PKG00263528-instructions.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases Extramural Research Program

Office

Global TravEpiNet (GTEN): The Heading Home Healthy Program and Global Travelers'

Health National Research Center Consortium, Guidance and Outreach Programs

RFA-CK-21-001

Application Due Date: 12/18/2020

Global TravEpiNet (GTEN): The Heading Home Healthy Program and Global Travelers'

Health National Research Center Consortium, Guidance and Outreach Programs

RFA-CK-21-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text 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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Emerging and Zoonotic Infectious Diseases Notice of Funding Opportunity (NOFO) Title Global TravEpiNet (GTEN): The Heading Home Healthy Program and Global Travelers' Health National Research Center Consortium, Guidance and Outreach Programs Activity Code U01 Research Project - Cooperative Agreement

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

RFA-CK-21-001

Assistance Listings (CFDA) Number(s) 93.084 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to: 1) increase the proportion of international travelers who receive a pre-travel health consultation with recommended preventative services before traveling to areas of risk for select infectious diseases; and 2) increase the quality of the health care advice given in the pre-travel health consultation. This NOFO will support research and surveillance activities in an active, nationwide network of clinics that provide pre-travel health services to persons with travel destinations outside of the United States, including those travelers at high risk for illness or injury while on travel. These clinics will utilize a novel, electronic, web-based pre-travel health consultation system that aids the health care provider in giving essential recommendations during the pre-travel medical encounter. During this pre-travel visit, this system will anonymously collect specific data exclusively on travelers visiting international destinations. Further, this NOFO will encourage high-risk travelers to seek pre-travel health consultations from a clinician and better prepare them to return healthy by contributing to the travel medicine scientific evidence base. Examples of contributions may include prospective traveler cohort studies and use of novel diagnostic techniques to quantify risks to travelers. Although some international travelers seek pre-travel health consultations with clinicians who specialize in travel medicine, international travelers often consult a non-expert provider, such as their primary care clinician or another medical specialist. This NOFO will also increase the awareness of travel medicine among primary care providers and provide them with appropriate tools to aid them in advising international travelers with up-to-date recommendations.

Key Dates Publication Date: To receive notification of any changes to RFA-CK-21-001, 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: 11/16/2020

Application Due Date: 12/18/2020

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. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

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: 02/11/2021

Secondary Review: 03/16/2021

Estimated Start Date: 09/30/2021

Expiration Date: 12/19/2020 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

https://www.grants.gov

It is critical that applicants follow the instructions in the SF 424 (R&R) 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 25 pages.

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

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

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

Executive Summary

Purpose: The purpose of this NOFO is to: 1) increase the proportion of international travelers who receive a pre-travel health consultation with recommended preventative services before traveling to areas of risk for select infectious diseases; and 2) increase the quality of the health care advice in the pre-travel health consultation. This NOFO will support research and surveillance activities in an active, nationwide network of clinics providing pre-travel health services to persons with travel destinations outside of the United States, including those travelers at high risk for illness or injury while on travel. These clinics utilize a novel, electronic, web-based pre-travel health consultation system that aids the health care provider in providing essential recommendations during the pre-travel medical encounter. During this pre-travel visit, this system anonymously collects specific data exclusively on travelers visiting international destinations. Further, this NOFO will encourage high-risk travelers to seek pre-travel health consultations from a clinician and better prepare them to return healthy by contributing to the travel medicine scientific evidence base. Examples of contributions may include prospective traveler cohort studies and use of novel diagnostic techniques to quantify risks to travelers. Although some international travelers seek pre-travel health consultations with clinicians who specialize in travel medicine, international travelers often consult a non-expert provider, such as their primary care clinician or another medical specialist. This NOFO will also increase the awareness of travel medicine among primary care providers and provide them with appropriate tools to aid them in advising international travelers with up-to-date recommendations.

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 $7,500,000. 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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf 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 $1,500,000 with individual awards ranging from $750,000 to $1,500,000 for the first year. The estimated total funding (direct and indirect) for the entire project period is $7,500,000. The project period is anticipated to run from 09/30/2021 to 09/29/2026.

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

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 allowed 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 F is to be used when downloading the application package.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act, Sections 301(a) [42 USC 241(a)] and 317(k)(2) [42 USC 247b(k)(2)], as amended.

1. Background and Purpose The purpose of this NOFO is to support a research cooperative agreement to: 1) increase the proportion of international travelers who receive a pre-travel health consultation with recommended preventative services before traveling to areas of risk for infectious diseases; and

2) increase the quality of the health care advice in the pre-travel health consultation. The pre-travel health consultation represents an opportunity for the health care provider to educate patients about reducing the risk of illness and injury during travel and to provide recommended vaccinations and drug prophylaxis for the prevention of diseases such as yellow fever and malaria, respectively. Travel to international destinations has increased among U.S. residents, including travel to areas with a higher risk of acquiring an infectious disease and travel with higher risk activities, such as adventure travel. Therefore, it is vital for health care providers to ascertain the possible risks for travelers visiting such destinations and the risks the traveler might encounter during travel.

High-risk travelers of concern include, but are not limited to, the following:

U.S. residents traveling to visit friends and relatives (VFRs) abroad;

U.S. students studying abroad;

Very young or very old travelers, and travelers with underlying conditions at higher risk for acquiring an illness during travel; and Travelers visiting destinations at increased risk for infections such as sub-Saharan

Africa, south Asia, and parts of Mexico, Central America, South America, and the Caribbean.

This NOFO will support research and surveillance activities in an active, nationwide network of clinics providing pre-travel health consultations to persons with travel destinations outside the United States, including those travelers at high risk for illness or injury while on travel. These clinics will utilize a novel, electronic, web-based pre-travel health consultation system that aids health care providers in providing essential recommendations during the pre-travel medical encounter. During this pre-travel visit, this system anonymously collects specific data exclusively on travelers visiting international destinations. Collection of these anonymous data from travelers continues to inform CDC's recommendations on international travelers by providing data on travelers at higher risk, and those traveling to high-risk destinations, and what preventative services they are/are not utilizing.

Further, this NOFO will encourage high-risk travelers to seek pre-travel health consultations from a clinician. Although some international travelers seek pre-travel health consultations with clinicians that specialize in travel medicine, the international traveler often consults a non-expert provider, such as their primary care clinician or another medical specialist. This NOFO will also increase the awareness of travel medicine among primary care providers and provide them with appropriate tools to aid them in advising international travelers with up-to-date recommendations.

Healthy People 2030 and other National Strategic Priorities

Healthy People:

o Clinical Preventive Services (Children aged 19 to 35 months who receive the recommended doses of DTaP, polio, MMR, Hib, hepatitis B, varicella, and PCV vaccines [IID-8])

CDC Priorities:

o Excellence in surveillance, epidemiology, and laboratory sciences and services.

o Prevent illness, injury, disability, and premature death

Public Health Impact According to the United Stations World Tourism Organization (UNWTO), international tourist arrivals reached 1,138 million in 2014 and were expected to grow by 3% to 4% in 2015

(UNWTO, 2015). The risk of becoming ill or injured during travel depends on many factors, such as the traveler's destination, duration of travel, activities, age, health status, risk of disease at the destination and the traveler's pre-travel preparation. As more travelers venture beyond historically popular tourist destinations in developed nations to "off the beaten path" locales, they may come in contact with infectious diseases such as malaria, schistosomiasis, dengue fever, and typhoid fever. Travelers may also import infectious diseases into their country of origin, as evidenced in recent years by the global spread of severe acute respiratory syndrome (SARS), pandemic H1N1 influenza, chikungunya fever, dengue fever, Ebola virus disease, measles and, more recently, COVID-19.

The pre-travel health consultation represents an opportunity for a health care provider to educate patients about reducing the risk of illness and injury during travel and to provide recommended vaccinations and drug prophylaxis for the prevention of diseases. Such consultations can also reduce the likelihood for importation of diseases, particularly those preventable by vaccines.

Unfortunately, many travelers do not seek pre-travel health consultations before travel.

This NOFO will impact public health by encouraging high-risk international travelers to seek pre-travel health consultations to mitigate the risk of illness and injury while traveling. Such outreach will target travelers that may not know the importance of such a consultation, where and how to seek such consultation, and what a consultation might entail. In addition, the NOFO will also provide tools and outreach to non-expert travel medicine providers who may see international travelers before their travel. These tools and outreach will provide travel health recommendations in a concise, easy-to-use format for providers who do not routinely see patients who travel internationally.

Further, the NOFO will support data collection from a national network of clinics providing pre-travel care to travelers. Analyses of these pre-travel consultations should highlight gaps and successes in pre-travel care. Such information informs CDC's recommendations on international travelers by providing data on travelers at high risk, and those traveling to high-risk destinations, and what preventative services they are/are not utilizing.

Relevant Work

CDC's National Center for Emerging and Zoonotic Infectious Diseases' Strategic Plan:

2018-2023 (https://www.cdc.gov/ncezid/pdf/ncezid-strategic-plan-2018-2023-508.pdf)

CDC Travelers' Health Traveler Information Center. Accessed August 25, 2020: http ://wwwnc.cdc.gov/travel/page/traveler-information-center

CDC Travelers' Health Clinician Information Center. Accessed August 25, 2020: http ://wwwnc.cdc.gov/travel/page/clinician-information-center

CDC Travelers' Health Travel Industry Information Center. Accessed August 25, 2020:

http://wwwnc.cdc.gov/travel/page/travel-industry-information-center

CDC Travelers' Health "Health Information for International Travel" or "Yellow Book".

Accessed August 25, 2020: http://wwwnc.cdc.gov/travel/page/yellowbook-home

Refugee and Immigrant Health. 2004. Kemp, C. and Rasbridge, L.A. eds. Cambridge University Press: Cambridge, U.K.

Migrant Health Guide. Accessed August 25, 2020: https://www.gov.uk/government /collections/migrant-health-guide-countries-a-to-z https://www.cdc.gov/ncezid/pdf/ncezid-strategic-plan-2018-2023-508.pdf http://wwwnc.cdc.gov/travel/page/traveler-information-center http://wwwnc.cdc.gov/travel/page/traveler-information-center http://wwwnc.cdc.gov/travel/page/clinician-information-center http://wwwnc.cdc.gov/travel/page/clinician-information-center http://wwwnc.cdc.gov/travel/page/travel-industry-information-center http://wwwnc.cdc.gov/travel/page/yellowbook-home https://www.gov.uk/government/collections/migrant-health-guide-countries-a-to-z https://www.gov.uk/government/collections/migrant-health-guide-countries-a-to-z

2. Approach Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

Objectives/Outcomes The overall goal of this NOFO is to increase the proportion of international travelers who attend a pre-travel health consultation for recommended preventative services before traveling to areas of risk for select infectious diseases. The pre-travel health consultation represents an opportunity for the health care provider to educate patients about reducing the risk of illness and injury during travel, and to provide recommended vaccinations and drug prophylaxis for the prevention of diseases, such as yellow fever and malaria, respectively.

The current need is to collect robust and methodologically standardized data over time from multiple traveler populations and enroll these populations in prospective research studies. Quantifying risk, or incidence of infection and disease, in locations and sub-populations is desired. Ongoing real-time data collection under standardized protocols makes longitudinal comparison of data possible and can be used to determine if transmission is beyond what is expected, and what interventions can reduce the rate to the expected threshold within a well-described population. This would fill a global gap in knowledge regarding travel medicine.

The application should address the following objectives:

1. Conduct research and surveillance activities in an active, nationwide network of clinics providing pre-travel health services to persons with travel destinations outside the United States, including those travelers at high-risk.

a. Maintain and evaluate an electronic, web-based pre-travel health consultation system that is user-friendly to both clinical and lay audiences.

i. Methods should include the changing epidemiology of diseases, travel health warnings/notices for specific destinations, and changing vaccination or medication recommendations.

ii. Methods might include additional questions, such as those asking for reasons a patient might decline the clinician's recommendations for vaccinations or medications.

b. Recruit and add clinics to the network, as appropriate, if they include high-risk travelers in their patient catchments. Clinics to be included should have a high volume of patients traveling to destinations outside of the United States (average > 15 travelers per week). Recruited clinics that serve high-risk populations should be geographically diverse and should have a high percentage (>25%) of patients who would qualify to be high-risk travelers (defined in the "Background and Purpose" and "Target Population" sections of this NOFO).

c. Conduct data collections, analyses, evaluations, and publications of anonymous data collected on travelers during the pre-travel consultation, in order to identify and address the fundamental gaps in pre-travel preparation of travelers, especially those at high risk.

Further analyses could be proposed in the application, such as cost-benefit analyses of pre-travel health consultations, or other similar types of projects.

d. Collect data in real time to rapidly respond to outbreaks (such as the current COVID-19 outbreak).

e. Focus on high interest global pathogens, including high transmission pathogens and those with high levels of antimicrobial resistance, and apply high throughput technology and/or rapid diagnostics to identify chains of transmission, pathogens of global importance, behavioral factors impacting transmission and ways to interrupt these transmission chains.

f. Strong economic modeling goal, with foci on evidence for and impact of interventions as well as outcome analyses.

2. The application should include programs that provide outreach to travelers to international destinations, especially those at high-risk, and encourage them to seek pre-travel health consultations.

a. Methods should include outreach to international travelers in U.S. cities or counties with a previous history of travel-related disease outbreaks or with large communities of travelers who visit friends and relatives (VFRs).

b. Methods might include direct or indirect contact with international travelers through departments of health, travel agents, houses of worship, or personal service providers (e.g., hairdressers).

3. The application should include programs that outreach to health care providers who do not see travelers on a regular basis, and who have limited knowledge of travel medicine. These may include primary care providers or specialists whose patients mention travel plans during visits for other health concerns.

a. Methods should include outreach to providers in U.S. cities or counties with a previous history of travel-related disease outbreaks or with large communities of VFR travelers.

b. Methods might include direct or indirect contact to health care providers' travelers through departments of health, national associations of health care providers, national conferences, existing professional networks with both travel medicine providers and non-expert travel medicine providers (e.g., same hospital system), or ethnic medical associations.

4. (Optional) The application may include investigator-initiated studies on travelers' health, including longitudinal epidemiologic and demographic data collection, specimen collection, and laboratory testing.

Target Population The target population for this NOFO is international travelers. High-risk travelers are a particular concern and include, but are not limited to, the following:

U.S. residents traveling to visit friends and relatives (VFRs);

U.S. students studying abroad;

Very young, very old, and travelers with immunosuppressive conditions at higher risk for acquiring an illness during travel; and Travelers visiting destinations at increased risk for illness such as sub-Saharan Africa, south Asia, and parts of Mexico, Central America, South America, and the Caribbean.

The application will include outreach to the above high-risk populations; such populations might not typically access medical care before international travel, be up-to-date on routine vaccinations, or be aware of increased risk for illness and injury at their destination.

Collaboration/Partnerships Collaborations or partnerships that might be identified in the outreach plan to travelers could include state and local departments of health, travel agents, houses of worship, or personal service providers (e.g., hairdressers).

Collaborations and partnerships that might be identified in the outreach plan to health care providers could include state and local departments of health, national associations of health care providers, national conferences, existing professional networks with both travel medicine providers and non-expert travel medicine providers (e.g., same hospital system), or ethnic medical associations.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5)-year research project period. The award recipient will collaborate with CDC to: 1) establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application's project plan; and 2) develop and implement project performance measures that are based on specific programmatic objectives. The application should provide an evaluation plan.

PD/PIs of funded applications must submit an annual progress report showing project activities and outcomes based on the overall research goals and timeline. For more information on required Reporting, please see Section VI. of this NOFO.

Translation Plan This application should include how the results and findings of the project will be tailored for the appropriate audience when disseminated. For example, scientific results should be prepared for a clinical or scientific audience whereas outcome results to travelers should be prepared in plain language. The recipient should publish the project's research and surveillance findings as well as outcomes, as appropriate.

Section II. Award Information Funding Instrument Type: 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: $7,500,000 The estimated total funding (direct and indirect) for the first year (12-month budget period) is $1,500,000. The estimated total funding (direct and indirect) for the entire five (5)-year project period is $7,500,000.

Anticipated Number of Awards: 1

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

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $1,500,000 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 (http://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.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or 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):

Nonprofits (Other than Institutions of

Higher Education)

Governments:

Eligible Agencies of the Federal

Government U.S. Territory or Possession

Other:

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."

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

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

N/A

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If an applicant requests a funding amount greater than the ceiling of $1,500,000 as indicated in Section II. of this NOFO, HHS/CDC will consider the application non-responsive and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

6. Required Registrations https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

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.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://cage.dla.mil/

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/index.html .

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 Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle 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 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.

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 https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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 https://www.sam.gov/index.html.

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 FOA 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 In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist 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:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal https://www.sam.gov/index.html http://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/assist holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf, 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 Support".

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

Mandatory

1. SF424(R&R)[V2.0];

2. PHS 398 Cover Page Supplement [V4.0];

3. Research and Related Other Project Information [V1.4];

4. Project/Performance Site Location(s) [V2.0];

5. Research and Related Senior/Key Person Profile (Expanded) [V2.0];

6. Research and Related Budget [V1.4];

7. PHS 398 Research Plan [V4.0];

8. PHS Human Subjects and Clinical Trials Information [V1.0].

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

o 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.

o 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.

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

o 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.

http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf o Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

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

o 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: 11/16/2020

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 CIO 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 institution 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 (NOFO)

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/AIDS, 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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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

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) https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf http://grants.nih.gov/grants/how-to-apply-application-guide.htm

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and here: http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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).

Examples of DMPs may be found here: USGS, http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans and University of California, https://dmp.cdlib.org/

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PLEASE NOTE all page limitations in this NOFO. Pages over the limit may be removed and not peer reviewed, possibly negatively affecting the overall impact score and funding.

7. Page Limitations https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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 https://dmp.cdlib.org/

All page limitations described in this individual NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for…