Notice for Public Comment on Administration for Native Americans' Program Policies and Procedures
| Published date | 19 February 2021 |
| Citation | 86 FR 10283 |
| Record Number | 2021-03345 |
| Section | Notices |
| Court | Children And Families Administration |
10283
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
a disaster or emergency, waivers and
flexibilities assist health care providers/
suppliers in providing timely healthcare
and services to people who have been
affected and enables states, Federal
districts, and U.S. territories to ensure
Medicare and/or Medicaid beneficiaries
have continued access to care. During
disasters and emergencies, it is not
uncommon to evacuate Medicare-
participating facilities and relocate
patients/residents to other provider
settings or across state lines, especially,
during hurricane and tornado events.
CMS must collect relevant information
for which a provider is requesting a
waiver or flexibility to make proper
decisions about approving or denying
such requests. Collection of this data
aids in the prevention of gaps in access
to care and services before, during, and
after an emergency. CMS must also
respond to inquiries related to a PHE
from providers and beneficiaries. CMS
is not collecting information from these
inquiries; we are merely responding to
them.
Prior to this request, CMS did not
have a standard process or OMB
approval for providers/suppliers
impacted to submit 1135 waiver/
flexibility requests or inquiries, as these
were generally seen on a smaller scale
(natural disasters) prior to the COVID–
19 public health emergency. CMS has
provided general guidance to Medicare-
participating facilities which can be
viewed at https://www.cms.gov/
Medicare/Provider-Enrollment-and-
Certification/SurveyCertEmergPrep/
1135-Waivers. The requests and
inquiries would be sent directly, via
email, to the Survey Operations Group
in each CMS Location (previously
known as CMS Regional Offices) and
the entity would provide a brief
summary to CMS for a waiver/flexibility
request or an answer to an inquiry. We
are now developing a streamlined,
automated process to standardize the
1135 waiver requests and inquiries
submitted based on lessons learned
during COVID–19 PHE, primarily based
on the volume of requests to ensure
timely response to facility needs. The
waiver request form was approved
under an Emergency information
collection request on October 15, 2020.
Furthermore, the normal operations of
a healthcare provider are disrupted by
emergencies or disasters occasionally.
When this occurs, State Survey
Agencies (SA) deliver a provider/
beneficiary tracking report regarding the
current status of all affected healthcare
providers and their beneficiaries. This
report includes demographic
information about the provider, their
operational status, beneficiary status,
and planned resumption of normal
operations. This information is provided
whether or not a PHE has been declared.
We are now developing a streamlined,
automated process to standardize
submission of this information directly
by the provider during emergencies and
eliminating the need for SA to provide
it. It will consist of a public facing web
form.
This information will be used by CMS
to receive, triage, respond to and report
on requests and/or inquiries for
Medicare, Medicaid, and CHIP
beneficiaries. This information will be
used to make decisions about approving
or denying waiver and flexibility
requests and may be used to identify
trends that inform CMS Conditions for
Coverage or Conditions for Participation
policies during public health
emergencies, when declared by the
President and the HHS Secretary.
Subsequent to the Emergency
information collection request, we
revised the package to include a second
form, Healthcare Facility Status
Workflow, which is for operational
status information which will be used to
assist providers in delivering critical
care to beneficiaries during
emergencies. Subsequent to the 60-day
Federal Register notice which
published on October 21, 2020 (85 FR
66990), we conducted user acceptance
testing, resulting in enhancements to the
public-facing web form that streamline
the submission process and improve the
flow and readability of the web form.
These enhancements make the
automated process easier to use for
healthcare providers. We are also
remediating a violation of the
Paperwork Reduction Act by adding the
Acute Hospital Care at Home waiver to
this package. The initiative was
established on November 23, 2020, in
response to the unprecedented strain on
hospital capacity due to the severe
national increase in coronavirus disease
2019 (COVID–19). There is an increase
in burden due to adding this waiver
initiative to this package. Form Number:
CMS–10752 (OMB control number:
0938–1384); Frequency: Occasionally;
Affected Public: Private Sector: Business
or other for-profits and Not-for-profit
institutions and State, Local or Tribal
Governments; Number of Respondents:
5,729; Total Annual Responses: 5,729;
Total Annual Hours: 5,729. (For policy
questions regarding this collection,
contact Adriane Saunders at 404–562–
7484.)
Dated: February 16, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–03419 Filed 2–18–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Numbers: 93.581, 93.587, 93.612]
Notice for Public Comment on
Administration for Native Americans’
Program Policies and Procedures
AGENCY
: Administration for Native
Americans (ANA), Administration for
Children and Families (ACF),
Department of Health and Human
Services (HHS).
ACTION
: Notice for public comment.
SUMMARY
: Pursuant to Section 814 of the
Native American Programs Act of 1974
(NAPA), as amended, ANA is required
to provide members of the public an
opportunity to comment on proposed
changes in interpretive rules and
general statements of policy and to give
notice of the proposed changes no less
than 30 days before such changes
become effective. In accordance with
notice requirements of NAPA, ANA
herein describes proposed interpretive
rules and general statements of policy
that relate to ANA’s funding
opportunities in Fiscal Year (FY) 2021.
Changes to FY 2021 funding
opportunity announcements (FOAs)
will be based on the following
previously published programs:
Environmental Regulatory Enhancement
(ERE), HHS–2021–ACF–ANA–NR–1907;
Native American Language Preservation
and Maintenance-Esther Martinez
Immersion (EMI), HHS–2021–ACF–
ANA–NB–1958; Native American
Language Preservation and Maintenance
(P&M), HHS–2021–ACF–ANA–NL–
1924; Social and Economic
Development Strategies (SEDS), HHS–
2021–ACF–ANA–NA–1906; Social and
Economic Development Strategies-
Alaska (SEDS–AK), HHS–2021–ACF–
ANA–NK–1902; and Social and
Economic Development Strategies-
Growing Organizations (SEDS–GO),
HHS–2021–ACF–ANA–NN–1918.
DATES
: Comments are due by March 22,
2021. If ANA does not receive any
significant comments within the 30-day
comment period, ANA will proceed
with the proposed changes in the
respective published FOAs. The FOAs
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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
will serve as the final notice of these
proposed changes.
ADDRESSES
: Comments may be
submitted to Carmelia Strickland,
Director of Program Operations,
Administration for Native Americans,
330 C Street SW, Washington, DC 20201
or via email to ANAComments@
acf.hhs.gov.
FOR FURTHER INFORMATION CONTACT
:
Carmelia Strickland, Director, Division
of Program Operations, Administration
for Native Americans, 330 C Street SW,
Washington, DC 20201. Telephone:
(877) 922–9262; Email:
ANAComments@acf.hhs.gov.
SUPPLEMENTARY INFORMATION
: Section
814 of NAPA, as amended, (42 U.S.C.
2992b–1) incorporates provisions of the
Administrative Procedure Act that
require ANA to provide notice of its
proposed interpretive rules and
statements of policy, and to seek public
comment on such proposals. This notice
serves to fulfill the statutory notice and
public comment requirement. ANA
voluntarily includes rules of practice
and procedures in this notice in an
effort to be transparent. The proposed
interpretive rules, statements of policy,
and rules of ANA practice and
procedure reflected in clarifications,
modifications, and new text will appear
in the following six FY 2021 FOAs: ERE,
EMI, P&M, SEDS, SEDS–AK, and SEDS–
GO.
ANA’s past FOAs can be accessed at
https://ami.grantsolutions.gov/
index.cfm?switch=searchresult&type=
office¶m=ANA&page=ANA.
Synopses and application forms will be
available on https://www.grants.gov.
A. Interpretive rules, statements of
policy, procedures, and practice. The
proposals below reflect ANA’s proposed
changes in rules, policy, or procedures
that will take effect in the FY 2021
FOAs.
1. Letter of Intent—ANA will include
a provision in all of its FOAs to ask
potential applicants to submit a Letter of
Intent within 30 days of publication, but
it is not mandatory. By doing so,
respondents will receive information
about ANA’s training and technical
assistance support for applicants. This
will also enable ANA to estimate the
number of applications that will be
submitted in order to plan for the peer
review process.
2. Intellectual Property—Based on
feedback from grantees and through
tribal consultations, ANA is concerned
about the protection of intellectual
property of materials created with grant
funding. Therefore, ANA will include
information in all FOAs that encourages
applicants to educate themselves on
intellectual property rights and the
protection of ownership of Native
language materials, ceremonies, music
and dance, and other forms of
knowledge and cultural practices that
originate from Native communities.
3. Previously Funded Projects—ANA
has a long-standing policy in place that
it provides project-specific funding and
not ongoing program funding. There is
existing authority for ANA to choose not
to fund a project that is essentially
identical or similar in whole or in part
to previously funded projects proposed
by the same applicant or activities or
projects proposed by a consortium that
duplicate activities for which any
consortium member also receives or has
received funding from ANA. It will be
clarified in the FOAs this year that
applicants that propose a project similar
to a previously funded ANA grant
should acknowledge past funding and
explain what was accomplished. In
addition, the applicant should be
explicit and provide a detailed
description of how the new project is
different and is not duplicative of the
past project.
4. Eligibility—In December, Congress
passed the Indian Community Economic
Enhancement Act of 2020, which
reauthorized certain sections of NAPA
related to funding for economic
development projects including adding
Native community development
financial institutions (CDFIs) as an
eligible entity; therefore, ANA will add
Native CDFIs to the list of eligible
applicants. In addition, during tribal
consultation in 2020, a comment was
received that asked ANA to ensure that
Urban Indian Organizations were
eligible to apply for ANA grants.
Therefore, ANA will clarify in the FOAs
that Urban Indian Organizations (UIOs),
as defined by 25 U.S.C.1603(29), are
eligible under current regulations (45
CFR1336.33) as ‘‘incorporated non-
profit multi-purpose community-based
Indian organizations’’ and as ‘‘urban
Indian centers’’. However, Native CDFIs
and UIOs are not eligible to apply for
the ERE program, which is limited to
tribes and tribal entities. Additionally,
like all applicants that are not tribes or
Alaska Native Villages, Native CDFIs
and UIOs must also meet the ANA’s
Assurance of Community
Representation on the Board of
Directors.
5. Application Requirements and
Evaluation Criteria Scores—Sections
803 and 806 of NAPA, 42 U.S.C. 2991b;
2991d–1. In FY 2018, ANA made
substantial revisions to the application
requirements and evaluation criteria
included in our FOAs. The purpose of
the revisions was to shift from a deficit-
based to a strengths-based approach for
application planning and development,
to design each project to follow the
ANA Project Framework, and to
emphasize a community-based
approach to project planning and
implementation. ANA stands behind the
revisions made in FY 2018 and does not
plan to change the information being
requested; however, efforts have been
made to reduce redundancy and number
of scoring criteria. ANA proposes the
following evaluation criteria scores for
the SEDS, SEDS–AK, ERE, and P&M
FOAs for FY 2021:
Approach for a maximum of 73
points, to consist of the following: Long
Term Community Goal (2 points),
Current Community Condition (3
points); Project Goal (2 points);
Objectives (6 points); Outcomes and
Indicators (5 points); Outputs (3 points);
Outcome Tracker and Outcome
Tracking Strategy (7 points).
Community-Based Strategy (10 points),
Readiness and Implementation Strategy
(20 points); and the Objective Work Plan
(OWP) (15 points).
Organizational Capacity for a
maximum of 12 points.
Budget and Budget Justification for a
maximum of 15 points, to consist of the
following: Line Item Budget (5 points)
and Budget Justification (10 points).
These changes are meant to
streamline the information required for
a successful grant application and
provide specific point allotments in
order to make ANA’s evaluation
criterion more approachable. In
addition, it is intended to provide
greater guidance to panel reviewers on
how to allocate scores.
6. Changes to the SEDS–FOA—
Priorities and bonus points—Sections
803 and 803B of NAPA, 42 U.S.C.
2991b; 2991b–2. As previously
mentioned, recently passed legislation
requires ANA to prioritize applications
seeking assistance for the following: (1)
The development of a tribal code or
courts system for purposes of economic
development, including commercial
codes, training for court personnel, and
the development of nonprofit
subsidiaries or other tribal business
structures; (2) the development of a
native community development
financial institution, including training
and administrative expenses; (3) the
development of a tribal master plan for
community and economic development
and infrastructure. The new economic
development legislative priorities will
be incorporated into the new program
areas of interest for the SEDS FOA. Ten
bonus points will be awarded to
applications that address one or more of
these priority areas. Applications that
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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
propose a legislative priority project
should include the priority area(s) in the
project goal, all objectives and
indicators as reflected in the project’s
framework, project approach, Objective
Work Plan and Outcome Tracker.
Reviewers should provide 10 points if
all elements are included in the
application to address one or more of
the economic development priority
areas.
In addition, during tribal
consultation, additional social
development priorities areas were
identified by Native communities to
potentially fund through the SEDS
program. Therefore, 5 bonus points will
be awarded to applications that address
one or more of the following Native
community priority areas: Native
Veterans, Missing and Murdered Native
Americans (MMNA), or Emergency
Preparedness and Response.
Applications that address one of more of
these priorities areas should include the
priority area in the project goal, all
objectives, indicator(s), and target
population (either as participants or
beneficiaries). Reviewers should
provide 5 points if all elements are
included in the application to address
one or more priority areas. Since social
and economic development projects
have different project goals, no
application will be eligible to receive
both sets of bonus points. In addition,
the SEDS program areas of interest will
be expanded to include MMNA and
Anti-Human Trafficking.
7. Changes to SEDS–AK FOA—
Section 803 of NAPA, 42 U.S.C. 2991b.
ANA will also incorporate the new
legislative economic development
priorities into the SEDS–AK FOA.
Therefore, new program areas of interest
for SEDS–AK will include the
following: (1) The development of a
Tribal code or court system for purposes
of economic development, including
commercial codes, training for court
personnel, and the development of
nonprofit subsidiaries or other tribal
business structures; (2) the development
of native community development
financial institutions, including training
and administrative expenses; (3) the
development of a tribal master plans for
community and economic development
and infrastructure. Therefore, 10 bonus
points will be awarded to applications
that address one or more of these
priority areas. Applications that propose
a legislative priority project should have
it included in the project goal, all
objectives and indicators as reflected in
the project’s framework, the project
approach, and the Objective Work Plan
and Outcome Tracker. Reviewers should
provide 10 points if all elements are
included in the application to address
one or more of the economic
development priority areas. In addition,
ANA plans to modify the description of
the program purpose for the SEDS–AK
FOA to provide a competitive advantage
for smaller Alaska Native villages or
organizations that have never received
ANA funding. Therefore, the FOA will
state that reviewers should award 5
bonus points in the scoring criteria if an
eligible entity has never received an
ANA award. ANA staff will confirm
during the objective review process if an
applicant organization for SEDS–AK has
received a past ANA award.
8. Changes to EMI FOA—Section
803C of NAPA, 42 U.S.C. 2991b–3. In
accordance with 42 U.S.C. 2991b–
3(c)(7), applicants for an EMI grant must
submit an official document that
certifies the applicant has at least 3
years of experience in operating and
administering a Native American
language survival school, a Native
American language nest, or any other
educational program in which
instruction is conducted in a Native
American language, in accordance with
Public Law 109–394. Therefore, the EMI
FOA will have a new evaluation
criterion to score 10 points to ensure the
application includes a certification
document that demonstrates the
applicant has at least 3 years of
experience in operating a language nest,
survival school, or other native language
educational program. As a result, the
EMI FOA’s scoring criteria will change
as follows:
Approach for a maximum of 75
points, to consist of the following: Nest
or Survival School Certification (10
points); Long Term Community Goal (2
points); Current Community Condition
(3 points); Project Goal (2 points);
Objectives (6 points); Outcomes and
Indicators (5 points); Outputs (3 points);
Outcome Tracker and Outcome
Tracking Strategy (7 points);
Community-Based Strategy (8 points);
Readiness and Implementation Strategy
(16 points); and the Objective Work Plan
(OWP) (13 points).
Organizational Capacity for a
maximum of 10 points.
Budget and Budget Justification for a
maximum of 15 points, to consist of the
following: Line Item Budget (5 points)
and Budget Justification (10 points).
9. Changes to SEDS–GO FOA—
Sections 803 and 803B of NAPA, 42
U.S.C. 2991b; 2991b–2. In FY 2020,
ANA introduced a new FOA as a special
initiative under the SEDS program to
support growing organizations to
provide funding to enhance their
internal capacity and infrastructure to
better serve their members or their
communities. There will be no
substantive changes to application
requirements in the FY 2021 SEDS–GO
FOA. There will be slight changes to the
evaluation scoring criteria, which will
be as follows:
Approach (for a maximum of 70
points) to consist of the following:
Introduction to the Applicant
Organization (6 points); Targeted
Challenge (6 points); Project Goal (6
points); SMART Objectives (6 points);
Outcomes and Indicators (6 points);
Description of Project Implementation
Strategy (25 points); Objective Work
Plan (OWP) (15 points).
Organizational Capacity—15 points.
Budget and Budget Justification (for a
maximum of 15 points) to consist of a
Line Item Budget (5 points) and a
Budget Justification (10 points).
Bonus Points—5 bonus points may be
provided to applicants that have never
received an ANA grant award.
Statutory Authority: Section 814 of
the Native American Programs Act of
1974, as amended.
Elizabeth Leo,
Senior Grant Policy Specialist, Office of
Administration, Administration for Children
and Families.
[FR Doc. 2021–03345 Filed 2–18–21; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1136]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice of availability.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
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