[Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
[Notices]
[Pages 28718-28719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13819]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93S-0220]


Discontinuation of an Electronic Docket for Medical Device/
Radiological Health Policy Statements and Operating Procedures Guide; 
Establishment of World Wide Web Site

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is discontinuing an electronic docket for policy speeches, policy 
statements, and standard operating procedure guides pertaining to 
product evaluation and regulatory enforcement for its medical device 
and radiological health programs. In its place, the agency has 
established a World Wide Web (WWW) site. The electronic docket, a 
computer bulletin board service which has been operating since 1993, 
served both as a repository for critical policy documents generated by 
the Center for Devices and Radiological Health (CDRH) and as a public 
display mechanism for access by representatives of the industry and 
other interested persons. That service ended October 1, 1996, and its 
contents transferred to a CDRH web site

[[Page 28719]]

on the WWW. FDA believes that the transfer will allow CDRH to expand 
both the amount of information available and the number of users that 
can access the information.

ADDRESSES: Submit written comments on the electronic docket to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John F. Stigi, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-443-6597 ext. 124, E-Mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of July 27, 1993 (58 
FR 40150), FDA announced, among other things, the establishment of a 
public docket for policy speeches, policy statements, and standard 
operating procedure guides pertaining to product evaluation and 
regulatory enforcement for its medical device and radiological health 
programs. This docket was intended to operate on a 1-year trial basis 
and serve as a repository for critical policy documents generated by 
the Center for Devices and Radiological Health (CDRH) and as a public 
display mechanism for access by representatives of the industry and 
other interested persons. The public docket contained ``hard copies'' 
of documents and was maintained through FDA's Dockets Management 
Branch. This action was intended to serve as an overall communications 
initiative to endure uniform and timely access to important 
information. The trial period for this public began July 27, 1993, and 
was intended to end July 27, 1994.

    To further increase industry access to major CDRH documents in a 
real time and dynamic fashion, a nationwide electronic docket was 
established concurrently with the public (``hard copy'') docket and 
contained the same information as the public docket. The electronic 
docket allowed medical device companies, clinical researchers, 
manufacturers of radiation-emitting products, and others to 
electronically access the same documents available in the public 
docket. The documents could be read directly on the requestor's 
computer screen, printed at the requestor's terminal, downloaded to the 
requestor's personal computer, or be requested by mail. The system was 
menu-driven and included automated searching capabilities.
    In the Federal Register of February 7, 1995 (60 FR 7204), FDA 
issued a notice that extended, for an indefinite period of time, this 
electronic docket. The agency also decided to stop maintaining a public 
``hard copy'' docket. During its trial period, the success of the 
electronic docket as an information dissemination source was clearly 
demonstrated by the high volume of electronic accessions and transfers. 
However, demand soon outstripped the ability of the computer bulletin 
board service, which restricts the numbers of users that can 
simultaneously access the system. In order to increase the level of 
service to the public, the computer bulletin board service has been 
supplanted by the WWW. The technology offered by the WWW has enabled 
CDRH to logarithmically expand both the amount of information available 
and the number of users that can access the information. The CDRH web 
site Home Page is located at TTP://WWW.FDA.GOV/CDRH and is linked to 
FDA's Home Page. Through FDA's Home Page, the web site Home Pages of 
many other FDA components, such as Import Operations and Field 
Activities, can also be accessed.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the discontinuation of the 
electronic docket. 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. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 19, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-13819 Filed 5-23-97; 8:45 am]
BILLING CODE 4160-01-F