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HHS/FDA | RIN: 0910-AA49 | Publication ID: Spring 2014 |
Title: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs | |
Abstract: The rule will reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, including certain biological drugs, and animal drugs. These regulations contain information on when, how, and where to register drug establishments and list drugs, and what information must be submitted. They also address National Drug Codes and associated labeling. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 20 21 CFR 201 and 207 21 CFR 314 and 330 21 CFR 514 to 516 21 CFR 601 and 607 21 CFR 610 21 CFR 1271 | |
Legal Authority: 21 USC 321 and 331 21 USC 351 to 353 21 USC 355 to 356c 21 USC 360 and 360b 21 USC 360c to 360f 21 USC 360h to 360j 21 USC 371 and 374 21 USC 379e and 381 21 USC 393 15 USC 1451 to 1561 42 USC 262 and 264 42 USC 271 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
Public Comment URL: www.regulations.gov | |
RIN Data Printed in the FR: No | |
Agency Contact: David Joy Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6254, Silver Spring, MD 20993 Phone:301 796-2242 Email: david.joy@fda.hhs.gov |