[Federal Register: May 9, 2003 (Volume 68, Number 90)]
[Notices]
[Page 25049-25050]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my03-95]
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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: FDADockets@oc.fda.gov, 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, lemleyl@cder.fda.gov.
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]
BILLING CODE 4160-01-S