Document ID: FDA-2013-N-0375-0011
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
Posted Date: 2022-08-12T04:00Z

[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49863-49864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17325]

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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 or we) 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: Submit written comments (including recommendations) on the 
collection of information by September 12, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0131. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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 (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 at 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) contact information of the 
firms involved and the identification of the signature authority of the 
shipper and receiver, (2) instructions for maintaining accountability 
of the number of units in each shipment, (3) acknowledgment that the 
devices that are nonsterile are being shipped for further processing, 
and (4) 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 (see 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 in recent 
years. It is estimated that each of the firms subject to this 
requirement prepares an average of 37.5 written agreements each year. 
This estimate varies greatly, from 1 to 218, because some firms provide 
sterilization services on a part-time basis for only 1 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 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 March 15, 2022 (87 FR 14540), 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:

[[Page 49864]]

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                  Number of
                 21 CFR part                      Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records                                                      \2\
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Record retention, 801.150(a)(2)..............             218            37.5           8,175  0.50 (30 minutes)........................           4,088
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the nearest hour.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                        Number of
                           21 CFR part                                Number of      disclosures per     Total annual    Average burden    Total hours
                                                                     respondents        respondent       disclosures     per disclosure
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Agreement and labeling requirements, 801.150(e)..................             218               37.5            8,175                4           32,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall increase of 27,778 hours and a corresponding increase of 6,175 
responses/records. We attribute this adjustment to an increase in the 
number of submissions we received over the last few years.

    Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17325 Filed 8-11-22; 8:45 am]
BILLING CODE 4164-01-P