Foa_Content_of_RFA-CK-22-002.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Technological Advancement of Global Rabies Surveillance and Control

RFA-CK-22-002

02/28/2022

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 Technological Advancement of Global Rabies Surveillance and Control Activity Code U01 Research Project - Cooperative Agreements

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

RFA-CK-22-002

Assistance Listings Number(s) 93.084 Category of Funding Activity HL - Health NOFO Purpose The purpose of this notice of funding opportunity (NOFO) is to support research to implement, monitor, and evaluate technologically driven methods and tools that can be used to reduce human rabies burden globally and track progress towards canine rabies elimination. This research should be global in scope, but focus on countries in Asia, Africa, and the Americas with high rabies burden. Research activities should focus on evaluating low-cost electronic tools for tracking human and dog vaccinations, human bite investigations, improving systems for rabies diagnostic laboratory information management systems, economic modelling of dog-mediated rabies interventions, and enumerating rabies-susceptible dog populations. The research supported by this NOFO should provide CDC and international partners [e.g., World Health Organization (WHO), World Organization for Animal Health (OIE)] with data-driven strategies for reaching canine rabies elimination targets.

Key Dates Publication Date:

To receive notification of any changes to RFA-CK-22-002, 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.

1/31/2022

Application Due Date:

02/28/2022 2/28/2022

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:

04/28/2022 Secondary Review:

06/24/2022 Estimated Start Date:

09/01/2022 Expiration Date:

03/01/2022 https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

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 20 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: The purpose of this notice of funding opportunity (NOFO) is to support research to implement, monitor, and evaluate technologically driven methods and tools that can be used to reduce human rabies burden globally and track progress towards canine rabies elimination. This research should be global in scope, but focus on countries in Asia, Africa, and the Americas with high rabies burden. Research activities should focus on evaluating low-cost electronic tools for tracking human and dog vaccinations, human bite investigations, improving systems for rabies diagnostic laboratory information management systems, economic modelling of dog-mediated rabies interventions, and enumerating rabies-susceptible dog populations. The research supported by this NOFO should provide CDC and international partners [e.g., World Health Organization (WHO), World Organization for Animal Health (OIE)] with data-driven strategies for reaching canine rabies elimination targets.

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 $1,000,000. The estimated 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 $200,000 with individual awards ranging from $150,000 to $200,000 for the first year. The estimated total funding (direct and indirect) for the entire project period is $1,000,000. 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

SF424 (R&R) Form G is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description Statutory Authority Public Health Service Act, Section 307 [42 U.S.C. 242l] and Section 317(k) [42 U.S.C.

247b(k)(2)], as amended.

1. Background and Purpose Globally, rabies is responsible for an estimated 59,000 deaths annually. Despite evidence that control of dog-mediated rabies through animal vaccination programs and responsible pet ownership can reduce the incidence of human rabies, dog-mediated rabies remains common in many low- and middle-income countries. Exposure to rabid dogs is still the cause of 99% of human rabies deaths worldwide. In 2018, a global strategic plan to end human deaths from dog-mediated rabies by 2030 was published by the World Health Organization (WHO) and supported by the Food and Agriculture Organization of the United Nations (FAO), the World Organization for Animal Health (OIE), and the CDC Poxvirus and Rabies Branch (PRB). These international agencies subsequently launched the United Against Rabies (UAR) Forum to increase understanding of policy and research work needed to improve coordination (including resource mobilization) and information sharing between partners.

PRB serves as a WHO collaborating center and OIE reference center for rabies and works directly with international governments and partners in Haiti, Bangladesh, India, and countries in Africa and Southeast Asia to implement rabies control programs and develop advanced techniques to improve rabies control practices. A lack of accurate data for rabies surveillance and vaccination creates significant challenges in implementing, evaluating, and expanding these programs. PRB intends to establish a cooperative agreement to reduce the burden of rabies in partner countries through data-driven and evidence-based approaches.

The focus of the research supported by this cooperative agreement should be on utilizing electronic data collection tools to improve data quality in partner countries, improve the timeliness from data collection to analysis, and increase partner engagement by rapidly disseminating rabies control program data for the purpose of informing control program operations. This should be achieved by developing and implementing electronic data collection tools to improve data quality in surveillance, post exposure prophylaxis (PEP), and dog vaccination programs.

Surveillance: PRB adheres to the global recommendations and standards established by WHO and OIE for implementing rabies surveillance programs. Public health surveillance systems are based on early detection of suspected rabies exposures in people and animals, investigation of these exposures, and collaboration between animal and human health sectors to make informed decisions about the need for people and animals to receive post-exposure vaccinations. Anti-rabies vaccines are costly and often in short supply in many rabies-endemic countries. One focus of the research supported by this cooperative agreement should be to modify existing electronic surveillance platforms to ensure rapid data-sharing between human and animal health sectors.

Whereas this type of surveillance is widely recognized as the gold-standard for rabies, the cost and benefit of its implementation and maintenance in low- and middle-income countries are not well understood. The electronic data platform should provide timely and accurate guidance to in-country health workers to inform costly post-exposure vaccination decisions, while also establishing an evidence base for how to implement these types of programs in a cost-effective manner. This cooperative agreement is designed to support operational research for the evaluation of different implementation and management approaches as well as research into risk factors for rabies exposures and health outcomes.

Post-exposure Vaccination: The only way to prevent human rabies death after an exposure is the timely recognition of exposed persons and provision of appropriate vaccination. Human rabies vaccines are often difficult to access in low- and middle-income countries, either because of cost or limited health facilities that carry the vaccine. This cooperative agreement is designed to support development or modification of a system to document rabies exposures, post-exposure vaccination practices, and health outcomes of vaccinated persons. The cooperative agreement is also designed to support development or modification of a system that manages human rabies vaccine stocks to reduce the frequency of stock-outs.

Dog Vaccination: One significant barrier to successful dog vaccination is an inability to achieve high coverage in the free-roaming dog population. The logistical constraints associated with vaccinating these often hard-to-access dog populations include a lack of trained personnel, unfamiliarity with advanced and mixed-methods vaccination approaches, and inability or refusal to properly conduct post-vaccination evaluations. This cooperative agreement is designed to support the modification of an electronic smartphone dog vaccination data collection device to overcome these limitations. This cooperative agreement is also designed to support research to study dog populations, population estimation methods, mixed-method dog vaccination programs, and cost-effective means of large-scale post-vaccination evaluation programs.

Health Equity:

CDC supports efforts to improve the health of populations disproportionately affected by infectious diseases 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 infectious diseases 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 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.

Applicants should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by infectious diseases and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, applicants should consider social determinants of health in the development, implementation, and evaluation of 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 work contributes to accomplishing the following CDC Healthy People 2030 goals:

Improve health by preventing, detecting, and responding to public health events worldwide.

This NOFO should support the continued development and implementation of critical infrastructure to prevent dog-mediated human rabies deaths as well as actionable field-level programs that help to achieve the United Against Rabies goal of “Elimination of Dog-Mediated Human Rabies Deaths by 2030”.

Public Health Impact The work performed under this NOFO should have a direct impact on preventing human rabies exposures and deaths in partner countries. The magnitude of this impact is dependent on which countries engage in collaborations. It is expected that the outcome of this research will result in the prevention of hundreds of human deaths each year and thousands of disability adjusted life years (DALYs). Furthermore, the results of the operational research supported by this cooperative agreement should inform international rabies guidance and standards. Tools modified and developed as a part of this cooperative agreement should be made freely available to countries upon request (operational costs such as server access and training may require support from the partner country).

This cooperative agreement is also designed to support the vaccination of thousands of dogs and https://www.cdc.gov/socialdeterminants/index.htm the associated measurement of the impact this has on the lives and livelihoods of affected communities. These efforts should prevent hundreds of human rabies deaths and thousands of dog rabies deaths. Furthermore, the tools developed are expected to reflect research outcomes and enable replication of these programs in non-partner countries

Relevant Work This NOFO should build upon ongoing activities to improve mobile app development for mass dog vaccination campaigns and surveillance as well as technical support to Ministries of Agriculture/Health.

One million dog vaccinations recorded on mHealth innovation used to direct teams in numerous rabies control campaigns

Vaccinate-assess-move method of mass canine rabies vaccination utilizing mobile technology data collection in Ranchi, India

Establishment of a canine rabies burden in Haiti through the implementation of a novel surveillance program https://wwwnc.cdc.gov/travel/destinations/traveler/none/haiti

Effect of counselling on health-care-seeking behaviours and rabies vaccination adherence after dog bites in Haiti, 2014-15: a retrospective follow-up survey

2. Approach The focus of the research supported by this cooperative agreement should be on utilizing electronic data collection tools to improve data quality in partner countries, improve the timeliness from data collection to analysis, and increase partner engagement by rapidly disseminating rabies control program data for the purpose of informing control program operations. This should be achieved by developing and implementing electronic data collection tools to improve data quality in surveillance, post exposure prophylaxis (PEP), and dog vaccination programs.

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term outcomes

1. Increased Global Rabies Surveillance

1.a.

Implementation of electronic surveillance platforms to reflect international standards

1.b. Modification of country-specific, language-appropriate versions of the electronic surveillance platform

1.a.

Investigation of over 1,000 suspected human rabies exposures within one year of program operation

1.b. Analysis of electronic surveillance data and cross-site comparison of implementation and management

1.a. Adoption of an electronic surveillance platform with proven examples of remote/virtual implementation, available in major languages

1.b. Endorsement of the electronic surveillance tool by international agencies, including clear ability for https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0200942 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0200942 https://pubmed.ncbi.nlm.nih.gov/26715371/ https://pubmed.ncbi.nlm.nih.gov/26715371/ https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0004245 https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0004245 https://wwwnc.cdc.gov/travel/destinations/traveler/none/haiti https://pubmed.ncbi.nlm.nih.gov/28911750/ https://pubmed.ncbi.nlm.nih.gov/28911750/

1.c.

Implementation of a monitoring and evaluation program to ensure that operational research needs are met

1.d.

Implementation of a data reporting and information sharing platform to meet One Health needs for participating partners operations

1.c.

Demonstration of in-country utilization of a surveillance management platform, including data management, analysis, and data reporting from in-country partners passive information-exchange between health sectors and between national and international health authorities (e.g., WHO Global Health Observatory)

1.c. Country level sustainability of the program

2. Improvements to Human Post- Exposure Vaccination Services

2.a.

Implementation of an electronic post-exposure vaccination tracking system that provides real-time guidance to healthcare practitioners on the risk of rabies, and is integrated into the rabies surveillance platform to promote One Health information exchange

2.b. Data obtained from 1,000 bite victims in the first year of operation

2.c. Analysis of data to complete

2.a. Multi-site evaluation comparing different rabies vaccine distribution methodology to inform Gavi and WHO vaccine implementation guidelines

2.a. Integration of human rabies vaccine electronic data collection into a comprehensive rabies control platform consisting of surveillance, dog-vaccination, and human vaccination data that is accessible and utilized by all relevant One Health partners the research objectives

3. Implementation and

Evaluation of Large- Scale Dog Vaccination Programs

3.a.

Implementation of smartphone application capable of implementing the vaccinate-assess-move methodology

3.b. Proof of concept implementation of the electronic application in a campaign of >50,000 dogs

3.a. Integration of dog vaccination data into other rabies systems to house all rabies program data in one system

3.b.

Development of automated risk-mapping technology based on electronically collected in-country data to inform location and design of dog vaccination programs

3.a. Adoption of a universal dog vaccination tool that provides in-app guidance on design, implementation, and evaluation of the campaign.

3.b. Demonstration of expansion of use of the tools developed in non-partner countries, and recognition of the tools and approaches by key international organizations (e.g., United Against Rabies)

Objectives/Outcomes

CDC is seeking a qualified applicant for this award with the following attributes: 1) an organization with specialized expertise in implementing comprehensive rabies control programs in foreign low- and middle-income countries; 2) experience developing fit-for-use electronic smart-phone-based data collection tools; 3) scientific expertise in designing and implementing operational research studies; 4) sustained (multi-year) management of field sites to document long-term success of activities; and 5) exceptional history of fostering successful partner engagements with non-governmental organizations, pharmaceutical manufacturers, and governments of rabies-endemic foreign countries.

At completion of the project period, the recipient should have developed and implemented a comprehensive rabies control program platform, suitable for implementation in the most heavily affected countries, using sustainable and data-driven rabies control practices. The platform should include data collection portals for all key rabies data elements necessary for operation of rabies surveillance, human post-exposure vaccine and dog vaccination components. The platform should be piloted in multiple settings with differing healthcare infrastructure. Operational research conducted during implementation programs should result in the dissemination of the findings including, but not limited to, public presentations, website materials, and peer-reviewed publications. The platform should ensure that rabies data is available to all relevant stakeholders, reflecting the spirit of One Health, and should be used to inform rabies control practices.

The activities performed during this performance period should be conducted in a scientific and systematic fashion, ensuring that appropriate data is collected to evaluate differing methods of implementation and operation, across a heterogenous landscape of healthcare infrastructures.

Lessons learned from these activities should be widely disseminated and used to inform guidance and standards for the international community.

Extensive cost-effectiveness evaluations should be conducted in addition to the operational research. These studies should be used to develop recommendations for implementing and operating sustainable programs. This research should inform the international community on the economic incentives and outcomes of differing funding strategies.

Target Population The population targeted in this NOFO are World Bank-defined low- to middle-income countries where rabies is endemic as described by WHO and where the partner country has expressed interest in adopting electronic evidence-based rabies control programs.

Collaboration/Partnerships The recipient should collaborate with key partners including OIE, WHO, FAO and UAR. The recipient will be expected to develop or have a relationship with government officials and key non-governmental organizations in countries identified as part of the target population.

Collaborations with vaccine manufacturers and animal welfare organizations would be of benefit to achieving the cooperative agreement objectives.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5)-year research performace period. The application should describe specific, measurable, achievable, realistic, and time-phased (SMART) project objectives for each activity described in the application’s project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

Strategy 1: Increased Global Rabies Surveillance The proposed evaluation measures for Strategy 1 are:

Identification of field sites and staff needed to carry out investigations Ensuring that all research study protocols receive appropriate human subjects protections and animal welfare approvals prior to the start of associated activities Monthly reports of bite investigations detailed by study site Record of implementing rabies surveillance programs that reflect the guidance from international organizations Management of data platform capable of collecting numerous variables, available in multiple languages, and updated on an as-needed basis Annual cross-site analysis of project implementation Copies of data sharing agreements required by national and local authorities at study sites Summary assessments of all training activities Presentation of results of research studies to local, national, and regional public health authorities in a timely fashion

Strategy 2: Improvements to Human Post-Exposure Vaccination Services The proposed evaluation measures for Strategy 2 are:

Implementation of systems capable of real-time data exchange with multiple partners, including both the human and animal health surveillance systems

Monthly reports of bite investigations and post-exposure vaccine utilization detailed by study site

Annual cross-site analysis of project implementation Summary assessments of all training activities Importation and management plan for rabies biologics

Strategy 3: Implementation and Evaluation of Large-Scale Dog Vaccination Programs The proposed evaluation measures for Strategy 3 are:

Implementation of smartphone-based applications that can provide 2-way communication with dog vaccination teams and allow for remote technical assistance and monitoring

Attendance at monthly conference calls with CDC staff and other project partners to provide updates from all study sites

Copies of training/educational materials provided to CDC and national agencies prior to any training event

Quarterly reports summarizing dog vaccination campaign results by study site Adoption of rabies risk mapping and vaccine prioritization tools based on electronically collected project data Importation and management plan for rabies biologics

Translation Plan Findings from this project should be made available to public health officials via oral presentations, written reports, workplans, newly developed tools, and in published manuscripts.

3. Funding Strategy N/A

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:

$1,000,000 Estimated Total Annual Budget Period Funding, including direct and indirect costs:

Year 1: $200,000 Year 2: $200,000 Year 3: $200,000 Year 4: $200,000 Year 5: $200,000

Anticipated Number of Awards:

Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $200,000

Estimated total funding available for the entire period of performance, including direct and indirect costs: $1,000,000

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

Award Ceiling:

$200,000 Per Budget Period

Award Floor:

$150,000 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 eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int/ AC135Public/Docs/US%20Instructions%2 0for%2 0NSPA%20NCAGE.pdf.

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may 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:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) 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

• U.S. Territory or Possession

• Faith-based or Community-based Organizations

• 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" when submitting via https://www.grants.gov

• 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://ecfr.io or https://www.nsf.gov/statistics/ffrdclist/

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.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf

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

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 https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov 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 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 http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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 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.

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.

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 https://public.era.nih.gov 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

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.

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 01/31/2022

01/31/2022

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 Fax: 404-718-8822 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:

mailto:GAnderson@cdc.gov

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

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8.…