View Rule

View EO 12866 Meetings

Printer-Friendly Version Download RIN Data in XML

HHS/FDA

RIN: 0910-AA49

Publication ID: Fall 2003

Title: Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and Biologics
Abstract: The proposed rule would amend FDA regulations on the registration of producers of drugs and the listing of drugs in commercial distribution. The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list drug or biologics regulated as drugs. The proposal describes when, how, and where to register and list, and what information must be submitted for registration and listing. The proposed regulations would also revise the requirements for the National Drug Code number and would require the electronic submission of most registration and listing information.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 20 21 CFR 201 21 CFR 207 21 CFR 314 21 CFR 330 21 CFR 514 21 CFR 515 21 CFR 601 21 CFR 607 21 CFR 610 21 CFR 1271
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 21 USC 352 21 USC 355 21 USC 360 21 USC 360b 21 USC 371 21 USC 374 42 USC 262 42 USC 264 42 USC 271

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	03/00/2004

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
Agency Contact: Mary H. Keyes Office of Policy Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Reserach, 1451 Rockville Pike, Rockville, MD 20852 Phone:301 594-2041 Fax:301 827-5562