[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