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Federal Register / Vol. 66, No.

143 / Wednesday, July 25, 2001 / Notices 38713

application. This time is consistent with Currently, sponsors of covered studies vitae. FDA estimates than an average of
the current recordkeeping requirements must maintain many records with 15 minutes will be required for each
for other information related to regard to clinical investigators, recordkeeper to add this record to
marketing applications for human including protocol agreements and clinical investigators’ file.
drugs, biologics, and medical devices. investigator resumes or curriculum

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Annual Frequency per Total Annual Hours per
21 CFR Section No. of Recordkeepers Total Hours
Recordkeeping Records Recordkeeper

54.6 1,000 1 1,000 .25 250
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: July 19, 2001. ADDRESSES: Submit written comments hospitals that are currently reusing and
Margaret M. Dotzel, on the collection of information to the internally reprocessing single-use
Associate Commissioner for Policy. Office of Information and Regulatory medical devices, whether they have
[FR Doc. 01–18479 Filed 7–24–01; 8:45 am] Affairs, OMB, New Executive Office registered with FDA, whether they are
BILLING CODE 4160–01–S Bldg., 725 17th St. NW., rm. 10235, aware of the FDA educational materials
Washington, DC 20503, Attn: Wendy on the reuse of single-use medical
Taylor, Desk Officer for FDA. devices, and, if they are not currently
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: internally reprocessing single-use
HUMAN SERVICES Peggy Schlosburg, Office of Information devices, whether they have reused and
Resources Management (HFA–250), reprocessed single-use medical devices
Food and Drug Administration Food and Drug Administration, 5600 in the past 3 years.
[Docket No. 01N–0175] Fishers Lane, Rockville, MD 20857,
FDA will use these results to estimate
301–827–1223.
Agency Information Collection the number of U.S. hospitals that reused
SUPPLEMENTARY INFORMATION: In
Activities; Submission for OMB and reprocessed single-use medical
compliance with 44 U.S.C. 3507, FDA devices in the past, and those that
Review; Comment Request; Survey of has submitted the following proposed
Single-Use Medical Device Reuse and currently reuse and internally reprocess
collection of information to OMB for
Reprocessing in Hospitals single-use medical devices. This
review and clearance.
information will help FDA design its
AGENCY: Food and Drug Administration, Survey of Single-Use Medical Device inspection plan, modify its education
HHS. Reuse and Reprocessing in Hospitals program, and evaluate the economic
ACTION: Notice.
Section 1701(a)(4) of the Public impact of current and future policies
SUMMARY: The Food and Drug Health Service Act (42 U.S.C. regarding single-use medical devices.
Administration (FDA) is announcing 300u(a)(4)) authorizes FDA to conduct The respondents to this collection of
that the proposed collection of research relating to health information. information will be U.S. hospitals.
information listed below has been The ‘‘Survey of Single-Use Medical In the Federal Register of April 30,
submitted to the Office of Management Device Reuse and Reprocessing in 2001 (66 FR 21399), the agency
and Budget (OMB) for review and Hospitals’’ will provide information on requested comments on the proposed
clearance under the Paperwork the frequency, nature, and scope of collection of information. No comments
Reduction Act of 1995. reuse and reprocessing of single-use regarding paperwork were received.
DATES: Submit written comments on the medical devices by U.S. hospitals. The
collection of information by August 24, survey will provide statistically reliable FDA estimates the burden of this
2001. estimates of the number of U.S. collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR TELEPHONE SURVEY1
Annual Frequency per
No. of Respondents Total Annual Responses Hours per Response Total Hours
Response

5,272 1 5,272 0.125 659
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 current estimates of the number of DEPARTMENT OF HEALTH AND
estimate for the telephone survey is hospitals in the United States. HUMAN SERVICES
based on a pretest of a preliminary Dated: July 18, 2001.
survey instrument administered to nine Food and Drug Administration
hospitals. The number of respondents, Margaret M. Dotzel,
total annual responses, and the total Associate Commissioner for Policy. Anesthetic and Life Support Drugs
burden hours in this notice differs from [FR Doc. 01–18426 Filed 7–24–01; 8:45 am] Advisory Committee; Notice of Meeting
the numbers in the notice published on BILLING CODE 4160–01–S AGENCY: Food and Drug Administration,
April 30, 2001 (66 FR 21399). This is HHS.
because the number of hospitals to be
ACTION: Notice.
surveyed has changed based on more

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