[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Page 27819-27820]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 

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 
    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]