[Federal Register Volume 61, Number 214 (Monday, November 4, 1996)]
[Notices]
[Pages 56685-56686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28209]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0298]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Extension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995,
Federal agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the voluntary collection of information for the
Medical Devices Standards Activities Report, a comprehensive listing of
current national and international standards for medical devices.
DATES: Submit written comments on the collection of information by
January 3, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1686.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To
comply with this requirement, FDA is publishing notice of the proposed
collection of information listed below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
[[Page 56686]]
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 since 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 Frequency per Total Annual
No. of Respondents Response Responses Hours per Response Total Hours
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39................... .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
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period.
Dated: October 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-28209 Filed 11-1-96; 8:45 am]
BILLING CODE 4160-01-F
