[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.

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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 (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                                  
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                                                      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       
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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