FD Form 200a entitled "Identification Record" and FD Form 200c entitled "Specification of General and Special Authority" are designated by the Commissioner of Food and Drugs:

(i) To perform the duties enumerated In subparagraph (1) (i) and (ii) of this paragraph.

(ii) As officers and employees having the authority to request and the authority to have access to and copy and verify records and reports required by sections 505 (i) and (j), 507 (d) and (g), and 512 (1) and (m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 (i) and (j), 357 (d) and (g), and 360b (1) and (m)).

(3) The Food and Drug Administration official credentials referred to in sub

paragraphs (1) and (2) of this paragraph are described as follows:

(i) FD Form 200a entitled "Identification Record" bears a color photograph, description, and signature of the bearer, an identification number, an expiration date, the Department of Health, Education, and Welfare seal with blue imprint centered to the left of the photograph and the Food and Drug Administration symbol centered to the right of the photograph.

(ii) FD Form 200b entitled "Specification of General Authority" bears the holder's name, his general authority, an identification number, an expiration date, and the Commissioner's signature.

(iii) FD Form 200c entitled "Specification of General and Special Authority" bears the holder's name, his general and special authority, an identification number, an expiration date, and the Commissioner's signature and is superimposed in the lower right corner with a red, white, and blue stripe imprint.

(iv) Both FD Form 200b and FD Form 200c bear the name of the Department of Health, Education, and Welfare, Public Health Service, and Food and Drug Administration and are superimposed with the Department seal with blue imprint.

(4) The Director and Deputy Director of the Bureau of Radiological Health are authorized to refuse admission of noncomplying electronic product imports and to notify the Secretary of the Treasury of such refusal under section 360(a) of the Public Health Service Act and are authorized to refuse or to grant permission and time extensions to bring such products into compliance, and are authorized to supervise or designate an official to supervise such operations under section 360(b) of the act.

(5) The Director and Deputy Director of the Bureau of Radiological Health and the Director of the Division of Compliance of that Bureau are authorized to perform all of the functions of the Commissioner of Food and Drugs under section 360A (a) of the Public Health Service Act relating to electronic product safety and inspection of electronic product manufacturers' premises, and to perform all of the functions of the Commissioner of Food and Drugs under section 360A(b) of the act relating to the establishment, maintenance, and inspection of electronic product manufacturers' records.

(6) The Director and Deputy Director of the Bureau of Radiological Health are authorized to designate officials to make accident and investigation reports under section 360A(d) of the Public Health Service Act.

(7) The Director of the Bureau of Biologics and the Associate Director for Regulatory and Administrative Management of that Bureau may authorize, pursuant to section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)), any officer, agent, or employee to enter and inspect any establishment which is subject to the provisions of section 351 of the act (42 U.S.C. 262).

(q) Delegations regarding certification following inspections. Regional Food and Drug Directors and Deputy Regional Food Food and Drug Directors are authorized to issue certificates of sanitation pursuant to § 72.181 (42 CFR 72.181).

(r) Delegations regarding grants and fellowships. (1) The Associate and Deputy Associate Commissioner for Science are authorized to approve or disapprove all applications for grants and fellowships and to select officials to serve as program managers to exercise scientific oversight and to monitor grantee progress.

(2) The Associate and Deputy Associate Commissioner for Administration and the Director and Deputy Director of the Division of Contracts and Grants Management of the Office of the Associate Commissioner for Administration are authorized to execute grant awards upon approval by the Associate or Deputy Associate Commissioner for Science under sections 301, 308, 311, and 356 of the Public Health Service Act, and to notify grantees of officials who will serve as the FDA program manager for their grant.

(s) Delegation regarding issuance, amendment, or repeal of regulations pertaining to antibiotic drugs for human use. The Director and Deputy Director of the Bureau of Drugs and the Assistant to the Director for Regulatory Affairs are authorized to perform all of the functions of the Commissioner of Food and Drugs under section 507 of the Federal Food, Drug, and Cosmetic Act regarding the issuance, amendment, or repeal of regulations pertaining to antibiotic drugs for human use.

(t) Delegation regarding issuance of notices of filing of petitions and notices of proposed rulemaking pertaining to food standards, food additives, and color