[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59239-59240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22204]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0440]
Draft Guidance for Industry on Computerized Systems Used in
Clinical Trials; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Computerized
Systems Used in Clinical Trials.'' This document provides guidance
about computerized systems that are used to create, modify, maintain,
archive, retrieve, or transmit clinical data required to be maintained
and/or submitted to FDA. This draft guidance, when finalized, will
supercede the guidance of the same name issued in April 1999.
DATES: Submit written or electronic comments on the draft
recommendations by January 3, 2005. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Training and Communications, Division of
Communications Management, Division of Drug Information (HFD-240),
Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville,
MD 20857; to 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;
to the Office of Health and Industry Programs,
[[Page 59240]]
Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850-
4307, Manufacturers Assistance: 800-638-2041 or 301-443-6597; or the
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests. Submit telephone requests to 800-835-4709 or 301-827-1800.
Submit written comments on the draft guidance to the Division of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:
Joseph Salewski, Center for Drug Evaluation and Research (HFD-45),
Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855,
301-594-0020; or
Patricia Holobaugh, Center for Biologics Evaluation and Research
(HFM-664), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301-827-6347; or
John Murray, Jr., Center for Devices and Radiological Health (HFZ-
340), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD
20850, 301-594-4646, ext. 107; or
John Welsh, Center for Food Safety and Applied Nutrition (HFS-205),
Food and Drug Administration, 1110 Vermont Ave., NW, Washington, DC
20005, 202-418-3057; or
Vernon Toelle, Center for Veterinary Medicine (HFV-234), Food and
Drug Administration, 7519 Standish Pl., Rockville, MD 20835, 301-827-
0312; or
James McCormack, Office of Enforcement (HFC-230), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20857, 301-827-0425; or
Patricia Beers Block, Good Clinical Practice Programs (HF-34), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3340.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Computerized Systems Used in Clinical Trials.'' This
document provides guidance about computerized systems that are used to
create, modify, maintain, archive, retrieve, or transmit clinical data
required to be maintained and/or submitted to FDA. These data form the
basis for the agency's decisions regarding the safety and effectiveness
of new human and animal drugs, biological products, medical devices,
and certain food and color additives. As such, these data have broad
public health significance and are expected to be of the highest
quality and integrity.
This draft guidance, when finalized, will supercede the guidance of
the same name issued in April 1999. This draft guidance is being
revised to make it consistent with agency policy as reflected in the
guidance for industry on ``Part 11, Electronic Records; Electronic
Signatures--Scope and Application,'' which issued in August 2003. It
also reflects policy consistent with regard to the agency's
international harmonization efforts.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). This draft
guidance, when finalized, will represent the agency's current thinking
on computerized systems used in clinical trials. 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 the approach
satisfies the requirements of the applicable statute and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Two paper copies of any 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 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
Copies of this draft guidance for industry are available on the
Internet at http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, http://www.fda.gov/cvm/guidance/guidance.html, and http://www.fda.gov/oc/gcp/draft.html.
Dated: September 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22204 Filed 9-29-04; 1:51 pm]
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