MP-CPI-20-004 TA Webinar Presentation-FINAL.pdf

O F F I C E O F T H E A S S I S TA N T S E C R E TA R Y F O R H E A LT H

FY2020 FOA Technical Assistance Webinar:

Sickle Cell Disease Clinical Data Collection Platform

MP-CPI-20-004

July 21, 2020

Sickle Cell Disease Clinical Data Collection Platform

O F F I C E T H E

Webinar Agenda

I. Overview of the Funding Opportunity Announcement (FOA)

II. Grants and Acquisitions Management

I. Competitive Application Requirements

III. Question and Answer Session

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

O F

Funding Announcement Role

O F F I C E O F T H E

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• The Funding Opportunity Announcement (FOA) provides information and guidance related to applications.

• Read the entire funding announcement.

• Follow the FOA carefully!

• The information provided in the FOA takes precedence over any conflicting information in other documents.

Executive Summary

The Office of the Assistant Secretary for Health and the Office of Minority Health (OMH) announce the availability of funds for a Fiscal Year (FY) 2020 grant award under the authority of

Section 1707 of the Public Health Service Act (42 U.S.C. § 300u-6). Sickle cell disease (SCD) is the most common inherited blood disorder in the United States, estimated to affect approximately

100,000 Americans, most of whom are African American. This notice solicits applications for demonstration projects for the Sickle Cell Disease Clinical Data Collection Platform Initiative to determine whether a standardized clinical data collection platform, shared across medical centers and other healthcare facilities, can serve as a central repository for analyzing data from large patient cohorts, recruiting patients for clinical trials, assessing adherence to evidence-based clinical guidelines, and identifying new areas for research.

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

O FO F F I C E T H E

Office of Minority Health (OMH)

Mission Statement

The mission of the Office of Minority Health is to improve the health of racial and ethnic minority populations through the development of policies and programs that will help eliminate health disparities.

O F F I C E O F T H E

OMH Activities and Priorities

• Broad portfolio encompassing chronic diseases, infectious diseases, injury, environmental health, access to care

• Prioritization of OMH activities:

Align with HHS strategic goals and initiatives (e.g. opioid epidemic, sickle cell disease)

Address underlying factors (e.g. biological and social determinants of health, workforce development)

Leverage partnerships

• Reduce health disparities

• Identify solutions that are effective, scalable, and replicable

O F F I C E O F T H E

Sickle Cell Disease Clinical Data Collection Platform Initiative

Primary Outcome (FOA Page 7)

O F F I C E O F T H E

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

The Sickle Cell Disease Clinical Data Collection Platform Initiative seeks to address the following outcome:

• Demonstrate the feasibility and utility of a secure clinical data collection platform for Sickle Cell Disease that can serve as a central repository for analyzing data from large patient cohorts, recruiting patients for clinical trials, assessing adherence to evidence-based clinical guidelines, and identifying new areas of research.

Program Description (FOA Pages 9-12)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

OMH expects the successful applicant to:

Design a secure SCD data collection platform, affording personally identifiable health information the protections of the Privacy Rule and Security Rule of the

Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Develop and implement the SCD clinical data collection platform and collaborative learning community.

Evaluate the SCD clinical data collection platform.

Develop and implement a dissemination plan to make the data collection platform widely available to healthcare providers who treat SCD patients.

Develop and implement a sustainability plan to support the project after the project period.

Data Platform Design Expectations (FOA Pages 9-10)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

Empanel a technical advisory group (TAG) with members knowledgeable of SCD patient care, clinical data platform development, CDC’s SCD clinical trials networks, private insurance and Medicaid reimbursement policies, patient/family engagement in care, and data security and privacy. The TAG should include community members living with SCD or family members with SCD. The TAG will provide input to the grantee on the following:

• Developing a plan for content and technical requirements of the platform

• Identifying priority patient outcomes

• Developing a plan to coordinate, collaborate and align priorities among participating institutions

• Developing a data management plan, including data security and privacy protections

Learning Community Expectations (FOA Pages 10-11)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Define criteria (e.g. IT capacity, number of patients with SCD served, etc.) for participating pilot sites, including hub sites (e.g. academic health centers, including those that are or are in Historically Black Colleges and Universities, or health systems) and satellite sites (e.g. community hospitals, federally qualified health centers)

• Identify and recruit hub sites and their satellite sites, based on defined selection criteria, to participate in the shared data collection platform and collaborative learning community

• Execute a Memorandum of Agreement (MOA) with participating hub sites.

OMH expects the MOA to include partnerships with relevant State Health

Department(s) and/or State Medicaid Offices

Learning Community Expectations (FOA Pages 10-11), Continued

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Convene annual meetings with state partners to inform them of progress on the data platform and discuss potential areas for collaboration

• Create and foster a collaborative learning community of participating institutions, SCD patients/family members, and other stakeholders

• Develop a plan to communicate to patients and their families about patient protections regarding how their health information will be collected and used

• Develop and continuously update a data collection plan based on quality improvement (QI) assessments and user feedback

• Provide continuing education (CE) credits, Maintenance of Certification

(MOC), and other educational incentives, as applicable

Evaluation Expectations (FOA Page 12)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Identify and develop appropriate measures/indicators to monitor and document the utilization, data quality, and progress of the SCD clinical data collection platform

• Assess feasibility of data collection and standardization, collaboration across institutions, and timeliness of incorporating user feedback

• Collect, analyze, and evaluate data to demonstrate the utility of the platform as measured by the number of providers using the platform, users’ self-reported satisfaction with the system, as well as users’ perception of its utility for the improvement of patient care

• Identify and document “lessons learned” from the development and implementation of the data collection platform

Dissemination Plan Expectations (FOA Pages 12, 25)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

OMH expects the recipient to:

• Develop and implement a plan to make the data collection platform widely available to healthcare providers who treat SCD patients.

Applicants should:

• Describe the method you will use to make the data collection platform widely available and to disseminate the project’s results and findings in a timely manner in easily understandable formats to the population served, the general public, and other interested parties.

• Propose 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.

Sustainability Expectations (FOA Pages 12, 25)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

OMH expects the recipient to:

• Develop and begin implementation of a plan to support the project after the project period

The applicant should:

• Include a summary for a feasible, time-phased sustainability plan. Feasible sustainability plans should address financial, staff and supervisory, and material resources that are needed to sustain the data collection platform and collaborative learning community after the project period ends.

Award Information (FOA Page 13)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Estimated Federal Funds Available: $1,000,000

• Anticipated Number of Awards: 1

• Award Ceiling (Federal Funds including indirect costs): $1,000,000 per budget period

• Award Floor (Federal Funds including indirect costs): $750,000

• Anticipated Start Date: 09/15/2020

• Estimated Period of Performance: Up to 2 years

• Anticipated Initial Budget Period Length: 12 months

• Type of Award: Grant

Application Review Criteria (FOA Pages 46-53)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Problem Statement (10 points)

• Organizational Capability (15 points)

• Goals, Objectives and Outcomes (10 points)

• Program Plan (25 points)

• Evaluation Plan (15 points)

• Dissemination Plan (10 points)

• Sustainability Plan (10 points)

• Budget (5 points)

O F F I C E O F T H E A S S I S T A N T S E C R E T A R Y F O R H E A L T H

APPLICATION SUBMISSION

OASH Grants and Acquisition Management Division

Submission Dates and Times

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Your application is due by 6 p.m. Eastern Time on August 18, 2020.

• Your submission time will be determined by the date and time stamp provided by Grants.gov when you complete your submission.

• Strongly encouraged to submit your application a minimum of 3-5 days prior to the application closing date.

• Grants.gov may take up to 48 hours to notify you of a successful submission.

• If you fail to submit your application by the due date and time, we will not review it, and it will receive no further consideration.

Eligible Applicants (FOA, pg. 14)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• State Governments

• County Governments

• City or township governments

• Special district governments

• Independent school districts

• 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 having 501(c)(3) status with the IRS, other than institutions of higher education

• Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education

• Private non-profit institutions of higher education

• U.S. Territories

Cost Sharing or Matching

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

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

Funding Announcement Role

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• The Funding Opportunity Announcement (FOA) provides information and guidance related to applications.

• Read the entire funding announcement.

• Follow the FOA carefully!

• The information provided in the FOA takes precedence over any conflicting information in other documents.

Address to Request Application Package

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Obtain an application package electronically by accessing Grants.gov at http://www.grants.gov/

• Find it by searching with the CFDA number provided on page 1 of the FOA

• CFDA Number is: 93.137

• Be sure to subscribe to the announcement in Grants.gov so you receive notification of any updates to the FOA or supporting documents http://www.grants.gov/

Application Submission

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• OASH requires that all applications be submitted electronically via Grants.gov unless an exemption has been granted. If you submit an application via any other electronic communication, it will not be accepted for review.

• Access Grants.gov website portal. All funding opportunities and grant application packages are made available on www.Grants.gov.

• An application will not be considered valid until all application components are entered in Grants.gov and received by the HHS Grants and Acquisitions Management according to the deadlines specified in the “DATES” section on page 1 of the FOA.

• Contact Grants.gov with any questions or concerns regarding the electronic application process 1-800-518-4726.

Application Submission (cont’d)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

Applications must be submitted as three (3) files:

• Upload #1: The ENTIRE project narrative

• Upload #2: The ENTIRE budget narrative, including supporting documentation described in the Budget Narrative content section

• Upload #3: All documents in the appendices uploaded in the Attachments section of your Grants.gov application as a single acceptable file

Exceptions: Required standard forms do not apply to the submission requirements as stated in Disqualification Criteria

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Any files uploaded or attached to the Grants.gov application must be of the following file formats – Microsoft Word, Adobe PDF, or image formats (JPG, GIF, TIFF, or BMP only).

• HHS/OASH strongly recommends that electronic applications be uploaded as

Adobe PDF. If you convert to a PDF document prior to submission, you may prevent any unintentional formatting that might occur with submission of an editable document.

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Be complete and do not leave blanks on forms unless the information is not applicable.

• The individual submitting the application forms must have the legal authority to act on behalf of the organization.

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• To ensure successful submission of your application, carefully follow the step-by-step instructions provided at http://www.grants.gov/web/grants/applicants/apply-for-grants.html

• These instructions are kept up-to-date and also provide links to

Frequently Asked Questions and other troubleshooting information.

http://www.grants.gov/web/grants/applicants/apply-for-grants.html

Application Elements (FOA pg 17-18)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Application for Federal Assistance (SF-424)

• Budget Information for Non-construction Programs (SF-424A)

• Assurances for Non-construction Programs (SF-424B)

• Disclosure of Lobbying Activities (SF-LLL)

• Project Abstract Summary

• Project Narrative – Submit all Project Narrative content as a single acceptable file.

• Budget Narrative – Submit all Budget Narrative content as a single acceptable file.

• Appendices – Submit all appendix content as a single acceptable file, in the Attachments section of your Grants.gov application.

Application Format

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Be sure to follow Project Narrative format instructions in the FOA. Your application will be disqualified if it does not conform to the format requirements.

• You must double-space the Project Narrative pages.

• You must use 12-point font.

• You should use an easily readable typeface, such as Times New Roman or

Arial.

• You may single-space tables or use alternate fonts but you must ensure the tables are easy to read.

• For Appendices and Budget Narrative, you should use the same formatting specified for the Project Narrative.

• Appendix documents such as résumés may use alternate formats common to such documents.

System for Award Management (SAM)

• You are required to provide a Dun and Bradstreet (D&B) Data Universal Numbering System

(DUNS) number when applying for Federal awards through Grants.gov. If you do not currently have a DUNS number, please contact Grants.gov to create a temporary DUNS number if you are unable to complete the SAM registration process prior to submitting your application.

• Your organization must register online in the System for Award Management (SAM). Under normal operating procedures Grants.gov will reject submissions from applicants with nonexistent or expired SAM Registrations.

• Because of the public health emergency with COVID-19, the requirement for SAM registration at the time of submission has been waived. Grants.gov will temporarily allow submissions without a current SAM registration. A completed registration in SAM may be required prior to receiving any award based on your application.

System for Award Management (SAM)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Grants.gov will reject submissions from applicants with nonexistent or expired SAM

Registrations. Currently waived at time of submission due to public health emergency for COVID-19. (Subject to Change)

• If you are registering a new entity in SAM.gov, you must mail an “Entity Administrator

Notarized Letter” to the FEDERAL SERVICE DESK, ATTN: SAM.GOV Registration

Processing. Your notarized letter with the details required must be mailed. Your registration will not be activated until the letter is submitted and reviewed.

• Minimum timeframe to complete an initial SAM registration (30 minutes).

• Timeframe for applicant’s registration to become active (up to 10 days).

• SAM registration MUST be renewed each year.

https://www.sam.gov/

SAM (cont’d)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Average timeframe for updates to take effect in Grants.gov (72 hours).

• Recommend applicants check active registration in SAM well before application deadline.

• If successful and receive award must maintain an active SAM registration w/current info at all times during the active award.

• If you have not complied with these requirements, HHS/OASH

May determine you are not qualified to receive an award; and

May use that determination as a basis for making an award to another applicant.

• Should you successfully compete and receive an award, all first-tier sub-award recipients must have a DUNS number at the time you, the recipient, make a sub-award.

Funding Restrictions

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Allowability, allocability, reasonableness, and necessity of direct expenses; indirect costs may be charged on HHS/OASH grants in accordance with Department regulations and current policy effective at the time of the award

• Current requirements can be found online via 45 CFR part 75 “Uniform

Administrative Requirements, Cost Principles, and Audit Requirements for HHS

Awards”

• Indirect costs may be included per 45 CFR 75.414. Applicants should indicate which method or rate is used for this application

• Current Salary Limitation: $192,700 effective January 2020

Budget Narrative and Forms

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

The Project Budget Information SF 424A budget forms

Budget narrative

Detailed budget justification

• Must be consistent with the requirements of the FOA

• Budgeted costs must reflect proposed activities

• Forms, narrative and detailed justification do not count towards page limit

• Budget line item descriptions and justification requirements are explained in FOA

• Refer to suggested table formats in the FOA

Appendices Content

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

Appendices should include any specific documents outlined in Section F.3.c., under the heading “Appendices” in the Application Content section of the FOA

• Supplemental Information/Supporting Documentation for Work Plan;

• Memorandum(s) of Agreement and/or Letters of Commitment (LOC) from

Partners and Subrecipient Organizations and Agencies;

• Organizational Documents such as Organizational Charts.

• Curriculum Vitae/Resume for Key Personnel;

• Tribal Letter or Resolution;

• Just-In-Time Institutional Review Board Agreement

Application Disqualification Criteria – 1 pgs. 15-16)

O F F I C E O F T H E

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

(FOA

• Submitted electronically via www.grants.gov by due date and time (unless an exemption was granted two (2) business days prior to the deadline).

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

• HHS/OASH/GAM deems your application eligible.

• Project Narrative must be double-spaced, on the equivalent of 8.5” X 11” page size with 1” margins on all sides and font size not less than 12 points.

• Application meets the Application Responsiveness Criteria.

Application Disqualification Criteria – 2 (FOA pgs. 15-16)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

FOA

pg. 13 & 16

Your Federal funds including indirect costs does not exceed the maximum indicated in Award Ceiling.

$1,000,000

Your Federal funds request including indirect costs is not below the minimum indicated in Award Floor.

$750,000

Project narrative does not exceed 40 pages

Total Application, including Project Narrative plus appendices does not exceed 60 pages

Application Review

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Applications that lack the required supporting documentation or submit additional appendix files will not be disqualified from competitive review; however, it may impact your application’s scoring under the evaluation criteria.

• Be sure to follow submission instructions carefully.

Application Review (cont’d)

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Eligible applications will be reviewed and scored by a panel of independent reviewers with technical expertise in applicable fields according to the criteria listed in the Program Announcement.

• Objective Review Committee process is formal and confidential. Federal staff are available for questions and to ensure the process is consistent and fair, but do not participate in discussion and scoring.

• Applications are also reviewed by:

GAM staff for administrative & business compliance.

Program Office staff for programmatic compliance.

Funding Decisions

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• Recommendations for funding will be made by the OMH Director to the

Grants Management Officer to conduct risk analyses.

Funding Process

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• We are not obligated to make any Federal award as a result of this announcement.

• Only the grants officer can bind the Federal government to the expenditure of funds.

• If you receive communications to negotiate an award or request additional or clarifying information, this does not mean you will receive an award; it only means that your application is still under consideration.

• All award decisions, including level of funding if an award is made, are final and you may not appeal.

Funding Process: Review of Risk Posed by Applicant

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• HHS/OASH will evaluate each application in the fundable range for risks posed by the applicant before issuing an award in accordance with 45 CFR 75.205

• OASH will use a risk-based approach and may consider any items such as the following as stated in the FOA:

Applicant’s financial stability;

Quality of management systems and ability to meet the management standards prescribed in 45 CFR part 75;

History of performance – Applicants record in managing Federal awards including timeliness of compliance with applicable reporting requirement, conformance to the terms and conditions of previous Federal awards;

Reports and findings from audits performed; and

The applicant’s ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities.

Risk Analysis Reporting

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• If we do not make an award to you because we determine your organization does not meet either or both of the minimum qualification standards as described in 45

CFR §75.205(a)(2), we must report that determination to FAPIIS, if certain conditions apply.

• At a minimum, if you are a prior Federal award recipient, information in the system must indicate that your organization “demonstrates a satisfactory record of executing programs or activities under Federal grants, cooperative agreements, or procurement awards; and integrity and business ethics.” 45 CFR § 75.205(a)(2)

• This information will then be available for other organizations to review when considering you for an award.

Funding Process - 1

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

Notice of Award (NOA)

• Notifies the successful applicant of the selection; award amount; project

& budget periods

• Includes any conditions on the award (for example, requirements that must be met as a condition of receiving the grant funds)

• Includes standard terms, reporting requirements and contact information for GAM and the Program Office

Funding Process - 2

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

• GAM is the official contact for the grantee.

• All official communication related to the grant is between GAM and the successful applicant.

• Program Office will notify unsuccessful applicants via letter.

Questions and Answers

Sickle Cell Disease Clinical Data Collection Platform FOA

Inquiries

O F F I C E O F T H E

A S S I S T A N T S E C R E T A R Y F O R H E A L T H

Programmatic Requirements

Office of Minority Health

Contact Name: Sandra Howard

Email: Sandra.Howard@hhs.gov

Administrative and Budgetary Requirments

HHS/OASH/Grants and Acquisitions Management

Grants Management Specialist

Contact Name: Roscoe Brunson

Email: Roscoe.Brunson@hhs.gov mailto:Sandra.Howard@hhs.gov mailto:Eric.West@hhs.gov