[Federal Register Volume 68, Number 201 (Friday, October 17, 2003)]
[Notices]
[Pages 59797-59798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0231]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Postmarketing Periodic Adverse Drug Experience 
Reports; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
December 16, 2003, the comment period for the draft guidance for 
industry

[[Page 59798]]

entitled ``Providing Submissions in Electronic Format--Postmarketing 
Periodic Adverse Drug Experience Reports.'' FDA published a notice of 
availability of the draft guidance in the Federal Register of June 24, 
2003 (68 FR 37504). The agency is taking this action in response to a 
request for an extension of the comment period.

DATES: Submit written or electronic comments on the draft guidance by 
December 16, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or the Office of Communication, 
Training and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATIONsection for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Randy Levin, CDER (HFD-140), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5411, [email protected], 
or
    Michael Fauntleroy, CBER (HFM-588), Food and Drug Administration, 
1401 Rockville Pike, Rockville, MD 20852, 301-827-5132, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 24, 2003 (68 FR 37504), FDA 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Providing Submissions in Electronic Format--
Postmarketing Periodic Adverse Drug Experience Reports.'' This draft 
guidance discusses issues related to the electronic submission of 
postmarketing periodic adverse drug experience reports for drug 
products marketed for human use with new drug applications (NDAs) and 
abbreviated new drug applications (ANDAs), and therapeutic and blood 
products marketed for human use with biologics license applications 
(BLAs). The draft guidance does not apply to vaccines, whole blood, or 
components of whole blood. Interested persons were given until August 
25, 2003, to submit written or electronic comments on the draft 
guidance. In response to a comment requesting an extension of the 
comment period, FDA has decided to reopen the comment period on the 
draft guidance until December 16, 2003, to allow interested persons 
additional time to submit comments.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance on 
or before December 16, 2003. Two copies of any mailed comments are to 
be submitted, except individuals may submit one copy. Comments are to 
be identified with the docket number found in the brackets in the 
heading of this document. The draft guidance and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/cber/guidelines.htm.

    Dated: October 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26266 Filed 10-16-03; 8:45 am]
BILLING CODE 4160-01-S