Office of Refugee Resettlement; Notice of Change of Eligibility, 13370-13371 [2025-04839]
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13370
Federal Register / Vol. 90, No. 54 / Friday, March 21, 2025 / Notices
submission consists of the Plan Benefit
Package (PBP) software, formulary file,
and supporting documentation, as
necessary. MA and PDP organizations
use the PBP software to describe their
organization’s plan benefit packages,
including information on premiums,
cost sharing, authorization rules, and
supplemental benefits. They also
generate a formulary to describe their
list of drugs, including information on
prior authorization, step therapy,
tiering, and quantity limits.
CMS requires that MA and PDP
organizations submit a completed PBP
and formulary as part of the annual
bidding process. During this process,
organizations prepare their proposed
plan benefit packages for the upcoming
contract year and submit them to CMS
for review and approval. CMS uses this
data to review and approve the benefit
packages that the plans will offer to
Medicare beneficiaries. This allows
CMS to review the benefit packages in
a consistent way across all submitted
bids during with incredibly tight
timeframes. This data is also used to
populate data on Medicare Plan Finder,
which allows beneficiaries to access and
compare Medicare Advantage and
Prescription Drug plans. Form Number:
CMS–R–262 (OMB control number:
0938–0763); Frequency: Annually;
Affected Public: Public sector
(Individuals and Households), Private
sector (Business or other for-profits and
Not-for-profit institutions); Number of
Respondents: 785; Total Annual
Responses: 8,337; Total Annual Hours:
46,026. (For policy questions regarding
this collection contact Kristy Holtje at
410–786–2209 or kristy.holtje@
cms.hhs.gov.)
5. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Dual Eligible
Special Needs Plan Contract with the
State Medicaid Agency; Use: Special
needs plans (SNPs) are Medicare
Advantage (MA) plans created by the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (Pub. L. 108–173) that are
specifically designed to provide targeted
care and limit enrollment to special
needs individuals. Under section
1859(b)(6) of the Act, D–SNPs restrict
enrollment to individuals entitled to
medical assistance under a State plan
under title XIX of the Social Security
Act (hereinafter referred to as the Act).
Section 1859(f)(3)(D) of the Act and
42 CFR 422.107 established the
requirement for D–SNPs to have
contracts with State Medicaid agencies
in addition to other contracting
requirements that that apply to all MA
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plans. MA organizations with D–SNPs
and States use the information in the
contract to provide benefits, or arrange
for the provision of Medicaid benefits,
to which an enrollee is entitled. CMS
reviews the D–SNP contract with the
State Medicaid agency to ensure that it
meets the minimum contract
requirements at § 422.107(c)&(d). CMS
uses the attestations and matrices in the
appendices of this package to identify
the types of D–SNPs an MA
organization(s) offers and the location of
the contract requirements in the
document. Form Number: CMS–10796
(OMB control number: 0938–1410);
Frequency: Annually; Affected Public:
Public sector (Individuals and
Households), Private sector (Business or
other for-profits and Not-for-profit
institutions); Number of Respondents:
886; Total Annual Responses: 893; Total
Annual Hours: 17,403. (For policy
questions regarding this collection
contact Marla Rothouse at 410–786–
8063 or Marla.rothouse@cms.hhs.gov.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2025–04887 Filed 3–20–25; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Refugee Resettlement; Notice
of Change of Eligibility
Administration for Children
and Families (ACF), HHS.
ACTION: Notice of change of eligibility
period.
AGENCY:
In accordance with ORR
regulations, the Director of ORR is
announcing the shortening of the
Refugee Cash Assistance (RCA) and
Refugee Medical Assistance (RMA)
eligibility period from 12 months to four
months of assistance for participants
who become eligible for ORR benefits 45
days after publication of this notice. For
30 years, ORR had not increased the
RCA and RMA eligibility period. In
2022, during a surge in refugee
admissions, ORR increased the
eligibility period from eight months to
12 months. ORR has determined that it
must shorten the RCA and RMA
eligibility period to four months to
avoid a significant budget shortfall.
DATES: The changes described in this
Federal Register notice are effective 45
days after the date of publication—
SUMMARY:
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exceeding the minimum permitted by
45 CFR 400.211(b).
FOR FURTHER INFORMATION CONTACT:
Colleen Mahar-Piersma, Refugee Policy
Unit, Division of Policy and Procedures,
Office of the Director, Office of Refugee
Resettlement, Administration for
Children and Families, by phone at
(202) 260–5493, and email at
refugeepolicy@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: The 1980
Refugee Act (8 U.S.C. 1522(e)(1))
authorized the Director of ORR
(hereinafter ‘‘the Director’’) to provide
RCA and RMA during the first 36
months after a refugee’s arrival in the
United States. For the first two years,
ORR provided refugees with RCA and
RMA for the first 36 months after a
refugee’s arrival. Thereafter, due to
reduced appropriations, ORR had to
decrease this assistance, first to 18
months, then to 12 months, and finally,
in FY 1992, to eight months. RCA and
RMA remained at eight months until FY
2022. In FY 2022, ORR expanded the
RCA and RMA eligibility period to 12
months. However, ORR is unable to
sustain this expansion based on current
and projected congressional
appropriations and the number of
refugees eligible for RCA and RMA.
Accordingly, the time-eligibility period
for RCA and RMA will be changed to
four months.
Prior to 1993, ORR would change the
text in the Code of Federal Regulations
each time it changed the number of
months for cash and medical assistance.
In 1993, ORR drafted regulations
removing the specific duration of RCA
and RMA from the regulatory text and
instead added 45 CFR 400.211(a)
establishing a methodology by which
the Director to determines the timeeligibility period for RCA and RMA
each year based on the appropriated
funds available for the fiscal year. 58 FR
64499 (Dec. 8, 1993). The preamble
explained that the methodology in the
regulation was the substantive rule
regarding how to determine RCA and
RMA duration but future determinations
of the actual months using the
methodology would be interpretive
rules. Id.
In recent years, annual refugee
admissions have been high, resulting in
an expanding pool of refugees and other
eligible populations in need of services.
As of March 3, 2025, approximately
109,800 refugees and other eligible
populations have been resettled in the
U.S. since October 1, 2024. In addition,
approximately 714,000 ORR-eligible
individuals were admitted to the U.S. in
FY 2024. The open border policies of
the Biden Administration have caused
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khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 54 / Friday, March 21, 2025 / Notices
budgetary shortfalls, requiring
supplemental appropriations or
transfers from other essential programs
each year since FY2022. In fiscal year
2024, Congress decreased
appropriations for Refugee and Entrant
Assistance by more than 35% The level
of funds appropriated for services has
not kept pace with arrivals over the past
two years, making it difficult to serve all
refugees in need of services with
available resources. Pursuant to 45 CFR
400.211, ORR calculated the costs of
providing RCA and RMA to current
recipients and the estimated number of
future recipients at 12, nine, eight, six,
and four months, and determined that it
must shorten the period of eligibility for
RCA and RMA to four months.
ORR acknowledges the reasoning
articulated in its March 28, 2022, notice
expanding the eligibility period for RCA
and RMA. 87 FR 17312. Namely, that a
longer eligibility period would
‘‘positively impact refugees’’ by
allowing them to address medical and
mental health conditions in order to
become self-sufficient and allowing
them to focus on learning English and
secure employment. Id. at 17312–13.
But such reasoning is not a basis to stay
with the 12-month eligibility period,
due to both legal considerations and
practical considerations. First, the
determination of the eligibility period
is, by ORR’s own regulation, supposed
to be straightforwardly derived from the
available appropriations. 45 CFR
400.211(a); see also 58 FR at 64502.
Second, as a practical reality, the
beneficial effects referenced in the 2022
notice must be weighed against resource
constraints. As explained above, budget
shortfalls require an adjustment of the
eligibility period in order to ensure
adequate coverage of the entire
population of ORR-eligible individuals.
Furthermore, the effective date of this
notice has been set to account for
reliance interests, in that the new
eligibility period will only come into
effect for those individuals who become
eligible in the future.
Refugees whose date of eligibility for
ORR benefits is on or after 45 days
following publication of this notice are
subject to the shortened RCA and RMA
eligibility period.
(Authority: 45 CFR 400.211)
Angie Salazar,
Acting Director, Office of Refugee
Resettlement.
[FR Doc. 2025–04839 Filed 3–20–25; 8:45 am]
BILLING CODE 4184–45–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2025–N–0648]
Over-the-Counter Monograph Drug
User Fee Program—Facility Fee Rates
for Fiscal Year 2025
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the over-the-counter
(OTC) monograph drug facility (MDF)
fee rates under the OTC monograph
drug user fee program (OMUFA) for
fiscal year (FY) 2025. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to assess and collect
user fees from qualifying manufacturers
of OTC monograph drugs and
submitters of OTC monograph order
requests (OMORs). This notice
publishes the OMUFA facility fee rates
for FY 2025.
DATES: These facility fees are effective
on October 1, 2024, and will remain in
effect through September 30, 2025.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo Ariyo, Office of Financial
Management, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 240–
402–4989; or the User Fees Support
Staff at OO-OFBA-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 744M of the FD&C Act (21
U.S.C. 379j–72), authorizes FDA to
assess and collect: (1) facility fees from
qualifying owners of OTC monograph
drug facilities and (2) fees from
submitters of qualifying OTC OMORs.
The OTC OMOR fee rates for FY 2025
were published on July 31, 2024.1
OMUFA fees are to support FDA’s OTC
monograph drug activities, which are
detailed in section 744L(6) of the FD&C
Act (21 U.S.C. 379j–71(6)) and include
various FDA activities associated with
OTC monograph drugs. For OMUFA
purposes:
• An OTC monograph drug is a
nonprescription drug without an
approved new drug application that is
governed by the provisions of section
505G of the FD&C Act (21 U.S.C. 355h)
(see section 744L(5) of the FD&C Act);
1 https://www.federalregister.gov/documents/
2024/07/31/2024-16878/over-the-countermonograph-drug-user-fee-program-otc-monographorder-request-fee-rates-for-fiscal.
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13371
• An OTC MDF is a foreign or
domestic business or other entity that,
in addition to meeting other criteria, is
engaged in manufacturing or processing
the finished dosage form of an OTC
monograph drug (see section 744L(10)
of the FD&C Act); and
• A contract manufacturing
organization (CMO) facility is an OTC
monograph drug facility where neither
the owner nor any affiliate of the owner
or facility sells the OTC monograph
drug produced at such facility directly
to wholesalers, retailers, or consumers
in the United States (see section 744L(2)
of the FD&C Act).
Under section 744M(a)(1)(A) of the
FD&C Act, a facility fee for FY 2025
shall be assessed with respect to each
facility that is identified as an OTC
monograph drug facility during the feeliable period from January 1, 2024,
through December 31, 2024.2 Consistent
with the statute, FDA will assess and
collect facility fees with respect to the
two types of OTC monograph drug
facilities—MDF and CMO facilities. A
full facility fee will be assessed to each
qualifying person that owns a facility
identified as an MDF (see section
744M(a)(1)(A) of the FD&C Act), and a
reduced facility fee of two-thirds will be
assessed to each qualifying person that
owns a facility identified as a CMO
facility (see section 744M(a)(1)(B)(ii) of
the FD&C Act). The facility fees for FY
2025 are due on June 2, 2025 (see
section 744M(a)(1)(D)(ii) of the FD&C
Act).3
As discussed in greater detail below:
• OTC monograph drug facilities are
exempt from FY 2025 facility fees if
they had ceased OTC monograph drug
activities, and updated their registration
with FDA to that effect, prior to
December 31, 2023 (see section
744M(a)(1)(B)(i) of the FD&C Act).
• Entities that registered with FDA
during the Coronavirus Disease 2019
(COVID–19) pandemic whose sole
activity with respect to OTC monograph
drugs during the pandemic consisted of
manufacturing OTC hand sanitizer
2 Under section 744M(a)(1) of the FD&C Act,
‘‘Each person that owns a facility identified as an
OTC monograph drug facility on December 31 of
the fiscal year or at any time during the preceding
12-month period shall be assessed an annual fee for
each such facility.’’ For purposes of FY 2025 facility
fees, that time period is January 1, 2024, through
December 31, 2024.
3 Assuming that, as we anticipate, the FY 2025 fee
appropriation will occur prior to June 3, 2025.
Under section 744M(a)(1)(D)(ii), the FY 2025
facility fees are due on the later of: (1) the first
business day of June 2025 (i.e., June 3, 2025) or (2)
the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of FY 2025 OMUFA fees.
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]]>Agencies
[Federal Register Volume 90, Number 54 (Friday, March 21, 2025)]
[Notices]
[Pages 13370-13371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04839]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Office of Refugee Resettlement; Notice of Change of Eligibility
AGENCY: Administration for Children and Families (ACF), HHS.
ACTION: Notice of change of eligibility period.
-----------------------------------------------------------------------
SUMMARY: In accordance with ORR regulations, the Director of ORR is
announcing the shortening of the Refugee Cash Assistance (RCA) and
Refugee Medical Assistance (RMA) eligibility period from 12 months to
four months of assistance for participants who become eligible for ORR
benefits 45 days after publication of this notice. For 30 years, ORR
had not increased the RCA and RMA eligibility period. In 2022, during a
surge in refugee admissions, ORR increased the eligibility period from
eight months to 12 months. ORR has determined that it must shorten the
RCA and RMA eligibility period to four months to avoid a significant
budget shortfall.
DATES: The changes described in this Federal Register notice are
effective 45 days after the date of publication--exceeding the minimum
permitted by 45 CFR 400.211(b).
FOR FURTHER INFORMATION CONTACT: Colleen Mahar-Piersma, Refugee Policy
Unit, Division of Policy and Procedures, Office of the Director, Office
of Refugee Resettlement, Administration for Children and Families, by
phone at (202) 260-5493, and email at [email protected].
SUPPLEMENTARY INFORMATION: The 1980 Refugee Act (8 U.S.C. 1522(e)(1))
authorized the Director of ORR (hereinafter ``the Director'') to
provide RCA and RMA during the first 36 months after a refugee's
arrival in the United States. For the first two years, ORR provided
refugees with RCA and RMA for the first 36 months after a refugee's
arrival. Thereafter, due to reduced appropriations, ORR had to decrease
this assistance, first to 18 months, then to 12 months, and finally, in
FY 1992, to eight months. RCA and RMA remained at eight months until FY
2022. In FY 2022, ORR expanded the RCA and RMA eligibility period to 12
months. However, ORR is unable to sustain this expansion based on
current and projected congressional appropriations and the number of
refugees eligible for RCA and RMA. Accordingly, the time-eligibility
period for RCA and RMA will be changed to four months.
Prior to 1993, ORR would change the text in the Code of Federal
Regulations each time it changed the number of months for cash and
medical assistance. In 1993, ORR drafted regulations removing the
specific duration of RCA and RMA from the regulatory text and instead
added 45 CFR 400.211(a) establishing a methodology by which the
Director to determines the time-eligibility period for RCA and RMA each
year based on the appropriated funds available for the fiscal year. 58
FR 64499 (Dec. 8, 1993). The preamble explained that the methodology in
the regulation was the substantive rule regarding how to determine RCA
and RMA duration but future determinations of the actual months using
the methodology would be interpretive rules. Id.
In recent years, annual refugee admissions have been high,
resulting in an expanding pool of refugees and other eligible
populations in need of services. As of March 3, 2025, approximately
109,800 refugees and other eligible populations have been resettled in
the U.S. since October 1, 2024. In addition, approximately 714,000 ORR-
eligible individuals were admitted to the U.S. in FY 2024. The open
border policies of the Biden Administration have caused
[[Page 13371]]
budgetary shortfalls, requiring supplemental appropriations or
transfers from other essential programs each year since FY2022. In
fiscal year 2024, Congress decreased appropriations for Refugee and
Entrant Assistance by more than 35% The level of funds appropriated for
services has not kept pace with arrivals over the past two years,
making it difficult to serve all refugees in need of services with
available resources. Pursuant to 45 CFR 400.211, ORR calculated the
costs of providing RCA and RMA to current recipients and the estimated
number of future recipients at 12, nine, eight, six, and four months,
and determined that it must shorten the period of eligibility for RCA
and RMA to four months.
ORR acknowledges the reasoning articulated in its March 28, 2022,
notice expanding the eligibility period for RCA and RMA. 87 FR 17312.
Namely, that a longer eligibility period would ``positively impact
refugees'' by allowing them to address medical and mental health
conditions in order to become self-sufficient and allowing them to
focus on learning English and secure employment. Id. at 17312-13. But
such reasoning is not a basis to stay with the 12-month eligibility
period, due to both legal considerations and practical considerations.
First, the determination of the eligibility period is, by ORR's own
regulation, supposed to be straightforwardly derived from the available
appropriations. 45 CFR 400.211(a); see also 58 FR at 64502. Second, as
a practical reality, the beneficial effects referenced in the 2022
notice must be weighed against resource constraints. As explained
above, budget shortfalls require an adjustment of the eligibility
period in order to ensure adequate coverage of the entire population of
ORR-eligible individuals. Furthermore, the effective date of this
notice has been set to account for reliance interests, in that the new
eligibility period will only come into effect for those individuals who
become eligible in the future.
Refugees whose date of eligibility for ORR benefits is on or after
45 days following publication of this notice are subject to the
shortened RCA and RMA eligibility period.
(Authority: 45 CFR 400.211)
Angie Salazar,
Acting Director, Office of Refugee Resettlement.
[FR Doc. 2025-04839 Filed 3-20-25; 8:45 am]
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