Notice2022-17325
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
August 12, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 155 (Friday, August 12, 2022)</title>
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[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49863-49864]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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#bdedeffceec9dcdbdbfddbd9dc93d5d5ce93dad2cb"><span class="__cf_email__" data-cfemail="1d4d4f5c4e697c7b7b5d7b797c3375756e337a726b">[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
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
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