[Federal Register Volume 66, Number 143 (Wednesday, July 25, 2001)]
[Notices]
[Page 38713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0175]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Survey of Single-Use Medical Device Reuse and 
Reprocessing in Hospitals

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 
August 24, 2001.

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: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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

Survey of Single-Use Medical Device Reuse and Reprocessing in 
Hospitals

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. The ``Survey of Single-Use Medical Device Reuse and 
Reprocessing in Hospitals'' will provide information on the frequency, 
nature, and scope of reuse and reprocessing of single-use medical 
devices by U.S. hospitals. The survey will provide statistically 
reliable estimates of the number of U.S. hospitals that are currently 
reusing and internally reprocessing single-use medical devices, whether 
they have registered with FDA, whether they are aware of the FDA 
educational materials on the reuse of single-use medical devices, and, 
if they are not currently internally reprocessing single-use devices, 
whether they have reused and reprocessed single-use medical devices in 
the past 3 years.
    FDA will use these results to estimate the number of U.S. hospitals 
that reused and reprocessed single-use medical devices in the past, and 
those that currently reuse and internally reprocess single-use medical 
devices. This information will help FDA design its inspection plan, 
modify its education program, and evaluate the economic impact of 
current and future policies regarding single-use medical devices. The 
respondents to this collection of information will be U.S. hospitals.
    In the Federal Register of April 30, 2001 (66 FR 21399), the agency 
requested comments on the proposed collection of information. No 
comments regarding paperwork were received.
    FDA estimates the burden of this collection of information as 
follows:

                       Table 1.--Estimated Annual Reporting Burden for Telephone Survey\1\
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                         Annual Frequency per
 No. of Respondents            Response           Total Annual Responses   Hours per Response      Total Hours
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5,272                             1                     5,272                      0.125             659
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This is a one-time survey. The burden estimate for the telephone 
survey is based on a pretest of a preliminary survey instrument 
administered to nine hospitals. The number of respondents, total annual 
responses, and the total burden hours in this notice differs from the 
numbers in the notice published on April 30, 2001 (66 FR 21399). This 
is because the number of hospitals to be surveyed has changed based on 
more current estimates of the number of hospitals in the United States.

    Dated: July 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-18426 Filed 7-24-01; 8:45 am]
BILLING CODE 4160-01-S