Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Produce Regulatory Program Standards, 89648-89649 [2024-26209]
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89648
Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
NUPLAZID (pimavanserin tartrate)
tablet, EQ 17 mg base, is the subject of
NDA 207318, held by Acadia
Pharmaceuticals, Inc., and initially
approved on April 29, 2016. NUPLAZID
is an atypical antipsychotic indicated
for the treatment of hallucinations and
delusions associated with Parkinson’s
disease psychosis.
In a letter dated January 8, 2019,
Acadia Pharmaceuticals, Inc., notified
FDA that NUPLAZID (pimavanserin
tartrate) tablet, EQ 17 mg base, was
being discontinued, and FDA moved the
drug product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Zydus Pharmaceuticals (USA), Inc.,
submitted a citizen petition dated May
22, 2024 (Docket No. FDA–2024–P–
2514), under 21 CFR 10.30, requesting
that the Agency determine whether
NUPLAZID (pimavanserin tartrate)
tablet, EQ 17 mg base, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
VerDate Sep<11>2014
17:40 Nov 12, 2024
Jkt 265001
§ 314.161 that NUPLAZID
(pimavanserin tartrate) tablet, EQ 17 mg
base, was not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that NUPLAZID
(pimavanserin tartrate) tablet, EQ 17 mg
base, was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
NUPLAZID (pimavanserin tartrate)
tablet, EQ 17 mg base, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NUPLAZID
(pimavanserin tartrate) tablet, EQ 17 mg
base, in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to NUPLAZID (pimavanserin tartrate)
oral tablet, EQ 17 mg base, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: November 6, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26318 Filed 11–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2275]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Produce
Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by December
13, 2024.
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 title
of this information collection is Produce
Regulatory Program Standards. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
Produce Regulatory Program Standards
OMB Control Number 0910–NEW
This information collection helps
establish and implement FDA’s
‘‘Produce Regulatory Program
Standards.’’ Section 1012 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
399c) authorizes FDA to administer
training and education programs for
employees of State, local, Territorial,
and Tribal food safety authorities
relating to regulatory programs. Also,
under section 205 of the FDA Safety
Modernization Act (codified in 21
U.S.C. 2224), FDA, together with the
Centers for Disease Control and
Prevention is directed to enhance
foodborne illness surveillance to
improve the collection, analysis,
reporting, and usefulness of data on
foodborne illnesses. As part of this
effort, we have initiated programs that
include developing and instituting
regulatory standards intended to reduce
the risk of foodborne illness through
coordinated efforts with our strategic
partners. Regulatory program standards
establish a uniform foundation for the
design and management of State, local,
Tribal, and Territorial programs that
have the responsibility for regulating
human and animal food. Partnering
with other regulatory officials also helps
maximize limited resources in
E:\FR\FM\13NON1.SGM
13NON1
Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices
administering FDA regulations
pertaining to the manufacturing/
processing, packing, or holding of food
for consumption in the United States.
The Produce Regulatory Program
Standards (PRPS) are the result of
external collaboration and coordination
with the Association of Food and Drug
Officials (AFDO), the National
Association of State Departments of
Agriculture (NASDA), and state produce
regulatory programs. FDA, NASDA,
AFDO, and states worked
collaboratively to develop the content of
the PRPS. A copy of the standards and
accompanying worksheets and forms is
available in the Federal Register docket
for this notice. We recommend that
State and Territorial produce safety
regulatory programs use these program
standards as the framework to design
and manage their produce safety
regulatory programs. The states that
assisted in the development of PRPS
were representative of the 43 State and
Territorial programs regulatory
programs enrolled currently conducting
produce safety inspections via funding
from a cooperative agreement grant,
‘‘The FDA’s Cooperative Agreement
Program for States and Territories to
Implement a National Produce Safety
Program, PAR–21–174,’’ (this program
also includes 4 programs which do not
conduct inspections). For more
information on this cooperative
agreement, we invite you to visit our
website at: https://www.fda.gov/federalstate-local-tribal-and-territorialofficials/grants-and-cooperativeagreements/fda-state-produce-safetyimplementation-cooperative-agreementprogram.
The PRPS identifies and includes
resource and training material for the
following standards: regulatory
foundations; training; inspection;
product-specific illnesses, outbreaks
and hazard response; compliance and
enforcement; industry and community
relations; program assessments; and
product sampling and testing. We
recommend using the worksheets and
forms contained in the standards,
however, alternate forms that are
equivalent may be used. The
educational worksheets and resource
materials include recordkeeping and
reporting activities that help FDA verify
participation and successful completion
89649
of the respective requirements. In the
first year of enrollment, information is
used to conduct a baseline selfassessment to determine whether the
materials meet the elements of each
standard. In subsequent years, we use
the information to conduct a
comprehensive review and evaluate
program effectiveness and participation.
We modify the program standards based
on the ongoing assessments as well as
comments and informal feedback
obtained from participants.
Description of Respondents:
Respondents are State Departments of
Agriculture or Health regulatory
officials who enroll in the PRPS (State
or Territorial governments). Currently
we estimate 43 respondents to the
information collection based on
expected participation.
In the Federal Register of June 28,
2024 (89 FR 54009), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
that did not pertain to the information
collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
State or Territorial Governments; Maintenance of data
records consistent with the PRPS ...................................
48
11
528
85.36
45,072
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 30, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26209 Filed 11–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
lotter on DSK11XQN23PROD with NOTICES1
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
Department of Health and Human
Services is hereby giving notice that the
Advisory Committee on Heritable
VerDate Sep<11>2014
17:40 Nov 12, 2024
Jkt 265001
ACHDNC
provides advice and recommendations
to the Secretary of Health and Human
Services (Secretary) on the development
of newborn screening activities,
technologies, policies, guidelines, and
programs for effectively reducing
morbidity and mortality in newborns
and children having, or at risk for,
heritable disorders. ACHDNC reviews
and reports regularly on newborn and
childhood screening practices,
recommends improvements in the
national newborn and childhood
screening programs, and fulfills
requirements stated in the authorizing
SUPPLEMENTARY INFORMATION:
Charter Renewal for the Advisory
Committee on Heritable Disorders in
Newborns and Children
SUMMARY:
Disorders in Newborns and Children
(ACHDNC) charter has been renewed.
DATES: The effective date of charter
renewal is November 10, 2024.
FOR FURTHER INFORMATION CONTACT:
Leticia Manning, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, 18N38A, Rockville, Maryland
20857; 301–443–8335; or lmanning@
hrsa.gov.
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
legislation. In addition, ACHDNC’s
recommendations regarding inclusion of
conditions for screening on the
Recommended Uniform Screening
Panel, following adoption by the
Secretary, are evidence-informed
preventive health services provided for
in the comprehensive guidelines
supported by HRSA pursuant to section
2713 of the Public Health Service Act
(42 U.S.C. 300gg–13). Under this
provision, non-grandfathered group
health plans and health insurance
issuers offering non-grandfathered
group or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is 1
year from the Secretary’s adoption of the
condition for screening.
The charter renewal for the ACHDNC
was approved on October 29, 2024. The
filing date is November 10, 2024.
Renewal of the ACHDNC charter
E:\FR\FM\13NON1.SGM
13NON1
]]>Agencies
[Federal Register Volume 89, Number 219 (Wednesday, November 13, 2024)]
[Notices]
[Pages 89648-89649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26209]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2275]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Produce Regulatory
Program Standards
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 December 13, 2024.
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 title of this
information collection is Produce Regulatory Program Standards. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Produce Regulatory Program Standards
OMB Control Number 0910-NEW
This information collection helps establish and implement FDA's
``Produce Regulatory Program Standards.'' Section 1012 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 399c) authorizes FDA to
administer training and education programs for employees of State,
local, Territorial, and Tribal food safety authorities relating to
regulatory programs. Also, under section 205 of the FDA Safety
Modernization Act (codified in 21 U.S.C. 2224), FDA, together with the
Centers for Disease Control and Prevention is directed to enhance
foodborne illness surveillance to improve the collection, analysis,
reporting, and usefulness of data on foodborne illnesses. As part of
this effort, we have initiated programs that include developing and
instituting regulatory standards intended to reduce the risk of
foodborne illness through coordinated efforts with our strategic
partners. Regulatory program standards establish a uniform foundation
for the design and management of State, local, Tribal, and Territorial
programs that have the responsibility for regulating human and animal
food. Partnering with other regulatory officials also helps maximize
limited resources in
[[Page 89649]]
administering FDA regulations pertaining to the manufacturing/
processing, packing, or holding of food for consumption in the United
States.
The Produce Regulatory Program Standards (PRPS) are the result of
external collaboration and coordination with the Association of Food
and Drug Officials (AFDO), the National Association of State
Departments of Agriculture (NASDA), and state produce regulatory
programs. FDA, NASDA, AFDO, and states worked collaboratively to
develop the content of the PRPS. A copy of the standards and
accompanying worksheets and forms is available in the Federal Register
docket for this notice. We recommend that State and Territorial produce
safety regulatory programs use these program standards as the framework
to design and manage their produce safety regulatory programs. The
states that assisted in the development of PRPS were representative of
the 43 State and Territorial programs regulatory programs enrolled
currently conducting produce safety inspections via funding from a
cooperative agreement grant, ``The FDA's Cooperative Agreement Program
for States and Territories to Implement a National Produce Safety
Program, PAR-21-174,'' (this program also includes 4 programs which do
not conduct inspections). For more information on this cooperative
agreement, we invite you to visit our website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safety-implementation-cooperative-agreement-program.
The PRPS identifies and includes resource and training material for
the following standards: regulatory foundations; training; inspection;
product-specific illnesses, outbreaks and hazard response; compliance
and enforcement; industry and community relations; program assessments;
and product sampling and testing. We recommend using the worksheets and
forms contained in the standards, however, alternate forms that are
equivalent may be used. The educational worksheets and resource
materials include recordkeeping and reporting activities that help FDA
verify participation and successful completion of the respective
requirements. In the first year of enrollment, information is used to
conduct a baseline self-assessment to determine whether the materials
meet the elements of each standard. In subsequent years, we use the
information to conduct a comprehensive review and evaluate program
effectiveness and participation. We modify the program standards based
on the ongoing assessments as well as comments and informal feedback
obtained from participants.
Description of Respondents: Respondents are State Departments of
Agriculture or Health regulatory officials who enroll in the PRPS
(State or Territorial governments). Currently we estimate 43
respondents to the information collection based on expected
participation.
In the Federal Register of June 28, 2024 (89 FR 54009), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received that did not
pertain to the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondent Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
State or Territorial Governments; Maintenance of data records 48 11 528 85.36 45,072
consistent with the PRPS..........................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 30, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26209 Filed 11-12-24; 8:45 am]
BILLING CODE 4164-01-P
