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HHS/FDA

RIN: 0910-AA49

Publication ID: Fall 2008

Title: Foreign and Domestic Establishment Registration and Listing Requirements 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. The rule will require that this information be submitted electronically, instead of the current requirement to submit the information to FDA on paper forms. 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 certain drug labels.
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 21 CFR 207 21 CFR 314 21 CFR 330 21 CFR 514 and 515 21 CFR 601 21 CFR 607 21 CFR 610 21 CFR 1271
Legal Authority: 21 USC 321 21 USC 331 21 USC 351 and 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	08/29/2006	71 FR 51276
NPRM Comment Period End	02/26/2007	72 FR 5944
Final Action	06/00/2009

Regulatory Flexibility Analysis Required: Undetermined	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.
RIN Data Printed in the FR: No
Agency Contact: Paula S. McKeever Senior Scientific Policy Analyst Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45, Rockville, MD 20857-0001 Phone:301 827-1520 Fax:301 443-9718 Email: paula.mckeever@fda.hhs.gov