[Federal Register Volume 60, Number 25 (Tuesday, February 7, 1995)]
[Notices]
[Pages 7204-7205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2991]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93S-0220]


Extension of Electronic Docket for Medical Device/Radiological 
Health Policy Statements and Operating Procedure Guides and Cessation 
of Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has decided to extend 
an electronic docket that was established over 1 year ago to enhance 
public access to policy speeches and statements, standard operating 
procedure guides, and other types of documents related to product 
evaluation and regulatory enforcement for its medical device and 
radiological health programs. The agency has also decided to cease 
maintaining a public ``hard copy'' docket, which was established 
concurrently with and contains the same information as the electronic 
docket. Both dockets have been operating on a 1-year pilot basis.

DATES: Continuation of the electronic docket will extend for an 
indefinite [[Page 7205]] period of time. Written comments and 
suggestions regarding operation of the electronic docket are acceptable 
at any time. Cessation of the public docket is effective immediately.

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

SUPPLEMENTARY INFORMATION: Throughout its existence, the Center for 
Devices and Radiological Health (CDRH) has employed a number of outlets 
to communicate with regulated industry, the medical community, and 
interested consumers about its policies and operations. Although these 
modes of communication were generally regarded as effective, many 
persons expressed the desire for even broader access to CDRH-generated 
information to better assist them in complying with FDA regulatory 
requirements. In response, CDRH created two dockets to serve as readily 
accessible repositories of current and important materials. FDA 
announced the establishment of both dockets in the Federal Register of 
July 27, 1993 (58 FR 40150), and stated there would be a 1-year trial 
period for both information retrieval systems.
    One docket, from which documents in ``hard copy'' form can be 
acquired, has been located at the Dockets Management Branch (address 
above). Interested persons were required to physically visit this 
facility in order to access the information.
    CDRH also established an electronic docket as a means to further 
increase industry access to policy documents. This menu-driven system 
allows interested persons to access, read, print, and download 
documents using personal computers at their places of business.
    Throughout the pilot year, CDRH has monitored the number of 
inquiries received through each of the two dockets. Approximately 100 
document requests were made through the public (``hard copy'') docket. 
In contrast, more than 17,000 inquiries were received through the 
electronic docket, and the number of system accesses continues to 
increase. During the period August through September 1994, slightly 
more than 5,800 requests were made. In addition to these utilization 
statistics, CDRH has taken note of articles, editorials in trade 
publications, and correspondence that have commented favorably about 
the usefulness of the electronic docket in particular.
    In view of the positive feedback on the electronic docket, as 
reflected by the comparatively large volume of inquiries, the agency 
believes there is sufficient justification for maintaining this public 
service. Persons interested in availing themselves of this information 
access system must have a video terminal or personal computer with 
communications software (VT emulation) and a modem that can operate at 
a baud rate of 1200, 2400, 4800, or 9600. For those persons who wish to 
transfer files from the electronic docket, the KERMIT file transfer 
protocol must be used. The telephone number to access the system is 1-
800-252-1366 or 301-594-2741.
    From the experience gained in operating the electronic docket, CDRH 
is contemplating a number of refinements to improve its information 
delivery capability, as well as the scope of material available for 
public access. These will include, for example, announcements of 
upcoming meetings of the agency's various medical device advisory 
panels. As other enhancements to the system are introduced, CDRH will 
inform potential users through CDRH newsletters, trade publications, 
public speeches, and other communication vehicles.
    Effective immediately, FDA is terminating the public docket pilot 
program. Because of the marginal utilization of the public docket, CDRH 
believes that the administrative costs associated with its operation 
are no longer justified.
    The actions announced in this notice do not affect the status of 
two other information access systems referred to in the Federal 
Register notice of July 7, 1993: (1) The CDRH ``Flash FAX'' system, 
from which virtually all documents formerly offered in the public 
docket are presently or shortly will be available; and (2) the 
premarket notification (510(k)) submission status reporting system.
    To receive information or assistance regarding any of the systems 
described in this notice, contact the CDRH Division of Small 
Manufacturers Assistance at 1-800-638-2041 or 301-443-6597, or by FAX 
at 301-443-8818, or write to the contact person above.

    Dated: January 13, 1995.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 95-2991 Filed 2-6-95; 8:45 am]
BILLING CODE 4160-01-F