[Federal Register Volume 72, Number 30 (Wednesday, February 14, 2007)]
[Notices]
[Pages 7042-7043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2467]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0452]


Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
16, 2007.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 Number 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 that are nonsterile are 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.
    In the Federal Register of November 15, 2006 (71 FR 66543), FDA 
published a 60-day notice soliciting comments on the proposed 
collection of information. In response to that notice, no comments were 
received.
    The respondents to this collection of information are device 
manufacturers and contact sterilizers.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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801.150(e)                        90                 20              1,800                  4              7,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 7043]]


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                         No. of        Annual Frequency     Total Annual
  21 CFR Section     Recordkeepers     of Recordkeeping       Records       Hours per  Record     Total Hours
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801.150(a)(2)                     90                 20              1,800                0.5                900
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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 reporting burden is based on actual data 
obtained from industry over the past several years where there are 
approximately 90 firms subject to this requirement. It is estimated 
that each of these firms on the average prepares 20 written agreements 
per year. The recordkeeping requirements of Sec.  801.150(a)(2) consist 
of making copies and maintaining the actual reporting requests which 
are required under the reporting section of this collection.

    Dated: February 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2467 Filed 2-13-07; 8:45 am]
BILLING CODE 4160-01-S