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HHS/FDA RIN: 0910-AA49 Publication ID: Fall 2005 
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 proposed rule would 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 proposed rule would 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 proposed rule would also require that the NDC number appear on drug labels. In addition, FDA would 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: Proposed 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   
Legal Deadline:  None

Statement of Need: FDA relies on establishment registration and drug listing for administering its postmarketing surveillance programs, such as identifying firms that manufacture a specific product or ingredient when that product or ingredient is in short supply or needed for a national emergency, for example, during a bioterrorism threat. FDA also uses registration and listing information for administering other programs such as assessing user fees. FDA is taking this action to improve its establishment registration and drug listing system and to utilize the latest technology in the collection of this information. In addition, improving the accuracy of and requiring NDC numbers on drug labels would help promote the Department's bar code, medication errors, and electronic prescribing initiatives.

Summary of the Legal Basis: The agency has broad authority under sections 301(p), 502(o), 510, and 701(a) of the act and sections 351 and 361 of the Public Health Service Act (PHS Act) to regulate certain establishments with respect to their submission of registration and listing information. Failure to register in accordance with section 510 of the act is a prohibited act under section 301(p) of the act. Failure to comply with section 510 of the act renders drugs misbranded under section 502(o) of the act.

Alternatives: The alternatives to this rulemaking include not updating the registration and listing regulations and not requiring the electronic submission of registration and listing information. FDA originally published the registration regulations in 1963 and the listing regulations in 1973. The registration and listing paper forms that are currently mailed to FDA have been in use since that time. For the reasons stated above, and as a result of the advances in data collection and transmission technology, FDA believes this rulemaking is the preferable alternative.

Anticipated Costs and Benefits: FDA estimates that the costs to industry resulting from the proposed rule would include annually recurring and one-time costs. The recurring costs would include, among other things, measures taken by registrants to protect the integrity of FDA's registration and listing database (such as the use of a unique electronic identifier). The one-time costs would include, among other things, additional time required to enter registration and listing data into FDA's database. In addition, certain registrants would need to convert their labeling to an electronically searchable format the first time they electronically list these products. The specific cost to FDA of developing, administering, and maintaining the Electronic Drug Registration and Listing System (EDRLS) is being calculated. EDRLS will not be ready for use until the rule is finalized. FDA believes that electronic registration and listing will be less costly to industry in the long run than the current requirements. The proposed rule would require less establishment and product information from many registrants and savings would result from not having to process paper copies of the registration and listing forms. The electronic registration and listing process would also enable registrants to receive on-screen feedback if the information submitted is not complete, reducing errors and the time and cost of communicating back and forth with FDA. Information search and retrieval time will also be reduced for FDA, allowing for quicker agency response time. The proposal would make the regulations more user-friendly and would make the registration and listing process easier by incorporating the use of the Internet to submit all information. The proposal would improve the ability to identify and catalogue marketed drugs by helping to eliminate inaccurate NDC numbers on drug labels.

Risks: None

Action Date FR Cite
NPRM  01/00/2006    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
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

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