Department
of Health and Human Services
Participating
Organizations
National Institutes of Health
(NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Institute of Mental Health (NIMH), ( http://www.nimh.nih.gov)
National
Institute on Aging (NIA), (http://www.nia.nih.gov)
National
Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
National
Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Title: Mouse
Models Containing Human Alleles: Novel Tools to Study Brain Function (R21/R33)
Announcement Type
This FOA is a
reissue of RFA-MH-08-050.
Update: The following updates relating to this announcement have been issued:
Program Announcement (PA) Number: PAR-08-158
NOTICE: Applications submitted in response to this Funding
Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4)weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
Key Dates
Release/Posted
Date: April 24, 2008
Opening Date: May 26, 2008 (Earliest date an application may be submitted
to Grants.gov)
Letters
of Intent Receipt Date(s): 30 days
prior to application receipt date
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): June 26, 2008; January 28, 2009; May 28, 2009; January 28,
2010; May 28, 2010; January 28, 2011
Peer Review Date(s): October 2008, June 2009, October 2009, June 2010, October 2010, June 2011
Council Review Date(s): January 2009, October 2009,
January 2010, October 2010, January 2011, October 2011
Earliest Anticipated Start Date(s): April 2009, December2009, April
2010, December 2010, April 2011, December 2011
Additional Information To Be Available Date (Activation
Date): Not Applicable
Expiration Date: January 29, 2011
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
This Funding Opportunity Announcement (FOA), issued by the National Institute of Mental Health (NIMH) with participation from the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Institute on Drug Abuse (NIDA), invites Phased Innovation (R21/R33) grant applications from organizations /institutions that propose the development and characterization of novel mouse models that express human genes or human genetic elements that can aid in understanding the molecular mechanisms underlying brain development and function relevant to candidate genes/gene dosing abnormalities that may be implicated in bipolar disorder, schizophrenia, depression, anxiety, developmental disorders, addiction, and alcoholism and neurodegenerative disorders of aging.
Background
In recent years, a number of genes have emerged as candidates for involvement in human mental disorders, addiction and alcohol dependence and age-related neurodegenerative disorders. Whole-genome association studies continue to identify potentially important genetic factors that may play a role in normal neural processes and in the etiology of psychopathologies, age-related neurodegeneration, alcoholism, and addiction. Although currently unclear, some of these may be specific disease alleles with polymorphisms present either in coding regions or in regulatory elements altering the function or expression characteristics of particular genes. Other genes may, in isolation or in combination, be protective for unknown functional reasons. In addition, there are preliminary indications that genetic copy number variations (CNVs) might play a role in various disorders of interest to NIMH, NIA, NIDA, and/or NIAAA. At present, little is known about the mechanisms or pathways that contribute to functional changes for these human gene products or the consequences of these changes on brain function or behavior. One approach to studying candidate genes is to examine the functional impact of variations in intact systems. Expressing specific human alleles of interest in mice may help elucidate gene/protein regulation and function and can provide novel model systems to study human genes related to brain development, aging and its attendant changes, physiology, pharmacology, neurochemistry, and behavior. While this approach is clearly exploratory, the mouse model represents a highly tractable system in which to examine the function of genes and genetic variants. The approach would provide critical information regarding the functional significance of human genes/proteins and has already been used with some success in multiple systems, including in the context of neurological conditions.
Nature of the Research Opportunity
This opportunity will stimulate the creation and validation of novel mouse models expressing human candidate genes/genetic elements that have the potential to inform the understanding of brain and behavioral function relevant to the etiology (e.g., candidates that confer risk, susceptibility, resilience) or treatment of mental disorders, aging-related disorders, addiction, and alcoholism. The FOA uses the NIH Exploratory/ Developmental Grant (R21) and the NIH Exploratory/ Developmental Grant Phase II Phased Innovation (R33) award mechanisms. The NIH envisions that the primary activities of the R21 phase will include making constructs, creating/breeding the genetically altered mice, and initial functional characterization of the mouse line(s). Upon achieving agreed-upon milestones for the R21 phase, investigators may be eligible to receive one additional year of support in the R33 phase to continue characterization and evaluation of mice. This FOA will only support studies to generate and characterize new mouse models beginning with the R21 phase. Applications proposing to study existing mouse lines, even those lacking characterization data will not be considered for support through this FOA.
In general, it is hoped that knowledge will be gained regarding functional aspects of human genes/genetic elements/gene products with regard to brain function and/or behavior relevant to NIMH, NIA, NIAAA, and NIDA research priorities. The following objectives would make appropriate topics for proposed R21/R33 projects. This list is not meant to be all-inclusive, but can provide guidance on the types of projects that are of interest to the participating NIH Institutes.
A number of approaches to create mice expressing human genes may be used to achieve the objectives outlined in this announcement. The approach should be well-justified and take into consideration expression of the endogenous mouse ortholog(s) as well as issues related to regulation of expression. Novel strategies such as recombinase-mediated cassette exchange (RMCE), recombinase-mediated genomic replacement (RMGR) may be used. Conventional gene targeting strategies, transgenics, or alternate approaches may be appropriate as long as investigator justifies the approach and has considered alternatives. Genetic background of the mouse lines should be carefully considered and justified based on the nature of the genetic manipulation, proposed mouse characterization protocol(s), and/or other issues. Proposed evaluation of the mice in the latter part of the R21 phase and throughout the R33 phase will be specific to important functional questions related to the human gene/genetic element expressed. Evaluation and characterization of the resulting mice may include gene/protein expression characteristics, biochemical, physiological, morphological, and/or behavioral measures or other specific validations.
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 NIH Exploratory/Developmental
Phased Innovation Grant (R21/R33) award mechanism. Applicants must apply for the
combined R21 and R33 award. Applicants using only the R21 mechanism or only
the R33 mechanism will not be considered. The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. ALL applicants must complete and submit budget requests using the Research and Related (R&R) Budget component. Modular budgets are not permitted for this funding opportunity.
2. Funds Available
The total project period for the
combined R21/R33 application submitted in response to this FOA may not exceed
three years. The R21 phase may not exceed two years or $200,000 in direct
costs, with no more that $150,000 in direct costs in any single year of the R21
phase. The R33 phase may not exceed one year or $150,000 in direct costs.
Separate detailed (non-modular) budgets are required for the R21 and R33
phases. Applicants may propose to create and validate one or more mouse lines
in a single application, however, the budget should appropriately reflect the
needs of the project and cannot exceed the guidelines for a single application
outlined here.
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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1.A. Eligible Institutions
The following organizations/institutions are eligible
to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. 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 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 more than one application, provided
that each application is scientifically distinct.
Exploratory/developmental grant support is for new projects only; renewal applications will not be accepted.
Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).
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 NIH eRA Commons.
Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application
Information
Applicants must download the SF424 (R&R)
application forms and the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.
For further assistance, contact GrantsInfo --
Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-0088.
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/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 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 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
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
This FOA uses ONLY the detailed Research & Related Budget. (Do not use the PHS398 Modular Budget.
Foreign Organizations (Non-domestic [non-U.S.] Entities)
NIH policies concerning grants to foreign (non-U.S.)
organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 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 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” [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, 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.
3.
Submission Dates and Times
See Section IV.3.A. for
details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: May 26, 2008 (Earliest date an
application may be submitted to Grants.gov)
Letters of Intent Receipt
Date(s): 30 days prior to application receipt
date
Application Due Date(s): June 26, 2008; January 28, 2009; May 28, 2009; January 28,
2010; May 28, 2010; January 28, 2011
Peer Review Date(s): October 2008, June 2009, October
2009, June 2010, October 2010, June 2011
Council Review Date(s): January 2009, October 2009,
January 2010, October 2010, January 2011, October 2011
Earliest Anticipated Start Date(s): April 2009, December 2009, April
2010, December 2010, April 2011, December 2011
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:
Andrea
Beckel-Mitchener, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard,
Room 7187, MSC 9641
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
Email: amitchen@mail.nih.gov
3.B. Submitting an Application
Electronically to the NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s)
and time, the application may be delayed in the review process or not reviewed.
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 weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
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. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons
acknowledgments. 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 FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
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.
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 or competing renewal award if such costs: 1) are necessary to
conduct the project, and 2) 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 or competing
renewal 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
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.”
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. 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 additional requirements:
Specific Instructions for Preparing a Combined R21/R33 Phased Innovation Award Application
For the R21/R33 Phased Innovation Award application, the initial review group will evaluate the specific goals for each phase and the feasibility milestones that would justify expansion to the R33 phase. A single priority score will be assigned to each scored application. For the R21/R33 application the initial review group may recommend that only the R21 phase be supported, based on concerns related to the application’s specific goals and the feasibility milestones justifying the expansion to the R33 phase. Deletion of the R33 phase by the review panel or presentation of inadequate milestones in the application may affect the merit rating of the application.
Prior to funding an application, the Program Officer will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Officer and the applicant will negotiate and agree on a final set of milestones. These will be the basis for judging the success of the R21 work. For funded applications, the Project Director/Principal Investigator (PD/PI) will submit a progress report to the Program Officer upon completion of the R21 milestones. Receipt of this progress report will trigger an administrative program review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of negotiated scientific milestones, on program priorities, and on the availability of funds.
The R21 and R33 cannot be funded in the same fiscal year.
1. In the “Research & Related Other Project Information” Component (item 6 – Project Summary/Abstract”)
As part of the Summary/Abstract attachment, identify concisely the human genetic element to be used, the mouse model to be developed, its innovative nature, its scientific relevance, and its expected impact on research.
2. In the “Research & Related Budget” Component – Section K (“Budget Justification”)
For the R21 phase of the application, direct costs are limited to a maximum of $200,000, with no more than $150,000 in direct costs for any single year and a maximum of two years. For the R33 phase of the application, direct costs are limited to $150,000 and a maximum of one year. Budgets can only exceed these caps to accommodate Facilities and Administrative (F&A) costs of subcontracts to the project. The combined R21/R33 application is limited to three years in duration.
The application should provide a detailed budget for each Budget Period of the R21 phase and the R33 phase. All budgets should include a written justification Section K, “Budget Justification.” In Section K of each Budget Period, the application should indicate whether it is the R21 or the R33 phase. The modular budget format is not permitted for this funding opportunity.
3. In the "PHS398 Research Plan Component" - Research Plan Attachments:
Item 1: Specific Aims.
A specific section labeled “Milestones” should appear at the beginning of the Specific Aims attachment. Milestones should be well described, quantifiable, and scientifically justified. Applicants should write the milestones assuming that scientifically literate program officers who may not be active researchers in the specific specialty being evaluated will use them to evaluate the progress that has been achieved. Milestones should not be simply a restatement of the specific aims or a timeline. The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones are critical.
The milestones should demonstrate the feasibility of the R21 and R33 phases and permit a straightforward decision as to whether or not the applicant is ready to initiate the R33 phase of the project. For example, milestones might include the construction of appropriate vectors, the generation of founders or prediction of having a breeding population (numbers of mice), and/or initial pilot studies addressing proposed characterization. Proposed milestones will be unique to each application depending on the number of mice proposed, the genetic technology used, breeding schemes necessary and other factors. This list is illustrative, rather than exhaustive or compulsory.
Applications lacking this information, as determined by the NIH staff, may be rejected or delayed in the review process. .
Include headers titled “R21 Phase Specific Aims” and “R33 Phase Specific Aims.” Under each header, state the specific objectives of the research and development effort, including the technical questions you will try to answer to determine the feasibility of the proposed approach. Since the goal of the R21 phase of this FOA is the development of novel mouse models, hypothesis testing, per se, may not be the driving force in developing such a proposal, and therefore, may not be applicable in the R21 phase.
Item 2: Background and Significance
Elaborate on the innovative nature of the proposed research. Clarify how the fundamental approach to be developed will result in a significant improvement over existing approaches. Clearly identify how the project, if successful, will result in new opportunities and how the proposed new model will have an impact on research and our understanding of brain function.
Item 3: Preliminary Studies
The R21 component will be considered exploratory, so that extensive preliminary data from the applicant's own laboratory are not required. However, the project must be based on a strong rationale, and the applicant should provide evidence that the initial exploratory work is promising. This section should provide current thinking or evidence in the literature that substantiates the feasibility of the R21 phase. Although not required, preliminary data should be included where available.
Item 4: Research Design and Methods
Follow the instructions in the SF424 Application Guide. Include headers titled “R21 Phase Research Design and Methods” and “R33 Phase Research Design and Methods,” and address the research design and methods for the R21 and R33 phases in the appropriate sub-section.
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 of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
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.NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
Applicants should describe in detail how resources (including constructs, ES cells, germplasm and live mice) will be made available. For mouse-related bioresources, it is strongly suggested that the applicant propose to deposit mice into NIH-supported repositories in a timely manner so that these lines can be made available to researchers and to ensure compliance with the NIH Model Organism Sharing Policy (http://grants2.nih.gov/grants/policy/model%5Forganism/). The applicant should budget appropriately for the cost of depositing mice.
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
A pplications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established Public Health Service (PHS) referral guidelines.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate scientific review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application.
Note
that an application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a meritorious 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.
Significance: Does this study address an important 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
the human genes/genetic elements to be expressed in
mice of significance in terms of increasing our understanding of basic brain
function? Do the proposed candidate genes/genetic elements have the potential
to inform understanding of brain and behavioral function
relevant to the etiology (e.g., candidates that confer risk, susceptibility,
resilience) or treatment of mental disorders, addiction, alcoholism, or
neurodegeneration?
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? For applications designating multiple PDs/PIs, 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? 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? Does the application present consideration of the potential pitfalls in both the mouse generation and validation stages?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?
Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) 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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support.
In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.
Milestones: Are the milestones quantitative? Are the proposed milestones appropriate for judging the success of the R21 work? Are the proposed milestones appropriate for judging the potential impact of the R33 phase? Are the proposed milestones appropriate in determining whether the R33 phase should be awarded? Do the milestones establish feasibility for all aspects of the proposed work?
2.A. Additional Review Criteria
In addition to the above criteria, the following items
will be considered in the determination of scientific merit and the rating:
Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
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 the “Human Subjects Sections” of
the PHS398 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 the “Human Subjects Sections” of the PHS398
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 adequacy of the plans for their care and use will
be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan
component of the SF424 (R&R).
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. Resource Sharing Plan(s)When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
The initial review group will assess the adequacy of the sharing plan. This includes DNA constructs, ES cells, and mice where applicable.
Applicants should describe in detail how resources (including constructs, ES cells, germplasm and live mice) will be made available. For mouse-related bioresources, it is strongly suggested that the applicant propose to deposit mice into NIH-supported repositories in a timely manner so that these lines can be made available to researchers and to ensure compliance with the NIH Model Organism Sharing Policy (http://grants2.nih.gov/grants/policy/model%5Forganism/). The applicant should budget appropriately for the cost of depositing mice.
3. Anticipated Announcement and Award Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
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
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Andrea
Beckel-Mitchener, Ph.D.
Division
of Neuroscience and Basic Behavioral Science
National
Institute of Mental Health
6001
Executive Boulevard, Room 7187, MSC 9641
Bethesda, MD 20892-9641
Telephone:
(301) 443-5288
Email: amitchen@mail.nih.gov
Lisa A. Neuhold, Ph.D.
Division of Neuroscience and
Behavior
National Institute on Alcohol
Abuse and Alcoholism
5635 Fishers Lane, Room 2065, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 594-6228
Email: lneuhold@mail.nih.gov
Jonathan Pollock, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4255, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1309
Email: jpollock@nida.nih.gov
D. Stephen Snyder, Ph.D.
Division
of Neuroscience
National
Institute on Aging
7201
Wisconsin Ave,
Room 350, MSC 9205
Bethesda, MD 20892-9205
Telephone:
(301) 496-9350
Email: ss82f@nih.gov
2. Peer Review Contact(s):
Dr. Joseph Rudolph
Division
of Physiology and Pathology
Center for Scientific Review
6701
Rockledge Drive, Room 5186, MSC 7844
Bethesda, MD 20892-7844
Telephone:
(301) 435-2212
Email: josephru@csr.nih.gov
3. Financial/Grants Management Contact(s):
S. Victoria
Carper, MPA
Division
of Extramural Activities
National
Institute of Mental Health
6001
Executive Boulevard, Room 6118, MSC 9608
Bethesda, MD 20892-9608
Telephone:
(301) 443-3858
Email: carpervictoria@mail.nih.gov
Section VIII. Other Information
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
institutional review board (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.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in
advancing genome-wide association studies (GWAS) to identify common genetic
factors that influence health and disease through a centralized GWAS data
repository. For the purposes of this policy, a genome-wide association study is
defined as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such as
blood pressure or weight), or the presence or absence of a disease or
condition. All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data repository
management (submission and access) is governed by the Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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.
Access to Research Data through the Freedom of Information
Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women 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 Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National Library of
Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version
of their final, peer-reviewed manuscripts upon acceptance for
publication, to be made publicly available no later than 12 months after the
official date of publication. The NIH Public Access Policy is available
at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
Internet addresses (URLs) or PubMed Central (PMC) submission identification
numbers must be used for publicly accessible on-line journal
articles. Publicly accessible on-line journal articles or PMC
articles/manuscripts accepted for publication that are directly relevant to the
project may be included only as URLs or PMC submission
identification numbers accompanying the full reference in either the
Bibliography & References Cited section, the Progress Report Publication
List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential 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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NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
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