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SMG 1410.30

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

PETITIONS UNDER TITLE 21, CODE OF FEDERAL REGULATIONS (21 CFR), PART 10

Effective Date: June 4, 2010

[PDF Version]

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

A. For drugs assigned to their organizations, the following officials are authorized to grant or deny citizen petitions submitted under 21 CFR Part 10 for a stay of an effective date in 21 CFR, Part 200, section 201.59, for compliance with certain labeling requirements for human prescription drugs:

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

2. The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER

3. The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OCTGT, CBER

4. The Director, the Deputy Director, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER)

5. The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER

6. The Directors and Deputy Directors of the Divisions in the Offices of Drug Evaluation I, II, III, Office of Antimicrobial Products (OAP), Office of Nonprescription Products (ONP) and Office of Oncology Drug Products (OODP), Office of New Drugs, CDER

B. The following officials are authorized to grant or deny citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, requesting in vitro test modifications under 21 CFR, Part 300, Sec. 331.29:

1. The Director, the Deputy Director, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, CDER

2. The Director, Office of Nonprescription Products, Office of New Drugs, CDER

C. The following officials are authorized to grant or deny citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30 for a stay of an effective date or for an exemption from the tamper-resistant packaging and labeling requirements set forth in 21 CFR, Parts 200, 700, and 800, Secs. 211.132, 700.25, or 800.12, 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, Center for Drug Evaluation and Research (CDER); Directors, Office of New Drugs (OND) and Office of Pharmaceutical Science, CDER; and the Director, Office of Nonprescription Products, OND, 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, Center for Devices and Radiological Health (CDRH)

D. The following officials are authorized to grant or deny citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, requesting exemption from the general pregnancy-nursing warning for over-the-counter (OTC) drugs required under 21 CFR Part 200, Sec. 201.63, requesting exemption from a general overdose warning required under Sec. 330.1(g) and requesting exemption from OTC drug administrative procedures under 21 CFR, Part 300, Sec. 330.10:

1. The Director, the Deputy Director, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, CDER

2. The Director, Office of Nonprescription Products, Office of New Drugs, CDER

E. The following officials are authorized to issue 180-day tentative responses to citizen petitions on food and cosmetic matters under 21 CFR, Part 10, Sec. 10.30(e)(2)(iii), that relate to the assigned functions of that Center:

1. The Director and Deputy Director, CFSAN

2. The Director of Regulations and Policy, CFSAN

3. The Director, Office of Cosmetics and Colors, CFSAN

4. The Director, Office of Nutritional Products, Labeling and Dietary Supplements, CFSAN

5. Director and Deputy Director, Office of Food Additive Safety. CFSAN

6. The Director, Office of Plant and Dairy Foods and Beverages, CFSAN

7. The Director, Office of Seafood, CFSAN

8. The Director, Office of Field Programs, CFSAN

F. The Director, the Deputy Director, and the Senior Advisor for Science Policy, Center for Veterinary Medicine (CVM), are authorized to issue 180-day tentative responses to citizen petitions on animal food and drug matters under 21 CFR, Part 10, Sec. 10.30(e)(2)(iii), that relate to the assigned functions of that Center.

G. The Director and Deputy Directors, CBER, the Director and Deputy Director, CDER, and the Associate Director for Policy, CDER are authorized to issue 180-day tentative responses to citizen petitions on biological product matters under 21 CFR, Part 10, Sec. 10.30(e)(2)(iii), that relate to the assigned functions of that Center.

H. The Director, the Deputy Director, and the Associate Director for Policy, CDER, are authorized to issue 180-day tentative responses to citizen petitions on drug product matters under 21 CFR, Part 10, Sec. 10.30(e)(2)(iii), that relate to the assigned functions of that Center.

I. The Director, Deputy Director, and the Associate Director for Regulations and Policy, CDRH, are authorized to issue 180-day tentative responses to citizen petitions on medical device matters under 21 CFR, Part 10, Sec. 10.30(e)(2)(iii) that relate to the assigned functions of that Center.

J. The Director and Deputy Director, Center for Tobacco Products (CTP), are authorized to issue 180-day tentative responses to citizen petitions on tobacco product matters under 21 CFR, Part 10, Sec. 10.30(e)(2)(iii), that relate to the assigned functions of that Center.

K. The Director and Deputy Directors, CBER, the Director and Deputy Director, CDER, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, CDER are authorized to grant or deny citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, on drug and biological product matters in program areas where they have been delegated final approval authority in the following SMGs:

1. SMG 1410.204 Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products

2. SMG 1410.205 Notification of release for distribution of biological products

3. SMG 1410.102 Termination of exemptions for new drugs for investigational use in human beings or in animals

4. SMG 1410.104 Approval of new drug applications and their supplements

5. SMG 1410.106 Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements

L. The Director and Deputy Director, CDER; and the Directors, Office of New Drugs and Office of Pharmaceutical Science, CDER, are authorized to grant or deny citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30 and petitions for stay of action submitted under 21 CFR, Part 10, Sec. 10.35, on drug product matters (including inspection issues) in program areas where they have been delegated final approval authority in the following sections of this chapter:

1. SMG 1410.101 Issuance of notices implementing the provisions of the Drug Amendments of 1962

2. SMG 1410.102 Termination of exemptions for new drugs for investigational use in human beings or in animals

3. SMG 1410.104 Approval of new drug applications and their supplements

4. SMG 1410.106 Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements

5. SMG 1410.35 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment

M. The Director and Deputy Director, Office of Generic Drugs, Office of Pharmaceutical Science, CDER, except for those drug products listed in 21 CFR, Part 300, Sec. 314.440(b) are authorized to issue responses to citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30 seeking a determination of the suitability of an abbreviated new drug application for a drug product.

N. The Directors and Deputy Directors of OBRR, OVRR, and OCTGT, CBER, for those drug products listed in 21 CFR, Part 300, Sec. 314.440(b), are authorized to issue responses to citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, seeking a determination of the suitability of an abbreviated new drug application for a drug product.

O. For drugs assigned to their organization, the following officials are authorized to issue responses to citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, from sponsors of an investigational new drug application who request approval to ship in interstate commerce, in accordance with 21 CFR, Part 2, Sec. 2.125(j) an investigational new drug for human use containing a chlorofluorocarbon:

1. The Director and Deputy Directors, CBER

2. The Director, the Deputy Director, and the Directors, Office of New Drugs and Office of Pharmaceutical Science, CDER

P. The Director, the Deputy Director, and the Senior Advisor for Science Policy, CVM, are authorized to issue responses to citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, from sponsors of an investigational new animal drug application who request approval to ship in interstate commerce, in accordance with 21 CFR, Part 2, Sec. 2.125(j), an investigational new animal drug for animal use containing a chlorofluorocarbon.

Q. The Director and Deputy Director, Office of New Animal Drug Evaluation, CVM, are authorized to issue responses to citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, seeking a determination of the suitability of an abbreviated new animal drug application for an animal drug product.

R. The Director, the Deputy Director, and the Senior Advisor for Science Policy, CVM, are authorized to grant or deny citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, concerning actions they are authorized to take under SMG 1410.35 Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.

S. The Director, Deputy Directors, and Associate Director for Regulations and Policy, CDRH, and the Director, Office of Compliance, CDRH, are authorized to grant or deny citizen petitions submitted under 21 CFR, Parts 10 and 800, Secs. 10.30 and 821.2(b), requesting an exemption or variance from medical device tracking requirements in part 821 of 21 CFR.

T. The Director and Deputy Director, CFSAN, the Deputy Director for Regulatory Affairs, CFSAN, and the Director, Office of Regulations and Policy, CFSAN, are authorized to deny citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, that pertain exclusively to food and cosmetic matters.

U. The Director, Deputy Directors, and Associate Director for Regulations and Policy, Center for Devices and Radiological Health (CDRH) are authorized to grant or deny petitions submitted under 21 CFR, Part 10, Sec. 10.30 and/or 10.35 on medical device matters in program areas where they have been delegated authority in the following SMGs:

1. SMG 1410.403 Detention of Adulterated or Misbranded Medical Devices

2. SMG 1410.404 Authorization to Use Alternative Evidence for Determination of the Effectiveness of Medical Devices

3. SMG 1410.406 Determination of Classification of Devices

4. SMG 1410.408 Approval, Disapproval, or Withdrawal of Approval of Product Development Protocols and Applications for Premarket Approval, and Humanitarian Device Exemptions for Medical Devices

5. SMG 1410.409 Determinations Concerning the Type of Valid Scientific Evidence Submitted in a Premarket Approval Application

6. SMG 1410.410 Determinations that Medical Devices Present Unreasonable Risk of Substantial Harm

7. SMG 1410.411 Orders to Repair or Replace, or Make Refunds for, Medical Devices

8. SMG 1410.412 Medical Device Recall Authority

9. SMG 1410.413 Temporary Suspension of a Medical Device Application

10. SMG 1410.414 Approval, Disapproval, or Withdrawal of Approval of Applications and Entering Into Agreements for Investigational Device Exemptions

11. SMG 1410.415 Postmarket Surveillance

12. SMG 1410.416 Authority Relating to Medical Device Reporting Procedures

13. SMG 1410.417 Medical Device Tracking

14. SMG 1410.418 Authority Pertaining to Accreditation Functions for Medical Devices

15. SMG 1410.419 Medical Device User Fee Authorities

16. SMG 1410.420 Requests for Information Concerning Device Classification (if any) and Requirements

V. The Director and Deputy Director, CTP, the Director, Office of Regulations, CTP, and the Director, Office of Policy, CTP, are authorized to deny citizen petitions submitted under 21 CFR, Part 10, Sec. 10.30, that pertain exclusively to Tobacco Product matters.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

The Commissioner of Food and Drugs approved this delegation, via memorandum, on June 4, 2010.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/23/2009N/aOC/OO/OM/OMPCommissioner of Food and Drugs
Revision06/04/2010N/aOC/OA/OM/OMPMargaret A. Hamburg M.D., Commissioner of Food and Drugs