Part 1. Overview Information

Key Dates

Applications will be accepted on a rolling basis, beginning November 1, 2022. Applications will be accepted through March 1, 2025.

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

Applications will be accepted on a rolling basis, beginning November 1, 2022. Applications will be accepted through March 1, 2024.

Not Applicable

Applications will be reviewed within 8 weeks.

Applications will be reviewed on an expedited basis

Within 4-6 months of application

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

BACKGROUND

This Funding Opportunity Announcement (FOA) establishes an accelerated review/award process to support novel behavioral and social science research (BSSR) to understand health outcomes related to an unexpected and/or time-sensitive event. Applications in response to this FOA must demonstrate that the research proposed is time-sensitive and must be initiated with minimum delay due to a limited window of opportunity to collect baseline data, answer key research questions, and/or prospectively evaluate a new policy or program that will likely impact health-related behavior or health outcomes in a given population. In other words, the urgency of the public health problem being studied will not, on its own, be sufficient justification for time sensitivity.

RESEARCH SCOPE

This FOA is intended to support research and data collection for unanticipated real-world events (i.e., those that occur outside of a laboratory or other controlled setting for research purposes). These events inherently have limited windows of opportunity for planning and conducting rigorous research and data collection. It is critical that researchers maximize these learning opportunities to better inform health care and public health efforts, as well as policymakers.

Key Definitions for this FOA:

• An event is a unique and often unanticipated issue that arises in a particular community/population, due to emerging environmental threats, other public health threats, disaster events, or policy changes.
• Policy is broadly defined to include both formal public policies at local, state, and federal levels of government, and organizational level policies, such as those implemented by large organizations, worksites, or school districts.
• Program is defined as a set of activities such as implementation of system-level interventions, tools, or guidelines initiated by governmental or other organizational bodies, within public or private entities in local, state, or federal jurisdictions.
• Infrastructure changes are alterations to the built environment such as housing, roads and other aspects of transportation systems, retail environments, and building of parks or green spaces.

This FOA encourages partnerships and collaboration between researchers and the impacted community, which may include the following types of entities (as appropriate): community-based organizations, local and state governments, private or non-profit organizations, behavioral health or health care systems, individual health care providers, departments of health, community health clinics, juvenile or criminal justice settings, schools, child welfare systems, etc.

The distinguishing features of a responsive study are:

(1) The unpredictable and unanticipated nature of the research opportunity.

(2) The clear scientific value and feasibility of the study.

(3) A feasible plan for collection of baseline data and primary data collection (although use of existing data is allowed, a plan for collecting important and new data rapidly should be provided).

(4) A justification for why an expedited review and funding (substantially shorter than the typical NIH grant review/award cycle) are required in order for the scientific question(s) to be addressed and the research design to be implemented. Expected study methodologies may include, but are not limited to, interrupted time-series, difference-in-difference designs, regression discontinuity, or propensity scoring.

In situations where applications under this FOA focus on a particular locality (region, community, or other defined geographic area), note that findings should have the potential to be generalizable beyond the particular locality or population. Proposed studies should demonstrate the ability to inform the understanding of the impact of the event, policy, program or infrastructure change in the near-term. Applicants are encouraged to include secondary implementation related outcomes that could inform interpretation of outcomes for future researchers and decision-makers, such as unintended consequences or barriers and facilitators associated with implementation.

Applicants are also encouraged to review the NIH-led efforts that recommend research strategies for ensuring study rigor and reducing bias, such as including an appropriate comparison group where possible: NIH Pathways to Prevention (P2P) Workshop: Method for Evaluating Natural Experiments in Obesity. Furthermore, attention should be paid to ongoing developments in strengthening causal inference from evaluation of these natural experiments or observational study designs. Considerable progress has been made on this topic in public health, econometrics, and diverse aspects of policy research.

STRUCTURE

This FOA will utilize a bi-phasic, milestone-driven R61/R33 mechanism, consisting of a R61 phase with developmental activities and a R33 phase with expanded activities designed to achieve the full research aims. The R61 phase will be up to one year, and will support developmental, exploratory research, Institutional Review Board approval for human subjects protection, further development of study partnerships, and the collection of baseline data. The R33 phase will build on this initial work for up to four years to include further development, application, follow-up data collection, or implementation as appropriate and relevant to the proposed research questions.

The application should articulate clear aims and objectives for each phase of the proposed research, with specific discussion of how results from the R61 phase will inform the R33 phase. In addition, applications must delineate explicit milestones for the R61 and R33 phases. A milestone is defined as a scheduled event in the project timeline that indicates completion of a project stage or activity. It is expected that baseline data collection will be conducted within six months of award, which should be included in the applicant’s submission of a project timeline and milestones. At the completion of the R61 phase, the Program Director (PD)/Principal Investigator (PI) will submit a report that includes the progress on each of the milestones and a clear description of how research during the R33 phase will be impacted by attainment of the R61 milestones. The IC program and other relevant staff will review the report and make recommendations on funding of the R33 grant based on two independent factors: 1) the preliminary research results and achievement of the milestones and 2) availability of funds and program priorities, irrespective of milestone achievements. Transition to the R33 phase is neither automatic nor guaranteed. Funding for the R33 phase is subject to availability of funds and program priorities, independent of milestone achievement. In addition, given the possibility for changes in policy or program implementation that are beyond the control of the grantee, grant awards may be terminated early if these changes limit the possibility to collect meaningful outcome data.

ADDITIONAL GUIDANCE

While applicants may propose to investigate time-sensitive opportunities outside the U.S., they must demonstrate within the application that all the proper logistics, human subjects concerns, and approvals, both domestic and international, can be addressed within the limited time frame outlined in this announcement. In addition, the applicant must demonstrate how information obtained from this study will have direct implications for US practice or policy.

Applicants are strongly encouraged to contact the relevant scientific contact(s) listed below to discuss whether their application would likely be responsive based on time-sensitivity four (4) weeks in advance of planned application.

Applications Not Responsive to this FOA

The following types of applications are not responsive to this FOA. Applications not responsive to this FOA will not be reviewed.

• Applications that do not explicitly justify the time sensitivity of the proposed work, the urgent need for data collection, and the need for an expedited review timeline. Include this explanation in the Significance section of the application.
• Applications that propose to use qualitative data exclusively (though mixed method approaches are encouraged).
• Applications that propose to conduct analyses of existing data exclusively (unless allowed in IC-specific interests).
• Applications aimed at addressing unanticipated needs or additional aims for an existing study (i.e., expansion of an existing study).
• Applications proposing to use animals (e.g., pets, laboratory animals, or wildlife) as surrogates for human health or exposure.
• Applications where the PD/PI of the evaluation study application is the Director and/or initiator of the policy, program, or infrastructure change that will be evaluated.
• Applications that independently propose initiation and/or delivery of new policies or programs.

All responsive applications to this FOA will be subject to an accelerated review and award process. It is intended that eligible applications selected for funding will be awarded within 4-5 months of the application due date. However, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline.

SPECIFIC AREAS OF RESEARCH INTEREST

National Cancer Institute (NCI)

NCI supports time-sensitive evaluation of programs, policies, and major events that concern aspects of cancer prevention and control including, but not limited to:

Evaluation of the effects of:

• Laws, regulations, or policies that may influence cancer risk factors including use of tobacco, alcohol, and other substances, sun safety and indoor tanning, diet, physical activity, and sleep.
• Changes to the built and natural environment involving factors such as housing, transportation infrastructure, food environment, parks and other green and blue spaces and the potential effect on cancer risk factors, exposure to environmental carcinogens, access to care, or other cancer-related health outcomes.
• Emerging programs and policies related to cancer screening, diagnosis, vaccination (e.g., HPV), treatment, and survivorship.
• New policies, programs, and practices in cancer care delivery related to standards of care, health insurance coverage, access to services, reimbursement, and other factors that influence delivery of cancer care services and its outcomes
• The impact and response to public health emergencies or disasters (natural or man-made) on acute stress, allostatic load or other aspects of accumulated stress, or cancer-related care, including preventative, diagnostic, treatment, and survivorship care.
• Natural and man-made disasters (e.g., chemical spills, fumes, weather events, and fires), and resulting environmental exposures on biomarkers, etiology, and healthcare delivery across the cancer control continuum.
• Natural and man-made disasters (e.g., chemical spills, fumes, weather events, and fires), and resulting environmental exposures on biomarkers, etiology, and healthcare delivery across the cancer control continuum.

Proposals evaluating policy and program efforts and responses to major events from diverse sectors, including government, educational, non-profit, and commercial sectors are of interest.

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

NICHD has particular interest in research on time-sensitive events, policies, programs, or infrastructure changes on vulnerable populations falling within the NICHD scientific mission area, including infants, children, and adolescents and pregnant and post-partum people; individuals with physical and/or intellectual disabilities; and children who are unhoused or in foster care. The NICHD Strategic Plan outlines high priority areas for the Institute.

Examples of research questions include but are not limited to the following:

• Understanding the short- and long-term impact of the time-sensitive event on child development outcomes, as well as family functioning.
• The impact of climate/environmental changes on dietary patterns, food choices, and eating behaviors.
• How changes in access to school lunch programs affect dietary patterns, food choices, and eating behaviors in children and their families.
• The impact of the event and the concomitant public health response on the management of complex medical conditions, critical illness, and severe, life-threatening injuries in children.
• The impact of the event on emergency medical services to children (EMSC) and the availability of these services during and after the event to affected children in low- to moderate- resourced communities.
• Studies identifying and developing data sources, tools and resources needed to strengthen tracking, reporting and communication among systems of care for traumatized, injured and affected children during and after the unexpected event.
• The impact of the event and the concomitant public health response on children and adults with physical and/or intellectual disabilities, and disparities in outcomes experienced by persons with disabilities compared to persons without disabilities.
• Studies that examine how unexpected disruptions in access to therapies and special education services affect developmental, behavioral and functional outcomes in children and adults with disabilities.

National Institute on Drug Abuse (NIDA)

This notice of funding opportunity (NOFO) will support pilot, feasibility or exploratory research in priority areas in substance use epidemiology, prevention, and health services, including: 1) responses to sudden and severe emerging drug issues (e.g. the ability to look into a large and sudden spike in opioid or synthetic cannabinoid use/overdoses in a particular community); 2) responses to emerging marijuana trends and topics related to the shifting policy landscape, related to imminent policy change; 3) responses to unexpected and time-sensitive prescription drug abuse research opportunities (e.g., new state or local efforts); 4) responses to unexpected and time-sensitive medical system issues (e.g. opportunities to understand addiction services in the evolving health care system); 5) responses to unexpected and time-sensitive criminal or juvenile justice opportunities (e.g. new system and/or structural level changes) that relate to drug abuse and access and provision of health care service; 6) partnerships between researchers and state or local organizations to support the evaluation of new local policies, programs, or practices in response to public health emergencies (e.g., the opioid crisis); 7) research examining how the COVID-19 pandemic has impacted drug markets and overdose risk; 8) research examining health outcomes associated with telehealth compared to in-person psychiatric care (e.g. risk of diversion/misuse, reduced treatment gap); 9) research examining the impact of the discontinuation of the Medicaid continuous enrollment provision that was enacted during the COVID-19 pandemic on populations with substance use disorders, and 10) research to understand outcomes related to states receiving and implementing Centers for Medicare and Medicaid Services (CMS) 1115 waivers that allow Medicaid to pay for health care services in carceral settings.

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities. NIMHD focuses on all aspects of health and health care for racial and ethnic minority populations in the U.S. and the full continuum of health disparity causes as well as the interrelation of these causes. NIMHD projects should include a focus on racial and ethnic minority populations (African Americans/Blacks, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders) and or less privileged socioeconomic groups, Projects may also examine intersectionality of race or ethnic minority identity and/or low socioeconomic status with rurality and/or sexual and gender minority identity and/or disability condition. Comparison groups/populations may also be included as appropriate for the research questions posed. NIMHD encourages research projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for more information). Studies based outside the U.S. or its territories will not be supported by NIMHD under this FOA. Time-sensitive research that NIMHD is interested in supporting includes:

• The effects of policy changes on health outcomes, and mechanisms of those health outcomes, in populations that experience health disparities, including: immigration policy, health care coverage, gun policy, police use-of-force policy, environmental regulations, prescribing practices, and vaccination requirements
• The immediate and longer-term impact of natural disasters on the health of populations that experience health disparities (particularly through the lens of understanding how climate change is impacting health disparities)
• Effects of changes to the built environment (e.g., greenspace, pedestrian walkways, bike paths) on health and health behaviors for populations that experience health disparities

National Institute of Nursing Research (NINR)

NINR supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest to NINR.

Research is encouraged in the following areas:

• Factors involved in a response to a time-sensitive event that affect health equity, including mechanisms involved.
• Effects of social determinants of health on the response to and health effects resulting from a time-sensitive event.
• Prevention and early detection of health effects of a time-sensitive event, including plans for health promotion during and following the event.
• Examining clinical, organizational and/or policy changes to address health related needs during and following a time-sensitive event.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA will support time-sensitive research in public health priority areas in alcohol and related substance use epidemiology, prevention, and health services, including but not necessarily limited to:

• time-sensitive research opportunities to study the effects of changes in alcohol-related policies, including effects on combined use of alcohol and other substances and evaluation of the implementation or effectiveness of policies, programs, or practices affecting alcohol-related behaviors and outcomes;
• time-sensitive research opportunities to study changes in factors affecting access, delivery, or financing of health care services for alcohol use disorder and alcohol-related conditions;
• time-sensitive research opportunities to study alcohol-related effects associated with sudden and severe events, such as natural disasters, acts of war, or epidemics;
• time-sensitive research opportunities to study the effects on diversity, health equity, inclusion, or access of unanticipated events affecting alcohol-related behaviors and outcomes; and
• time-sensitive research opportunities to inform state or local organizations of the alcohol-related consequences of new or changing policies, programs, or practices.

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

NIAMS is interested in applications focused on evaluating time-sensitive natural experiments that concern populations with or at risk for development of NIAMS core-mission diseases (arthritic and other rheumatic, musculoskeletal, and skin disorders. Examples include, but are not limited to, time-sensitive natural experiments of changes to the neighborhood food and physical activity environments on the health of populations experiencing or at risk for NIAMS core-mission diseases. Studies among underserved, vulnerable, diverse and health disparities populations are encouraged.

Office of Disease Prevention (ODP)

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP co-funds research that has strong implications for disease and injury prevention and health equity and that includes innovative and appropriate research design, measurement, and analysis methods. The ODP has a specific interest in projects that develop and/or test preventive interventions. Of particular interest is prevention research addressing leading causes and risk factors for premature morbidity and mortality, dissemination and implementation, and health disparities. The ODP does not award grants; therefore, applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed in this announcement. Please contact the relevant IC Scientific/Research Contact(s) listed for questions regarding IC research priorities and funding. ODP only accepts co-funding requests from NIH Institutes and Centers (ICs). For additional information about ODP, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.

Office of Research on Women's Health (ORWH)

ORWH works with the 27 NIH Institutes and Centers to advance rigorous research of relevance to women and individuals assigned female at birth. For this funding opportunity, ORWH is particularly interested in intersectional research into the health impacts of time-sensitive events, policies, programs, or infrastructure changes on women, including:

• Impacts of policy changes on the health of women and people who can become pregnant (e.g., state abortion regulations, extensions to postpartum insurance coverage)
• Impacts of policy changes that influence access to women's preventative health services (e.g., contraception, HPV vaccination, pre-exposure prophylaxis (PrEP))
• Gender-based violence following time-sensitive events (e.g., natural disasters; pandemics)

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

Section II. Award Information

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

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 Government

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

Other

• 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

Other

• 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

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

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

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 SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov 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.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov 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.

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

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 2.3.7.4 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 2.3.9.4 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov 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:

Sarika Parasuraman, PhD, MPH
Telephone: 301-594-1205
Fax: 301-402-1150
Email: sarika.parasuraman@nih.gov

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

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.

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

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

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

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.

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

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

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

Research Strategy: Applications should justify the time sensitivity of the proposed work, the urgent need for data collection, and the need for an expedited review timeline in the Significance section of the application.

The Research Strategy should include a description of both the R61 and R33 phases, each with clear aims and objectives. Include a specific section labeled "Milestones". Milestones should be clearly described, feasible, well developed, quantifiable, and scientifically justified to transition to the R33 phase. A discussion of the milestones relative to the progress of the R61 phase and the implications of successful completion of the milestones for the R33 phase should be included. It is expected that baseline data collection will be conducted within six months of award, which should be included in the applicant’s submission of a project timeline and milestones.

If applicable and proposing to investigate time-sensitive opportunities outside the U.S., the application must include information demonstrating that all the proper logistics, human subjects concerns, and approvals, both domestic and international, can be addressed within the limited time frame outlined in this announcement. In addition, the applicant must demonstrate how information obtained from this study will have direct implications for US practice or policy.

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.

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.

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 Grants.gov

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 Grants.gov (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 Grants.gov 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 Grants.gov 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. This FOA accepts applications on a rolling basis. Applications are reviewed on an expedited schedule and assigned to an Advisory Council round based on their actual submission date. Because the Scientific Merit Review assignment deadline listed in Part 1. Key Dates is not an application due date, the NIH Policy on Late Application Submission does not apply to the Scientific Merit Review or Advisory Council round assigned.

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.

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.

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 provided on the application is the same identifier 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, NIH. Applications that are incomplete , non-compliant or non-responsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in 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?

Milestones and timeline: Is there a unifying research question that transcends both R61 and R33 phases? Does the application provide well described, feasible and quantifiable milestones for the R61 phase and related scientific goals and objectives for the R33 phase? Are those milestones conducive to accomplishing the study aims? Are the goals of the R33 phase based, in part, on findings collected during the R61 phase? Does the timeline demonstrate baseline data collection within six months of award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

If applicable and proposing to investigate time-sensitive opportunities outside the U.S., is there appropriate justification of how the information obtained from the study will have direct implications for US practice and/or policy? Is there adequate information provided demonstrating that all the proper logistics, human subjects concerns, and approvals, both domestic and international, can be addressed within the limited time frame outlined in this announcement.

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.

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Time Sensitivity

Reviewers will assess whether or not (i.e., yes/no) applications demonstrate the time sensitivity of the research opportunity; in other words, will an important opportunity for scientific inquiry and data collection be lost if the work is not initiated in an expedited way (i.e., with minimum delay). It should be clear that the knowledge gained from the proposed study is time-sensitive such that an expedited review and funding are required in order for the scientific question(s) to be answered. Reviewers are also asked to determine whether or not the event described in the application offers an uncommon and scientifically compelling opportunity that might only be available through this mechanism. Of particular relevance is that an expedited award would facilitate baseline data collection at a critical point in the timeline of the event in question.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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).

Resource Sharing Plans

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).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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 Center for Scientific Review (CSR) 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.

• 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.5. 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:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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 identify, 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 https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html 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.

Not Applicable

Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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 www.fsrs.gov on all subawards over $25,000. 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 Appendix XII to 45 CFR Part 75, 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 Award Term and Conditions 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.

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: http://grants.nih.gov/support/ (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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Sarika Parasuraman, PhD, MPH
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-594-1205
Email: sarika.parasuraman@mail.nih.gov

Gregory Bloss
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-3865
E-mail: gregory.bloss@nih.gov

Karen A. Kehl, PhD, RN
National Institute of Nursing Research
Telephone: 301-594-8010
Email: karen.kehl@nih.gov

Stephanie M George, PhD, MPH, MA
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-4974
E-mail: stephanie.george@nih.gov

Elizabeth Anne Barr, Ph.D.
Office of Research on Women's Health (ORWH)
Phone: 301-402-7895
E-mail: elizabeth.barr@nih.gov

Arielle Samantha Gillman
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: arielle.gillman@nih.gov

Layla Esposito, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6888
Email: espositl@mail.nih.gov

Marsha Lopez
National Institute on Drug Abuse (NIDA)
Phone: 301-402-1846
E-mail: lopezmar@mail.nih.gov

Marissa Shams-White
National Cancer Institute (NCI)
Phone: 240-276-7654
Email: marissa.shams-white@nih.gov

Bramaramba Kowtha MS, RDN, LDN
Office of Disease Prevention (ODP)
Telephone: 301-435-8052
Email: bramaramba.kowtha@nih.gov

Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov

The Office of Behavioral and Social Sciences Research (OBSSR) cannot accept assignments of applications or manage funded research projects. Please contact the IC-based grants management professionals below for related inquiries .

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: jfox@mail.nih.gov

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov

Sahar Rais-Danai
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-5032
E-mail: sahar.rais-danai@nih.gov

Priscilla Grant
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Phone: 240-276-6277
Email: crystal.wolfrey@nih.gov

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.

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.