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

 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

 Funding Agency  National Heart, Lung and Blood Institute (NHLBI) (  One of the 27 Institutes and Centers of the National Institutes of Health (NIH) The SCD in SSA Program: Overview

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

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

 Worldwide burden of SCD is rising  >75% SCD births occur in sub- Saharan Africa (SSA)  Clinical Care -Health resources are limited in many areas % 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

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 )

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

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

 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

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

 Applicants must  Carefully follow the FOA instructions html  Download the SF424 (R&R) application package 000http://grants.nih.gov/grants/guide/url_redirect.htm?id= 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

 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

 STEP 1: Request an NCAGE (NATO Commercial and Government Entity) Code /CageList.aspx /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; earch.aspx earch.aspx The Collaborative Consortium: Registration

 STEP 2: Get a DUNS Number  Register with Dun & Bradstreet (D&B) to get a Data Universal Numbering System (DUNS) Number The Collaborative Consortium: Registration

 STEP 3: Register with the System for Award Management (SAM) _International_Entity_Registration.pdf _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 from SAM.gov. Allow 5 business days The Collaborative Consortium: Registration

 STEP 4: Complete eRA Commons registration on/registrationInstructions.jsp 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

 STEP 5: Register at Grants.gov  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

 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

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

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

 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

 FOA Questions: Registration Questions:  FAQs: sickle-cell-disease-sub-saharan-africa- collaborative-consortium sickle-cell-disease-sub-saharan-africa- collaborative-consortium  Webinar Slides will soon be available on the FAQ page as shown above Resources

 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 as soon as possible Questions??