[Federal Register Volume 61, Number 238 (Tuesday, December 10, 1996)]
[Notices]
[Pages 65069-65070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31360]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0266]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Reinstatement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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
January 9, 1997.
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, Attn: Desk
Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Judy V. Bigelow, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1479.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the
following proposed collection of information to OMB for review and
clearance.
Surgical Instrument Marking Tape Survey
The mandate of FDA's Center for Devices and Radiological Health
under the authority of sections 201-905 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 321-395), 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 1-7) 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.
[[Page 65070]]
Dated: December 3, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31360 Filed 12-9-96; 8:45 am]
BILLING CODE 4160-01-F
