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

• Purpose. The purpose of this Funding Opportunity Announcement (FOA) is to invite investigators to apply for access to government-funded contract resources needed for the preclinical development of therapeutic agents.
• Mechanism of Support. This FOA will utilize the X01 Resource Access award mechanism. These resource awards offer the availability of non-financial agency resources to the successful applicants.
• Funds Available and Anticipated Number of Awards. There are no funds associated with a Resource Access award. Successful applicants receive access to NIH contract resources. The number of awards will depend upon the quality and duration of the applications received, and the resource capacity of the program.
• Budget and Project Period. Not Applicable.
• Application Research Strategy Length: The Research Strategy is limited to 12 pages for applications submitted in response to this FOA.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Include Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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.
• Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
• Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
• Resubmissions. Applicants may submit a Resubmission application, but such application must include an introduction addressing the previous peer review critique (Summary Statement).
• Renewals. Renewal applications are not allowed.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
  All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.
• General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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

• Synthesis
• Scale-up production
• Development of analytical methods
• Development of suitable formulations
• Isolation and purification of natural products
• Pharmacokinetic/ADME studies including bioanalytical method development
• Range-finding initial toxicology
• IND-directed toxicology
• Manufacture of clinical trial supplies
• Product development planning and advice in IND preparation

For recombinant proteins and monoclonal antibodies

• Pharmacokinetic/ADME studies including bioanalytical method development
• Range-finding initial toxicology
• IND-directed toxicology
• Product development planning and advice in IND preparation

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

• Synthesis
• Development of analytical methods
• Isolation and purification of natural products
• Preliminary Pharmacokinetic/ADME studies, including bioanalytical method development
• Preliminary toxicology

For recombinant proteins and monoclonal antibodies

• Preliminary Pharmacokinetic/ADME studies, including bioanalytical method development
• Preliminary toxicology

Scope limitations and clarifications

• Applications will not be accepted for the optimization of therapeutic agents, including medicinal chemistry.
• Applications will not be accepted for the synthesis of therapeutic agents without demonstrated activity against a disease related target or in a disease model.
• Applications will not be accepted for the performance of in vitro or in vivo efficacy testing.
• Applications will be accepted for the manufacture of eligible materials for use in efficacy or other lead selection studies conducted by the applicant or a collaborator.
• Applications for services in support of lead selection can also include requests for late-stage services to support an IND submission.
• Manufacture of gene vectors is limited to non-GMP viral and non-viral gene vectors and GMP-grade adeno-associated virus and lentivirus vectors. Because not all gene vectors can be manufactured, applicants are encouraged to contact the NIH-RAID point of contact regarding their specific vector.
• Applicants are responsible for the completion of chemistry, manufacturing and controls (CMC) tasks and for supplying sufficient material to the NIH-RAID program for projects involving therapeutic agents not manufactured by NIH-RAID.
• Product development plans may also be requested without submitting an application under this FOA if no other NIH-RAID services are requested. These requests may be sent by email to the NIH-RAID program on or before the dates established for this FOA. Requests should be limited to five pages and include information on the lead indication, the planned clinical use, and the evidence for efficacy. Additional information on the therapeutic agent, if available, should also be included. Decisions on requests for product development plans will be based upon program priorities and availability of resources.

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:

• Public/State Controlled Institutions of Higher Education
• 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
• 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)
• Small Businesses
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations.

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:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

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

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons.In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization.PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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 301-710-0267, Email: [email protected].

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:

• Not include any charge-back of customs and import fees;
• Comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF;
• Comply with Federal/NIH policies on human subjects, animals, and biohazards; and
• Comply with Federal/NIH biosafety and biosecurity regulations (see Section VI.2., Administrative and National Policy Requirements)

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:

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

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: [email protected]

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

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

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:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

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.

• If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the Division of Receipt and Referral, Center for Scientific Review, NIH, after two business days, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed or if information was lost or compromised during transmission. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or did not transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

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.

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

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:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the appropriate NIH program staff.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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?