[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Pages 21631-21632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 May 26, 
2010.

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: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0131. 
Also include the FDA 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, 
[email protected].

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)(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'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 4 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

[[Page 21632]]

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.
    In the Federal Register of February 18, 2010 (75 FR 7276), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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   21 CFR          No. of        Annual Frequency      Total Annual          Hours per
  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
                 21 CFR Section                     Recordkeepers      per 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 associated with this collection of information.

    Due to a clerical error, the operating and maintenance costs that 
appeared in a document published in the Federal Register of February 
18, 2010, were incorrect. There are actually no operating and 
maintenance costs associated.

    Dated: April 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9555 Filed 4-23-10; 8:45 am]
BILLING CODE 4160-01-S