[Federal Register Volume 65, Number 179 (Thursday, September 14, 2000)]
[Notices]
[Pages 55634-55635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1303]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Agreement for Shipment of Devices for 
Sterilization

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.

DATES: Submit written comments on the collection of information by 
October 16, 2000.

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, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 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(e) (OMB Control No. 0910-0131)--Extension

    Under sections 501(c) and 502(a) of the Federal Food, Drug, and 
Cosmetic Act (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(e) (21 CFR 801.150(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(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 misbranded 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. 
The respondents to this collection of information are device 
manufacturers and contract sterilizers.
    In the Federal Register of June 12, 2000 (65 FR 36816), the agency 
requested comments on the proposed collection of information. No 
significant comments were received.

[[Page 55635]]

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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801.150(e)                             80              20           1,800               4           7,200
Total                                                                                              7,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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.
    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.

    Dated: September 7, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-23547 Filed 9-10-00; 8:45 am]
BILLING CODE 4160-01-F