Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

National Eye Institute (NEI)

National Heart, Lung, and Blood Institute (NHLBI)

National Human Genome Research Institute (NHGRI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

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

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Pre-application: Opportunities for Collaborative Research at the NIH Clinical Center (X02 Clinical Trial Optional)
Activity Code

X02 Preapplication

Announcement Type
Reissue of PAR-18-950
Related Notices

  • October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
  • September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
  • August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169
  • August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
  • April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109

Funding Opportunity Announcement (FOA) Number
PAR-21-342
Companion Funding Opportunity
PAR-21-343 , U01 Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.865, 93.242, 93.172, 93.121, 93.867, 93.394, 93.395, 93.173, 93.846, 93.273, 93.213, 93.838, 93.837, 93.839, 93.840, 93.233, 93.855, 93.853
Funding Opportunity Purpose

The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs).

Specifically, the program seeks to broaden and strengthen patient-centric translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.

In order to be eligible for this program, the application must include at least one intramural scientist as a co-Program Director/Principal Investigator (co-PD/PI) and at least some of the clinical research must be conducted at the NIH Clinical Center. Through this collaboration, external researchers may gain access to the NIH Clinical Center and leverage the diverse Clinical Center resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential for advancing disease diagnosis, treatment and prevention. The special environment of the Clinical Center can support studies that may not be readily supported elsewhere. This may include collaborations that propose targeted increases in new patients enrolled in protocols at the Clinical Center. For this initiative, patients must be seen at the NIH Clinical Center. Projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked samples or data, will not be considered for funding.

This funding opportunity announcement (FOA) encourages X02 pre-applications for Opportunities for Collaborative Research at the NIH Clinical Center. The X02 pre-application is the recommended (not required) first step in the application process for the companion U01 FOA (PAR-21-343). Potential applicants should read both FOAs. Investigators whose X02 pre-applications are meritorious, can be accommodated by the resources of the NIH Clinical Center and the relevant intramural program, and align with the research missions of the participating NIH Institutes, will be notified of the opportunity to submit a U01 application under PAR-21-343 .

No awards will be made under this FOA.

Key Dates

Posted Date
November 19, 2021
Open Date (Earliest Submission Date)
November 11, 2021
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
December 14, 2021 December 14, 2021 December 14, 2021 January 2022 Not Applicable Not Applicable
December 13, 2022 December 13, 2022 December 13, 2022 January 2023 Not Applicable Not Applicable
December 13, 2023 December 13, 2023 December 13, 2023 January 2024 Not Applicable Not Applicable

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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
December 14, 2023
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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The goal of this funding opportunity announcement (FOA) is to support collaborative, patient-centric translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to promote partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs and clinics outside of the NIH). It will provide support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center (https://ocr.od.nih.gov/new_u01/new_u01.html) by conducting research projects in collaboration with NIH intramural investigators. For this initiative, while some study participants may be seen at extramural sites, other study subjects must be seen at the NIH Clinical Center. Projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked specimens or data, would not be considered for funding.

While translating basic research into clinical practice is increasingly difficult, time consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients. As such, this FOA intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science. All teams must have at least one intramural and one extramural investigator.

This program will provide access for external researchers to the NIH Clinical Center and will leverage the diverse Clinical Center resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential implications for disease diagnosis, treatment and prevention in human subjects. The NIH Clinical Center is a hospital exclusively dedicated to clinical research, thus research is the culture and research studies are routine. Its mission includes the support of clinical studies that are considered intellectually challenging and risky but with the potential of high reward with new breakthroughs in medicine. The special environment of the Clinical Center supports studies that may not be readily supported elsewhere. This includes collaborations that propose targeted increases in new patients enrolled in protocols at the Clinical Center.

Examples of the special resources of the Clinical Center include:

  • Large cohorts of patients, including studies of >500 rare diseases;
  • The manufacturing and use of newly designed PET ligands for imaging studies;
  • The availability of blood products for special research studies;
  • Collaborative opportunities on clinical protocols (http://clinicalstudies.info.nih.gov/) on unique pharmaceutical agents and/or other modes of therapy, or extraordinarily rare diseases with investigators who are known experts;
  • A robust training curriculum in clinical research;
  • The ability to support long-term clinical studies at minimal cost to patients and their families.
  • On-campus amenities (e.g., Family Lodge and Children's Inn) to assist patients and families in supportive, home-like environments as they leave their own homes to participate in clinical research; and
  • A number of other resources

For entry to the program, projects must have a collaborating Investigator in the NIH Intramural Program. As a collaborative partner, the intramural investigator will be actively involved in the planning and execution of the research project. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact listed in Section VII if the collaborating intramural investigator is from an NIH Institute or Center that is different from the Institute or Center expected to receive the X02/U01 applications. Additional information is available on the "Frequently Asked Questions" website for the program (https://ocr.od.nih.gov/new_u01/faqs.html).

Specific Areas of Interest

Awards for high quality science demonstrating the potential to result in understanding an important disease process or lead to a new therapeutic intervention will be available in topics relevant to the research interests and priorities of the participating NIH Institutes/Centers (ICs), to include:

NCI

The National Cancer Institute (NCI) invites applications in research areas relevant to the Institute's mission, which is to provide global leadership for research, training, health information dissemination, and other programs with respect to the cause, prevention, diagnosis, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and their families.Translational and clinical research areas of interest to the NCI include, but are not limited to:

  • Enhanced understanding of the molecular and physiological basis of health and cancer;
  • Enhanced understanding of the clinical mechanisms underlying responses and non-responses of cancer to treatment regimens to further improve prevention, diagnosis, and treatment strategies;
  • Enabling the translation of basic discoveries into clinical practice to benefit cancer patients; and
  • Enabling the reverse translation of clinical study data to improve mechanistic studies in clinically relevant preclinical models, and to accelerate clinical evaluation of safe, effective, and durable therapeutic interventions.

The NCI Vision and Priorities are found at http://www.cancer.gov. Information about the NCI intramural investigators and their research interests can be found at https://ccr.cancer.gov/. The NCI particularly encourages well-balanced extramural-intramural contributions to impactful, innovative collaborative research projects. Of note, the NCI does not support conducting Phase 3 clinical trials in any area of cancer research through this funding opportunity announcement. Therefore, applications proposing such Phase 3 clinical trials will be deemed non-responsive and will not be reviewed. However, applications proposing to perform correlative studies with well-annotated clinical specimens from Phase 3 trials will be accepted.

NEI

The National Eye Institute's mission is to "conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual function, preservation of sight, and the special health problems and requirements of the blind." Specific areas of interest include:

  • Eye movement recording facility including stimuli presentation, video and eye coil recording equipment, and software to analyze the recordings is available for collaborative research in eye movement research;
  • Collaborative genetic research through eyeGENE. Collaborative research using cohorts of children and adults with inherited eye diseases and ocular malformations including but not limited to: uveal coloboma, Stargardt disease/ABCA4 retinopathy, for spinocerebellar ataxia, type 7 (SCA7), albinism, and modeling disease pathogenesis using induced pluripotent (iPS) cells derived from patients;
  • Collaboration in ongoing studies with a focus on retinal vascular diseases and uveitis. Examples can be found at http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html;
  • Collaborative research using cohorts of children with ocular inflammatory disease, including juvenile ideopathic arthritis (JIA) as well as monogenic disorders;
  • Collaboration in evaluating African Americans with ocular inflammatory disease with a particular emphasis on Sarcoidosis. In addition, studying the role of the immune system in African American patients with age-related macular degeneration (AMD);
  • Collaboration with those interested in investigating autoimmune retinopathy, the underlying pathophysiology and treatment; and
  • Evaluating patients

NHGRI

The National Human Genome Research Institute research areas of interest include the genetics, genomics and molecular biology of normal and abnormal human development.

NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) invites applications in research areas relevant to the Institute's mission, which is to provide global leadership for a research, training, and education program to prevent and treat heart, lung, blood, and sleep disorders and diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI encourages basic research to increase understanding of the molecular and physiological basis of health and disease; stimulates clinical discoveries about the mechanisms underlying disease to develop improved prevention, diagnosis, and treatment; enables the translation of basic discoveries into clinical practice for the benefit of personal and public health; fosters training and mentoring of emerging scientists and physicians; and communicates research advances to the public.

Specific research interests of the Institute are identified in the NHLBI Strategic Plan. More information about research conducted by NHLBI intramural investigators can be found at https://www.nhlbi.nih.gov/research/intramural/researchers.

NIAAA

The mission of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) is to generate and disseminate knowledge about the effects of alcohol misuse and alcohol use disorders (AUD) on health and well-being. NIAAA invites translational, collaborative research projects aimed at reducing alcohol related problems within the programmatic priorities established by its strategic plan. Of particular interest to this FOA are medications development for alcohol misuse and AUD, studies on health effects of alcohol misuse and AUD, and studies advancing prevention and treatment of AUD via measures pertinent to the addiction neuroclinical assessment framework. Studies that increase understanding of normal and abnormal biological functions and behavior relating to alcohol misuse in a wide range of scientific areas including genetics, neuroscience, and epidemiology are of interest.

Research shows that diverse teams working together outperform homogenous teams. Scientists from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific workforce. It is expected that the research program will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT-OD 20-031 (Notice of NIH's Interest in Diversity). NIAAA is especially interested in enhancing representation from racial, ethnic and gender minorities and early-stage investigators.

NIAID

The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. To accomplish its mission, NIAID conducts and supports a comprehensive portfolio of research on the biology, pathogenesis, and host response to microbes; the mechanisms of normal immune function and immune dysfunction resulting in autoimmunity, immunodeficiency, allergy, and transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat the many infectious, immune-mediated, and allergic diseases that afflict people throughout the world. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID. http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/.) NIAID will prioritize applications that will increase the numbers of patients seen at the NIH Clinical Center.

NIAMS

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. Areas of particular interest to the NIAMS intramural clinical program which would enhance the use of Clinical Center resources include studies on the genetics, genomics, prevention, and treatment of vasculitis; systemic lupus erythematosus; inflammatory muscle disease; autoinflammatory diseases; ankylosing spondylitis and spondyloarthropathies; and inflammatory disease associated with primary immunodeficiencies.

NICHD

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports research in areas relevant to normal and abnormal human development, including: contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development; childhood development through adolescence; intellectual and developmental disabilities; and rehabilitation medicine. NICHD encourages applications that address its extramural program priorities and will consider how well research projects align with one or more of those priorities when making award decisions. A detailed list of NICHD high priority research areas may be found at https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/areas-research/Pages/priorities.aspx.

NIDCD

NIDCD seeks to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. The faculty and research interests of the NIDCD intramural research program can be found a thttp://www.nidcd.nih.gov/research/faculty/pages/alpha.aspx. The intramural program uses a variety of tools of molecular and cellular biology, genetics, development, physiology, neuroimaging and systems biology to understand normal and disordered processes. The research areas of focus for intramural/extramural collaborations under this FOA include hearing and balance.

NIDCR

The National Institute of Dental and Craniofacial Research (NIDCR) seeks to conduct and support collaborative translational projects addressing programmatic priorities of the Institute while enhancing a partnership with the NIH Clinical Center and available resources unique to the NIH. The mission of the NIDCR is to improve oral, dental and craniofacial health while promoting the timely translation to clinical application. Areas of particular interest to the NIDCR intramural clinical program include collaborations in salivary gland dysfunction, oral inflammatory diseases, and craniofacial congenital disorders to diagnose, prevent or treat these conditions. More information about the NIDCR intramural investigators and research interests in these areas can be found at https://www.nidcr.nih.gov/research/conducted-at-nidcr.

NIMH

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for recovery, prevention, and cure. To support its mission, NIMH has formulated a Strategic Plan with the following four overarching objectives:

These four Strategic Objectives form a broad roadmap for the Institute's research priorities over the next 5 years, beginning with the fundamental science of the brain and behavior, and ending with public health impact. NIMH's overall funding strategy is to support a broad spectrum of investigator-initiated research in fundamental science, with increasing use of Institute-solicited initiatives for applied research where public health impact is a short-term measure of success. Full implementation of these Strategies, will, we hope, transform the diagnosis, treatment, and prevention of these devastating illnesses.

NINDS

NINDS intramural investigators conduct research at the NIH Clinical Center in the following areas: Neuroimmunology and Neurovirology, Surgical Neurology, Neurogenetics, Autonomic Disorders, Muscle Disorders, Epilepsy, Motor Neuron Diseases, Clinical Neurophysiology, Movement Disorders, Neurorehabilitation, Stroke, and Neuroimaging. More details about these areas and investigators can be found at: https://dir.ninds.nih.gov/ninds/PatientClinicalPrograms.html.

NCCIH

The NCCIH encourages applications for collaboration with one or more of its intramural investigators focused on better understanding of central pain pathways and the mechanisms by which complementary health approaches modulate pain. NCCIH's intramural research program focuses on mechanistic understanding of acute and chronic pain, the development and maintenance of chronic pain, and the modulation of pain by non-pharmacological interventions. Much of the research is targeted at understanding how cognitive, emotional and environmental factors influence pain states. Studies to test the efficacy of specific interventions are not appropriate for this mechanism of support. More details about the program and its investigators can be found at https://nccih.nih.gov/research/intramural.

ORWH

The Office of Research on Women’s Health (ORWH) is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH, and throughout the scientific community. ORWH has a research directive encompassing both the influence of sex and gender on health and disease, and the total health of women across the full spectrum of research. ORWH encourages interdisciplinary approaches in translating pre-clinical, basic research to clinical, and/or health services research, including behavioral research. ORWH is interested in partnering to support research in the areas of interest identified by the participating institutes and centers listed in this announcement. Please see the 2019-2023 Trans-NIH Strategic Plan for Women’s Health Research on the ORWH website (https://orwh.od.nih.gov) for further details.

IMPORTANT: 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. Early contact provides an opportunity for IC staff to discuss the program scope and goals, and to provide information and guidance. Other aspects of an application that are unique to this program including collaboration with Intramural Investigators may also be discussed.

For a more complete listing of resources in these research areas at the NIH Clinical Center and for assistance in how to apply, please refer to the website for the program at https://ocr.od.nih.gov/new_u01/new_u01.html.

Non-Responsive Applications:

X02 applications will be considered non-responsive if they take only minimal advantage of Clinical Center resources, such as utilizing only banked samples or data.

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

Section II. Award Information

Funding Instrument

Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications.

Application Types Allowed
New
Resubmission

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?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

No awards will be made under this announcement.

Award Budget

Awards through the companion U01 application (PAR-21-343) will be up to $500,000 direct costs per year, for a period of up to 5 years.

The scope of the proposed project should determine the project period. The maximum project period is 5 years for projects that include a planning year as part of the research plan. For projects that do not need a planning year, the maximum project period is 4 years.

Potential applicants are reminded to consider the project period limitation for the companion U01 application when developing their research plans for the X02 pre-application.

Award Project Period

Not Applicable

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

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)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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. 

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.

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.

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.

This program requires the full collaboration of the extramural PD/PI of the applicant institution and the intramural investigator.

Applications must include at least one intramural scientist as co-Program Director/Principal Investigator (co-PD/PI), and at least some of the clinical research must be conducted at the NIH Clinical Center.Intramural investigators whose involvement would not be classified as substantial should be assigned a collaborator role.

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.

 

Page Limitations

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

For this specific FOA, the Research Strategy section is limited to 6 pages.

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.

Type of Submission: Select "Pre-application".

Total Federal Funds Requested: Enter "0".

Total Federal and Non-Federal Funds: Enter "0".

Estimated Program Income: Enter "0".

Cover Letter: Applicants are encouraged to indicate the appropriate NIH Institute/Center in the cover letter.

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.

The following attachments must be included, as applicable.

1. Collaboration Plan

Applications must include a proposed Collaboration Plan, describing how the proposed collaboration will be maintained throughout the duration of the award. The following areas should be addressed:

  • Organizational structure;
  • Management plan detailing how existing resources, including unique resources available through the NIH Clinical Center, will be utilized;
  • Planned interactions and responsibilities of key personnel; and
  • Description of how research teams will communicate (e.g., videocast, web meeting, etc.).

2. Attachments Related to Clinical Trials
Attachments such as the Clinical Protocol, Statistical Analysis Plan, Data and Safety and Monitoring Plan, Informed Consent Forms, etc., are NOT required for the X02 pre-application. These materials will, however, be required for the companion U01 FOA.

SF424(R&R) Senior/Key Person Profile

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: Specific Aims for the proposed research project should be included in the X02 pre-application.

Research Strategy: Within the Research Strategy, the applicant must describe how the application fulfills the requirements of this program. Specifically, the application must include at least one (NIH) intramural scientist as co-PD/PI, and at least some of the research must be conducted at the NIH Clinical Center. (Projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked samples or data, will not be considered for funding.)

In describing the collaboration between the extramural applicant and the intramural investigator and the research they will conduct, applicants should demonstrate that each investigator will devote an appropriate amount of time/effort to the project and briefly describe the responsibilities of each investigator.

In describing the research to be conducted at the NIH Clinical Center, applicants should provide the following information, as applicable:

  • Describe the research population (e.g., pediatric, geriatric, behavioral health, etc.).
  • Indicate whether inpatient, outpatient or both.
  • Indicate whether the project will utilize an existing NIH clinical protocol, or if a new protocol will be written.
  • Estimate the number of patients/human subjects and approximate lengths of stay/clinic visits.
  • Identify any special procedures/tests and estimate the number of patients/human subjects undergoing the procedures/tests.
  • Indicate whether any of the following describe the Clinical Center and/or intramural resources (technology, specimens, etc.) that will be used: metabolic chambers, biomechanics lab, bone marrow transplantation, operating rooms, Clinical Center cell processing facility, PET ligand development, or imaging facilities. For a more complete listing of resources and for assistance in how to apply, please see: https://ocr.od.nih.gov/new_u01/new_u01.html.
  • Describe the intramural resources (technology, specimens, etc.) that will be used. Although a detailed budget justification is not required for the X02 pre-application, it is important to indicate whether the intramural NIH program can accommodate the project with existing resources or whether significant additional staff or resources will be needed.
  • Describe any study drugs that will be given, including drugs that are currently the standard of care for the disease under investigation. This information is necessary to determine whether the NIH Clinical Center can absorb the costs of the study drugs or if industry or the grant will need to offset those costs.

Letters of Support: Letters of support are NOT required for the X02 pre-application, but will be required for the U01 application. More information about the required letters of support may be found in the companion U01 announcement (PAR-21-343) and at: https://ocr.od.nih.gov/new_u01/letters_of_support.html.

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 should include a Data Sharing Plan that would be applicable to the data collected under the U01. The Data Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program. It is expected that the results of NIH-funded research will be shared with the wider scientific community in a timely manner.

Awardees of the U01sare required to deposit large-scale, human genomic data in the database for Genotype and Phenotype “dbGaP” (https://www.ncbi.nlm.nih.gov/gap). For other data and biospecimens from human genetic or non-genomic studies, awardees are encouraged to use broad-sharing data and/or biospecimen repositories.

The following resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing:https://www.nlm.nih.gov/cde/?.

Appendix:

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.

Not required.

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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 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.

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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides 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.

 

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.

For this particular announcement, note the following:

  • Is there a collaborative team of at least one NIH intramural investigator and one (non-NIH) extramural investigator?
  • Does the NIH intramural investigator plan to devote an appropriate amount of time/effort to the research project?
  • Is the Collaboration Plan well defined with identifiable responsibilities for the NIH intramural investigator and the (non-NIH) extramural applicant?
  • Is a plan for management of the collaboration clearly presented, with well-defined descriptions of what each participant proposes to provide to the collaborative partnership?
  • Is there a clear and well described advantage to bringing the intramural and extramural investigators together in a collaborative partnership?
  • Does the research plan clearly describe the work that will be performed at the NIH Clinical Center?
  • Is it clear which unique research opportunities in the NIH Clinical Center will be utilized?
  • Can the NIH Clinical Center facilities accommodate the proposed research?
  • Can the Intramural laboratory or program accommodate the proposed research?
  • Does the research project address an important problem that is of programmatic relevance to one of the participating Institutes/Centers?
  • If the research project includes a clinical trial are regulatory requirements in place?
  • Will this project utilize an existing NIH clinical protocol, or will a new protocol be written?
  • Can the proposed objectives be accomplished within the requested project period?

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
 






 

 






 

 





 

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?

In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
 

 

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
 

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.

 

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

 

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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

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 by NIH staff, using the review criteria described in Section V.1., above.

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

Applications will be reviewed by appropriate staff of the participating NIH Institutes/Centers and the NIH Clinical Center.

Investigators will be notified of the opportunity to submit a U01 application under PAR-21-343.

3. Anticipated Announcement and Award Dates

 Refer to Part 1 for dates for 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

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. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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 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: 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

Scientific/Research Contact(s)

CLINICAL CENTER PARTNERSHIP

David J. Eckstein, PhD
Program Director, Strategic Partnerships and Policy Development

NIH Office of Clinical Research (OD)
Telephone: 301-496-4121
Email:ClinicalCtrPartner@mail.nih.gov

Forbes D. Porter, MD, PhD
Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-4432
Email:fdporter@mail.nih.gov

Melissa Parisi, MD, PhD
Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1383
Email: parisima@mail.nih.gov

Shilpa Amin, MD

Office of Research on Women's Health (ORWH)

Telephone: 301-402-1770

Email: shilpa.amin@nih.gov

Sarah Temkin, MD

Office of Research on Women's Health (ORWH)

Telephone: 301-402-7630

Email: sarah.temkin@nih.gov

Janice Lee, DDS, MD, MS
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-1647
Email: janis.lee@nih.gov

Dena Fischer, DDS
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4876
E-mail: fischerdj@mail.nih.gov

David Wesley Schopfer
National Heart, Lung, And Blood Institute (NHLBI)
Phone: (301) 402-3833
E-mail: david.schopfer@nih.gov

Minkyung (Min) H. Song, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6139
Email: songm@mail.nih.gov

William Dahut, M.D.
National Cancer Institute (NCI)
Telephone: 301-496-4251
Email: dahutw@mail.nih.gov

Kathy Jung, Ph.D.
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-443-8744
E-mail: jungma@mail.nih.gov

David Goldman, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0059
Email:  davidgoldman@mail.nih.gov 

Dr. Lisa Cunningham, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (301) 443-2766
E-mail: lisa.cunningham@nidcd.nih.gov

Judith Cooper, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (301) 496-5061
E-mail: cooperj@nidcd.nih.gov

Donald F Everett
National Eye Institute (NEI)
Phone: 301-451-2020
E-mail: dfe@nei.nih.gov

David Shurtleff, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-435-6826
Email: David.Shurtleff@nih.gov

Andrea Wurster, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 669-5062
E-mail: wurstera@mail.nih.gov

Maryland Pao, MD
National Institute of Mental Health (NIMH)
Telephone: 301-496-4588
Email: paom@mail.nih.gov

Becky Wagenaar-Miller, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-0322
Email: rwagenaa@mail.nih.gov

Debra Babcock, Ph.D., M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-9964
E-mail: dbabcock@mail.nih.gov

Xincheng Zheng (Ted), MD, PhD
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-4953
E-mail: zhengx4@mail.nih.gov

Robert Colbert, MD, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-693-2950 
Email: colbertr@mail.nih.gov

Bettie Graham
National Human Genome Research Institute (NHGRI)
Phone: 301-496-7531
E-mail: grahamb@odder.nhgri.nih.gov

Peer Review Contact(s)

Not applicable

Financial/Grants Management Contact(s)

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

Telephone: 301-642-4552
Email: margaret.young@nih.gov

Diana Rutberg, MBA
National Institute Of Dental & Craniofacial Research (NIDCR)
Phone: (301) 594-4798
E-mail: rutbergd@mail.nih.gov

Tyrone A Smith
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301.827.8053
E-mail: smithty@nhlbi.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov

Christopher Myers
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: (301) 435-0713
E-mail: myersc@nidcd.nih.gov

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail:kyr@nei.nih.gov

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@nih.gov

Tina M. Carlisle
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2947
E-mail: tc48k@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov  

Leslie Littlejohn
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: (301) 594-2545
E-mail: littlele@mail.nih.gov

Deanna L Ingersoll
National Human Genome Research Institute (NHGRI)
Phone: 301-435-7858
E-mail: deanna.ingersoll@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.

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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