Foa_Content_of_RFA-CK-22-004.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Optimization and Standardization of Methods to Suppress Ixodes scapularis and Disrupt Enzootic Pathogen Transmission in Settings Posing an Elevated Risk to Humans

RFA-CK-22-004

02/15/2022

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Emerging and Zoonotic Infectious Diseases Notice of Funding Opportunity (NOFO) Title Optimization and Standardization of Methods to Suppress Ixodes scapularis and Disrupt Enzootic Pathogen Transmission in Settings Posing an Elevated Risk to Humans Activity Code U01 Research Project - Cooperative Agreement

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-CK-22-004

Assistance Listings Number(s) 93.084 Category of Funding Activity HL - Health NOFO Purpose This NOFO intends to support research to: 1) optimize and standardize implementation of existing strategies to reduce the abundance of host-seeking Ixodes scapularis nymphs infected with human pathogens, especially Lyme disease spirochetes (DIN); 2) evaluate efficacy and reproducibility of operational use (e.g., in the hands of pest control professionals or the public, as appropriate) of these protocols in high-risk settings (e.g., wooded residential properties, high-use wooded recreational areas) across the Midwest, Northeast and Mid-Atlantic United States where baseline DIN is elevated; and 3) develop standard operating procedures that may be used by homeowners or vector control professionals to implement these interventions within communities at risk for exposure to Lyme disease spirochetes and other I. scapularis-borne pathogens.

Key Dates Publication Date:

To receive notification of any changes to RFA-CK-22-004, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

01/15/2022

Application Due Date:

02/15/2022 02/15/2022

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

E-mail: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

04/14/2022 Secondary Review:

06/24/2022 Estimated Start Date:

09/01/2022 Expiration Date:

https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

02/16/2022 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 15 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Applications that do not comply with these instructions may be delayed or may not be accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: This NOFO intends to support research to: 1) optimize and standardize implementation of existing strategies to reduce the abundance of host-seeking Ixodes scapularis nymphs infected with human pathogens, especially Lyme disease spirochetes (DIN); 2) evaluate efficacy and reproducibility of operational use (e.g., in the hands of pest control professionals or the public, as appropriate) of these protocols in high-risk settings (e.g., wooded residential properties, high-use wooded recreational areas) across the Midwest, Northeast and Mid-Atlantic United States where baseline DIN is elevated;

and 3) develop standard operating procedures that may be used by homeowners or vector control professionals to implement these interventions within communities at risk for exposure to Lyme disease spirochetes and other I. scapularis-borne pathogens.

Mechanism of Support: U01 Research Project - Cooperative Agreement.

Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire five (5)-year project period is $5,000,000. The anticipated number of awards is one (1). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards will depend upon the number, quality, duration, and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $1,000,000 with individual awards ranging from $750,000 to $1,000,000 for the first year. The estimated total funding (direct and indirect) for the entire project period is $5,000,000. The project period is anticipated to run from 09/01/2022 to 08/31/2027.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

https://grants.nih.gov/grants/how-to-apply-application-guide.html

Eligible Institutions/Organizations. Institutions/organizations listed in Section III. of this announcement are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for each application.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Application Type. New.

Application Materials. See Section IV.1 for application materials. Please note that

Form G is to be used when completing the application package.

Section I. Funding Opportunity Description Statutory Authority Public Health Service Act, Section 317(k)(2) [42 U.S.C. 247b(k)(2)], as amended.

1. Background and Purpose In the eastern United States, the blacklegged tick, Ixodes scapularis, is a vector of seven human pathogens, including those causing Lyme disease, anaplasmosis, babesiosis, Borrelia miyamotoi disease, Powassan virus disease, and ehrlichiosis associated with Ehrlichia muris eauclairensis. Lyme disease alone is estimated by CDC to account for nearly 500,000 cases of human illness every year in the United States, with most cases occurring in the Northeast and Upper Midwest. Human exposure to infected Ixodes scapularis ticks, including the small and easily overlooked nymphal life stage, which is considered to account for most human infections, is thought to occur commonly on residential properties, especially in the Northeast, but can also occur in neighborhood green spaces and on public lands.

Strategies to prevent Lyme disease and other Ixodes scapularis-associated infections have focused on personal protection (e.g., avoiding tick habitat, using repellents, and performing daily tick checks and promptly removing attached ticks) or environmentally-targeted interventions aimed at reducing human contact with infected ticks (e.g., reducing the amount of suitable tick habitat, suppressing tick populations by targeting host-seeking ticks or ticks infesting key host species, and reducing tick infection rates through vaccination of rodent pathogen reservoirs). In field experiments, some environmentally targeted strategies have been demonstrated to effectively reduce the density of host-seeking infected I. scapularis nymphs (DIN; an acarological correlate of human risk of infection), but none have been proven to reduce either human tick bites or Lyme disease cases. However, efforts to optimize the implementation of these tick control strategies have been limited, and the efficacy of tick suppression in the environment has been highly variable for some methods, with performance differences attributed to ecological setting, timing or spatial extent of application, method of application (e.g., acaricide broadcast method, equipment and product used; product and deployment density used for topical treatment of rodents with acaricide) and other factors. Under the best-case scenarios, these strategies show promise in suppressing ticks and their associated pathogens to the point where it is reasonable to expect reductions also for human tick bites or tick-borne disease cases.

To significantly reduce the incidence of Lyme disease and other tick-borne diseases, a case has been made that tick control must shift from being exclusively a personal responsibility to also include elements of community responsibility, in much the same way that mosquito-borne infections are addressed in the United States. However, a recent survey highlighted that organized tick control is very seldomly implemented; only 12% of survey respondents indicated that their jurisdiction conducts or financially supports tick control and included research projects rather than being restricted to operational tick control. After funding constraints, the greatest barrier cited was “lack of evidence-based, large-scale tick management practices”. Noting that several existing tick suppression strategies have demonstrated substantial efficacy in some studies, and surprisingly poor efficacy in others, there is a need for optimization and standardization of implementation methods to suppress ticks and disrupt enzootic pathogen transmission to ensure maximal efficacy and reproducibility of results.

This NOFO intends to support research to: 1) optimize and standardize existing strategies to reduce the density of host-seeking I. scapularis nymphs infected with human pathogens, especially Lyme disease spirochetes (DIN); 2) evaluate efficacy and reproducibility of operational use (e.g., in the hands of pest control professionals or the public, as appropriate) of these protocols in high-risk settings (e.g., wooded residential properties, high-use wooded recreational areas) across the Midwestern, Northeastern and Mid-Atlantic United States where baseline DIN is elevated; and 3) develop standard operating procedures that may be used by homeowners or vector control professionals to implement these interventions within communities at risk for exposure to Lyme disease spirochetes and other I. scapularis-borne pathogens. Objectives 1 and 2 should yield data that guide recommendations on the ecological settings where specific control methods are expected to be efficacious and provide guidance on the expected range in reduction in DIN based on when and where they are deployed.

Health Equity:

The program supports efforts to improve the health of populations disproportionately affected by HIV, Viral Hepatitis, sexually transmitted diseases (STDs) and TB by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

A health disparity occurs when a health outcome is seen to a greater or lesser extent between populations. Health disparities in HIV, Viral Hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these infections and diseases.

Social determinants are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes (https://www.cdc.gov/socialdeterminants/index.htm ). These include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion. Health equity is a desirable goal that entails special https://www.cdc.gov/socialdeterminants/index.htm efforts to improve the health of those who have experienced social or economic challenges. It requires:

Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and

Continuous efforts to maintain a desired state of equity after health disparities are eliminated.

Programs should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by HIV, Viral Hepatitis, STDs and TB and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, programs should consider social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

Healthy People 2030 and other National Strategic Priorities This NOFO intends to support a workforce of trained and competent field entomologists/biologists to optimize the efficacy of environmental tick control strategies that may be used to reduce human tick bites and the incidence of Lyme and other Ixodes-associated diseases.

Public Health Impact Key outcomes may include: improved methodology to suppress tick vectors in the environment;

a stronger evidence base to select the most promising environmentally based tick control methods for larger-scale, costly intervention studies that include human-based outcome measures; better evidence to support data-driven recommendations for tick-borne disease control and prevention focusing on environmental interventions; and standard operating procedures that may be used by homeowners or vector control professionals to implement these interventions within communities at risk for exposure to Lyme disease spirochetes.

Relevant Work

1. Eisen L. Control of ixodid ticks and prevention of tick-borne diseases in the United

States: The prospect of a new Lyme disease vaccine and the continuing problem with tick exposure on residential properties. Ticks Tick Borne Dis. 2021 May;12(3):101649. doi:

10.1016/j.ttbdis.2021.101649. Epub 2021 Jan 20. PMID: 33549976; PMCID:

PMC8056288.

2. Eisen L, Dolan MC. Evidence for personal protective measures to reduce human contact with blacklegged ticks and for environmentally based control methods to suppress host-seeking blacklegged ticks and reduce infection with Lyme disease spirochetes in tick vectors and rodent reservoirs. J Med Entomol. 2016 Sep 1;53(5):1063-1092. doi:

10.1093/jme/tjw103. PMID: 27439616; PMCID: PMC5788731.

3. Eisen L, Stafford KC. Barriers to effective tick management and tick-bite prevention in the United States (Acari: Ixodidae). J Med Entomol. 2020 May 6:tjaa079. doi:

10.1093/jme/tjaa079. Epub PMID: 32372075; PMCID: PMC8056842.

4. Hayes EB, Piesman J. How can we prevent Lyme disease? N Engl J Med. 2003 Jun 12;348(24):2424-30. doi: 10.1056/NEJMra021397. PMID: 12802029.

5. Eisen RJ, Eisen L. The blacklegged tick, Ixodes scapularis: An increasing public health concern. Trends Parasitol. 2018 Apr;34(4):295-309. doi: 10.1016/j.pt.2017.12.006. Epub 2018 Jan 11. PMID: 29336985; PMCID: PMC5879012.

6. Fischhoff IR, Bowden SE, Keesing F, Ostfeld RS. Systematic review and meta-analysis of tick-borne disease risk factors in residential yards, neighborhoods, and beyond. BMC Infect Dis. 2019 Oct 17;19(1):861. doi: 10.1186/s12879-019-4484-3. Erratum in: BMC Infect Dis. 2019 Dec 5;19(1):1035. PMID: 31623574; PMCID: PMC6798452.

7. Hahn MB, Bjork JKH, Neitzel DF, Dorr FM, Whitemarsh T, Boegler KA, Graham CB, Johnson TL, Maes SE, Eisen RJ. Evaluating acarological risk for exposure to Ixodes scapularis and Ixodes scapularis-borne pathogens in recreational and residential settings in Washington County, Minnesota. Ticks Tick Borne Dis. 2018 Feb;9(2):340-348. doi:

10.1016/j.ttbdis.2017.11.010. Epub 2017 Nov 22. PMID: 29195857.

8. Kugeler KJ, Schwartz AM, Delorey MJ, Mead PS, Hinckley AF. Estimating the frequency of Lyme disease diagnoses, United States, 2010-2018. Emerg Infect Dis. 2021 Feb;27(2):616-619. doi: 10.3201/eid2702.202731. PMID: 33496229; PMCID:

PMC7853543.

9. Kugeler KJ, Farley GM, Forrester JD, Mead PS. Geographic distribution and expansion of human Lyme disease, United States. Emerg Infect Dis. 2015 Aug;21(8):1455-7. doi:

10.3201/eid2108.141878. PMID: 26196670; PMCID: PMC4517724.

10. Mead P, Hook S, Niesobecki S, Ray J, Meek J, Delorey M, Prue C, Hinckley A. Risk factors for tick exposure in suburban settings in the Northeastern United States. Ticks Tick Borne Dis. 2018 Feb;9(2):319-324. doi: 10.1016/j.ttbdis.2017.11.006. Epub 2017 Nov 21. PMID: 29174449.

11. Rosenberg R, Lindsey NP, Fischer M, Gregory CJ, Hinckley AF, Mead PS, Paz-Bailey G, Waterman SH, Drexler NA, Kersh GJ, Hooks H, Partridge SK, Visser SN, Beard CB, Petersen LR. Vital Signs: Trends in reported vectorborne disease cases - United States and Territories, 2004-2016. MMWR Morb Mortal Wkly Rep. 2018 May 4;67(17):496-

501. doi: 10.15585/mmwr.mm6717e1. PMID: 29723166; PMCID: PMC5933869.

12. Stafford KC, Williams SC, Molaei G. Integrated pest management in controlling ticks and tick-associated diseases. J Integrated Pest Manag. 2017;8(1):28.

2. Approach The proposed approach is expected to involve a team of scientists and public health practitioners and be developed in collaboration with partners from academia, state/local public health agencies, and vector management programs. The team should include partners from at least one high-incidence state for Lyme disease in each of the Midwest, Northeast and Mid-Atlantic regions. The project should address each of the following three objectives: 1) optimize and standardize existing strategies for reducing the density of host-seeking Borrelia burgdorferi-infected Ixodes scapularis nymphs (DIN); 2) evaluate efficacy and reproducibility of these strategies in high-risk settings (e.g., wooded residential properties, high-use wooded recreational areas) across the Midwest, Northeast, and Mid-Atlantic United States where baseline DIN is elevated; and 3) develop standard operating procedures that may be used by homeowners or vector control professionals to implement these interventions within communities at risk for exposure to Lyme disease spirochetes. If the application is successful, the project team is expected to plan, initiate, complete, evaluate, analyze, and report out on the accomplishments and/or findings of the project components with technical assistance from CDC as warranted.

Objectives/Outcomes The proposed research projects should be guided by public health needs and are expected to be scientifically sound, statistically robust, and directly relevant to the mission of state, local or tribal public health agencies, publicly funded vector management programs, and private pest control companies or homeowners involved in control of Ixodes scapularis. The emphasis of the research activities should be on intervention studies to evaluate, optimize and standardize implementation of existing environmentally based approaches to suppress the density of Ixodes scapularis ticks infected with human pathogens. Depending on the nature of the intervention, outcome measures may include density of host-seeking ticks; prevalence of infection in the ticks;

density of infected host-seeking ticks; tick infestation of key reproductive or pathogen reservoir hosts; and pathogen infection in reservoir hosts. Proposed research should focus on the following:

Field evaluations of implementation strategies of existing technologies or approaches to:

1) reduce suitable tick habitat; 2) suppress host-seeking Ixodes scapularis ticks or ticks on key host species, by means of application of acaricide or biological control agents; or

3) disrupt pathogen transmission cycles. These field evaluations should aim to maximize intervention efficacy across ecological settings posing an elevated acarological risk for exposure to ticks and/or to define ecological contexts under which such strategies are efficacious. Moreover, implementation strategies must be clearly defined and reproducible. Evaluation of existing technologies should include commercially available products and/or experimental products previously evaluated in the peer-reviewed literature that show reasonable efficacy in at least a limited setting and show promise of achieving >80% efficacy if implementation strategies are improved.

Field studies aimed at optimizing implementation of tick control products to provide recommendations for pest control firms and homeowners regarding how to optimize tick suppression depending on type of product used, application method, application timing, and vegetation structure in the treated area.

If integrated strategies are evaluated, each component of the integrated strategy should also be tested singly to allow for evaluation of additive effects of combined interventions.

Assessments of the potential for incorporating tick management into existing mosquito management programs.

Target Population The target population is all residents of the eastern U.S. living in areas affected by Lyme disease and other Ixodes scapularis-borne diseases (e.g., upper Midwest, Mid-Atlantic and Northeast).

This would include individuals of all races, ethnicities, gender identities, sexual orientations, geographic regions, socioeconomic status, disability status, primary language, health literacy, and other relevant dimensions who live in areas that are at risk for contracting an illness that is caused by an agent transmitted by Ixodes scapularis.

Collaboration/Partnerships It is recommended that the research team be led by a Principal Investigator with demonstrated experience working with Ixodes scapularis under field conditions. The application should be developed in collaboration with a diverse group of experts from academic institutions and public health agencies to ensure that the project is scientifically sound, statistically robust, and directly relevant to the mission of state/local, tribal public health agencies, publicly funded vector management programs, and private pest control firms involved in tick control. The team should include partners from at least one high-incidence state for Lyme disease in each of the Midwest, Northeast and Mid-Atlantic regions. Applications should demonstrate access to field sites with elevated densities of Borrelia burgdorferi-infected host-seeking Ixodes scapularis nymphs. Letters of support should be included from key partners to demonstrate their willingness and commitment to work together as a team to accomplish the project objectives. It is expected that a project of this magnitude will involve multiple institutions spanning at least three Lyme disease high incidence states in each of the Midwest, Northeast and Mid-Atlantic regions.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5)-year research project period. The application should describe specific, measurable, achievable, realistic, and time-phased (SMART) project objectives for each activity in the project plan and describe the development and implementation of project performance measures based on specific programmatic objectives. Additionally, the application should propose specific milestones and deliverables related to the work plan. These milestones and deliverables may be used to help assess progress and performance.

Translation Plan Dissemination of project outcomes is expected to occur via: 1) publication of research results in peer-reviewed scientific journals; 2) presentation of research results at scientific conferences and meetings of professional vector control organizations; 3) presentation of project information and outcomes via a publicly accessible project website; and 4) inclusion of key findings on the webpages of CDC and state/local public health agencies or revised CDC guidance documents or management handbooks.

3. Funding Strategy Section II. Award Information Funding Instrument Type:

CA (Cooperative Agreement) A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding:

$5,000,000 Anticipated Number of Awards:

Estimated Total Funding, including direct and indirect costs: $5,000,000

Estimated Total Annual Budget Period Funding, including direct and indirect costs:

Year 1: $1,000,000 Year 2: $1,000,000 Year 3: $1,000,000 Year 4: $1,000,000 Year 5: $1,000,000

Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $1,000,000

Estimated total funding available for the entire project period, including direct and indirect costs: $5,000,000

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling:

$1,000,000 Per Budget Period

Award Floor:

$750,000 Per Budget Period

Total Period of Performance Length:

5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility The following types of Higher Education Institutions are always encouraged to apply for

CDC support as Non-profit Public or Non-profit Private Institutions of Higher Education:

o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf o Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education) Private non-profit institutions of higher education Eligible Agencies of the Federal Government Faith-based or Community-based Organizations U.S. Territory or Possession Regional Organizations Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If applications request a funding amount greater than the ceiling indicated in Section II. of this NOFO, HHS/CDC may consider the application non-responsive.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS. If already registered in SAM.gov, a UEI was automatically generated for your entity and is visible in both SAM.gov and Grants.gov. Entities registering in SAM.gov prior to April 2022 must still obtain a DUNS number before registering in SAM and a UEI will be assigned during SAM.gov registration.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code:

https://eportal.nspa.nato.int/AC135Public/Docs/US Instructions for NSPA NCAGE.pdf https://gov.ecfr.io/cgi-bin/searchECFR https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete.

However, it is best to start the registration process at least two weeks prior to application submission.

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS. If already registered in SAM.gov, a UEI was automatically generated for your entity and is visible in both SAM.gov and Grants.gov. Entities registering in SAM.gov prior to April 2022 must still obtain a DUNS number before registering in SAM and a UEI will be assigned during SAM.gov registration.

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at the SAM internet site at SAM.gov and the SAM.gov Knowledge Base.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 HHS/CDC support.

9. Cost Sharing This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement,(https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html

Email: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

2. Content and Form of Application Submission Applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, 2022.

Application guides for FORMS-G application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2021.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms. Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Please use the form and instructions for SF424 (R&R) Form G. Applicants must use FORMS-G application packages for due dates on or after January 25, 2022.

Letters of Support from partners or other organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please include all of the eight (8) mandatory forms listed below in the application package:

Mandatory

1. SF424(R&R);

2. PHS 398 Cover Page Supplement;

3. Research and Related Other Project Information;

4. Project/Performance Site Location(s);

5. Research and Related Senior/Key Person Profile (Expanded);

6. Research and Related Budget;

7. PHS 398 Research Plan;

8. PHS Human Subjects and Clinical Trials Information.

http://grants.nih.gov/support/index.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

If multiple collaborating institutions will be involved, please include in this section of the application your single IRB (sIRB) Plan:

Describe how you will comply with the single IRB review requirement under the Revised Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the IRB that you anticipate will serve as the sIRB of record.

Indicate that all identified engaged institutions or participating sites will agree to rely on the proposed sIRB and that any institutions or sites added after award will rely on the sIRB.

Briefly describe how communication between institutions and the sIRB will be handled.

Indicate that all engaged institutions or participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.

Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

Note: If you anticipate research involving human subjects but cannot describe the study at the time of application, include information regarding how the study will comply with the single Institutional Review Board (sIRB) requirement prior to initiating any multi-site study in the delayed onset study justification.

Please include the one (1) optional form listed below, if applicable, in the application package:

Optional

1. R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT.

3. Letter of Intent Due Date for Letter Of Intent 01/15/2022

01/15/2022

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. “Overview Information”, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the applicant organization Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s)

Names of other key personnel Participating institutions Number and title of this notice of funding opportunity

The letter of intent should be sent to:

Gregory Anderson, MPH, MS Extramural Research Program Office Office of the Associate Director of Science National Center for HIV, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS US8-1 Atlanta, GA 30333 Telephone: 404-718-8833 Email: GAnderson@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide at How to Apply

- Application Guide for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the NOFO.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation and Approach. Describe the proposed research plan, including staffing and time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections mailto:GAnderson@cdc.gov

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide at How to Apply - Application Guide must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application.

A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

A description of the data to be collected or generated in the proposed project;

Standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);

Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

CDC OMB approved templates may be used (e.g. NCCDPHP template https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx)

Other examples of DMPs may be found here: USGS, http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

Applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

2022.

Application guides for FORMS-G application packages will be posted to the How to Apply - Application Guide page no later than October 25, 2021.

Please use the form and instructions for SF424 (R&R) Form G. Applicants must use FORMS-G application packages for due dates on or after January 25, 2022.

Letters of Support from partners or other…