Transcript HRSA-16-189 Pre-Review Call Presentation

Pre-Review Webinar
Jurisdictional Approach to Curing Hepatitis C among
HIV/HCV Coinfected People of Color – Jurisdictional Sites
Competitive Funding Opportunity HRSA-16-189
July 21, 2016
Department of Health and Human Services
Health Resources and Services Administration
HIV/AIDS Bureau
Office of Training and Capacity Development
Special Projects of National Significance (SPNS)
Welcome and Introductions
 Harold Phillips
Director, OTCD
 April Stubbs-Smith
Director, Division of Domestic Programs,
OTCD
 Rupali Doshi, MD
Medical Officer, OTCD Domestic
 Jewel Bazilio-Bellegarde
Senior Advisor, OTCD Domestic
 Adan Cajina
Branch Chief, SPNS
 Natalie Solomon
Public Health Analyst, SPNS
 Thelma Iheanyichukwu
HRSA Scholar, SPNS
 Michael Goldrosen
Director, Division of State HIV/AIDS
Programs
 Susan Robilotto, DO
Clinical Consultant/Medical Officer
 Beverly Smith
HRSA Grants Management Specialist
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Agenda
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Overview and Background
Program Requirements and Expectations
Application – Format and Order
Review Process
Selection Criteria
Questions & Answers
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Overview | HIV/AIDS Bureau
The mission of the HIV/AIDS Bureau is to
provide leadership and resources to assure
access to and retention in high quality,
integrated care and treatment services for
vulnerable people living with HIV/AIDS and
their families.
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Purpose | HRSA-16-189
• Increase jurisdiction-level capacity to provide comprehensive
screening, care and treatment of hepatitis C (HCV) among
HIV/HCV coinfected people of color
• Increase numbers of HIV/HCV coinfected people of color who
are diagnosed, treated, and cured of HCV infection
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Summary of Funding HRSA-16-189
• $2.6 million is expected to be available annually to fund up to 4 Jurisdictional
Sites. Applicants may apply for a ceiling amount of up to $650,000 per year
• Funding requests must not exceed the ceiling amount
• If the requested amount exceeds this ceiling, the application will be deemed
non-responsive and will not be considered for funding
• Type of Award: Cooperative Agreement
• Start Date: September 30, 2016
• Project period: 3 years (September 30, 2016 – September 29, 2019)
• Funding beyond the first year is dependent on:
• Availability of appropriated funds in subsequent fiscal years
• Recipient satisfactory performance
• Decision that funding is in the best interest of the Federal government
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Award Information | Cooperative
Agreement
A cooperative agreement is an award instrument of
financial assistance where there is substantial
involvement of the Federal government during
performance of the project.
Federal Grant and Cooperative Agreement Act of 1977
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Eligible Applicants | HRSA-16-189
• Eligible applicants are limited to current recipients under RWHAP Part A
and current recipients under RWHAP Part B
• Applicants must have a high prevalence of HIV/HCV coinfected people of
color
• At least 20% of people of color living with HIV are coinfected with HCV, and
• At least 750 HIV/HCV coinfected people of color in the jurisdiction
• Applicants should use the CDC HIV Surveillance Report, Supplemental
Report, HIV/AIDS data to determine the number of people living with HIV
(PLWH) (HIV and AIDS) living in the jurisdiction
• Applicants should clearly state the sources of data used for eligibility
determination
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Background | Target Population
• Populations of interest include people of color living
with HIV that have a high prevalence of coinfection with
HCV
• Inclusive of Blacks/African Americans, Latinos/as,
American Indians/Alaska Natives
• People who inject drugs (PWID)
• Men who have sex with men (MSM)
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Background | HIV/HCV Coinfection
• Emerged as a major concern, with approximately one quarter of
PLWH also coinfected with HCV
• People who become infected with HCV are at increased risk for
HIV
• People with HIV/HCV coinfection have higher liver-related
morbidity and mortality
• Newer medications have been shown to be equally effective in
curing HCV in people who are coinfected with HIV and HCV as
they are in HCV-monoinfected people
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Program Expectations | PreImplementation Phase
• Within the first six (6) months of the award, recipient will:
• Conduct a needs assessment to identify gaps in RWHAP services provision
in the existing HCV screening, care and treatment system of the
jurisdiction
• Prepare and submit the need assessment with identified gaps and barriers
to the ETAC
• Conduct a patient HCV care and treatment knowledge assessment among
HIV/HCV coinfected people of color
• Conduct a Provider Assessment to identify gaps in knowledge, skills, and
behavior regarding HCV services
• Begin the Development of the Project Implementation Plan
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Program Expectations | Project
Implementation
• Implement plan for enhancing existing HCV screening, referral and
treatment system for HIV/HCV co-infected people of color and
describe all system components including:
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Provider training
Patient education
Practice transformation
Enhanced HCV screening
Improved access to HCV care and treatment
Medication adherence support
Document project (e.g., manuals, tools, policies, and protocols)
• Attend an annual multi-site meeting per year
• Host, at minimum, one site visit per year as conducted by the ETAC
and the SPNS Program project officer
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Program Expectations | Evaluation
• Participate in the development of a common multisite evaluation
data collection instrument
• Collect and report relevant quantitative and qualitative outcome,
process and cost measures of their models to the ETAC
• Submit all data collection instruments, informed consents and any
other related materials to respective Institutional Review Boards
(IRBs)
• Develop and implement local evaluation
• Participate in publication and dissemination activities
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Application Submission | Guidance
• Funding Opportunity Announcement (FOA) focuses on the
program-specific content, including goals, expectations, and
requirements of the program
• SF-424 Application Guide contains general language and
instructions as referenced in the FOA
(Updated May 26, 2016)
http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf
• Applicants must use both the FOA and the SF-424 Application Guide to
successfully complete and submit an application
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Application Format
The application kit is as follows (and as noted in Section 4.3 of SF-424
Application Guide )
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SF-424 Face Page
Project Abstract
Project Narrative
SF-424A Budget
Budget Narrative
SF-424B Assurances
Project/Performance
Site Location form
viii. Grants.gov Lobbying
form
ix. Attachments
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Work Plan
Project Organizational
Chart
Letters of Agreement
Line Item Budgets
Staffing Plan
Job Descriptions for Key
Personnel
Biographical Sketches
Items in RED are discussed in following slides.
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Project Abstract | Snapshot of the
Project
• Project Title, Applicant Organization Name and Contact
Information
• Proposed Evaluation and Technical Assistance Structure
• Overall project goals
Reminder: Abstract is only 1 page in length
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Project Narrative
The Project Narrative provides a comprehensive framework and description of all
aspects of the proposed project. It contains the following seven (7) sections:
• Introduction
• Needs Assessment
• Methodology
• Work Plan
• Resolution of Challenges
• Evaluative and Technical Support Capacity
• Organizational Information
Note – In order for reviewers to understand your proposal, ensure that the
Project Narrative is succinct, self-explanatory and well-organized.
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Budget | Overview
This FOA is for a multi-year (3-year) non-construction program. Accordingly,
Budget Information consists of three major parts:
• SF-424A: Complete Sections B for each year of the 3-year project period
• Line Item Budget: While the budget period is for one year, you must
submit line item budgets for each of the 3 budget periods (Attachment 4)
• Budget Justification: Describe each cost element and explain how each
cost contributes to meeting the project’s objectives/goals
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Budget | SF-424A Section A – Budget Summary
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Budget | Section B – Budget Categories
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Budget Justification Narrative
• List ALL staff names and position titles to be funded
• Be consistent with names and position titles
• Clearly describe each line-item in the budget justification narrative,
specific to the cost category
• Include details of contracts, by cost category in both the line-item
budget and budget justification narrative
• Include calculations for all items in the budget justification
narrative (unit cost, total number of units)
• Provide a Budget Justification for Year One, then summarize any
changes in Years Two through Three
Remember Be Clear and Concise!
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Budget | Salary Rate Limitation
• The General Provisions in Division H, § 202, of the Consolidated
Appropriations Act, 2016 (P.L. 114-113), includes provisions for
a salary rate limitation
• Award funds may not be used to pay more than $185,100
annually for an individual’s salary (exclusive of fringe)
• The salary limitation applies to subrecipients
• Note these or other salary limitations will apply in FY 2017 as
required by law
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Budget | Funding Restrictions 16-189
Funds may not be used for the following purposes:
• Costs of HCV treatments and any
other charges that are billable to
third party payers (e.g., private
health insurance, prepaid health
plans, Medicaid, Medicare, HUD,
other RWHAP funding including
the AIDS Drug Assistance
Program [ADAP]);
• Purchase, construction of new
facilities or capital improvements
to existing facilities;
• Purchase of medications;
• Lobbying activities and expenses;
• Purchase or improvement to
land;
• Purchase vehicles;
• Fundraising expenses;
• Cash payments to intended
recipients of RWHAP services;
• Reimbursement of pre-award
costs; and/or
• Preexposure (PrEP) or
Postexposure Prophylaxis (PEP);
• International travel
www.ecfr.gov 45 CFR Part 75 Subpart E
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Attachment 1 | Work Plan
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Goals
Objectives
Action Steps
Staff Responsible
Timeline for Action Steps
Measurable Outcomes
Recommend providing work plan in a table format
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Attachment 1 | Work Plan Tips
Your Work Plan should include objectives and key
action steps that are:
• SPECIFIC
• MEASUREABLE
• ACHIEVABLE
• REALISTIC &
• TIME FRAMED
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Attachment 5 | Staffing Plan
• Staffing plan should include sufficient personnel to
successfully implement proposed project activities and goals
• Include education, experience, qualifications, and rationale
for the amount of time being requested for each staff
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Application Review | Selection
Process
• Division of Independent Review (DIR) is responsible for managing
objective reviews within HRSA
• Applications competing for Federal funds receive an objective and
independent review performed by a committee of relevant and qualified
experts (Objective Review Committee [ORC])
• Applications submitted by the published deadline that pass the initial
HRSA eligibility and completeness screening will be reviewed and rated
by a panel based on the review criteria in Section V of the FOA
• The competitive objective review process is based solely on the merits of
the application. It is critical that the applicant paint a clear picture of the
approach and the specific work plan proposed and the capabilities that
the applicant brings to the work
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Award Administration | Award
Notices
• Anticipated that awards will be announced prior to the start date
of September 30, 2016
• Notices will be sent electronically to the applicant’s Authorized
Organization Representative (AOR) and reflects the only
authorizing document
• Any other correspondence announcing that a application has
been selected for award is not an authorization to begin
performance
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Award Administration | Reporting
Requirements HRSA-16-189
Successful applicants must comply with Section 6 of HRSA’s SF-424
Application Guide and the following reporting and review activities:
• Annual Progress Report(s). The recipient must submit a progress report to
HRSA that covers activities for each budget year. Further information will be
provided in the notice of award.
• Final Project Report. The recipient must submit a final report to HRSA that
covers activities for the entire project period.
• Integrity and Performance Reporting. The Notice of Award will contain a
provision for integrity and performance reporting in FAPIIS, as required in 45
CFR 75 Appendix XII
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Narrative Guidance
HRSA-16-189
In order to ensure that the Review Criteria are fully addressed, this table provides a crosswalk between the
narrative language and where each section falls within the review criteria.
Narrative Section
Review Criteria
Introduction
(1) Need
Needs Assessment
(1) Need
Methodology
(2) Response and (4) Impact
Work Plan
(2) Response
Resolution of Challenges
Evaluation Capacity
(2) Response
(3) Evaluative Measures, (4) Impact and
(5) Resources/Capabilities
Organizational Information
(5) Resources/Capabilities
(6) Support Requested – the budget section should include
sufficient justification to allow reviewers to determine the
reasonableness of the support requested.
Budget and Budget Narrative
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Application Review | Scoring Criteria
HRSA-16-189
Review Criteria are used to review and rank applications. For this FOA,
there are 6 review criteria:
Criteria
Criterion 1: Need
Criterion 2: Response
Criterion 3: Evaluative Measures
Criterion 4: Impact
Criterion 5: Resources/Capabilities
Criterion 6: Support Requested
Total Points
Points
25
25
15
10
15
10
100
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Criterion 1: NEED (25 points)
• Target populations, epidemiology review
• Need for comprehensive HCV screening, care and treatment
system
• Existing HCV screening, care and treatment system, service
gaps
• Current state of knowledge and training needs of providers
on HCV
• Current state of knowledge and education needs of patients
on HCV
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Criterion 2: RESPONSE (25 points)
• Methodology (18 points)
• Assessment methods and resources
• Addresses service gaps
• Comprehensive system that targets all program expectations
• Work Plan (5 points)
• Strength, clarity and feasibility of 3-year work plan
• Meets program requirements
• SMART objectives
• Resolution of Challenges (2 points)
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Criterion 3: EVALUATIVE MEASURES
(15 points)
• Extent to which HCV Care Continuum markers can be measured
and reported
• Local evaluation plan
• Strength of methodology to be used to assess program
effectiveness
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Criterion 4: IMPACT (10 points)
• Commitment to work collaboratively with ETAC, attend annual
working meetings
• Sustainability
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Criterion 5: RESOURCES/CAPABILITIES
(15 points)
• Project personnel and organization qualified to implement the
project, including leveraging existing relationships in the
jurisdiction and other entities funded by RWHAP (A, B, C and F)
to implement the project
• Project personnel qualified to design and implement the
program evaluation
• Evidence that Direct Acting Antiviral (DAA) medications are
available in the jurisdiction
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Criterion 6: SUPPORT REQUESTED (10
points)
• Key personnel have adequate time devoted to the project
• Appropriateness of the line item budgets to the work plan
• Appropriateness of the budget justification narrative
appropriate for each line item
• Clear descriptions and reasonableness of contracts and
consultant fees
• Inclusive of costs for travel to annual working meetings
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Questions and Answers
Contact Information
Program Questions
Budget Questions
Rupali Doshi, MD, MS
Beverly Smith
(301) 443-7065
[email protected]
(301) 443-5313
[email protected]
For an archive of this session, go to the
TARGET Center Website:
https://careacttarget.org/
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