SMG 1410.31

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

AUTHORITY TO SELECT TEMPORARY VOTING MEMBERS FOR ADVISORY COMMITTEES AND AUTHORITY TO SIGN CONFLICT OF INTEREST WAIVERS

Effective Date: 02/07/2005

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

A. Each Center director is authorized to select members of, and consultants to, scientific and technical FDA advisory committees under that center's management to serve temporarily as voting members on another advisory committee under that center's management when expertise is required that is not available among current voting standing members of a committee or to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking. When additional voting members are added to a committee to provide needed expertise not available among current voting standing members of a committee, a quorum will be based on the total of regular and added members. Authority to select temporary voting members to advisory committees, if such voting members are serving on an advisory committee managed by another Center, has not been redelegated. This authority will continue to be exercised by the Commissioner of Food and Drugs (the Commissioner) or the Associate Commissioner for External Relations, Office of the Commissioner.

B. Each Center director is authorized, under 18 U.S.C. 208(b)(1), to sign conflict of interest waivers for special Government employees without substantial interest to serve as consultants to advisory committees or in any other capacity within the Centers except as advisory committee members.

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

On February 7, 2005, this delegation was approved and became effective via memorandum, signed by Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner of Food and Drugs.