Proposed Information Collection Activity; State Plan for Grants to States for Refugee Resettlement (OMB #0970-0351), 71347-71348 [2020-24777]
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Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices
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A. Components of the Review Process
The review of NCQA’s renewal
application for approval of MA deeming
authority includes, but is not limited to,
the following components:
• The types of MA plans that it would
review as part of its accreditation
process.
• A detailed comparison of NCQA’s
accreditation requirements and
standards with the Medicare
requirements (for example, a crosswalk)
in the following 5 areas: Quality
Improvement, Anti-Discrimination,
Confidentiality and Accuracy of
Enrollee Records, Information on
Advance Directives, and Provider
Participation Rules.
• Detailed information about the
organization’s survey process,
including—
++ Frequency of surveys and whether
surveys are announced or unannounced.
++ Copies of survey forms, and
guidelines and instructions to
surveyors.
++ Descriptions of—
— The survey review process and the
accreditation status decision making
process;
— The procedures used to notify
accredited MA organizations of
deficiencies and to monitor the
correction of those deficiencies; and
— The procedures used to enforce
compliance with accreditation
requirements.
• Detailed information about the
individuals who perform surveys for the
accreditation organization, including—
++ The size and composition of
accreditation survey teams for each type
of plan reviewed as part of the
accreditation process;
++ The education and experience
requirements surveyors must meet;
++ The content and frequency of the
in-service training provided to survey
personnel;
++ The evaluation systems used to
monitor the performance of individual
surveyors and survey teams; and
++ The organization’s policies and
practice for the participation, in surveys
or in the accreditation decision process,
by an individual who is professionally
or financially affiliated with the entity
being surveyed.
• A description of the organization’s
data management and analysis system
for its surveys and accreditation
decisions, including the kinds of
reports, tables, and other displays
generated by that system.
• A description of the organization’s
procedures for responding to and
investigating complaints against
accredited organizations, including
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policies and procedures regarding
coordination of these activities with
appropriate licensing bodies and
ombudsmen programs.
• A description of the organization’s
policies and procedures for the
withholding or removal of accreditation
for failure to meet the accreditation
organization’s standards or
requirements, and other actions the
organization takes in response to
noncompliance with its standards and
requirements.
• A description of all types (for
example, full, partial) and categories (for
example, provisional, conditional,
temporary) of accreditation offered by
the organization, the duration of each
type and category of accreditation and a
statement identifying the types and
categories that would serve as a basis for
accreditation if CMS approves the
accreditation organization.
• A list of all currently accredited MA
organizations and the type, category,
and expiration date of the accreditation
held by each of them.
• A list of all full and partial
accreditation surveys scheduled to be
performed by the accreditation
organization.
• The name and address of each
person with an ownership or control
interest in the accreditation
organization.
• CMS will also consider NCQA’s
past performance in the deeming
program and results of recent deeming
validation reviews or equivalency
reviews conducted as part of continuing
federal oversight of the deeming
program under § 422.157(d).
B. Notice Upon Completion of
Evaluation
Upon completion of our evaluation,
including a review of comments
received as a result of this proposed
notice, we will publish a notice in the
Federal Register announcing the result
of our evaluation. Section 1852(e)(4)(C)
of the Act provides a statutory timetable
to ensure that our review of deeming
applications is conducted in a timely
manner. The Act provides us with 210
calendar days after the date of receipt of
a completed application to complete our
survey activities and application review
process. At the end of the 210-day
period, we will publish an approval or
denial of the application in the Federal
Register.
III. Collection of Information
Requirements
This document does not impose any
new or revised ‘‘collection of
information’’ requirements or burden.
Consequently, there is no need for
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71347
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501 et seq.). With respect to
the PRA and this section of the
preamble, collection of information is
defined under 5 CFR 1320.3(c) of the
PRA’s implementing regulations.
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the ‘‘DATES’’ section
of this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Seema Verma, having reviewed and
approved this document, authorizes
Lynette Wilson, who is the Federal
Register Liaison, to electronically sign
this document for purposes of
publication in the Federal Register.
Lynette Wilson,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2020–24799 Filed 11–5–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; State Plan for Grants to States
for Refugee Resettlement (OMB #0970–
0351)
Office of Refugee Resettlement,
Administration for Children and
Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR) is
requesting a 3-year extension of the ACF
form ORR–0135 State Plan for Grants to
States for Refugee Resettlement (OMB
#0970–0351, expiration 3/31/2021).
ORR is proposing changes to the form.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
SUMMARY:
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71348
Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: A State Plan is a required
comprehensive narrative description of
the nature and scope of a state’s or
Replacement Designee’s (RD) Refugee
Resettlement Program and provides
assurances that the program will be
administered in conformity with the
specific requirements stipulated in 45
CFR 400.4–400.9. The State Plan must
include all applicable state or RD
procedures, designations, and
certifications for each requirement as
well as supporting documentation. The
plan assures ORR that the state or RD is
capable of administering refugee
assistance and coordinating
employment and other social services
for eligible caseloads in conformity with
specific requirements.
Changes proposed to the previously
approved State Plan for Grants to States
for Refugee Resettlement information
collection are described below. ORR is
proposing:
• Streamlining/formatting changes to
multiple sections of the form including
technical corrections to regulatory
citations and removing a number of
requirements related to the now
obsolete Wilson-Fish Alternative
Program (superseded by the Wilson-Fish
TANF Coordination Program, which
will have its own separate reporting
requirements).
• adding a number of requirements
related to Replacement Designees (RDs)
to ensure that they are administering the
Refugee Resettlement Program with
transparency and equity and to the same
standard as a state, including quarterly
consultation process, Refugee Medical
Assistance, Unaccompanied Refugee
Minors (URM), and emergency planning
to ensure ORR populations receive all
necessary information and services to
the extent possible.
• requesting additional information
related to the Refugee Support Services
(RSS) program; ORR’s current template
does not provide sufficient detailed
information for ORR to ascertain how a
grantee intends to provide RSS services
to its client base.
• improving the URM section to
correct inefficiencies, eliminate
unnecessary items, and address the
needs of victims of trafficking and
Special Immigrant Juveniles now
eligible for the URM program. In
particular, ORR is soliciting states’ and
RDs’ plans for placing children referred
by ORR and ensuring alignment with
federal capacity priorities.
Respondents: State agencies and RDs
under 45 CFR 400.301(c) administering
or supervising the administration of
programs.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden
hours per
response
Total
burden
hours
Annual
burden
hours
62
3
18
3,348
1,116
State Plan for Grants to States for Refugee Resettlement
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Estimated Total Annual Burden
Hours: 1,116.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 8 U.S.C. 1522 of the
Immigration and Nationality Act (the Act)
[Title IV, Sec. 412 of the Act] for each state
agency requesting federal funding for refugee
resettlement under 8 U.S.C. 524 [Title IV,
Sec. 414 of the Act].
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–24777 Filed 11–6–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2268]
Insanitary Conditions at Compounding
Facilities; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Insanitary Conditions at Compounding
Facilities.’’ Drug products compounded
under insanitary conditions could
become contaminated and cause serious
adverse events, including death, in
patients. FDA is issuing this guidance to
help compounding facilities and State
regulatory agencies understand some
examples of what FDA considers to be
insanitary conditions that could cause a
drug to become contaminated or
rendered injurious to health. These
examples are intended to help
compounding facilities take action to
SUMMARY:
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prevent the occurrence of these and
other insanitary conditions, as well as to
implement appropriate corrective
actions when such conditions already
exist.
The announcement of the
guidance is published in the Federal
Register on November 9, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances on any guidance at
any time as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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
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Agencies
[Federal Register Volume 85, Number 217 (Monday, November 9, 2020)]
[Notices]
[Pages 71347-71348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24777]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; State Plan for Grants
to States for Refugee Resettlement (OMB #0970-0351)
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF), Office of
Refugee Resettlement (ORR) is requesting a 3-year extension of the ACF
form ORR-0135 State Plan for Grants to States for Refugee Resettlement
(OMB #0970-0351, expiration 3/31/2021). ORR is proposing changes to the
form.
DATES: Comments due within 60 days of publication. In compliance with
the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995, ACF is soliciting public comment on the specific aspects
of the information collection described above.
ADDRESSES: Copies of the proposed collection of information can be
[[Page 71348]]
obtained and comments may be forwarded by emailing
[email protected]. Alternatively, copies can also be obtained
by writing to the Administration for Children and Families, Office of
Planning, Research, and Evaluation (OPRE), 330 C Street SW, Washington,
DC 20201, Attn: ACF Reports Clearance Officer. All requests, emailed or
written, should be identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: A State Plan is a required comprehensive narrative
description of the nature and scope of a state's or Replacement
Designee's (RD) Refugee Resettlement Program and provides assurances
that the program will be administered in conformity with the specific
requirements stipulated in 45 CFR 400.4-400.9. The State Plan must
include all applicable state or RD procedures, designations, and
certifications for each requirement as well as supporting
documentation. The plan assures ORR that the state or RD is capable of
administering refugee assistance and coordinating employment and other
social services for eligible caseloads in conformity with specific
requirements.
Changes proposed to the previously approved State Plan for Grants
to States for Refugee Resettlement information collection are described
below. ORR is proposing:
Streamlining/formatting changes to multiple sections of
the form including technical corrections to regulatory citations and
removing a number of requirements related to the now obsolete Wilson-
Fish Alternative Program (superseded by the Wilson-Fish TANF
Coordination Program, which will have its own separate reporting
requirements).
adding a number of requirements related to Replacement
Designees (RDs) to ensure that they are administering the Refugee
Resettlement Program with transparency and equity and to the same
standard as a state, including quarterly consultation process, Refugee
Medical Assistance, Unaccompanied Refugee Minors (URM), and emergency
planning to ensure ORR populations receive all necessary information
and services to the extent possible.
requesting additional information related to the Refugee
Support Services (RSS) program; ORR's current template does not provide
sufficient detailed information for ORR to ascertain how a grantee
intends to provide RSS services to its client base.
improving the URM section to correct inefficiencies,
eliminate unnecessary items, and address the needs of victims of
trafficking and Special Immigrant Juveniles now eligible for the URM
program. In particular, ORR is soliciting states' and RDs' plans for
placing children referred by ORR and ensuring alignment with federal
capacity priorities.
Respondents: State agencies and RDs under 45 CFR 400.301(c)
administering or supervising the administration of programs.
Annual Burden Estimates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total number of Average burden
Instrument Total number of responses per hours per Total burden Annual burden
respondents respondent response hours hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Plan for Grants to States for Refugee Resettlement........... 62 3 18 3,348 1,116
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,116.
Comments: The Department specifically requests comments on (a)
whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Authority: 8 U.S.C. 1522 of the Immigration and Nationality Act
(the Act) [Title IV, Sec. 412 of the Act] for each state agency
requesting federal funding for refugee resettlement under 8 U.S.C.
524 [Title IV, Sec. 414 of the Act].
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-24777 Filed 11-6-20; 8:45 am]
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