View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AA49 | Publication ID: Spring 2002 |
Title: Establishment Registration and Product Listing 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 biological products. 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 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: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 201 21 CFR 207 21 CFR 314 | |
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 |
Legal Deadline:
None |
||||||
Timetable:
|
Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Federalism: Undetermined | |
Included in the Regulatory Plan: No | |
Agency Contact: Howard P. Muller Office of Regulatory Policy Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 Email: howard.mullerjr@fda.hhs.gov |