03-26266. Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Postmarketing Periodic Adverse Drug Experience Reports; Reopening of the Comment Period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.

SUMMARY:

The Food and Drug Administration (FDA) is reopening until December 16, 2003, the comment period for the draft guidance for industry entitled “Providing Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports.” FDA published a notice of availability of the draft guidance in the Federal Register of June 24, 2003 (68 FR 37504).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Submit written or electronic comments on the draft guidance by December 16, 2003.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Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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, [e-mail], or

Michael Fauntleroy, CBER (HFM-588), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-5132, [e-mail].

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In the Federal Register of June 24, 2003 (68 FR 37504), FDA published a notice announcing the availability of a draft guidance for industry entitled “Providing Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience Reports.” This draft guidance discusses issues related to the electronic submission of postmarketing periodic adverse drug experience reports for drug products marketed for human use with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.