[Federal Register Volume 68, Number 121 (Tuesday, June 24, 2003)]
[Notices]
[Pages 37504-37505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15889]


-----------------------------------------------------------------------

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Draft Guidance for Industry on Providing Regulatory Submissions 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; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Periodic 
Adverse Drug Experience Reports.'' This is one in a series of guidance 
documents on providing regulatory submissions to FDA in electronic 
format. This specific 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). This guidance does not apply to vaccines, 
whole blood or components of whole blood. The submission of these 
reports in electronic format will significantly improve the agency's 
efficiency in processing, archiving, and reviewing the reports.

DATES:  Submit written or electronic comments on the draft guidance by 
August 25, 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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, 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, 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draft guidance to the Division of Dockets Management (HFA-305), Food 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, Center for Drug 
Evaluation and Research (HFD-001), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5411, [email protected]; 
or Michael Fauntleroy, Center for Biologics Evaluation and Research 
(HFM-588), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, (301)827-5132, [email protected].

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Postmarketing Periodic Adverse Drug Experience Reports.'' A 
postmarketing periodic adverse drug experience report includes 
individual case safety reports (ICSRs), attachments to ICSRs (ICSR 
attachments), if applicable, and descriptive information. The 
descriptive information includes the narrative summary and analysis of 
the information in the report, an analysis of the 15-day alert reports 
submitted during the reporting interval, and the history of actions 
taken since the last report because of adverse drug experiences (e.g., 
labeling changes, studies initiated).
    This draft guidance discusses general issues related to the 
electronic submission of postmarketing periodic adverse drug experience 
reports. It provides guidance on the submission of periodic ICSRs, ICSR 
attachments, and descriptive information in electronic format. 
Applicants are referred to the draft guidance for industry ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Expedited 
Safety Reports'' (May 2001) for details on submitting periodic ICSRs 
and ICSR attachments to FDA.\1\ Applicants are also referred to the 
guidance for industry ``Providing Regulatory Submissions in Electronic 
Format--General Considerations'' (January 1999) for details on 
submitting the descriptive information to FDA on physical media.
---------------------------------------------------------------------------

    \1\FDA is considering comments from the public on this draft 
guidance for industry and plans to issue a final guidance on this 
topic in the future.
---------------------------------------------------------------------------

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on providing 
postmarketing periodic adverse drug experience reports in electronic 
format. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments 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. 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. Paperwork Reduction Act of 1995

    This notice contains no new collections of information. The 
information requested for marketed human drug and biological products 
is already covered by the collection of

[[Page 37505]]

information on postmarketing safety reporting regulations (21 CFR 
314.80 and 600.80) submitted to the Office of Management and Budget 
(OMB) for review and clearance. This notice merely provides applicants 
with an alternative mechanism for submitting postmarketing periodic 
adverse drug experience reports to the agency.
    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520), OMB approved the information collection for MedWatch--The 
FDA Medical Products Reporting Program (Forms FDA 3500 and FDA 3500A) 
and assigned it OMB control number 0910-0291. The approval for 0910-
0291 expires on June 30, 2003; an extension of the approval is pending 
at OMB. OMB also approved the information collection for adverse 
experience reporting for marketed drugs and licensed biological 
products and assigned them OMB control numbers 0910-0230 and 0910-0308, 
respectively. The approval for 0910-0230 expires on September 30, 2005, 
and the approval for 0910-0308 expires on May 31, 2005.

IV. Electronic Access

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

    Dated: June 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15889 Filed 6-23-03; 8:45 am]
BILLING CODE 4160-01-S