Notice Number: NOT-HL-15-273
Key Dates
Release Date: September 25, 2015
RFA-HL-17-007
Issued by
National Heart, Lung, and Blood Institute (NHLBI)]
Purpose
On September 1, 2015, the NHLBI issued Funding Opportunity Announcement (FOA) RFA-HL-17-007 “Sickle Cell Disease in Sub-Saharan Africa: Data Coordinating Center (U24)". This Notice provides supplemental information for applicants regarding eligibility requirements for the Data Coordinating Center Program Director/Principal Investigator (PD/PI) and allowable budget items. The following sections of the FOA are revised accordingly:
Part 2. Section III. 1. Eligible Applications
Eligible Individuals (Program Director/Principal Investigator)
Current Language
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Revised Language
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Data Coordinating Center Program Director/Principal Investigator (PD/PI): It is expected that the PD's/PI's primary academic appointment will be at the applicant institution in Africa. It is also expected that the PD/PI will be present at this institution for at least 9 to 10 months a year while fulfilling the activities associated with this funding announcement.
Part 2. Section IV. 2. Content and Form of Application Submission
R&R Budget
Current Language
All instructions in the SF424 (R&R) Application Guide must be followed. Also follow these additional instructions:
The operational budget including 8% Facilities and Administrative (F&A) costs should include, but not be limited to, the following items:
- PD(s)/PI(s) supervision of day to day operation and oversight of DCC professional activities
- Collaborative Consortium staff training and certification in core operations and procedures
- Conducting visits to each site each year. The DCC should assume two site visits (5 days each, including travel) for each of three to five sub-Saharan sites during the first year of the grant period and one to two site visits in each subsequent year. The applicant should plan to have one DCC participant at each site visit.
- Planning and conducting regular meetings and conference calls for the Consortium Hub and Collaborating Sites, Steering Committee (SC), and Observational Study Monitoring Board (OSMB):
- The budget should specifically include costs for planning, meeting space, equipment, and coordination of the SCD in SSA program meetings that will be held twice a year, usually in Africa. Costs for Steering Committee meetings, held at the same time, should also be included. (Specific information regarding numbers of attendees at these two meetings is covered below under travel costs.)
OSMB meetings will be held exclusively via conference calls and will use web-based systems. The DCC should assume that the OSMB will consist of 5 members, including individuals from African nations and from the United States. Assume three calls annually, each 3 hours in duration, with a $200 per call honorarium for each Board member. - Costs for preparation and distribution of meeting and conference call minutes should also be included in the budget.
- Reimbursement of the Steering Committee (SC) Chair - Consultant budget at 1.8 person months (15% full-time professional effort) should be included as well as travel to two meetings a year (see below under travel costs), and modest administrative expenses
Other costs may be included, such as for:
- Webinars, teleconferences, production of manuals etc.
- Development and maintenance of a secure private website for the distribution of program documents and reports
- Development and maintenance of a public website for communications with outside interests
- Design of data collection forms, database structures, and implementation of systems for data collection, including participant accrual, follow-up rates, and data quality that are available to sites on a 24-hour, 7 day a week basis with appropriate feedback, monitoring, backup, and security
- Development of a Manual of Operating Procedures (MOP) for the SCD in SSA program
- Implementation of methods for timely monitoring and reporting of study events to insure participant safety and confidentiality, including notification and reports to the NHLBI, OSMB, and other appropriate agencies
- Ensuring and monitoring attainment of informed consents from all participants before enrollment
- Overseeing regulatory compliance at the Collaborative Consortium Hub and Collaborating Sites
- Providing DCC resource management, including any needed subcontracts and outsourcing
- Meeting other responsibilities as detailed in the strategy section
Travel Costs (Suggested travel commitments for planning purposes):
- SCD in SSA Program Meetings - The NIH plans to hold two meetings of program participants per year, and applicants should request funds to travel to these meetings in their applications. Meetings will be held in Africa. It is expected that each collaborative site and the DCC will bring two to four people (including those also attending the Steering Committee Meeting) to program meetings. Appropriate travel funds for DCC participants at these meetings must be requested in the application. (Hub and site participants will be supported by separate Collaborative Consortium funds.)
- Steering Committee Meetings - These will be held at the same time as the program meetings. It is expected that the DCC will have two people at the Steering Committee meeting. These individuals will also attend the Initiative meetings. Notably, additional travel funds for the SC chair should be requested in the application. (Consortium Hub and Collaborating Site participants will be supported by separate Collaborative Consortium funds).
Revised Language
All instructions in the SF424 (R&R) Application Guide must be followed. Also follow these additional instructions:
The operational budget including 8% Facilities and Administrative (F&A) costs should include, but not be limited to, the following items:
- PD(s)/PI(s) supervision of day to day operation and oversight of DCC professional activities
- Collaborative Consortium staff training and certification in core operations and procedures
- Conducting visits to each site each year. The DCC should assume two site visits (5 days each, including travel) for each of three to five sub-Saharan sites during the first year of the grant period and one to two site visits in each subsequent year. The applicant should plan to have one DCC participant at each site visit.
- Planning and conducting regular meetings and conference calls for the Consortium Hub and Collaborating Sites, Steering Committee (SC), and Observational Study Monitoring Board (OSMB):
- The budget should specifically include costs for planning, meeting space, equipment, and coordination of the SCD in SSA program meetings that will be held twice a year, usually in Africa. Costs for Steering Committee meetings, held at the same time, should also be included. (Specific information regarding numbers of attendees at these two meetings is covered below under travel costs.)
OSMB meetings will be held exclusively via conference calls and will use web-based systems. The DCC should assume that the OSMB will consist of 5 members, including individuals from African nations and from the United States. Assume three calls annually, each 3 hours in duration, with a $200 per call honorarium for each Board member. - Costs for preparation and distribution of meeting and conference call minutes should also be included in the budget.
- Reimbursement of the Steering Committee (SC) Chair - Consultant budget at 1.8 person months (15% full-time professional effort) should be included as well as travel to two meetings a year (see below under travel costs), and modest administrative expenses
Other costs may be included, such as for:
- Webinars, teleconferences, production of manuals etc.
- Development and maintenance of a secure private website for the distribution of program documents and reports
- Development and maintenance of a public website for communications with outside interests
- Design of data collection forms, database structures, and implementation of systems for data collection, including participant accrual, follow-up rates, and data quality that are available to sites on a 24-hour, 7 day a week basis with appropriate feedback, monitoring, backup, and security
- Development of a Manual of Operating Procedures (MOP) for the SCD in SSA program
- Implementation of methods for timely monitoring and reporting of study events to insure participant safety and confidentiality, including notification and reports to the NHLBI, OSMB, and other appropriate agencies
- Ensuring and monitoring attainment of informed consents from all participants before enrollment
- Overseeing regulatory compliance at the Collaborative Consortium Hub and Collaborating Sites
- Providing DCC resource management, including any needed subcontracts and outsourcing
- Meeting other responsibilities as detailed in the strategy section
Travel Costs (Suggested travel commitments for planning purposes):
- SCD in SSA Program Meetings - The NIH plans to hold two meetings of program participants per year, and applicants should request funds to travel to these meetings in their applications. Meetings will be held in Africa. It is expected that each collaborative site and the DCC will bring two to four people (including those also attending the Steering Committee Meeting) to program meetings. Appropriate travel funds for DCC participants at these meetings must be requested in the application. (Hub and site participants will be supported by separate Collaborative Consortium funds.)
- Steering Committee Meetings - These will be held at the same time as the program meetings. It is expected that the DCC will have two people at the Steering Committee meeting. These individuals will also attend the Initiative meetings. Notably, additional travel funds for the SC chair should be requested in the application. (Consortium Hub and Collaborating Site participants will be supported by separate Collaborative Consortium funds).
Consultants living outside the African continent: This funding opportunity will not provide salary support or funding for transportation to project consultants who reside outside the African continent.
All other aspects of this FOA remain the same.
Inquiries
Please direct all inquiries to:
Norma B. Lerner, MD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-0081
Email: [email protected]
and Human Services (HHS)
