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HHS/FDA

RIN: 0910-AA49

Publication ID: Spring 2011

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 at 21 CFR part 207 concerning who must register establishments and list human drugs, 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 for initial registration and listing and for changes to registration and listing. Consistent with amended statutory requirements, the rule will require that this information be submitted electronically. The rule will also make certain changes to the National Drug Code (NDC) system and would require that the appropriate human-readable NDC number appear on labels for drugs subject to the listing requirement.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
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

Timetable:

Action	Date	FR Cite
NPRM	08/29/2006	71 FR 51276
NPRM Comment Period End	02/26/2007
Final Action	To Be Determined

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: Paul Loebach Operations Research Analyst Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 51, Room 4268, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-2173 Email: paul.loebach@fda.hhs.gov