RFA-CK-21-002 Amend 1.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases Extramural Research Program

Office

Emerging Infections Network - Research for Preventing, Detecting, and Managing Travelers who Acquire Infectious Diseases Abroad

RFA-CK-21-002

Application Due Date: 12/18/2020

Emerging Infections Network - Research for Preventing, Detecting, and Managing Travelers who Acquire Infectious Diseases Abroad

RFA-CK-21-002

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 Emerging Infections Network - Research for Preventing, Detecting, and Managing Travelers who Acquire Infectious Diseases Abroad Activity Code U01 – Research Project - Cooperative Agreement

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

RFA-CK-21-002

Assistance Listings (CFDA) Number(s) 93.860 93.084 Category of Funding Activity:

Health NOFO Purpose The purpose of this notice of funding opportunity (NOFO) is to support research activities that will assist with the prevention, detection, and management of international travelers who become ill during or after travel. The project must have a focus on travel and tropical medicine providers with the capability to participate in both research and surveillance to determine the disease prevention strategies, burden, severity, optimal diagnostics, treatment interventions, and outcomes of infectious diseases acquired by travelers while abroad. This research will bridge the gap between clinical medicine and public health by assisting with improving patient care, better understanding the natural history of disease, and implementing optimal diagnostic and treatment strategies, with the ultimate outcome being an advancement in the global health security of the United States.

Key Dates Publication Date: To receive notification of any changes to RFA-CK-21-002, 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: 11/16/2020

Application Due Date: 12/18/2020 https://www.grants.gov

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: 09/01/2021

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.

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 12 pages.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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 support research activities that will assist with the prevention, detection, and management of international travelers who become ill during or after travel. The project must have a focus on travel and tropical medicine providers with the capability to participate in both research and surveillance to determine the disease prevention strategies, burden, severity, optimal diagnostics, treatment interventions, and outcomes of infectious diseases acquired by travelers while abroad. This research will bridge the gap between clinical medicine and public health by assisting with improving patient care, better understanding the natural history of disease, and implementing optimal diagnostic and treatment strategies, with the ultimate outcome being an advancement in the global health security of the United States.

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 number of awards is estimated to be one (1). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $1,500,000 with individual awards ranging from $1,000,000 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 09/01/2021 to 08/31/2026.

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 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 307 [42 USC 242l] and 317(k)(2) [42 USC 247b(k)(2)], as amended and

Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, Public Law 116-123

Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136 Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139

1. Background and Purpose The purpose of this NOFO is to support a research cooperative agreement aiming to: 1) conduct research activities that will assist with the prevention, detection, and management of international travelers who become ill during or after travel; 2) monitor for and detect sentinel infectious disease threats in a timely and efficient manner for the containment and response to emerging infectious diseases; and 3) decrease the number of international travelers who acquire a travel-related infectious disease.

Healthy People 2030 and other National Strategic Priorities Topic Areas Global Health (http://www.healthypeople.gov/2020/topics-objectives/topic/global-health)

Conduct research related to expanding the global capacity to respond to infectious disease threats.

Improve the management of patients who acquire infectious diseases.

Perform sentinel surveillance of emerging infectious diseases to protect the public’s health.

Preparedness (http://www.healthypeople.gov/2020/topics-objectives/topic/preparedness)

Establish mechanisms for prevention and mitigation of health issues encountered by international travelers.

Collaborate with external entities to investigate public health concerns.

Improve the capacity and capability of clinicians and laboratories in identifying infectious disease threats.

http://www.healthypeople.gov/2020/topics-objectives/topic/global-health http://www.healthypeople.gov/2020/topics-objectives/topic/preparedness

Public Health Impact

Surveillance:

o Monitor for and detect sentinel infectious disease threats in a timely and efficient manner for the containment and response to emerging infectious diseases o Detect novel and emerging pathogens and outbreaks of infectious diseases among international travelers o Identify travelers at risk of acquiring antimicrobial resistance to help save lives and prevent spread o Bridge public health surveillance and patient clinical care through collection of data that are both timely and high quality o Collect data that are representative of an at-risk population and use this information to inform data collection practices and clinical outreach

Epidemiology:

o Use research and surveillance data to prevent, detect, and respond to infectious diseases acquired by international travelers and migrants o Perform cohort studies to evaluate outcomes among international travelers at risk of illness abroad, including those on acquisition of antimicrobial resistance o Conduct epidemiological analyses to contribute to population-based health management and existing frameworks o Implement interventions to improve the health needs of international travelers and migrants o Establish mechanisms to prevent health issues encountered by international travelers o Conduct epidemiologic investigations with stakeholders and partners as needed

Laboratory:

o Create a repository of biologic specimens from travelers that may later be tested, for example, with novel diagnostics for emerging pathogens o Develop novel approaches to infectious disease diagnostics o Improve the capability of laboratories to identify emerging infectious diseases o Characterize antibiotic-resistant organisms in the context of international travel

Communications:

o Disseminate case information rapidly to appropriate partners and stakeholders, which is essential to the network and to local and national public health authorities o Develop modalities for rapid publication of findings to the scientific and medical community to contribute to disease detection and prevention o Collaborate with the healthcare community and public health partners during an outbreak to communicate evidence-based recommendations for management and care of ill travelers o Contribute to global health security through the timely dissemination of research findings

Relevant Work CDC research activities regarding international travelers at multiple sites are limited. This is a gap in CDC’s activity portfolio in the Travelers’ Health Branch, which the award recipient of this NOFO will fill.

Please see 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)

Strategy 1: Strengthen public health fundamentals o Objective 1.1: Improve infectious disease epidemiologic capacity domestically and globally

Strategy 2: Implement high-impact prevention and intervention strategies o Objective 2.2: Conduct research and implement proven methods to prevent and control unknown, emerging, and re-emerging high-consequence pathogens o Objective 2.5: Increase public health action to identify, prevent, and reduce infectious diseases and disparities in at-risk populations

Strategy 3: Enhance preparedness, outbreak detection, and outbreak response o Objective 3.3: Strengthen global capacity to prevent, detect, and respond to international outbreaks of public health concern that cross borders by air, land, or sea o Objective 3.4: Detect and respond to infectious diseases spread through the movement of people, animals, and cargo o Objective 3.5: Improve international collaboration and capacities for emerging infectious disease prevention, surveillance, control, and research

Strategy 4: Innovate to stop emerging and zoonotic infections o Objective 4.1: Optimize innovative ways to capture, analyze, and visualize critical public health data for decision making o Objective 4.5: Conduct and invest in innovative research to identify and combat antibiotic resistance

2. Approach Strategies and Activities Outputs Outcomes

Conduct scientific research activities to improve outcomes among ill international travelers

· Use research and surveillance data to help prevent, detect, and respond to infectious diseases acquired by international

Network of sites that have capacity to perform travel-related scientific research

Literature contributions that provide a meaningful contribution to improvement in clinical care

Identify clinical practices that are associated with the best patient outcomes

Development of novel approaches to infectious disease diagnostics https://www.cdc.gov/ncezid/pdf/ncezid-strategic-plan-2018-2023-508.pdf travelers and migrants

· Perform cohort studies to evaluate outcomes

· Implement interventions to improve the health needs of travelers

· Focus on neglected infectious diseases and vulnerable populations

· Collect biologic specimens for testing and comply with shipment regulations of biologic specimens for testing

· Improve understanding of antimicrobial resistance among international travelers

Research on aspects of travel medicine that are emerging or overlooked

Create a repository of biologic specimens from travelers with unknown diseases

Increase public health action based upon results

Contribute to global health security and bridging public health with clinical medicine

Operate a global provider-based emerging infectious sentinel network

· Organize around travel and

A robust global network of clinicians with systems of rapid and effective communication and

Improved monitoring of travel-related infections (e.g., antibiotic resistance) and infectious diseases tropical medicine practitioners and sites

· Recruit/maintain sites that have diverse geographic location, large patient volume, diagnostic and laboratory capability, research experience and interest, and access to specific traveler populations (e.g., migrants)

· Ensure continued research capacity (e.g., specimen storage, collection, and shipment capability; advanced diagnostics)

· Maintain a network that bridges clinical medicine and public health information dissemination

Sites that contribute meaningfully through the network, not only through the submission of cases, but also through participation in projects and research

Strategic direction that is robust and clear for future directions

Centralized and electronic database to maintain relevant information according to CDC policy among specific traveler populations (e.g., migrants)

Detection of sentinel events to increase global health security

Provision of evidence-based recommendations for diagnosis of ill travelers

Facilitate more rapid detection of new and emerging infectious disease threats and sentinel events

Conduct surveillance for travel-related infectious diseases

· Monitor for and detect sentinel events based upon novel geography, clinical presentation, population, severity, and outcomes

· Detect novel and emerging pathogens and outbreaks of infectious diseases among international travelers

· Ensure accurate and high-quality data collection

Peer-reviewed manuscripts reporting on the analyses of surveillance data

Resource-efficient methods for preventing, detecting, and responding

Continuous data quality assessments to ensure relevant and robust data

Surveillance data that include relevant and important target populations (e.g., migrants)

Promote global health security

Contribute to the evidence base of literature for travel-associated infectious diseases

Highlight the vulnerabilities and infectious disease consequences of travel-related infections among susceptible populations

Communicate and respond

· Disseminate information rapidly to partners and

Solid relationships with partners and stakeholders that include entities beyond CDC and ministries of health within

Identify clinical practices that are associated with the best patient outcomes stakeholders, both internally and externally (e.g., Ministries of Health, CDC, World Health Organization [WHO], Public Health Agency of Canada [PHAC], European Centre for Disease Prevention and Control [ECDC], etc.)

· Collaborate with the healthcare community and public health partners during an outbreak to communicate evidence-based recommendations for management and care

· Conduct epidemiologic investigations

· Disseminate the results of scientific publications and research countries represented by the network

Increasing knowledge on the epidemiology of emerging infectious diseases

Clinical care improvements from research results and evidence-based recommendations

Objectives/Outcomes The purpose of this NOFO is to support a research cooperative agreement aiming to: 1) conduct research activities that will assist with the prevention, detection, and clinical management of international travelers who become ill during or after travel; 2) monitor for and detect sentinel infectious disease threats in a timely and efficient manner for the containment of and response to emerging infectious diseases; and 3) decrease the number of international travelers that acquire a travel-related infectious disease.

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

The application should address the following objectives:

1. Conducting research activities through an active, global network of travel and tropical medicine clinical sites that provide travel-related health services, including diagnostics and treatment to persons during or after international travel, to prevent and improve outcomes among ill international travelers.

a. Conducting data collection, analyses, evaluation, and publication on travelers receiving health assessments, during or after travel, in order to identify and address the fundamental gaps in prevention, clinical presentation, management of diagnostics and treatment, and outcomes of infectious diseases acquired by this population.

i. The application should propose methods that enhance the ability to prevent, detect, and respond to infectious disease threats.

ii. The projects proposed may include (but are not limited to) cost-benefit analyses, cohort studies, and intervention or treatment-based evaluations.

b. Focusing projects on neglected and emerging infectious diseases, and vulnerable populations.

i. The projects proposed may include (but are not limited to) studies of antimicrobial resistance, malaria, zoonotic influenza, zoonotic coronaviruses, and other zoonotic diseases.

ii. The projects proposed may include (but are not limited to) studies of migrants, students, humanitarian aid workers, and travelers visiting friends and relatives.

2. Operating a global, provider-based, emerging infectious sentinel network, which includes the ability to perform robust research studies and surveillance and to detect sentinel and emerging infectious disease threats.

a. Including multiple, geographically diverse sites with a spectrum of patient populations (e.g., visiting friends and relatives, migrants, students, etc.) to ensure significant numbers international travelers based upon network strategic direction.

i. Including sites with diverse geographic locations, large patient volume, diagnostic and laboratory capability, research experience and interest, and access to specific traveler populations (e.g., migrants).

ii. Including sites with research capacity (e.g., specimen storage, collection, and shipment capability; advanced diagnostics capability).

iii. Including sites with specialization in the clinical assessment of tropical medicine.

b. Maintaining, evaluating, and updating an electronic, web-based database.

i. Methods should reflect the changing epidemiology of infectious diseases, the identification of new or emerging infectious diseases, and the clinical spectrum of illness for a particular disease.

ii. Updates may include addition of new diagnostic codes, refining current epidemiological case definitions, or expanding the focus of data collection.

iii. Outcomes and markers of disease severity should be included.

3. Conducting surveillance (including identification of sentinel events) for travel-associated infectious diseases.

a. Conducting data collection, analyses, evaluation, and publication on travelers receiving health assessments during or after travel in order to identify and address the fundamental gaps in travel medicine.

b. Developing systems to quickly identify unusual cases or clusters.

4. Communicating and responding

a. Incorporating novel modalities for rapid dissemination of research and surveillance findings and publications, including sentinel events and clusters, to both internal and external partners.

i. Studies or investigations should be robust; data should be analyzed and results published.

ii. Periodic updates should be given to both the scientific and clinical community and stakeholders.

iii. Methods should include direct or indirect contact with healthcare providers through existing professional networks, medical associations, national conferences, etc.

iv. Methods might include real-time updates during epidemiologic investigations to stakeholders.

b. Responding to infectious disease outbreaks, either as the lead or in collaboration with other public health authorities and jurisdictions.

5. (Optional) The application may include investigator-initiated studies on travelers’ health.

Target Population The target population for this NOFO is all international travelers, with possible focus on specific traveler sub-populations including, but not limited to, migrants as defined in the application. The application may specifically target certain sub-populations for further research and surveillance, such as migrant and immigrant populations who are largely non-English speaking and who may have limited health literacy. These groups are also known to be at increased risk of acquiring serious travel-related illnesses, such as typhoid fever and malaria, when traveling from their countries of origin or returning from visiting friends and relatives (VFRs). Knowledge gained through this research will contribute to the understanding of the dynamics of illness acquisition among sub-populations of travelers that could be used to develop programs designed to address health disparities.

Collaboration/Partnerships Collaborations and partnerships that might be considered include:

Global public health agencies (e.g., national ministries of health, WHO, ECDC, PHAC) Local or national public health, academic, and research laboratories State and local health departments Existing professional networks (including both in and out of the specialties of travel and tropical medicine) Travel medicine providers outside the network

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5)-year research project period. It should establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the research plan and develop and implement project performance measures that are based on specific programmatic objectives.

The application should identify outputs and include measures/metrics to assess outcomes in an Evaluation and Performance Measurement plan. Award recipients will be required to submit a more detailed Evaluation and Performance Measurement plan within the first 6 months of award. For more information on Reporting, please see Section VI. of this NOFO.

Translation Plan The application should include how the results and findings of the project will be tailored for appropriate audiences when disseminated. For example, scientific results will be prepared for a clinical or scientific audience, whereas outcome results to travelers will be prepared in plain language. The award recipient will 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

Estimated total funding available for the first year (first 12-month budget period), including direct and indirect costs: $1,500,000 Estimated total funding available for the entire five (5)-year project period, including direct and indirect costs: $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: $1,000,000 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 the IRS, other than institutions of higher education Private institutions of higher education

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):

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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 Foreign Organizations: a Foreign

Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

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 eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy 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/AC135 Public/Docs/US%20Instructions%20for%20NSPA%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 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 and/or the budget of $7,500,000 for the entire project period, 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 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 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 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 https://cage.dla.mil/ 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 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.

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 https://www.sam.gov/index.html

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 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 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 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 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:

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: 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 iinstitution 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/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)

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 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 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 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 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 12 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 http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans…