PKG00248346-instructions.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

AGENCY: Office of the Secretary, Office of Minority Health (OMH)

FUNDING OPPORTUNITY TITLE: OMH Hepatitis B Demonstration Grant Program

ACTION: Notice

ANNOUNCEMENT TYPE: Initial Competitive Grant

FUNDING OPPORTUNITY NUMBER: MP-CPI-19-001

CFDA NUMBER: 93.137

CFDA PROGRAM: Community Programs to Improve Minority Health

DATES:

Technical Assistance: Technical assistance will be provided via email (Sonsiere.Cobb-

Souza@hhs.gov) starting February 19, 2019. Please be sure to review the entire announcement promptly so you can have any questions answered well in advance of the application due date. We also recommend you subscribe to this announcement in

Grants.gov so you receive any amendments, question and answer documents, or other updates.

Applications: Your application is due April 13, 2019 by 6 p.m. Eastern Time. To receive consideration, you must submit your application electronically via Grants.gov no later than this due date and time. If you do not submit your application by the specified deadline, we will return it to you unread. You must submit electronically via Grants.gov unless you obtain a mailto:Sonsiere.Cobb-Souza@hhs.gov mailto:Sonsiere.Cobb-Souza@hhs.gov written exemption from this requirement 2 business days in advance of the deadline from the

Director, HHS/Office of the Assistant Secretary for Health (OASH) Office of Grants

Management (OGM). To obtain an exemption, you must request one via email from the

HHS/OASH OGM, and provide details as to why you are technologically unable to submit electronically through Grants.gov. Your request should be submitted at least 4 business days prior to the application deadline to ensure your request can be considered prior to 2 business days in advance of the deadline. If you request an exemption, include the following in your e-mail request: the HHS/OASH announcement number; your organization's DUNS number; your organization’s name, address and telephone number; the name and telephone number of your

Authorizing Official; the Grants.gov Tracking Number (for example, GRANT####) assigned to your submission; and a copy of the "Rejected with Errors" notification from Grants.gov. Send the request with supporting documentation to ogm.oash@hhs.gov. Note: failure to have an active

System for Account Management (SAM) registration prior to the application due date will not be grounds for receiving an exemption to the electronic submission requirement. Failure to follow

Grants.gov instructions to ensure software compatibility will not be grounds for receiving an exemption to the electronic submission requirement.

The HHS/OASH OGM will only accept applications via alternate methods

(hardcopy paper via U.S. mail or other provider or PDF via email) from applicants obtaining prior written approval. If you receive an exemption, you must still submit your application by the deadline. Only applications submitted through the Grants.gov portal or alternate format (hardcopy paper via U.S. mail or other service or PDF via email) with an approved written exemption will be accepted. See Section D.7 (“Other Submission

Requirements”) for information on application submission mechanisms.

mailto:ogm.oash@hhs.gov

Executive Order 12372 comment due date: The State Single Point of Contact (SPOC) has 60 days from the application due date to submit any comments. For more information on the

SPOC see section D.4 Intergovernmental Review.

To ensure adequate time to submit your application successfully, HHS/OASH recommends that you register as early as possible in Grants.gov since the registration process can take up to one month. You must register an authorizing official for your organization.

HHS/OASH does not determine your organization’s authorizing official; your organization makes that designation. For information on registering for Grants.gov, refer to http://www.grants.gov or contact the Grants.gov Contact Center 24 hours a day, 7 days a week

(excluding Federal holidays) at 1-800-518-4726 or support@grants.gov.

Your organization is strongly encouraged to register multiple authorized organization representatives in Grants.gov to ensure someone is available to submit your application.

EXECUTIVE SUMMARY: The HHS Office of Minority Health (OMH) announces the anticipated availability of funds for Fiscal Year (FY) 2019 grant awards for the OMH Hepatitis

B Demonstration Program (Hepatitis B Program) for a project period of up to three years under the authority of 42 U.S.C. § 300 u-6, (Public Health Service Act § section 1707).

The Office of Minority Health (OMH) in consultation with the HHS/OASH Office of

HIV/AIDS and Infectious Diseases Policy, and Centers for Disease Control and Prevention, Division of Viral Hepatitis, seeks to develop model comprehensive hepatitis B programs, that include strategic partnerships between community-based organizations servicing communities at risk, departments of health, perinatal hepatitis B programs, safety net providers, research centers, http://www.grants.gov/ mailto:support@grants.gov and healthcare facilities that have capacity to deliver widespread vaccination, scale-up testing, care and link/provide treatment services. The Hepatitis B Program will advance progress toward the national hepatitis B elimination goals and strategic actions recommended by National

Academies of Sciences, Engineering, and Medicine (NAS): (1) End transmission of hepatitis B virus (HBV) (perinatal, children and adults); and (2) Reduce morbidity and mortality attributable to ongoing HBV infection1. The Hepatitis B Program also is directly aligned with the four goals of the U.S. National Viral Hepatitis Action Plan (NVHAP) for 2017-2020 (Action Plan): (1)

Goal 1 Prevent New Viral Hepatitis Infections; (2) Goal 2 Reduce Deaths and Improve the

Health of People Living with Viral Hepatitis; (3) Goal 3 Reduce Viral Hepatitis Health

Disparities; and (4) Goal 4 Coordinate, Monitor, And Report on Implementation of Viral

Hepatitis Activities2.

In support of the NAS HBV elimination goals and the Action Plan, OMH will support

Hepatitis B model programs to implement all of the following strategic actions to: (1) prevent new HBV cases, reduce deaths, and improve the health of people living with viral hepatitis: (2) provide the birth dose coverage (vaccination); (3) provide maternal HBsAg testing followed by

HBV DNA testing as appropriate; (4) treat HBV exposed newborns; (5) provide community based testing and linkage to care; (6) provide HBV Positives linkage to care, treatment, and contact tracing; (7) vaccinate HBV Negatives; (8) increase availability of testing kits and provide education to health care providers and patients; and (9) utilize care coordinators for linkage to care; and implement standing orders or utilization of Electronic Health Records (EHR) for testing and linkage to care. The target populations for the Hepatitis B Program are persons born

1 National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press.

https://doi.org/10.17226/24731.

2 https://www.hhs.gov/hepatitis/viral-hepatitis-action-plan/index.html https://doi.org/10.17226/24731 https://www.hhs.gov/hepatitis/viral-hepatitis-action-plan/index.html in countries (Africa and Asia) with a high prevalence of HBV infection (≥2 percent); all pregnant women during the first trimester of pregnancy; U.S.-born persons not vaccinated as infants whose parents were born in countries with a very high prevalence of HBV infection (≥8 percent);

household contacts or sexual partners of persons with HBV infection; perinatal/child/adolescent vaccination; and at-risk Adults. Programs must include performance measures that align with the viral hepatitis indicators by NVHAP (see Appendix A of this announcement).

Each applicant under the Hepatitis B Program must serve as the lead agency for a collaborative partnership that covers each category below:

1. an academic research center, prevention research center, teaching hospital, safety net provider, Tribal Epidemiology Center, a public or state controlled institution of higher education, a private institution of higher education, a Native American tribal government

(Federally or State recognized), or a Native American tribal organization;

2. a community-based minority serving organization with experience in case management, coordination of care for high-risk populations, and implementation of HBV evidence-based disease interventions, preventive health services, chronic disease management programs, social, support, and/or behavioral treatment programs; and

3. a local social service, supportive service, and/or behavioral treatment organization

(social, support, and/or behavioral treatment services may include case management, eligibility assistance for health coverage, housing, and/or food subsidy programs, transportation, behavioral therapy, etc.).

An organizational partner, including community-based and/or social service organizations, may fill one or two of these types of roles.

OMH’s awarding of grants for the Hepatitis B Program is grounded in the prevalence of

HBV. According to the CDC, there are an estimated 850,000 to 2.2 million people living with

Chronic Hepatitis B (CHB). The majority of the chronic hepatitis B disease burden within the

U.S. is among foreign-born persons. About 95 percent of new cases of CHB infection in the

United States are imported. Persons born in high endemic regions such as Africa and Asia and countries with a prevalence of CHB infection of 2 percent or greater are at the highest risk for chronic infection. Asian Americans alone account for over half of the CHB cases. Foreign-born blacks and people born in Asia account for 72.6 percent of CHB cases. There are no CHB curative therapies. However, diagnosis, monitoring, and viral suppression with recommended antiviral therapy when indicated can reduce the risk of cirrhosis, hepatocellular carcinoma, and liver related death. It is cost effective to screen adults at high-risk for CHB, treat those who are chronically infected and vaccinate their unprotected household contacts or sex partners. The U.S.

Preventive Services Task Force recommended routine hepatitis B screening beyond pregnant women to include persons born in countries with CHB prevalence of 2 percent or greater

(USPSTF, 2016). Routine hepatitis B screening in the primary care setting in accordance to

USPSTF recommendation is covered by the Centers for Medicare and Medicaid Services in

2016. In the United States, only an estimated one-third of those living with CHB are diagnosed, and among them, a third are receiving care and 45 percent of those who are eligible for treatment based on treatment guidelines are receiving treatment. One of the four overarching goals of the

HHS Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis is to double the proportion of persons aware of their CHB infection from 33 to 66 percent by 2020. 3

3 http://www.nationalacademies.org/hmd/reports/2017/national-strategy-for-the-elimination-of-hepatitis-b-and-c.aspx

OMH encourages applicants to review all program requirements, eligibility information, responsive criteria, application format and submission information, evaluation criteria, and other information in this funding announcement to ensure that its application complies with all requirements and instructions.

A. PROGRAM DESCRIPTION:

Through this announcement, OMH seeks to develop Hepatitis B model programs that will end transmission of HBV (perinatal, children and adults) and reduce morbidity and mortality attributable to ongoing HBV infection. Service delivery efforts will focus on delivery of prompt, responsive and efficient care for persons born in countries where HBV infection is endemic; U.S.-born persons not vaccinated as infants whose parents were born in countries with a very high prevalence of HBV infection; household contacts or sexual partners of persons with

HBV infection; and infants/children/adolescents who may otherwise slip through the cracks and improve reach of services essential to eliminating hepatitis B. OMH will fund collaborative partnerships to build capacity for scale-up HBV vaccination, testing and linkage to care services and surveillance to advance progress toward national hepatitis B elimination goals recommended by the National Academies of Sciences (NAS). Successful applicants and their collaborative partnerships will implement all of the community-level strategies outlined below.

Program Requirements

a. Encourage adherence to established HBV recommendations for screening, vaccination, management and treatment for perinatal and adult HBV prevention

i. Ensure the Advisory Committee on Immunization Practices (ACIP) recommended hepatitis B vaccination schedule is executed as part of routine practice of medicine.

ii. Incorporate the relevant Healthcare Effectiveness Data and Information

Set (HEDIS) indicators to collect and verify data and monitor performance for results in aiding the national hepatitis B elimination effort.

iii. Test and treat or vaccinate adults at-risk

b. Adhere to Screening Guidelines

i. Conduct HBV screening for everyone at high risk of chronic infection, including persons born in countries and regions with a high prevalence of

HBV infection (≥2 percent); all pregnant women during the first trimester of pregnancy; U.S.-born persons not vaccinated as infants whose parents were born in regions with a very high prevalence of HBV infection (≥8 percent), such as sub-Saharan Africa and central and Southeast Asia; HIV-positive persons; people who inject drugs; men who have sex with men;

household contacts or sexual partners of persons with HBV infection (U.S.

Preventive Services Task Force, 2014, 2015).

ii. Establish measures to monitor compliance with viral hepatitis screening guidelines and hepatitis B vaccine birth dose coverage and include the new measures in the HEDIS.

iii. Develop and execute standing orders to ensure:

1. All infants receive the first dose of the hepatitis B vaccine within

24 hours of birth.

2. Children born to HBsAg+ women or to women who have never been tested for HBV receive vaccination within 12 hours or birth.

3. Full immunization, completion of the three dose series, against

HBV during the first 2 years of life.

c. Reach Patients

i. Build capacity in primary care providers, pharmacists and other paraprofessionals to employ evidence-based interventions including each of the following:

1. Educate primary-care and other providers to assure delivery of recommended care and treatment services. Partner with primary care providers and their professional organizations to build capacity to treat hepatitis in primary care and provide linkage-to-care/navigation services for medically complex patients.

2. Develop and implement clinical decision tools, electronic health records (EHRs), standing orders, and other health information technology strategies such as EHR data analysis of patients with a diagnosis of HBV to identify existing patients.

3. Identify opportunities to expand testing for HBV, either via existing health services or through provision of testing through the proposed project.

ii. Prevent Mother-to-Child transmission of HBV.

iii. Ensure all HBsAg+ pregnant women have early prenatal HBV DNA and liver enzyme tests to evaluate whether antiviral therapy is indicated for prophylaxis to eliminate mother-to-child transmission or for treatment of chronic active hepatitis.4

d. Target Priority Populations

Develop and implement services aimed at strengthening health-care capacity to diagnose, link to medical evaluation and care for persons with HBV infection. Viral hepatitis B disproportionately impacts certain populations. The U.S. Preventive Services Task

Force guidelines recommend screening for HBV infection in persons at high-risk for infection. Important risk groups (in non-pregnant adolescents and adults) for HBV infection that should be screened include: persons born in countries and regions with a high prevalence; persons born in countries and regions with a high prevalence of HBV infection (≥2 percent); U.S.-born persons not vaccinated as infants whose parents were born in regions with a very high prevalence of HBV infection (≥8 percent), such as sub-

4 http://www.nationalacademies.org/hmd/reports/2017/national-strategy-for-the-elimination-of-hepatitis-b-and-

Saharan Africa and central and Southeast Asia; HIV-positive persons; Injection drug users; Men who have sex with men;

Household contacts or sexual partners of persons with HBV infection.

ii. Educate the target population about viral hepatitis B to facilitate patient requests for recommended interventions during medical visits.

iii. Expand access to adult hepatitis B vaccination, removing barriers to immunization in pharmacies and other easily accessible settings.5

iv. Decrease health disparities by partnering with and educating disproportionately impacted communities where priority populations live about the benefits of viral hepatitis prevention, screening, care, and treatment.

v. Improve access to care and the delivery of culturally competent, and linguistically appropriate viral hepatitis prevention and care services.

i. Train health care providers in the delivery of culturally competent education, counseling, care, and treatment for viral hepatitis.

ii. Foster collaboration between organizations serving priority populations affected by viral hepatitis and academic researchers to

5 http://www.nationalacademies.org/hmd/reports/2017/national-strategy-for-the-elimination-of-hepatitis-b-and-identify effective strategies to improve access to care and treatment for viral hepatitis.

iii. Develop culturally competent and linguistically appropriate viral hepatitis educational materials and strategies to increase testing and linkage to care and treatment and disseminate through various channels including the HHS Viral Hepatitis website https://www.hhs.gov/hepatitis/index.html .

e. Monitor viral hepatitis-associated health disparities, transmission, and disease.

i. Evaluate the burden of viral hepatitis in priority populations and their communities, share that information, and focus efforts on disproportionately affected areas and populations.

ii. Promote effective strategies to collect information on viral hepatitis incidence, care, and treatment to inform a better estimate of local prevalence.

f. Advance basic, clinical, translational, and implementation research to improve understanding of viral hepatitis health disparities.

g. Encourage participation of community members in community and academic viral hepatitis research.

h. Publish and disseminate findings and evaluations of strategies to improve viral hepatitis screening, care, and treatment practices.6

6 https://www.hhs.gov/hepatitis/viral-hepatitis-action-plan/index.html https://www.hhs.gov/hepatitis/index.html

AUTHORITY: OMH announces the Hepatitis B Program under the authority of 42 U.S.C.

§ 300u-6, (Section 1707 of the Public Health Service Act).

B. FEDERAL AWARD INFORMATION

OMH intends to make funds available for competing grants for the Hepatitis B Program.

We will fund awards in annual increments (budget periods) and generally for a project period up to 3 years, although we may approve shorter project periods. Funding for all approved budget periods beyond the first is generally level with the initial award amount and is contingent upon the availability of funds, satisfactory progress of the project, adequate stewardship of Federal funds, and the best interests of the Government.

Award Information

Estimated Federal Funds Available: $3,000,000

Anticipated Number of Awards: Up to 7

Award Ceiling (Federal Funds including indirect costs): $500,000 per budget period

Award Floor (Federal Funds including indirect costs): $400,000 per budget period

Anticipated Start Date: 07/01/2019

Estimated Period of Performance: Not to exceed 3 years

Anticipated Initial Budget Period Length: 12 months

Type of Award: Grant

Type of Application Accepted: Electronic via Grants.gov ONLY unless an exemption is granted

C. ELIGIBILITY INFORMATION

1. Eligible Applicants. Public and nonprofit private entities and indigenous human resource providers in communities of color are eligible to apply. Examples of eligible entities include:

State governments

County governments

Special district governments

Public and State controlled institutions of higher education

Native American tribal governments (Federally recognized)

Public Housing authorities/Indian housing authorities

Native American tribal organizations (other than federally recognized tribal governments)

Nonprofits with 501 (c)(3) IRS status (other than institution of higher education)

Nonprofits without 501(c)(3) IRS status (other than institution of higher education)

Private nonprofit institutions of higher education

2. Cost Sharing or Matching

You are not required to provide cost sharing or matching in your proposed budget.

3. Other Eligibility Information

Application Responsiveness Criteria

We will review your application to determine whether it meets the following responsiveness criteria. If your application does not meet the responsiveness criteria, we will eliminate it from the competition and it will not be reviewed.

The application addresses all Hepatitis B Program requirements.

The applicant must submit with the application a Just-in-Time agreement signed by the applicant’s authorized official assuring that if funding is secured the applicant will submit an application to an Institutional Review Board for approval. If the Just-in-Time agreement is not signed, the application will be deemed ineligible and will not be considered for competitive funding.

The applicant is focused on serving target populations located in a state with high prevalence chronic HBV infection. Refer to Appendix B, CDC Viral Hepatitis Surveillance United

States, 2016. Table 3.3 Number of newly reported case reports of confirmed chronic hepatitis

B submitted by states and jurisdictions, 2016.

Application Disqualification Criteria

If you successfully submit an application, we will screen it to ensure it meets the below requirements. If we determine your application fails to meet the criteria described below we will disqualify it, that is, we will not review it and will give it no further consideration.

a) You must submit your application electronically via www.grants.gov (unless an exemption was granted 2 business days prior to the deadline) by the date and time indicated in the

DATES section of this announcement.

b) If you successfully submit multiple applications from the same organization for the same project, we will only review the last application received by the deadline.

c) HHS/OASH/OGM deems your application eligible according to section C.1 Eligible

Applicants.

d) You must complete the required forms in the application package: SF-424, SF-424A, SF-

424B, SF-LLL, and Project Abstract Summary.

e) Your Project Narrative section of the application must be double-spaced, on the equivalent of

8 ½ ” x 11” inch page size, with 1” margins on all sides (top, bottom, left and right) and font size not less than 12 points.

f) Your Project Narrative must not exceed 70 pages. NOTE: The following items do not count toward the Project Narrative page limit: all required forms, including SF-424, SF-424A, SF-

424B, SF-LLL, Project Abstract Summary, and Budget Narrative (including budget tables).

g) Your total application, including the Project Narrative plus Appendices, must not exceed 100 pages. NOTE: items listed in “e” immediately above do not count toward total page limit.

h) Your Federal funds request including indirect costs must not exceed the maximum indicated in Award Ceiling.

i) Your Federal funds request including indirect costs must not be below the minimum indicated in Award Floor.

j) Your application must meet the Application Responsiveness Criteria outlined above.

D. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

You may obtain an application package electronically by accessing Grants.gov at http://www.grants.gov/. You can find it by searching on the CFDA number shown on page 1 of this funding opportunity announcement. If you have problems accessing the application or difficulty downloading, contact:

Office of Grants Management

Phone: 240-453-8822

Email: ogm.oash@hhs.gov

2. Content and Form of Application Submission

Application Format

Your application must be prepared using the forms and information provided in the online application package.

The Project Narrative, and total application including appendices, must adhere to the page limit indicated in Application Disqualification Criteria listed in Section C. The page limit does not include the Budget Narrative (including budget tables), required forms, assurances, and certifications as described in the Application Disqualification Criteria. Please do not number pages or include a table of contents. Our grants management system will generate page numbers once your application is complete. If your application exceeds the specified page limits for the Project Narrative or Project Narrative plus Appendices when printed on 8.5” X 11” paper by HHS/OASH/OGM, we will not review it. We recommend you print out your application before submitting electronically to ensure that it is within the page limits and is easy to read.

You must double-space the Project Narrative pages.

You should use an easily readable typeface, such as Times New Roman or Arial. You must use 12-point font. You may single-space tables or use alternate fonts but you must ensure the tables are easy to read.

Appendices Format

Your Appendices should include any specific documents outlined in Section D.2.iii., under the heading “Appendices” in the Application Content section of this funding opportunity announcement. Your documents should be easy to read. You should use the same formatting mailto:ogm.oash@hhs.gov specified for the Project Narrative. However, documents such as résumés/CVs, organizational charts, tables, or letters of commitment may use formatting common to those documents, but the pages must be easy to read. All of your appendices must be uploaded as a single, consolidated file in the Attachments section of your Grants.gov application.

Project Abstract Summary Format

You must complete the Project Abstract Summary form provided in the application package. The abstract will be used to provide reviewers with an overview of the application and will form the basis for the application summary in grants management and program summary documents. If your project is funded, HHS may publish information from your form; therefore, do not include sensitive or proprietary information.

Budget Narrative Format

The Budget Narrative should use the formatting required of the Project Narrative for the explanatory text. Budget tables may be single-spaced but should be laid out in an easily-readable format and within the printable margins of the page.

i. Application Content

Successful applications will contain the following information:

Problem Statement/Project Narrative Content

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether your project meets the minimum requirements for an award under this announcement. The Project Narrative should provide a clear and concise description of your project. HHS/OASH recommends that your project narrative include the following components:

Problem Statement

Organizational Capability

Goals and Objectives

Performance Measures: Process and Outcome Measures

Program Plan (Proposed Intervention)

Staffing and Management

Evaluation

Dissemination Plan

Budget Narrative

Problem Statement

Describe the purpose of the program, target population(s), proposed services and interventions, and anticipated outcomes.

Describe the target population(s), to include demographics, number of targeted persons residing in the project area, any statistics that demonstrate the impact of viral hepatitis infection, and known barriers to accessing medical care and treatment for the population(s) you will serve.

Define the geographic areas you will serve and describe how the applicant organization is strategically located to facilitate access to viral hepatitis services for the target population.

List anticipated challenges and opportunities for enhancing viral hepatitis prevention and control efforts in participating venues.

Describe how you determined the need for services, including any pertinent statistics to substantiate this rationale.

Describe any prior experience with viral hepatitis testing and linkage to care in the targeted communities. Describe how these efforts involved collaborations among public health partners, community-based organizations (CBOs), and other agencies/institutions.

Organizational Capacity

Document that the applicant’s organizational mission, goals, and activities are consistent with relevant national viral hepatitis prevention and control priorities and conducted in accordance with HHS recommendations.

Provide evidence of relevant experience, leadership, capacity, and infrastructure (e.g., resources, facilities, and technical and administrative systems) to successfully conduct viral hepatitis B prevention, care and treatment programs and the proposed activities.

Demonstrate established linkages with other programs in the community for client outreach and recruitment.

If the applicant organization intends to work and collaborate with community partners to conduct the activities outlined in the FOA:

o describe the community partner’s capacity and ability to accomplish them;

o describe the specific agencies, organization and partners with which the applicant is currently collaborating;

o describe how collaborators were and will be involved in designing and implementing activities and include specifics about their roles and requested collaborative activities; and o include original letters of commitment from appropriate non-applicant organizations, individuals, institutions, public health department, and others needed to carry out the proposed activities, and ensure that such letters clearly indicate the organization’s roles and responsibilities.

Describe the applicant’s capacity to successfully enter and retrieve clinical information using electronic health records systems, HEDIS, and/or other data collection systems that meet the requirements established by HHS. Evidence of Surveillance: Acute Hep B, Perinatal HBV infection, persons who test positive for HBsAg (ID chronic infections) and other relevant items.

Describe how the applicant intends to maximize resources, reduce duplication of efforts, and improve quality, efficiency, and accessibility of health-care services associated with viral hepatitis services.

Provide evidence of authority and capacity to institute new/adapt EHRs and technology-based applications to guide and assess provider behaviors to align with ACIP and CDC recommendations for HBV testing, care, treatment, and linkage to medical services for complex medical needs of patients.

Goals and Objectives

Describe overall project goals and annual short-term and long-term objectives. Identify impact outcomes and performance measures for the proposed activities. Tie outcomes/impacts and measures to long-term goals and objectives.

Describe how all objectives are related to the Hepatitis B Program and state them in

SMART (specific, measurable, accurate, realistic and timely) terms. SMART objectives should include baseline data and quantifiable timeframes for achievement. Objectives must focus on overall goals of the project rather than project activities. Goals must be ambitious and achievable in the project's timeframe/project period.

Performance Measures: Process and Outcome Measures

This section of the project narrative must clearly identify the measurable outcome(s) that will result from your project. OMH will not fund any project that does not include measurable outcomes. In addition to discussion in the narrative, applicants must describe how they envision the project will benefit the field at large. A "measurable outcome" is an observable end-result that describes how a particular intervention benefits program participants. It demonstrates the "impact" of the intervention.

OMH requires that all funded projects document program progress through the use of process and outcome performance measures throughout the project's period of performance. The process and outcome measures should be depicted in the proposed project's logic model, and clearly align with the proposed project's objectives, strategies and practices or activities, and long-term goals.

All projects should include process and outcome measures of implementation of the

National Standards for Culturally and Linguistically Appropriate Services in Health and Health

Care (National CLAS Standards)7.To measure the impact of implementation of the National

CLAS Standards, OMH recommends use of the Consumers Assessment of Health Providers and

Systems (CAHPS) Cultural Competency Item Set8 and/or the Experience of Care and Health

Outcomes Survey.9 To demonstrate significant program impact, all proposed projects should employ either an experimental or quasi-experimental evaluation design with sufficiently large intervention and control groups to detect statistically significant differences when comparing the population receiving the intervention compared with control group over time, at .05 alpha.

Hepatitis B Program measures should include the following outcomes:

Ending HBV Transmission

Support the development of implementation of community-level strategies aimed at preventing new viral hepatitis infections.

o Recommended Process Measures

Number of estimated and (reported) acute hepatitis B cases.

Number of children who received the first dose of hepatitis B vaccine within three days of birth.

Identify HBV-infected mothers to ensure compliance with ACIP recommendations birth-dosing.

7 https://www.thinkculturalhealth.hhs.gov/clas 8 https://www.ahrq.gov/cahps/surveys-guidance/item-sets/cultural/index.html.

9 ECHO Survey: https://www.ahrq.gov/cahps/surveys-guidance/echo/index.html https://www.thinkculturalhealth.hhs.gov/clas https://www.ahrq.gov/cahps/surveys-guidance/item-sets/cultural/index.html https://www.ahrq.gov/cahps/surveys-guidance/echo/index.html

Number of safety net personnel with direct patient care responsibilities, 19 years of age and older, serving persons at high risk for HBV infection reporting they are fully vaccinated.

o Recommended Outcome Measures

Decrease the number of new HBV infections.

Increase the rate of hepatitis B vaccine “birth dose” coverage.

Reducing HBV morbidity and mortality attributable to ongoing infection

Identify and implement the most effective strategies to reduce deaths and improve the health of people living with viral hepatitis.

o Recommended Process Measures

Number of persons who indicate they were aware they had hepatitis B prior to laboratory testing.

Number of deaths in the (identify geographic area) for which hepatitis B is listed as the underlying or a contributing cause of death.

o Recommended Outcome Measures

Increase the percent of persons aware of their HBV virus infection.

Reduce the number of HBV-related deaths.

Develop and Implement strategies to reduce HBV health disparities.

o Recommended Process Measures

Number of fully-vaccinated children/adolescents.

Number of fully-vaccinated adults.

Number of providers trained in the management of chronic HBV infection

Number of reported acute hepatitis B cases for adults 30-49 years of age living in the United States.

Number of deaths among AAPI living in the identified geographic area for which hepatitis B is listed as the underlying or a contributing cause of death.

Number of deaths among Blacks/African Americans living in the identified geographic area for which hepatitis B listed as the underlying or a contributing cause of death.

Number of deaths among persons aged 45 and older in the identified geographic area for which hepatitis B is listed as the underlying or a contributing cause of death.

o Recommended Outcome Measures

Reduce morbidity and mortality attributable to ongoing infection.

Decrease the number of new HBV infections among individuals 30-49 years of age.

Reduce the number of HBV-related deaths among Asian Americans/

Pacific Islanders.

Reduce the number of HBV-related deaths among Blacks/African

Americans.

Reduce the number of HBV-related deaths among individuals 45 years of age and older.

Program Plan/Description

Provide detailed methodology on how testing activities and counseling will be accomplished, to include:

o expansion and/implementation of hepatitis B testing activities;

o provision of patient counseling; and, o provision of referral and linkage to care, treatment, and preventive services.

Describe how linkage to care, treatment, and preventive services and follow up for clients who test positive for HBV infection will be conducted and documented, ensuring that positive persons obtain and attend an initial follow-up appointment with a clinical provider.

Describe the rationale for selecting participating Health Center, health department, Tribal

Epidemiology Center, and staff of the academic medical and prevention research center.

Describe telehealth technology, timeline for project development, training protocols, proposed schedule for case based presentations and consultations, and expected number of case presentations and participating staff.

Outline clinical care standards to support activities being implemented and to improve program quality and accountability.

Present a viable plan that includes project goals and objectives that are specific, measurable, achievable, realistic and time-phased (SMART), to include a timeline for accomplishing project activities, referencing Appendix III of this FOA.

Delineate the estimated number of individuals expected to be tested; vaccinated; or linked to care, treatment, and contact tracing under your proposed program and how this has been determined.

Describe how local data (e.g., U.S. Census estimates of numbers of targeted foreign-born persons, local epidemiology, and surveillance data) and technical assistance materials will support implementation of activities in target settings and at-risk population(s) during the project period.

Identify specific organizations and venues that will collaborate and participate in the project (for applicants who plan to collaborate with other organizations) and describe settings’ ability to:

o provide clinical or outreach services to foreign-born populations and marginalized immigrants from hepatitis B-endemic countries;

o engage linguistically and culturally competent health care providers and identify resources to manage and conduct intended activities;

o provide culturally appropriate educational materials to these populations;

o provide HBV awareness and education to staff and target populations, adopt screening practices for identification of persons infected with HBV; and, o use guidelines for counseling persons at risk for infection.

Staffing and Management

Provide a description of proposed program staff, including job descriptions for key staff

(including the Project Director), qualifications and responsibilities of each staff member and percentage time each will commit to the project.

Provide a description of duties for proposed consultants and volunteers, if applicable.

Include an organization chart that illustrates the project reporting structure and timeline.

Include charts of the required partnership organizations’ structure.

Discuss how these organizations will interface with the applicant organization and each other. Describe the approach that will be used to monitor and track progress on the project’s tasks and objectives. OMH expects that, throughout the grant period, the

Project Director will have involvement in, and substantial knowledge about, all aspects of the project.

Define the roles of collaborative partner organizations including staff reporting channels and that of any proposed consultants.

Identify and describe partner organizations and the rationale for including each of them in the project. Discuss how partner organizations will interface with the applicant organization.

The application should describe the community advisory board for the project as stated in the Project Requirement section above. This should describe how you plan to involve community-based organizations, network partners, and stakeholders in a meaningful way in the planning and implementation of the proposed project.

Additionally, this section should outline who you consider vested stakeholders in the successful operation, how they were/will be identified, and how they will be meaningfully incorporated into the project.

Evaluation Plan

Specify process and outcome measures to be used. OMH expects you to propose specific measures and not an intent to develop such tools. OMH expects the applicant to ensure that the evaluation plan is implemented at the beginning of the project in order to capture and document actions contributing to relevant project impact and outcomes.

The extent to which appropriate resources are proposed to be devoted to evaluation, including whether the applicant proposes to allocate at least 10% of the total award to evaluation or provide in-kind services equivalent to that amount to evaluation. OMH recommends use of an external evaluator for all aspects of program evaluation.

Describe data collection systems and how you will collect and store data.

Describe the process the applicant will use to ensure that data collection, entry, management (including quality assurance activities), submission, and data security and confidentiality are consistent with state and CDC, National Notifiable Disease

Surveillance System (NNDSS).

If you propose activities at multiple sites, describe how you will monitor and collect data.

Provide a realistic plan for working with OMH and describe how the applicant will comply with the data reporting requirements for activities to be conducted and for collaboration with the OMH project evaluation process.

Dissemination Plan

The applicant should describe the method you will use to disseminate the project’s results and findings in a timely manner and in easily understandable formats to the population served, the general public, and other parties who might be interested in using the results of the project. HHS/OMH may publish (including on a website), all appropriate findings and products. Therefore, you should propose other, innovative approaches to informing parties who might be interested in using the results of your project to inform practice, service delivery, program development, and/or policy-making, especially to those parties who would be interested in replicating the project. HHS/OMH expects that nationwide dissemination of products and knowledge will occur through conference presentations and submissions to peer-reviewed journals.

Budget Narrative Content

You must complete the required budget forms and submit a budget narrative with detailed justification as part of your application. You must enter the project budget on the Budget

Information Non-construction Programs standard form (SF 424A) according to the directions provided with this standard form. The budget narrative consists of a detailed line-item budget that includes calculations for all costs and activities by "object class categories" identified on the

SF-424A and justification of the costs. You must indicate the method you are selecting for your indirect cost rate. See Indirect Costs below for further information.

Project budget calculations must include estimation methods, quantities, unit costs, and other similar quantitative detail sufficient to verify the calculations. If matching or cost sharing is required, you must include a detailed listing of any funding sources identified in box 18 of the

SF-424 (Application for Federal Assistance).

Please be sure to carefully review section D.6 Funding Restrictions for specific information regarding allowable, unallowable, and restricted costs.

You must provide an object class category budget using Section B, box 6 of the SF 424A for the first year of the proposed project. Provide a budget justification, which includes explanatory text and line-item detail, for the first year of the proposed project. The budget narrative should describe how the categorical costs are derived. Discuss the necessity, reasonableness, and allocation of the proposed costs.

For subsequent budget years, provide a summary narrative and line item budget. For categories or items that differ significantly from the first budget year, provide a detailed justification explaining these changes. Note, do not include costs beyond the first budget year in the object class budget in box 6 of the SF- 424A or box 18 of the SF-424; the amounts entered in these sections should only reflect the first budget year.

Your budget narrative should justify the overall cost of the project as well as the proposed cost per activity, service delivered, and/or product. For example, the budget narrative should define the amount of work you have planned and expect to perform, what it will cost, and an explanation of how the result is cost effective. For example, if you are proposing to provide services to clients, you should describe how many clients are you expecting to serve, the unit cost of serving each client, and how this is cost effective.

Use the following guidelines for preparing the detailed object class budget required by box 6 of the SF-424A. The object class budget organizes your proposed costs into a set of defined categories outlined below. Both federal and non-federal resources (when required) must be detailed and justified in the budget narrative. "Federal resources" refers only to the

HHS/OMH funds for which you are applying. "Non-federal resources" are all other non-

HHS/OMH federal and non-federal resources. We recommend you present budget amounts and computations in a columnar format: first column, object class categories; second column, federal funds requested; third column, non-federal resources; and last column, total budget.

Sample Budget Table

Object Class Federal Funds

Requested

Non-federal

Resources

Total Budget

Personnel $100,000 $25,000 $125,000

Note, subrecipient/contract and consultant detailed costs should all be included in those specific line items, not in the overall project object class line items, i.e., subrecipient travel should be included in the Contractual line item not in Travel.

Object Class Descriptions and Required Justifications

Personnel Description: Costs of staff salaries and wages, excluding benefits.

Personnel Justification: Clearly identify the project director or principal investigator, if known at the time of application. Provide a separate table for personnel costs detailing for each proposed staff person: the title; full name (if known at time of application), time commitment to the project as a percentage or full-time equivalent: annual salary and/or annual wage rate;

federally funded award salary; non-federal award salary, if applicable; and total salary. No salary rate may exceed the statutory limitation in effect at the time you submit your application

(see D.6 Funding Restrictions, Salary Rate Limitation for details). Do not include the costs of consultants, personnel costs of delegate agencies, or of specific project(s) and/or businesses to be financed by the applicant. Contractors and consultants should not be placed under this category.

Sample Personnel Table

Position Title and Full Name

Percent Time Annual Salary Federally-funded Salary

Non-federal

Salary

Total

Project

Salary

Project

Director, John

K. Doe

50% $100,000 $50,000 $0 $50,000

Data Assistant, Susan R.

Smith

10% $30,000 $3,000 $3,000

Fringe Benefits Description: Costs of employee fringe benefits unless treated as part of an approved indirect cost rate.

Fringe Benefits Justification: Provide a breakdown of the amounts and percentages that comprise fringe benefit costs such as health insurance, Federal Insurance Contributions Act

(FICA) taxes, retirement insurance, and taxes.

Travel Description: Costs of travel by staff of the applicant organization only. The budget must allocate sufficient funding to enable the grantee Point of Contacts to attend one

OMH-sponsored or sanctioned technical assistance meeting or conference each year (e.g., the grantee orientation meeting and/or national viral hepatitis meetings/conferences).

Travel Justification: For each trip proposed for applicant organization staff only, show the date of the proposed travel, total number of traveler(s); travel destination; duration of trip; per diem; mileage allowances, if privately owned vehicles will be used; and other transportation costs and subsistence allowances. Do not include travel costs for subrecipients or contractors.

Equipment Description: "Equipment" means an article of nonexpendable, tangible personal property having a useful life of more than one year per unit and an acquisition cost that equals or exceeds the lesser of: (a) the capitalization level established by the organization for the financial statement purposes, or (b) $5,000. (Note: Acquisition cost means the net invoice unit price of an item of equipment, including the cost of any modifications, attachments, accessories, or auxiliary apparatus necessary to make it usable for the purpose for which it is acquired.

Ancillary charges, such as taxes, duty, protective in-transit insurance, freight, and installation, shall be included in or excluded from acquisition cost in accordance with your organization's regular written accounting practices.)

Equipment Justification: For each type of equipment requested you must provide a description of the equipment; the cost per unit; the number of units; the total cost; and a plan for use of the equipment in the project; as well as a plan for the use, and/or disposal of, the equipment after the project ends.