national commissions, and appoint members to such committees or commissions.

(33) Functions vested in the Secretary under section 2672(a)(1) (A) and (B) (Provisions Relating to Blood Banks) and section 2672(a)(2) (Information and Training Programs) of the Public Health Service Act (42 U.S.C. 300ff et seq.), as amended, insofar as these authorities pertain to the functions assigned to the Food and Drug Administration. The delegations exclude the authority to promulgate regulations, submit reports to the Congress, establish advisory committees or national commissioners, and appoint members to such committees or commissions.

(34) Functions vested in the Secretary under sections 1322(b) and (c) of the Food, Agriculture, Conservation, and Trade Act of 1990 (the National Laboratory Accreditation Program) (7 U.S.C. 138a), as amended hereafter, which relate to setting standards for the National Laboratory Accreditation Program and approving State agencies or private, nonprofit entities as accrediting bodies to implement certification and quality assurance programs in accordance with the requirements of this section. The delegation excludes the authority to submit reports to Congress.

(35) Functions vested in the Secretary under part C, subtitle 2 of title XXI of the Public Health Service Act (42 U.S.C. 300aa-25 et seq.), as amended, and the National Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1 note), as amended hereafter, as follows:

(i) Section 2125 of the Public Health Service Act (42 U.S.C. 300aa-25)-Recording and reporting of information.

(ii) Section 2127 of the Public Health Service Act (42 U.S.C. 300aa27)—Mandate for safer childhood vac

(vii) The delegation excludes the authority to issue regulations and submit reports to Congress.

(b) The Chief Counsel of the Food and Drug Administration, i.e., the Associate General Counsel in charge of the Food and Drug Division, 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, and section 9(b) of the Federal Caustic Poison Act.

(c) The Director, Office of Management, Public Health Service, has redelegated to the Commissioner of Food and Drugs, with authority to redelegate, the authority to certify true copies of any books, records, or other documents on file within the Food and Drug Administration or extracts from such; to certify that true copies are true copies of the entire file of the Administration; 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 of be affixed to such certifications and to agreements, awards, citations, diplomas, and similar documents.

(d) The Executive Officer, Public Health Service, has redelegated to the Commissioner of Food and Drugs appeal authority to take final action upon an individual's appeal of a refusal to correct or amend the individual's record when the appeal has been made by the individual under Privacy Act regulations (part 21 of this chapter and 45 CFR part 5b). The authority may not be redelegated.

(e) [Reserved]

(f) The Secretary of Health and Human Services has redelegated to the Commissioner of Food and Drugs, or his designee, the authority to take final action on matters pertaining to section 203 of the Equal Access to Justice Act (5 U.S.C. 504), and to develop

(1) Establish procedural rules applicable to a general class of foods, drugs, cosmetics, medical devices, or other subjects of regulation; or

(2) Present highly significant public issues involving the quality, availability, marketability, or cost of one or more foods, drugs, cosmetics, medical devices, or other subjects of regulation.

(b) Nothing in this section precludes the Secretary from approving a regulation, or being notified in advance of an action, to which sections 556 and 557 of title 5 U.S.C. apply, which meets one of the criteria in paragraph (a) of this section.

(c) This reservation of authority is intended only to improve the internal management of the Department of Health and Human Services, and is not intended to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, the Department of Health and Human Services, the Food and Drug Administration, any agency, officer, or employee of the United States, or any person. Regulations issued by the Food and Drug Administration without the approval of the Secretary are to be conclusively viewed as falling outside the scope of this reservation of authority.

[47 FR 16318, Apr. 16, 1982]

Subpart B-Redelegations of Authority from the Commissioner of Food and Drugs

§ 5.20 General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration.

(a) Final authority of the Commissioner of Food and Drugs is redelegated as set forth in this subpart.

(b) The Deputy Commissioner and the Associate Commissioner for Regulatory Affairs are authorized to perform all of the functions of the Commissioner of Food and Drugs.

(c) During the absence or disability of the Commissioner or in the event of a vacancy in that position, the first official who is available in the following positions, or who has been designated by the Commissioner to act in such position, shall act as Commissioner:

(1) Deputy Commissioner.

(2) Associate Commissioner for Regulatory Affairs.

(3) Associate Commissioner for Management and Operations.

For a planned period of absence, the Commissioner may specify a different order of succession.

(d) Authority delegated to a position by title may be exercised by a person officially designated to serve in that position in an acting capacity or on a temporary basis, unless prohibited by a restriction in the document designating him as "acting" or unless not legally permissible.

(e) The Deputy Commissioner for Operations is authorized to make determinations that advisory committee meetings are concerned with matters listed in 5 U.S.C. 552(b) and may be closed to the public in accordance with § 5.10(a)(18).

(f)(1) The Deputy Commissioner for Policy is authorized to perform any of the functions of the Commissioner of Food and Drugs with respect to the issuance of FEDERAL REGISTER notices and proposed and final regulations of the Food and Drug Administration.

(2) The Deputy Commissioner for Policy is authorized to issue responses to the following matters under part 10 of this chapter as follows:

(v) Requests for advisory opinions under § 10.85.

(3) With respect to any matter delegated to the Deputy Commissioner for Policy under this paragraph, the Deputy Commissioner for Policy is authorized to perform the functions of the Commissioner under §§ 10.40, 10.45, 10.50, 10.55, 10.60, 10.65, 10.80, 10.90, and 10.95 and of the Deputy Commissioner under § 10.206 (g) and (h) of this chapter.

(g) The following officials are authorized to perform all the functions of the officials under them in their respective offices:

(1) Deputy Commissioner for Operations.

(2) Deputy Commissioner for Policy. (3) Deputy Commissioner for External Affairs.

(4) Deputy Commissioner for Management and Systems.

(h) Authority delegated in the following sections of this subpart may not be redelegated.

[43 FR 20487, May 12, 1978, as amended at 48 FR 43300, Sept. 23, 1983; 56 FR 36001, July 30, 1991; 57 FR 12875, Apr. 14, 1992; 58 FR 17095, Apr. 1, 1993]

§ 5.21 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 and Human Services 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 continuity 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.

§ 5.22 Certification of true copies and use of Department seal.

(a) 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 Food and Drug Administration, and to cause the seal of the Department to be affixed to such certifications:

(1) The Associate and Deputy Associate Commissioners.

(2)(i) The Director, Office of the Executive Assistant.

(ii) The Director, Executive Secretariat.

(iii) The Director, Program Management Staff.

(3) The Executive Officer, Office of the Commissioner.

(4)(i) The Director and Deputy Director, Office of Enforcement, Office of Regulatory Affairs (ORA).

(ii) The Director and Deputy Director, Office of Regional Operations, ORA.

(iii) The Director and Deputy Director, Office of Regulatory Resource Management ORA.

(iv) The Chief, Administrative Management Staff, Office of Regulatory Resource Management, ORA.

(5)(i) The Director, Division of Management Systems and Policy, Office of Management and Operations (OMO).

(ii) The Chief, Dockets Management Branch, Division of Management Systems and Policy, OMO.

(6) The Director, Freedom of Information Staff, Office of Public Affairs. (7)(i) The Director and Deputy Director, Center for Biologics Evaluation and Research (CBER).

(ii) The Director, Office of Management, CBER.

(iii) The Directors and Deputy Directors of the Offices of Compliance, Biological Product Review and Biologics Research, CBER.

(iv) The Directors of the Case Management Staff, the Inspections and Surveillance Staff, Regulations and Bioresearch Monitoring Staff, and the Congressional and Public Affairs Staff, Office of Compliance, CBER.

(v) The Special Projects Officer, Chief of the Freedom of Information Section, and Freedom of Information Officers, Congressional and Public Affairs Staff, Office of Compliance, CBER.

(8)(i) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN).

(ii) The Director, Office of Management, CFSAN.

(iii) The Director, Office of Compliance, CFSAN.

(iv) The Director, Division of Regulatory Guidance, and the Director, Division of Cooperative Programs, Office of Compliance, CFSAN.

(v) The Director, Division of Food Chemistry and Technology, Office of Physical Sciences, CFSAN.

(9)(i) The Director and Deputy Director, Center for Devices and Radiological Health (CDRH).

(ii) The Director, Office of Management Services, CDRH.

(iii) The Director and Deputy Director, Office of Compliance and Surveillance, CDRH.

(iv) The Director and Deputy Director, Division of Compliance Operations, Office of Compliance and Surveillance, CDRH.

(v) The Director and Deputy Director, Office of Standards and Regulations, CDRH.

(vi) Freedom of Information Officers, Office of Standards and Regulations, CDRH.

(10)(i) The Director and Deputy Director, Center for Veterinary Medicine (CVM).

(ii) The Director and Deputy Director, Office of Management, CVM.

(iii) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.

(iv) The Director and Deputy Director, Division of Compliance, Office of Surveillance and Compliance, CVM.

(11)(i) The Director and Deputy Director, National Center for Toxicological Research (NCTR).

(ii) The Director, Office of Management, NCTR.

(12)(i) The Director and Deputy Director, Center for Drug Evaluation and Research (CDER).

(ii) The Directors and Deputy Directors of the Offices of Management, Epidemiology and Biostatistics, Compliance, Drug Evaluation I, Drug Evaluation II, Drug Standards, and Research Resources, CDER.

(iii) The Chief, Freedom of Information Staff and Freedom of Information Officers, Office of Management, CDER.

(iv) The Directors of the Divisions of Drug Labeling Compliance, Drug Quality Evaluation, and Manufacturing and Product Quality, Office of Compliance, CDER.

(v) The Director and Deputy Director (Bioequivalence), Office of Generic Drugs, CDER.

(13)(i) Regional Food and Drug Directors.

(ii) District Directors.

(iii) The Director, St. Louis Branch. (iv) The Director, Winchester Engineering and Analytical Center.

(v) The Director, New York Laboratory Division, Northeast Region.

(vi) The Director, Science Division, Southeast Region.

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

(1) The Associate and Deputy Associate Commissioners.

(2) The Director, Division of Human Resources Management, Office of Management and Operations.

(c) The Chief, Regulations Editorial Section and his/her alternates, Regulations Policy and Management Staff, Office of Policy, Office of the Commissioner are authorized to certify true copies of FEDERAL REGISTER documents.

[50 FR 4858, Feb. 4, 1985, as amended at 51 FR 11428, Apr. 3, 1986; 51 FR 32452, Sept. 12, 1986; 51 FR 41765, Nov. 19, 1986; 52 FR 41986, Nov. 2, 1987; 54 FR 8315, Feb. 28, 1989; 54 FR 11866, Mar. 22, 1989; 54 FR 43961, Oct. 30, 1989; 55 FR 6247, Feb. 22, 1990; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992; 58 FR 17095, Apr. 1, 1993]

§ 5.23

Disclosure of official records.

(a) The following officials are authorized to make determinations to disclose official records and information under part 20 of this chapter, except that only the officials listed in paragraph (a)(1) may disclose official records and information under

§§ 20.82 and 20.85 of this chapter. (1) Associate and Deputy Associate Commissioners.

(2)(i) The Director, Office of the Executive Assistant.

(ii) The Director, Executive Secretariat.

(iii) The Director, Program Management Staff.

(3) Executive Officer, Office of the Commissioner.

(4) The Chief, Dockets Management Branch, Division of Management Systems and Policy, Office of Management and Operations.

(5) Program officials at all organizational levels down to and including branch level for all Headquarters organizations.

(6) Regional Food and Drug Directors and District Directors.

(7) Director, Winchester Engineering and Analytical Center.

(8) Chiefs of branches Field/District Offices and Centers.

(9) Freedom of Information Officers and other employees engaged in Freedom of Information activities.

(b) The Chief, Drug Listing Branch, Division of Drug Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research (CDER), is authorized to sign affidavits regarding the presence or absence of records of Registration of Drug Establishments.

(c) The following officials are authorized to sign affidavits regarding the presence or absence of medical device establishment registration records:

(1) The Director and Deputy Director, Center for Devices and Radiological Health (CDRH).

(2) The Director and Deputy Director, Office of Compliance and Surveillance, CDRH.

(3) The Director, Division of Product Surveillance, Office of Compliance

and Surveillance, CDRH.

(4) The Chief, Device Registration and Listing Branch, Division of Prod

uct Surveillance, Office of Compliance and Surveillance, CDRH.

(d) The Chief of the Records Section of the Administrative Services Branch, Division of Management Services, Office of Management and Operations, is authorized to sign affidavits regarding the presence or absence of records in the files of that section.

(e) The Director and Deputy Director, Division of Product Certification, Office of Biological Product Review, Center for Biologics Evaluation and Research, are authorized to sign affidavits regarding the presence or absence of records of registration of blood product establishments.

[43 FR 29286, July 7, 1978, as amended at 48 FR 56946, Dec. 27, 1983; 49 FR 14932, Apr. 16, 1984; 50 FR 4859, Feb. 4, 1985; 51 FR 11428, Apr. 3, 1986; 54 FR 8315, Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992]

§ 5.24 Authority relating to technology transfer.

(a) The Associate Commissioner for Regulatory Affairs is authorized to perform the functions of the Commissioner of Food and Drugs as requested by the Commissioner regarding the authority to disapprove or require modification of cooperative research and development agreements and licensing agreements and transmit written explanation of such approval or disapproval to the head of the laboratory concerned under sections 11(c)(5) (A) and (B) of the Stevenson-Wydler Technology Innovation Act of 1980 (the Act) (15 U.S.C. 3710a(c)(5) (A) and (B)), as amended.

(b) The following officials are authorized to perform the functions of the Commissioner of Food and Drugs as requested by the Commissioner under the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3701 et seq.), as amended, and Executive Order 12591 of April 10, 1987, except to the extent that redelegation of those functions is specifically limited in § 5.10(a)(29) of this part, as they pertain to the functions of their respective organizations, including the authority to perform the functions of laboratory directors under the Act as the heads of their respective Federal laboratories, subject to the discretion