[Federal Register Volume 62, Number 35 (Friday, February 21, 1997)]
[Notices]
[Page 8024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4227]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0025]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
March 24, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collection of information to OMB for review and 
clearance:

Medical Devices Standards Activities Report (OMB Control Number 
0910-0219--Extension)

    FDA is collecting information necessary to update a comprehensive 
listing of current national and international standards activities in 
the field of medical devices. The collection of this information is 
authorized by section 514(a)(4)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360d(a)(4)(B)), which requires FDA to consult 
with other nationally or internationally recognized standard-setting 
entities, including other Federal agencies concerned with standard-
setting, in carrying out its responsibility to establish special 
controls for medical devices. This report is used by approximately 39 
standards-developing organizations to coordinate their standards 
activities. This coordination prevents duplication of effort and 
insures efficient and expeditious management of standards development. 
Over 700 copies of this report are used by government, hospitals, 
libraries, industry, private citizens, and State and local government 
agencies, including FDA, to keep abreast of standards development 
activities and current technology concerning the safety of medical 
devices. Without the report, there would be duplication of standards 
efforts by voluntary standards organizations because there is no other 
publication that can be easily referenced to ascertain if a certain 
medical device standard is being or has been developed.
    FDA estimates the burden of this collection of information as 
follows:

                    Estimated Annual Reporting Burden                   
------------------------------------------------------------------------
                     Annual                                             
     No. of      Frequency per   Total Annual    Hours per   Total Hours
  Respondents       Response      Responses      Response               
------------------------------------------------------------------------
39.............         0.5           19.5             3          58.5  
------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated
  with this collection of information.                                  

    This collection occurs biennially and is voluntary. There are 39 
national and international organizations with one report each reporting 
period.

    Dated: February 12, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-4227 Filed 2-20-97; 8:45 am]
BILLING CODE 4160-01-F