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Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

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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.

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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 Survey1

No. of RespondentsAnnual Frequency per ­ResponseTotal Annual ResponsesHours per ResponseTotal Hours
5,27215,2720.125659
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.

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Dated: July 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 01-18426 Filed 7-24-01; 8:45 am]

BILLING CODE 4160-01-S