95-2991. Extension of Electronic Docket for Medical Device/Radiological Health Policy Statements and Operating Procedure Guides and Cessation of Public Docket  

  • [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
    
    

Document Information

Published:
02/07/1995
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
95-2991
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.
Pages:
7204-7205 (2 pages)
Docket Numbers:
Docket No. 93S-0220
PDF File:
95-2991.pdf