[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Pages 42082-42084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16867]



Food and Drug Administration

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

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.


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 August 
14, 2013.

[[Page 42083]]

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 emailed 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.

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 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.
    In the Federal Register of April 5, 2013 (78 FR 20658), 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 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                         Number of
                      Activity/21 CFR section                           Number 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.

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

    Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16867 Filed 7-12-13; 8:45 am]