FRN - TANF Pilot GenIC_0970-0531_5.21.25

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Federal Register / Vol. 90, No. 97 / Wednesday, May 21, 2025 / Notices

Capitated Financial Alignment
Demonstrations (MMPs)) and 1876 Cost
Plans), Prescription Drug Plan sponsors
(PDPs), and Programs of All-Inclusive
Care for the Elderly (PACE)
organizations report financial
information demonstrating the
organization has a fiscally sound
operation. The FSRR is designed to
capture financial data of these
contracting entities. The Division of
Finance and Benefits (DFB) within the
Medicare Advantage Contract
Administration Group (MCAG) of CMS
is assigned the responsibility of
reviewing ongoing financial
performance of the contracting entities.
All contracting organizations must
submit audited annual financial
statements once per year. In addition to
the annual submission audited, Health
Plans with a negative net worth and/or
a net loss and the amount of that loss
is greater than one-half of the
organization’s total net worth submit
quarterly financial statements for fiscal
soundness monitoring. Part D
organizations are required to submit
three (3) quarterly financial statements.
Lastly, PACE organizations are required
to file four (4) quarterly financial
statements for the first three (3) years in
the program. After the first three (3)
years, PACE organizations with a
negative net worth and/or a net loss and
the amount of that loss is greater than
one-half of the organization’s total net
worth must submit quarterly financial
statements for fiscal soundness
monitoring. Form Number: CMS–906
(OMB control number: 0938–0496);
Frequency: Quarterly and Yearly;
Affected Public: Private Sector (Business
or other for-profits, Not-for-Profit
Institutions); Number of Respondents:
251; Total Annual Responses: 1,004;
Total Annual Hours: 335. (For policy
questions regarding this collection
contact Christa M. Zalewski at (410)
786–1971.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: State-based
Exchange, SBE, SBE Budget Template,
SBE Enrollment Metrics, Open
Enrollment; Use: The Patient Protection
and Affordable Care Act, Public Law
111–148, enacted on March 23, 2010,
and the Health Care and Education
Reconciliation Act, Public Law 111–
152, enacted on March 30, 2010
collectively, ‘‘Affordable Care Act’’,
expanded access to health insurance for
individuals and employees of small
businesses through the establishment of
new Affordable Insurance Exchanges
(Exchanges), including the Small
Business Health Options Program

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(SHOP). Beginning January 1, 2014, the
Exchanges became operational. The
Exchanges enhance competition in the
health insurance market, expand access
to affordable health insurance for
millions of Americans, and provide
consumers with a place to easily
compare and shop for health insurance
coverage.
States can choose to establish and
operate a State-based Exchange (SBE) or
a State-based Exchange on the Federal
Platform (SBE–FP). States electing to
operate as an SBE–FP rely on the
Federal Healthcare.gov platform to carry
out eligibility and enrollment functions.
For states that do not elect to operate
either an SBE or SBE–FP, the Secretary
of the U.S. Department of Health and
Human Services (HHS) will establish
and operate a Federally-facilitated
Exchange (FFE) in those states. Form
Number: CMS–10371 (OMB control
number: 0938–1119; Frequency:
Occasionally; Affected Public: State,
Local or Tribal Government; Number of
Respondents: 23; Total Annual
Responses: 343; Total Annual Hours:
7,317. (For policy questions regarding
this collection contact Tiffany Y.
Animashaun at Tiffany.Animashaun@
cms.hhs.gov).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2025–09144 Filed 5–20–25; 8:45 am]
BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB #: 0970–0531]

Proposed Information Collection and
Submission for Office of Management
and Budget Review; Fiscal
Responsibility Act TANF Pilot Program
2025 Information Collection
AGENCY: Office of Family Assistance,

Administration for Children and
Families, U.S. Department of Health and
Human Services.
ACTION: Request for public comments.
SUMMARY: The Administration for

Children and Families (ACF) is
proposing to reissue an information
collection to request information from
interested states for the Fiscal
Responsibility Act of 2023 (FRA)
Temporary Assistance for Needy
Families (TANF) pilot program. This
request is proposed under Office of
Management and Budget (OMB) #:

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0970–0531 and is a reissuing of a
previously approved information
collection to select states for the FRA
pilot program.
DATES: Comments due June 20, 2025.
OMB will make a decision about the
collection of information after this
public comment period ends and
comments have been considered.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
[email protected]. Identify all
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The FRA authorized a
new opportunity for states to pilot
program performance and
accountability measures in TANF.
Under the pilot, the U.S. Department of
Health and Human Services (HHS) may
select up to five state TANF grantees to
negotiate performance benchmarks for
work and family stability outcomes
instead of adhering to the standard
TANF Work Participation Rate. The
ACF Office of Family Assistance (OFA)
administers federal grant programs that
foster family economic stability and
independence, including the TANF
program. As such, OFA is responsible
for designing and carrying out the FRA
TANF Pilot Program, including
selecting the five states to participate in
the pilot, working with the states to
identify performance benchmarks and
associated targets, and monitoring
performance of the pilot states
throughout the duration of the pilot.
ACF received approval for a previous
information collection (Title: Fiscal
Responsibility Act TANF Pilot Program;
OMB #: 0970–0531) on July 17, 2024.
Twenty-three states and territories
responded to the information collection
from July through September 2024. In
November 2024, ACF announced the
selection of five states to participate in
the FRA TANF Pilot Program. In March
2025, the Trump Administration
announced a new direction for the FRA
TANF Pilot Program, ending pilot
participation for the states selected in
November of 2024 and communicating
plans to issue a new request for pilot
proposals aligned with the
Administration’s focus on promoting
work and reducing dependency and the
key measures of success related to those
priorities. This new request to OMB is
to collect information from states about
their interest and suitability for
participation in the new direction being
taken for the FRA TANF Pilot Program.
OFA also intends to provide
programmatic technical assistance (TA)
to the pilot states. ACF’s Office of

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Federal Register / Vol. 90, No. 97 / Wednesday, May 21, 2025 / Notices
Planning, Research, and Evaluation
(OPRE) studies ACF programs,
including TANF, and the populations
they serve through rigorous research
and evaluation projects. OPRE will be
responsible for the federal evaluation of
the FRA TANF Pilots Program and
intends to provide data- and evaluationrelated TA to the pilot states.
Respondents: States operating TANF
programs and interested in innovations
within those programs focused on
promoting work and reducing

data. Therefore, ACF estimates that a
state will spend approximately 10 hours
compiling information and responding
to the request. In the first issuing of this
information collection in July 2024,
ACF received responses from 23 states
and territories. The estimated number of
respondents in the table below is based
on the number of responses received in
the first round and ACF’s expectations
for number of responses in the second
round.

Annual Burden Estimates
The Proposal for TANF Pilot Program
Participation is intentionally succinct
and will be considered in combination
with existing sources of administrative

Instrument

Total number of
respondents

Total number of
responses per
respondent

Average
burden hours
per response

Total burden
hours

Proposal for TANF Pilot Program Participation .............................

25

1

10

250

Authority: 42 U.S.C. 611(e).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2025–09098 Filed 5–20–25; 8:45 am]
BILLING CODE 4184–36–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]

Product-Specific Guidance on
Roflumilast; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration,

HHS.
ACTION: Notice of availability.
SUMMARY: The Food and Drug

ddrumheller on DSK120RN23PROD with NOTICES1

dependency. In accordance with title
IV–A of the Social Security Act, states
is defined as the 50 States of the United
States, the District of Columbia, the
Commonwealth of Puerto Rico, the
United States Virgin Islands, Guam, and
American Samoa. See 42 U.S.C. 619(5).

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Administration (FDA or Agency) is
announcing the availability of a new
draft guidance for industry entitled
‘‘Draft Guidance on Roflumilast.’’ The
new draft guidance, when finalized, will
provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs) for
roflumilast topical cream.
DATES: Submit either electronic or
written comments on the draft guidance
by July 21, 2025 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.

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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:
• 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. FDA–
2007–D–0369 for ‘‘Draft Guidance on
Roflumilast.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at

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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
in the body of your comments 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 to
read background documents or the
electronic and written/paper comments
received, 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

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