Notice2025-18612
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 25, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 184 (Thursday, September 25, 2025)</title>
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[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Notices]
[Pages 46227-46228]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18612]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0426]
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: Submit written comments (including recommendations) on the
collection of information by October 27, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#26767467755247404066404247084e4e5508414950"><span class="__cf_email__" data-cfemail="b0e0e2f1e3c4d1d6d6f0d6d4d19ed8d8c39ed7dfc6">[email protected]</span></a>.
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
This information collection helps to support FDA regulations. 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.
In the Federal Register of July 2, 2025 (90 FR 29022), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR part; activity Number of responses per Total annual Average burden per Total
respondents respondent responses response hours
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Record retention, 801.150(a)(2) 218 37.5 8,175 .5 (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.
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.
[[Page 46228]]
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of Average
21 CFR part; activity Number of disclosures per Total annual burden per Total
respondents respondent disclosures disclosure hours
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Agreement and labeling requirements, 218 37.5 8,175 4 32,700
801.150(e).........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18612 Filed 9-24-25; 8:45 am]
BILLING CODE 4164-01-P
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