Document ID: FDA-2010-N-0070-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals:Agreement for Shipment of Devices for Sterilization
Posted Date: 2010-02-18T05:00Z

[Federal Register: February 18, 2010 (Volume 75, Number 32)]
[Notices]               
[Page 7276-7277]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe10-36]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0070]

 
Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements relating to shipment of nonsterile devices that are to be 
sterilized elsewhere or are shipped to other establishments for further 
processing, labeling, or repacking.

DATES:  Submit written or electronic comments on the collection of 
information by April 19, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under 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 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, including 
each proposed extension of an existing 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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

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)(1), 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 (Sec.  801.150(a)(2)).
    The respondents to this collection of information are device 
manufacturers and contact sterilizers.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 7277]]

                                 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.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                           No. of        Annual Frequency     Total Annual      Hours per                             Total Operating &
           21 CFR Section               Recordkeepers    per Recordkeeping      Records           Record           Total Hours        Maintenance Costs
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801.150(a)(2)                                       90                  20            1,800              0.5                   900               $55,800
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\1\ There are no capital 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 
each year. This estimate varies greatly, from 1 to 100, because some 
firms provide sterilization services on a part time basis for only one 
customer while others are large facilities with many customers. The 
average time required to prepare each written agreement is estimated to 
be four hours. This estimate varies depending on whether the agreement 
is the initial agreement or an annual renewal, on the format each firm 
elects to use, and on the length of time required to reach agreement. 
The estimate applies only to those portions of the written agreement 
that pertain to the requirements imposed by this regulation. The 
written agreement generally also includes contractual agreements that 
are a customary and usual business practice. On the average, the total 
annual recordkeeping burden is 7,200 hours (90 firms x 20 agreements x 
4 hours).
    The recordkeeping requirements of Sec.  801.150(a)(2) consist of 
making copies and maintaining the actual reporting requests which were 
required under the reporting section of this collection. To fulfill 
this requirement, FDA estimates it will take about 30 minutes to copy 
each package, for a total of 900 recordkeeping hours and includes 
$55,800 operating and maintenance costs.

    Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3027 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S