SMG 1410.25

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

AUTHORITY RELATING TO TECHNOLOGY TRANSFER

Effective Date: 04/02/2001

1. AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A. The Associate Commissioner for Regulatory Affairs is authorized to perform the functions of the Commissioner of Food and Drugs as requested by the Commissioner regarding the authority to disapprove or require modification of cooperative research and development agreements and licensing agreements and transmit written explanation of such approval or disapproval to the head of the laboratory concerned under section 11(c)(5) (A) and (B) of the Stevenson-Wydler Technology Innovation Act of 1980 (the Act) (15 U.S.C. 3710a(c)(5) (A) and (B)), as amended. 

B. The following officials are authorized to perform the functions of the Commissioner of Food and Drugs (Commissioner) requested by the Commissioner under the Act (15 U.S.C. 3701 et seq.), as amended, and Executive Order 12591 of April 10, 1987 (except to the extent that redelegation of those functions is specifically limited in SMG 1410.10, paragraph 10(a)(26)), as they pertain to the functions of their respective organizations, including the authority to perform the functions of laboratory directors under the Act as the heads of their respective Federal laboratories, subject to the discretion of the Commissioner to require that agreements entered into under section 11(a) of the Act (15 U.S.C. 3710a(a)) include provisions in accordance with section 11(c)(5)(A) of the Act (15 U.S.C. 3710a(c)(5)(A)):

1. The Director, Center for Biologics Evaluation and Research.

2. The Director, Center for Devices and Radiological Health.

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

4. The Director, Center for Food Safety and Applied Nutrition.

5. The Director, Center for Veterinary Medicine.

6. The Director, National Center for Toxicological Research.

7. The Associate Commissioner for Regulatory Affairs.

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.