[Federal Register Volume 66, Number 87 (Friday, May 4, 2001)]
[Notices]
[Pages 22585-22586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11235]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0185]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Postmarketing Expedited Safety Reports; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

[[Page 22586]]

availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Postmarketing Expedited 
Safety 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 expedited safety reports for drug products marketed 
for human use with new drug applications (NDAs) and abbreviated new 
drug applications (ANDAs), prescription drug products marketed for 
human use without an approved NDA or ANDA, and therapeutic biological 
products marketed for human use with biologic license applications 
(BLAs). This guidance does not apply to vaccines. The submission of 
these reports in an electronic format will significantly improve the 
agency's efficiency in processing, archiving, and reviewing the 
reports.

DATES: Submit written comments on the draft guidance by July 3, 2001. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Deborah Yaplee, Center for Drug Evaluation and Research (HFD-400), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-3237, [email protected]; or
    Michael Fauntleroy, Center for Biologics Evaluation and Research 
(HFM-588), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, 301-827-5101, [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 Expedited Safety Reports.'' FDA has cooperated with 
industry associations and the regulatory authorities of certain other 
nations to promote international harmonization of regulatory 
requirements. Much of this effort has been coordinated through the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). Under the auspices 
of the ICH, standards for electronic submission of safety information 
for human drug and biological products have been developed, including a 
standard medical terminology for regulatory purposes, ICH M1; 
electronic standards for the transfer of regulatory information, ICH 
M2; and standardized data elements for transmission of individual case 
safety reports, ICH E2B and E2BM formats.
    This draft guidance is intended to provide guidance to industry 
regarding submission of postmarketing expedited safety reports to FDA 
electronically using the standards established by the ICH. FDA believes 
the changes recommended by the ICH will result in more effective and 
efficient safety reporting to regulatory authorities worldwide.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). The draft guidance represents the agency's current thinking 
on providing postmarketing expedited safety reports in an 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 Dockets Management Branch 
(address above) written comments on the draft guidance. Two copies of 
any comments are to be submitted, except that individuals may submit 
one 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 Dockets 
Management Branch 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 information on postmarketing 
safety reporting regulations (21 CFR 310.305, 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 expedited safety 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 April 30, 2003.
    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 May 31, 2002, and 
the approval for 0910-0308 expires on April 30, 2003.

IV. Electronic Access

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

    Dated: April 27, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-11235 Filed 5-3-01; 8:45 am]
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