[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Notices]
[Pages 21399-21400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0175]


Agency Information Collection Activities; Proposed Collection; 
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 
an opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the proposed voluntary survey 
of hospitals to collect information on the extent and nature of current 
practice of reprocessing of single-use medical devices by these 
institutions.

DATES: Submit written or electronic comments on the collection 
of information by June 29, 2001.

ADDRESSES: Submit electronic comments on the collection of 
information to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management

[[Page 21400]]

Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. All comments should be identified with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-26, Rockville, MD 20857, 
301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 
Federal agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (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, before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    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.

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.
    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
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours
                                                     Response        Responses       Response
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4,480                                                   1           4,480               0.125         560
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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.

    Dated: April 24, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-10626 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S