Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles, 38058-38059 [2023-12512]
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38058
Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section
10.19—request for waiver, suspension, or modification of requirements.
10.30 and 10.31—citizen petitions and petitions related to ANDAs certain NDAs,2 or certain BLAs 3.
10.33—administrative reconsideration of action ........
10.35—administrative stay of action ..........................
10.65—meetings and correspondence ......................
10.85—requests for Advisory opinions ......................
10.115(f)(3)—submitting draft guidance proposals ....
12.22—Filing objections and requests for a hearing
on a regulation or order.
12.45—Notice of participation ....................................
External requests for FDA speakers ..........................
Total ....................................................................
Total annual
responses
Average burden per
response
Total hours
7
1
7
1 ..............................
7
200
1
200
24 ............................
4,800
9
12
37
1
26
18
1
1
1
1
1
1
9
12
37
1
26
18
10 ............................
10 ............................
5 ..............................
16 ............................
4 ..............................
20 ............................
90
120
185
16
104
360
5
3,900
1
1
5
3,900
3 ..............................
0.17 (10 minutes) ....
15
663
........................
........................
4,215
..................................
6,360
1 There
2 New
are no capital costs or operating and maintenance costs associated with this collection of information.
drug applications.
license applications.
3 Biologics
Based on submissions to FDA’s
Division of Dockets Management since
our last evaluation of the information
collection, we have made adjustments to
burden estimates associated with the
individual activities that correspond to
the applicable provisions.
We have also added 3,900 responses
and 663 hours, annually, to reflect
burden we believe is associated with
requests to FDA for speaker
participation at an external Agency
event, assuming an average burden of 10
minutes for each request. As a result of
these adjustments, the information
collection reflects an annual increase in
responses of 3,119 and an annual
decrease in hours of 3,360.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12523 Filed 6–9–23; 8:45 am]
BILLING CODE 4164–01–P
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2010–N–0598]
Food and Drug Administration,
HHS.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
17:39 Jun 09, 2023
Current Good Manufacturing Practice
Regulations for Type A Medicated
Articles—21 CFR Part 226
OMB Control Number 0910–0154—
Extension
Notice.
VerDate Sep<11>2014
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:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice Regulations for
Type A Medicated Articles
ACTION:
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 0910–0154. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
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 July 12,
2023.
Jkt 259001
This information collection supports
the implementation of FDA statutory
and regulatory requirements that govern
PO 00000
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Fmt 4703
Sfmt 4703
current good manufacturing practice
(cGMP) for Type A medicated articles.
A Type A medicated article is an animal
feed product containing a concentrated
drug diluted with a feed carrier
substance. A Type A medicated article
is intended solely for use in the
manufacture of another Type A
medicated article or a Type B or Type
C medicated feed. Medicated feeds are
administered to animals for the
prevention, cure, mitigation, or
treatment of disease or for growth
promotion and feed efficiency. Section
501 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
351), governs current cGMP for drugs,
including Type A medicated articles,
and these statutory requirements are
codified in part 226 (21 CFR part 226).
Manufacturers are required to
establish, maintain, and retain records
for Type A medicated articles including
records to document procedures
required under the manufacturing
process to assure that proper quality
control is maintained under part 226.
Type A medicated articles, which are
not manufactured in accordance with
these regulations, are considered
adulterated under section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B)).
Description of Respondents: The
respondents to this information
collection are manufacturers of Type A
medicated articles.
In the Federal Register of January 31,
2023 (88 FR 6281), FDA published a 60day 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\12JNN1.SGM
12JNN1
Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
38059
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
21 CFR part; activity
226.42, 226.58, 226.80, 226.102, 226.110, and 226.115;
Recordkeeping and maintenance of records for components used in the manufacture of the medicated premixes, laboratory controls, packaging and labeling, master formula and batch-production, distribution records
and complaint files.
1 There
Number of
responses per
respondent
65
Total annual
responses
1,370
89,050
Average
burden per
response 2
∼1 hour ..........
Total hours
89,050
are no capital costs or operating and maintenance costs associated with this collection of information.
rounded.
2 Decimals
The burden we attribute to
recordkeeping activities associated with
the provisions in 21 CFR part 226 are
assumed to be distributed among the
individual elements and averaged
among respondents. Based on a review
of the information collection since our
last request for OMB approval, we have
made no adjustments to our burden
estimate.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12512 Filed 6–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–3011]
Luis Anarbol Moran: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) debarring Luis Anarbol Moran for
a period of 5 years from importing or
offering for import any drug into the
United States. FDA bases this order on
a finding that Mr. Moran was convicted
of one felony count under Federal law
for smuggling goods into the United
States. The factual basis supporting Mr.
Moran’s conviction, as described below,
is conduct relating to the importation
into the United States of a drug or
controlled substance. Mr. Moran was
given notice of the proposed debarment
and was given an opportunity to request
a hearing to show why he should not be
debarred. As of March 30, 2023 (30 days
after receipt of the notice), Mr. Moran
had not responded. Mr. Moran’s failure
to respond and request a hearing
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:39 Jun 09, 2023
Jkt 259001
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable June 12,
2023.
ADDRESSES: Any application by Mr.
Moran for termination of debarment
under section 306(d)(1) of the FD&C Act
(21 U.S.C. 335a(d)(1)) may be submitted
as follows:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application 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
application, that information will be
posted on https://www.regulations.gov.
• If you want to submit an
application with confidential
information that you do not wish to be
made available to the public, submit the
application as a written/paper
submission and in the manner detailed
(see ‘‘Written/Paper Submissions’’ and
‘‘Instructions’’).
Written/Paper Submissions
• 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 a written/paper application
submitted to the Dockets Management
Staff, FDA will post your application, as
well as any attachments, except for
information submitted, marked, and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
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Frm 00045
Fmt 4703
Sfmt 4703
Instructions: All applications must
include the Docket No. FDA–2022–N–
3011. Received applications 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 an application with confidential
information that you do not wish to be
made publicly available, submit your
application 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 your application.
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
in the body of your application and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket, go to
https://www.regulations.gov and insert
the docket number, found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852 between 9 a.m.
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38058-38059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0598]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Type A Medicated Articles
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 July 12, 2023.
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 0910-0154. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Current Good Manufacturing Practice Regulations for Type A Medicated
Articles--21 CFR Part 226
OMB Control Number 0910-0154--Extension
This information collection supports the implementation of FDA
statutory and regulatory requirements that govern current good
manufacturing practice (cGMP) for Type A medicated articles. A Type A
medicated article is an animal feed product containing a concentrated
drug diluted with a feed carrier substance. A Type A medicated article
is intended solely for use in the manufacture of another Type A
medicated article or a Type B or Type C medicated feed. Medicated feeds
are administered to animals for the prevention, cure, mitigation, or
treatment of disease or for growth promotion and feed efficiency.
Section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 351), governs current cGMP for drugs, including Type A medicated
articles, and these statutory requirements are codified in part 226 (21
CFR part 226).
Manufacturers are required to establish, maintain, and retain
records for Type A medicated articles including records to document
procedures required under the manufacturing process to assure that
proper quality control is maintained under part 226. Type A medicated
articles, which are not manufactured in accordance with these
regulations, are considered adulterated under section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B)).
Description of Respondents: The respondents to this information
collection are manufacturers of Type A medicated articles.
In the Federal Register of January 31, 2023 (88 FR 6281), 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 38059]]
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR part; activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
226.42, 226.58, 226.80, 226.102, 226.110, and 65 1,370 89,050 ~1 hour.............................. 89,050
226.115; Recordkeeping and maintenance of
records for components used in the manufacture
of the medicated premixes, laboratory controls,
packaging and labeling, master formula and batch-
production, distribution records and complaint
files.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded.
The burden we attribute to recordkeeping activities associated with
the provisions in 21 CFR part 226 are assumed to be distributed among
the individual elements and averaged among respondents. Based on a
review of the information collection since our last request for OMB
approval, we have made no adjustments to our burden estimate.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12512 Filed 6-9-23; 8:45 am]
BILLING CODE 4164-01-P
