[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Draft Guidance for Industry on Computerized Systems Used in 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availability of a draft guidance for industry entitled ``Computerized 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 This draft guidance, when finalized, will 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Training and Communications, Division of 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Submit written comments on the draft guidance to the Division of 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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