to sign affidavits regarding the presence or absence of records of Registration of Drug Establishments. This official may not further redelegate this authority.

(c) The following officials are authorized to sign affidavits regarding the presence or absence of medical device establishment registration records and these officials may not further redelegate this authority:

(1) The Director, the Deputy Director for Regulations and Policy, and the Deputy Director for Science, CDRH.

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

(3) The Director and Deputy Director, Division of Program Operations, Office of Compliance, CDRH.

(4) The Chief, Information Processing and Office Automation Branch, Division of Program Operations, Office of Compliance, CDRH.

(d) The Director, Office of Resource Management, Office of Regulatory Affairs is authorized to sign affidavits regarding the presence or absence of records in the files of that office and this official may not further redelegate this authority

(e) The Director and Deputy Directors, CBER, the Director and Deputy Director, Office of Blood Research and Review (OBRR), and the Director and Deputy Director, Division of Blood Applications, OBRR, CBER, are authorized to sign affidavits regarding the presence or absence of records of registration of blood product establishments. These officials may not further redelegate this authority.

§ 5.24 Authority relating to technology transfer.

(a) The Associate Commissioner for Regulatory Affairs is authorized to perform the functions of the Commis

sioner 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 section 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 (Commissioner) requested by the Commissioner under the Act (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)(26)), 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 of the Commissioner to require that agreements entered into under section 11(a) of the Act (15 U.S.C. 3710a(a)) include provisions in accordance with section 11(c)(5)(A) of the Act (15 U.S.C. 3710a(c)(5)(A):

(1) The Director, Center for Biologics Evaluation and Research.

(2) The Director, Center for Devices and Radiological Health.

(3) The Director, Center for Drug Evaluation and Research.

(4) The Director, Center for Food Safety and Applied Nutrition.

(5) The Director, Center for Veterinary Medicine.

(6) The Director, National Center for Toxicological Research.

(7) The Associate Commissioner for Regulatory Affairs.

(c) These officials may not further redelegate these authorities.

$5.25 Research, investigation,

and

testing programs and health information and promotion programs.

(a) The following officials are authorized under sections 301, 307, 311, 1701, 1702, 1703, and 1704 of the Public Health Service Act (the PHS Act) (42 U.S.C. 241, 2421, 243, 300u, 300u-1, 300u-2, 300u3) to establish research, investigation, and testing programs and health information and health promotion programs, which relate to their assigned functions, and to approve grants for conducting such programs:

(1) The Director, the Deputy Director for Washington Operations, and the Deputy Center Directors, Offices of Research and Management, respectively,

National Center for Toxicological Research (NCTR).

(2) The Director and Deputy Directors for Science and for Regulations and Policy, Centers for Devices and Radiological Health (CDRH).

(3) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).

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

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

(6) The Director and Deputy Director, the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

(7) The Director, Office of Orphan Products Development (OPD), Office of the Senior Associate Commissioner (OSAC), Office of the Commissioner (OC).

(b) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, are authorized to establish an electronic product radiation control program and to approve grants for conducting the program under section 532 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ii).

(c) The Senior Associate Commissioner for Management and Systems, Office of Management and Systems (OMS), OC; the Director and Deputy Director, Office of Facilities, Acquisitions, and Central Services (OFACS), OMS, OC; the Director, Division of Contracts and Procurement Management (DCPM), OFACS, OMS, OC; and the Chief Grants Management Officer and the Grants Management Officer, DCPM, OFACS, OMS, OC are authorized to sign and issue all notices of grant awards and amendments thereto and sign and issue notices of suspension and termination thereof for grants approved under the authority delegated in paragraphs (a) and (b) of this section.

(d) The Director, NCTR, is authorized under section 301 of the PHS Act (42 U.S.C. 241), as amended by Public Law 95-622, to make available to educational institutions, for biomedical and behavioral research, laboratory animals bred for research purposes of

the Center that are not required to support Center research programs.

(e) The Senior Associate Commissioner for Management and Systems may further redelegate the authorities in paragraph (c) of this section. With the exception for paragraph (c) of this section, these officials may not further redelegate these authorities.

§ 5.26 Service fellowships.

(a) Under authority of sections 207(g) and 208(f) of the PHS Act (42 U.S.C. 209(g) and 210(f)), and within the limits of an approved service fellowship plan, the following officials are authorized to designate persons to receive service fellowships, appoint service fellows, and determine specific stipend rates for individual actions within the ranges established under an approved service fellowship plan:

(1) The Deputy Commissioner; the Senior Associate Commissioner; the Deputy Commissioner for International and Constituent Relations; the Senior Associate Commissioner for Management and Systems; the Senior Associate Commissioner for Policy, Planning, and Legislation; the Chief Counsel and Deputy Chief Counsels; and the Associate Commissioners and their Deputies.

(2) The Director, the Deputy Director for Washington Operations, the Deputy Center Directors for Research and Management, respectively, and the Associate Director, Office of Management Services, National Center for Toxicological Research (NCTR).

(3) The Director, the Deputy Directors for Science and for Regulations and Policy, and the Director, Office of Systems and Management, Center for Devices and Radiological Health

(CDRH).

(4) The Director, the Deputy Directors, the Associate Director for Research, the Office Directors, and the Director, Office of Management, Center for Biologics Evaluation and Research (CBER).

(5) The Director, the Deputy Director, and Director, Office of Management Systems, Center for Food Safety and Applied Nutrition (CFSAN).

(6) The Director, the Deputy Director, and the Director, Office of Management and Communications, Center for Veterinary Medicine (CVM).

(7) The Director and Deputy Director, the Directors, Office of Review Management and Office of Pharmaceutical Science, and the Director and Deputy Director, Office of Management, Center for Drug Evaluation and Research (CDER).

(8) The Director, Office of Executive Operations, Office of the Senior Associate Commissioner, Office of the Commissioner and the Director, Office of Resource Management, ORA.

(9) Director, Office of Human Resources and Management Services, Office of Management and Systems, Office of the Commissioner.

(b) These officials may further redelegate this authority, with the limitation that the Director, Office of Human Resources and Management Services, OMS, OC, is delegated the authority to approve service fellowship plans and exceptions to the approved plans, and this official may not further redelegate this authority.

$5.27 Patent term extensions for human drug products, medical devices, and food and color additives; and authority to perform due dili gence determinations and informal hearings.

(a) The Deputy Commissioner is authorized to perform the due diligence determinations and informal hearings functions under section 156(d)(2)(B)(ii) of title 35 U.S.C. (35 U.S.C. 156), as amended, relative to patent term extensions.

(b) The Director, Center for Drug Evaluation and Research (CDER) and the Associate Director for Regulatory Policy, CDER, are authorized to perform the functions delegated to the Commissioner under title 35 U.S.C. 156, as amended, except for making due diligence determinations and holding of informal hearings under title 35 U.S.C. 156(d)(2)(B).

(c) The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of the Senior Associate Commissioner, Office of the Commissioner, is authorized to perform the functions delegated to the Commissioner to make due diligence determinations under title 35

U.S.C. 156 (d)(2)(B), as amended, except for holding of informal hearings under title 35 U.S.C. 156(d)(2)(B)(ii).

(d) These officials may not further redelegate this authority.

§ 5.28 Hearings.

(a) The following officials are authorized to designate officials to hold informal hearings that relate to their assigned functions under sections 305, 404(b), and 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335, 344(b), and 381(a)); section 6 of the Fair Packaging and Labeling Act (15 U.S.C. 1455) (21 U.S.C. 145); section 9(b) of the Federal Caustic Poison Act (44 Stat. 1406; see also Public Law 86-613, section 19 formerly section 18); 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 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 part:

(1) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN); and the Director of Regulations and Policy, CFSAN.

(2) The Director and Deputy Director, the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER); the Associate Director for Regulatory Policy and the Associate Director for Medical Policy, CDER; the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER; and the Director and Deputy Director, Office of Compliance, CDER.

(3) The Director and Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).

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

(5) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER.

(6) Regional Food and Drug Directors.

(7) District Directors.

(8) The Director, St. Louis Branch. (b) The Director and Deputy Directors for Science and for Regulations Policy, CDRH, are authorized to hold hearings, and to designate other officials to hold informal hearings, under section 360(a) of the PHS Act.

(c) The following officials are authorized to serve as the presiding officer, and to designate other Food and Drug Administration employees to serve as the presiding officer, at a regulatory hearing and to conduct such a hearing under the provisions of part 16 of this chapter. An official can serve as the presiding officer in a particular hearing only if he or she satisfies the requirements of § 16.42(b) of this chapter with respect to the action that is the subject of the hearing. Such officials 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, or deposition for use in any prosecution or proceeding under, or in enforcement of, any law as cited in this part:

(1) The Chief Mediator and Ombudsman, Office of the Ombudsman, Office of the Senior Associate Commissioner, Office of the Commissioner of Food and Drugs (Commissioner).

(2) The Director and Deputy Director, CFSAN.

(3) The Director and Deputy Director, Center for Drug Evaluation and Research (CDER); the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER; the Associate Director for Regulatory Policy and the Associate Director for Medical Policy, CDER, the Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER; and the Director and Deputy Director, Office of Compliance, CDER.

(4) The Director and Deputy Directors for Science and for Regulations Policy, CDRH.

(5) The Director and Deputy Director, CVM.

(6) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of

Blood Research and Review, Office of Vaccines Research and Review, Office of Therapeutics Research and Review, and Office of Compliance and Biologics Quality, CBER.

(7) Regional Food and Drug Directors.

(8) District Directors.

(9) The Director, St. Louis Branch. (10) Such other FDA official as is designated by the Commissioner by memorandum in the proceeding.

(d) These officials may not further redelegate this authority.

$5.29 Petitions under part 10.

(a) For drugs assigned to their organizations, the following officials are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter for a stay of an effective date in §201.59 of this chapter for compliance with certain labeling requirements for human prescription drugs:

(1)(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).

(ii) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Therapeutics Research and Review (OTRR), CBER.

(iii) The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OTRR, CBER.

(2)(i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

(ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.

(iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.

(b) The following officials are authorized to grant or deny citizen petitions submitted under §10.30 of this chapter requesting in vitro test modifications under § 331.29 of this chapter:

(1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER.

(2) The Director, Office of Drug Evaluation V, Office of Review Management, CDER.

(3) The Director and Deputy Director, Division of Over-the-Counter Drug Products, Office of Drug Evaluation V, Office of Review Management, CDER.

(c) The following officials are authorized to grant or deny citizen petitions submitted under §10.30 of this chapter for a stay of an effective date or for an exemption from the tamper-resistant packaging and labeling requirements set forth in §§ 211.132, 700.25, or 800.12 of this chapter for certain over-thecounter human drug and cosmetic products and medical devices which relate to the assigned functions of the respective organizations:

(1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER.

(2) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN); and the Director of Regulations and Policy, CFSAN.

(3) The Director and the Deputy Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH).

(d) The following officials are authorized to grant or deny citizen petitions submitted under §10.30 of this chapter requesting exemption from the general pregnancy-nursing warning for overthe-counter (OTC) drugs required under $201.63 of this chapter, requesting exemption from a general overdose warning required under §330.1(g) of this chapter, and requesting exemption from OTC drug administrative procedures under § 330.10 of this chapter:

(1) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, CDER.

(2) The Director, Office of Drug Evaluation V, Office of Review Management, CDER.

(3) The Director and Deputy Director, Division of Over-the-Counter Drug Products, Office of Drug Evaluation V, Office of Review Management, CDER.

(e)(1) The following officials are authorized to issue 180-day tentative responses to citizen petitions on food and cosmetic matters under §10.30(e)(2)(iii)

of this chapter that relate to the assigned functions of that Center:

(i) The Director and Deputy Director, CFSAN.

(ii) The Director of Regulations and Policy, CFSAN.

(iii) The Director, Office of Cosmetics and Colors, CFSAN.

(iv) The Director, Office of Nutritional Products, Labeling and Dietary Supplements, CFSAN.

(v) The Director, Office of Premarket Approval, CFSAN.

(vi) The Director, Office of Plant and Dairy Foods and Beverages, CFSAN. (vii) The Director, Office of Seafood, CFSAN.

(viii) The Director, Office of Field Programs, CFSAN.

(2) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to issue 180-day tentative responses to citizen petitions on animal food and drug matters under §10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.

(3) The Director and Deputy Directors, CBER, are authorized to issue 180day tentative responses to citizen petitions on biological product matters under §10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.

(4) The Director, the Deputy Director, and the Associate Director for Regulatory Policy, CDER, are authorized to issue 180-day tentative responses to citizen petitions on drug product matters under §10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.

(5) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, are authorized to issue 180-day tentative responses to citizen petitions on medical device matters under §10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.

(f)(1) The Director and Deputy Directors, CBER, are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter on drug and biological product matters in program areas where they have been delegated final approval authority in the following sections of this chapter: