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HHS/FDA RIN: 0910-AA97 Publication ID: Fall 2004 
Title: Safety Reporting Requirements for Human Drug and Biological Products 
Abstract: This regulation is one component of the Secretary's initiative to reduce medical errors. The final rule would amend the expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and propose other revisions to these regulations to enhance the quality of safety reports received by FDA. 
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: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 600; 21 CFR 601; 21 CFR 606 
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 USC 263; 42 USC 263a to 263-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 
Legal Deadline:  None

Statement of Need: FDA currently has safety reporting requirements in section 21 CFR 312.32 for sponsors of investigational drugs for human use. FDA also has safety reporting requirements in sections 21 CFR 310.305, 314.80, 314.98 and 600.80 and 600.81 for applicants, manufacturers, packers, and distributors of approved human drug and biological products. FDA has undertaken a major effort to clarify and revise these regulations to improve the management of risks associated with the use of these products. For this purpose, the agency is proposing to implement certain definitions and reporting formats and standards recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to provide more effective and efficient safety reporting to regulatory authorities worldwide. Currently, the United States, European Union, and Japan require submission of safety information for marketed drug and biological products using different reporting formats and different reporting intervals.

Summary of the Legal Basis: The agency has broad authority under sections 505 and 701 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355 and 371) and section 351 of the Public Health Service Act (42 U.S.C. 262) to monitor the safety of drug and biological products for human use.

Alternatives: The alternatives to the proposal include not amending our existing safety reporting requirements. This alternative would be inconsistent with FDA's efforts to harmonize its safety reporting requirements with international initiatives and with its mission to protect public health.

Anticipated Costs and Benefits: Manufacturers of human drug and biological products currently have limited incentives to invest capital and resources in standardized global safety reporting systems because individual firms acting alone cannot attain the economic gains of harmonization. This final rule would harmonize FDA's safety reporting requirements with certain international initiatives, thereby providing the incentive for manufacturers to modify their safety reporting systems. Initial investments made by manufacturers to comply with the rule are likely to ultimately result in substantial savings to them over time. The impact on industry includes costs associated with revised safety reporting and recordkeeping requirements. The benefits of the proposed rule are public health benefits and savings to the affected industries. The expected public health benefits would result from the improved timeliness and quality of the safety reports and analyses, making it possible for health care practitioners and consumers to expedite corrective actions and make more informed decisions about treatments. Savings to the affected industry would accrue from more efficient allocation of resources resulting from international harmonization of the safety reporting requirements.

Risks: None

Action Date FR Cite
NPRM  03/14/2003  68 FR 12406 
NPRM Comment Period Extended  06/18/2003   
NPRM Comment Period End  07/14/2003   
NPRM Comment Period Extension End  10/14/2003   
Comment Review End  04/00/2005   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
Agency Contact:
Elizabeth J. Sadove
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Avenue, Bldg. 51, Room 6368,
Silver Spring, MD 20993-0002
Phone:301 796-3522
Fax:301 847-8440

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