Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
This Funding Opportunity Announcement (FOA) is developed as a NIH Roadmap for Medical Research initiative (http://nihroadmap.nih.gov). All NIH Institutes and Centers participate in roadmap initiatives. This FOA will be administered by the National Institute of Neurological Disorders and Stroke (NINDS) on behalf of the NIH.

Title: National Institutes of Health Rapid Access to Interventional Development (NIH-RAID) Program (X01)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-07-358

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PAR-09-027

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4)weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.310

Key Dates
Release/Posted Date: November 14, 2008
Opening Date: December 16, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 16, 2008; April 15, 2009; August 17, 2009; December 16, 2009; April 14, 2010; August 16, 2010; December 15, 2010; April 18, 2011; August 16, 2011
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): January 15, 2009; May 15, 2009; September 15, 2009; January 15, 2010; May 14, 2010; September 15, 2010; January 14, 2011; May 16, 2011; September 15, 2011 (May 16, 2011; September 15, 2011 removed per NOT-RM-11-013)
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): Three to four months following application receipt dates
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): Five months following peer review dates
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: (Now Expired March 31, 2011 per NOT-RM-11-013), Original Date: September 16, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Promising ideas for novel therapeutic interventions can sometimes encounter roadblocks in the pipeline for preclinical development. Translation can be facilitated by alliances with corporate or other private sector partners, but high risk ideas or therapies for uncommon disorders frequently do not attract private-sector investment. Where private-sector capacity is limited or not available, developmental resources provided by the federal government can bridge the gap between discovery and clinical testing so that more efficient translation of promising discoveries can occur.

The NIH Roadmap for Medical Research (http://nihroadmap.nih.gov/) has established a program called NIH-RAID (Rapid Access to Interventional Development; http://nihroadmap.nih.gov/raid/) to make available on a competitive basis certain critical resources needed for the development of new therapeutic agents. The NIH-RAID program is intended to reduce some of the common barriers between laboratory discoveries and clinical trials of new therapeutic entities, and projects in both the early and late stages of preclinical development are suitable for NIH-RAID proposals. Approved NIH-RAID projects are completed using resources of the National Cancer Institutes (NCI) Developmental Therapeutics Program (http://dtp.nci.nih.gov/) and the National Heart Lung and Blood Institutes (NHLBI) Gene Therapy Resource Program (http://www.gtrp.org).

NIH-RAID is not a grant program. Successful projects gain access to government contract resources, and are assisted by the NIH in establishing and implementing a product development plan. Projects are supported by individual Institutes and Centers within NIH and by the NIH Roadmap, through the Common Fund. The Common fund was created by the NIH in 2004 and enacted into law by Congress through the 2006 NIH Reform Act to support cross-cutting, trans-NIH programs. Institutes and Centers may request the inclusion of specific project milestones as a requirement for co-sponsorship of NIH-RAID projects.

Available Services

The services provided will depend upon the stage of the project and the strength of the preliminary data.

When a lead therapeutic agent has been selected and proposed for preclinical development, the following services are available:

For small molecules, natural products, peptides, oligonucleotides, and gene vectors

For recombinant proteins and monoclonal antibodies

When a lead therapeutic agent has not yet been selected and proposed for preclinical development, the following services are available:

For small molecules, natural products, peptides, oligonucleotides, and gene vectors

For recombinant proteins and monoclonal antibodies

Scope limitations and clarifications

In some cases the NIH-RAID program will support only one or two key steps for preclinical development, while in other cases it may be possible to provide assistance with most of the development tasks needed to file an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). When the NIH-RAID program does not provide all of the remaining services required for IND submission, it is expected that other resources will be in place to complete development steps not supported by NIH-RAID.

Role of NIH Institutes and Centers

All NIH Institutes and Centers are participating in the funding of this Roadmap program. NIH-RAID projects are co-sponsored by the NIH Roadmap and one or more NIH Institutes and Centers. Through this co-sponsorship appropriate resources and expertise are made available, and because NIH-RAID fills gaps encountered during therapeutics development, but does not support the full developmental pipeline, partnership with a specific NIH Institute or Center may be important for subsequent translational efforts. Applicants do not have to establish Institute or Center co-sponsorship prior to submitting a proposal, but may contact the NIH-RAID program office or members of the NIH-RAID Project Team to discuss possible Institute and Center co-sponsorship. When preliminary work for a project has been supported by the NIH, applicants are encouraged to contact program staff of the Institute or Center that funded the preliminary work to discuss the suitability of the project for the NIH-RAID program. Several Institutes already support services like those provided by NIH-RAID through other mechanisms, and have elected not to co-sponsor requests to this program in those areas.

Material Transfer

The output of NIH-RAID program activities, both products and information, will be made fully available to the originating investigator institution (awardee institution), as appropriate, in support of additional studies, an IND application, or performance of clinical trials. Data and products will be transferred to the applicant under the terms of a non-negotiable Material Transfer Agreement (MTA).

Drug product for clinical use will be delivered in a single shipment. The NIH-RAID program cannot distribute drug product in multiple shipments or on a per patient basis

Intellectual Property

It is expected that the originating investigator institution or a collaborating partner will have acquired or be in the process of acquiring appropriate intellectual property protection prior to application to the NIH-RAID program. All intellectual property relevant to the proposal should be fully described in the application.

As noted previously, most NIH-RAID tasks will be accomplished through the use of contracts in the NCI Developmental Therapeutics Program and the NHLBI Gene Therapy Resource Program. Normally, the NIH will not acquire intellectual property rights to inventions made by its staff under the NIH-RAID program, unless the originating investigator institution and the NIH agree that to do so would be in the best interest of the project, consistent with the NIH policies, law, and regulations. If the NIH does file a patent application, the originating investigator institution will be given the opportunity to negotiate for an exclusive license under procedures set forth in 37 CFR Part 404.

NIH contractors, under the Bayh-Dole Act, may elect to retain rights for a contribution they make that rises to the level of invention. However, some contractors, as a term of their funding agreements, have agreed to offer a first option to the originating investigator institution for license negotiation. Certain other contractors or subcontractors may be subject to a Determination of Exceptional Circumstances (DEC) through which their rights in subject inventions may be assigned to the originating investigator institution.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the X01 Resource Access award mechanism. Investigators should not request funds.

2. Funds Available

Through its funding of the NIH-RAID program, the NIH will support the costs of the requested tasks approved for completion. Applications received in response to this FOA will not receive any additional funds.

The total number of X01s awarded will depend on the number of applications received, their relative scientific merit, and the availability of NIH Roadmap and Individual Institute and Center funds.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model.Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically.Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit a resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Renewals are not allowed.

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

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Research Plan

Optional Components:
PHS398 Cover Letter File
PHS398 Cover Page Supplement

Foreign Organizations (Non-domestic [non-U.S.] Entities)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from Foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component.All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI.Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission.The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component.Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts.The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only.Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: December 16, 2008(Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): December 16, 2008; April 15, 2009; August 17, 2009; December 16, 2009; April 14, 2010; August 16, 2010; December 15, 2010; April 18, 2011; August 16, 2011
Application Due Date(s): January 15, 2009; May 15, 2009, September 15; 2009; January 15, 2010; May 14, 2010; September 15, 2010; January 14, 2011; May 16, 2011; September 15, 2011
Peer Review Date(s): Three to four months following application receipt dates
Council Review Date(s): Not Applicable
Earliest Anticipated Start Date(s): Five months following peer review dates

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Tony Jackson
NIH-RAID
6001 Executive Boulevard, Room 2141
Bethesda, MD 20892
Telephone: (301) 594-4660
Email: nih-raid@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

4. Intergovernmental Review

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.

6. Other Submission Requirements and Information.

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

SF424 (R&R) Cover Component

13. Proposed Project. These dates will be determined by the duration of the tasks approved by the NIH. A general suggestion for the start and ending dates are 10 months and 3 years from the applications submission respectively.

16. Estimated Project Funding. Enter zero for lines a, b and c. Since the X01 (Resource Access Award) results in the award of resources NOT funds, any non-zero value will be treated as an ERROR. No budget forms will be used in the X01 submission and applications are NOT expected to request specific funds or even estimate costs.

SF424 Research & Related Other Project Information

1. Are Human Subjects Involved? Check no.

2. Are Vertebrate Animals Used? Check no.

6. Project Summary/Abstract. The Project Summary/Abstract must state the applications broad, long-term objectives and specific aims. The abstract should state explicitly which services are being requested from the NIH-RAID program.

9. Facilities & Other Resources. Not applicable. Do not include an attachment here.

10. Equipment. Not applicable. Do not include an attachment here.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

The PHS 398 Research Plan includes:

2. Specific Aims. Provide a clear statement of the aims of the project, including the scientific rationale for studying of the therapeutic agent under consideration and a description of the potential clinical application(s). The description of the critical preliminary data supporting the proposal should be detailed enough to permit peer review.

3. Significance. This section should cover three areas.

Background: Provide a brief summary of the field to allow appropriate understanding of the scientific and medical context from which the opportunity emerges.

Uniqueness: Discuss related or functionally similar molecules already under development, and why the NIH should undertake development in light of this.

Justification for NIH Investment: Address reasons why the project under consideration represents a particularly innovative or promising approach, and why public sector funds are needed to overcome translational barriers and meet needs not being met by private-sector support.

4. Preliminary Studies. In addition to describing the studies and data that support the proposed development tasks, applicants should present data that support the efficacy of the therapeutic agent under development.

5. Research Design & Methods. This section should cover two areas.

Subsequent Development Plans: For projects requesting one or more NIH-RAID services, but not all of the services needed to prepare an IND application, applicants should outline how they propose to approach the key steps in product development which would not be supported by NIH-RAID, including proposed milestones and decision points. For projects requesting either production of clinical lot or IND-directed toxicology, applicants should summarize briefly the plans for clinical testing, including methods to assess clinical efficacy. Include potential collaborators and institutional arrangements for oversight and IRB review.

Additional Support: a clear statement by the applicant of all current, anticipated, and hoped for sources of support for the project. This includes a summary of the status of past, planned, or ongoing negotiations with companies related to licensure or future development of the product. This section should also include information on any peer-reviewed grants and/or grant applications pertaining to the project. The applicant should be sure to indicate how NIH-RAID support would complement, not duplicate, other sources of support.

16. Letters of Support. All investigators requesting production of clinical lot and/or IND-directed toxicology should provide a letter of commitment from an academic institution prepared to provide a venue for clinical testing and oversight of human subjects protections in the eventual clinical testing. Individual NIH Institutes and Centers may request documentation and specific details regarding the proposed clinical testing and the oversight of human subjects protections. The letter is intended to assure the reviewers and NIH that the products and data produced by the NIH-RAID program have a clinical outlet, and as such the letter should indicate that the institution is committed to the filing of an IND and conduct of a clinical trial once NIH-RAID activities are completed. In cases where IND-directed toxicology is requested, but no commitment for clinical testing has been obtained, the letter should indicate that the institution is committed to the filing of an IND and describe plans to identify and confirm a commitment for clinical testing. Letters of support are not included in the Research Plan page limits, and must be provided as a separate attachment in PDF format in Item 9 Other Attachments.

17. Resource Sharing plan. No Resource Sharing Plan is required.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

Research Strategy Page Limitations

Item 3 of PHS 398 are limited to 12 pages for applications submitted in response to this FOA.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

Foreign Applications (Non-domestic [non-U.S.] Entities)

Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate scientific review group convened by CSR in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious impact/priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Overall Impact. Reviewers will provide an overall impact/priority 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 five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

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

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.

When a lead therapeutic agent has been selected and proposed for preclinical development:

  • Would development of the therapeutic agent potentially represent a significant advance over currently available treatments or address an unmet medical need?
  • Do the existing data provide compelling support for the efficacy of the therapeutic agent?
  • Will the requested NIH-RAID services significantly advance the therapeutic agent toward a clinical trial?
  • Are plans and resources available to complete the tasks required for IND submission if those services are not requested from the NIH-RAID program?
  • Are appropriate plans in place and potential resources identified to initiate clinical testing of the therapeutic agent?
  • Are there any intellectual property or patent issues described in the application that would significantly hinder the development and/or marketability of the therapeutic agent?

When a lead therapeutic agent has not yet been selected and proposed for preclinical development:

  • Could further study of the therapeutic agent(s) potentially lead to a promising advance over currently available treatments or address an unmet medical need?
  • Do the existing data provide compelling support for studying the efficacy, pharmacology or toxicology of the therapeutic agent?
  • Will the requested NIH-RAID services significantly increase the applicants ability to indentify the best compound out of a group of similar compounds (if applicable)?
  • Are plans and resources available to complete any proposed efficacy or other lead selection studies?
  • Are there any intellectual property or patent issues described in the application that would significantly hinder the development and/or marketability of the therapeutic agent?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the rating:

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Additional Review Considerations

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

Select Agents 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).

Applications from Foreign Organizations. 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.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

  • Data Sharing Plan. Not Applicable
  • Sharing Model Organisms. Not Applicable
  • Genome Wide Association Studies (GWAS). Not Applicable

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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 NIH eRA Commons.

If the application is under consideration for funding, the applicant will be invited to present a seminar on the compound and discuss the potential conditions of an award with NIH staff. After the seminar, the applicant will receive final notification of the status of the application.

2. Administrative and National Policy Requirements

Not Applicable

3. Reporting

Not Applicable

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Tony Jackson
NIH-RAID
6001 Executive Boulevard, Room 2141
Bethesda, MD 20892
Telephone: (301) 594-4660
Email: nih-raid@mail.nih.gov

2. Peer Review Contact(s):

James Li, Ph.D.
Scientific Review Officer
Center for Scientific Review
6701 Rockledge Drive,
Bethesda, MD 20892
Telephone: (301) 435-2417
Email: lijames@csr.nih.gov

3. Financial/Grants Management Contact(s):

Not Applicable

Section VIII. Other Information


Required Federal Citations

Vertebrate Animals:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women, Minorities, and Children:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the submitting individual to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential submitting individuals may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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