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 Cancer Institute (NCI)
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 Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
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
Announcement Type
Reissue of PAR-15-286.
Related Notices
None
Funding Opportunity Announcement (FOA) Number
PAR-18-950
Companion Funding Opportunity
PAR-18-951 , U01 Research Project – Cooperative Agreements
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.865, 93.213, 93.393, 93.394, 93.395, 93.396, 93.399, 93.867, 93.172, 93.233, 93.837, 93.838, 93.839, 93.273, 93.846, 93.286, 93.279, 93.173, 93.121?, 93.242, 93.853, 93.321, 93.313
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 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 Program Director/Principal Investigator or collaborator, 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 FOA ( PAR-FY-NNN ). 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-FY-NNN .

 

No awards will be made under this FOA.

Key Dates

Posted Date
October 5, 2018
Open Date (Earliest Submission Date)
November 11, 2018
Letter of Intent Due Date(s)
Not Applicable
Application Due Date(s)
December 11, 2018; December 11, 2019; December 11, 2020, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)
December 11, 2018; December 11, 2019; December 11, 2020, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review

January 2019, January 2020, January 2021

Advisory Council Review

Not applicable

Earliest Start Date

Not applicable

Expiration Date
December 12, 2020
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

Purpose

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 (http://www.cc.nih.gov/translational-research- resources/resources.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. 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 may include 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 a different NIH Institute/Center.)

 

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 the families of cancer patients.  The NCI encourages translational and clinical research to:

 

  • Increase understanding of the molecular and physiological basis of health and cancer;
  • Stimulate clinical discoveries about the mechanisms underlying cancer before, during and after treatment with interventions to develop improved prevention, diagnosis, and treatment strategies;
  • Enable the translation of basic discoveries into clinical practice for the benefit of cancer patients; and
  • Enable 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. The NCI particularly encourages well-balanced extramural-intramural contributions towards accomplishing the proposed aims for the intellectually-challenging collaborative projects.

 

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 National Institute on Alcohol Abuse and Alcoholism invites translational, collaborative research projects aimed at reducing alcohol related problems in a wide range of scientific areas including genetics; neuroscience; epidemiology; health risks and benefits from alcohol consumption; and prevention and treatment. Of particular interest are studies which increase the understanding of normal and abnormal biological functions and behavior relating to alcohol use as well as improving the diagnosis, prevention and pharmacological/behavioral treatment of alcohol use disorders across the lifespan.  Studies investigating the underlying neurobiological, psychological, and social mechanisms of behavior change are also encouraged.

 

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.

 

NIBIB

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) seeks to improve human health through the development and acceleration of applications of biomedical technologies. The Institute is committed to integrating engineering and physical sciences with the life sciences to advance basic research and medical care. The NIBIB Intramural Research Program plays a key role in fulfilling the Institute's mission, particularly to advance knowledge in imaging and bioengineering research using a combination of basic, translational, and clinical science and to develop effective training programs in related fields.  Advanced imaging resources at the NIH Clinical Center available for investigators include high field MR imaging, MRI/PET, advanced cardiovascular CT/MRI/PET capability, and interventional oncology capabilities.  Multiple cyclotrons are on-site, and advanced radiotracer synthesis is available for application in oncology, neurological, cardiovascular, and infectious disease research.  Image processing services are available for 3D analysis and processing, as well as transfer/ storage of large scale image data.  More information about research conducted by NIBIB intramural investigators can be found at http://www.nibib.nih.gov/Research/Intramural.

 

For this Funding Opportunity Announcement, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility or other small clinical trials that inform early-stage technology development. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials or trials in which the primary outcome is efficacy, effectiveness or a post-market concern. Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies and consistent with the types of clinical trial applications that NIBIB supports.

 

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.

 

NIDA

The mission of the National Institute on Drug Abuse (NIDA) is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. To achieve this mission, NIDA encourages researchers to build strategic alliances, including those with the NIH Clinical Center that will increase the pace at which translational research findings can become clinical applications that improve community and population health. NIDA is interested in collaborative translational projects addressing programmatic priorities established by its strategic plan.  For this FOA NIDA will prioritize applications proposing neuroscience and medication development projects. Areas of specific interest include research in human genetics, imaging, the comorbidity of HIV and substance use, treatment of opioid overdose and addiction and implementation of specific measures pertinent to negative affect, incentive salience, and executive function for deep phenotyping. Research to further understand the mechanisms and utility of neuromodulation approaches for the treatment of pain and addiction are also of interest.

 

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 at http://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 oral cancer 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 http://www.nidcr.nih.gov/Research/NIDCRLaboratories/OverviewDIR/.

 

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: Neurogenetics, Movement Disorders, Neurosurgery, Neuroimmunology, and Neurovirology.  More details about specific investigators can be found at http://irp.nih.gov/our-research/principal-investigators.

 

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 many of the areas that are encouraged by the participating institutes and centers in this announcement in their specific areas of interest. A new trans-NIH Strategic Plan for Health of Women covering FY 2019 - 2023 will be released in October 2018. Please visit 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 identifying intramural scientists for possible collaboration, please refer to the web-based listing of resources at http://clinicalcenter.nih.gov/translational-research-resources/index.html.
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.

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
No awards will be made under this announcement.  Awards through the companion FOA (PAR-18-951 ) will be up to $500,000 direct costs per year, for a period of up to 5 years.
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)

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)
  • Eligible Agencies of the Federal Government (including the Intramural Research Program of the NIH)
  • 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) (formerly CCR) – 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

2. Cost Sharing

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

3. Additional Information on Eligibility

 

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.  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 NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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.

Are Human Subjects Involved: Answer "No".

 

Are Vertebrate Animals Used: Answer "No".

 

Other Attachments

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.
 

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

Not applicable
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Not applicable
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 m ust include at least one (NIH) intramural scientist as PD/PI or collaborator , 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 list description of these Clinical Center resources, please see: http://clinicalcenter.nih.gov/translational-research-resources/resources.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

 

Letters of Support: Letters of support are NOT required for the X02 pre-application.

 
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 include a Data Sharing Plan.  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 are strongly encouraged to deposit large-scale, human genetic 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-genetic 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.
Not applicable:  Appendix material is NOT required for the X02 pre-application.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or 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

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 (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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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, NIH. Applications that are incomplete or non-compliant 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, the following review criteria will be used:

 

  • 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?

 

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

 

Not Applicable

 

Not Applicable

 

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.

Applications will be evaluated by NIH staff, using the review criteria described in Section V.1., above.

 

Applications will be administratively assigned to NICHD for processing, but will be reviewed by appropriate staff of the participating NIH Institutes/Centers and the NIH Clinical Center.

 

Investigators whose X02 pre-applications are meritorious, can be supported by the resources of the NIH Clinical Center, and align with the research missions of the participating NIH Institutes, will be notified of the opportunity to submit a U01 application under PAR-18-951 .

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

 

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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.

Cooperative Agreement Terms and Conditions of Award
Not Applicable
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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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.
Application Submission Contacts
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, 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 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

Hana Smith, MS, Health Science Specialist

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

 

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

 

NICHD

Constantine A. Stratakis, MD, D(Med)Sc
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-5984
Email: stratakc@mail.nih.gov

 

Eugene G. Hayunga, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6856
Email:  ehayunga@mail.nih.gov

 

NCI

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

 

NEI

Donald F. Everett, MA
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: dfe@nei.nih.gov

 

NHGRI

Dan Kastner, MD, PhD
Division of Intramural Research
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-2023
Email: kastnerd@mail.nih.gov

 

Bettie J. Graham, PhD
Division of Extramural Research
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: bettie_graham@nih.gov 

 

NHLBI

Michelle Olive, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: olivem@mail.nih.gov

 

NIAAA

M. Katherine Jung, PhD

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-8744

Email: jungma@mail.nih.gov 

 

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

 

NIAMS

James Witter, MD, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: witterj@mail.nih.gov  

 

Robert Colbert, MD, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301 443-8935
Email: colbertr@mail.nih.gov

 

NIBIB

Steven Krosnick, MD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-594-3009
Email: krosnics@mail.nih.gov

 

NIDA

Petra Jacobs, MD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6501
Email: pjacobs@mail.nih.gov

 

NIDCD

Andrew Griffith, MD, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-2829
Email: griffita@nidcd.nih.gov

 

Judith A Cooper, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: cooperj@nidcd.nih.gov

 

NIDCR

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 and Craniofacial Research (NIDCR) Telephone: 301-594-4876
Email:  fischerdj@mail.nih.gov

 

NIMH

Maryland Pao, MD
National Institute of Mental Health (NIMH)
Telephone: 301-435-5770
Email: paom@mail.nih.gov

 

Meena Hiremath, PhD

National Institute of Mental Health (NIMH)

Telephone: 301-443-3367

Email: meenaxi.hiremath@nih.gov

 

NINDS

Debra J. Babcock, PhD, MD
National Institute of Neurological Disorders and Stroke(NINDS)
Telephone:  301-496-9964
Email: dbabcock@mail.nih.gov

 

NCCIH

M. Catherine Bushnell, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2222
Email: Mary.bushnell@nih.gov

 

ORWH

Margaret Bevans, PhD
Office of Research on Women's Health (ORWH)
Telephone: 301-496-3934
Email:mbevans@mail.nih.gov

 
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)

NICHD

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

 

NHGRI

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 240-669-2989
Email:  Deanna.Ingersoll@nih.gov 

 

NHLBI

Ron Caulder
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8020
Email:  Caulderr@nhlbi.nih.gov

 

NEI

Karen Robinson-Smith

National Eye Institute (NEI)
Telephone: 301-451-2020
Email: Karen.Robinson.Smith@nei.nih.gov

 

NIAAA

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

 

NIAMS

Mark Langer
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-8216
Email: langerM@mail.nih.gov

 

NIBIB

Angela M. Eldridge
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4793
Email: Angela.Eldridge@nih.gov 

 

NIDCD

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@nidcd.nih.gov

 

NIDCR

Diana Rutberg
National Institute of Dental and Craniofacial Research NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov 

 

NIMH

Tamera Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

 

NINDS

Tijuanna Decoster
National Institute of Neurological Diseases and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

 

NCCIH

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nih.gov

 

NIDA

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov 

 

NCI

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.