81 FR 51204 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 149 (August 3, 2016)

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.

[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Notices]
[Pages 51204-51205]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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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 
September 2, 2016.

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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [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--
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 data obtained from industry over the past several 
years. It is estimated that each of the firms subject to this 
requirement prepares an average of 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

[[Page 51205]]

imposed by this regulation. The written agreement generally also 
includes contractual agreements that are a usual and customary business 
practice. The recordkeeping requirements of Sec.  801.150(a)(2) consist 
of making copies and maintaining the records required under the third-
party disclosure section of this collection.
    In the Federal Register of April 20, 2016 (81 FR 23309), 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 
follows:

                                 Table 1--Estimated Annual Recordkeeping Burden
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                                                                                  Average burden
                                     Number of       Number of     Total annual         per
         21 CFR section            recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                       (hours)
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Record retention, 801.150(a)(2).              90              20           1,800              .5             900
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                             Table 2--Estimated Annual Third-Party Disclosure Burden
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                                                     Number of                    Average burden
     Activity/21 CFR section         Number of      disclosures    Total annual   per disclosure    Total hours
                                    respondents   per respondent    disclosures       (hours)
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Agreement and labeling                        90              20           1,800               4           7,200
 requirements, 801.150(e).......
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    Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18299 Filed 8-2-16; 8:45 am]
 BILLING CODE 4164-01-P