[Federal Register Volume 68, Number 90 (Friday, May 9, 2003)]
[Notices]
[Pages 25049-25050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11497]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0528]


Risk Management; Public Workshop; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until May 
30, 2003, the comment period for three concept papers entitled 
``Premarketing Risk Assessment,'' ``Risk Management Programs,'' and 
``Risk Assessment of Observational Data: Good Pharmacovigilance 
Practices and Pharmacoepidemiologic Assessment.'' The document that 
requested public input, review, and comments for the three concept 
papers was published in

[[Page 25050]]

the Federal Register of March 7, 2003 (68 FR 11120). The agency is 
taking this action in response to informal requests for an extension of 
the comment period.

DATES: Submit written or electronic comments on the concept papers by 
May 30, 2003.

ADDRESSES: Submit written requests for single copies of the concept 
paper(s) to Lee Lemley, Executive Operations Staff (HFD-006), Center 
for Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the concept papers.
    Submit written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, e-mail: [email protected], or on the Internet at http://accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm.

FOR FURTHER INFORMATION CONTACT: Lee Lemley, Center for Drug Evaluation 
and Research (HFD-006), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-594-6218, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 7, 2003 (68 FR 11120), FDA 
published a document announcing a public workshop to discuss risk 
management activities for drug and biological products (excluding blood 
products other than plasma derivatives). The public workshop was held, 
as scheduled, on April 9, 10, and 11, 2003. To facilitate public input 
and discussion, FDA simultaneously had issued three concept papers for 
review and comment entitled: (1) ``Premarketing Risk Assessment,'' (2) 
``Risk Management Programs,'' and (3) ``Risk Assessment of 
Observational Data: Good Pharmacovigilance Practices and 
Pharmacoepidemiologic Assessment.'' Interested persons were given until 
April 30, 2003, to submit written or electronic comments on the concept 
papers. In response to informal requests from interested persons for 
additional time to submit comments on the concept papers, FDA has 
decided to reopen the comment period until May 30, 2003.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the concept papers. You 
should annotate and organize your comments to identify the specific 
concept paper and issue to which the comments refer. Where possible, 
comments should reference line numbers in the concept papers. Two paper 
copies of any mailed comments are to be submitted, 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. The concept papers and received comments may be seen at the 
Dockets Management Branch between 9 a.m. and 4 p.m. Monday through 
Friday.

III. Electronic Access

    Electronic versions of the concept papers are available via the 
Internet at http://www.fda.gov/cder/meeting/riskmanagement.htm.

    Dated: May 2, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11497 Filed 5-8-03; 8:45 am]
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