[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Notices]
[Pages 46651-46652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22441]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0266]
Agency Information Collection Activities: Proposed New
Collection; Comment Request
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,
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 a proposed survey of operating room nurse managers at
health care facilities. The purpose of the survey is to estimate the
proportion of the population at risk from the use of adhesive-backed
tape to mark surgical instruments.
DATES: Submit written comments on the collection of information by
November 4, 1996.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1686.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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
[[Page 46652]]
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 listed below.
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.
Surgical Instrument Marking Tape Survey
The mandate of FDA's Center for Devices and Radiological Health
under the authority of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 301-395) and regulations contained in Title 21 of the
Code of Federal Regulations includes the approval and adequate labeling
of medical devices. Section 903(b)(2)(c) of the act (21 U.S.C.
393(b)(2)(c)) authorizes FDA to conduct research relating to medical
devices.
The regulatory status of adhesive-backed, colored tape on medical
devices is under review by FDA. The tape is frequently applied to
medical devices, particularly surgical instruments, to facilitate
sorting. It may be considered an accessory to medical devices used in
surgical treatment as defined by 21 CFR 878.4800.
There are two case reports in the literature in which adverse
events are attributed to the use of adhesive-backed, colored tape to
mark surgical instruments (Journal of Oral Maxillofacial Surgery,
41:687-688, 1983; and British Journal of Surgery, 74:696, 1987). Two
additional adverse event reports have been submitted to FDA.
The purpose of the survey is to estimate the proportion of the
population at risk from this practice, and to determine if use of
operating room nurse managers as proxies for sampling health care
facilities for this purpose is effective. In addition, data will be
collected to identify tape durability, extent of use, and whether there
are any practices or procedures for marking surgical instruments and/or
any human factors that could be altered to better protect the public
health. Labeling information will also be collected.
The proposed randomized survey will be a one-time data collection
effort. Completion of the survey is voluntary, and anonymity of
individuals and institutions will be protected. Survey results will be
available to participants upon request.
The only respondent burden will derive from the time needed to
respond to survey questions. This will occur on a one-time basis. The
length of the screening portion (questions 1 to 7) is estimated at 5
minutes, and the full survey length is estimated at an additional 25
minutes. Burden estimates are based on the need to have 308 surveys
returned to achieve a statistically significant sampling.
FDA estimates the burden of this collection of information as
follows:
Estimated Annual Reporting Burden
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Annual
Burden Element No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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Screening Questions Only (30%) 92 1 92 0.083 7.63
Complete Survey (70%) 216 1 216 0.50 108
TOTAL 308 - - - 115.63
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There are no capital costs or operating and maintenance costs associated with this survey.
Dated: August 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-22441 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F