[Federal Register Volume 62, Number 171 (Thursday, September 4, 1997)] [Notices] [Page 46744] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-23507] [[Page 46744]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97N-0022] Agency Information Collection Activities Submission for OMB Review; Comment Request 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 (the PRA). DATES: Submit written comments on the collection of information by October 6, 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 20503, Attention: Desk Officer for FDA. FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1479. SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA (44 U.S.C. 3507), FDA has submitted the following proposed collection of information to OMB for review and clearance. Agreement for Shipment of Devices for Sterilization--21 CFR 801.150(a)(2) and (e) (OMB Control No. 0910-0131--Reinstatement) Under sections 501(c) and 502(a) of the act (21 U.S.C. 351(c) and 352(a)), nonsterile devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are adulterated and misbranded. FDA regulations in Sec. 801.150(a)(2) and (e) (21 CFR 801.150(a)(2) and (e)) establish a control mechanism by which firms may manufacture and label medical devices as sterile at one establishment and ship the devices in interstate commerce for sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Under Sec. 801.150(a)(2) and (e), manufacturers and sterilizers may sign an agreement containing the following: (1) Instructions for maintaining accountability of the number of units in each shipment; (2) acknowledgment that the devices are nonsterile, being shipped for further processing; and (3) specifications for sterilization processing. This agreement allows the manufacturer to ship nonsterile products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. During routine plant inspections, FDA normally reviews agreements that must be kept for 2 years after final shipment or delivery of devices. To discontinue this reporting and recordkeeping procedure would place an economic hardship on the industry and an additional burden on FDA to monitor products in interstate commerce for failure to comply with adulteration and misbranding provisions of the act. The respondents to this collection of information are device manufacturers and contract sterilizers. FDA estimates the reporting burden of this collection of information as follows: Table--1. Estimated Annual Reporting Burden ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- 801.150 90 20 1,800 4 7,200 ---------------------------------------------------------------------------------------------------------------- There are no capital costs or operating and maintenance costs associated with this collection of information. No burden has been estimated for the recordkeeping requirement in Sec. 801.150(a)(2) because these records are maintained as a usual and customary part of normal business activities. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. FDA's estimate of the burden is based on actual data obtained from industry during the past 3 years where there are approximately 90 firms subject to this requirement. Dated: August 27, 1997. William B. Schultz, Deputy Commissioner for Policy. [FR Doc. 97-23507 Filed 9-3-97; 8:45 am] BILLING CODE 4160-01-F