Submission for OMB Review; Office of Refugee Resettlement Cash and Medical Assistance Program Quarterly Report on Expenditures and Obligations (ORR-2) (OMB #0970-0407), 48483-48484 [2022-17078]
Download as PDF
<![CDATA[
Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
jspears on DSK121TN23PROD with NOTICES
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–437A and CMS–437B
Rehabilitation Unit and Hospital
Criteria Worksheet
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Rehabilitation
Unit and Hospital Criteria Worksheet;
Use: Inpatient Rehabilitation Facility
(IRF) hospitals and units must initially
attest that they meet the Inpatient
Prospective Payment System (IPPS)
exclusion criteria set forth at 42 CFR
VerDate Sep<11>2014
18:04 Aug 08, 2022
Jkt 256001
412.20 to § 412.29 prior to being placed
into IPPS exempt status. Form CMS–
437A must be completed by IRF units
and form CMS–437B must be completed
by IRF hospitals.
For first time verification requests for
exclusion from the IPPS, an IRF unit or
hospital must notify the Regional Office
(RO) servicing the State in which it is
located that it believes it meets the
criteria for exclusion from the IPPS.
Currently, all new IRF units or hospitals
must provide written certification that
the inpatient population it intends to
serve will meet the requirements of the
IPPS exclusion criteria for IRFs. The
completed CMS–437A and 437B forms
are submitted to the State Agency (SA)
no later than 5 months before the date
the IRF unit or hospital would become
subject to Inpatient Rehabilitation
Facility Prospective Payment System
(IRF–PPS). For IRF units and hospitals
already excluded from the IPPS, annual
onsite re-verification surveys by the SA
are no longer required. IRF units and
hospitals must now re-attest to meeting
the exclusion criteria every 3 years
thereafter.
IRF units and hospitals that have
already been excluded need not reapply
for exclusion. These facilities will
automatically be reevaluated yearly to
determine whether they continue to
meet the exclusion criteria. For the triannual re-verification, IRF units and
hospitals will be provided with a copy
of the appropriate CMS–437 worksheet
at least 5-months prior to the beginning
of its cost reporting period, so that the
IRF unit or hospital official may
complete and sign an attestation
statement and complete and return the
appropriate form CMS–437A or CMS–
437B at least 5-months prior to the
beginning of the cost reporting period.
However, Fiscal Intermediaries (FIs)
will continue to verify, on an annual
basis, compliance with the 60 percent
rule (42 CFR 412.29(b)(2)) for IRF units
and hospitals through a sample of
medical records and the SA will verify
the medical director requirement.
The SA will notify the RO at least 60
days prior to the end of the IRF unit’s
or hospital’s cost reporting period of the
status of compliance or non-compliance
with the payment requirements. The
information collected on the 437A and
437B forms, along with other
information submitted by the IRF is
necessary for determining the IRF’s IPPS
exclusion status. We have revised the
CMS–437A and 437B forms so that they
more adequately reflect the regulatory
requirements of § 412.20 to § 412.29.
More specifically, we have updated the
text in the 3rd column of the form,
which tells the facility what actions
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
48483
must be taken and what information
must be verified to receive IPPS
excluded status.; Form Number: CMS–
437A and CMS–437B (OMB control
number: 0938–0986); Frequency: triannually; Affected Public: Private sector
(Business or other for-profits); Number
of Respondents: 497; Total Annual
Responses: 497; Total Annual Hours:
497. (For policy questions regarding this
collection contact Caroline Gallaher at
410–786–8705).
Dated: August 4, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–17063 Filed 8–8–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Office of
Refugee Resettlement Cash and
Medical Assistance Program Quarterly
Report on Expenditures and
Obligations (ORR–2) (OMB #0970–
0407)
Office of Refugee Resettlement,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Refugee
Resettlement (ORR) is requesting a 3year extension of the ORR–2, Cash and
Medical Assistance Program Quarterly
Report on Expenditures and Obligations
(OMB #0970–0407, expiration 9/30/
2022). There are no changes requested
to the form.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
SUMMARY:
E:\FR\FM\09AUN1.SGM
09AUN1
48484
Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: ORR reimburses, to the
extent of available appropriations,
certain non-federal costs for the
provision of cash and medical
assistance (CMA) to refugees, along with
allowable expenses for the
administration of the refugee
resettlement program at the state level.
States and Replacement Designees
currently submit the ORR–2 Quarterly
Report on Expenditures and
Obligations, which provides aggregate
expenditure and obligation data. The
ORR–2 collects expenditures and
obligations data separately for each of
the four following CMA program
components: refugee cash assistance,
refugee medical assistance, CMA
administration, and services for
unaccompanied minors. This
breakdown of financial status data
allows ORR to track program
expenditures in greater detail to
anticipate any funding issues and to
meet the requirements of ORR
regulations at CFR 400.211 to collect
these data for use in estimating future
costs of the refugee resettlement
program. ORR must implement the
methodology at CFR 400.211 each year
after receipt of its annual appropriation
to ensure that appropriated funds will
be adequate for reimbursement to states
of the costs for assistance provided to
entering refugees. The estimating
methodology prescribed in the
regulations requires the use of actual
past costs by program component. If the
methodology indicates that
appropriated funds are inadequate, ORR
must take steps to reduce federal
expenses, such as by limiting the
number of months of eligibility for
Refugee Cash Assistance and Refugee
Medical Assistance. The ORR–2 is a
single-page financial report that allows
ORR to collect the necessary data to
ensure that funds are adequate for the
projected need and thereby meet the
requirements of both the Refugee Act
and ORR regulations.
Respondents: State governments and
Replacement Designees.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden hours
per response
Annual burden
hours
63
4
1.5
378
ORR–2, Cash and Medical Assistance Program, Quarterly Report on Expenditures and Obligations ..........................................................................
Estimated Total Annual Burden
Hours: 378.
Authority: 8 U.S.C. 1522 Sec. 412 and
8 U.S.C. 524 (Title IV), Sec. 414.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–17078 Filed 8–8–22; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1694]
Determination That AVC
(Sulfanilamide) Vaginal Cream, 15%,
and Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that the drug products listed
in this document were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:04 Aug 08, 2022
Jkt 256001
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is generally known
as the ‘‘Orange Book.’’ Under FDA
regulations, a drug is 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).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table are no longer
being marketed.
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48483-48484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17078]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Office of Refugee Resettlement Cash
and Medical Assistance Program Quarterly Report on Expenditures and
Obligations (ORR-2) (OMB #0970-0407)
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Refugee Resettlement (ORR) is requesting a 3-
year extension of the ORR-2, Cash and Medical Assistance Program
Quarterly Report on Expenditures and Obligations (OMB #0970-0407,
expiration 9/30/2022). There are no changes requested to the form.
DATES: Comments due within 30 days of publication. OMB must make a
decision about the collection of information between 30 and 60 days
after publication of this document in the Federal Register. Therefore,
a comment is best assured of having its full effect if OMB receives it
within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. You can
also obtain copies of the proposed collection of information by
emailing [email protected]. Identify all emailed
[[Page 48484]]
requests by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: ORR reimburses, to the extent of available
appropriations, certain non-federal costs for the provision of cash and
medical assistance (CMA) to refugees, along with allowable expenses for
the administration of the refugee resettlement program at the state
level. States and Replacement Designees currently submit the ORR-2
Quarterly Report on Expenditures and Obligations, which provides
aggregate expenditure and obligation data. The ORR-2 collects
expenditures and obligations data separately for each of the four
following CMA program components: refugee cash assistance, refugee
medical assistance, CMA administration, and services for unaccompanied
minors. This breakdown of financial status data allows ORR to track
program expenditures in greater detail to anticipate any funding issues
and to meet the requirements of ORR regulations at CFR 400.211 to
collect these data for use in estimating future costs of the refugee
resettlement program. ORR must implement the methodology at CFR 400.211
each year after receipt of its annual appropriation to ensure that
appropriated funds will be adequate for reimbursement to states of the
costs for assistance provided to entering refugees. The estimating
methodology prescribed in the regulations requires the use of actual
past costs by program component. If the methodology indicates that
appropriated funds are inadequate, ORR must take steps to reduce
federal expenses, such as by limiting the number of months of
eligibility for Refugee Cash Assistance and Refugee Medical Assistance.
The ORR-2 is a single-page financial report that allows ORR to collect
the necessary data to ensure that funds are adequate for the projected
need and thereby meet the requirements of both the Refugee Act and ORR
regulations.
Respondents: State governments and Replacement Designees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Average burden
Instrument Total number of responses hours per Annual burden
of respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
ORR-2, Cash and Medical Assistance Program, 63 4 1.5 378
Quarterly Report on Expenditures and
Obligations................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 378.
Authority: 8 U.S.C. 1522 Sec. 412 and 8 U.S.C. 524 (Title IV), Sec.
414.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022-17078 Filed 8-8-22; 8:45 am]
BILLING CODE 4184-45-P
