22908 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 

which helps ensure that suppliers 

produce food that meets U.S. safety 

standards. 

Occasionally, FDA will need to 

communicate with consumers and other 

stakeholders about immediate health 

issues which could affect public health 

and safety. This collection of 

information allows the use of fast-track 

methods of communication such as 

quick turnaround surveys, focus groups, 

and in-depth interviews collected from 

consumers and other stakeholders to 

communicate FDA issues of immediate 

and important public health 

significance. We plan on using these 

methods of communication to collect 

vital public health and safety 

information. 

For example, these methods of 

communication might be used when 

there is a foodborne illness outbreak, 

food recall, or other situation requiring 

expedited FDA food, dietary 

supplement, cosmetics, or animal food 

or feed communications. So that FDA 

may better protect the public health, the 

Agency needs quick turnaround 

information provided by this collection 

of information to help ensure its 

messaging has reached the target 

audience, has been effective, and, if 

needed, to update its communications 

during these events. 

Respondents to this collection of 

information include a wide range of 

consumers and other FDA stakeholders 

such as producers and manufacturers of 

FDA-regulated food and cosmetic 

products, dietary supplements, and 

animal food and feed. Participation will 

be voluntary. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Survey type Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

In-depth Interviews, Cognitive Interviews Screener 45 1 45 0.083 (5 minutes) ..... 4 

In-depth Interviews, Cognitive Interviews ................. 9 1 9 1 ................................ 9 

In-depth Interviews Screener .................................... 900 1 900 0.083 (5 minutes) ..... 75 

In-depth Interviews ................................................... 180 1 180 1 ................................ 180 

Survey Cognitive Interviews Screener ..................... 45 1 45 0.083 (5 minutes) ..... 4 

Survey Cognitive Interviews ..................................... 9 1 9 1 ................................ 9 

Pretest survey screener ............................................ 750 1 750 0.083 (5 minutes) ..... 62 

Pretest survey ........................................................... 150 1 150 0.25 (15 minutes) ..... 38 

Self-Administered Surveys—Study Screener ........... 75,000 1 75,000 0.083 (5 minutes) ..... 6,225 

Self-Administered Surveys ....................................... 15,000 1 15,000 0.25 (15 minutes) ..... 3,750 

Focus Group/Small Group, Cognitive Groups 

Screener.

180 1 180 0.083 (5 minutes) ..... 15 

Focus Group/Small Group, Cognitive Groups .......... 60 1 60 1.5 (90 minutes) ....... 90 

Focus Group/Small Group Participant Screening .... 720 1 720 0.083 (5 minutes) ..... 60 

Focus Group/Small Group Discussion ..................... 240 1 240 1.5 (90 minutes) ....... 360 

Total ................................................................... ........................ ........................ ........................ ................................... 10,881 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08189 Filed 4–15–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Ending the HIV/HCV Epidemics in 

Indian Country: A Program for 

American Indian/Alaska Native Tribes 

and Urban Indian Communities 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2022–IHS–ETHIC–0001. 

Assistance Listing (Catalog of Federal 

Domestic Assistance or CFDA) Number: 

93.933. 

Key Dates 

Application Deadline Date: June 17, 

2022. 

Earliest Anticipated Start Date: 

August 1, 2022. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) is 

accepting applications for a cooperative 

agreement for the Ending the Human 

Immunodeficiency Virus (HIV) and 

Hepatitis C Virus (HCV) Epidemics in 

Indian Country (ETHIC) program. This 

program is authorized under the Snyder 

Act, 25 U.S.C. 13; the Transfer Act, 42 

U.S.C. 2001(a); and the Indian Health 

Care Improvement Act, 25 U.S.C. 1621q, 

1660e. This program is described in the 

Assistance Listings located at https://

sam.gov/content/home (formerly known 

as the CFDA) under 93.933. 

Background 

In February 2019, the White House 

announced a new initiative, Ending the 

HIV Epidemic in the U.S. (EHE). This 

10-year initiative beginning with fiscal 

year (FY) 2020, seeks to achieve the 

critical goal of reducing new HIV 

infections in the United States (U.S.) to 

less than 3,000 per year by 2030. The 

first phase of the initiative focuses on 48 

counties, Washington, DC, San Juan, 

Puerto Rico, and seven states with a 

substantial rural HIV burden. By 

focusing on these geographic focus areas 

(see https://files.hiv.gov/s3fs-public/ 

Ending-the-HIV-Epidemic-Countiesand-Territories.pdf) in the first phase of 

the initiative, the U.S. Department of 

Health and Human Services (HHS) 

plans to reduce new HIV infections by 

75 percent within five years. To reduce 

new HIV infections in the U.S. by 75 

percent by 2025 and 90 percent by 2030, 

EHE focuses on four key strategies that 

together can end the HIV epidemic in 

the U.S.: Diagnose, Treat, Prevent, and 

Respond. In this cooperative agreement, 

the IHS directs applicants to implement 

activities specific to strategies one, two, 

and three: Diagnose, Treat, and Prevent. 

EHE is a collaboration of HHS 

agencies, primarily the Health 

Resources and Services Administration, 

the Centers for Disease Control and 


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1https://hivgov-prod-v3.s3.amazonaws.com/s3fspublic/NHAS-2022-2025.pdf Accessed 3/11/2022 

2https://www.hhs.gov/sites/default/files/ViralHepatitis-National-Strategic-Plan-2021-2025.pdf 

Accessed 3/11/2022. 

3https://www.npaihb.org/wp-content/uploads/

2020/08/HCV-Elimination-Strategy-for-AIANCommunities.pdf Accessed 3/11/2022. 

4http://www.cdc.gov/nchhstp/newsroom/2019/

hiv-vital-signs.html. 

5A Regional Analysis of Hepatitis C Virus 

Collaborative Care With Pharmacists in Indian 

Health Service Facilities https://

journals.sagepub.com/doi/full/10.1177/ 

2150132718807520. 

6Evaluation of the Cherokee Nation Hepatitis C 

Virus Elimination Program in the First 22 Months 

of Implementation, Mera, Williams, Essex; et al 

https://jamanetwork.com/journals/jamanet

workopen/article-abstract/2774323. 

7Evaluation of the Cherokee Nation Hepatitis C 

Virus Elimination Program in the First 22 Months 

of Implementation, Mera, Williams, Essex; et al 

https://jamanetwork.com/journals/ 

jamanetworkopen/article-abstract/2774323. 

Prevention (CDC), the National 

Institutes of Health, the IHS, and the 

Substance Abuse and Mental Health 

Services Administration. HHS recently 

released two national strategic plans, 

and the IHS expects applicants to adopt 

these plans as they design and carry out 

activities toward HIV and HCV 

elimination: (1) The HIV National 

Strategic Plan: A Roadmap to End the 

Epidemic in the United States (2022– 

2025); 1 and (2) The Viral Hepatitis 

National Strategic Plan for the U.S.: A 

Roadmap to Elimination 2021–2025.2

The HIV National Strategic Plan 

(2021–2025) is a 5-year plan that details 

principles, priorities, and actions to 

guide the national response to the HIV 

epidemic. The IHS promotes robust 

advances and innovations in HIV health 

care using the HIV National Strategic 

Plan to end the epidemic as its 

framework. Therefore, to the extent 

possible, activities funded by the IHS 

focus on addressing these four goals: 

(1) Reduce new HIV infections; 

(2) Increase access to care and 

improve health outcomes for people 

with HIV; 

(3) Reduce HIV-related health 

disparities and health inequities; 

(4) Achieve a more coordinated 

national response. 

To achieve these shared goals, 

recipients should align their 

organization’s efforts to ensure that 

people with HIV are linked to and 

retained in high-quality HIV care and 

have timely access to HIV treatment and 

the supports needed (e.g., mental health 

and substance use disorders services) to 

achieve HIV viral suppression. 

The Viral Hepatitis National Strategic 

Plan for the U.S.: A Roadmap to 

Elimination 2021–2025, released on 

January 7, 2021, is a new phase in the 

fight against viral hepatitis in the U.S. 

Building on three prior National Viral 

Hepatitis Action Plans over the last 10 

years, the Viral Hepatitis National 

Strategic Plan is the first to aim to 

eliminate viral hepatitis as a public 

health threat in the U.S. 

The Viral Hepatitis Plan sets forth a 

clear vision for how the U.S. will be a 

place where new viral hepatitis 

infections are prevented, every person 

knows their status, and every person 

with viral hepatitis has high-quality 

health care and treatment and lives free 

from stigma and discrimination. Both 

the HIV and viral hepatitis national 

strategic plans include AI/AN people in 

their priority populations. 

In addition, for resources specific to 

AI/AN communities, the Northwest 

Portland Area Indian Health Board, with 

funding from the IHS and the Minority 

HIV/AIDS Fund, designed a document 

to help AI/AN health advocates, 

decision makers, and medical providers 

address the HCV epidemic in their 

communities through programmatic and 

policy changes. IHS encourages 

applicants to review the Hepatitis C 

Elimination Strategy for AI/AN 

Communities 3 document’s objectives 

which describes the rationale and 

program design, and provides a tool kit 

for implementing an HCV microelimination program in an AI/AN 

community—Tribal or IHS clinic, 

hospital, or health system. 

A 2019 CDC analysis 4 shows that the 

vast majority (about 80 percent) of new 

HIV infections in the U.S. in 2016 came 

from the nearly 40 percent of people 

who either did not know they had HIV 

or who received a diagnosis but were 

not receiving HIV care and treatment. 

This highlights the need to increase the 

proportion of people with HIV or HCV 

who are aware of their status and help 

them get into care and treatment. 

Diagnosing AI/AN people with HIV or 

HCV, linking those with HIV or HCV to 

primary care, and achieving viral 

suppression are necessary public health 

steps toward ending the HIV and HCV 

epidemics in Indian Country. The HIV/ 

HCV care continuum has five main 

‘‘steps’’ or stages that include (1) 

diagnosis, (2) linkage to care, (3) 

retention in care, (4) adherence to 

therapy (ART), and (5) viral suppression 

(HIV)/viral clearance (HCV). The care 

continuum depicts a series of stages in 

which people with HIV or HCV engage 

in care from initial diagnosis through 

their successful treatment with 

medication. It also demonstrates the 

proportion of individuals living with 

HIV or HCV who are engaged at each 

stage. The care continuum allows 

recipients and planning groups to 

measure progress and direct resources 

most effectively. For this funding 

opportunity, the IHS requires applicants 

to address, implement, and measure the 

HIV and HCV continuum of care. For 

example, applicants should be prepared 

to collect data on the number of new 

diagnosis of HIV, numbers of positive 

cases linked to care, how many of those 

linked to care are retained in care and 

adhering to therapy, and the number of 

those achieving an undetectable viral 

load. 

Federal health care facilities in an 

administrative area of the IHS 

conducted a review to identify and 

address gaps in HCV treatment. 

Facilities generally treated HCV with a 

strong pharmacy component using a 

collaborative practice agreement and 

HCV telehealth services to external 

specialists. These data indicate that: (1) 

Rural clinics can be successful 

providing HCV diagnosis and treatment; 

(2) pharmacists can play a key role in 

HCV clinical services; (3) the outcomes 

of each step in the treatment process at 

the facility level can vary widely due to 

local factors; and (4) the barriers to HCV 

care that persist are nonclinical.5 In a 

study published in The Journal of the 

American Medical Association,6 the 

Cherokee Nation Health Services HCV 

elimination program demonstrated that 

implementation of a community-based 

HCV elimination program was 

associated with an improved cascade of 

care. In this cohort study, first-time HCV 

screening coverage increased from 20.9 

percent to 38.2 percent from 3 years 

before to 22 months into 

implementation.7 This information may 

serve other organizations planning to 

implement similar programs in large 

rural areas. 


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22910 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 

8Centers for Disease Control and Prevention. HIV 

Surveillance Report, 2019; vol.32. http:// 

www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2021. 

9U.S. Census Bureau. Annual Estimates of the 

Resident Population: 2010–2020. Available at 

https://www.census.gov/programs-surveys/popest/ 

technical-documentation/research/evaluationestimates/2020-evaluation-estimates/2010s-totalsnational.html. 

10 Department of Health and Human Services, 

Centers for Disease Control and Prevention. HIV in 

the U.S. and dependent areas https://www.cdc.gov/ 

hiv/statistics/overview/ataglance.html. Updated 

January 29, 2019. Accessed February 5, 2019. 

11https://health.gov/healthypeople/objectivesand-data/leading-health-indicators Accessed 3/11/ 

2020. 

12Centers for Disease Control and Prevention. 

HIV Surveillance Report, 2019; vol.32. http://

www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2021. 

13 Garg S, Brooks J, Luo Q, Skarbinski J. 

Prevalence of and Factors Associated with Hepatitis 

C Virus (HCV) Testing and Infection Among HIVinfected Adults Receiving Medical Care in the U.S. 

Infectious Disease Society of America (IDSA). 

Philadelphia, PA, 2014. 

14 Yehia BR, Herati RS, Fleishman JA, Gallant JE, 

Agwu AL, Berry SA, et al. Hepatitis C virus testing 

in adults living with HIV: A need for improved 

screening efforts. PLoS ONE 2014;9(7):e102766. 

https://pubmed.ncbi.nlm.nih.gov/25032989/. 

15Spradling PR, Richardson JT, Buchacz K. 

Trends in hepatitis C virus infection among patients 

in the HIV Outpatient Study, 1996–2007. J Acquir 

Immune Defic Syndr 2010;53:388–396. 

16 Yehia BR, Herati RS, Fleishman JA, Gallant JE, 

Agwu AL, Berry SA, et al. Hepatitis C virus testing 

in adults living with HIV: A need for improved 

screening efforts. PLoS ONE 2014;9(7):e102766. 

https://pubmed.ncbi.nlm.nih.gov/25032989. 

17Spradling PR, Richardson JT, Buchacz K. 

Trends in hepatitis C virus infection among patients 

in the HIV Outpatient Study, 1996–2007. J Acquir 

Immune Defic Syndr 2010;53:388–396. 

18Centers for Disease Control and Prevention. 

Centers for Disease Control and Prevention. HIV 

Surveillance Report, 2019; vol.32. http://

www.cdc.gov/hiv/library/reports/hivsurveillance.html. Published May 2021. Atlanta: 

U.S. Department of Health and Human Services, 

Centers for Disease Control and Prevention; 2017. 

19Panel on Opportunistic Infections in HIVInfected Adults and Adolescents. Guidelines for the 

prevention and treatment of opportunistic 

infections in HIV-infected adults and adolescents: 

Recommendations from the Centers for Disease 

Control and Prevention, the National Institutes of 

Health, and the HIV Medicine Association of the 

Infectious Diseases Society of America. Available at 

https://www.ncbi.nlm.nih.gov/pubmed/19357635. 

July 6, 2018. 

20https://aspe.hhs.gov/system/files/pdf/260026/ 

HepC.pdf. 

For nearly four decades, the national 

investments in HIV have shown 

remarkable results in preventing new 

infections, improving health outcomes, 

and reducing deaths in hundreds of 

thousands of Americans. Despite this, 

progress has plateaued, and additional 

effort is needed to ensure that all 

affected groups benefit equally. Some 

groups, like AI/AN people, African 

American and Latino gay and bisexual 

men, transgender individuals, or people 

living in the South, have a higher 

burden of HIV and experience health 

disparities at each stage of the HIV care 

continuum. Southern states today 

account for an estimated 44 percent of 

all people living with an HIV diagnosis 

in the U.S.,8 despite having only about 

one-third (37 percent) of the overall U.S. 

population.9 Diagnosis rates for people 

in the South are higher than for 

Americans overall. Eight of the ten 

states and all ten metropolitan statistical 

areas with the highest rates of new HIV 

diagnoses are in the South. In addition 

to the severe burden in the South, 

nationally there is a high incidence of 

HIV among transgender individuals, 

high-risk heterosexuals, and persons 

who inject drugs.10

The U.S. has an unprecedented 

opportunity to end the HIV and HCV 

epidemics in America. We have access 

to the most powerful HIV and HCV 

prevention and treatment tools in 

history and new technology that allows 

us to pinpoint where infections are 

spreading most rapidly. By effectively 

equipping all vulnerable AI/AN 

communities with these tools, we can 

end the HIV and HCV epidemics in 

Indian Country. This ETHIC funding 

opportunity acts boldly on this 

unprecedented opportunity by 

providing the hardest-hit AI/AN 

communities with resources to 

implement the additional expertise, 

technology, and resources required to 

address the HIV and HCV epidemics in 

their communities. 

HHS recently developed a set of 

critical health priorities for the nation 

known as ‘‘Leading Health 

Indicators’’ 11 (or LHIs) that are a call to 

action in critical public health areas. 

The IHS will use the LHIs to assess the 

health of the AI/AN population over the 

next decade, to facilitate collaboration 

among diverse groups, and to motivate 

individuals and communities to take 

action to improve their health. The 

following LHIs also will be used by the 

IHS and public health professionals to 

track progress in local AI/AN 

communities as they work toward 

meeting these key national health goals: 

(1) Diagnose 95 percent of persons 

living with HIV or HCV who are aware 

of their status by 2025, working from a 

baseline of 85.8 percent in 2016. 

(2) Treat 95 percent of persons via 

linkage to appropriate care within one 

month of diagnosis by 2025, working 

from a baseline of 78.3 percent in 2017. 

(3) Treat 95 percent of persons 

diagnosed with HIV or HCV via 

sufficient viral suppression/viral 

clearance by 2025, working from a 

baseline of 61.5 percent in 2016. 

(4) Prevent new HIV infections by 

achieving 25 percent pre-exposure 

prophylaxis (PrEP) coverage among 

those for whom PrEP was indicated by 

2025. 

There are notable concerns in new 

HIV diagnoses in AI/AN populations: 

(1) New HIV diagnoses among AI/AN 

populations increased by 18 percent 

from 2015 to 2019; (2) rates of new HIV 

diagnoses among AI/AN adolescents 

increased by 53 percent; and (3) both 

male and female AI/AN individuals had 

the highest percent of estimated 

diagnoses of HIV infection attributed to 

injection drug use.12 Mortality data also 

found that AI/AN individuals have 

significantly higher death rates from 

HIV/AIDS than whites, which could be 

attributable to later diagnosis, lack of 

linkage to care, difficulty accessing care, 

challenges to treatment adherence, or 

other factors or combination of factors. 

HCV is a common co-morbidity for 

bloodborne HIV infections. In 2009, 

approximately 21 percent of HIVinfected adults who were tested for past 

or present HCV infection tested positive, 

although co-infection prevalence varies 

substantially according to HIV-infected 

risk group (e.g., men who have sex with 

men (MSM), high-risk heterosexuals, 

and persons who inject drugs).13 14 15 As 

HCV is a bloodborne virus, primarily 

transmitted through direct contact with 

the blood of an infected person, 

coinfection with HIV and HCV is 

common among HIV-infected injectiondrug users.16 17 18 Although 

transmission via injection drug use 

remains the most common mode of HCV 

acquisition in the U.S., sexual 

transmission is an important mode of 

acquisition among certain groups, 

including HIV-infected MSM with 

certain risk factors.19 Data have shown 

that HCV disproportionately affects AI/ 

AN people, with HCV-related mortality 

more than double the national rate.20 In 

a recent IHS survey, almost 50 percent 

of the AI/AN individuals diagnosed 

with HCV were born after 1965 and 

were younger than the targeted birth 

cohort for HCV screening campaigns 

(1945–1965, ‘Baby Boomers’). Untreated 

HCV can lead to a myriad of 

extrahepatic manifestations and 

cirrhosis with complications such as 

portal hypertension, end stage liver 

disease, and hepatocellular carcinoma 

(HCC). Early diagnosis and treatment of 

HCV infection prevents the 

development of extrahepatic 

manifestations and progressive liver 

disease including cirrhosis. Recently 

developed treatments for HCV are more 

accessible and highly effective at greatly 

reducing HCV- and HCC-related 


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21 2015 Indian Health Surveillance Report 

Sexually Transmitted Infections https://

www.cdc.gov/std/stats/ihs/18IHS-DEDP102_

REPORT_STD_M_508.pdf. 

22https://www.hhs.gov/hepatitis/viral-hepatitisnational-strategic-plan/national-viral-hepatitisaction-plan-overview/index.html. 

mortality. Treatment for HCV can be 

highly successful at the primary care 

level with appropriate planning and 

support. 

Data also show that sexually 

transmitted infection (STI) rates remain 

elevated in Indian Country. Recurrent 

STIs can increase the likelihood of HIV 

transmission. Gonorrhea and syphilis 

often present as co-morbid conditions 

with HIV diagnosis, particularly among 

MSM. The latest Indian Health 

Surveillance Report: Sexually 

Transmitted Diseases 2015 21 showed 

that AI/AN people have 3.8 times the 

incidence rate of whites for chlamydia 

and 4.4 times the rate of whites for 

gonorrhea. AI/AN people have the 

second highest rates for both chlamydia 

and gonorrhea compared to other races/ 

ethnicities. Gonorrhea rates have 

continued to increase drastically since 

2011. Regional differences in STI 

incidence in Indian Country are also 

observed. AI/AN youth and AI/AN 

women, particularly women of 

reproductive age, have a disparate and 

increased STI burden. In addition, 

recent outbreaks of syphilis have been 

observed among AI/AN communities. 

Some of these outbreaks are connected 

to the use of injection drugs and 

methamphetamines, all known risk 

factors for HIV transmission. 

Finally, treatment for substance use 

disorders can be difficult to access in 

IHS catchment areas, as the 

appropriated budget includes fewer 

dollars per patient compared to other 

Federal direct-care networks. Untreated 

substance use disorders can exacerbate 

risk-taking behavior and reduce 

adherence to treatment. IHS 

recommends collaboration whenever 

possible between behavioral health 

services and HIV/HCV/STI prevention 

and care. 

Confronting these intersecting 

epidemics requires collaboration across 

sectors and disciplines and the use of 

existing public health and clinical 

infrastructures. Lasting changes to these 

trends for HIV and related comorbidities among AI/AN communities 

will also require innovative new 

approaches, incorporating existing and 

new data sources, all driven by 

community input. IHS recommends 

applicants research evidence-based 

approaches or identify culturally 

appropriate interventions as bestpractices for collaborative efforts. 

Purpose 

The purpose of this program is to 

support communities in reducing new 

human HIV infections and relevant comorbidities, specifically STI and HCV 

infections, improve HIV-, STI-, and 

HCV-related health outcomes, and 

reduce HIV-, STI-, and HCV-related 

health disparities among AI/AN people. 

In two separate but related parts, this 

initiative aims to implement effective 

and innovative strategies, interventions, 

approaches, and services to reduce new 

HIV and HCV infections among AI/AN 

communities in the U.S. This initiative’s 

overarching goals are to: (1) Reduce new 

HIV infections in the U.S. to less than 

3,000 per year by 2030; and (2) achieve 

a 90 percent reduction in new HCV 

infections and a 65 percent reduction in 

mortality, compared to a 2015 

baseline.22

II. Award Information 

Funding Instrument—Cooperative 

Agreement 

Estimated Funds Available 

The total funding identified for FY 

2022 is approximately $2,480,000. 

Individual award amounts are 

anticipated to be between $160,000 and 

$200,000. The funding available for 

competing and subsequent awards 

issued under this announcement is 

subject to the availability of 

appropriations and budgetary priorities 

of the Agency. The IHS is under no 

obligation to make awards that are 

selected for funding under this 

announcement. 

Anticipated Number of Awards 

Approximately 14 awards will be 

issued under this program 

announcement. 

Period of Performance 

The period of performance is for 3 

years. 

Cooperative Agreement 

Cooperative agreements awarded by 

the HHS are administered under the 

same policies as grants. However, the 

funding agency, IHS, is anticipated to 

have substantial programmatic 

involvement in the project during the 

entire period of performance. Below is 

a detailed description of the level of 

involvement required of the IHS. 

Substantial Agency Involvement 

Description for Cooperative Agreement 

A. The IHS Office of Clinical and 

Preventive Services (OCPS), Division of 

Clinical and Community Services 

(DCCS) will provide ongoing 

consultation and technical assistance to 

plan, implement, and evaluate each 

component as described under 

Recipient Activities (see Section V.1.B, 

Application Review Information, 

Evaluation Criteria, Project Objective(s), 

Work Plan, and Approach). 

B. The IHS will conduct site visits to 

recipient sites and/or coordinate 

recipient visits to IHS facilities to assess 

work plans and ensure data security, 

confirm compliance with applicable 

laws and regulations, assess program 

activities, and to resolve problems, as 

needed mutually. 

C. DCCS will provide a forum for 

outreach and education to advance this 

program’s goals through existing and 

new partnerships. The IHS will 

facilitate the formation of an IHS 

National HIV/HCV/STI Prevention 

workgroup, from clinical, public health, 

advocacy, and education sectors 

working in HIV/HCV/STI control. The 

pupose of the workgroup is to align IHS 

efforts with the HIV, Viral Hepatitis, and 

STI National Strategies. 

D. DCCS will coordinate the various 

internal IHS and external HHS required 

reporting activities and provide 

recipients with program-related 

technical assistance as appropriate to 

provide leadership, advocacy, and 

support. 

III. Eligibility Information 

1. Eligibility 

To be eligible for this funding 

opportunity, an applicant must be one 

of the following as defined under 25 

U.S.C. 1603: 

• A federally recognized Indian Tribe 

as defined by 25 U.S.C. 1603(14). The 

term ‘‘Indian Tribe’’ means any Indian 

Tribe, band, nation, or other organized 

group or community, including any 

Alaska Native village or group, or 

regional or village corporation, as 

defined in or established pursuant to the 

Alaska Native Claims Settlement Act (85 

Stat. 688) [43 U.S.C. 1601 et seq.], which 

is recognized as eligible for the special 

programs and services provided by the 

United States to Indians because of their 

status as Indians. 

• A Tribal organization as defined by 

25 U.S.C. 1603(26). The term ‘‘Tribal 

organization’’ has the meaning given the 

term in section 4 of the Indian SelfDetermination and Education 

Assistance Act (25 U.S.C. 5304(1)): 

‘‘Tribal organization’’ means the 


khammond on DSKJM1Z7X2PROD with NOTICES
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recognized governing body of any 

Indian Tribe; any legally established 

organization of Indians which is 

controlled, sanctioned, or chartered by 

such governing body or which is 

democratically elected by the adult 

members of the Indian community to be 

served by such organization and which 

includes the maximum participation of 

Indians in all phases of its activities: 

Provided that, in any case where a 

contract is let or grant made to an 

organization to perform services 

benefiting more than one Indian Tribe, 

the approval of each such Indian Tribe 

shall be a prerequisite to the letting or 

making of such contract or grant. 

Applicant shall submit letters of support 

and/or Tribal Resolutions from the 

Tribes to be served. 

• An Urban Indian organization as 

defined by 25 U.S.C. 1603(29). The term 

‘‘Urban Indian organization’’ means a 

nonprofit corporate body situated in an 

urban center, governed by an Urban 

Indian controlled board of directors, and 

providing for the maximum 

participation of all interested Indian 

groups and individuals, which body is 

capable of legally cooperating with 

other public and private entities for the 

purpose of performing the activities 

described in 25 U.S.C. 1653(a). 

Applicants must provide proof of 

nonprofit status with the application, 

e.g., 501(c)(3). 

The program office will notify any 

applicants deemed ineligible. 

Note: Please refer to Section IV.2 

(Application and Submission 

Information/Subsection 2, Content and 

Form of Application Submission) for 

additional proof of applicant status 

documents required, such as Tribal 

Resolutions, proof of nonprofit status, 

etc. 

2. Cost Sharing or Matching 

The IHS does not require matching 

funds or cost sharing for grants or 

cooperative agreements. 

3. Other Requirements 

Applications with budget requests 

that exceed the highest dollar amount 

outlined under Section II Award 

Information, Estimated Funds Available, 

or exceed the period of performance 

outlined under Section II Award 

Information, Period of Performance, are 

considered not responsive and will not 

be reviewed. The Division of Grants 

Management (DGM) will notify the 

applicant. 

Additional Required Documentation 

Tribal Resolution 

The DGM must receive an official, 

signed Tribal Resolution prior to issuing 

a Notice of Award (NoA) to any Tribal 

or Tribal organization applicant selected 

for funding. An applicant that is 

proposing a project affecting another 

Indian Tribe must include resolutions 

from all affected Tribes to be served. 

However, if an official, signed Tribal 

Resolution cannot be submitted with the 

application prior to the application 

deadline date, a draft Tribal Resolution 

must be submitted with the application 

by the deadline date in order for the 

application to be considered complete 

and eligible for review. The draft Tribal 

Resolution is not in lieu of the required 

signed resolution but is acceptable until 

a signed resolution is received. If an 

application without a signed Tribal 

Resolution is selected for funding, the 

applicant will be contacted by the 

Grants Management Specialist (GMS) 

listed in this funding announcement 

and given 90 days to submit an official, 

signed Tribal Resolution to the GMS. If 

the signed Tribal Resolution is not 

received within 90 days, the award will 

be forfeited. 

Tribes organized with a governing 

structure other than a Tribal council 

may submit an equivalent document 

commensurate with their governing 

organization. 

Proof of Nonprofit Status 

Organizations claiming nonprofit 

status must submit a current copy of the 

501(c)(3) Certificate with the 

application. 

IV. Application and Submission 

Information 

1. Obtaining Application Materials 

The application package and detailed 

instructions for this announcement are 

available at https://www.Grants.gov. 

Please direct questions regarding the 

application process to Mr. Paul Gettys at 

(301) 443–2114 or (301) 443–5204. 

2. Content and Form Application 

Submission 

Mandatory documents for all 

applicants include: 

• Abstract (one page) summarizing 

the project. 

• Application forms: 

1. SF–424, Application for Federal 

Assistance. 

2. SF–424A, Budget Information— 

Non-Construction Programs. 

3. SF–424B, Assurances—NonConstruction Programs. 

• Project Narrative (not to exceed 10 

pages). See Section IV.2.A, Project 

Narrative for instructions. 

1. Background information on the 

organization. 

2. Proposed scope of work, objectives, 

and activities that provide a description 

of what the applicant plans to 

accomplish. 

• Budget Justification and Narrative 

(not to exceed five pages). See Section 

IV.2.B, Budget Narrative for 

instructions. 

• Tribal Resolution(s), if applicable. 

• Letters of Support from 

organization’s Board of Directors, if 

applicable. 

• Biographical sketches for all Key 

Personnel. 

• Contractor/Consultant resumes or 

qualifications and scope of work. 

• Disclosure of Lobbying Activities 

(SF–LLL), if applicant conducts 

reportable lobbying. 

• Certification Regarding Lobbying 

(GG-Lobbying Form). 

• Work plan with timeline for 

proposed activities. 

• Logic model. 

• Map of area identifying project 

location(s). 

• Copy of current Negotiated Indirect 

Cost (IDC) rate agreement (required in 

order to receive IDC). 

• Organizational Chart. 

• Documentation of current Office of 

Management and Budget (OMB) 

Financial Audit (if applicable). 

Acceptable forms of documentation 

include: 

1. Email confirmation from Federal 

Audit Clearinghouse (FAC) that audits 

were submitted; or 

2. Face sheets from audit reports. 

Applicants can find these on the FAC 

website at https://facdissem.census.gov/. 

Public Policy Requirements 

All Federal public policies apply to 

IHS grants and cooperative agreements. 

Pursuant to 45 CFR 80.3(d), an 

individual shall not be deemed 

subjected to discrimination by reason of 

their exclusion from benefits limited by 

Federal law to individuals eligible for 

benefits and services from the IHS. See 

https://www.hhs.gov/grants/grants/ 

grants-policies-regulations/index.html. 

Requirements for Project and Budget 

Narratives 

A. Project Narrative 

This narrative should be a separate 

document that is no more than 10 pages 

and must: (1) Have consecutively 

numbered pages; (2) use black font 12 

points or larger (tables may be done in 

10 point font); (3) be single-spaced; and 

(4) be formatted to fit standard letter 

paper (81⁄2 x 11 inches). Be sure to 

succinctly answer all questions listed 

under the evaluation criteria (refer to 

Section V.1, Evaluation Criteria) and 

place all responses and required 

information in the correct section noted 


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below or they will not be considered or 

scored. If the narrative exceeds the page 

limit, the application will be considered 

not responsive and will not be 

reviewed. The 10-page limit for the 

narrative does not include the work 

plan, standard forms, Tribal 

Resolutions, budget, budget 

justifications, narratives, and/or other 

items. 

There are three parts to the narrative: 

Part 1—Program Information; Part 2— 

Program Planning and Evaluation; and 

Part 3—Previous HIV/HCV Prevention, 

Care, or Treatment Work. See below for 

additional details about what must be 

included in the narrative. 

The page limits below are for each 

narrative and budget submitted. 

Part 1: Program Information (Limit—3 

Pages) 

Section 1: Community Infrastructure 

Describe the applicant’s current 

health program activities, how long it 

has been operating, and what programs 

or services the organization is currently 

providing. Describe how the applicant 

has determined it has the administrative 

infrastructure to support the activities 

proposed. 

Part 2: Program Planning and Evaluation 

(Limit—3 Pages) 

Section 1: Program Plans 

Describe fully and clearly the 

applicant’s plans to conduct activities 

that lead to increased HIV and Hepatits 

C diagnoses, enhanced prevention, and 

to recruit and retain people in HIV and 

Hepatits C treatment. 

Section 2: Program Evaluation 

Describe fully and clearly the 

improvements that will be made by the 

applicant to meet the public health 

needs of the community in the context 

of the funding requirements. 

Part 3: Previous HIV/HCV Prevention, 

Care, or Treatment Work (Limit—4 

Pages) 

Section 1 

Describe your organization’s 

significant program activities and 

accomplishments over the past five 

years associated with HIV/HCV 

prevention, care, and/or treatment to 

enhance quality health care services. 

B. Budget Narrative (Limit—5 Pages) 

Provide a budget narrative that 

explains the amounts requested for each 

line item of the budget from the SF– 

424A (Budget Information for NonConstruction Programs). The budget 

narrative can include a more detailed 

spreadsheet than is provided by the SF– 

424A. The budget narrative should 

specifically describe how each item will 

support the achievement of proposed 

objectives. Be very careful about 

showing how each item in the ‘‘Other’’ 

category is justified. For subsequent 

budget years (see Multi-Year Project 

Requirements in Section V.1, 

Application Review Information, 

Evaluation Criteria), the narrative 

should highlight the changes from the 

first year or clearly indicate that there 

are no substantive budget changes 

during the period of performance. Do 

NOT use the budget narrative to expand 

the project narrative. 

3. Submission Dates and Times 

Applications must be submitted 

through Grants.gov by 11:59 p.m. 

Eastern Time on the Application 

Deadline Date. Any application received 

after the application deadline will not 

be accepted for review. Grants.gov will 

notify the applicant via email if the 

application is rejected. 

If technical challenges arise and 

assistance is required with the 

application process, contact Grants.gov 

Customer Support (see contact 

information at https://www.Grants.gov). 

If problems persist, contact Mr. Paul 

Gettys (Paul.Gettys@ihs.gov), Deputy 

Director, DGM, by telephone at (301) 

443–2114 or (301) 443–5204. Please be 

sure to contact Mr. Gettys at least 10 

days prior to the application deadline. 

Please do not contact the DGM until you 

have received a Grants.gov tracking 

number. In the event you are not able 

to obtain a tracking number, call the 

DGM as soon as possible. 

The IHS will not acknowledge receipt 

of applications. 

4. Intergovernmental Review 

Executive Order 12372 requiring 

intergovernmental review is not 

applicable to this program. 

5. Funding Restrictions 

• Pre-award costs are allowable up to 

90 days before the start date of the 

award provided the costs are otherwise 

allowable if awarded. Pre-award costs 

are incurred at the risk of the applicant. 

• The available funds are inclusive of 

direct and indirect costs. 

• Only one cooperative agreement 

may be awarded per applicant. 

6. Electronic Submission Requirements 

All applications must be submitted 

via Grants.gov. Please use the https://

www.Grants.gov website to submit an 

application. Find the application by 

selecting the ‘‘Search Grants’’ link on 

the homepage. Follow the instructions 

for submitting an application under the 

Package tab. No other method of 

application submission is acceptable. 

If the applicant cannot submit an 

application through Grants.gov, a 

waiver must be requested. Prior 

approval must be requested and 

obtained from Mr. Paul Gettys, Deputy 

Director, DGM. A written waiver request 

must be sent to GrantsPolicy@ihs.gov 

with a copy to Paul.Gettys@ihs.gov. The 

waiver request must: (1) Be documented 

in writing (emails are acceptable) before 

submitting an application by some other 

method; and (2) include clear 

justification for the need to deviate from 

the required application submission 

process. 

Once the waiver request has been 

approved, the applicant will receive a 

confirmation of approval email 

containing submission instructions. A 

copy of the written approval must be 

included with the application that is 

submitted to the DGM. Applications 

that are submitted without a copy of the 

signed waiver from the Deputy Director 

of the DGM will not be reviewed. The 

Grants Management Officer of the DGM 

will notify the applicant via email of 

this decision. Applications submitted 

under waiver must be received by the 

DGM no later than 5:00 p.m. Eastern 

Time on the Application Deadline Date. 

Late applications will not be accepted 

for processing. Applicants that do not 

register for both the System for Award 

Management (SAM) and Grants.gov 

and/or fail to request timely assistance 

with technical issues will not be 

considered for a waiver to submit an 

application via alternative method. 

Please be aware of the following: 

• Please search for the application 

package in https://www.Grants.gov by 

entering the Assistance Listing (CFDA) 

number or the Funding Opportunity 

Number. Both numbers are located in 

the header of this announcement. 

• If you experience technical 

challenges while submitting your 

application, please contact Grants.gov 

Customer Support (see contact 

information at https://www.Grants.gov). 

• Upon contacting Grants.gov, obtain 

a tracking number as proof of contact. 

The tracking number is helpful if there 

are technical issues that cannot be 

resolved and a waiver from the agency 

must be obtained. 

• Applicants are strongly encouraged 

not to wait until the deadline date to 

begin the application process through 

Grants.gov as the registration process for 

SAM and Grants.gov could take up to 20 

working days. 

• Please follow the instructions on 

Grants.gov to include additional 

documentation that may be requested by 

this funding announcement. 


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23https://hivgov-prod-v3.s3.amazonaws.com/ 

s3fs-public/HIV-National-Strategic-Plan-2021- 

2025.pdf. 

24https://www.hhs.gov/hepatitis/viral-hepatitisnational-strategic-plan/national-viral-hepatitisaction-plan-overview/index.html. 

• Applicants must comply with any 

page limits described in this funding 

announcement. 

• After submitting the application, 

the applicant will receive an automatic 

acknowledgment from Grants.gov that 

contains a Grants.gov tracking number. 

The IHS will not notify the applicant 

that the application has been received. 

Dun and Bradstreet (D&B) Data 

Universal Numbering System (DUNS) 

Applicants and recipient organizations 

are required to obtain a DUNS number 

and maintain an active registration in 

the SAM database. The DUNS number 

is a unique 9-digit identification number 

provided by D&B that uniquely 

identifies each entity. The DUNS 

number is site specific; therefore, each 

distinct performance site may be 

assigned a DUNS number. Obtaining a 

DUNS number is easy, and there is no 

charge. To obtain a DUNS number, 

please access the request service 

through https://fedgov.dnb.com/ 

webform, or call (866) 705–5711. 

The Federal Funding Accountability 

and Transparency Act of 2006, as 

amended (‘‘Transparency Act’’), 

requires all HHS recipients to report 

information on sub-awards. 

Accordingly, all IHS recipients must 

notify potential first-tier sub-recipients 

that no entity may receive a first-tier 

sub-award unless the entity has 

provided its DUNS number to the prime 

recipient organization. This requirement 

ensures the use of a universal identifier 

to enhance the quality of information 

available to the public pursuant to the 

Transparency Act. 

System for Award Management (SAM) 

Organizations that are not registered 

with SAM must have a DUNS number 

first, then access the SAM online 

registration through the SAM home page 

at https://sam.gov (U.S. organizations 

will also need to provide an Employer 

Identification Number from the Internal 

Revenue Service that may take an 

additional 2–5 weeks to become active). 

Please see SAM.gov for details on the 

registration process and timeline. 

Registration with the SAM is free of 

charge but can take several weeks to 

process. Applicants may register online 

at https://sam.gov. 

Additional information on 

implementing the Transparency Act, 

including the specific requirements for 

DUNS and SAM, are available on the 

DGM Grants Management, Policy Topics 

web page: https://www.ihs.gov/dgm/ 

policytopics/. 

V. Application Review Information 

Possible points assigned to each 

section are noted in parentheses. The 

project narrative should be written in a 

manner that is clear to outside reviewers 

unfamiliar with prior related activities 

of the applicant. It should be well 

organized, succinct, and contain all 

information necessary for reviewers to 

fully understand the project. 

Attachments requested in the criteria do 

not count toward the page limit for the 

narratives. Points will be assigned to 

each evaluation criteria adding up to a 

total of 100 possible points. Points are 

assigned as follows: 

1. Evaluation Criteria 

A. Introduction and Need for Assistance 

(10 Points) 

Must include the applicant’s 

background information, a description 

of HIV and/or HCV service, capacity, 

and history of support for such 

activities. Applicants need to include 

current public health activities, what 

program services are currently being 

provided, and interactions with other 

public health authorities in the region 

(state, local, or Tribal). 

Please describe how the applicant 

will make improvements in capacity to 

address the IHS, Tribal, and urban (I/T/ 

U), local-level, and/or Area-level HIV/ 

HCV/STI burden. In order to 

significantly reduce transmission of 

HIV/HCV/STI, I/T/U need baseline and 

annual measurements of HIV/HCV/STI 

diagnoses, linkage to care, and viral load 

measurements, as applicable. 

Applicants will also help evaluate 

geographies with higher burden of HIV/ 

HCV/STI and assist communities in 

targeting interventions. 

B. Project Objective(s), Work Plan, and 

Approach (25 Points) 

a. Clearly identify the operational 

strategies to be addressed by the 

applicant. Include objectives that are 

Specific, Measurable, Attainable, 

Relevant, and Time-bound (also known 

as SMART). In addition, the IHS 

encourages applicants to assume 

relevant objectives from (1) The 

National Strategic Plan: A Roadmap to 

End the Epidemic for the United States 

| 2021–2025; 23 and (2) The Viral 

Hepatitis National Strategic Plan for the 

U.S.: A Roadmap to Elimination 2021– 

2025.24

b. Activities in at least two of three 

ETHIC’s key operational strategies 

(Diagnose, Treat, Prevent) must be 

planned for completion within the 

program period (indicate these two 

activities in bold). 

c. Applicants will outline their 

approach for addressing the operational 

strategies in the work plan or logic 

model. Outline overarching activities, 

short-term, and long-term outcomes. 

Make note of proposed timelines and 

partners who will be involved in each 

activity. 

Recipient Activities 

Proposals must include the following 

activities: 

1. Coordination Operational Strategy 

i. Recipients will send at least one 

representative to the annual IHS HIV 

meeting. The budget should include 

travel and associated costs for 

participation. 

ii. Recipients will participate in the 

IHS National AI/AN STI Prevention 

workgroup. 

iii. Recipients will provide technical 

assistance and/or support to AI/AN 

communities by developing or sharing 

analytical reports that examine the 

burden of HIV/HCV and other relevant 

co-morbidities such as STIs in Native 

communities. 

2. Diagnosis Operational Strategy 

The recipients will collaborate with 

communities to increase local capacity 

to expand the availability of HIV/HCV/ 

STI testing in health centers, emergency 

departments, substance abuse 

prevention and treatment programs, 

mobile units, as well as communitybased organizations and non-traditional 

settings such as bars, parks, and during 

community festivals to diagnose all 

people with HIV/HCV/STIs as early as 

possible. 

3. Treatment Operational Strategy 

The recipients will provide support to 

communities in the development of 

enhanced activities and expanded 

capacity to identify and better serve 

people who are not in HIV/HCV/STI 

care by working with health care 

providers, Ryan White clinics and I/T/ 

U health centers, state and local health 

departments, and other partners to 

expand capacity, strengthen systems, 

establish new programs and services, 

and forge new partnerships to tailor and 

implement these approaches as 

appropriate in their communities. 

4. Prevention Operational Strategy 

The recipients will develop local 

plans with community member input to 

guide the scale-up of proven prevention 

interventions and strategies that 

increase the access to and availability of 

PrEP and safe syringe programs (SSPs)— 


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Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 22915 

where permitted by local laws—in the 

communities where these services are 

needed most. 

PrEP is a pill that reduces the risk of 

getting HIV when taken as prescribed. 

However, of the estimated 1 million 

Americans at substantial risk for HIV 

who could benefit from PrEP, fewer 

than 1 in 4 actually use it. HHS agencies 

will support states and local 

communities to implement strategies to 

increase access to and use of PrEP— 

especially among populations 

disproportionately affected by HIV. 

C. Program Evaluation (30 Points) 

a. Clearly identify plans for program 

evaluation to ensure that objectives of 

the program are met at the conclusion 

of the funding period. 

b. Include evaluation criteria based on 

SMART objectives. 

c. Evaluation should minimally 

include summaries of activities in each 

of the proposed key operational 

strategies. 

D. Organizational Capabilities, Key 

Personnel, and Qualifications (30 

Points) 

a. Include an organizational capacity 

statement that demonstrates the ability 

to execute program strategies within the 

program period. 

b. Provide a project management and 

staffing plan. Detail that the 

organization has the current staffing and 

expertise to address each of the program 

activities. If current capacity does not 

exist, please describe the actions that 

the applicant will take to fulfill this gap 

within a specified timeline. 

c. Applicant must demonstrate a plan 

to work with Tribal Epidemiology 

Centers and local partners on the 

proposed efforts. 

d. Demonstrate that the applicant has 

previous successful experience 

providing technical or programmatic 

support to Tribal communities. 

E. Categorical Budget and Budget 

Justification (5 Points) 

a. Provide a detailed budget and 

accompanying narrative to explain the 

activities being considered and how 

they are related to proposed program 

objectives. 

Additional documents can be 

uploaded as Other Attachments in 

Grants.gov. These can include: 

• Work plan, logic model, and 

timeline for proposed objectives. 

• Position descriptions for key staff. 

• Resumes of key staff that reflect 

current duties. 

• Consultant or contractor proposed 

scope of work and letter of commitment 

(if applicable). 

• Current Indirect Cost Rate 

Agreement (if applicable). 

• Organizational chart. 

• Map of area identifying project 

location(s). 

• Additional documents to support 

narrative (i.e., data tables, key news 

articles, etc.). 

2. Review and Selection 

Each application will be prescreened 

for eligibility and completeness as 

outlined in the funding announcement. 

Applications that meet the eligibility 

criteria shall be reviewed for merit by 

the Objective Review Committee (ORC) 

based on evaluation criteria. Incomplete 

applications and applications that are 

not responsive to the administrative 

thresholds (budget limit, project period 

limit) will not be referred to the ORC 

and will not be funded. The applicant 

will be notified of this determination. 

Applicants must address all program 

requirements and provide all required 

documentation. 

3. Notifications of Disposition 

All applicants will receive an 

Executive Summary Statement from the 

IHS DCCS within 30 days of the 

conclusion of the ORC outlining the 

strengths and weaknesses of their 

application. The summary statement 

will be sent to the Authorizing Official 

identified on the face page (SF–424) of 

the application. 

A. Award Notices for Funded 

Applications 

The NoA is the authorizing document 

for which funds are dispersed to the 

approved entities and reflects the 

amount of Federal funds awarded, the 

purpose of the award, the terms and 

conditions of the award, the effective 

date of the award, and the budget/ 

project period. Each entity approved for 

funding must have a user account in 

GrantSolutions in order to retrieve the 

NoA. Please see the Agency Contacts list 

in Section VII for the systems contact 

information. 

B. Approved but Unfunded 

Applications 

Approved applications not funded 

due to lack of available funds will be 

held for 1 year. If funding becomes 

available during the course of the year, 

the application may be reconsidered. 

Note: Any correspondence, other than 

the official NoA executed by an IHS 

grants management official announcing 

to the project director that an award has 

been made to their organization, is not 

an authorization to implement their 

program on behalf of the IHS. 

VI. Award Administration Information 

1. Administrative Requirements 

Awards issued under this 

announcement are subject to, and are 

administered in accordance with, the 

following regulations and policies: 

A. The criteria as outlined in this 

program announcement 

B. Administrative Regulations for Grants 

• Uniform Administrative 

Requirements, Cost Principles, and 

Audit Requirements for HHS Awards 

currently in effect or implemented 

during the period of award, other 

Department regulations and policies in 

effect at the time of award, and 

applicable statutory provisions. At the 

time of publication, this includes 45 

CFR part 75, at https://www.govinfo.gov/ 

content/pkg/CFR-2020-title45-vol1/pdf/ 

CFR-2020-title45-vol1-part75.pdf. 

• Please review all HHS regulatory 

provisions for Termination at 45 CFR 

75.372, at https://www.ecfr.gov/cgi-bin/ 

retrieveECFR?gp&

SID=2970eec67399fab1413

ede53d7895d99&mc=true

&n=pt45.1.75&r=PART&

ty=HTML&se45.1.75_

1372#se45.1.75_1372. 

C. Grants Policy 

• HHS Grants Policy Statement, 

Revised January 2007, at https://

www.hhs.gov/sites/default/files/grants/ 

grants/policies-regulations/ 

hhsgps107.pdf. 

D. Cost Principles 

• Uniform Administrative 

Requirements for HHS Awards, ‘‘Cost 

Principles,’’ at 45 CFR part 75 subpart 

E. 

E. Audit Requirements 

• Uniform Administrative 

Requirements for HHS Awards, ‘‘Audit 

Requirements,’’ at 45 CFR part 75 

subpart F. 

F. As of August 13, 2020, 2 CFR 200 

was updated to include a prohibition on 

certain telecommunications and video 

surveillance services or equipment. This 

prohibition is described in 2 CFR 

200.216. This will also be described in 

the terms and conditions of every IHS 

grant and cooperative agreement 

awarded on or after August 13, 2020. 

2. Indirect Costs 

This section applies to all recipients 

that request reimbursement of IDC in 

their application budget. In accordance 

with HHS Grants Policy Statement, Part 

II–27, the IHS requires applicants to 

obtain a current IDC rate agreement and 

submit it to the DGM prior to the DGM 


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issuing an award. The rate agreement 

must be prepared in accordance with 

the applicable cost principles and 

guidance as provided by the cognizant 

agency or office. A current rate covers 

the applicable grant activities under the 

current award’s budget period. If the 

current rate agreement is not on file 

with the DGM at the time of award, the 

IDC portion of the budget will be 

restricted. The restrictions remain in 

place until the current rate agreement is 

provided to the DGM. 

Per 45 CFR 75.414(f) Indirect (F&A) 

costs, ‘‘any non-Federal entity (NFE) 

[i.e., applicant] that has never received 

a negotiated indirect cost rate, . . . may 

elect to charge a de minimis rate of 10 

percent of modified total direct costs 

which may be used indefinitely. As 

described in Section 75.403, costs must 

be consistently charged as either 

indirect or direct costs, but may not be 

double charged or inconsistently 

charged as both. If chosen, this 

methodology once elected must be used 

consistently for all Federal awards until 

such time as the NFE chooses to 

negotiate for a rate, which the NFE may 

apply to do at any time.’’ 

Electing to charge a de minimis rate 

of 10 percent only applies to applicants 

that have never received an approved 

negotiated indirect cost rate from HHS 

or another cognizant federal agency. 

Applicants awaiting approval of their 

indirect cost proposal may request the 

10 percent de minimis rate. When the 

applicant chooses this method, costs 

included in the indirect cost pool must 

not be charged as direct costs to the 

grant. 

Available funds are inclusive of direct 

and appropriate indirect costs. 

Approved indirect funds are awarded as 

part of the award amount, and no 

additional funds will be provided. 

Generally, IDC rates for IHS recipients 

are negotiated with the Division of Cost 

Allocation at https://rates.psc.gov/ or 

the Department of the Interior (Interior 

Business Center) at https://ibc.doi.gov/ 

ICS/tribal. For questions regarding the 

indirect cost policy, please call the 

Grants Management Specialist listed 

under ‘‘Agency Contacts’’ or the main 

DGM office at (301) 443–5204. 

3. Reporting Requirements 

The recipient must submit required 

reports consistent with the applicable 

deadlines. Failure to submit required 

reports within the time allowed may 

result in suspension or termination of 

an active grant, withholding of 

additional awards for the project, or 

other enforcement actions such as 

withholding of payments or converting 

to the reimbursement method of 

payment. Continued failure to submit 

required reports may result in the 

imposition of special award provisions 

and/or the non-funding or non-award of 

other eligible projects or activities. This 

requirement applies whether the 

delinquency is attributable to the failure 

of the awardee organization or the 

individual responsible for preparation 

of the reports. Per DGM policy, all 

reports must be submitted electronically 

by attaching them as a ‘‘Grant Note’’ in 

GrantSolutions. Personnel responsible 

for submitting reports will be required 

to obtain a login and password for 

GrantSolutions. Please see the Agency 

Contacts list in Section VII for the 

systems contact information. 

The reporting requirements for this 

program are noted below. 

A. Progress Reports 

Program progress reports are required 

quarterly. The progress reports are due 

within 30 days after the reporting period 

ends (specific dates will be listed in the 

NoA Terms and Conditions). These 

reports must include a brief comparison 

of actual accomplishments to the goals 

established for the period, a summary of 

progress to date or, if applicable, 

provide sound justification for the lack 

of progress, and other pertinent 

information as required. A final report 

must be submitted within 90 days of 

expiration of the period of performance. 

B. Financial Reports 

Federal Cash Transaction Reports are 

due 30 days after the close of every 

calendar quarter to the Payment 

Management Services at https://

pms.psc.gov. Failure to submit timely 

reports may result in adverse award 

actions blocking access to funds. 

Federal Financial Reports are due 30 

days after the end of each budget period, 

and a final report is due 90 days after 

the end of the period of performance. 

Recipients are responsible and 

accountable for reporting accurate 

information on all required reports: the 

Progress Reports, the Federal Cash 

Transaction Report, and the Federal 

Financial Report. 

C. Data Collection and Reporting 

The recipient must report their 

progress quarterly towards data points 

in their ETHIC objectives and activities 

via a standardized form co-developed 

with the IHS program officer. 

The recipient and the IHS will jointly 

develop the report for the data and 

objectives proposed in the application. 

The recipient will then report on these 

data points annually. Due dates for 

these reports will be included in the 

Terms & Conditions in the NoA. The 

recipient will participate in quarterly 

calls with the program office. 

D. Federal Sub-Award Reporting System 

(FSRS) 

This award may be subject to the 

Transparency Act sub-award and 

executive compensation reporting 

requirements of 2 CFR part 170. 

The Transparency Act requires the 

OMB to establish a single searchable 

database, accessible to the public, with 

information on financial assistance 

awards made by Federal agencies. The 

Transparency Act also includes a 

requirement for recipients of Federal 

grants to report information about firsttier sub-awards and executive 

compensation under Federal assistance 

awards. The IHS has implemented a 

Term of Award into all IHS Standard 

Terms and Conditions, NoAs, and 

funding announcements regarding the 

FSRS reporting requirement. This IHS 

Term of Award is applicable to all IHS 

grant and cooperative agreements issued 

on or after October 1, 2010, with a 

$25,000 sub-award obligation threshold 

met for any specific reporting period. 

For the full IHS award term 

implementing this requirement and 

additional award applicability 

information, visit the DGM Grants 

Management website at https://

www.ihs.gov/dgm/policytopics/. 

E. Non-Discrimination Legal 

Requirements for Recipients of Federal 

Financial Assistance 

Should you successfully compete for 

an award, recipients of Federal financial 

assistance (FFA) from HHS must 

administer their programs in 

compliance with Federal civil rights 

laws that prohibit discrimination on the 

basis of race, color, national origin, 

disability, age and, in some 

circumstances, religion, conscience, and 

sex (including gender identity, sexual 

orientation, and pregnancy). This 

includes ensuring programs are 

accessible to persons with limited 

English proficiency and persons with 

disabilities. The HHS Office for Civil 

Rights provides guidance on complying 

with civil rights laws enforced by HHS. 

Please see https://www.hhs.gov/civilrights/for-providers/providerobligations/index.html and https://

www.hhs.gov/civil-rights/forindividuals/nondiscrimination/ 

index.html. 

• Recipients of FFA must ensure that 

their programs are accessible to persons 

with limited English proficiency. For 

guidance on meeting your legal 

obligation to take reasonable steps to 

ensure meaningful access to your 

programs or activities by limited English 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 22917 

proficiency individuals, see https://

www.hhs.gov/civil-rights/forindividuals/special-topics/limitedenglish-proficiency/fact-sheet-guidance/ 

index.html and https://www.lep.gov. 

• For information on your specific 

legal obligations for serving qualified 

individuals with disabilities, including 

reasonable modifications and making 

services accessible to them, see https:// 

www.hhs.gov/civil-rights/forindividuals/disability/index.html. 

• HHS funded health and education 

programs must be administered in an 

environment free of sexual harassment. 

See https://www.hhs.gov/civil-rights/forindividuals/sex-discrimination/ 

index.html. 

• For guidance on administering your 

program in compliance with applicable 

Federal religious nondiscrimination 

laws and applicable Federal conscience 

protection and associated antidiscrimination laws, see https://

www.hhs.gov/conscience/conscienceprotections/index.html and https://

www.hhs.gov/conscience/religiousfreedom/index.html. 

F. Federal Awardee Performance and 

Integrity Information System (FAPIIS) 

The IHS is required to review and 

consider any information about the 

applicant that is in the FAPIIS at 

https://www.fapiis.gov/fapiis/#/home 

before making any award in excess of 

the simplified acquisition threshold 

(currently $250,000) over the period of 

performance. An applicant may review 

and comment on any information about 

itself that a Federal awarding agency 

previously entered. The IHS will 

consider any comments by the 

applicant, in addition to other 

information in FAPIIS, in making a 

judgment about the applicant’s integrity, 

business ethics, and record of 

performance under Federal awards 

when completing the review of risk 

posed by applicants, as described in 45 

CFR 75.205. 

As required by 45 CFR part 75 

appendix XII of the Uniform Guidance, 

NFEs are required to disclose in FAPIIS 

any information about criminal, civil, 

and administrative proceedings, and/or 

affirm that there is no new information 

to provide. This applies to NFEs that 

receive Federal awards (currently active 

grants, cooperative agreements, and 

procurement contracts) greater than 

$10,000,000 for any period of time 

during the period of performance of an 

award/project. 

Mandatory Disclosure Requirements 

As required by 2 CFR part 200 of the 

Uniform Guidance, and the HHS 

implementing regulations at 45 CFR part 

75, the IHS must require an NFE or an 

applicant for a Federal award to 

disclose, in a timely manner, in writing 

to the IHS or pass-through entity all 

violations of Federal criminal law 

involving fraud, bribery, or gratuity 

violations potentially affecting the 

Federal award. 

All applicants and recipients must 

disclose in writing, in a timely manner, 

to the IHS and to the HHS Office of 

Inspector General of all information 

related to violations of Federal criminal 

law involving fraud, bribery, or gratuity 

violations potentially affecting the 

Federal award. 45 CFR 75.113. 

Disclosures must be sent in writing to: 

U.S. Department of Health and Human 

Services, Indian Health Service, 

Division of Grants Management, 

ATTN: Paul Gettys, Deputy Director, 

5600 Fishers Lane, Mail Stop: 09E70, 

Rockville, MD 20857, (Include 

‘‘Mandatory Grant Disclosures’’ in 

subject line), Office: (301) 443–5204, 

Fax: (301) 594–0899, Email: 

Paul.Gettys@ihs.gov. 

And 

U.S. Department of Health and Human 

Services, Office of Inspector General, 

ATTN: Mandatory Grant Disclosures, 

Intake Coordinator, 330 Independence 

Avenue SW, Cohen Building, Room 

5527, Washington, DC 20201, URL: 

https://oig.hhs.gov/fraud/reportfraud/, (Include ‘‘Mandatory Grant 

Disclosures’’ in subject line), Fax: 

(202) 205–0604 (Include ‘‘Mandatory 

Grant Disclosures’’ in subject line), or 

Email: 

MandatoryGranteeDisclosures@

oig.hhs.gov. 

Failure to make required disclosures 

can result in any of the remedies 

described in 45 CFR 75.371 Remedies 

for noncompliance, including 

suspension or debarment (see 2 CFR 

part 180 and 2 CFR part 376). 

VII. Agency Contacts 

1. Questions on the programmatic 

issues may be directed to: Mr. Rick 

Haverkate, Public Health Advisor, 

Office of Clinical and Preventive 

Services, Division of Clinical and 

Community Services, Indian Health 

Service, 5600 Fishers Lane, Mailstop: 

08N34A, Rockville, MD 20857, Phone: 

(954) 909–4834, Email: 

Richard.Haverkate@ihs.gov. 

2. Questions on grants management 

and fiscal matters may be directed to: 

Willis Grant, Grants Management 

Specialist, Indian Health Service, 

Division of Grants Management, 5600 

Fishers Lane, Mail Stop: 09E70, 

Rockville, MD 20857, Phone: (301) 443– 

2214, Email: Willis.Grant@ihs.gov. 

3. Questions on systems matters may 

be directed to: Paul Gettys, Deputy 

Director, Indian Health Service, 

Division of Grants Management, 5600 

Fishers Lane, Mail Stop: 09E70, 

Rockville, MD 20857, Phone: (301) 443– 

2114; or the DGM main line (301) 443– 

5204, Email: Paul.Gettys@ihs.gov. 

VIII. Other Information 

The Public Health Service strongly 

encourages all grant, cooperative 

agreement, and contract recipients to 

provide a smoke-free workplace and 

promote the non-use of all tobacco 

products. In addition, Public Law 103– 

227, the Pro-Children Act of 1994, 

prohibits smoking in certain facilities 

(or in some cases, any portion of the 

facility) in which regular or routine 

education, library, day care, health care, 

or early childhood development 

services are provided to children. This 

is consistent with the HHS mission to 

protect and advance the physical and 

mental health of the American people. 

Elizabeth A. Fowler, 

Acting Director, Indian Health Service. 

[FR Doc. 2022–08250 Filed 4–15–22; 8:45 am] 

BILLING CODE 4165–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Notice of Purchased/Referred Care 

Delivery Area Redesignation for the 

Minnesota Chippewa Tribe, Minnesota, 

Mille Lacs Band of Ojibwe 

AGENCY: Indian Health Service, Health 

and Human Services. 

ACTION: Final notice. 

SUMMARY: Notice is hereby given that 

the Indian Health Service (IHS) has 

decided to expand the geographic 

boundaries of the Purchased/Referred 

Care Delivery Area (PRCDA) for the 

Mille Lacs Band of Ojibwe in the State 

of Minnesota to include the Minnesota 

counties of Crow Wing and Morrison in 

the State of Minnesota. The final 

PRCDA for the Mille Lacs Band of 

Ojibwe is now the Minnesota counties 

of Aitkin, Crow Wing, Kanebec, Mille 

Lacs, Morrison, and Pine. Mille Lacs 

Band of Ojibwe members residing 

outside of the PRCDA are eligible for 

direct care services, however, they are 

not eligible for Purchased/Referred Care 

(PRC) services. The sole purpose of this 

expansion is to authorize additional 

Mille Lacs Band of Ojibwe members and 

beneficiaries to receive PRC services. 

DATES: This expansion is effective as of 

the publication date of this notice. 


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