[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.29]

[Page 62-65]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
              Subpart B_General Redelegations of Authority
 
Sec. 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 Sec. 10.30 of this chapter for a stay of an effective date in 
Sec. 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).

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    (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 Sec. 10.30 of this chapter requesting in 
vitro test modifications under Sec. 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 Sec. 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 Sec. Sec. 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 Sec. 10.30 of this chapter requesting 
exemption from the general pregnancy-nursing warning for over-the-
counter (OTC) drugs required under Sec. 201.63 of this chapter, 
requesting exemption from a general overdose warning required under 
Sec. 330.1(g) of this chapter, and requesting exemption from OTC drug 
administrative procedures under Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 
10.30(e)(2)(iii) of this chapter that relate to the assigned functions 
of that Center.

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    (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 Sec. 
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 Sec. 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 Sec. 
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 Sec. 314.440(b) of this chapter, are authorized to issue 
responses to citizen petitions submitted under Sec. 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 Sec. 314.440(b) of this 
chapter, are authorized to issue responses to citizen petitions 
submitted under Sec. 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 Sec. 10.30 of this chapter from sponsors of an 
investigational new drug application who request approval to ship in 
interstate commerce, in accordance with Sec. 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 Sec. 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 
Sec. 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 Sec. 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 Sec. 10.30

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of this chapter concerning actions they are authorized to take under 
Sec. 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 
Sec. Sec. 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.