FAQ for CK22-2203.pdf

Q&A NOFO

https://www.cdc.gov/amd/whats-new/PGCOE-NOFO-QA.html

Question Answer

Section 1: Overview 1-1) Would it be possible to arrange a Zoom call with you to discuss more about our proposed application?

We are not able to discuss proposal ideas with individual applicants. We can respond to questions submitted by email and also will be holding an informational call on March 31 at 2 pm ET. Phone number 1-866-620-0420; Passcode: 8943360.

Questions and answers from this call will be posted on this page.

1-2) Does CDC intend to release a companion solicitation for a Data Management and Coordination Center that would support the activities of the PGCoE network, or will data management, coordination, and scientific communication activities be carried out by network members and/or CDC? The PGCoE NOFO describes many data management, network coordination, and scientific communication activities as key to the success of the network, but it’s not clear who and how those will be supported.

CDC does not intend to release a companion solicitation for data management, coordination, and scientific communication activities. These activities will be supported through this NOFO and should be described within applications that are submitted.

1-3) Are applications required to focus on any specific pathogens? Are there any specific pathogens that would not be within the scope of this NOFO?

This NOFO is not limited to any particular pathogens of public health concern.

Work of the network is intended to meet the needs of public health and to align with the strategic direction of CDC programs, and to incorporate new technologies and approaches from the rapidly evolving field of genomics. Therefore, the network and individual PGCoEs are expected to be agile and flexible in identifying, implementing, and amending specific activities, to the extent consistent with the terms of this cooperative agreement. Annually, by way of the PGCoE cooperative agreement continuation planning and process, projects will be evaluated and amended as necessary in light of public health priorities, advancement in the field and emerging issues and infectious threats.

1-4) I was unable to attend the informational call. Is it possible for me to view a recording of that call?

Questions and Answers from the informational call will be on this page.

https://www.cdc.gov/amd/whats-new/PGCOE-NOFO-QA.html#Section-1:-Overview

1-5) Could you please explain the funding strategy for year one and years two through five?

Year one is largely focused on a number of landscape analyses and individual site projects. Projects in years two through five would include projects that span multiple PGCoEs or are network-wide.

Please see page 22 of the NOFO for more details.

1-6) How do you envision this working with state public health laboratories or state health departments that have active Bioinformatics Regional Resource (BRR) programs for advanced molecular detection or other Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC)-funded programs that are focused on genome sequencing capabilities and workforce development?

There are a number of different initiatives that span multiple efforts around genomics and workforce development. This is an opportunity to build upon ongoing and synergistic activities;

however, this funding opportunity should be considered to be self-standing.

1-7) How many PGCoEs will be funded? It is anticipated that six PGCoEs will be funded.

1-8) On page 48 of the NOFO, it states that the recipient may not use funds for research. Please clarify.

This NOFO allows both research and non-research activities. This is clarified elsewhere in other sections of the NOFO and supersedes the information on page 48.

1-9) Could you confirm if the subject NOFO is intended to result only in a Cooperative Agreement, or if a cost-plus-fixed-fee (CPFF) contract would be acceptable for this effort?

Yes, the mechanism selected is a Cooperative Agreement, this cannot be applied

1-10) Section C (Announcement Type) and section 14 (Funding Restrictions) of the NOFO states that this announcement is only for non-research activities supported by CD. However, in each of these sections, the following paragraph is included: "Please note for this particular NOFO, CDC-RFA-CK22-2204, research activities are allowable and will be subject to all applicable laws, regulations and policy requirements. Note research and human subjects protection requirements inserted throughout this NOFO. All instructions pertaining to research should be addressed and followed as indicated in this NOFO." Will you confirm that research activities are allowable for CDC-RFA- CK22-2204 (US Public Health Pathogens Genomics Centers of Excellence) and that applications proposing research will be considered?

Yes, research activities are allowable for this NOFO. CDC-RFA-CK22-2204 (US Public Health Pathogens Genomics Centers of Excellence) and applications proposing research will be considered. As detailed in H. Other Information the application should describe research and non-research activities for the Mandatory Component (Core) Translation and Response Base strategies and for the Mandatory Component (Response Implementation).

1-11) The NOFO indicates that the Mandatory Component (Response Implementation) would be funded only in the event of a new infectious disease threat. So, does that mean the amount of guaranteed funding is $4 million per year for the 6 network members for the Mandatory Component (Core)?

Funding levels are not guaranteed for any portion of this NOFO. Funding for all components is based on merit review, programmatic priorities, and funding availability.

1-12) Is there a cap on the indirect cost rate that academic centers are able to claim if serving as a subcontractor on this grant?

The academic institution may use its existing indirect cost rate agreement already in place, provided it has not expired. New indirect cost rate agreements may also be negotiated, and the rate will be determined through that negotiation.

1-13) For the letter of intent, should the listed PIs solely be from the primary applicant (health department/lab) or should PIs also be listed for the academic partners?

Although a letter of intent (LOI) is not required, it is helpful for CDC staff to have the information contained within it for the purpose of planning the peer review. The name, address, and telephone number of the PI and any Co-PIs from the applicant health department or public health laboratory should be included in the LOI. The names of all other key personnel, including any Co-PIs from academic or other institutions, should also be included in the LOI.

Section 2: Eligibility

2-1) Regarding eligibility, can this go through a Public Health Department, or does this need to come through the Governor’s office? Can activities involve multiple state public health departments? Can the academic partner subcontract and coordinate all activities of the network?

Eligibility criteria can be found on page 35. U.S. state, local, Tribal, or territorial public health departments or public health laboratories are eligible to be prime recipients. Applications should be submitted by the intended prime recipient. For each site the cooperative agreement will be with one prime recipient, which needs to be a health department. A single CoE may include more than one health department, but a single health department will be the prime recipient. Our intent is that each CoE be a true partnership between the public health agency and its academic partners.

The intent is not that the public health agency act solely as a subaward manager.

2-2) Would a foreign entity such as a research institute or a ministry of health in a country other than the U.S. be eligible for this grant?

This NOFO has been published as a domestic opportunity, therefore foreign entities are not eligible to apply. However, we encourage you to continue accessing grants.gov for opportunities that address global needs.

2-3) Is there a restriction on the number of public health agencies that can be partners in a single application, given the requirement that only one is the prime contractor?

A single CoE may include more than one health department, but a single health department will be the prime recipient.

2-4) Are we able to apply for this cooperative agreement as a state university?

Eligibility criteria can be found on page 35.

U.S. state, local, Tribal, or territorial public health departments or public health laboratories are eligible to be prime recipients.

2-5) Please clarify whether industry is allowed to be involved as a collaborator.

The PGCoE is specifically meant to be a partnership between a health department and academia.

There may be opportunities to involve industry as well, but the primary structure of the PGCoE is a partnership between a health department and an academic institution.

2-6) We are writing to clarify whether a Federally Funded Research and Development Center (FFRDC) would be regarded as a partner academic institution in the context of this FOA or could be regarded as a public health laboratory. In addition, we would like to confirm that a public health department MUST be a Prime on this proposal, regardless of the composition of the overall team.

Eligibility criteria can be found on page 35.

U.S. state, local, Tribal, or territorial public health departments or public health laboratories are eligible to be prime recipients. If an FRFCC is a research organization with expertise in areas relevant to the cooperative agreement, they would be eligible to be an academic partner. FFRDCs operate under specific rules regarding the types of Federal funding they can accept and would need to consult with their own legal counsel regarding serving as an academic partner for this cooperative agreement.

2-7) Can for-profit businesses serve as subcontractors to public health department or public health laboratory Prime recipients, or to academic subcontractors? The solicitation notes that one of the goals of the PGCoE network is to expand partnerships across public health, academia, the private sector that can be rapidly engaged for infectious threats, but does not clearly state whether business subcontractors are allowed.

Applicants may propose inclusion of entities in addition to the prime recipient and primary academic partner(s). Such proposals will be reviewed and considered; however, it is expected that inclusion of additional entities will not dilute the primary partnership between a public health department or public health laboratory and the primary academic partner(s).

2-8) If a public health laboratory does not have at least one year of sequencing experience, is the respective public health department eligible for this NOFO?

As described on page 28, the applicant (specifically the health department) should have at least one year of sequencing experience. At least one year of sequencing experience by the public health laboratory is expected for applicants.

2-9) To be eligible, an applicant must have a partner in the private sector - can you please elaborate on that?

Eligibility requires the prime recipient to be a health department or public health laboratory that must partner with an academic partner or partners.

2-10) If the prime recipient is a public health agency subcontracting to an academic institution, can that academic institution then subcontract in turn to another institution?

The intent of the NOFO is to have the health department as the prime recipient partnering with an academic partner or partners. Multiple levels of subcontracts are not encouraged to avoid creating a passthrough entity, which is not allowed.

2-11) It sounds like all work should originate from a public health department or public health laboratory. Is there a level below which the laboratory or partner is not viable for this award?

The capacity of the laboratory or partner to complete the work will be evaluated as part of the application review process. It is not the size of the laboratory or partner per se that will be evaluated but rather having the important capabilities needed that are detailed in the NOFO.

Please see page 28 for specific expectations of laboratory capacity for the prime recipient:

"Sequencing using next generation sequencing methods. Applicants (specifically, the public health department) should have at least one year of sequencing experience."

2-12) Would a state public health laboratory be eligible to be the prime recipient, if they are not embedded within a state health department?

U.S. state, local, Tribal, or territorial public health departments or public health laboratories are eligible to be prime recipients. It is not a requirement that public health laboratories be embedded within health department.

2-13) Is the multiple PI (MPI) model allowable for this opportunity? If yes, may a PI at a 501 (c) (3) nonprofit research institute serve as one of the MPI?

Each Center of Excellence will have a principal investigator from the public health department or public health laboratory (prime recipient) and the partner organization(s).

2-14) Is an institute allowed to partner up with different public health institutes? So, for example, would it be possible for: i) one to partner up with institute A and B to address a similar project/pathogen (e.g., viral and fungal); ii) or can one partner up with institute A with project 1 (e.g., viral and fungal) and with institute B with project 2 (e.g., bacterial); iii) or one can only partner up with institute A or only with institute B.

The Centers of Excellence program was originally conceived of and budgeted to support a single health department paired with a single academic research center at each funded site. However, in recognition that there may be advantages in some cases for there to be more than two entities at certain sites, the funding opportunity allows applicants to propose including more than one academic or more than one public health organization. Such proposals will be reviewed and considered. However, any such arrangement should be organized in such a way that within the proposed site, both the public health and academic partners can contribute meaningfully to the partnership. The objective of the program is not to establish a network of sub-networks, with each of those sub-networks doing research disconnected from that being carried out by the others;

rather the objective is to establish a network of a small number of sites, each an active partnership, with each site working collaboratively with other sites in the network to improve public health and public health practice.

2-15) Is this NOFO open to all universities or is it published to allow pre-selected groups to apply? Is this NOFO an open competition?

Eligibility criteria can be found on page 35. U.S. state, local, Tribal, or territorial public health departments or public health laboratories are eligible to be prime recipients. The primary partner(s) for the public health department or public health laboratory at each Pathogen Genomics Center of Excellence will be an academic institution(s). This NOFO does not restrict academic partners to specific universities or other specific institutions. Applications should be submitted by the intended prime recipient. Applications should include input from both the public health agency and their intended academic partner(s).

2-16) Can an academic institution be the prime recipient for the Optional Component (Lead PGCoE for Education)?

Eligibility criteria can be found on page 35. U.S. state, local, Tribal, or territorial public health departments or public health laboratories are eligible to be prime recipients for both Mandatory and Optional Components of this NOFO. Recipients are expected to collaborate with one or more academic centers with strong programs in pathogen genomics or genomic epidemiology for all components (Mandatory and Optional).

2-17) Can the academic partner manage sub-contracts to other institutions and coordinate research activities in partnership with the health department (prime recipient)?

Our intent is for the health department or laboratory (prime recipient) and each academic partner, if there is more than one, to form a true partnership. In recognition that there may be advantages in some cases for there to be more than two partners at certain sites, the funding opportunity allows applicants to propose including more than one academic or more than one public health organization. Such proposals will be reviewed and considered. However, any such arrangement should be organized in such a way that within the proposed site, both the public health and academic partners can contribute meaningfully to the partnership.

2-18) May a governmental applicant with multiple academic partners include a subaward to a 501 (c) (3) nonprofit research institute?

501 (c) (3) organizations whose primary mission is research may serve as partners to the prime recipient (public health department or public health laboratory).

2-19) Are there any requirements for the governmental applicant to hold the majority of the funds (i.e., is it allowable for the subs to receive the majority of the award)?

The governmental applicant is not required to hold the majority of the funds. Please note that the health department cannot play merely as a "pass-through" entity in the partnership. The intent is that the health department plays a substantial and meaningful role in the partnership.

2-20) Are industry laboratories eligible for this NOFO?

The primary partner(s) for the public health department or public health laboratory at each Pathogen Genomics Center of Excellence will be an academic institution(s). Industry laboratories are not able to serve as the primary partner to a public health department or public health laboratory.

2-21) Is it possible to have foreign collaborators or partners as part of this application?

Can we include foreign partners if they do not receive funding?

Can we indicate foreign partners as recipients of fee-for-service funds?

This NOFO has been published as a domestic opportunity; therefore, foreign entities are not eligible to be prime recipients or primary academic partners.

Applicants may propose inclusion of entities in addition to the prime recipient and primary academic partner(s). Proposals may include foreign entities. Such proposals will be reviewed and considered; however, it is expected that inclusion of additional entities will not dilute the primary partnership between a public health department or public health laboratory and the primary academic partner(s).

2-22) Will the award allow for subs to subs or must all subs flow from the lead (submitting) institution? For example, if a state health department submits/leads the proposal and a university is a sub-recipient, would an additional entity need to be a sub from the lead or is it allowed for it to be a sub-recipient from the university?

Our intent is for the health department or laboratory (prime recipient) and each academic partner, if there is more than one, to form a true partnership. In recognition that there may be advantages in some cases for there to be more than two partners at certain sites, the funding opportunity allows applicants to propose including more than one academic or more than one public health organization. Such proposals will be reviewed and considered. However, any such arrangement should be organized in such a way that within the proposed site, both the public health and academic partners can contribute meaningfully to the partnership.

2-23) Can one applicant have more than one partner?

The applicant must be a US state, local, Tribal, or territorial public health department or public health laboratory and must partner with at least one academic institution. There is no limit to the number of partners the recipient may have provided each partner has a meaningful and productive role.

The Centers of Excellence program was originally conceived of and budgeted to support a single health department paired with a single academic research center at each funded site. However, in recognition that there may be advantages in some cases for there to be more than two entities at certain sites, the funding opportunity allows applicants to propose including more than one academic or more than one public health organization. Such proposals will be reviewed and considered. However, any such arrangement should be organized in such a way that within the proposed site, both the public health and academic partners can contribute meaningfully to the partnership. The objective of the program is not to establish a network of sub-networks, with each of those sub-networks doing research disconnected from that being carried out by the others;

rather the objective is to establish a network of a small number of sites, each an active partnership, with each site working collaboratively with other sites in the network to improve public health and public health practice.

2-24) Can one organization collaborate with more than one State DoPH?

The PGCoEs are expected to operate collaboratively as a network. One organization may collaborate with more than one state health department; however, the collaborating organization must not duplicate percent effort or budget with two or more recipients. Should applications from the multiple state health departments be selected for award, the collaborating organization's involvement in multiple awards will be assessed for possible overlap.

2-25) If a health department is not set up for developing/administering contracts with external entities (such as the academic partners in this case), can it apply through a fiscal agent - e.g., another non-profit that applies on behalf of the health department and receives/distributes the funding, and the health department would still be the lead on the grant and take final responsibility for the SOW and deliverables?

The applicant must be a US state, local, Tribal, or territorial public health department or public health laboratory which has at least one academic partner. It is the applicant’s responsibility to establish collaborations with at least one academic partner and to administer the funds received post-award. The health department may be able to use a fiscal agent to help the health department administer the funds after award on a case-by-case basis. The health department must include this intent in the application.

2-26) How many Co-PIs are allowed, and are there any requirements related to the institutions? (e.g., all PIs must be from the health department, or may there be one PI from health department, one from an academic institution, etc.)

The only eligible applicants are US state, local, Tribal, or territorial public health departments or public health laboratories; multiple Co-PIs are allowed and there must be one PI from the applicant institution serving as the point of contact for all award-related actions and one from the primary academic partner at a minimum. Co-PIs may be situated at the applicant institution or at any of the collaborating institutions.

Section 3: Application

3-1) A process evaluation metric for Strategy 2) Education is “performance of an evaluation to determine gaps and educational needs for the public health workforce.” A gap or landscape analysis is not identified as a deliverable for Strategy 2 on pg. 15 but does appear for the optional educational response. Should responses to the core educational section include a proposal for a gap analysis of the educational needs of the public health workforce?

For the Mandatory Component (Core) Education strategy, activities expected for this strategy are described on page 15 and those expected for the Optional Component (Lead PGCoE for education) are described on page 18. A landscape analysis is not required for the Mandatory (Core) education strategy. Applicants are not required to use the performance measures listed on page 23. The Performance Measures listed for "Educate Public Health Workforce" may be used as applicable to a particular application's Mandatory Component (Core) Education strategy or, if included in the application, Optional Component (Lead PGCoE for Education).

3-2) May we use NIH biographical sketches as the format for this (resumes/CVs)? Do resumes/CVs count towards the page limit?

There is no required format for resumes or CVs. Resumes and CVs do not count against the page limit.

3-3) Should the Project Narratives for all mandatory components be submitted as one single PDF file? Or one PDF file per component?

The narratives for the Mandatory Components (Core, Response Implementation) should be submitted as a single file as detailed on page 72.

3-4) Do references/bibliographies count in the total page count? Additionally, a bibliography is only listed as a required section in the Project Narrative for Mandatory Component (Core) strategy Translation (one per broad area, given current structure discussed in question 1 above). Does that mean references are not needed for all other components?

References are only required for the Project Narrative for the Mandatory Component (Core) strategy Translation. References do count toward the total page count of the narrative.

3-5) Is there a specific format required for the work plans to be included in the project narratives for each mandatory component?

A separate work plan must be provided for each of the Components. For each component, the applicant must provide detailed work plans for the first year and a high-level work plan for subsequent years. For the Mandatory Component (Core) the work plan must be divided by strategy. The Mandatory Component (Core) has three strategies: Translation, Education, and Response Base. For the Mandatory Component (Core) strategies Translation and Response Base and for the Mandatory Component (Response Implementation), there should be a separate work plan for each of the 5 broad areas as described on pages 69-70. Activities proposed under the respective work plans must align with the approach (logic model, strategies, outcomes, and evaluation/performance measures) outlined throughout the NOFO. A sample table format for a work plan is shown on page 30. No specific work plan format is required, as long as it is clear how the components in the work plan crosswalk to the strategies and activities, outcomes, and evaluation and performance measures presented in the logic model and the narrative sections of the NOFO. This will ensure that the applicant sees the work plan as proceeding from what was presented earlier and not as a separate, standalone document.

3-6) What is the correct structure of the Project Narrative for the Translation strategy of the Mandatory Component (Core)?

Should it include 5 separate IRB plans, one within each broad area section? This same question applies to the Project Narrative for the Mandatory Component (Core) strategy Response Base and Mandatory Component (Response Implementation), which also require multiple separate sections for each broad area.

Full Question:

For the Mandatory Component (Core) strategy Translation, for example, pages 69-70 of the NOFO specify a list of sections that should be included for each of the 5 broad areas. Therefore, our understanding is that the headings for this component narrative should look like this:

• Broad Area 1 (wet lab methods)

• Background

• Activities (with 11 required subheadings)

• Resource Sharing Plan

• Evaluation and Performance Measurement Plan

• Organizational Capacity

• Work Plan

• Bibliography

• Broad Area 2 (bioinformatics)

• Background

• Activities (with 11 required subheadings)

• Broad Area 3 (data standardization, etc.)

• Background

• Activities (with 11 required subheadings)

• etc.

Under this structure, we would submit 5 different work plans within the Project Narrative for the Translation strategy of the Mandatory Component (Core). Similarly, the NOFO states that the “Approach” subsection (listed under the “Activities” section) should contain the IRB plan. Does that mean we should include 5 separate IRB plans, one within each broad area section? What is the correct structure of this Project Narrative? This same question applies to the Project Narrative for the Mandatory Component (Core) strategy Response Base and Mandatory Component (Response Implementation), which also require multiple separate sections for each broad area (background, approach, evaluation plan, organizational capacity, work plan; pages 70 and 71).

Answer:

The Narrative for the Mandatory Component (Core) strategy Translation should be organized according to the 5 broad areas listed on page 69. For each of these 5 broad areas, the narratives should be organized by sections in the list of 7 bullets and 11 sub-bullets that begins with "Background" and ends with " Bibliography and References." This means that a separate IRB plan should be provided for each of the 5 broad areas of the Mandatory (Core) Translation strategy. A separate work plan must be provided for each of the Components. For the Mandatory Component (Core) the work plan must be divided by strategy. For the Mandatory Component (Core) strategy Translation, there should be a separate work plan for each of the 5 broad areas as described on pages 69-70. For the Mandatory (Core) strategy Response Base and Mandatory Component (Response Implementation) the narratives should be organized into the 5 broad areas described on page 70 and within each of those 5 broad areas the narrative should include the 5 sections:

Background, Approach, Application Evaluation and Performance Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. For the Mandatory (Core) strategy Education and for the Optional Component (Lead PGCOE for Education) the narrative should be organized into the 5 sections: Background, Approach, Application Evaluation and Performance Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan.

3-7) Please clarify the structure of the Project Narrative for the Mandatory Component (Core) Translation strategy. On pages 69-70, five broad areas are listed and each of the five areas has seven sections (Background, Activities, Resource Sharing Plan, etc.). Is this correct?

This is correct.

For the Mandatory Component (Core) Translation strategy, each of the five broad areas listed should have a detailed description of the seven sections listed on pages 69-70. The seven sections are 1) Background, 2) Activities (note, this section has 11 sub-sections), 3) Resource Sharing Plan (including Data Management Plan), 4) Evaluation and Performance Measurement Plan, 5) Organizational Capacity of Applicant to Implement the Approach (Including Investigator qualifications and institutional Environment to successfully complete objectives), 6) Work Plan, 7) Bibliography and References Cited

3-8) Do you want a Work Plan for each of the five broad areas listed or just one per Component?

Separate work plans must be provided for each of the Components. For the Mandatory Component (Core) the work plan must be divided by strategy. For the Mandatory Component (Core) strategies Translation and Response Base and for the Mandatory Component (Response Implementation), there should be a separate work plan for each of the 5 broad areas as described on pages 69-70.

3-9) Should the budget include only direct costs, or should it also include indirect costs?

The budget submitted should include both direct and indirect costs. No additional indirect costs will be added to the budget once submitted.

3-10) What is the page limit? Is it not over 100 for the narratives + budgets + work plans?

There is not a page limit for budgets. Please see page 72 of the NOFO for instructions on page limits for the narratives (which include work plans): Disregard page limits stated under Section D.10 for "Program Narrative," (but do follow other page and type format instructions). Maximum number of pages for the Mandatory Components (Core, Response Implementation) Project Narrative file is 75 (excluding budget, budget narrative, appendices, and required forms).

Maximum number of pages for the Optional Component (Lead PGCoE for Education) is 25 (excluding budget, budget narrative, appendices, and required forms). If Project Narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

3-11) What is the page limit for attachments? There is no page limit for attachments.

3-12) Is there a limit on the number of academic partners and letters of support that can be submitted as part of this application? Should these be submitted as a single PDF file entitled “Academic Letter of Support” as listed in the NOFO, or should we submit a separate PDF for each letter of support?

Additionally, can we submit letters of support from non-academic partners, such as non-prime public health institutes or industry partners? Can we also submit letters of support from other center applicants (to show existing collaboration) and should these be included in the single PDF?

All letters of support from academic partners should be submitted as a single PDF file entitled “Academic Letter of Support.” Additional letters of support may be provided as attachments.

The Centers of Excellence program was originally conceived of and budgeted to support a single health department paired with a single academic research center at each funded site. However, in recognition that there may be advantages in some cases for there to be more than two entities at certain sites, the funding opportunity allows applicants to propose including more than one academic or more than one public health organization. Such proposals will be reviewed and considered. However, any such arrangement should be organized in such a way that within the proposed site, both the public health and academic partners can contribute meaningfully to the partnership. The objective of the program is not to establish a network of sub-networks, with each of those sub-networks doing research disconnected from that being carried out by the others;

rather the objective is to establish a network of a small number of sites, each an active partnership, with each site working collaboratively with other sites in the network to improve public health and public health practice.

3-13) To whom should the required Academic Letter of Support be addressed, the applicant agency or CDC?

The Academic Letter of Support should be addressed to the applicant.

3-14) What is the page limit for applications? If I’m reading correctly, base gives us 15 pages and then 4 additional pages per component. How many components are considered to be in this grant? Is it three- two mandatory (core and response) and one optional? Or is each strategy considered to be a separate component (making four mandatory components and one optional?)

Please see page 72 of the NOFO for instructions on page limits for the narratives (which include work plans): “Disregard page limits stated under Section D.10 on page 43 for "Program Narrative," (but do follow other page and type format instructions).”

The maximum number of pages for the Project Narrative file (which includes workplans) for the two Mandatory Components (Core, Response Implementation) combined is 75 (excluding budget, budget narrative, appendices, and required forms). Maximum number of pages for the Optional Component (Lead PGCoE for Education) is 25 (excluding budget, budget narrative, appendices, and required forms).

If an applicant chooses to apply only for the Mandatory Components (Core, Response Implementation) the total page limit for the application Narrative (which includes work plans) is 75 pages. If an applicant chooses to apply for both the Mandatory Components (Core, Response

Implementation) and Optional (Lead PGCoE for Education) Component the total page limit for the application Narratives (which includes work plans) is 100 pages. There are no page limits for other sections of the application.

3-15) How can I create a workspace in order to draft this application?

This is a question that should be directed to the grants.gov helpdesk, as this is more of a systems and access question and does not relate directly to the content of the Notice of Funding Opportunity. A link to the support desk is below:

“d. Technical Difficulties: If technical difficulties are encountered at www.grants.gov, applicants should contact Customer Service atwww.grants.gov. The www.grants.gov Contact Center is available 24 hours a day, 7 days a week, except federal holidays. The Contact Center is available by phone at 1-800-518-4726 or by e-mail at support@grants.gov. Application submissions sent by e-mail or fax, or on CDs or thumb drives will not be accepted. Please note that www.grants.gov is managed by HHS.”

3-16) On page 46 it states, “The applicant must provide a detailed budget for the first year and high-level budgets for subsequent years.” I understand that a detailed budget is needed for the first year, but I’m unclear as to what is needed for the subsequent years. Could you please clarify?

Estimated funding levels for subsequent years should be indicated on application form SF242a in sections 16b, c, d, and e.

3-17) From Pgs 43-45, there is an alternative outline to the project narrative that the one outlined in pgs 69-71. Does that mean the application requires an overall project narrative in addition to the narrative for each component as described in section H? Or are the only elements needed for the project narrative the ones outlined in section H, pgs 69-71?

The only elements needed for the project narrative are the ones outlined in Section H, pages 69- 71, of the NOFO.

3-18) Pages 12-16 discuss what elements must be included in the Mandatory Component (Core) Translation strategy (e.g., how we will develop networked approaches, do a landscape analysis, implement a platform to pilot new technologies, and assist with implementing the technologies broadly). Section H asks applicants to describe one research and one non-research initial project for each of the 5 broad areas. So, in addition to proposing detailed projects, are we expected to discuss within

For the Mandatory Component (Core) Translation strategy there is not a requirement to do one research and one non-research activity for each of the 5 broad topic areas; but within each of the 5 broad topic areas proposed activities should include both research and non-research activities.

Detailed instructions for the Narrative section are in Section H. Other Information of the NOFO.

The activities proposed under each of the 5 topic areas should address areas of activity specified in the logic model and detailed on pages 12-16. Activities should include contribution toward a landscape analysis in each of the 5 broad topic areas.

each of the sub-narratives (i.e., the 7 bullets and 11 sub-bullets) for the broad areas how we will develop networked approaches, do a landscape analysis, implement a platform to pilot new technologies, and assist with implementing the technologies broadly?

3-19) The NOFO says "Applicants should propose an initial research and non-research project or projects that include all 5 of these broad topic areas." Does it mean an applicant is required to have a minimum of 1 research project, and a minimum of 1 non-research project, both of which address the 5 broad topic areas?

The Mandatory Component (Core) Translation strategy, the Mandatory Component (Core) Response Base strategy, and the Mandatory Component (Response Implementation) should include a research project or projects and should also include non-research projects. Projects should address the 5 broad topic areas.

The Mandatory Component (Core) Education strategy and the Optional Component (Lead PGCoE Education) may not include a research project or projects.

3-20) Do we have to complete the Lobbying Form if there is nothing to disclose?

Yes. If there is nothing to disclose the form should be completed and signed to verify that there is nothing to disclose.

3-21) I am confused about the structure of the narrative we submit. Should it be structured as indicated in the yellow boxes beginning on path 52 of the FoA? Or, should we carefully adhere to each bullet point listed for the Project Narrative, beginning on page 69? These two outlines are very different, making it hard to identify which way to structure the text. We want to make sure we address all the specific bullet points appropriately.

The format for the narratives should follow the instructions in H. Other Information starting on page 69. The yellow boxes in section E. Review and Selection Process, beginning on page 51, detail review criteria that will be used to evaluate applications during Phase II review. It is best to address the elements listed as Review Criteria, as well as those for Additional Review Criteria (i.e., Human Subjects and Vertebrate Animals; Inclusion of Women, Minorities, and Across the Lifespan;

Biohazards/Dual Use Research of Concern), found on pages 52-57 when completing the Activities sections of the same name in H. Other Information (as applicable) for each of the 5 broad areas of the Mandatory Component (Core) because these criteria could influence the score the application receives.

Section 4: Response Implementation

4-1) Regarding the response implementation section, are we intended to propose activities we would aim to take on if CDC initiated an emergency response? We are wondering if response implementation is targeted to implementing, validating, or applying the methods developed in the translation section to standard public health response activities, but it seems like that is not the expectation and rather this section would just be activated in an emergency, so the response here should be pathogen agnostic. It would also

The Mandatory Component (Response Implementation) will only be funded and implemented when and if there is a need to respond to an infectious threat. As described on page 16, applications should describe the types of experiments, research studies, and non-research activities that could be done in the event of an infectious threat. Applications should include working with other network sites to analyze and synthesize pathogen genomic and other diverse data and preparing informational reports. Applications should also describe implementation activities in the five broad areas listed.

imply that this section would not necessarily be funded. Are we interpreting that correctly?

4-2) How much of the Response Implementation Component should be directed toward SARS-CoV-2 versus other emerging and seasonal pandemic and epidemic diseases?

This NOFO is to establish a platform for pathogen genomics and innovation in the US. Response implementation should involve collaboration with CDC and CDC programs and is meant to be a broad and flexible platform that can be adapted for use with a specific pathogen or pathogens.

4-3) What are the conditions upon which the Response Implementation funding will be released?

Response implementation funding will be activated when there is an infectious disease threat present.

4-4) Should we think of Response Implementation as funding to start implementing a response with targeted interventions or programs within a public health department or to build capacity to be ready for when an initiating event occurs?

There are two parts to the answer:

1) Within the Mandatory Component (Core), there are funds to build a Response Base to prepare for an infectious disease threat. For example, this could include establishing data use agreements, protocols, operating procedures, and planning for a response to an infectious disease threat.

2) There is a separate Mandatory Component (Response Implementation) that would be activated if there is an actual infectious disease threat. The Response Implementation Component would be activated according to whatever disease threat is present at the time. In the NOFO, "Section H.

Other Information" details some of the elements that should be included in the application's Project Narrative. This includes activities that could be stood up in a flexible way depending on what the actual infectious disease threat is, includes the five broad areas of work listed in this section of the NOFO, and includes activities that might be needed such as genomic sequencing, bioinformatics, rapidly analyzing diverse data and synthesizing information, etc.

Section 4: Response Implementation

5-1) In terms of indirect costs for the subcontract that the health department would have with the academic institution, can the academic institution use the existing indirect cost rate it already has in use, or would the academic institution need to negotiate a new indirect cost rate agreement?

The academic institution can use the existing indirect cost rate it now uses as long as the indirect cost rate agreement has not expired.

5-2) Is there any guidance for what academic partners and the depth of knowledge/information that should be included in the letter of support from academic and other entities for the application?

An "Academic Letter of Support" from the partnering academic organization(s) should articulate the nature of the partnership and the partner’s commitment to participate in the proposed activities.

5-3) Can you provide us the definition of an academic partner?

Would a large health system that is a teaching institution qualify or does the grant require a more traditional academic institution for partnership?

A health system that is a teaching institution would be considered an academic institution. The academic partner for a CoE is expected to be an entity with expertise in microbial genomics and genomic epidemiology.

5-4) As stated in the RFA, the health department must partner with at least one academic institution but may partner with more than one. Does CDC recommend limiting the number of academic partnerships to a certain number?

The Centers of Excellence program was originally conceived of and budgeted to support a single health department paired with a single academic research center at each funded site. However, in recognition that there may be advantages in some cases for there to be more than two entities at certain sites, the funding opportunity allows applicants to propose including more than one academic or more than one public health organization. Such proposals will be reviewed and considered. However, any such arrangement should be organized in such a way that within the proposed site, both the public health and academic partners can contribute meaningfully to the partnership. The objective of the program is not to establish a network of sub-networks, with each of those sub-networks doing research disconnected from that being carried out by the others;

rather the objective is to establish a network of a small number of sites, each an active partnership, with each site working collaboratively with other sites in the network to improve public health and public health practice.