submitted under §§10.30 and 821.2(b) of this chapter, requesting an exemption or variance from medical device tracking requirements in part 821 of this chapter.

[47 FR 38480, Aug. 31, 1982]

EDITORIAL NOTE: For FEDERAL REGISTER Citations affecting §5.31, see the List of CFR Sections Affected in the Finding Aids section of this volume.

§5.32 Authority relating to determination of product primary jurisdiction.

The FDA ombudsman as product jurisdiction officer is authorized to determine whether the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), or the Center for Drug Evaluation and Research (CDER) has primary responsibility for premarket review and regulation of a product that constitutes a combination of a drug, device, or biological product under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act or that is a drug, device or biologic product where the center with primary jurisdiction is unclear or in dispute. [56 FR 58758, Nov. 21, 1991]

$5.33 Premarket approval of a product that is or contains a biologic, a device, or a drug.

For a product that is or contains a biologic, a device, or a drug, the following officials in the Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, or Center for Drug Evaluation and Research who currently hold delegated premarket approval authority for biologics, devices, or drugs, respectively, are hereby delegated all the authorities necessary for premarket approval of any product that is a biologic, a device, or a drug, or any combination of two or more of these products:

(a) The Director and Deputy Director, Center for Biologics Evaluation and Research (CBER) and the Director, Office of Biological Product Review, CBER.

(b) The Director and Deputy Director, Center for Devices and Radiological Health (CDRH) and the Director, Office of Device Evaluation, CDRH.

(c) The Director and Deputy Director, Center for Drug Evaluation and Research (CDER); the Director, Pilot Drug Evaluation Staff, CDER; and the Directors of the Offices of Drug Evaluation I and Drug Evaluation II, CDER. [56 FR 58759, Nov. 21, 1991]

§ 5.34 Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers.

(a) Each center director is authorized to select members of, and consultants to, scientific and technical FDA advisory committees under that center's management to serve temporarily as voting members on another advisory committee under that center's management when expertise is required that is not available among current voting standing members of a committee or to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking. When additional voting members are added to a committee to provide needed expertise not available among current voting standing members of a committee, a quorum will be based on the total of regular and added members. Authority to select temporary voting members to advisory committees if such voting members are serving on an advisory committee managed by another center has not been redelegated. This authority will continue to be exercised by the Commissioner or his designee.

(b) Each center director is authorized, under 18 U.S.C. 208(b)(1), to sign conflict of interest waivers for special government employees without substantial interest to serve as consultants to advisory committees or in any other capacity within the centers except as advisory committee members. [58 FR 39142, July 22, 1993]

$5.35 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 FDA-200A, Identification Record, and Form FDA200B, 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) Any officer or employee of the Food and Drug Administration who has been designated by the Commissioner to conduct examinations, investigations, or inspections under the act relating to counterfeit drugs and issued the Food and Drug Administration Official Credential consisting of Form FDA-200D, Special Authority for Criminal Investigators, is authorized to do the following:

(1) As set forth under section 702(e)(1) through (e)(5) of the act:

(i) Carry firearms;

(ii) Serve and execute search warrants and arrest warrants;

(iii) Execute seizure by process issued pursuant to libel under section 304 of the act;

(iv) Make arrests without warrant for an offense under the act with respect to counterfeit drugs if the offense is committed in the presence of the criminal investigator or, in the case of a felony, if the investigator has probable cause to believe that the person so arrested has committed, or is committing, such offense; and

(v) Make, prior to the institution of libel proceedings under section 304(a)(2) of the act, seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling, or other things, if they are, or the criminal investigator has reasonable grounds to believe that they are, subject to seizure

(2) Perform such other functions under the act, or any other law, as the Commissioner of Food and Drugs may prescribe.

(3) 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.

(c) Any officer or employee of the Food and Drug Administration who has been designated by the Commissioner to provide specialized law enforcement support involving criminal investigations under the Federal Food, Drug, and Cosmetic Act (the act), and other duties as assigned by the Commissioner, and issued the Food and Drug Administration Official Credential consisting of Form FDA-200E, Special Authority for Criminal Investigative Specialists, is authorized to receive information as to all matters relating to such act and regulations promulgated under the act.

(d) The Food and Drug Administration's official credentials referred to in paragraphs (a), (b), and (c) 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.

(3) Form FDA-200D, entitled "Special Authority for Criminal Investigators,' is in two parts and bears the holder's name, a color photograph, the signature of the holder, his or her special

authority under 21 U.S.C. 334 and 372 and other duties as assigned by the Commissioner, an identification number, the Commissioner's or his designee's signature, the names of the Department of Health and Human Services, the Public Health Service, and the Food and Drug Administration. Part 1 of the form is superimposed with the symbol FDA with blue imprint, and part 2 is superimposed with the FDA criminal investigator's badge with blue imprint.

(4) Form FDA-200E, entitled "Special Authority for Criminal Investigative Specialists," is in two parts and bears the holder's name, a color photograph, the signature of the holder, his or her special authority under the act, and other duties under the law, as assigned by the Commissioner, an identification number, the Commissioner's or his designee's signature, the names of the Department of Health and Human Services, the Public Health Service, and the Food and Drug Administration. Part 1 of the form is superimposed with the symbol FDA with blue imprint, and part 2 is superimposed with the FDA criminal investigative specialist's

badge with blue imprint.

[49 FR 19973, May 11, 1984, as amended at 53 FR 22293, June 15, 1988; 56 FR 23788, May 24, 1991; 58 FR 494, Jan. 6, 1993; 58 FR 42496, Aug. 10, 1993; 59 FR 47799, Sept. 19, 1994]

85.36 Certification following inspections.

Regional Food and Drug Directors and District Directors are authorized to issue certificates of sanitation under § 1240.20 of this chapter.

[60 FR 15871, Mar. 28, 1995]

$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 309 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 and Surveillance, CDRH.

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

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

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

(ii) The Director, Office of Policy, Planning, and Strategic Initiatives, CFSAN.

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

(iv) The Director, Division of Enforcement, Office of Field Programs, 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, 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. (v) The Director, Northeast Regional Laboratory, Northeast Region.

(vi) The Director, Southeast Regional Laboratory, Southeast Region.

(vii) The Director, Winchester Engineering and Analytical Center.

(viii) The Director, National Forensic Chemistry Center.

(b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under section 539(d) of the Federal Food, Drug, and Cosmetic 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 and Surveillance, CDRH.

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

(4) The Director, Division of Standards Enforcement, Office of Compliance and Surveillance, CDRH.

(5) Regional Food and Drug Directors; District Directors; the Director, St. Louis Branch; the Director, Northeast Regional Laboratory, Northeast Region; the Director, Southeast Regional Laboratory, Southeast Region; the Director, Winchester Engineering and Analytical Center; and the Director, National Forensic Chemistry Center, 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; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992; 59 FR 42491, Aug. 18, 1994; 60 FR 15871, Mar. 28, 1995]

§ 5.38 Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs, new animal drugs, and feeds bearing or containing new animal drugs.

(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) regarding the issuance of written notices.

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

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

(3) The Director and Deputy Director, Division of Drug Labeling Compliance, Office of Compliance, CDER.

(4) The Director and Deputy Director, Division of Manufacturing and Product Quality, Office of Compliance, CDER.

(5) The Director and Deputy Director, Division of Drug Quality Evaluation, Office of Compliance, CDER.

(6) The Director and Deputy Director, Division of Scientific Investigations, Office of Compliance, CDER.

(7) Regional Food and Drug Directors.

(8) District Directors.

(b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs under sections 512(e) and 512 (m)(4)(B)(ii) and (m)(4)(B)(iii) of the act regarding the issuance of written notices.

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

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

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

(4) Regional Food and Drug Directors.

(5) District Directors.

[57 FR 18823, May 1, 1992]

§ 5.39 Redelegation of the Center for Biologics Evaluation and Research Director's program authorities.

The following officials are authorized to perform all the functions of the Director, Center for Biologics Evaluation and Research (CBER) with regard to program authorities for their respective areas:

(a) Associate Directors, CBER. (b) Office Directors, CBER. (c) Division Directors, CBER. [58 FR 18346, Apr. 9, 1993]

$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 disease:

(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]

§ 5.45 Imports and exports.

(a) The Regional Food and Drug Directors, District Directors, and the Director, St. Louis Branch, are authorized, under section 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA), to perform the following functions or to designate officials to:

(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 and Surveillance, 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 and Surveillance, 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 and Surveillance, CDRH.

(3) Regional Food and Drug Directors.

(4) District Directors.

(5) The Director, St. Louis Branch.