PKG00263625-instructions.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases Extramural Research Program

Office

Monitoring Cause-specific School Absenteeism for Estimating Community-wide Influenza and

SARS-CoV-2 Transmission

RFA-CK-21-003

Application Due Date: 12/18/2020

Monitoring Cause-specific School Absenteeism for Estimating Community-wide Influenza and

SARS-CoV-2 Transmission

RFA-CK-21-003

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 Monitoring Cause-specific School Absenteeism for Estimating Community-wide Influenza and SARS-CoV-2 Transmission Activity Code U01- Research Project - Cooperative Agreement

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

RFA-CK-21-003

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 support a research project that implements an influenza-like illness (ILI)-specific student absentee monitoring system in kindergarten through twelfth grade (K-12) schools and assess its usability for early detection of influenza, SARS-CoV-2, and other respiratory pathogen transmission in schools and surrounding communities. To achieve this aim, the project team will: 1) rapidly determine the causes of school absenteeism in students across selected school district(s) over a three-year period; 2) detect within-household transmission of influenza and SARS-CoV-2 in a subset of households from which a student has been absent from school due to ILI; and 3) assess comparability between influenza-specific and SARS-CoV-2-specific student absenteeism data from the participating schools and multiple layers of complementary influenza and SARS-CoV- 2 surveillance data routinely collected in the health care facilities serving the general population of this school district.

Key Dates Publication Date: To receive notification of any changes to RFA-CK-21-003, 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 https://www.grants.gov

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: 09/01/2021

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.

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

Note: The Research Strategy component of the Research Plan is limited to 20 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 notice of funding opportunity (NOFO) is to support a research project that implements an influenza-like illness (ILI)-specific student absentee monitoring system in kindergarten through twelfth grade (K-12) schools and assess its usability for early detection of influenza, SARS-CoV-2, and other respiratory pathogen transmission in schools and surrounding communities. To achieve this aim, the project team will: 1) rapidly determine the causes of school absenteeism in students across selected school district(s) over a three-year period; 2) detect within-household transmission of influenza and SARS-CoV-2 in a subset of households from which a student has been absent from school due to ILI; and 3) assess comparability between influenza-specific and SARS-CoV-2-specific student absenteeism data from the participating schools and multiple layers of complementary influenza and SARS-CoV-2 surveillance data routinely collected in the health care facilities serving the general population of this school district.

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 3-year project period is $3,000,000. The number of awards will 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) will be $1,000,000. The estimated total funding (direct and indirect) for the entire project period will be $3,000,000. The project period is anticipated to run from 09/01/2021 to 08/31/2024.

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. This is a single source NOFO. Only one application is expected.

Application Type. New.

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

Form F is to be used when completing 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 Children shed more virus, and have the highest influenza attack rates, compared with other age groups. Because of these biological factors, and the congregation that occurs in schools, it is recognized that schools can serve as amplification points of influenza transmission in communities. Influenza transmission among school-aged children frequently precedes subsequent community transmission. Therefore, early recognition of school-based transmission of influenza should contribute to the timely implementation of mitigation efforts to reduce morbidity and mortality in the wider community. School absenteeism due to influenza-like illness (ILI) can be an indicator of influenza activity in school children and can be used as a proxy for influenza transmission in the community. One of the advantages of school absentee systems is the availability of data in real time, which can potentially be useful as an early warning system for influenza activity in the broader community. Despite this advantage, utility of cause-specific school absentee data is not fully understood, and more studies are needed to assess this. In addition, the role of children in the transmission of SARS-CoV-2 is not understood at all. The added inclusion of SARS-CoV-2 detection among students absent because of respiratory illness, and detection in their household members, can strengthen the evidence base regarding household transmission.

The purpose of this NOFO is to support a research project that implements an influenza-like illness (ILI)-specific student absentee monitoring system in K-12 schools and assess its usability for early detection of influenza, SARS-CoV-2, and other respiratory pathogen transmission in schools and surrounding communities. The project aims at developing and implementing an influenza-like like illness (ILI)-specific absentee monitoring system and assessing its usability for early detection of influenza, SARS-CoV-2, and other respiratory pathogens in the surrounding community. To achieve this aim, the project team should: 1) rapidly determine the causes of school absenteeism in K-12 students across selected school district(s) over a three-year period; 2) detect within-household transmission of influenza and SARS-CoV-2 in households from which a student has been absent from school due to ILI; and 3) assess comparability between surveillance based on ILI-specific absenteeism and multiple layers of complementary influenza and SARS-CoV-2 surveillance centered on this school district.

Healthy People 2030 and other National Strategic Priorities This NOFO addresses the Healthy People 2020 focus area of Immunization and Infectious Diseases. The NOFO is in the alignment with the National Prevention Strategy, Healthy and Safe Community Environments strategic direction. For more information see http://www.healt hypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases and http ://www.surgeongeneral.gov/priorities/prevention/strategy/healthy-and-safe-community-envir onments.html

Public Health Impact Development and implementation of an early warning system substantially contributes to timely detection and containment of infectious disease outbreaks. Because of the congregation of children at schools, and their susceptibility to infectious diseases, transmission and amplification of influenza within schools has been purported to be a driving mechanism for subsequent outbreaks in surrounding communities. Therefore, the collection of ILI-specific absenteeism data should be a useful tool for providing real-time information needed to detect and mitigate influenza at schools, and reduce the impact of influenza outbreaks in the broader community, by timely implementation of appropriate influenza mitigation measures. The added inclusion of SARS-CoV-2 detection among students who are absent because of respiratory illness, and detection in their household members, will strengthen the evidence base regarding household transmission of SARS-CoV-2 and help assess if monitoring ILI-specific absenteeism may be helpful to timely detection of SARS-CoV-2 activity in schools and the surrounding community.

Relevant Work This NOFO anticipates the proposed project to be a multi-component, effectively functioning system that includes ongoing school-based surveillance that tracks influenza-like illness (ILI)-specific student absentee data, laboratory support that provides near real-time test results shared with study participants, and access to data from “traditional” surveillance systems that monitor influenza activity, including RT-PCR confirmation of influenza and other respiratory pathogens, most critically, SARS-CoV-2, in the community surrounding the school district. Examples of relevant work includes the following:

1. Temte JL, Uzicanin A, Goss M, Comp L, Temte E, Barlow S, Reisdorf E, Shult P, Wedig M, Florek K. Sequential, within-season infection with influenza A (H3N2) in a usually healthy vaccinated child. Influenza Other Respir Viruses. 2019; 00:1-4.

2. Arnold M, Temte JL, Uzicanin A, Bell C, Goss MD, Barlow S, Temte E, Reisdorf E, Scott S, Guenther K, Wedig M, Shult P. Adequacy of study participant – vs. research staff – collected respiratory specimens for detection of influenza viruses by RT-PCR. (in press; PLOS ONE, 2020).

3. Temte JL, Barlow S, Goss M, Temte E, Schemmel A, Maerz B, Bell C, Reisdorf E, Shult P, Wedig M, Haupt T, Conway J, Gangnon R, Fowlkes A, and Uzicanin A. The Oregon Child Absenteeism Due to Respiratory Disease Study (ORCHARDS):

http://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases http://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases http://www.surgeongeneral.gov/priorities/prevention/strategy/healthy-and-safe-community-environments.html http://www.surgeongeneral.gov/priorities/prevention/strategy/healthy-and-safe-community-environments.html http://www.surgeongeneral.gov/priorities/prevention/strategy/healthy-and-safe-community-environments.html

Rationale, Objectives, and Design. (in review; 2020).

2. Approach The project team will verify reasons for student absence in K-12 grade students and collect data and specimens from eligible students (i.e., those absent from school because of respiratory illness). Data and specimens will also be collected from household members of the eligible students in order to evaluate influenza and SARS-CoV-2 transmission within student households. Data from existing surveillance systems will be obtained and compared with absentee data, as well as data collected during the study home visits from eligible students and household members.

The surveillance system should be a multi-component, effectively functioning system that includes: 1) school-based surveillance that tracks influenza-like illness (ILI)-specific absentee data; 2) routine near real-time laboratory confirmation using RT-PCR to detect influenza and other ILI-associated pathogens, most notably SARS-CoV-2, for at least a subset of students with ILI-associated school absenteeism; and 3) access to data from “traditional” laboratory-supported surveillance systems that monitor medically attended influenza and other respiratory pathogens in the community surrounding the school district.

Objectives/Outcomes Applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound). Specifically, the project should develop and implement an ILI-specific absentee monitoring system as described in the Approach section above and assess its usability for the early detection of influenza and other respiratory pathogens in the surrounding community. To achieve these aims, the study team should:

1) Rapidly determine cause-specific school absences in K-12 students across selected school district(s) over the project period.

2) Consent and enroll eligible students to participate in the study.

3) Conduct home visits to collect:

a. Data about clinical and epidemiological characteristics of student illness.

b. Specimens for laboratory testing from eligible students.

4) Perform multiplex-PCR to detect influenza, SARS-CoV-2, and other respiratory viruses in eligible students.

5) Detect within-household transmission of influenza and SARS-CoV-2 in households from which a student has been absent from school due to ILI, by:

a. Collecting data about the clinical characteristics, and severity, of influenza and COVID- 19 in household members.

b. Collecting specimens from household members and performing RT-PCR for influenza.

6) Assess comparability between ILI-specific absenteeism and multiple layers of complimentary influenza surveillance centered on this school district.

7) Assess comparability between SARS-CoV-2-specific absenteeism and multiple layers of complimentary SARS-CoV-2 surveillance centered on this school district.

8) Maintain adequate long-term storage of the laboratory samples obtained from participants who consented for future testing for other respiratory infectious diseases.

Target Population The study will target students enrolled in K-12 grades in one or more school districts in the United States. Additionally, family members of students absent from school for influenza-like illness (due to influenza, SARS-CoV-2, or other respiratory pathogens) will also participate in the study.

Collaboration/Partnerships The application should provide evidence for an established, or to be established, effective working relationship with key partners necessary to conduct the proposed research/surveillance project such as:

- School district administration

- Laboratory that performs RT-PCR testing for the study

- Local Health Department that shares surveillance data with the study team

- State Immunization Registry that assist with ascertaining vaccination status of study participants

Evaluation/Performance Measurement The application should include measurable goals and aims based on a three (3)-year research project period. The application should describe specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application's project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

Translation Plan Applications must include a plan to estimate and report the potential translatability and public health impact of the proposed research.

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: $3,000,000

Estimated total funding available for the first year (first 12-month budget period), including direct and indirect costs: $1,000,000 Estimated total funding available for the entire three (3)-year project period, including direct and indirect costs: $3,000,000

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: $1,000,000 Per Budget Period Award Floor: $500,000 Per Budget Period Total Period of Performance Length: 3 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) http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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 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 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

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If an applicant requests a funding amount greater than the ceiling of $1,000,000 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 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 https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov

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.

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 http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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

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

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

Mandatory

1. SF424(R&R)[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:

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 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.

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

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) http://grants.nih.gov/grants/how-to-apply-application-guide.htm

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 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

Please note: According to the Additional Requirement-25 (AR-25) (https://www.cdc.gov/grants /additionalrequirements/ar-25.html), investigators who 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 as follows:

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://www.cdc.gov/grants/additionalrequirements/ar-25.html

The DMP must describe how investigators will make data readily available. Investigators 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. A Data Management Plan (DMP) is required for each collection of public health data proposed. The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include the following five elements:

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 de-identified data).

Examples of DMPs may be found here: University of California, https://dmp.cdlib.org/ or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

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.

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 20 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 https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php 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 successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems.

The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes.

Organizations must submit applications using the ASSIST web-based application preparation and submission process.

ASSIST will validate applications before submission. If the system detects errors, then the applicant must correct errors before their application can be submitted.

Applicants are responsible for viewing their application in ASSIST after submission to ensure accurate and successful submission through Grants.gov. If the submission is not successful and post-submission errors are found, then those errors must be corrected and the application resubmitted in ASSIST.

Applicants are able to access, view, and track the status of their applications in the eRA Commons.

Information on the submission process is provided in the SF-424 (R&R) Application Guidance and ASSIST User Guide at https://era.nih.gov/files/ASSIST_user_guide.pdf.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the grant 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).

Applicants who encounter problems when submitting their applications must attempt to resolve them by contacting the NIH eRA Service desk at:

Toll-free: 1-866-504-9552; Phone: 301-402-7469 http://grants.nih.gov/support/index.html Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time (closed on federal holidays)

Problems with Grants.gov can be resolved by contacting the Grants.gov Contact Center at:

Toll-free: 1-800-518-4726 https://www.grants.gov/web/grants/support.html support@grants.gov Hours: 24 hours a day, 7 days a week; closed on Federal holidays

It is important that applicants complete the application submission process well in advance of the due date time.

After submission of your application package, applicants will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. A third and final e-mail message is generated once the applicant's application 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 https://era.nih.gov/files/ASSIST_user_guide.pdf http://grants.nih.gov/support/index.html https://www.grants.gov/web/grants/support.html mailto:support@grants.gov package has passed validation and the grantor agency has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states "rejected," be sure to save time stamped, documented rejection notices, and do #2a or #2b

2. Check emails from both Grants.gov and NIH eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grants Management contact listed in the Agency Contacts section of this announcement explaining why the submission failed.

b. If there is time before the deadline, correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 12/18/2020

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

11. Funding Restrictions Expanded Authority:

For more information on expanded authority and pre-award costs, go to https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf and speak to your GMS.

All HHS/CDC awards are subject to the federal regulations, 45 CFR 75, terms and conditions, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

Protecting Life in Global Health Assistance:

In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organization (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award, either as a prime recipient or subrecipient, are strictly prohibited, regardless of the source of funds, from performing abortions as a method of family planning or engaging in any activity that promotes abortion as a method of family planning, or to provide financial support to any other foreign non-governmental organization that conducts such activities. See Additional Requirement (AR) 35 for applicability (https://www.cdc.gov/grants/additional-requirements/ar-35.html).

Public Health Data:

https://grants.nih.gov/grants/policy/nihgps/HTML5/section_10/10.10.1_executive_orders.htm https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.cdc.gov/grants/additional-requirements/ar-35.html

CDC requires that mechanisms for, and cost of, public health…