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HHS/FDA RIN: 0910-AC42 Publication ID: Spring 2003 
Title: Records and Reports Concerning Experience With Approved New Animal Drugs 
Abstract: In the Federal Register of December 17, 1991 (56 FR 65581), FDA published a proposed rule to revise section 510.300 (21 CFR 510.300) and to redesignate it as section 514.80 (21 CFR 514.80). This regulation implements section 512(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(l)), which provides that, following approval of a new animal drug application or an abbreviated new animal drug application, applicants must establish and maintain records and make reports to the agency as prescribed by regulation or order. FDA proposed the revision to define more clearly the kinds of information to be maintained and submitted by the applicant and to revise the timing and content of certain reports to enhance the usefulness of the information. After considering comments submitted in response to the proposed rule for records and reports, FDA adopted the rule in modified form as an interim final rule on February 4, 2002 (67 FR 5046). The interim final rule differed in some respects from the proposed rule. For instance, the interim final rule did not address medicated feed applications because they were eliminated by the Animal Drug Availability Act of 1996. Also, while the proposed rule for records and reports proposed to remove 21 CFR 510.310, which addressed records and reports for new animal drugs approved before June 20, 1963, FDA issued a final rule that revoked this provision in response to the Administration's "Reinventing Government Initiative" (61 FR 37680, July 19, 1996). The proposed rule for records and reports followed a style and format similar to the human drug records and reports regulations in part 314 (21 CFR part 314) in effect at that time. The interim final rule maintained a similar style and format, but removed many of the proposed records and reports requirements that are not necessary to monitor animal drugs. FDA received four sets of comments on the interim final rule. In response to those comments, the agency further streamlined and clarified the regulation. FDA intends to affirm the interim final rule on its requirements for records and reports concerning experiences with approved new animal drugs (67 FR 5046) with modifications. The modifications include: revising the definitions of "applicant" and "serious adverse drug experience;" modifying the reporting requirement for summary reports of increased frequency of adverse drug experiences; clarifying what safety and efficacy records a nonapplicant versus an applicant must maintain; changing one word in the title of the section of the regulation pertaining to nonclinical laboratory studies and clinical data; eliminating the requirement of submission of prepublication manuscripts relating to completed clinical trials; changing distributor's labeling so that the qualifying phrase that must precede the name and address of the distributor is as permitted by 21 CFR 201.1; and revising the section of the rule pertaining to distributor's signed statements to state that the distributor will promote the product only for use under the conditions stated in the approved labeling. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 514.80   
Legal Authority: 21 USC 360b(l)   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/17/1991  56 FR 65581   
NPRM Comment Period End  02/18/1992    
Interim Final Rule  02/04/2002  67 FR 5046   
Interim Final Rule Comment Period End  04/05/2002    
Interim Final Rule Effective Date Delayed  07/31/2002  67 FR 49568   
Final Action  03/31/2003  68 FR 15255   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Related RINs: Previously reported as 0910-AA02 
Agency Contact:
Glenn Peterson
Mathematician/Statistician (Biomedical)
Department of Health and Human Services
Food and Drug Administration
HFV-212, Center for Veterinary Medicine, 7500 Standish Place,
Rockville, MD 20855
Phone:301 827-0224
Fax:301 827-1485

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