[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