Document ID: FDA-2013-N-0375-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection Comment Request; Agreement for Shipment of Devices for Sterilization
Posted Date: 2013-04-05T04:00Z

[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20658-20660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07916]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0375]

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

[[Page 20659]]

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 either electronic or written comments on the collection 
of information by June 4, 2013.

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 FD&C 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 contract 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.
    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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      Activity/21 CFR section                             No. of       responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Agreement and labeling requirements, Sec.   801.150(e).............              90               20            1,800                4            7,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 20660]]

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       No. of records                    Average burden
                      Activity/21 CFR section                             No. of            per          Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record retention, Sec.   801.150(a)(2).............................              90               20            1,800            0.5 *              900
--------------------------------------------------------------------------------------------------------------------------------------------------------
* (30 minutes)
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07916 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P