Notice of Supplemental Award; Infant-Toddler Court Program-National Resource Center, 65369-65370 [2024-17663]
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 154 / Friday, August 9, 2024 / Notices
food ingredients after the MOU with
AAFCO expires on October 1, 2024, and
while FDA evaluates the animal Food
Additive Petition and GRAS
Notification programs. In addition, this
draft guidance describes FDA’s
enforcement policy for certain
ingredients reviewed using the AFIC
process.
The Food, Drug, and Cosmetic Act
(FD&C Act) gives FDA the authority to
regulate substances used in animal food,
including substances that are food
additives and substances that are GRAS
for their intended uses in food.1
Since 1920, AAFCO has maintained
the AAFCO Official Publication (OP),
which contains, among other things, a
comprehensive list of animal food
ingredients, including FDA-approved
food additives, substances that are
GRAS for one or more intended uses,
and animal food ingredient definitions
established through the AAFCO
Ingredient Definition Request Process.
In 2007, FDA entered into an MOU,
225–07–7001, with AAFCO that
outlines how FDA would provide its
scientific and technical expertise to
AAFCO in reviewing requested
ingredient definitions requested by
industry or AAFCO. This MOU has been
renewed and revised several times. The
current MOU 225–07–7001 expires in
October 2024 and will not be renewed.
See https://www.fda.gov/animalveterinary/animal-food-feeds/fda-letterstakeholders-acknowledgment-expiringfda-aafco-mou.
Following the expiration of the MOU,
FDA plans to evaluate its animal Food
Additive Petition and GRAS
Notification programs to determine if
changes are needed to promote the
efficient development and review of
new animal food ingredients.
We are issuing this draft guidance to
announce the creation of the AFIC
process to provide an additional way for
engagement with FDA regarding animal
food ingredients following the
expiration of the MOU with AAFCO and
during this interim evaluation period.
AFIC will provide a process that will
help FDA be aware of new ingredients
that are marketed in interstate
commerce and any potential safety
concerns associated with such
ingredients. AFIC will serve to provide
a baseline of safety information
available about such an ingredient,
making it easier to compare
developments that might occur during
marketing. AFIC also will give FDA an
opportunity to discuss any potential
safety concerns with the developer,
1 See
21 CFR part 570, subpart E.
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ideally before the ingredient is
marketed.
AFIC also will allow for public
awareness of and input on ingredients
for which FDA is providing
consultation. Our goal is to support
innovation in animal food technologies
while maintaining as our priority the
production of safe animal food.
FDA generally does not intend to
initiate enforcement action with respect
to the food additive approval
requirements of the FD&C Act for an
ingredient, or animal food containing
such ingredient, if such an ingredient
has been reviewed and is the subject of
a ‘‘consultation complete’’ letter under
the AFIC process, and is used in
accordance with the ‘‘consultation
complete’’ letter, as long as there
continues to be no questions or
concerns about the safety of the
ingredient.
Elsewhere in this issue of the Federal
Register, we are publishing a notice of
availability for a draft guidance #293,
‘‘FDA Enforcement Policy for AAFCODefined Animal Feed Ingredients.’’ This
draft guidance communicates FDA’s
enforcement policy regarding certain
ingredients listed in chapter 6 of the
2024 AAFCO OP (or recommended by
FDA for inclusion in the AAFCO OP)
after the expiration of the Agency’s
MOU with AAFCO.
Elsewhere in this issue of the Federal
Register, we also are publishing a notice
seeking stakeholder input regarding our
current Food Additive Petition and
GRAS Notification review processes for
animal food ingredients. Additionally,
we intend to hold listening sessions and
will later provide scheduling
information for those listening sessions.
This level 1 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 ‘‘Animal Food
Ingredient Consultation (AFIC).’’ 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
FDA tentatively concludes that this
draft guidance contains no collection of
information subject to review and
approval by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521), as at this time we believe that
fewer than 10 persons will avail
themselves of this process in any given
year. The draft guidance does refer to
previously approved FDA collections of
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65369
information. The collections of
information in 21 CFR 570 have been
approved under 0910–0342; the
collections of information in 21 CFR 571
have been approved under 0910–0546.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17778 Filed 8–8–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Award; InfantToddler Court Program—National
Resource Center
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of supplemental award.
AGENCY:
HRSA is providing up to
$1,750,000 in supplemental award
funds in federal fiscal year (FY) 2024 to
the current recipient of the InfantToddler Court Program (ITCP)—
National Resource Center (NRC) award,
to expand activities to help lead
nationwide improvements to child
welfare and early childhood systems.
FOR FURTHER INFORMATION CONTACT:
Kateryna Zoubak, Early Childhood
Systems Analyst, Division of Home
Visiting and Early Childhood Systems,
Maternal and Child Health Bureau,
HRSA, at ezoubak@hrsa.gov or 240–
475–8014.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
ZERO TO THREE National Center for
Infant, Toddler and Families, Inc.
Amount of Non-Competitive
Award(s): One award of up to
$1,750,000.
Project Period: September 30, 2022, to
September 29, 2027.
Assistance Listing (CFDA) Number:
93.110.
Award Instrument: Non-competitive
supplemental funding to the existing
Cooperative Agreement.
Authority: 42 U.S.C. 701(a)(2) (title V,
sec. 501(a)(2) of the Social Security Act)
SUMMARY:
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65370
Federal Register / Vol. 89, No. 154 / Friday, August 9, 2024 / Notices
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Grant number
Award recipient name
City, state
U2DMC32394 .........
ZERO TO THREE National Center for Infant, Toddler and Families, Inc. .........
Washington, DC ....
Justification: The FY 2023 and 2024
appropriations for Maternal and Child
Health Block Grant Special Projects of
Regional and National Significance
increased funding for the ITCP,
compared to the FY 2022 enacted level
when the most recent new awards were
made. A Congressional Report
accompanying the Further Consolidated
Appropriations Act, 2024 (Pub. L. 118–
47) indicated the funding would
‘‘continue and expand research-based
Infant-Toddler Court Teams to change
child welfare practices to improve
wellbeing for infants, toddlers, and their
families’’ (Senate Report 118–84).
Consistent with this language, HRSA
plans to use this funding to continue
work initiated in FY 2023 by the ITCP
NRC to expand subawards and technical
assistance to ITCP teams and advance
reach and impact of the program.
Activities included financial and
technical support for infant-toddler
court sites that previously received
funding under announcement number
HRSA–18–123, but that do not currently
receive HRSA funding under
announcement number HRSA–22–073/
074.
The planned supplemental award to
the ITCP NRC will be used for project
activities within the scope of the most
recent funding opportunity (HRSA–22–
074), to continue and expand current
technical assistance, evaluation and
evidence-building activities, and
implementation support to local ITCP
sites. Supplemental funding for similar
activities may be considered in future
years, subject to the availability of
funding for the activity and satisfactory
performance.
Carole Johnson,
Administrator.
[FR Doc. 2024–17663 Filed 8–8–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Supplemental Award; Early
Childhood Developmental Health
Systems Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of supplemental award.
AGENCY:
HRSA is providing
supplemental award funds in federal
fiscal year (FY) 2024 to the current
recipient of the Early Childhood
Developmental Health Systems Program
SUMMARY:
Award amount
Up to $1,750,000.
(ECDHS) cooperative agreement (HRSA–
22–091), to support existing activities
relating to early childhood
developmental health services.
FOR FURTHER INFORMATION CONTACT:
Lynlee Tanner Stapleton, Ph.D.; Lead
Public Health Analyst, Division of
Home Visiting and Early Childhood
Systems, Maternal and Child Health
Bureau. Telephone: (301) 443–5764;
Email: lstapleton@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
ZERO TO THREE National Center for
Infant, Toddler and Families, Inc.
Amount of Non-Competitive Award:
One combined award of up to
$1,000,000 (consisting of a $600,000
supplement and a $400,000
supplement).
Supplement Project Period:
September 30, 2024, to September 29,
2025.
Assistance Listing (CFDA) Numbers:
93.110/93.129.
Award Instrument: Non-competitive
supplemental funding to the existing
Cooperative Agreement.
Authorities: Social Security Act,
section 501(a)(2) (42 U.S.C. 701(a)(2))
supplement part A; and Public Health
Service Act section 330(l) (42 U.S.C.
254b(l)) supplement part B.
TABLE 1—RECIPIENTS AND AWARD AMOUNTS
Grant number
Award recipient name
ddrumheller on DSK120RN23PROD with NOTICES1
UK2MC46349 .........................................
Zero to Three National Center for Infant, Toddler, and Families, Inc..
Justification: The Consolidated
Appropriations Act, 2023 (Pub. L.117–
328) and the Further Consolidated
Appropriations Act, 2024 (Pub. L. 118–
47) made available additional funding
beyond the original FY 2022 enacted
level to ‘‘expand placements of early
childhood development experts in
pediatrician offices with a high
percentage of Medicaid and Children’s
Health Insurance Program patients’’ (per
Senate Report 118–84). To implement
this increase, HRSA funds an additional
four Transforming Pediatrics for Early
Childhood (TPEC) recipients beyond the
original four (for a total of eight) and
will continue to provide a supplement
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19:21 Aug 08, 2024
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City, state
Washington, DC ....................................
of $600,000 to the current ECDHS
recipient to provide technical assistance
to these additional TPEC recipients and
support national ECD integration in
pediatric care.
The Further Consolidated
Appropriations Act, 2024, also provided
funding to HRSA’s Bureau of Primary
Health Care to support health centers,
including ‘‘to further integrate early
childhood development services and
expertise’’ (as described in Senate
Report 118–84). To implement this
funding, HRSA will provide an
additional supplement of $400,000 to
the ECDHS recipient to continue their
current technical assistance support,
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FY23 supplement
award amount
$1,000,000
which began in FY 2023, to HRSA
funded Health Centers expanding their
early childhood development services
with funds awarded under HRSA–23–
028.
Supplemental funding for similar
activities may be considered in future
years, depending on the availability of
funding for the activity and satisfactory
performance.
Carole Johnson,
Administrator.
[FR Doc. 2024–17662 Filed 8–8–24; 8:45 am]
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Agencies
[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65369-65370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17663]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Supplemental Award; Infant-Toddler Court Program--
National Resource Center
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of supplemental award.
-----------------------------------------------------------------------
SUMMARY: HRSA is providing up to $1,750,000 in supplemental award funds
in federal fiscal year (FY) 2024 to the current recipient of the
Infant-Toddler Court Program (ITCP)--National Resource Center (NRC)
award, to expand activities to help lead nationwide improvements to
child welfare and early childhood systems.
FOR FURTHER INFORMATION CONTACT: Kateryna Zoubak, Early Childhood
Systems Analyst, Division of Home Visiting and Early Childhood Systems,
Maternal and Child Health Bureau, HRSA, at [email protected] or 240-475-
8014.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: ZERO TO THREE National Center for
Infant, Toddler and Families, Inc.
Amount of Non-Competitive Award(s): One award of up to $1,750,000.
Project Period: September 30, 2022, to September 29, 2027.
Assistance Listing (CFDA) Number: 93.110.
Award Instrument: Non-competitive supplemental funding to the
existing Cooperative Agreement.
Authority: 42 U.S.C. 701(a)(2) (title V, sec. 501(a)(2) of the
Social Security Act)
[[Page 65370]]
Table 1--Recipients and Award Amounts
----------------------------------------------------------------------------------------------------------------
Grant number Award recipient name City, state Award amount
----------------------------------------------------------------------------------------------------------------
U2DMC32394.................... ZERO TO THREE National Center for Infant, Washington, DC... Up to $1,750,000.
Toddler and Families, Inc..
----------------------------------------------------------------------------------------------------------------
Justification: The FY 2023 and 2024 appropriations for Maternal and
Child Health Block Grant Special Projects of Regional and National
Significance increased funding for the ITCP, compared to the FY 2022
enacted level when the most recent new awards were made. A
Congressional Report accompanying the Further Consolidated
Appropriations Act, 2024 (Pub. L. 118-47) indicated the funding would
``continue and expand research-based Infant-Toddler Court Teams to
change child welfare practices to improve wellbeing for infants,
toddlers, and their families'' (Senate Report 118-84). Consistent with
this language, HRSA plans to use this funding to continue work
initiated in FY 2023 by the ITCP NRC to expand subawards and technical
assistance to ITCP teams and advance reach and impact of the program.
Activities included financial and technical support for infant-toddler
court sites that previously received funding under announcement number
HRSA-18-123, but that do not currently receive HRSA funding under
announcement number HRSA-22-073/074.
The planned supplemental award to the ITCP NRC will be used for
project activities within the scope of the most recent funding
opportunity (HRSA-22-074), to continue and expand current technical
assistance, evaluation and evidence-building activities, and
implementation support to local ITCP sites. Supplemental funding for
similar activities may be considered in future years, subject to the
availability of funding for the activity and satisfactory performance.
Carole Johnson,
Administrator.
[FR Doc. 2024-17663 Filed 8-8-24; 8:45 am]
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