Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices 10283 

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 Medicareparticipating 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 Medicareparticipating facilities which can be 

viewed at https://www.cms.gov/ 

Medicare/Provider-Enrollment-andCertification/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 StrategiesAlaska (SEDS–AK), HHS–2021–ACF– 

ANA–NK–1902; and Social and 

Economic Development StrategiesGrowing 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 


tkelley on DSKBCP9HB2PROD with NOTICES
10284 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 nonprofit 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 deficitbased 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 10285 

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. 


tkelley on DSKBCP9HB2PROD with NOTICES