[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]


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

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.

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

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                                       
----------------------------------------------------------------------------------------------------------------
                                                      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.                      



[[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