(i) Section 5.203 Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products;

(ii) Section 5.204 Notification of release for distribution of biological products;

(iii) Section 5.101 Termination of exemptions for new drugs for investigational use in human beings or in animals;

(iv) Section 5.103 Approval of new drug applications and their supplements.

(v) Section 5.105 Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements.

(vi) Section 5.34 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.

(2) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, 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 authority in the following sections of this chapter:

(i) Section 5.100 Issuance of notices implementing the provisions of the Drug Amendments of 1962;

(ii) Section 5.101 Termination of exemptions for new drugs for investigational use in human beings or in animals;

(iii) Section 5.103 Approval of new drug applications and their supplements.

(iv) Section 5.105 Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements.

(v) Section 5.34 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.

(3) The Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, 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 Directors and Deputy Directors of OBRR, OVRR, and OTRR, CBER, for those drug products listed in §314.440(b) of this chapter, are author

ized 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 investigational new drug for human use containing chlorofluorocarbon.

a

(i) The Director and Deputy Directors, CBER.

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

(8) The Director and Deputy Director, CVM, are authorized to grant or deny citizen petitions submitted under § 10.30 of this chapter concerning actions they are authorized to take under §5.34 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.

(g) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH, and the Director, Office of Compliance, CDRH, are authorized to grant or deny citizen petitions 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.

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

§ 5.30 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 of Food and Drugs (Commissioner) or the Senior Associate Commissioner, Office of the Commis

sioner.

(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.

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

$5.31 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) (21 U.S.C. 372 (e) (5)); and to supervise compliance operations for the enforcement of the act, the Fair Packaging and Labeling Act (15 U.S.C. 14511461), the Federal Caustic Poison Act (44 Stat. 140b; see also Public Law 86613, section 19, formerly section 18), the Import Milk Act (21 U.S.C. 141-149), the Filled Milk Act (21 U.S.C. 61-64), and sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264).

(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 of Food and Drugs (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 (21 U.S.C. 372 (e)(1)-(e)(5)):

(i) Carry firearms;

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

(iii) Execute seizure by process issued under libel under section 304 of the act (21 U.S.C. 334);

(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 (21 U.S.C. 334(a)(2)), 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 and condemnation under section 304(a)(2) of the act.

(2) Perform such other functions under the act, or any other law, as the Commissioner 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 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 issued under the act.

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

§ 5.32 Certification following inspections.

Regional Food and Drug Directors and District Directors are authorized to issue certificates of sanitation under § 1240.20 of this chapter. These officials may not further redelegate this authority.

§ 5.33 Issuance of reports of minor violations.

(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) under section 309 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 336) (the act) regarding the issuance of written notices or warnings:

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

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

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

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

(iii) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH.

(iv) The Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, CDRH.

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

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

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

(iv) The Director, Division of Enforcement and Programs, 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, the Deputy Director, the Associate Director for Regulatory Policy, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

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

(iii) The Associate Director for Medical Policy, CDER.

(iv) The Director, Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, 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.

(ix) The Director, Arkansas Regional Laboratory.

(b) The following officials are authorized to perform all the functions of the Commissioner under section 539(d) of the act (21 U.S.C. 360pp(d)) regarding the issuance of written notices or warnings:

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

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

(3) For medical devices assigned to their respective divisions, the Division Directors, Office of Compliance, CDRH.

(4) The Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH, and the Director and Deputy Director, Division of Surveillance Systems (DSS), OSB, 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; the Director, National Forensic Chemistry Center, and the Director, Arkansas Regional Laboratory 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.

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

§5.34 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.

(a) The Director, the Deputy Director, and the Associate Director for Regulatory Policy, Center for Drug Evaluation and Research, the Director and Deputy Director, Center for Veterinary Medicine, and the Director and Deputy Directors, Center for Biologics Evaluation and Research are authorized to issue the following notices and make all findings required in relation to these notices under section 306 of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 335a) which relate to the assigned functions of their organizations:

(1) Notices of opportunity for hearing on proposals for mandatory or permissive debarment.

(2) Notices ordering debarment when opportunity for a hearing has been waived.

(3) Notices ordering debarment where the person notifies the agency that the person consents to debarment under section 306(c)(2)(B) of the act (21 U.S.C. 335a(c)(2)(B)).

(4) Notices of opportunity for hearing on proposals denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)). (5) Orders denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)) when opportunity for a hearing has been waived.

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

$5.35 Officials authorized to make certification under 5 U.S.C. 605(b) for any proposed and final rules.

(a) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to decisions made under the Regulatory Flexibility Act (5 U.S.C. 605(b)), to certify that a proposed or final rule, if issued, will not have a significant economic impact on a substantial number of small entities:

(1) The Associate Commissioner for Regulatory Affairs.

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

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

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

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

(6) The Director, Center for Veterinary Medicine.

(7) Other Food and Drug Administration Officials authorized to issue FEDERAL REGISTER documents.

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

Subpart C-Human Drugs;
Redelegations of Authority

$5.100 Issuance of notices implementing the provisions of the Drug Amendments of 1962.

The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research; and the Director, the Deputy Directors for Regulations and Policy and for Science, and the Director and Deputy Directors, Office of Device Evaluation, Center for Devices and Radiological Health, are authorized to issue notices and amendments thereto implementing section 107(c)(3) of the Drug Amendments of 1962 (Pub. L. 87-781) by announcing new or revised efficacy findings on human drugs that are or were subject to the provisions of section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). These officials may not further redelegate this authority.

85.101 Termination of exemptions for new drugs for investigational use in human beings.

(a) The following officials, for drugs under their jurisdiction, are authorized to perform all the functions of the Commissioner of Food and Drugs on the termination of exemptions for new drugs (including those that are biological products which are subject to the licensing provisions of the Public Health Service Act) for investigational use in human beings under §312.44 of this chapter and in animals under § 312.160 of this chapter:

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

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

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

(b) The following officials, for drugs under their jurisdiction, are authorized to terminate exemptions for new drugs for investigational use when sponsors fail to submit an annual progress re

port under §312.44(b)(1)(viii) of this chapter:

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

(2) 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.

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

(4) The Directors and Deputy Directors of the Division of Blood Applications, OBRR, the Division of Vaccines and Related Products Applications, OVRR, and the Division of Application Review and Policy, OTRR, CBER.

(5) The Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH.

(c) The following officials, for drugs under their jurisdiction, are authorized to make the findings set forth in §312.44(b) of this chapter and to notify sponsors and invite correction before termination action on such exemptions:

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

(2) 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.

(3) 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.

(4) The Directors and Deputy Directors of the Division of Blood Applications, OBRR, the Division of Vaccines and Related Products Applications, OVRR, and the Division of Application Review and Policy, OTRR, CBER.

(5) The Director and Deputy Directors, ODE, CDRH.

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