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
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.gov)

Title:  Collaborative Research to Explore New Uses for Existing Radioligands (R21/R33)

Announcement Type

New

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 weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-DA-08-001

Catalog of Federal Domestic Assistance Number(s)
.93.279, 93.853, 93.866, 93.242

Key Dates
Release/Posted Date: August 8, 2007
Opening Date: December 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 28, 2007
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 Submission/Receipt Date(s): January 28, 2008
Peer Review Date(s): May/June 2008
Council Review Date(s): October 2008
Earliest Anticipated Start Date(s): December 1, 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: January 29, 2008

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
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

Purpose

The purpose of this Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), and the National Institute of Mental Health (NIMH) is to facilitate collaborations to extend the utility of positron emission tomography (PET) or single photon emission tomography (SPECT) radioligands in the study of brain and other organ systems to diseases beyond those for which the ligand was originally developed. An example might be the use of radioligands synthesized for probing brain systems in substance abuse for the investigation of other diseases such as cancer, schizophrenia, or obesity, or of organs other than the brain, e.g., heart, kidney, adrenal gland, ovary. Similarly, radioligands developed in a patient population afflicted with a specific disease or condition might be applied to other clinical populations with different conditions or diseases. Very often, PET or SPECT radioligands are developed at a single site with a single intended application in mind. This FOA seeks to encourage collaborations between sites that develop and use PET and/or SPECT radioligands for the purpose of expanding the range of ligand applications as well as sharing the ligands themselves or the procedures used in their development/synthesis. The overall goal of this solicitation is to optimize the utility of PET/SPECT radiotracers across organ systems and diseases and between and among sites in human subjects. Applications for this RFA should demonstrate a high degree of risk, innovation, and novelty with regard to the new uses for existing radioligands, as this initiative is targeting unique and innovative collaborations across disciplines, fields, and diseases. Although there is no requirement for preliminary data, a clear scientific rationale is advisable. The primary focus of the proposal must be on human studies. Animal studies are allowable only if required to obtain regulatory approval for the ligands.

This initiative is intended to complement other efforts within the National Institutes of Health (NIH) that presently exist to expand the development of PET radioligands for the study of disease. For example, a number of NIH Roadmap initiatives are underway to support the development of molecular probes to explore various systems and diseases at molecular, cellular, and in vivo levels, particularly the Molecular Libraries and Imaging initiative that has been established to identify lead compounds for tracer development, the Molecular Imaging & Contrast Agent Database (MICAD) that serves as an online resource for in vivo molecular imaging agents, and the Imaging Probe Development Center (IPDC) that has been established to produce known imaging probes where no viable commercial supplier exists and to develop novel imaging probes for research purposes. In addition, NIMH has supported a Tracer Database Initiative in conjunction with the Society for Non-Invasive Imaging in Drug Development (SNIDD) to make information about PET and SPECT tracers available as a resource to the community (http://kidb.bioc.cwru.edu/snidd/). These initiatives are targeted at expanding the numbers of new imaging agents.

The present initiative builds upon these efforts and encourages collaborative interactions between laboratories (including industry) to optimize the utility and application of radioimaging agents and promote their use in novel ways and their application to new or different clinical populations. The overarching goal of this RFA is to broaden the clinical application of the limited supply of PET/SPECT radioligands in both normal and pathological states, to monitor disease progression and treatment efficacy, to enhance medication development and drug discovery, and moreover, to allow the opportunity for novel application of existing PET/SPECT radioimaging agents to improve the public health.

Background

This FOA is intended to stimulate research collaborations between two or more laboratories or sites at different institutions to enhance the utilization of radiopharmaceuticals used in PET/SPECT. PET/SPECT technology has been extremely useful in the evaluation and characterization of brain and other organ systems, in furthering our understanding of disease processes, and in monitoring the effects of therapeutic interventions. However, one of the biggest, single limitations to the application of PET/SPECT technology is the general lack of availability of radiopharmaceutical/radioligand imaging agents.

Radiopharmaceutical imaging agents are typically developed with a specific organ system, utility, or disease in mind, but the targets of the agents are often relevant to multiple organs and diseases. To facilitate development and utilization of clinically useful PET/SPECT radiopharmaceutical imaging agents beyond a single clinical application or disease indication, the National Institute on Drug Abuse, along with other participating NIH institutes, is soliciting applications to establish collaborations that will serve to facilitate the exchange of applicable clinical populations to enhance the utility of these probes and/or to provide mechanisms to increase the availability of PET/SPECT imaging probes across sites.

Research Scope

To maximize the impact and utility of the limited resource of PET radiopharmaceutical agents, applications are being sought to establish novel collaborative efforts across institutions to expand the application of established radioligands in clinical investigation. For example, a radioligand that is presently being used to probe brain systems in substance abuse might have important clinical utility for the study of other neurological, neuropsychiatric, developmental or neurobehavioral diseases or disorders, or in organs other than the brain (e.g., peripheral nervous system, heart, kidney, adrenal gland, ovary). Alternatively, an existing radioligand evaluated in patients with a single disease or condition might be applied to other clinical populations with multiple co-morbidities and/or altered blood flow, metabolism, or clearance mechanisms, which occur commonly in elderly patients. This initiative encourages linkages between groups designed to expand the application of radioligands.

Possible collaborations that might be proposed to explore new uses of existing radiopharmaceutical agents under this initiative include but are not limited to:

A PET/SPECT center routinely utilizing an existing radioligand(s) to probe one system or disease condition collaborating with a second institution to investigate a clinical population not previously studied with that radioligand.

A PET/SPECT center with existing radioligand(s) collaborating with a second institution to allow the second institution to synthesize and utilize the radiochemistry to investigate a clinical population not previously studied with that radioligand.

Two or more PET/SPECT centers collaborating to collect comparable data across multiple sites. A potential barrier in PET/SPECT studies is the collection of uniform data across sites. If investigators propose to study a particular radioligand at two or more sites, evidence must be provided that collection and comparability of equipment and methodology will result in data that can be compared across sites.

In order to further its mission of reducing the burden of neurological disease, the NINDS is interested in supporting applications that focus specifically on the use of existing radioligands for detecting, delimiting, and/or diagnosing neurodegeneration or neurodegenerative disorders. Although pilot data on blood-brain barrier permeability is not required in the initial submission, relevant proposals should include plans to demonstrate in the R21 phase that the ligand of interest crosses the blood-brain barrier.

Proposals with an aging-related focus could address the geriatric syndromes of frailty or sarcopenia, age-related dementia/cognitive impairment, reproductive senescence, unexplained fatigue of the elderly, multiple-coexisting medical conditions including cardiovascular disease, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, and osteoporosis, or other aging-related conditions.

Since regulatory approvals (e.g., IRB, IND, RDRC) can constitute major impediments to dissemination of radioligands and/or patient populations across institutions, the Phased Innovation Award (R21/R33) will be used as the funding mechanism. The initial R21 phase of the award is intended to support planning and the preparation and submission of the applications necessary to gain regulatory approval. No support for human subject research will be provided in the R21 phase. Animal studies are allowable only if required to obtain regulatory approval for the ligands. The R33 award will be contingent on the achievement of the specific, stated milestones necessary to permit human subjects research with the radiotracer(s) proposed in the application.

All applications must include a justification for the time needed to complete the R21 phase. Since the specific milestones may vary depending on institutional regulations, a table or timeline of such milestones must be explicitly provided in the application. The milestones must not only specify the types of regulatory approval needed, but also document what arrangement and agreements between institutions will be established with regard to issues of administrative management across multiple participants and institutions (e.g., intellectual property agreements, shared resources patient management including professional care, liability and confidentiality assurances). Documentation of institutional commitment to resolution of administrative management issues should be verified by letters from appropriate administrative officials (e.g., Deans, Provosts, etc.) It is expected that it may take up to two project years in the R21 phase to obtain all regulatory approvals when the collaboration involves establishing the synthesis and use of a ligand at a new institution. In contrast, only a single project year may be needed to complete the R21 phase in the case of bringing patients from one institution to a second institution where the radioligand is currently in routine use. Program staff will be responsible for reviewing whether achievement of the milestones has been sufficient to justify award of the R33 component.

The actual human subjects studies would be conducted during the R33 phase of the award. The primary focus of the proposal must be on human studies; animal studies are allowable only if required to obtain regulatory approval for the ligands. It is expected that the aim of the studies proposed in the R33 phase will be exploratory and will serve to generate hypotheses about the applicability of the targeted ligand; i.e., the goal of this phase of the program should be directed towards demonstrating the feasibility and utility of the new application of the radioligand, not towards the completion of a full clinical study. The goal of this FOA is to provide funding for demonstration projects showing that: 1) it is feasible to transport patients and/or radiotracer synthesis capabilities, and 2) that the radiotracer is capable of generating a detectable signal in the novel disease condition or organ system. It is expected that the conduct of full clinical studies with adequate controls to rule out alternative mechanistic hypotheses would be the subject of subsequent investigations.

Given the exploratory and descriptive nature of the proposals, only preliminary data that demonstrate feasibility of the studies should be included in the application, pilot data showing the utility of the radiotracer in the novel patient population or organ system are not required. As an example, one of the linked applications might show the ability to recruit and characterize the desired patient population, whereas the second linked application might demonstrate the ability to synthesize and use the radiotracer in human populations.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.

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

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the R21/R33 Phased Innovation award mechanism. In addition, collaborations between separate institutions must be submitted as linked applications. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses the non-modular budget format. Applicants must complete and submit budget request using the SF424 Research and Related (R&R) Budget component found in the application package.

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

All applications must be new applications. No competing renewal or competing supplement applications will be accepted. It is not known at this time whether this FOA will be reissued.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

NIDA intends to commit approximately $2 million dollars in FY2008 to fund 6-8 applications. NINDS intends to commit approximately $450,000 dollars in FY2008 to fund 1-2 applications. NIA intends to contribute funding or co-funding for at least one project, contingent on the receipt of at least one meritorious application relevant to aging issues such as those described above. NIMH intends to contribute funding or co-funding to at least one proposed project, contingent on the receipt of at least one meritorious application relevant to neuropsychiatric or developmental disorders.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (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, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does 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 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 single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, 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 PD/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.

Eligibility is limited to applications involving collaborations between two or more separate institutions.

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

All applications must be new applications. No resubmission, competing renewal or competing revision applications will be accepted. All applications must include human subjects research.

Applicants may submit more than one application, provided 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, 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 eRA Commons.

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

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

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/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 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: 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. There are fields within the SF424 (R&R) application components that, 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/PI’s 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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Research & Related Budget (required for foreign applications)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic (non-U.S.) Entity)

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 or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple Program Directors/Principle Investigators (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 15 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 of the 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 (Section 14 of the Research Plan Component in the SF424 (R&R)), 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, including 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.

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,

Projects must involve collaborations between two or more separate institutions. Applications involving multiple institutions can either be submitted as a set of linked collaborative research applications or using sub-contracts within a single application. Linked applications must incorporate the following items in the application from each of the institutions:

All applications must be submitted individually and use the electronic cover letter to indicate that the application is a part of a linked group. The cover letter must mention all the participating sites, the name of the site’s Principal Investigator, the complete title of that site’s application (see title instructions below). The cover letter should also identify the lead application.

1) A common base title plus a tag denoting the linkage of the form 1/N in the Title field, e.g. 1/6 Multisite Investigation of Radioligand X in Disease Condition Y . Titles need to be succinct so that they do not exceed 80 characters.

2) A cover letter that lists all of the linked applications with the PD/PI name, Title (including the tag) and Applicant Institution. The list must be identical for all of the linked applications.

3) An attachment to each application that lists all of the linked applications. The list must be included in Item 11. Other Attachments in the Other Project Information Component. The list must be the same in format and content as in the cover letter and must be the same in each of the applications. In the body of the text, the section must begin with the heading Linked Applications . When saving the file, it must be named Linked Applications as well to ensure the application is bookmarked properly.

The research plan should describe a feasible strategy for integration of research procedures, managerial and administrative responsibilities, and training across sites to ensure the integrity of the research effort.

Plans for ensuring access to data by all sites, analytic resources, publication and authorship procedures, public use of data, dissemination of results, and means of arbitrating disagreements should be addressed.

If a sub-contract mechanism is used, then 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. 

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: November 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 28, 2007
Application Submission/Receipt Date(s): January 28, 2008
Peer Review Date(s): May/June 2008
Council Review Date(s): October 2008
Earliest Anticipated Start Date(s): December 1, 2008

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:

DA-08-001

Director Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland 20892-8401
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@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/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the National Institute on Drug Abuse Referral Office by email (tlevitin@mail.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any 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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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.

No support for Human Subjects research can be included in the R21 phase of the award. Animal studies are allowable in the R21 phase only if required to obtain regulatory approval for the ligands for use in humans. All human subjects research must be conducted in the R33 phase of the award. Award of the R33 phase will be contingent on the achievement of the institutional and regulatory approval milestones specified in the application. The milestones must not only specify the types of regulatory approval needed, but also document what arrangement and agreements between institutions will be established with regard to issues of administrative management across multiple participants and institutions (e.g., intellectual property agreements, shared resources patient management including professional care, liability and confidentiality assurances). Documentation of institutional commitment to resolution of administrative management issues should be verified by letters from appropriate administrative officials (e.g., Deans, Provosts, etc.) Program staff will be responsible for the administrative review of whether the milestones have been achieved sufficiently to justify award of the R33 component.

Direct costs for this Phase Innovation Awards are limited to $150,000 per year for the R21 phase and $250,000 per year for the R33 phase. These budget limits represent the aggregated direct costs summed across all of the clustered applications from the institutions participating in a given collaboration. The R21 phase may not exceed two years, and the R33 phase may not exceed 3 years. Transition from the R21 to the R33 phase will be contingent on demonstrated achievement of specific milestones detailed in the application.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

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

The NIH requires the PD/PI 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. 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 Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

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.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

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 requirements for R21/R33 applications:

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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 of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.  

Foreign Applications (Non-domestic (non-U.S.) Entity)

Collaborative Applications

Collaborative applications must incorporate the following items in the application from each of the clustered institutions:

1) A common base title plus a tag denoting the linkage of the form 1/N in the Title field, e.g. 1/6 Multisite Investigation of Radioligand X in Disease Condition Y . Titles need to be succinct so that they do not exceed 80 characters.

2) A cover letter that lists all of the collaborative applications with the PD/PI name, Title (including the tag) and Applicant Institution. The list must be identical for all of the collaborative applications.

3) An attachment to each application that lists all of the collaborative applications. The list must be included in Item 11. Other Attachments in the Other Project Information Component. The list must be the same in format and content as in the cover letter and must be the same in each of the collaborating applications. In the body of the text, the section must begin with the heading Collaborative Applications . When saving the file, it must be named Collaborative_Applications as well to ensure the application is bookmarked properly.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The R21 phase of the award is strictly for the support of planning and submission of institutional and other regulatory approval activities. No support for human subjects research can be included in the R21 phase of the award. Animal studies are allowable in the R21 only if required to obtain regulatory approval for the ligands in humans. All human subjects research must be conducted in the R33 phase of the award. Award of the R33 phase will be contingent on the achievement of the institutional and regulatory approval milestones specified in the application. Program staff will be responsible for the administrative review of whether the milestones have been achieved sufficiently to justify award of the R33 component. For example, one of the linked applications might show the ability to recruit and characterize the desired patient population, while the second, linked application would demonstrate the ability to synthesize and use the radiotracer in human populations.

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, weighting them 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 high 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.

Pilot data showing the utility of the radiotracer in the novel patient population or organ system are not required. Presence or absence of such pilot data will not be a review criterion.

Significance: Does this study address an important/significant health problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Are there likely to be uses of the radiotracer(s) with a new disease condition and/or new organ system? Will this study contribute significantly to the field, and will it extend significantly the utility of PET/SPECT radioligands?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there strong scientific rationale for the proposed studies? Is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? Are there specific and reasonable milestones regarding both regulatory and administrative management issues that will allow evaluation of progress to justify the transition between the R21 and R33 phases of funding?

Do the studies proposed in the R33 phase provide novel exploratory and descriptive information? Is the goal of such studies demonstration of feasibility and utility of the new application of the radioligand, not towards completing a full clinical study? Will demonstration projects proposed show that: 1) it is feasible to transport patients and/or radiotracer synthesis capabilities, and 2) the radiotracer is capable of generating a detectable signal in the novel disease condition or organ system? Is it likely that the proposed studies will lead to full clinical studies with adequate controls to address mechanistic hypothesis in subsequent applications?

Given the descriptive and exploratory nature expected from these applications, are preliminary data that demonstrate feasibility of the studies provided? Only preliminary data demonstrating feasibility should be included, pilot data showing the utility of the radiotracer in the novel patient population or organ system are not required.

For applications designating multiple Program Directors/Principal Investigators (PDs/PIs), does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs?  Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?

Innovation: Is the project original and innovative? For example,
is emphasis placed on the novelty and innovation of the use of the radiotracer to a new disease condition and/or new organ system?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.  See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

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. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.

Model Organism Sharing Plan:  Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations

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/her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.        

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Steven Grant, Ph.D.
Clinical Neuroscience Branch
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd, 3170
Bethesda, MD 20892-9593
Telephone: (301) 443-4877
Fax: 301-443-6814
Email: sgrant@nida.nih.gov

Debra Babcock, Ph.D., M.D.
Behavioral and Cognitive Neuroscience
National Institute of Neurological Disorders and Stroke/NIH/DHSS
6001 Executive Blvd, Room 2108
Bethesda, MD 20892-9521
Telephone: (301) 496-9964
Fax: 301-402-2060
Email: dbabcock@ninds.nih.gov

Susan Molchan, M.D.
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging/NIH/DHSS
7201 Wisconsin Avenue, Suite 350
Bethesda, MD 20892
Telephone: (301) 496-9350
Fax: (301) 496-1494
Email: molchans@mail.nih.gov

Basil Eldadah, M.D., Ph.D.
Geriatrics and Clinical Gerontology Program
National Institute on Aging/NIH/DHSS
7201 Wisconsin Avenue, Suite 3C-307
Bethesda, MD 20892
Telephone: (301) 496-6761
Fax: (301) 402-1784
Email: eldadahb@nia.nih.gov

Linda Brady, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health/NIH/DHHS
6001 Executive Blvd, 7204
Bethesda, MD 20892-9645
Telephone: (301) 443-3563
Fax: 301-402-4740
Email: lbrady@nimh.nih.gov

2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:

Deborah Wertz
Grants Management Specialist
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD  20892-9541
Telephone:  301-443-6710
Fax:  301-594-6849
E-mail:  dwertz@nida.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
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).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
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-02-005.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 applicant 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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

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) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 applicants 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 or Health Systems Agency review. 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.


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