Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
U.S. Food and Drug Administration  (FDA)

Components of Participating Organizations

National Center for Advancing Translational Sciences (NCATS)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
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)

Funding Opportunity Title

Pre-application for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (X02)

Activity Code

X02 Pre-application

Announcement Type

Reissue of PAR-12-203

Related Notices

NOT-TR-14-001

  • June 3, 2014 - this Notice is to inform potential applicants that the National Cancer Institute (NCI) and the National Heart, Lung, and Blood Institute (NHLBI) are participating, effective immediately, in PAR-14-213. See Notice NOT-TR-14-007.
Funding Opportunity Announcement (FOA) Number

PAR-14-213

Companion Funding Opportunity

PAR-14-212 UH2/UH3 Phase Innovation Awards Cooperative Agreement; PAR-14-211 UH3 Exploratory/Developmental Cooperative Agreement Phase II; PAR-14-210 UH2/UH3 Phase Innovation Awards Cooperative Agreement)

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.350, 93.867, 93.866, 93.273, 93.865, 93.279, 93.173, 93.121, 93.242, 93.853, 93.103, 93.395, 93.837, 93.838, 93.839

Funding Opportunity Purpose

The National Center for Advancing Translational Sciences (NCATS) seeks to expand the therapeutics discovery program piloted in 2012, to explore new therapeutic uses for proprietary drug candidates (Agents) across a broad range of human diseases. This innovative program allows investigators to propose new therapeutic uses for Agents from pharmaceutical company partners.  A strong application will be supported by scientific evidence that modulation of the Agent’s target will have a positive impact on the disease/condition.

PAR-14-213 encourages X02 pre-applications for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules.  The X02 pre-application is the first step in the application process for PAR-14-212, PAR-14-211 and PAR-14-210; applicants must read all of the companion FOAs. The X02 pre-applications will be evaluated by outside experts.

Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 under PAR-14-212 or a UH3 application under PAR-14-211 or a UH2/UH3 application under PAR-14-210 in the case of a pediatric indication.

Key Dates
Posted Date

May 12, 2014

Open Date (Earliest Submission Date)

June 15, 2014

Letter of Intent Due Date(s)

June 15, 2014

Application Due Date(s)

July 15, 2014, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2014

Advisory Council Review

Not Applicable

Earliest Start Date

Not Applicable

Expiration Date

July 16, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

In June 2012, NCATS issued its first Request for Applications (RFAs) which were for an NIH-Industry Pilot Program: Discovering New Therapeutic Uses for Existing Molecules. The pilot was designed to increase engagement and partnerships between academia and industry in drug repurposing and to enhance the success of these efforts. These objectives were met using several innovative strategies.  When the RFAs were published, information about investigational Agents (new molecular entities (NMEs) and biologics) from pharmaceutical companies was made publicly available. Also made publicly available were template collaborative research agreements (CRAs) and template confidential disclosure agreements (CDAs) that would be executed between the NIH applicant and the pharmaceutical company providing the Agent. The use of the template CDAs and CRAs in the pilot program led to rapid establishment of pharmaceutical-academic collaborations. The increased awareness and availability of these Agents to the research community resulted in submissions to NIH of almost 160 pre-applications for a wide array of diseases.    

This robust response from both the pharmaceutical industry and from the research community was a strong indicator of a high level of enthusiasm for the pilot.  Based on these indicators as well as feedback obtained through a Request for Information (RFI; http://grants.nih.gov/grants/guide/notice-files/NOT-RM-13-021.html), and surveys of awardees, the pharmaceutical companies, and NIH Components, NCATS is issuing this new round of Funding Opportunity Announcements (FOAs).

 FOA

Type of research supported

Period of support (maximum)

X02

Requisite pre-application (no research supported)

N/A

UH3

Phase 2a Clinical Trial

2 years

UH2/UH3

UH2: Pre-clinical and/or Phase 1b; UH3: Phase 2a Clinical Trial

1 year for UH2 and 2 years for UH3

UH2/UH3 Pediatrics*

UH2: Pre-clinical, Phase 1a Clinical Trial, pediatric toxicology, and Phase 1b; UH3: Phase 2a Clinical Trial

2  years for UH2 and 2 years for UH3

*In general, pediatric populations to be considered for this FOA refer to disease populations for which there is no adult equivalent and therefore, there is no adult population in which the drug could be tested prior to testing in children. However, trials in pediatric or juvenile populations for indications that also have an adult population (e.g., type 2 diabetes, autism, osteoarthritis) may be considered if there is a strong scientific rationale that justifies why phase 2a trials in the pediatric population are required even though an adult patient population exists. 

Research Objectives

This funding opportunity announcement (FOA) intends to support innovative ideas from the biomedical research community for the discovery of potential therapeutic uses of those Agents in previously unexplored diseases. Proposed human trials can include: 1) use of an Agent as a stand-alone intervention, or 2) as an adjunctive intervention with existing standard of care (if there is no evidence of drug-drug interactions with the proposed standard of care treatment). Strategies to inform the selection of patients for proposed new uses of the Agents are of interest.

For this FOA, Phase 1b, and Phase 2a trials are defined as follows: Phase 1b trials are defined as studies usually conducted in the target patient population to establish feasibility (e.g., target engagement, pharmacodynamics/pharmacokinetics (PD/PK), initial dosing of the Agent) prior to a Phase 2a trial. Phase 2a clinical trials provide data on the relationship of dosing and response for the particular intended use (including trials on the impact of dose ranging on safety, biomarkers, and proof of concept), typically 150 subjects or less for trials in adults.

Through the Limited Competition for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules FOAs, PAR-14-212 (UH2/UH3), PAR-14-210 (UH2/UH3) or PAR-14-211 (UH3), investigators will have an opportunity to investigate Agents with known pharmacologic mechanisms of action for clinical efficacy in new therapeutic areas. Investigators whose X02 pre-applications are judged to be the most meritorious will be notified of the opportunity to submit a UH2/UH3 or UH3 application under these Limited Competition FOAs.

The UH2/UH3 PAR-14-212 is a single application in two stages. The UH2 stage will support milestone-driven preclinical studies to verify target engagement in a disease model and/or Phase 1b clinical trials using the selected Agent in its existing formulation/route of administration to identify the dose or exposure of the Agent in the proposed patient group, and inform patient selection. Investigators should consider the use of pharmacokinetic (PK) and pharmacodynamic (PD) biomarkers to assess the selection of doses and exposure of the Agent at the target site of action, binding at the target, and expression of functional pharmacological activity of the Agent at the target site of action. The duration of the UH2 project period is anticipated to vary in time from 6 months up to one year. UH2 projects that have met the scientific milestones and feasibility requirements, as evaluated by NIH administrative review, will be eligible for rapid transition to the second, UH3, stage. The UH3 stage will support milestone-driven Phase 2a trials to demonstrate that the Agent modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population and assess its potential for further clinical development. The inclusion of biomarkers in the design of the trial is encouraged, when appropriate: e.g., the inclusion of PK/PD biomarkers to assess target engagement, exposure and functional pharmacological activity of the Agent; or the use of molecular markers of disease, pharmacogenomics, or other biomarkers as patient selection strategies. The project period for the UH3 stage is up to two years.

The PAR-14-211 (UH3) FOA will support a standalone UH3 for Phase 2a trials in which no preclinical studies or Phase 1b trials are needed to establish dosing or tolerability of the Agent in the selected patient population. As in the companion FOA, the UH3 will support milestone-driven Phase 2a trials to demonstrate that the Agent modulates the target and has the potential to yield the desired clinical outcome in the proposed disease population and assess its potential for further clinical development. The inclusion of biomarkers in the design of the trial is encouraged, when appropriate: e.g., the inclusion of PK/PD biomarkers to assess target engagement, exposure and functional pharmacological activity of the Agent; or the use of molecular markers of disease, pharmacogenomics, or other biomarkers as patient selection strategies. The project period for the standalone UH3 stage is up to two years. If invited to apply to the Limited Competition FOAs, applicants for the UH3 standalone FOA will need to justify the rationale and availability of sufficient preliminary data to move directly into a Phase 2a trial.

PAR-14-210 For pediatric indications (UH2/UH3). In general, pediatric populations to be considered for this FOA refer to disease populations for which there is no adult equivalent and therefore, there is no adult population in which the drug could be tested prior to testing in children. However, trials in pediatric or juvenile populations for indications that also have an adult population (e.g., type 2 diabetes, autism, osteoarthritis) may be considered if there is a strong scientific rationale that justifies why phase 2a trials in the pediatric population are required even though an adult patient population exists (e.g., the target in the pediatric population may differ from that in the adult or treatment of children may reduce progression or severity of the disease). Agents pharmaceutical companies will consider for use in pediatric populations are listed in the Table of Agents for Pediatric Indications. The UH2/UH3 is a single application in two stages. The UH2 stage for pediatric studies will support milestone-driven pre-clinical studies including juvenile animal studies to assess the potential drug toxicity in one or more species and Phase 1a (for this FOA, Phase 1a trials are defined as initial studies in healthy adult volunteer subjects, using the proposed formulation that are designed to determine the metabolic and pharmacological actions and the side effects, including those associated with increasing drug doses) and Phase 1b clinical trials using the selected Agent to identify the dose or exposure of the Agent in the pediatric-patient group, and inform patient selection. Investigators should consider the use of PK and PD biomarkers to assess the selection of doses and exposure of the Agent at the target site of action, binding at the target, and expression of functional pharmacological activity of the Agent at the target site of action. The duration of the UH2 project period may vary in time from one to two years based on data needed to establish safety in children and exposure or PK/PD data to inform dose-selection in the pediatric patient population (as specified in the specific aims of the UH2 project). UH2 projects that have met the scientific milestones, as evaluated by NIH administrative review, will be eligible for rapid transition to the second, UH3, stage. The UH3 stage will support milestone-driven, exploratory, Phase 2a trials designed to demonstrate that the Agent modulates the target and has the potential to yield the desired clinical outcome in the proposed pediatric disease population. The inclusion of biomarkers in the design of the study is encouraged, when appropriate: e.g., the inclusion of PK/PD biomarkers to assess target engagement, exposure and functional pharmacological activity of the Agent; or the use of molecular markers of disease, pharmacogenomics, or other biomarkers as patient selection strategies. The project period for the UH3 stage is up to two years.

Research Areas of Interest

National Center for Advancing Translational Sciences (NCATS)

NCATS will consider co-funding projects that address a disease for which there is no or inadequate treatment and for which there is strong scientific rationale.  NCATS is particularly interested in rare diseases.  

National Eye Institute (NEI)

NEI will consider funding projects to treat eye diseases, as well as those projects aimed at interventions to preserve vision.

National Institute on Aging (NIA)

NIA will consider funding projects consistent with its mission of reducing the burden of diseases and conditions associated with aging.

National Institute of Alcohol Abuse and Alcoholism (NIAAA)

Currently, there are only a few FDA-approved drugs to treat alcohol use disorder (AUD).  Given the heterogeneity of this disorder, the modest effect size of approved medications, and the numerous targets involved with AUDs, development of new, effective medications to treat AUD is a top priority for NIAAA.  NIAAA will consider funding projects to investigate the use of existing molecules to treat AUD.

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

NICHD will consider funding projects with a pediatric focus, particularly pediatric rare and neglected diseases.

National Institute on Drug Abuse (NIDA)

Currently, there are no FDA-approved medications to treat substance use disorders (SUDs) involving stimulants (cocaine and methamphetamine), although there are approved medications for SUDs involving opiates.  The development of medications to treat SUDs is a top priority for NIDA.  NIDA will consider funding projects to investigate the use of existing molecules to treat SUDs involving cocaine, methamphetamine, cannabis, nicotine, or opiates.

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIDCD will consider funding projects focused on communication disorders of hearing (including tinnitus), balance, taste, smell, voice, speech and language, including biomedical and behavioral problems associated with people who have these communication impairments or disorders. 

National Institute of Dental and Craniofacial Research (NIDCR)

NIDCR will consider funding projects to treat conditions affecting the oral cavity or that improve dental and craniofacial health.

National Institute of Mental Health (NIMH)

NIMH will consider funding projects that focus on the treatment and prevention of psychiatric disorders in adults and children and are consistent with the NIMH’s emphasis on the experimental therapeutic approach. Consistent with the Research Domain Criteria (RDoC), NIMH is particularly interested in testing novel interventions that focus on operationally defined, empirically-supported functional domains or symptom(s) of psychiatric disorders in subjects that share the same underlying disease processes.

National Institute of Neurologic Disease and Stroke (NINDS)

NINDS will consider funding projects consistent with its mission of reducing the burden of neurologic disease.

Food and Drug Administration (FDA)

FDA will consider co-funding projects that meet rare disease criteria per the Orphan Drug Act.

Application Process

The submission of an X02 pre-application is a necessary first step in applying for an award under PAR-14-212, PAR-14-211, or PAR-14-210; applicants must also read the three companion FOAs prior to submitting an X02 pre-application. Pre-applications submitted to this FOA will be evaluated by outside experts. X02 applicants will receive feedback on the scientific merit (particularly the association between the agent’s mechanism of action and the disease indication proposed), technical feasibility, expertise of the investigative team, medical need, and overall potential of the science proposed. No awards will be made for X02 pre-applications under this FOA. Investigators of  X02 pre-applications, which are identified as being highly meritorious and relevant to NIH program priorities, will be provided contact information for the appropriate pharmaceutical company based on the Agent or mechanism of action identified in their X02 pre-application. The X02 applicants and pharmaceutical company partner will jointly decide whether a UH2/UH3 or UH3 application should be submitted.

X02 applicants put in contact with the pharmaceutical company partner for the Agent that was selected for studies in the X02 pre-application are expected to execute an appropriate Confidential Disclosure Agreement (see template CDAs). Under the CDA, the applicant and pharmaceutical company partner will exchange confidential information (e.g., additional information on the Agent and studies to test the proposed new therapeutic use of the Agent), as deemed necessary, to initiate discussions. Subsequently, it is anticipated that a Collaborative Research Agreement (CRA) between the applicant and the pharmaceutical company partner will be the vehicle through which the applicant obtains permission to work with the Agent on the research project plan for the UH2/UH3 or UH3 standalone application. The applicant must provide the NIH with documentation of access to the Agent and associated data needed for filing an investigator-sponsored Investigational New Drug (IND) Application and for conducting the proposed clinical trial (e.g., an executed CRA).

Partnership Information

A key aspect of this FOA is the formation of collaborative partnerships between the biomedical research community and industry partners. NCATS has executed a Memorandum of Understanding (MOU) with each of the pharmaceutical company partners to provide a framework under which specific proprietary Agents will be provided by these partners to the program awardees. Template agreements have been developed for this program: Confidential Disclosure Agreements (CDAs) and Collaborative Research Agreements (CRAs) between the pharmaceutical company partner and the applicant. These template agreements have been developed to streamline interactions among the parties for the Program, and it is anticipated that applicants will use the agreements. Applicants whose X02 pre-applications are identified as being highly meritorious and relevant to NIH program priorities will be put in contact with the appropriate pharmaceutical company and should work with their institutional technology transfer or sponsored research office to finalize the terms and conditions of the CDA and CRA with the pharmaceutical company partner for the selected Agent, prior to submitting a UH2/UH3 or UH3 standalone application. A complete UH2/UH3 and UH3 application   is contingent on the applicant’s ability to provide the NIH with documentation of access to the selected Agent and associated data needed for conducting the proposed pre-clinical studies and for filing an investigator-sponsored IND in order to conduct the proposed clinical trials (e.g., an executed CRA or letter from the pharmaceutical partner).

Agents Available for the Program

The list of Agents and non-confidential information can be found at http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/directory2014.html . The Agents are posted in two separate tables: 1) Table of Agents for Adult Indications and 2) Table of Agents for Pediatric Indications.  

Timeline for the Program

June 15, 2014

X02 Letters of Intent (LOIs) due

July 15, 2014

Due date for X02 pre-application

August 2014

Evaluation of pre-application by outside experts

Late September/Early October 2014

Notification of opportunity to submit a full UH2/UH3 application

January 16, 2015

Due date for UH2/UH3 applications

February/March 2015

Scientific merit review for UH2/UH3 applications

May 2015

Advisory Councils for review of applications

July 2015

Earliest possible start date for awarded grants

Technical Assistance Webinar for Applicants

A technical assistance teleconference will be held on May 29, 2014, from 1:00 to 2:30 PM EDT. All prospective applicants are invited to participate. In order to support the number of participants on the conference call, participants are encouraged to register by May 27 via email at Therapeutics.Discovery@nih.gov. Please submit questions to be addressed at this webinar on or before May 27. 

Please also refer to the FAQ page as an additional source of information about the program.

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

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

No awards will be made under this announcement. Awards will be made through the companion FOAs, PAR-14-212, PAR-14-210, and PAR-14-211

Award Budget

Not Applicable

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 in response to 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 NIH Intramural Research Program
  • 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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

  • 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • 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.

Eligible PD(s)/PI(s) develop an X02 pre-application for the opportunity to submit a UH2/UH3 or UH3 standalone application. For these X02 pre-applications, the PD/PI listed on the X02 pre-application must be the same PD/PI listed on a subsequent UH2/UH3 or UH3 application. For X02 pre-applications proposing multiple PD(s)/PI(s), the contact PD/PI listed on the X02 pre-application must be the same PD/PI listed on a subsequent UH2/UH3 or UH3 application. The contact PD/PI is strongly encouraged to continue the multiple PD(s)/PI(s) leadership identified in the X02 pre-application if notified of the opportunity to submit a UH2/UH3 or UH3 application.

NIH Intramural Research Program (IRP) investigators are eligible to submit an X02 pre-application, subject to the availability of intramural funds to support the project. IRP investigators can apply as PD(s)/PI(s), as multiple PD(s)/PI(s) in conjunction with extramural investigators (http://grants.nih.gov/grants/multi_pi/index.htm), or as collaborators with extramural academic or biotechnology company investigators.

If the applicant institution is an NIH Institute or Center, funds may not be requested for an extramural component/collaborator in the subsequent UH2/UH3 or UH3 application.

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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

Letter of Intent

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

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

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

The letter of intent should be sent to: Therapeutics.Discovery@nih.gov  

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

  • For this specific FOA, the Research Strategy section is limited to 4 pages.
Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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".

SF424(R&R) Project/Performance Site Locations

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

Consortium/Contractual Arrangements. Do not use this attachment

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: Attach Agent information for the Agent selected for use in the project, available at http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/directory2014.html, and title it "Agent Information".

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:  The Specific Aims section should include Aims delineated for the UH2 stage, if proposed, and UH3 stage:

1. UH2 (Stage 1)

a. Define the aims of the pre-clinical studies, if any are proposed.

b. Define the aims of the Phase 1 clinical trials, if any are proposed.

2. UH3 (Stage 2)

a. Define the aims of the Phase 2a clinical trial.

1). The aims should address target modulation and efficacy.

2). The clinical data resulting from the UH3 stage should provide sufficient evidence that the drug candidate modulates the target/mechanism and a biomarker of PD effect, and has the potential to yield the desired clinical outcome in the disease population.

Research Strategy: Within the Research Strategy, provide the following information.

1. Background & Significance

a. Identify the proposed Agent (or identify the mechanism of action if multiple Agents are listed with the same mechanism of action) from among those made available for this Program that you are interested in using, its known pharmacologic mechanism of action or target, and the new therapeutic use which will be investigated.

b. Clearly describe the patient population to be studied. If the disease/condition exists in both children and adults, include strong scientific justification for testing the Agent in a pediatric patient population instead of testing in an adult patient population (e.g., the target in the pediatric population may differ from that in the adult or treatment of children may reduce progression or severity of the disease).

c. Provide the scientific rationale for selection of the Agent and its proposed new therapeutic use.

d. Describe the potential impact of the novel therapeutic use of the Agent for the disease or disorder.

  • Describe how the mechanism under investigation differs from previous studies/trials for this indication. Include any information on ongoing or completed clinical trials investigating the same target/mechanism of action in the proposed patient population. What is the value added of the proposed studies?

e. Address the global burden of disease, which patients may benefit, how they may benefit, how use of the Agent might be superior to current therapy options, potential for impact on public health.

2. Preliminary Studies

a. The Preliminary Studies section may contain data and information that validate feasibility for conducting the proposed studies.

1). Evidence that the target or specific pathway is involved in the disease pathology. Examples may include but are not limited to:

(a) In vitro or in vivo evidence that a specific target/pathway is involved in the disease pathology.

(b) Evidence that modulation of the Agent’s target will have a positive impact on the disease or disorder proposed

2). Data to support the selection and relevance of the proposed models to assess the efficacy of the Agent in the new disease area (e.g., choice of assays, models, species, outcome or endpoints selected).

3. Approach

a. Provide a plan to assess the validity of the biological hypothesis for use of the Agent in the new disease area.

1). Describe the types of approaches that will be used and how the results will be used to establish feasibility for moving from the UH2 to UH3 stage of the project, or in some cases, moving directly into a UH3 Phase 2a clinical trial.

b. Define go/no go decision points and milestones for advancing the Agent to Phase 1b and/or Phase 2a clinical trials to validate the new therapeutic use.

1). Each project will be expected to move forward expeditiously, with the goal of rapid transition to Phase 2a clinical trials designed to test the Agent's early evidence of therapeutic benefit.

2). Phase 1b or 2a clinical trials will be dependent on the grantee filing an investigator-sponsored Investigational New Drug (IND) Application.

c. Describe the design of clinical trials to assess efficacy of the Agent.

1). Provide appropriate metrics for determining feasibility to begin Phase 2a clinical trials.

2). Define the approach to be used to determine statistical end points and justification for the size of the trial.

4. Administration and Management

a. Provide an operational plan for managing the pre-clinical studies and clinical trials necessary to fully develop a new use for the Agent.

1). Describe institutional and/or project personnel experience with FDA regulatory processes.

2). Explain the proposed contribution of each of the key participants in achieving the objectives of the project.

3). It will be important for the PD/PI to describe experience in meeting milestones.

b. Explain the proposed contribution of each of the administrative components to achieving the objectives of the program.

c. Describe relevant experience and knowledge of public-private partnerships.

d. Describe the team's experience in the methods and approaches for design and implementation of human clinical trials and readiness to test the hypothesis.

e. Describe the team's requisite competencies and experience with clinical trials recruitment and execution and ability to recruit and enroll patients in the target disease population.

Letters of Support:

Applicants MUST include a letter from an appropriate institutional official, generally a dean or provost, documenting institutional commitment to the project, including provision of resources, space, and available faculty. Include in the letter confirmation of the Institution’s willingness to engage in the necessary negotiations with the pharmaceutical company regarding the terms and conditions of the template CDA and CRA for the selected Agent. A successful UH2/UH3 or UH3 application will be contingent on the applicant’s ability to provide the NIH with documentation of access to the selected Agent and associated data needed for conducting the proposed pre-clinical studies and for filing an investigator-sponsored IND in order to conduct the proposed clinical trials (e.g., an executed CRA or letter from the pharmaceutical partner).

If multiple institutions are involved in an application, a letter should come from each institution.

For NIH Intramural Research Program (IRP) investigators, an official letter from the Scientific Director, which indicates approval of the IRP scientist's role as PD/PI or as collaborator in the project, must be included as a letter of support in the X02 application. The letter must specify the Scientific Director's commitment of intramural research funds to support the IRP investigator's proposed project or project component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

  • A Resource Sharing Plan (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) is not applicable for this FOA.

Appendix:  Appendices are not allowed for this FOA and will not be accepted. Do not use the Other Attachments section to circumvent this limitation.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at NCATSTDReview@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

No post-submission materials will be accepted.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

This pre-application FOA is soliciting ideas for new therapeutic uses of existing molecules (Agents) from pharmaceutical company partners.  The pre-application is the requisite first step toward gaining access to the Agents. Accordingly, reviewers will focus their evaluation on the scientific evidence that modulation of the Agent's target would positively impact the disease or condition, conceptual framework, the level of innovation, qualifications of the research team and the significance of the unmet medical need. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data on the target using alternative probes and methods.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will clinical practice be improved? How will successful completion of the aims change treatments, services, or preventative interventions that drive this field? Does the proposed novel use of the Agent have the potential to affect pharmacologic intervention for a disease or disorder with unmet medical need? Is there a strong biological rationale for the proposed clinical trials?  

Investigator(s)     

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) have the scientific and organizational vision and experience to serve effectively as the Director(s) of a therapeutic development effort? Is there evidence of sufficient management capabilities that include fiscal administration, personnel management, planning, and budgeting? Does the investigative team have the requisite competencies and experience with drug development including regulatory processes, clinical trials planning, recruitment and execution?  Does the team provide evidence to support their suitability to recruit and enroll patients from the target disease population? Do the PD(s)/PI(s) demonstrate relevant experience and knowledge of public-private partnerships?   

Innovation

Are there ongoing or completed clinical trials modulating the same target/mechanism of action for this patient population?  How would this clinical trial be novel?

Approach

Although the Agent itself was not accessible to the PD/PI, is sufficient evidence presented to support the scientific rationale for the proposed new use of the Agent (its pharmacologic mechanism of action or target) and relevance of the biology to therapeutic intervention in the proposed disease? If the applicant is proposing studies in a pediatric population for a disease/condition that exists in both children and adults, is there sufficient scientific justification for testing the Agent in a pediatric patient population instead of testing in an adult patient population? Are milestones, go/no go decisions clearly defined and appropriate to validate the new therapeutic use? Have the PD(s)/PI(s) provided an operational plan for managing the necessary collaborations between and among preclinical and clinical plan investigators, and the pharmaceutical company partner? If pre-clinical or Phase 1 trials are proposed, is there a plan for moving expeditiously to Phase 2a clinical trials once a new therapeutic use has been assessed for safety?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of institutional commitment to the project? Is there institutional confirmation that the terms and conditions of the CDA and CRA for the selected Agent are acceptable to the technology transfer or sponsored research office (for example, through the letter documenting the Institution's willingness to enter into the necessary agreements with the pharmaceutical company partner)? Does the scientific environment indicate the potential for a multi-disciplinary approach involving teams of investigators?  

Additional Review Criteria

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

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. For additional information to assist you in making these determinations, please refer to the Guidelines for the Review of the Human Subjects Section.

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. For additional information to assist you in making these determinations, please refer to the Guidelines for the Review of Inclusion on the Basis of Sex/Gender, Race, Ethnicity, and Age in Clinical Research.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. For additional information to assist you in making these determinations, please refer to the Worksheet for Review of the Vertebrate Animal section (VAS).

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Not Applicable

Budget and Period of Support

Not Applicable

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

  • Will receive a written critique.

Applications will be assigned to NCATS with potential secondary assignment, based on the proposed disease population, to the appropriate NIH Institute or Center.

Investigators whose X02 pre-applications are identified as being highly meritorious and relevant to program priorities will be notified of the opportunity to submit a UH2/UH3 application under PAR-14-212 or PAR-14-210 or a UH3 application under PAR-14-211

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

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

Section VI. Award Administration Information

1. Award Notices

Not Applicable

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

Not Applicable

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

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

For technical questions regarding the FOA (mechanisms, partnerships, application content or scientific management of the cooperative agreements), please contact:

Christine Colvis, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone:   301-451-3903
Email: therapeuticsdiscover@mail.nih.gov

George McKie, Ph.D.
National Eye Institute (NEI)
Telephone: 301-435-8152
Email: george.mckie@nih.gov

Linda Brady, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3563
Email: lbrady@mail.nih.gov

Jill Heemskerk, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-0081
Email: heemskej@mail.nih.gov

Janet Cyr, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: cyrj@nidcd.nih.gov

Ivan Montoya M.P.H., MD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-8639
Email: imontoya@nih.gov

Larry Refolo, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-594-7576
Email: refolol@mail.nih.gov

Fertig, Joanne, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0635
Email: jfertig@mail.nih.gov

Patricia Walicke, M.D., Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: Patricia.Walicke@nih.gov

Anne Zajicek, M.D., Pharm.D.
National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6865
Email: zajiceka@mail.nih.gov

R. Dwayne Lunsford, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-2421
Email: lunsfordr@mail.nih.gov

Katherine Needleman, Ph.D.
U.S. Food and Drug Administration (FDA)
Telephone: 301-796-8664
Email: Katherine.Needleman@fda.hhs.gov

Barbara Mroczkowski, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-496-4291
Email: mroczkowskib@mail.nih.gov

John W Thomas, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0065
Email: thomasj@nhlbi.nih.gov

Patricia J. Noel, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: noelp@nhlbi.nih.gov

Simhan Danthi, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-451-5170
Email: ndanthi@mail.nih.gov

FAQs:
http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/therapeutics-faq.html

For questions related to proposed new therapeutic uses of the Agents in specific disease areas, Institute or Center contacts can be found at http://www.ncats.nih.gov/research/reengineering/rescue-repurpose/therapeutic-uses/contacts.html.

Peer Review Contact(s)

Sheri Hild, Ph.D.
National Center for Advancing Translational Sciences, (NCATS)
Telephone: 301-435-0811
Email: NCATSTDReview@mail.nih.gov

Financial/Grants Management Contact(s)

Long Nguyen
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-402-6737
Email: nguyen1@mail.nih.gov

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: darbyw@mail.nih.gov

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: rclaycam@mail.nih.gov

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

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 410-254-1853
Email: wellse2@mail.nih.gov

Jillian Morris
National Institute on Aging (NIA)
Telephone: 301-496-8986
Email: morrisjil@mail.nih.gov

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

Tijuanna DeCoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

Bryan Clark
National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: Clarkb1@mail.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: dr258t@nih.gov

Garcia Nelson
National Cancer Institute (NCI)
Telephone: 240-276-5613
Email: garcian@efdb.nci.nih.gov

Kimberly Stanton
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Email: Kimberly.stanton@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

No awards will be made through this X02 announcement.

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