97-13819. Discontinuation of an Electronic Docket for Medical Device/ Radiological Health Policy Statements and Operating Procedures Guide; Establishment of World Wide Web Site  

  • [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
    
    
    

Document Information

Published:
05/27/1997
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
97-13819
Pages:
28718-28719 (2 pages)
Docket Numbers:
Docket No. 93S-0220
PDF File:
97-13819.pdf