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 of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA),(http://www.nida.nih.gov/
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)

Title: Mechanism for Time-Sensitive Research Opportunities (R03)

Announcement Type:
This is a reissue of PAR-05-150, which was previously released August 5, 2005.

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

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 SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

A registration process is necessary before submission and should be started at least four weeks in advance of the planned submission. See Section IV.

Two steps are required for on time submission:

1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see “Key Dates” below).  

2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.

Program Announcement (PA) Number:  PAR-06-249

Catalog of Federal Domestic Assistance Number(s)
93.242, 93.273, 93.279

Key Dates
Release/Posted Date: March 17, 2006
Opening Date:  May 2, 2006 (Earliest date an application may be submitted to Grants.gov) 
Letters of Intent Receipt Date(s): 4 weeks prior to planned submission date.
Application Submission Date(s): The 9th of each month.  NIDA will no longer accept applications related to Hurricane Katrina or Hurricane Rita related to this FOA.
Peer Review Date(s): Within 6 weeks of submission.
Council Review Date(s): Within 6 weeks of review.
Earliest Anticipated Start Date: Within 6 months after receipt.
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date:  June 10, 2009

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. Sending an Application 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
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

This Funding Opportunity Announcement (FOA) is intended to support mental health and/or substance abuse services research in rapidly evolving areas (e.g., changes in service systems, health care financing, policy, etc) where opportunities for empirical study are, by their very nature, only available through expedited award of support. There are three distinguishing features of an eligible study: 1) the study's scientific value and feasibility are clear; 2) rapid review and funding are required in order for the scientific question to be answered and for the research design to be carried out; and 3) the knowledge gained from the study cannot be obtained through the regular NIH cycle of review and award. It should be clear that the research question offers an uncommon and scientifically significant services research opportunity that could only become available if the project is initiated with minimum delay.

In particular, this FOA encourages innovative scientific partnerships between researchers and community or public partners (e.g., public mental health/substance abuse or health care systems, long-term care providers, criminal justice settings, health care providers, payers, health authorities, etc.) who cannot delay policy or program changes in order to obtain baseline research data related to such changes. Research collaborations intended to answer unique and innovative questions concerning changes in a health care system or policy are of most interest. The  provides a mechanism for accelerated review and award to support opportunities for this type of research.

This FOA responds to recommendations in the National Advisory Mental Health Council's Bridging Science and Service Report (http://www.nimh.nih.gov/publicat/nimhbridge.pdf), which calls for: “a mechanism for responding to unique, but fleeting research opportunities with great public mental health significance” and the Blue Ribbon Task Force on Health Services Research at the National Institute on Drug Abuse (http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf), which acknowledged the need for rapid response to “emerging policy changes and phenomena that affect the delivery and/or effectiveness of prevention and treatment services.” In addition, the FOA responds to components of the NIH Roadmap Initiative, which encourages efforts to lower “traditional barriers that have slowed interdisciplinary studies” and to foster “strategic partnerships between NIH, private industry and nonprofit organizations.” (http://nihroadmap.nih.gov/interdisciplinary/index.asp)

Examples of appropriate studies include, but are not limited to, the following:

Within the areas of alcohol and drug abuse research, appropriate studies might encompass, but are not limited to, epidemiological, prevention, treatment development, clinical neuroscience, and services research related to alcohol and drug use., misuse and disorders.  In addition, investigators are encouraged to examine the impact of the time-sensitive event on the intersection of substance use/substance use disorders with HIVAIDS risk factors.

IMPORTANT NOTE: All eligible applications responding to this FOA will be subject to an accelerated review and award process. It is intended that eligible applications selected for funding will be awarded within 4-6 months after the application receipt date. However, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline. Investigators pursuing support for mental health research in the immediate aftermath of a disaster are referred to Rapid Assessment Post-Impact of Disaster, PAR-02-133 at: http://grants.nih.gov/grants/guide/pa-files/PAR-02-133.html.

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

Section II. Award Information


Mechanism of Support

This Funding Opportunity Announcement (FOA) invites applications for small research projects (R03) that can be carried out in a short period of time with limited resources. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, since you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

Competing renewal (formerly “competing continuation”) applications will not be accepted.  Small grant support may not be used for thesis or dissertation research.  Two resubmissions (formerly “revisions") of a previously reviewed R03 grant application may be submitted as defined in NIH Policy. See NOT-OD-05-046 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-046.html 

For specific information about the R03 programs, see:

http://grants.nih.gov/grants/funding/r03.htm.

2. Funds Available

Although the financial plans of the 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.

A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your 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 is invited to work with their institution 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 programs.

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 each application is scientifically distinct. Small grant support may not be used for thesis or dissertation research. 

Section IV. Application and Submission Information


Registration and Instructions for Submission via Grants.gov


To download an Application Package and 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:

Project Directors/Principal Investigators (PD/PIs) should work with their institutions/organizations to make sure that institutional/organizational officials and PD/PIs are registered in the eRA Commons.

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

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

2) Organization/Institutional Registration in the eRA Commons

3) Principal Investigator Registration in the eRA Commons: Refer to the eRA Commons User Guide

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 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) 435-0714, Email:  Grantsinfo@nih.gov 

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

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 “Tips and Tools for Navigating Electronic Submission” on the front page of “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
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget

Optional Components:

PHS398 Cover Letter File
R&R Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations:

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the United States.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Opening Date: May 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): 4 weeks prior to planned submission date
Application Receipt Date(s): The 9th of each month
Peer Review Date(s): Within 6 weeks of submission
Council Review Date(s): Within 6 weeks of review
Earliest Anticipated Start Date: Within 6 months after receipt

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 expedited the review.

The letter of intent is to be sent 4 weeks prior to the planned submission date.

The letter of intent should be sent to:

Denise Juliano-Bult, M.S.W.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7137, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-1638
FAX: (301) 443-4045
Email: djuliano@mail.nih.gov

3.B. Electronic Transmission of an Application 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 permit the expedited review, applicants must notify by email, the NIMH Referral Office listed below, when the application has been submitted.   

Referral Office
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Blvd. Room 6154, MSC 9606
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: nimhreferral@mail.nih.gov

3.C. Application Processing

Applications may be submitted to Grants.gov on or after the opening date and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission dates. (See Section IV.3.A. for all dates.) If an application is not submitted by the submission dates and time, the application may be delayed in the review process or not reviewed. Applicants are reminded to follow the special submission dates cited in this FOA.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the SO for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR), 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

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. This does not preclude the submission of an application already reviewed with substantial changes, but such an application must include an “Introduction” addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).

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 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

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 “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.  

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.    

Research Plan

The Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods components of the Research Plan must not exceed 10 pages.  All tables, graphs, figures, diagrams, and charts must be included with the 10-page limit.  Be succinct and remember that there is no requirement to use all 10 pages allotted to the Research Plan.

Please note that a Progress Report is not needed.

For resubmission of an application, an Introduction (not to exceed one page) in addition
to the Research Plan is required.  This Introduction, which is not included in the ten-
page limit, must include responses to the criticisms and issues raised in the summary
statement. The changes in the Research Plan must be clearly marked by appropriate
bracketing, indenting or changing of typography, unless the changes include most of the
text.  Changes should be summarized in the Introduction.    

Specific Instructions for Modular Grant applications.

All R03 applications must be submitted in the modular budget format. The modular budget format simplifies the preparation of the budget by limiting the level of budgetary detail.  Applicants may request direct costs for two $25,000 modules, up to a total annual direct cost of $50,000 per year, for up to two years ($100,000 maximum, four modules of $25,000 each).

The SF 424 R&R Application Guide (http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc) includes step-by-step guidance for preparing modular budgets.  Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Plan for Sharing Research Data

A data sharing plan is not required; however, one may be proposed.  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.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information


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

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to NIMH, NIDA, or NIAAA, on the basis of established PHS referral guidelines. Appropriate scientific review groups will be convened at the NIMH, NIDA, or NIAAA in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) and will evaluate applications for scientific and technical merit.

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 NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding.  Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application.  Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data.  Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

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 comments, 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.  The scientific review group will address and consider each of these criteria in assigning the application’s 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.

Significance. Is the research question one that cannot be adequately answered unless the review and funding of the project is expedited? 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 this study on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?

Approach. Does the approach justify the need for rapid review and funding? 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?

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, methodologies, tools, or technologies for this area?

Investigators. Are the investigators appropriately trained and well suited to carry out this work including maintenance of any working partnerships proposed? 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? Do the collaborators adequately demonstrate both the capability and the commitment to carrying out the work proposed?

Environment. Do the environment(s) in which the work will be done contribute to the probability of success? Does the proposed study benefit from unique features of the environment(s) and subject populations and support the justification for rapid review and funding? Is there evidence of institutional support from all participants in the partnership? Are the collaborating community partners committed to the rapid nature of the project?

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 and Minorities in Research: The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups) 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).

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the effort listed for the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may 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 funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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.

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

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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.

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 Peer Review Results and Summary Statement (written critique) via the 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 Also 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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:

Denise Juliano-Bult, M.S.W
Division of Services and Interventions Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7137, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-1638
FAX: (301)443-4045
Email: djuliano@mail.nih.gov

Redonna K. Chandler, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5179, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-6504
FAX: (301) 443-6815
Email: rchandler@nida.nih.gov

Peter J. Delany, D.S.W.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, RM 2039, MSC 9304
Rockville, MD 20892-9304
Phone: (301)-443-0788
Fax: (301)-443-8774
E-mail: delanyp@mail.nih.gov

2. Peer Review Contacts:

David Armstrong, Ph.D.
Division of Extramural Research
National Institute of Mental Health
Neuroscience Center, Room 6138, MSC 9606
6001 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 443-3534
FAX: (301) 443-4720
Email: armstrda@mail.nih.gov  

3. Financial or Grants Management Contacts:

Rebecca Claycamp, M.S., CRA
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
FAX: (301) 443-6885
Email: rclaycam@mail.nih.gov

Gary Fleming, J.D., M.A.
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@nih.gov

Judy S. Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3021, MSC 9304
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email:  jfox@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) 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).

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 FOA 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 new PHS Form 398; 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).

Protections for Prisoners in Research involving Human Subjects:

It is not uncommon for persons receiving or in need of mental health or substance abuse services to come in contact with or be confined within the criminal justice system. Researchers must therefore be aware of the additional human subjects protections requires for “prisoners,” a term defined by the Department of Health and Human Services (DHHS) to include adults, adolescents, and children who are either confined or detained involuntarily in an institution or facility by virtue of criminal or civil statutes or commitment procedures.

All investigators proposing research involving prisoners or individuals who may enter prisoner status during study involvement should read the Code of Federal Regulations, Title 45, Public Welfare, Part 46 “Protection of Human Subjects,” which is available on the web at the following URL address: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy.

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.

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 (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) 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 DHHS 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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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