1. Sickle Cell Disease (SCD) in Sub-Saharan Africa (SSA) Collaborative Consortium Research Funding Opportunity Announcement (RFA HL-17- 006) Technical Assistance Webinar Norma B. Lerner MD, MPH W. Keith Hoots MD Christina Rinaldi October 20, 2015

2.  Program Overview  Program Background  Purpose of the Collaborative Consortium RFA  Goals  Award & Application Information  Registration Process for Foreign Applicants  Submission Process  Review  Resources  Questions The SCD in SSA Collaborative Consortium Webinar Outline 2

3.  Funding Agency  National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)http://www.nhlbi.nih.gov  One of the 27 Institutes and Centers of the National Institutes of Health (NIH) The SCD in SSA Program: Overview

4.  Funding Mechanisms  RFA–HL-17-006 -Collaborative Consortium (U24 – Cooperative Agreement)  RFA–HL-17-007 -Data Coordinating Center (U24- Cooperative Agreement) The SCD in SSA Program: Overview

5.  Structure National Heart Lung and Blood Institute (NHLBI) Consortium Hub (HL-17-006) Consortium Hub (HL-17-006) Data Coordinating Center (HL-17-007) Consortium Site Governing Body: Steering Committee Review & Monitoring: Observational Study Monitoring Board (OSMB) Governing Body: Steering Committee Review & Monitoring: Observational Study Monitoring Board (OSMB)

6.  Worldwide burden of SCD is rising  >75% SCD births occur in sub- Saharan Africa (SSA)  Clinical Care -Health resources are limited in many areas -50-80% of affected children die before age 5  Research -High disease prevalence should facilitate research -Many nations lack the required infrastructure SCD in SSA Program: Background

7. Purpose of this Funding Opportunity (FOA)  Build capacity  By supporting a founding Sickle Cell Disease (SCD) Collaborative Consortium in Sub-Saharan Africa (SSA)  Collaborative Consortium will establish an infrastructure for a future Sickle Cell Disease in Sub-Saharan Africa Research Network  Collaborative Consortium will work closely with a Data Coordinating Center (DCC) supported by a separate FOA (HL-17-007)

8. The Collaborative Consortium: Goals  Development of  A sickle hemoglobinopathy database  Shared database elements and harmonized phenotype definitions, ontologies  SCD standards of care  Links to existing training programs Consortium Hub Consortium Hub Consortium Site

9. The Collaborative Consortium: Goals  Planning for  Future SCD cohort studies, implementation of clinical practices, and inclusion of new African sites  Accomplishing activities over 4 years  Development phase: Years 1 and 2  Pilot/planning phase: Year 3  Implementation phase: Year 4 Consortium Hub Consortium Hub Consortium Site

10.  Cooperative Agreement  Requires substantial NHLBI scientific and programmatic involvement  After award, program staff and appointees assist and participate in project activities  Terms and conditions of this Cooperative Agreement are explained in detail in Section VI of the FOA The Collaborative Consortium: Award Information

11.  Eligible Applicants  Only institutions located in sub-Saharan Africa  Only one application per institution The Collaborative Consortium: Application Information

12.  Applicants must  Carefully follow the FOA instructions http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-17- 006.html  Download the SF424 (R&R) application package http://grants.nih.gov/grants/guide/url_redirect.htm?id=12 000http://grants.nih.gov/grants/guide/url_redirect.htm?id=12 000 and also follow these instructions except where the FOA instructs you to do otherwise  Adhere to the page limits described in both documents The Collaborative Consortium: Application

13.  Required registrations information for foreign award applicant organizations  Registration can take 6 weeks or more – start now  All registrations can be requested and completed via the web The Collaborative Consortium: Registration

14.  STEP 1: Request an NCAGE (NATO Commercial and Government Entity) Code https://eportal.nspa.nato.int/AC135Public/scage /CageList.aspx https://eportal.nspa.nato.int/AC135Public/scage /CageList.aspx Note: 48 hours after submitting your code request, confirm your correct legal business name and/or physical address is listed in the CAGE system. Go to the Business Identification Number Cross Reference System (BINCS) website; https://www.logisticsinformationservice.dla.mil/BINCS/begin_s earch.aspx https://www.logisticsinformationservice.dla.mil/BINCS/begin_s earch.aspx The Collaborative Consortium: Registration

15.  STEP 2: Get a DUNS Number http://fedgov.dnb.com/webform  Register with Dun & Bradstreet (D&B) to get a Data Universal Numbering System (DUNS) Number The Collaborative Consortium: Registration

16.  STEP 3: Register with the System for Award Management (SAM) https://www.sam.gov/sam/transcript/Quick_Guide_for _International_Entity_Registration.pdf https://www.sam.gov/sam/transcript/Quick_Guide_for _International_Entity_Registration.pdf  You must have NCAGE Code and DUNS Number before registering in SAM  SAM registration must be renewed annually  Once CAGE system approves your registration, you will receive a notification email from SAM.gov. Allow 5 business days The Collaborative Consortium: Registration

17.  STEP 4: Complete eRA Commons registration https://public.era.nih.gov/commons/public/registrati on/registrationInstructions.jsp https://public.era.nih.gov/commons/public/registrati on/registrationInstructions.jsp  eRA Commons requires at least one Signing Official (SO) and at least one Principal Investigator (PD/PI)  Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. The Collaborative Consortium: Registration

18.  STEP 5: Register at Grants.gov http://www.grants.gov/web/grants/register.html http://www.grants.gov/web/grants/register.html  System used for all NIH application submissions  Requires a one-time registration in order to submit applications  Applicants must have active DUNS number and SAM registration to complete Grants.gov registration  eRA commons and Grants.gov registration can be done simultaneously  Registration is not needed to download an application package or prepare application  Note: Before you can view and complete an application package, you MUST have Adobe Reader installed on your computer The Collaborative Consortium: Registration

19.  Letter of Intent (described in the FOA)  A letter of intent is encouraged but not required  Allows the NHLBI to estimate the potential review workload The Collaborative Consortium: Submission

20.  Key Dates:  Earliest application submission date: -January 26, 2016  Letter of Intent: -January 26, 2016  Application: -February 26, 2016 -No late applications accepted (no exceptions) -Advise to apply early to make corrections if needed before due date The Collaborative Consortium: Submission

21.  Key Dates:  Scientific Merit Review: -July, 2016  Advisory Council Review: -October, 2016  Earliest Start Date: -December, 2016 The Collaborative Consortium: Submission

22.  All applications to the NIH are evaluated through the NIH peer review system  Criteria are described in the FOA under Application Review Information  NHLBI will ensure that the review panel members have appropriate expertise Collaborative Consortium: Review

23.  Email: FOA Questions: norma.lerner@nih.govnorma.lerner@nih.gov Registration Questions: christina.rinaldi@nih.govchristina.rinaldi@nih.gov  FAQs: https://www.nhlbi.nih.gov/research/funding/faq- sickle-cell-disease-sub-saharan-africa- collaborative-consortium https://www.nhlbi.nih.gov/research/funding/faq- sickle-cell-disease-sub-saharan-africa- collaborative-consortium  Webinar Slides will soon be available on the FAQ page as shown above Resources

24.  Send questions via this WebEx to Christina Rinaldi and we will respond in real time  If we are unable to respond to your question during this session, we will get back to you via email as soon as possible Questions??