§ 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-the-counter 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 over-the-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 180-day 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:

(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 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 investigational new drug for human use containing a chlorofluorocarbon.

(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.