[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Notices]
[Page 27819-27820]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my03-48]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0194]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Agreement for Shipment of Devices for Sterilization
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 information
collection, 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
process labeling or repacking.
DATES: Submit written or electronic comments on the collection of
information by July 21, 2003.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the Dockets
Management Branch (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: Peggy Robbins, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of the 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: (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 reporting burden of this collection of
information as follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency
CFR Section No. of Respondents per Response Hours per Response Total Hours Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.150(e) 90 20 1,800 4 7,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total .................. .................. .................... .................... 7,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 over the past 6 years where there are approximately 90 firms
subject to this requirement.
No burden has been estimated for the recordkeeping requirement in
21 CFR 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
[[Page 27820]]
would occur in the normal course of activities.
Dated: May 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12718 Filed 5-20-03; 8:45 am]
BILLING CODE 4160-01-S