[Federal Register Volume 62, Number 169 (Tuesday, September 2, 1997)]
[Notices]
[Page 46366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0228]


Draft Guidance for Industry on Computerized Systems Used in 
Clinical Trials; Availability; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period on the draft guidance entitled ``Guidance for Industry: 
Computerized Systems Used in Clinical Trials'' until November 3, 1997. 
FDA published a notice of availability of the draft guidance in the 
Federal Register of June 18, 1997 (62 FR 33094). FDA is reopening the 
comment period in response to requests for additional time to review 
the agency's draft guidance on the use of computerized systems in 
clinical trials.
DATES: Written comments may be submitted on the draft guidance document 
by November 3, 1997. General comments on agency guidance documents are 
welcomed at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Comments should be identified with the docket 
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: James F. McCormack, Office of 
Enforcement (HFC-230), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0425.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 18, 1997, 
FDA announced the availability of a draft guidance for industry 
entitled ``Guidance for Industry: Computerized Systems Used in Clinical 
Trials.'' The draft guidance is intended to assist applicants who wish 
to use computer systems to generate, collect, maintain and transmit 
clinical data for submission to FDA in support of marketing or research 
applications. The notice invited interested persons to submit written 
comments on the draft guidance by August 18, 1997.
    The agency received a number of requests for additional time to 
comment on the draft guidance and is reopening the comment period until 
November 3, 1997.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). 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 may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: August 25, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-23180 Filed 8-29-97; 8:45 am]
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