Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization, 49863-49864 [2022-17325]
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Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
preparation of documentation, is
provided by HealthforAnimals.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Effectiveness of Anthelmintics:
Specific Recommendations for Bovines
(Revision 1).’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 have
been approved under OMB Control
Number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
Dated: August 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0375]
jspears on DSK121TN23PROD with NOTICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Agreement for
Shipment of Devices for Sterilization
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:38 Aug 11, 2022
Jkt 256001
Notice.
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.
SUMMARY:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150
OMB Control Number 0910–0131—
Extension
[FR Doc. 2022–17345 Filed 8–11–22; 8:45 am]
AGENCY:
ACTION:
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
§ 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.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
49863
Under § 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 § 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
§ 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:
E:\FR\FM\12AUN1.SGM
12AUN1
49864
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part
Record retention, 801.150(a)(2) ..................................
Number of
records per
recordkeeper
218
Average
burden per
recordkeeping
Total annual
records
37.5
8,175
0.50 (30 minutes) ..
Total hours 2
4,088
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
21 CFR part
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Agreement and labeling requirements, 801.150(e) .........
218
37.5
8,175
4
32,700
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.
You may submit comments
on any guidance at any time as follows:
BILLING CODE 4164–01–P
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1494 (Formerly
FDA–1990–D–0188)]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products;
Effectiveness of Anthelmintics:
Specific Recommendations for
Caprines (Revision 1); Draft Guidance
for Industry; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry GFI #97 (VICH
GL14(R1)) entitled ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Caprines
(Revision 1).’’ This draft guidance has
been developed for veterinary use by the
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
This revision clarifies the definition of
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:38 Aug 11, 2022
Submit either electronic or
written comments on the draft guidance
by October 11, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
ADDRESSES:
[FR Doc. 2022–17325 Filed 8–11–22; 8:45 am]
AGENCY:
adequate infection in individual
animals, updates considerations for
field studies, and makes additional
clarifying changes.
Jkt 256001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
PO 00000
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• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. [insert
Docket No.] for ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Caprines
(Revision 1).’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record retention, 801.150(a)(2).............. 218 37.5 8,175 0.50 (30 minutes)........................ 4,088
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Agreement and labeling requirements, 801.150(e).................. 218 37.5 8,175 4 32,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
