Delegations of Authority and Organization; Issuance of Notices Relating to Debarment
other · Food and Drug Administration · Rule · Published 1996-03-04 · Effective 1996-03-04 · 61 FR 8214
Document
Document number
96-4914
Federal Register citation
61 FR 8214
CFR reference
21 CFR 5
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1996-03-04
Effective date
1996-03-04
Abstract
The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to FDA officials in the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), and the Center for Biologics Evaluation and Research (CBER) by adding a new delegations section concerning the issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment. Additionally, FDA is amending the regulations regarding petitions so that certain officials of CDER, CVM, and CBER are authorized to respond to petitions concerning debarment and refusal to terminate debarment. This action will make the process of issuing such notices and responses to petitions more efficient.