Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Environmental Health Sciences (NIEHS)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

Fogarty International Center (FIC)

National Cancer Institute (NCI)

Funding Opportunity Title
Research Coordinating Center to Support Climate Change and Health Community of Practice (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects Cooperative Agreements

Announcement Type
Related Notices


Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Assistance Listing Number(s)
93.113, 93.307, 93.865, 93.989, 93.855, 93.242, 93.361, 93.393, 93.846, 93.837, 93.838, 93.839, 93.840, 93.233
Funding Opportunity Purpose

The National Institute of Environmental Health Science (NIEHS), in partnership with Fogarty International Center (FIC), National Institute of Minority Health and Health Disparities (NIMHD), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institute of Nursing Research (NINR), National Heart Blood and Lung Institute (NHBLI) and National Institute of Allergy and Infectious Disease (NIAID) are leading an NIH-wide Climate Change and Health (CCH) Initiative with the goals of reducing the health threats posed by climate change across the lifespan, including by improving the health of people who are at increased risk from or disparately affected by climate change impacts, and to build health resilience among individuals, communities, Tribal Nations, and nations around the world, thereby addressing health equity. This Funding Opportunity Announcement (FOA) solicits applications from eligible institutions to develop a Research Coordinating Center (RCC) to support the development of an NIH CCH Community of Practice (COP) by managing and supporting current CCH research and capacity building efforts and supporting the expansion of the COP in the long term.

Key Dates

Posted Date
June 06, 2022
Open Date (Earliest Submission Date)
July 25, 2022
Letter of Intent Due Date(s)

July 25, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
August 25, 2022 Not Applicable Not Applicable November 2022 January 2023 March 2023

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
August 26, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) 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.

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

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description


For some time, international scientific consensus has been that climate change poses an existential threat to human beings. A report of the Intergovernmental Panel on Climate Change (IPCC), the United Nation’s body for assessing the science related to climate change, concluded in a recent report: Any increase in global warming is projected to affect human health, with primarily negative consequences . The report further concluded that, Compared to current conditions, 1.5 C of global warming would nonetheless pose heightened risks to eradicating poverty, reducing inequalities and ensuring human and ecosystem well-being.

Climate change greatly elevates threats to human health across a wide range of illnesses and injuries. Adverse health impacts include asthma, respiratory airway and pulmonary diseases, cardiovascular disease and stroke, heat-related illness and deaths, allergic hypersensitivities and infectious diseases (notably, water-borne, food-borne, vector-borne, and zoonotic diseases), reproductive, birth outcome, and developmental effects, mental health disorders, and extreme weather-related morbidity and mortality Strong evidence indicates that climate change also disproportionately adversely affects communities that experience social and environmental vulnerabilities. Such communities could include American Indian/Alaskan Native, Asian Americans, Blacks/African Americans, Hispanic/Latinos, Native Hawaiian and other Pacific Islanders, sexual and gender minorities, socioeconomically disadvantaged populations, underserved rural populations,and those unduly burdened by exposure to environmental pollution. In addition to the need for research on understanding the effects of these emerging threats on human health, there is a significant need for climate change adaptation efforts to reduce the hazards and negative impacts of climate change on human health. Development of innovative research tools, technologies, methodologies, and approaches on climate change and health (CCH) will significantly increase the potential for understanding the complex drivers and mechanisms of adverse health outcomes and enable timely, effective and impactful interventions.

The Climate Change and Health (CCH) Initiative is a National Institutes of Health (NIH)-wide research effort established to address the effects/implications of climate change on the health of populations and create the evidence base to inform the response needed to improve health outcomes. Health Effects Research, Health Equity Research, Intervention Research, and Training and Capacity Building are key focus areas of the CCH initiative. The initiative will bring together NIH-funded CCH researchers and scientific, community, and interagency partners to form a CCH community of practice (CCH-COP) research network committed to advancing the science of climate change and health. It is envisioned that the CCH-COP will catalyze transdisciplinary research approaches to address multiple and emerging climate threats to human health, particularly in national and global populations most at risk. Through the overarching CCH initiative, the NIH intends to fund the Alliance for Community Engagement (ACE-CCH), a platform that will maximize community engagement to facilitate CCH research and achieve climate justice and health equity.


This Funding Opportunity Announcement (FOA) solicits applications from eligible institutions to develop a Research Coordinating Center (RCC) to support the development of an NIH CCH-COP by managing and supporting current and future CCH research and capacity building efforts. The RCC will create a robust, inclusive CCH-COP that fosters collaboration, capacity building, innovation and research that aligns with the NIH CCH initiative. The RCC will offer opportunities for collaboration between multiple disciplines required to conduct solutions-driven research on the health impacts of climate change. Additionally, the RCC seeks to promote inclusion of scientists from diverse backgrounds, including scientists from nationally underrepresented groups (see, Notice of NIH's Interest in Diversity, NOT-OD-20-031), and Historically Black Colleges and Universities, Tribal Colleges and other Minority Serving Institutions in the community of practice. Comprehensive initiative coordination, including supporting services such as data and project management, will be part of the RCC efforts. The RCC will develop and provide access to novel and innovative resources widely throughout the existing CCH-COP research network while promoting its expansion by facilitating transdisciplinary capacity building across the research continuum, including the engagement of a diverse workforce of trainees to promote CCH research. The RCC will collaborate in parallel with the NIH-funded community engagement platform (ACE-CCH), and other community engagement networks, to build trusting relationships between community members and CCH researchers in the U.S. The NIH anticipates a growing CCH research network and a growing COP. The RCC should anticipate this expansion and associated evolution of activities over the lifetime of the grant. The RCC Program Director(s)/Principal Investigator(s) will work closely with NIH program officials and network investigators to support its evolution. The efforts of the RCC will be instrumental in advancing the science of CCH and will contribute towards the development of a self-sustained CCH research network comprised of public and private partners from health and non-health sectors.

Applications are sought from multidisciplinary teams with national and global expertise in climate change and population health research and with strengths in the following areas: (1) leadership, project management, and engagement of multi-site, multi-disciplinary research teams; (2) developing and maintaining cloud-based systems that allow for data management, integration, and sharing; (3) multidisciplinary and community-based partnership and resource development; and (4) supporting research education and capacity building efforts. The RCC will mobilize and support the CCH community of practice and facilitate CCH research through the following functions.

Administrative Function

  • Internally manage the activities of the RCC.
  • Collaborate with the CCH Program Steering Committee to coordinate research network activities.
  • Convene an External Advisory Board that will provide guidance and strategic advice to the RCC.
  • Build and maintain inclusive and effective partnerships.
  • Expand the COP by promoting collaboration and communication across multiple service sectors (e.g., academic organization, environmental organizations, public health departments, federal agencies, community-based organizations, etc.)
  • In collaboration with the NIH and CCH-COP, plan/host stakeholder meetings, COP annual grantee meeting, technical assistance workshops/webinars, etc. to facilitate CCH research and create summary reports of the hosted events. It is expected that the annual grantee meeting will begin in the first year of the award.
  • Collaborate with the ACE-CCH and community engagement activities of the research network to promote partnerships among scientists, community organizations and stakeholders.
  • Evaluate research network operations to optimize performance.

Resource Function

  • Create database of active projects, personnel, publications, grants, leveraged by CCH-COP.
  • Facilitate engagement across the CCH-COP research network (i.e., social media, web-based communication platforms, idea incubator)
  • Create content for the NIH CCH website that promotes the CCH-COP.
  • Facilitate collaborations between researchers and Federal and international agencies involved in CCH research and practice.
  • Identify topics of importance to the network and organize working groups that will address issues and make recommendations for implementing solutions (i.e., data integration, predictive modeling).
  • Develop/Adapt data collection instruments, measures, and training content for researchers to facilitate CCH knowledge sharing and advance CCH research.
  • Develop guidelines (e.g., technical, policy, data access, ethical data sharing).
  • Provide consultative and technical assistance to recipients regarding data access and sharing.
  • Disseminate CCH-COP advances with research community, policymakers, and the public (e.g., research briefs, blogs, spotlights, etc.).
  • Share best practices across the research network (guidelines, lessons learned, toolkits, etc.).

Data Management Function

  • Conduct a regional, national, and global data landscape analysis to identify existing data resources and datasets applicable to CCH.
  • Develop data management options for CCH initiatives.
    • Distribute data with metadata links to enable collaborations.
    • Standardize data collection instruments.
    • Provide initial data management plan with expectation that it will evolve as the network grows.
  • Coordinate data and linkages for data collection and use (e.g., link health, social, environmental data).
  • Provide high-security-compliant, high-capacity informatics infrastructure suitable for data integration, storage, management, and sharing and ensure that the data meet the FAIR

    principles: findability, accessibility, interoperability, and reusability.

  • Develop/collect common data elements across CCH research projects.

  • Harmonize data elements to create combined datasets for future meta-analyses.

Research Capacity Building Function

Domestic and Global

  • Develop/Adapt/Leverage curricula, educational content, learning modules, that are culturally, linguistically, and literacy-appropriate to increase awareness and education about the health implications of climate change especially among underserved communities.
  • Facilitate training, mentorship, and professional development in CCH research, especially among professionals from underrepresented groups.
  • Develop a plan for research and training opportunities such as pilot research projects and training support that aligns with CCH research priorities.
  • Share capacity-building best practices.
  • Consider and facilitate strategies, approaches, processes, and best practices to promote the research community’s capacity to develop and implement time-critical health research, as well as longer-term studies, in response to extreme weather disasters, wildfires, and other health emergencies


  • Collaborate with the Data Management team to make data management and research tools, including infrastructure, and datasets accessible to global members of the CCH-COP.
  • Assist global CCH recipients in identifying research partners and resources to enhance the recruiting/hiring of investigators with climate change and public health research experience.
  • Develop and deliver distance learning and mentorship opportunities to facilitate collaboration across the CCH-COP research network and other partners.
  • Facilitate working groups on topics specific to unique global health challenges and to conducting CCH research in Low and Middle-Income Countries (LMIC) impacted by ongoing climate events and risks.
  • Promote collaborations between LMIC scientists and researchers from other parts of the world and encourage intellectual exchanges and data sharing.

Applicant institutions should have the infrastructure, diverse teams and partnerships, and commitment to manage a Coordinating Center. The Program Director(s)/Principal Investigator(s), PD(s)/PI(s), are expected to be experienced in leading multi-site research networks in the US and globally, including in LMICs. To meet the needs of a national and global program, the Coordinating Center should consist of strong central leadership and experienced management personnel to implement the key activities of the CCH research network.

Proposals that do not include national and global CCH research and population health expertise on the multi/trans-disciplinary team will be considered non-responsive to this funding opportunity and will be withdrawm without review.

Applicants are strongly encouraged to consult with the Scientific/Research contacts for the area of science for which they are planning to develop an application prior to submitting to this FOA.

The NIH will hold an informational webinar/Q&A session June 17, from 1:00pm-3:00pm EDT on Zoom (Registration required at:

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed


The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2023 for a total of $2,250,000 to support one award:

NIEHS, $500,000 towards one award

NIAID, $400,000 towards one award

NCI, $300,000 towards one award

NIMHD, $250,000 towards one award

NIMH, $250,000 towards one award

NHLBI, $250,000 towards one award

NICHD, $125,000 towards one award

NIAMS, $100,000 towards one award

FIC, $50,000 towards one award

NINR, $25,000 towards one award

Award Budget

Application budgets are limited to $2.250M total costs per year.

Award Project Period

The maximum project period is 3 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH 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
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession


  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Applicants must have an active SAM registration in order to complete the registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 NIH support. See, e.g., Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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.

Letter of Intent

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 IC 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:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Linda K. Bass, PhD

National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3236

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Outline the general objectives of the proposed CCH Research Coordinating Center (RCC) and the overall approach to achieving these goals.

Research Strategy: The Research Strategy section should document the applicant’s national and global experience in climate change and population health research and the capacity for coordinating multidisciplinary and multi-site research. Include plans for carrying out the main functions of the RCC according to the subsections below.

Administrative activities should, at minimum, describe:

  • The governance structure of the RCC.
  • Plans for developing a dynamic national and global CCH-COP research network.
  • Research network coordination, collaborative, and community engagement efforts.
  • Processes for facilitating meetings (e.g., annual grantee, technical assistance workshops, etc.)
  • A proposed timeline of planned activities.

Resource development activities should, at minimum, describe:

  • A catalog of CCH-COP research projects, personnel, publications, grants leveraged.
  • How data access and sharing will be facilitated for CCH research network and external investigators.
  • Plans for sharing network accomplishments (e.g., via NIH CCH website, briefs, blogs, etc.).
  • How the RCC will address disputes regarding resources within the CCH-COP.

Data Management activities should, at minimum, describe:

  • A plan for developing a data management system and procedures.
  • The infrastructure for data collection, integration, and sharing processes.
  • Processes for identifying, developing, and harmonizing common data elements across the research network.

Research Capacity Building activities should, at minimum, describe:

  • How training, mentorship, and professional development in CCH research will be facilitated, especially for professionals from underrepresented groups.
  • A plan for how research pilot projects and research training priorities could be identified, including how the COP could be expanded to include new and diverse researchers as well as time-sensitive proposals such as post-climate disaster research.
  • A plan for expanding CCH training and research opportunities to support short-term research training experiences of pre/post-doctoral students and early-stage investigators.
  • How the RCC will promote collaborations between established NIH-funded researchers within the COP with scientists in relevant fields outside the COP, investigators at minority serving institutions in climate vulnerable regions of the U.S., as well as LMIC researchers from other parts of the world.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.

  • Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
  • NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories(NOT-OD-21-016).
  • NIH encourages the use of data standards including the PhenX Toolkit ( (for example, see NOT-DA-12-008, NOT-MH-15-009)

Recipients conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).


Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier (UEI) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the Scientific Review Officer, Dr. Linda Bass by email at when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the proposed RCC address the needs of the CCH research program that it will serve? Is the scope of activities proposed for the RCC appropriate to meet those needs?

Specific to this FOA:

What is the likelihood that the proposed RCC will significantly support and advance the goals of the CCH research program and increase research capacity at the national and global levels?

To what extent has the proposed RCC described robust methods and systems to build a diverse COP, promote collaborations and capacity building, develop common resources, and provide sound data management for the conduct of CCH research projects.

Are the PD(s)/PI(s) and other personnel well suited to their roles in the RCC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing multi-site research networks in the US and globally? Do the investigators demonstrate significant experience with coordinating collaborative research? If the RCC is multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA:

Do management personnel and the overall team have the appropriate skills for implementing the key activities of the RCC?

Do key personnel have appropriate expertise and experience in the conduct of multi-site CCH research to achieve the scientific objectives of the CCH research network?

Does the application propose novel organizational concepts in coordinating the research network the RCC will serve? Does the application describe innovative methods for fostering research collaboration across geographically distant locations in the CCH research program?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the RCC will serve? Will the proposed capacity building efforts increase the likelihood of success of the national and global centers? Have the investigators proposed methods to collaborate with the ACE-CCH to build and promote transdisciplinary team efforts?

Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Is an adequate plan provided for how the RCC will build a diverse COP, compile and disseminate shareable data resources, and foster collaboration across the COP?

Is there a clear plan to identify important scientific topics for exploration and recommendations by scientific working groups?

Are plans to provide technical assistance to the research network, individually and as a whole appropriate? Is the Data Sharing Plan reasonable?

Will the institutional environment in which the RCC will operate contribute to the probability of success in facilitating the CCH research program it serves? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the RCC proposed? Will the RCC benefit from particular features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Is there capacity to create virtual platforms for meetings and resource sharing?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIEHS in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity , sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see and

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Coordinating project activities technically, scientifically, and administratively at the awarded institution and coordinating with project activities at participating sites
  • Creating web-based resources for the CCH research network including a website addressing NIH policies, procedures, application information and materials, web-based course content, and email and other web-based systems for group communication
  • Serving as a voting member on the CCH Research Network Steering Committee
  • Soliciting, receiving, and selecting applications for pilot grant funding in collaboration with NIH
  • Assisting network investigators who are participating in research involving human subjects in securing appropriate Institutional Review Board approvals and certifications
  • Organizing an annual face-to-face or virtual meeting, conferences, workshops
  • Submitting interim progress reports, when requested, to the NIEHS
  • Sharing knowledge, data, research education materials, and any other resources necessary and relevant to the CCH research program

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH Project Scientists(s) will:

Serve as the contact point for all facets of the scientific interaction with the recipient. As required for the coordination of activities and to expedite progress, NIEHS may designate additional NIH staff to provide advice to the recipient on specific scientific and/or analytic issues.

  • Review and comment on critical stages in the program implementation
  • Convene meetings/workshops to address emerging areas of high priority
  • Facilitate communication between the RCC and other NIH programs or recipients to share project information as appropriate
  • Interact with the Program Director(s)/Principal investigator(s) on a regular basis, which may include regular communications with the Program Director/Principal Investigator and staff, periodic site visits, quality control, fiscal review, and other relevant matters, as well as attendance at Steering Committee related meetings
  • The NIEHS Project Scientist or designee may be co-authors on study publications. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscript

The NIEHS Program Official will:

  • Assist in ensuring general statutory, regulatory, or administrative assistance policy requirements.
  • Make recommendations for continued funding based on the recipients: a) overall study progress and b) cooperation in carrying out the project (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements).
  • Additionally, the Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

  • Establishing and participating in a Steering Committee consisting of: 1) the PD(s)/PI(s) (who will serve as Chair(s)); 2) two external members selected by the PD(s)/PI(s) and 3) the NIEHS Program Official, and 4) NIH/NIEHS Project Scientists. Each member will have one vote except for the NIEHS Program Official who is not a voting member. The Steering Committee will meet in person or virtually at least once a year and will convene by telephone or in-person as needed. The Steering Committee has primary responsibility to oversee research activities, establish priorities, review progress, and monitor participant accrual. Major scientific decisions regarding adjustments to the project will be determined by the Steering Committee.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: (preferred method of contact)
Telephone: 301-480-7075 Customer Support (Questions regarding registration and Workspace)
Contact Center Telephone: 800-518-4726

Scientific/Research Contact(s)

Abee L. Boyles, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3241

Curt DellaValle, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7225

Arielle S. Gillman, PhD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366

Email: Stephanie George, PhD, MPH, MA
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Telephone: 301-594-4974

Flora N Katz
Fogarty International Center (FIC)
Phone: 301-402-9591

Regina Bures, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9485

Adriana Costero-Saint Denis, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-292-4284

Liz Perruccio, MS, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-8084

Curt DellaValle, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7225

Megan Kinnane, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3679

Larry Fine
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0305

Peer Review Contact(s)

Linda K. Bass, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3236

Financial/Grants Management Contact(s)

Jenny L. Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332

Dawn M. Mitchum, MPH, CRA
National Cancer Institute (NCI)
Telephone: 240-276-5699

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412

Sahar Rais-Danai
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-5032

Bruce R Butrum
Fogarty International Center (FIC)
Phone: 301-451-6830

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552

Vandhana Khurana, M.B.A.
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-669-2966

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807

Dawn M. Mitchum, MPH, CRA
National Cancer Institute (NCI)
Telephone: 240-276-5699

Maggie Paolini
National Institute of Mental Health (NIMH)
Phone: 301-443-2746

Francesca Alicia Hunter
National Heart, Lung, and Blood Institute (NHLBI)
Phone: none

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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