[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Notices]
[Page 66543-66544]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no06-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0452]
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 January 16, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. 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: 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: 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), 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.
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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21 CFR Annual Frequency Total Annual
Section No. of Respondents per Response Responses Hours per 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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21 CFR Annual Frequency of Total Annual
Section No. of Recordkeepers Recordkeeping Records Hours per Record Total Hours
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801.150(a)( 90 20 1,800 0.5 900
2)
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 66544]]
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 21 CFR 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: November 9, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19283 Filed 11-14-06; 8:45 am]
BILLING CODE 4160-01-S