Foa_Content_of_RFA-CK-22-006.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Clinical and Applied Research Strategies for the Prevention and Control of Fungal Diseases

RFA-CK-22-006

02/15/2022

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

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

National Center for Emerging and Zoonotic Infectious Diseases Notice of Funding Opportunity (NOFO) Title Clinical and Applied Research Strategies for the Prevention and Control of Fungal Diseases Activity Code Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-CK-22-006

Assistance Listings Number(s) 93.084 Category of Funding Activity HL - Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to conduct high quality clinical and applied fungal public health research activities to improve fungal public health outcomes in the United States and territories. Projects may be quantitative, qualitative, or mixed-methods epidemiological studies, laboratory-based studies, or other types of research projects focusing on:

a) Improving the understanding of fungal disease epidemiology;

b) Optimizing the diagnosis and treatment of patients with fungal diseases;

c) Understanding the impact of public health interventions to mitigate the impact of fungal diseases.

This NOFO addresses both established and emerging fungal pathogens and encompasses domestic health projects. All clinical and applied research projects should include clear mechanisms for informing fungal public health policy and practice at local, national, and regional levels.

Key Dates Publication Date:

To receive notification of any changes to RFA-CK-22-006, 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:

01/14/2022 Application Due Date:

02/15/2022 On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S. Eastern Time.

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

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

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

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

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

Scientific Merit Review:

04/12/2022 Secondary Review:

05/19/2022 Estimated Start Date:

09/01/2022 Expiration Date:

02/15/2022 https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

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

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

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

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

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

Executive Summary Purpose: The purpose of this NOFO is to conduct high quality research aimed at reducing the morbidity and mortality of patients affected by fungal diseases. Research projects may involve quantitative, qualitative, and/or mixed-methods epidemiological studies, laboratory-based studies, or other types of research projects that focus on: a) improving the understanding of fungal disease epidemiology; b) optimizing the diagnosis and treatment of patients with fungal diseases; and c) assessing the impact of public health interventions to mitigate the impact of fungal diseases. This NOFO addresses both known and emerging fungal pathogens and encompasses domestic fungal health projects.

All clinical and applied research projects should include clear mechanisms for informing fungal public health policy and practice at local, national, and regional levels.

Mechanism of Support: U01 Research Project - Cooperative Agreement.

Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire five (5)-year project period is $7,500,000. The estimated number of awards is up to three (3). 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 $1,500,000 with individual awards ranging from $400,000 to $500,000 for the first year. The estimated total funding (direct and indirect) for the entire project period will be $7,500,000. The project period is anticipated to run from 09/01/2022 to 08/31/2027.

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

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

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

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

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

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

Application Type. New.

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

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

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

1. Background and Purpose Fungal diseases pose an important global public health threat. Infections from fungi may be acquired in community or healthcare settings. Certain pathogenic fungi are more common in particular regions or climates, but their distribution may shift as a result of many factors, including climate change. Fungal diseases most often impact persons with weakened immune systems, including those with transplants, cancer, or advanced HIV disease; however, fungal infections are increasingly reported in persons without classical risk factors. In particular, severe fungal infections are an important concern in patients with COVID-19 or influenza and are associated with poor outcomes. The global burden of fungal diseases is increasing because of the expanding number of patients at risk for these infections. Unfortunately, patients are often misdiagnosed and receive delayed or inappropriate treatment; this may be due to low awareness of fungal diseases, among both clinicians and the general public, and limited laboratory diagnostic capacity. The emergence of antifungal drug resistant organisms constitutes an urgent public health threat; specifically, Candida auris, other drug-resistant Candida species, and azole-resistant Aspergillus fumigatus included on CDC’s 2019 AR Threats Report.

The purpose of this NOFO is to conduct high quality research aimed at reducing the morbidity and mortality of patients affected by fungal diseases. Research projects may involve quantitative, qualitative, and/or mixed-methods epidemiological studies, laboratory-based studies, or other types of research projects that focus on: a) improving the understanding of fungal disease epidemiology; b) optimizing the diagnosis and treatment of patients with fungal diseases; and c) assessing the impact of public health interventions to mitigate the impact of fungal diseases. This NOFO addresses both known and emerging fungal pathogens and encompasses domestic fungal health projects. All clinical and applied research projects should include clear mechanisms for informing fungal public health policy and practice at local, national, and regional levels.

Heath Equity CDC supports efforts to improve the health of populations disproportionately affected by infectious diseases by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

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

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

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

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

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

Healthy People 2030 and other National Strategic Priorities HP 2030 goal to increase immunization rates and reduce preventable infectious diseases.

Infectious Disease - Healthy People 2030 | health.gov HP 2030 metrics related to avoiding workplace injury, which is related to any adverse infection-associated outcomes in a workplace setting. Reduce work-related injuries resulting in missed workdays — OSH-02 - Healthy People 2030 | health.gov

HP 2030 healthcare-associated infection metrics that are specific to bloodstream infections. Health Care-Associated Infections - Healthy People 2030 | health.gov

HP 2030 metrics specific to sexually transmitted infections. Sexually Transmitted Infections - Healthy People 2030 | health.gov https://www.cdc.gov/socialdeterminants/index.htm

Public Health Impact This NOFO will directly and substantially impact public health by supporting high-quality clinical and applied fungal public health research. Specifically, research will guide stakeholders to prioritize resources, inform policies, and implement practices and interventions that mitigate the impact of fungal diseases.

Relevant Work The Mycotic Diseases Branch (MDB) of the U.S. Centers for Disease Control and Prevention (CDC) is one of few public health groups in the world devoted solely to the prevention and control of fungal infections. For decades, MDB has worked to increase knowledge of fungal diseases, improve testing practices, provide guidance to health care professionals, and support partners engaged in work to mitigate the impact of fungal diseases. A list of selected publications from the Mycotic Diseases Branch is below.

1. Gold JAW, Seagle EE, Nadle J, Barter DM, Czaja CA, Johnston H, Farley MM, Thomas S, Harrison LH, Fischer J, Pattee B, Mody RK, Phipps EC, Shrum Davis S, Tesini BL, Zhang AY, Markus TM, Schaffner W, Lockhart SR, Vallabhaneni S, Jackson BR, Lyman M. Treatment Practices for Adults with Candidemia at Nine Active Surveillance Sites - United States, 2017-2018. Clin Infect Dis. 2021 Jun 3: ciab512. doi: 10.1093/cid/ciab512.

2. Benedict K, McCracken S, Signs K, Ireland M, Amburgey V, Serrano JA, et

al. Enhanced surveillance for histoplasmosis — nine states, 2018–2019 Open Forum Infect Dis. 2020 Aug 17

3. Caceres DH, Arauz AB, Flores C, Santiago E, Montoya S, Carlos Saenz, et

al. Implementation of Rapid Diagnostics Assays for Detection of Histoplasmosis and Cryptococcosis in Central American People Living with HIV. Mycoses: Diagnosis, Therapy, and Prophylaxis of Fungal Diseases. 2021 May 9

4. Verweij PE, Rijnders BJA, Brüggemann RJM, Azoulay E, Bassetti M, Blot S, et

al. Review of influenza-associated pulmonary aspergillosis in ICU patients and proposal for a case definition: an expert opinion. Intensive Care Med. 2020 Jun 22

5. Toda M, Beekmann SE, Polgreen PM, Chiller TM, Jackson BR, Beer KD. Knowledge of infectious disease specialists regarding aspergillosis complicating influenza, United States. Emerg Infect Dis. 2020 Apr

6. Donovan FM, Wightman P, Zong Y, Gabe L, Majeed A, Ynosencio T, Bedrick EJ, et

al. Delays in coccidioidomycosis diagnosis and associated healthcare utilization, Tucson, Arizona, USA. Emerg Infect Dis. 2019 Sep

7. Haumba SM, Toda M, Jeffries R, Ehrenkranz P, Pasipamire M, Ao T, et al. Prevalence of cryptococcal antigen (CrAg) among HIV-positive patients in Eswatini, 2014–2015. Afric J Lab Med. 2020 Jul 29

8. Chi GC, Benedict K, Beer KD, Jackson BR, McCotter O, Xie F, Lawrence JM, et

al. Antibiotic and antifungal treatment among persons with confirmed coccidioidomycosis – Southern California, 2011. Med Mycol. 2019 Jul 9.

2. Approach Research projects should aim to improve the understanding of fungal disease epidemiology, optimize the diagnosis and treatment of patients with fungal diseases, and/or improve understanding of public health interventions to mitigate disease impact:

https://www.cdc.gov/fungal/cdc-and-fungal.html https://www.cdc.gov/fungal/cdc-and-fungal.html https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofaa343/5893591 https://onlinelibrary.wiley.com/doi/abs/10.1111/myc.13303 https://onlinelibrary.wiley.com/doi/abs/10.1111/myc.13303 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7306567/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7306567/ https://wwwnc.cdc.gov/eid/article/25/9/19-0023_article https://wwwnc.cdc.gov/eid/article/25/9/19-0023_article https://ajlmonline.org/index.php/ajlm/article/view/933 https://ajlmonline.org/index.php/ajlm/article/view/933 https://academic.oup.com/mmy/article-lookup/doi/10.1093/mmy/myz073 https://academic.oup.com/mmy/article-lookup/doi/10.1093/mmy/myz073

Improve understanding of fungal disease epidemiology o Define populations at risk of disease acquisition or poor outcomes; risk factors might be genetic, occupational, socioeconomic, or underlying medical conditions, medical therapies, or behaviors o Identify emerging trends in disease epidemiology (e.g., changes in antifungal drug resistance patterns, species distribution, emerging populations at-risk) o Identify factors associated with reactivation of previous disease o Characterize disease impact (e.g., financial, psychosocial, reduced quality of life, inability to work, etc.).

Optimize diagnosis and treatment for patients with fungal diseases o Assess algorithms for testing and/or treatment of fungal diseases o Evaluate performance of fungal diagnostic tests (might include tests to diagnose current or previous infection) o Identify barriers to medication adherence o Identify treatment factors associated with improved outcomes o Evaluate the performance of biomarkers in patients to predict risk for current or future infection, or reactivation of latent disease.

Evaluate and optimize public health interventions (e.g., fungal decolonization, environmental/air sampling methods and strategies, vaccines) to decrease the morbidity and mortality from fungal diseases.

Please note: This NOFO may fund health information systems infrastructure, including workforce and public health laboratories, to support the specific strategies, activities, and outcomes described in this NOFO. Any proposed health information system infrastructure activities should be reflected in the detailed budget submitted by grant applicants.

Objectives/Outcomes The objective of this cooperative agreement is to ultimately improve the public health of persons at risk for fungal diseases. Research activities should fill critical gaps in knowledge regarding fungal infections and ultimately allow prevention, earlier detection, improved outcomes, and decreased morbidity and mortality.

The below logic model outlines the short-term, intermediate, and long-term outcomes towards which the recipients are expected to make progress in achieving objectives during the period of performance. Not all outcomes will be relevant to every recipient’s project plan and will depend on the program strategies used by the recipient.

Objectives Short-term outcomes

Intermediate outcomes

Goals o Improve the understanding of fungal disease epidemiology o Optimize diagnosis and treatment of patients with fungal diseases o Evaluate diagnostic delays or misdiagnoses o Evaluate antifungal stewardship o Identify barriers to following evidence-based guidelines for antifungal drug treatment and utilization of antifungal susceptibility testing o Evaluate adherence to treatment guidelines and strategies for improvement o Identify barriers to limited capacity for and utilization of antifungal susceptibility testing to guide treatment and strategies for improvement o Identify barriers to medication adherence o Increase awareness of fungal diseases among clinicians, public health practitioners and the general public o Increase earlier diagnosis and improved outcomes for affected patients o Reduce barriers to testing and treatment for fungal diseases o Increase implementation of effective public health measures to reduce burden from fungal diseases o Prevent death and severe disease through improved control, identification, and appropriate treatment for established and emerging fungal infections and outbreaks

Objectives Short-term outcomes

Intermediate outcomes

Goals o Identify factors associated with improved outcomes o Assess algorithms for testing and/or treatment of fungal diseases o Evaluate tests to diagnose current or previous infection o Evaluate biomarkers to predict risk for current or future infection, or reactivation of latent disease

Target Population Target populations will vary depending on the activities proposed or specific fungal pathogen studied under this NOFO. Target populations might include multiple groups, including healthcare providers from a variety of clinical specialties, healthcare provider groups (e.g., physicians, nurses, nurse assistants, etc.), laboratories, public health organizations, and persons at risk of, or affected by, fungal infections.

Collaboration/Partnerships Collaborations with a broad range of partners are critical to generate data, make recommendations, and implement those recommended actions and inform policies relevant to fungal diseases. Collaborations and/or research that involves a network of partners are strongly encouraged. If an investigator chooses to include collaborations or partnerships in the application, it should outline the nature of these collaborations/partnerships and how these collaborations/partnerships will help to achieve the outcomes proposed in the application.

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

Translation Plan The application should describe plans for how research and scientific findings will be reported and disseminated (e.g., peer-reviewed journals, scientific presentations, reports, meetings, and conferences) and specify how these activities are integrated into the project plans. The recipient should use appropriate scientific journals to disseminate research findings to the broader scientific community. The recipient should present important evaluation and research findings at relevant national or international scientific meetings and conferences. The translation of findings should be tailored to appropriate audiences when disseminated, including policy makers, practitioners, public health programs, health care institutions, professional organizations, community groups, researchers, and other potential users.

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

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

Application Types Allowed:

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

Estimated Total Funding:

$7,500,000

Estimated Total Funding, including direct and indirect costs: $7,500,000 Estimated Total Annual Budget Period Funding, including direct and indirect costs:

Year 1: $1,500,000 (up to $500,000 per award) Year 2: $1,500,000 (up to $500,000 per award) Year 3: $1,500,000 (up to $500,000 per award) Year 4: $1,500,000 (up to $500,000 per award) Year 5: $1,500,000 (up to $500,000 per award)

Anticipated Number of Awards:

Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $1,500,000

Estimated total funding available for the entire period of performance, including direct and indirect costs: $7,500,000

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

Award Ceiling:

$500,000 Per Budget Period

Award Floor:

$400,000 Per Budget Period

Total Period of Performance Length:

5 year(s)

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

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

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

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

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

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

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

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

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

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

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

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

o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education) Private non-profit institutions of higher education Eligible Agencies of the Federal Government Faith-based or Community-based Organizations U.S. Territory or Possession

Regional Organizations Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via https://www.grants.gov

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

4. Justification for Less than Maximum Competition N/A

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

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

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

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

https://eportal.nspa.nato.int/AC135Public/Docs/US Instructions for NSPA NCAGE.pdf

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

Grants.gov eRA Commons https://www.grants.gov https://gov.ecfr.io/cgi-bin/searchECFR https://gov.ecfr.io/cgi-bin/searchECFR https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons

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

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

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

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

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

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

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

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

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

https://www.Grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0

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

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

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

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

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

Section IV. Application and Submission Information

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

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

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

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

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

https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov http://grants.nih.gov/support/index.html

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

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

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

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

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

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

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

Mandatory

1. SF424(R&R);

2. PHS 398 Cover Page Supplement;

3. Research and Related Other Project Information;

4. Project/Performance Site Location(s);

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

6. Research and Related Budget;

7. PHS 398 Research Plan;

8. PHS Human Subjects and Clinical Trials Information.

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.

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

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

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

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

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

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

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

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

Optional

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

3. Letter of Intent Due Date for Letter Of Intent 01/14/2022

01/14/2022

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

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

Name of the applicant organization Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this notice of funding opportunity

The letter of intent should be sent to:

Gregory Anderson, MPH, MS Extramural Research Program Office

Office of the Associate Director of Science National Center for HIV, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS US8-1 Atlanta, GA 30333 Telephone: 404-718-8833 Fax: 404-718-8822 Email: GAnderson@cdc.gov

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

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

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

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

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.

mailto:GAnderson@cdc.gov

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

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

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

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

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

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

Standards to be used for the collected or generated data;

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

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

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

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

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

Applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, 2022.

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

https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

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

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

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 publicly available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PLEASE NOTE: If applications go beyond the page limit designated for a given section of this NOFO, excess pages will be removed from the application prior to peer review and may negatively affect the application’s scoring.

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 for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide at .How to Apply - Application Guide.

Applicants must use FORMS-G application packages for due dates on or after January 25, 2022 and must use FORMS-F application packages for due dates on or before January 24, 2022.

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

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

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

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.