SMG 1410.36

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

OFFICIALS AUTHORIZED TO MAKE CERTIFICATION UNDER 5 U.S.C. 605(B) FOR ANY PROPOSED AND FINAL RULES

Effective Date: 04/02/2001

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

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.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

The Acting Principal Deputy Commissioner approved this delegation on April 2, 2001 (Via Memorandum from the Acting Senior Associate Commissioner for Management and Services to the Acting Principal Deputy Commissioner, Subject: Comprehensive Update to 21 CFR Part 5, Delegations of Authority and Organization - ACTION, dated April 2, 2001, and Tab C - Delegations of Authority Statement signed by the Acting Principal Deputy Commissioner, dated April 2, 2001). This information was previously published in the June 8, 2001, Final Rule, 66 Federal Register 30992-31025.