SMG 1410.35

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - GENERAL REDELEGATIONS OF AUTHORITY

ISSUANCE OF NOTICES RELATING TO PROPOSALS AND ORDERS FOR DEBARMENT AND DENIAL OF AN APPLICATION TO TERMINATE DEBARMENT

Effective Date: 03/13/2009

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

A. The Director, Deputy Director, and Director of the Division of Compliance Policy, Office of Enforcement, Office of Regulatory Affairs are authorized to issue the following notices and make all findings required in relation to these notices under section 306 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a):

1. Notices of opportunity for hearing on proposals for mandatory or permissive debarment.

2. Final debarment orders when opportunity for a hearing has been waived.

3. Final debarment orders where the person notifies the agency that the person acquiesces to debarment under section 306(c)(2)(B) of the act (21 U.S.C. 335a(c)(2)(B)).

4. Orders granting an application for termination or special termination of debarment under section 306(d)(3) or (d)(4) of the act (21 U.S.C. 335a(d)(3) or (d)(4)).

5. Notices of opportunity for hearing on proposals denying an application for termination or special termination of debarment under section 306(d)(3) or (d)(4) of the act (21 U.S.C. 335a(d)(3) or (d)(4)).

6. Orders denying an application for termination or special termination of debarment under section 306(d)(3) or (d)(4) of the act (21 U.S.C. 335a(d)(3) or (d)(4)) when opportunity for a hearing has been waived.

B. The Assistant Commissioner for Integrity and Accountability is authorized to issue the following orders and make all findings required in relation to those orders under section 306 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a).

1. Orders denying a hearing and final debarment orders when a person responding to a proposal for debarment fails to present a genuine and substantial issue of fact, or other reason, to justify a hearing, under 21 CFR part 12.

2. Orders granting a request for a hearing and notices of hearing under 21 CFR part 12 on proposals for debarment.

3. Orders granting or denying requests for a hearing, and all orders associated with such grant or denial, under 21 CFR part 12 or 16 in response to a proposal to deny an application for termination or special termination of debarment under section 306(d)(3) or (d)(4) of the act (21 U.S.C. 335a(d)(3) or (d)(4)).

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

The Acting Commissioner of Food and Drugs approved this delegation on March 13, 2009 (Via Memorandum from the Deputy Commissioner for Policy to the Acting Commissioner, Subject: "SMG 1410.35, 'Issuance of Notices Relating to Proposals and Orders for Debarment and Denial of Applications to Terminate Debarment' and (new) SMG 7712 'Debarment Proceedings.'" - ACTION, dated March 5, 2009, and Tab C - Delegations of Authority Statement signed by the Acting Commissioner, dated March 13, 2009).