Program Policy and Procedures Manual Guide 1240.3605 Regulating Animal Foods With Drug Claims; Withdrawal, 43857-43858 [2024-10936]
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Federal Register / Vol. 89, No. 98 / Monday, May 20, 2024 / Notices
administering SNAP (recipient nonfederal agencies).
Authority for Conducting the Matching
Program
The authority for conducting the
matching program is 42 U.S.C.
653(j)(10). State SNAP agencies are
required to participate in the matching
program, as provided by 7 U.S.C.
2020(e)(24).
Purpose(s)
The purpose of the matching program
is to provide each participating state
agency administering SNAP with new
hire, quarterly wage, and
unemployment insurance information
from the OCSS NDNH system of records
to assist them in establishing or
verifying SNAP applicants’ and
recipients’ eligibility for assistance,
reducing payment errors, and
maintaining program integrity,
including determining whether
duplicate participation exists or if the
applicant or recipient resides in another
state. The state SNAP agencies may also
use the NDNH information for the
secondary purpose of updating SNAP
recipients’ reported participation in
work activities and updating the
recipients’ and their employers’ contact
information maintained by the state
SNAP agencies.
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Categories of Individuals
The categories of individuals whose
data is used in the matching program
are adult members of households who
have applied for or receive SNAP
benefits.
Categories of Records
The categories of records used in the
matching program, which may include
personal identifiers, are new hire,
quarterly wage, and unemployment
insurance information. The specific data
elements that will be provided to OCSS
in a state agency input file are:
• Submitting state code (two-digit
Federal Information Processing
Standard code)
• Date stamp (input file transmission
date)
• Adult SNAP caseload month and year
of adult SNAP applicants and
recipients
• Adult SNAP applicant/recipient
Social Security number
• Adult SNAP applicant/recipient’s
first, middle, and last name
The SNAP–NDNH Record
Specifications offer optional
programming for the state to customize
matching. For example, states may use
the Passback field to identify specific
records in a file, use the same State Data
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19:14 May 17, 2024
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43857
Indicator field whether or not to receive
NDNH data that was provided by the
state, and notify OCSS whether or not
to verify the name and Social Security
number combinations in the state
agency’s input file using Social Security
Administration processes, as states may
undergo verification prior to sending the
file to OCSS. The NDNH data elements
that OCSS will return to the state agency
are as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
a. New Hire File
HHS.
•
•
•
•
ACTION:
•
•
•
•
•
New hire processed date
Employee name and address
Employee date and state of hire
Federal and state employer
identification numbers
Department of Defense code
Employer name and address
Transmitter agency code
Transmitter state code
Transmitter state or agency name
b. Quarterly Wage File
• Quarterly wage processed date
• Employee name
• Federal and state employer
identification numbers
• Department of Defense code
• Employer name and address
• Employee wage amount
• Quarterly wage reporting period
• Transmitter agency code
• Transmitter state code
• Transmitter state or agency name
c. Unemployment Insurance File
• Unemployment insurance processed
date
• Claimant name and address
• Claimant benefit amount
• Unemployment insurance reporting
period
• Transmitter state code
• Transmitter state or agency name
System(s) of Records
The NDNH data used in this matching
program will be disclosed from the
following OCSS system of records, as
authorized by routine use 15: OCSS
National Directory of New Hires, System
No. 09–80–0381; see System of Records
Notice (SORN) published in full at 89
FR 25625 (April 11, 2024).
[FR Doc. 2024–10928 Filed 5–17–24; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2022–N–2015]
Program Policy and Procedures
Manual Guide 1240.3605 Regulating
Animal Foods With Drug Claims;
Withdrawal
AGENCY:
Food and Drug Administration,
Notice of withdrawal.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the withdrawal of the
Center for Veterinary Medicine’s
(CVM’s) Program Policy and Procedures
Manual Guide (PPM) 1240.3605
Regulating Animal Foods with Drug
Claims. This 1998 document presented
guidance to CVM staff for the regulation
of animal food that may have intended
uses that result in the products also
being drugs. FDA is withdrawing PPM
1240.3605 after determining that it no
longer reflects Agency current thinking.
FOR FURTHER INFORMATION CONTACT:
Kelly A. Louviere, Center for Veterinary
Medicine (HFV–200), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5815,
kelly.louviere@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the withdrawal of CVM’s
PPM 1240.3605 Regulating Animal
Foods with Drug Claims. This 1998
document presented guidance to CVM
staff for the regulation of animal food
that may have intended uses that result
in the products being drugs under
section 201(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(g)).
In 2021, CVM initiated a review of
PPM 1240.3605, spurred by stakeholder
interest, including industry and
government (e.g., Congressional)
stakeholders. Congress requested FDA
‘‘review [PPM] 1240.3605 for solutions
on how ingredient claims for animal
production, animal well-being, food
safety and the environment can be
regulated as animal food.’’ In making
this request, Congress expressed
concern that PPM 1240.3605 had not
been updated since 1998 and had not
kept pace with science (H. Rep. No.
117–82 at 91 (2022)).
On October 18, 2022, CVM held a
virtual listening session to gather
information and stakeholder feedback to
be considered during our review of the
regulation of animal food with certain
types of claims, such as claims about
environmental benefits (e.g., reduced
greenhouse gas emissions), production
SUMMARY:
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Federal Register / Vol. 89, No. 98 / Monday, May 20, 2024 / Notices
(e.g., growth promotion, feed efficiency),
and effects on the animal microbiome.
We specifically asked for feedback on
how we could modernize or improve
PPM 1240.3605, what challenges were
presented by this PPM, and what
additional types of claims or ingredients
CVM should consider during its review
of the policy. Many stakeholders
requested that we update our PPM to
provide for a larger set of ingredients
that can be safely used in animal food
to be treated other than as drugs and to
encourage innovation that supports
human and animal health, promotes
sustainable animal production, and
provides benefits to the environment.
After a thorough review of PPM
1240.3605, and careful consideration of
stakeholder feedback, FDA has
determined that PPM 1240.3605 no
longer reflects Agency current thinking
and is therefore withdrawing the PPM.
FDA encourages firms developing
animal food, nutritional ingredients, or
non-nutritive ingredients with intended
uses that could make them a drug,
including substances that are for use in
animal food and are intended to affect
the structure or any function of the
animal’s body, to contact the Agency
early in the product development
process. To contact FDA’s Center for
Veterinary Medicine about an animal
food substance intended to have the
effects described above, please email
animalfood-premarket@fda.hhs.gov.
FDA intends to issue guidance to
clarify our current thinking on the
regulation of certain substances that are
for use in animal food and are intended
to affect the structure or any function of
an animal’s body.
Dated: May 14, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSK11XQN23PROD with NOTICES1
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
19:14 May 17, 2024
Jkt 262001
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–23–004
Human Islet Research Network—Consortium
on Modeling Autoimmune Diabetes (UG3/
UH3).
Date: June 26, 2024.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
NIDDK, Democracy II, Suite 7000A, 6707
Democracy Boulevard, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Tori Stone, Ph.D.,
Scientific Review Officer, National Institutes
of Health, National Institute of Diabetes and
Digestive and Kidney Diseases, Bethesda, MD
20892, (301) 827–0994, tori.stone@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: May 15, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–10992 Filed 5–17–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
[FR Doc. 2024–10936 Filed 5–17–24; 8:45 am]
VerDate Sep<11>2014
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of K99/R00 Applications.
Date: June 24–25, 2024.
Time: 10:00 a.m. to 6:00 p.m.
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Tracy Koretsky, Ph.D.,
Scientific Review Officer, National Institute
of General Medical Sciences, National
Institutes of Health, 45 Center Drive, MSC
6200, Room 3AN12F, Bethesda, Maryland
20892, 301–594–2886, tracy.koretsky@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: May 15, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–10988 Filed 5–17–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Health Promotion in Communities Study
Section.
Date: June 10–11, 2024.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave. NW, Washington, DC 20037 (In-Person
Meeting).
Contact Person: Helena Eryam Dagadu,
MPH, Ph.D., Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3137,
Bethesda, MD 20892, (301) 435–1266,
dagaduhe@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Community Influences on Health Behavior
Study Section.
Date: June 11–12, 2024.
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[Federal Register Volume 89, Number 98 (Monday, May 20, 2024)]
[Notices]
[Pages 43857-43858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10936]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2015]
Program Policy and Procedures Manual Guide 1240.3605 Regulating
Animal Foods With Drug Claims; Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the withdrawal of the Center for Veterinary Medicine's
(CVM's) Program Policy and Procedures Manual Guide (PPM) 1240.3605
Regulating Animal Foods with Drug Claims. This 1998 document presented
guidance to CVM staff for the regulation of animal food that may have
intended uses that result in the products also being drugs. FDA is
withdrawing PPM 1240.3605 after determining that it no longer reflects
Agency current thinking.
FOR FURTHER INFORMATION CONTACT: Kelly A. Louviere, Center for
Veterinary Medicine (HFV-200), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-5815,
[email protected].
SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of CVM's
PPM 1240.3605 Regulating Animal Foods with Drug Claims. This 1998
document presented guidance to CVM staff for the regulation of animal
food that may have intended uses that result in the products being
drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)).
In 2021, CVM initiated a review of PPM 1240.3605, spurred by
stakeholder interest, including industry and government (e.g.,
Congressional) stakeholders. Congress requested FDA ``review [PPM]
1240.3605 for solutions on how ingredient claims for animal production,
animal well-being, food safety and the environment can be regulated as
animal food.'' In making this request, Congress expressed concern that
PPM 1240.3605 had not been updated since 1998 and had not kept pace
with science (H. Rep. No. 117-82 at 91 (2022)).
On October 18, 2022, CVM held a virtual listening session to gather
information and stakeholder feedback to be considered during our review
of the regulation of animal food with certain types of claims, such as
claims about environmental benefits (e.g., reduced greenhouse gas
emissions), production
[[Page 43858]]
(e.g., growth promotion, feed efficiency), and effects on the animal
microbiome. We specifically asked for feedback on how we could
modernize or improve PPM 1240.3605, what challenges were presented by
this PPM, and what additional types of claims or ingredients CVM should
consider during its review of the policy. Many stakeholders requested
that we update our PPM to provide for a larger set of ingredients that
can be safely used in animal food to be treated other than as drugs and
to encourage innovation that supports human and animal health, promotes
sustainable animal production, and provides benefits to the
environment.
After a thorough review of PPM 1240.3605, and careful consideration
of stakeholder feedback, FDA has determined that PPM 1240.3605 no
longer reflects Agency current thinking and is therefore withdrawing
the PPM.
FDA encourages firms developing animal food, nutritional
ingredients, or non-nutritive ingredients with intended uses that could
make them a drug, including substances that are for use in animal food
and are intended to affect the structure or any function of the
animal's body, to contact the Agency early in the product development
process. To contact FDA's Center for Veterinary Medicine about an
animal food substance intended to have the effects described above,
please email [email protected].
FDA intends to issue guidance to clarify our current thinking on
the regulation of certain substances that are for use in animal food
and are intended to affect the structure or any function of an animal's
body.
Dated: May 14, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10936 Filed 5-17-24; 8:45 am]
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