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HHS/FDA | RIN: 0910-AA49 | Publication ID: Fall 2010 |
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 |
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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: 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 |