[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