[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]
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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.
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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
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Annual
No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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39............. 0.5 19.5 3 58.5
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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
