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Proposed Rule

Safety Reporting Requirements for Human Drug and Biological Products; Extension of Comment Period

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.


Proposed rule; extension of comment period.


The Food and Drug Administration (FDA) is extending to October 14, 2003, the comment period for a proposed rule published in the Federal Register of March 14, 2003 (68 FR 12406). The proposed rule would amend the agency's pre- and postmarketing safety reporting regulations for human drug and biological products. The agency is taking this action in response to a request for more time to submit comments to FDA.


Submit written or electronic comments on the proposed rule by October 14, 2003.


Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to or on the Internet at​scripts/​oc/​dockets/​commentdocket.cfm.

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For information concerning human drug products: Audrey A. Thomas, Center for Drug Evaluation and Research (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5626.

For information concerning human biological products: Miles Braun, Center for Biologics Evaluation and Research (HFM-220), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6079.

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I. Background

In the Federal Register of March 14, 2003 (68 FR 12406), FDA published a proposed rule that, if finalized, would amend its pre-and postmarketing safety reporting regulations for human drug and biological products to:

  • Implement definitions and reporting formats and standards recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and by the World Health Organization's Council for International Organizations of Medical Sciences;
  • Codify the agency's expectations for timely acquisition, evaluation, and submission of relevant safety information for marketed drugs and licensed biological products;
  • Require that certain information, such as domestic reports of medication errors, be submitted to the agency in an expedited manner; and
  • Clarify certain requirements and make other minor revisions.

FDA also proposed to amend its postmarketing annual reporting regulations for human drug and licensed biological products by revising the content for these reports.

Interested persons were given until July 14, 2003, to submit written or electronic comments to the agency on the proposal. On May 7, 2003, FDA received a written request to allow an additional 90 days for interested persons to comment. FDA believes that an extension of 90 days to the comment period is appropriate, given the length and complexity of the proposed rule. Therefore, FDA is extending the comment period until October 14, 2003. This extension will provide the public with a total of 210 days to submit comments.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the proposal. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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Dated: June 11, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 03-15341 Filed 6-17-03; 8:45 am]