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| HHS/FDA | RIN: 0910-AA49 | Publication ID: Fall 2006 |
| 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 via the Internet into the FDA registration and listing database, instead of the current requirement to submit the information to FDA on paper forms. The rule will also require that the NDC number appear on certain drug labels. In addition, FDA will assign the NDC number to newly listed drugs and take other steps to minimize the use of inaccurate NDC numbers on 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; 21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 1271 | |
| 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; 42 USC 264; 42 USC 271 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
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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 |
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