[Federal Register Volume 68, Number 117 (Wednesday, June 18, 2003)]
[Proposed Rules]
[Page 36527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15341]



[[Page 36527]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310, 312, 314, 320, 600, 601, and 606

[Docket No. 2000N-1484]
RIN 0910-AA97


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: 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.

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

ADDRESSES: 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 
[email protected] or on the Internet at http://accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT:
    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.

SUPPLEMENTARY INFORMATION:

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:
    [sbull] 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;
    [sbull] Codify the agency's expectations for timely acquisition, 
evaluation, and submission of relevant safety information for marketed 
drugs and licensed biological products;
    [sbull] Require that certain information, such as domestic reports 
of medication errors, be submitted to the agency in an expedited 
manner; and
    [sbull] 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.

    Dated: June 11, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15341 Filed 6-17-03; 8:45 am]
BILLING CODE 4160-01-S