[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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                                       
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         Burden Element               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
Screening Questions Only (30%)         92               1              92               0.083           7.63    
Complete Survey (70%)                 216               1             216               0.50          108       
TOTAL                                 308               -               -               -             115.63    
----------------------------------------------------------------------------------------------------------------
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