01-10626. 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.

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 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 Survey¹

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