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 Associate Commissioner for Health Affairs.

(2) The Director and Deputy Director, CFSAN.

(3) The Director and Deputy Director, CDER, and the Directors and Deputy Directors of the Offices of Drug Evaluation I, Drug Evaluation II, and Compliance.

(4) The Director and Deputy Director, CDRH.

(5) The Director and Deputy Director, CVM.

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

[48 FR 8440, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49 FR 14932, 14936, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8316, Feb. 28, 1989; 54 FR 9034, Mar. 3, 1989]

§ 5.31

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 Director, Center for Biologics Evaluation and Research (CBER).

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

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

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

(ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I and Drug Evaluation II, CDER.

(iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I and Drug Evaluation II, 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 and Deputy Director, CDER.

(2) The Director and Deputy Director, Office of Drug Standards, CDER. (3) The Director and Deputy Director, Division of OTC Drug Evaluation, Office of Drug Standards, 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 tamperresistant packaging and labeling requirements set forth in § 211.132, § 700.25, or § 800.12 of this chapter for certain over-the-counter human drug and cosmetic products and medical devices which relate to the assigned functions of the respective organizations:

(1) The Director and Deputy Director, CDER, and the Director and Deputy Director, Office of Complince, CDER.

(2) The Director and Deputy Director, Center for Food Safety and Applied Nutrition (CFSAN), and the Director, Office of Compliance, CFSAN.

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

(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 over-the-counter (OTC) drugs required under § 201.63 of this chapter:

(1) The Director and Deputy Director, CDER.

(2) The Director and Deputy Director, Office of Drug Standards, CDER.

(e)(1) The Director and Deputy Director, CFSAN, are authorized to issue 180-day tentative responses to citizen petitions on food matters under

§ 10.30(e)(2)(iii) of this chapter that relate to the assigned functions of that Center.

(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 Director, 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 and Deputy Director, 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.

(f)(1) The Director and Deputy Director, 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 part:

(i) Section 5.68 Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products;

(ii) Section 5.69 Notification of release for distribution of biological products;

(iii) Section 5.71 Termination of exemptions for new drugs for investigational use in human beings or in animals;

(iv) Section 5.80 Approval of new drug applications and their supplements; and

(v) Section 5.82 Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements.

(2) The Director and Deputy Director, CDER, are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter on drug product matters in program areas where they have been delegated final approval au

thority in the following sections of this part:

(i) Section 5.70 Issuance of notices implementing the provisions of the Drug Amendments of 1962 (DESI);

(ii) Section 5.71 Termination of exemptions for new drugs for investigational use in human beings or in animals;

(iii) Section 5.73 Certification of insulin;

(iv) Section 5.74 Issuance, amendment, or repeal of regulations pertaining to drugs containing insulin;

(v) Section 5.75 Designation of official master and working standards for antibiotic drugs;

(vi) Section 5.76 Certification of antibiotic drugs;

(vii) Section 5.78 Issuance, amendment, or repeal of regulations pertaining to antibiotic drugs;

(viii) Section 5.80 Approval of new drug applications and their supplements; and

(ix) Section 5.82 Issuance of notices relating to proposals to refuse aproval or to withdraw approval of new drug applications and their supplements.

(3) The Director and Deputy Director, Office of Drug Standards, CDER, except for those drug products listed in § 314.440(b) of this chapter, are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter seeking a determination of the suitability of an abbreviated new drug application for a drug product.

(4) The Director and Deputy Director, Office of Biological Product Review, CBER, for those drug products listed in § 314.440(b) of this chapter, are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter seeking a determination of the suitability of an abbreviated new drug application for a drug product.

(5) For drugs assigned to their organization, the following officials are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter from sponsors of an investigational new drug application who request approval to ship in interstate commerce, in accordance with § 2.125(j) of this chapter, an investiga

tional new drug for human use containing a chlorofluorocarbon.

(i) The Director and Deputy Director, CBER.

(ii) The Director and Deputy Director, CDER.

(6) The Director and Deputy Director, CVM, are authorized to issue responses to citizen petitions submitted under 10.30 of this chapter from sponsors of an investigational new animal drug application who request approval to ship in interstate commerce, in accordance with § 21.125(j) of this chapter, an investigational new animal drug for animal use containing a chlorofluorocarbon.

(7) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM, are authorized to issue responses to citizen petitions submitted under § 10.30 of this chapter, seeking a determination of the suitability of an abbreviated new animal drug application for an animal drug product.

[47 FR 38480, Aug. 31, 1982, as amended at 47 FR 54757, Dec. 3, 1982, 47 FR 55471, Dec. 10, 1982; 48 FR 56946, Dec. 27, 1983; 49 FR 5094, Feb. 10, 1984; 49 FR 14933, 14936, Apr. 16, 1984; 50 FR 30696, July 29, 1985; 51 FR 17011, May 8, 1986; 52 FR 2514, Jan. 23, 1987; 54 FR 6884, Feb. 15, 1989; 54 FR 8316, Feb. 28, 1989]

85.35 Enforcement activities.

(a) Designated officers and employees of the Food and Drug Administration who have been issued the Food and Drug Administration official credentials consisting of Form FDA200A, Identification Record, and Form FDA-200B, Specification of General Authority, are authorized:

(1) To conduct examinations, inspections, and investigations; to collect and obtain samples; to have access to and to copy and verify records as authorized by law; to make seizures of items under section 702(e)(5) of the Federal Food, Drug, and Cosmetic Act (the Act); and to supervise compliance operations for the enforcement of the 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 sections 351 and 354 through 361 of the Public Health Service Act.

(2) 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.

(b) The Food and Drug Administration's official credentials referred to in paragraph (a) of this section are described as follows:

(1) Form FDA-200A entitled "Identification Record" bears a color photograph, a description, and the signature of the holder, an identification number, an expiration date, the Department of Health and Human Services' seal with blue imprint, on the left of the photograph, and the Food and Drug Administration's symbol, on the right of the photograph.

(2) Form FDA-200B entitled "Specification of General Authority" bears the holder's name, his or her general authority, an identification number, an expiration date, the Commissioner's signature, the names of the Department of Health and Human Services, the Public Health Service, and the Food and Drug Administration. The form is superimposed with the Department's seal with blue imprint.

[49 FR 19973, May 11, 1984, as amended at 53 FR 22293, June 15, 1988]

85.36 Certification following inspections.

Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized to issue certificates of sanitation under § 1240.20 of this chapter.

[51 FR 32452, Sept. 12, 1986]

§ 5.37 Issuance of reports of minor violations.

(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under section 306 of the Federal Food, Drug, and Cosmetic Act regarding the issuance of written notices or warnings:

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

(ii) The Director and Deputy Director, Office of Compliance, CBER.

(2)(i) The Director and Deputy Director of the Center for Devices and Radiological Health (CDRH).

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

(iii) The Director, Division of Compliance Operations, Office of Compliance, CDRH.

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

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

(iii) The Director, Division of Regulatory Guidance, Office of Compliance, CFSAN.

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

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

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

(5)(i) The Director and Deputy Director, Center for Drug Evaluation and Resarch (CDER).

(ii) The Director and Deputy Director, Office of Compliance, CDER. (6)(i) Regional Food and Drug Directors.

(ii) District Directors.

(iii) Chiefs of District Compliance Branches.

(iv) The Director, St. Louis Branch.

(b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under section 360C(d) of the Public Health Service Act regarding the issuance of written notices or warnings:

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

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

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

(4) Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, when such functions relate to:

(i) Assemblers of diagnostic x-ray systems, as defined in § 1020.30(b) of this chapter; and

(ii) Manufacturers of sunlamp products and ultraviolet lamps intended for use in any sunlamp product as defined in § 1040.20(b) of this chapter.

[48 FR 8441, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49 FR 14933, 14936, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8317, Feb. 28, 1989]

§ 5.44 Export of unapproved drugs.

(a) The following officials are authorized, under section 802(b) of the Federal Food, Drug, and Cosmetic Act, to approve or disapprove applications to export unapproved new drugs and biological products and to issue notices of receipt of such applications:

(1) For human drugs assigned to their respective organizations:

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

(ii) The Director and Deputy Director, Office of Compliance, CBER.

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

(iv) The Director and Deputy Director, Office of Compliance, CDER.

(2) For new animal drugs assigned to their respective organizations:

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

(ii) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM.

(b) The following officials are authorized, under section 802(f) of the Federal Food, Drug, and Cosmetic Act, to approve or disapprove an application to export a drug (including a biological product) to be used in the prevention or treatment of a tropical dis

ease:

(1) For human drugs assigned to their respective organizations:

(i) The Director and Deputy Director, CBER.

(ii) The Director and Deputy Director, Office of Compliance, CBER.

(iii) The Director and Deputy Director, CDER.

(iv) The Director and Deputy Director, Office of Compliance, CDER.

(2) For veterinary drugs subject to their jurisdiction:

(i) The Director and Deputy Director, CVM.

(ii) The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM.

(c) The following officials are authorized, under section 351(h) of the Public Health Service Act, to approve or disapprove an application to export a partially processed biological product:

(1) The Director and Deputy Director, CBER.

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

[52 FR 7269, Mar. 10, 1987, as amended at 54 FR 8317, Feb. 28, 1989]

(1) Request from the Secretary of the Treasury samples of food, drugs (including biological products), devices, or cosmetics imported or offered for import.

(2) Determine whether such articles are in compliance with the FFDCA.

(3) Authorize relabeling or other compliance actions to bring articles into compliance under the FFDCA.

(4) Supervise such compliance actions.

(b) The Director and Deputy Director, Center for Devices and Radiological Health (CDRH); the Director and Deputy Director, Office of Compliance, CDRH; Regional Food and Drug Directors; District Directors; and the Director, St. Louis Branch, are authorized, under section 360 of the Public Health Service Act (PHSA), to perform the following functions or to designate officials to:

(1) Request from the Secretary of the Treasury samples of electronic products imported or offered for import to determine whether such products are in compliance with the PHSA.

(2) Refuse admission of noncomplying products and notify the Secretary of the Treasury of such refusal.

(3) Supervise operations to bring noncomplying products into compliance under the PHSA.

(4) Refuse or grant permission and time extensions to bring noncomplying products into compliance with the PHSA in accordance with a corrective action plan approved by the Director, Office of Compliance, CDRH.

(c) The following officials are authorized, under section 360B(b) of the PHSA, to exempt persons from issuing a certification, as required by section 358(h) of the PHSA, for electronic products imported into the United States for testing, evaluation, demonstrations, or training, which will not be introduced into commerce and upon completion of their function will be destroyed or exported in accord with U.S. Customs Service's regulations:

(1) The Director and Deputy Director, CDRH.

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

(3) Regional Food and Drug Directors.

(4) District Directors.

(5) The Director, St. Louis Branch.

(d) The Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized to exercise all of the functions of the Commissioner of Food and Drugs under section 362 of the PHSA that refers to the prohibition of the introduction of foods, drugs, devices, cosmetics, and electronic products and other items or products regulated by the Food and Drug Administration into the United States when it is determined that it is required in the interest of public health, and such functions relate to the law enforcement functions of the Food and Drug Administration.

(e) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs pertaining to exportation of medical devices under section 801(e) of the FFDCA:

(1) For medical devices assigned to their respective organization:

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