RFA-JG-26-034_Questions and Answers.pdf

Centers for Disease Control and Prevention

Global Health Center

Office of Associate Director for Science

Extramural Research Program Office

RFA-JG-26-034 Enhancing Understanding of and Preparedness for Public Health Threats Through Research in Kenya

SUBMISSIONS FOR EACH PRIORITY AREA

1. Should a full research strategy be submitted for each of the four priorities?

2. Should a separate budget be included for each priority area?

3. Should applicants include one consolidated Data Management Plan covering all priority areas, or separate DMP sections for each priority-area research plan?

4. Should applicants submit separate Human Subjects and Clinical Trials Information entries for each study/protocol under the priority areas, or one consolidated entry if protocols are not yet finalized?

5. Should applicants include a translation and dissemination plan within each research strategy, or provide one consolidated translation plan across all priority areas?

Response: A separate application should be submitted for each priority area. Each application must include an SF-424 R&R with a separate research plan, budget, and strategy to address each priority area. All research plans (applications) submitted by an eligible institution must name the same, single lead Principal Investigator/Principal Director (PI/PD), along with all key staff responsible for programmatic oversight, as stated in the Research plan section on page

32. A consolidated translation plan is allowed and may be included in the Priority 1A application.

6. Should Priority Areas 1A–1D be designed as stand-alone studies, or may they be integrated into existing surveillance platforms such as PBIDS, KEMRI laboratories, or clinical research centers described in the NOFO?

Response: As stated in Collaborations section (page 18), you are required to collaborate with other recipients of CDC assistance on activities that are complementary to this NOFO, such as those supporting surveillance and laboratory platforms.

RESEARCH INFRASTRUCTURE COORDINATION AND ADMINISTRATION.

1. Should we integrate our approaches to Program Area 2 under the 4 priority areas of

Program Area 1 (page 16), i.e., throughout the actual research strategies, or address as a separate section?

2. The responsiveness criteria state that applicants must submit a separate research plan for each priority area, does that include a separate plan for “Research coordination and administration”? If so, should that follow the full PHS 398 Research Plan structure, or should it be addressed only in the required Overall Management Plan?

Response: Research coordination and administration should be a separate section included in the Overall Management Plan, which should be submitted along with the application for Priority are 1 A.

3. The NOFO lists Year 1 budget amounts for the four priority 1 areas only, with no Year 1 budget allocation “Research coordination and administration.” Should applicants budget research coordination separately, or should those costs be embedded within the budgets for Priority Areas 1A–1D?

Response: Costs for Research coordination and administration should be embedded within the budgets for priority area 1A-1D.

BUDGET

1. The NOFO states that expected funding per applicant per budget period is $3M–$6M, however, the listed Year 1 priority-area amounts appear to total approximately $2.575M– $3.6M. Should applicants request within the sum of the listed priority-area allocations, or may applicants request up to $6M in Year 1 to include costs for support to KEMRI research coordination?

Response: As noted on the Research plan section (pages 31-32) - “Note that you must also include a separate budget narrative that does not exceed the provided funding levels for each priority area.”

2. Is the overall amount is $30 million total costs, not direct?

Response: Yes, the total maximum amount for the 5-year project period, including direct and indirect costs, is $30 million.

3. Should applicants include subaward budgets for KEMRI, KEMRI affiliates, or collaborating institutions, or is CDC expecting a different financial relationship or mechanism for work conducted “through KEMRI”?

Response: Applicants may include budgets for KEMRI and other collaborating institutions.

As noted in the Research plan section on page32, applications from consortia are allowed, and the lead applicant is responsible for managing all subrecipient arrangements.

Consortium and contractual arrangements are required if you include any consortiums or contracts in your budget.

KEMRI COLLABORATIONS

1. The NOFO states that the award aims to support KEMRI while Kenya consolidates its public health functions under the Kenya National Public Health Institute. What does “consolidates its public health functions under KNPHI” mean operationally for this award?

2. Should applicants include KNPHI as a formal partner or subrecipient, or should the proposal focus only on KEMRI and Kenya MoH?

3. Are applicants expected to support transition planning related to KNPHI consolidation?

Response: Collaboration with Kenya Ministry of Health (MoH) and the Kenya Medical

Research Institute (KEMRI) is required (See Collaborations section, page 18). Applicants are not expected to support KNHPI.

4. The NOFO requires evidence of prior or current research activities conducted in partnership with KEMRI or MoH. What types of documentation are acceptable: letters of support, MOUs, prior award documentation, publications, subaward agreements, project reports, or institutional collaboration records?

5. Should letters of support from KEMRI and MoH be included as required letters of support?

Response: The NOFO does not specify the evidence. As stated on page 35: To be responsive to this notice of funding opportunity, you must submit an attachment titled “Responsiveness

Criteria.” Include the following:

1. Evidence of an existing institutional presence (such as an office and staff) in Kenya.

2. Evidence of prior or current research activities conducted in partnership with KEMRI or

MoH.

OTHER QUESTIONS

1. Are applicants expected to propose implementation of science and public health evaluation activities in addition to traditional research, or can the application focus primarily on research studies if all required priority areas are addressed?

Response: Please refer to the Approach (Objectives and outcomes section) starting on page 15 for required objectives that must be addressed for each priority area.

2. Is there any other administrative oversight document that we should include? There is mention of a “consortium agreement” - what does that entail?

Response: Please refer to the “Application contents and format” section for all required documents. See the Research plan section (page 32), if your application is submitted by a consortium. You must provide details on the consortium agreement, including the management structure. The lead entity of the consortium has overall responsibility for the management plan.