Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
Title: Exploratory Centers for Translational
Research on the Clinical Neurobiology of Drug Addiction (P20)
Announcement Type
This
is a reissue of RFA-DA-08-022.
Request For Applications (RFA) Number: RFA-DA-09-012
Catalog of Federal Domestic Assistance Number(s)
93.279
Key Dates
Release Date: September 12, 2008
Letters of
Intent Receipt Date: January
27, 2009
Application Receipt Date: February 27, 2009
Peer Review
Date(s): June/July 2009
Council Review
Date: August 2009
Earliest
Anticipated Start Date: September 2009
Additional Information To Be Available Date (Url
Activation Date): Not applicable.
Expiration Date: February 28, 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(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
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 Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose of this FOA
The National Institute on Drug Abuse invites applications to support the development of highly translational research centers on the clinical neurobiology of drug abuse and addiction. For this FOA, the concept of a “translational research center on the clinical neurobiology of drug addiction” is an entity with a strong primary human neurobiology focus in which preclinical research directly informs or provides a mechanistic foundation for the clinical research, and the preclinical science may, in turn, be informed and modified by the outcomes of the clinical research. The emphasis of this solicitation is on translation between human and animal experimental investigation; extension of the research aims to the translation to clinical treatment is not required. Advances in the technological armamentarium that can now be brought to bear on questions concerning the acute and chronic effects of drugs of abuse, the factors that influence addiction liability or vulnerability to the effects of drugs, the neurobiological alterations that may lead to abuse and addiction, how drugs of abuse may affect brain systems and processes that change throughout the course of development (including aging) and the effects of intrinsic and extrinsic influences on the course of treatment and relapse now make it possible to pose very specific questions about the nature of drug effects in the human nervous system.
Despite increasing technical advances in clinical neuroscience, however, limits exist in our ability to probe processes in the human brain; the spectrum of approaches that can be used in preclinical investigations renders animal research much more suitable for mechanistic studies of the neurobiology of drug abuse and addiction that cannot be conducted in humans. This solicitation, therefore, is designed to encourage interdisciplinary/multidisciplinary teams of investigators to propose the development of exploratory research programs (very specifically planning grants) with a clear and primary focus on distinctly defined issues in drug abuse and addiction in clinical populations that can be further investigated in animal models with the aim of, ultimately, using the preclinical findings to extend, refine and direct the clinical research and vice-versa. Such teams can represent new collaborations or teams of researchers that currently collaborate or have collaborated in the past. It should be emphasized, however, that for those teams with a history of current or past collaboration, the proposed exploratory center must specifically focus on a scientific goal that is clearly distinct and separable from their other efforts. By virtue of the funding provided through this FOA, it is expected that the research teams and administrative and management structure developed over the course of the funding period will be well positioned to compete for funding through a subsequent solicitation for mature Centers for Translational Research on the Clinical Neurobiology of Drug Addiction. It is important to emphasize that the exploratory centers solicited here are not expected to be full-fledged research centers, and thus the P20 mechanism is used to underscore the planning and exploratory nature of these centers. The expectation is that these exploratory centers will provide up to 4 years of funding to allow for the development, planning, and combination of requisite teams with scientific insights and endeavors that would be capable of transitioning to a full P50-type Center of Excellence. In other words, at the end of the P20 funding period, these exploratory centers should have sufficient preliminary findings and should have established sufficient evidence that the assembled team is capable of the next step – a full P50 center.
Research Objectives:
Given the recent advancement of clinical neurobiological technologies and methodologies, the field of drug addiction research is now poised to make major advances in the human neuroscience of addiction and to build on the research to date. Animal models have yielded very important data on the neurobiological mechanisms of addiction and have been extremely useful in elucidating some of these mechanisms at the basic molecular, cellular, and systems levels. With advances in specific areas such as structural, functional and chemical imaging and human genetics, recent human neurobiological studies have provided new insights into the factors that can influence use and vulnerability to drug abuse as well as the neurobiological changes caused by drug exposure and the factors that influence those changes. Most frequently, animal investigations and human investigations proceed on parallel tracks and, while clinical and preclinical findings may inform one another, the integration of the two is only rarely accomplished in a setting that has their integration as an explicit goal and an infrastructure to support that effort. A need exists in the drug abuse field for integrative/translational research centers capable of both clinical and preclinical investigations that are principally driven by a common, shared set of clinical questions and issues and comprised of projects that continually inform one another over the course of the research program. This FOA represents a first step in addressing this need within a unified center.
Understanding the clinical neurobiology of drug abuse and drug addiction is an incredibly complex problem; to achieve a true understanding of any single facet of the problem requires an interdisciplinary and integrative research approach that employs a range of disciplines, levels of analysis and methodologies beyond those suitable for neurobiological studies in human participants. The exploratory centers supported by this FOA must have as their primary focus the neurobiology of drug abuse/addiction in humans and utilize methodologies and investigative approaches available for use in animal studies, but not available for use in human studies for technical/design/feasibility/ethical reasons, to inform or extend the directions of the clinical investigations and refine the clinical questions. A clear exposition of how the preclinical studies are directly relevant to the clinical question that is the central theme of the proposed center must be provided. For example, neuroimaging studies now provide an important opportunity to advance significantly our understanding of the areas of the brain, and to a limited extent, the processes involved in drug addiction. Neuroimaging studies in humans, however, can only provide very indirect information concerning the alterations induced by abused drugs at the cellular, molecular, genetic, or even the connectional level. It is expected that centers competing successfully for funding through this FOA will propose a program of highly integrative research that has, as its main focus, a well-defined clinical neurobiological question that will be investigated at multiple levels, taking advantage of model systems that offer methodological advantages that have the potential to yield results that can be directly translated into the human investigations. Success of these exploratory centers will be judged on the basis of effective integration of the projects so that clear integration of hypotheses and approaches exist across the interdisciplinary boundaries. It should be noted that applications that do not have a clearly articulated human neurobiological focus will be deemed nonresponsive to this FOA and will be returned without review.
Finally, it is expected that the centers established in response to this solicitation will serve as a venue for training junior investigators in the neurobiology of drug abuse/addiction and in multidisciplinary approaches to scientific investigation.
Objectives and Scope:
The primary aim of this FOA is to support early stage development of interdisciplinary teams of investigators dedicated to the study of the impact of drug exposure, abuse, and addiction on the human brain, and to provide a mechanism for these teams to compete successfully for Centers for Exploratory/Translational Research on the Clinical Neurobiology of Drug Addiction that will be established in a future initiative. Such teams can represent new collaborations or teams of researchers that currently collaborate or have collaborated in the past. For those teams with a history of current or past collaboration the proposed exploratory/developmental center must focus on a scientific goal that is clearly distinct and separable from their other efforts and this distinction must be delineated in the application. Successful applications will demonstrate a strategy for the development of an Exploratory Center that will provide a structure for the support of the team’s goals, a strong scientific rationale for both the composition of the team and the role of the team members, a clear exposition of plans for information exchange/integration between the clinical and preclinical projects, and a coherent plan for the maturation of the center scientifically and administratively.
Proposed centers must be comprised of at least three, but no more than five, scientific projects. At least one of the scientific projects must propose to conduct the main clinical (human) neuroscience research that directly addresses the clinical neurobiological focus of the Center and at least one must conduct integrated preclinical (non-human) research. Scientific projects in the P20 Center are expected to be smaller in scale than might be proposed for a traditional individual research application. Because one of the goals of this FOA is to foster the development of new collaborations and research teams, projects that are high risk/exploratory are encouraged. For such projects, preliminary data are not expected, although evidence of capacity to contribute to the research collaborations is expected. Each project should demonstrate a significant integrative contribution to the goal of the Center as a whole. The interdependence and integration of all of the projects in pursuit of the central clinical neurobiological question must be clearly described, synergy and interdependence in both conceptualization and approach must be demonstrated - the whole must be greater than the sum of the parts. Although an important goal of this FOA is to foster new collaborations and new research teams, this does not preclude teams of researchers that currently collaborate or have collaborated in the past from seeking support through this mechanism. It is very important to emphasize that, for those teams the proposed exploratory/developmental center must focus on a scientific goal that is clearly distinct and separable from their other efforts and this distinction must be specifically described in the application.
It is expected that the investigators directing each of the projects be established scientists in their respective fields. The Exploratory Center mechanism may not be used as a substitute for individual grant support. Scientists named as Project Directors of the scientific projects, therefore, are expected to have independent, peer-reviewed, research support. In specific instances in which the individual proposed to lead a project does not meet these criteria, the qualifications of the proposed Project Director must be clearly described and a strong justification of the choice of that individual to lead the project must be provided.
It may be that one or more of the scientists best suited to address the scientific questions central to the proposed center is not sited at the center’s administrative home. Given the current facility of distance communication and information exchange, such collaborations among different institutions are encouraged if deemed the optimal way for achieving the goals of the proposed center. In those instances in which project investigators are geographically separated, however, it is imperative that a detailed plan for the feasibility of the collaboration be delineated, including plans for regular communication and coordination among the projects given the constraints that geographic separation might impose.
The Director of the Exploratory Center must be a scientist with substantial research and scholarly experience related to the scientific goals of the proposed center. S/he must have a demonstrated ability to organize, administer, and direct the Center. The Director must be the scientific leader of the Center and must also be the Principal Investigator on at least one of the individual research projects. The Director must have a minimum time commitment of 20 percent to the Center grant (including both administrative and research efforts).
If appropriate to the scientific aims of the proposed center, support for core facilities should be requested. Each Core must provide essential services to two or more approved individual research projects. Support provided by Cores must be clearly nonredundant with support provided within projects. The contribution that each of the cores will make to the overall goals of the proposed center, and their integration into the overall structure of the center, should be clearly described.
The proposed center should provide opportunities for young investigators who have the potential for independent research careers to gain skills and experience in state-of-the-art approaches to research in drug abuse and addiction. To achieve this aim, it is expected that relationships be developed between the center and the relevant pre- and postdoctoral training programs at the participating institutions.
Advisory Board: An external advisory board should serve as an important source of guidance from experts in the field who do not have a vested interest in the Center or in the research to be conducted by the Center. Funds may be requested to support travel of board members for meetings in the beginning of the second and fourth years of funding. To avoid reducing the pool of potential reviewers, applicants should NOT identify prospective board members by name in the application or contact them before a funding decision is made.
Areas of Scientific Interest:
The following areas are illustrative of the topics that address the mission of the National Institute on Drug Abuse and should not be considered as being either comprehensive or exclusive of other areas.
The neurobiological processes leading to abuse and addiction – what brain processes, structures and circuits are affected by abused drugs; how are these altered over the time course of exposure; is there an exposure threshold beyond which addiction is inevitable and what factors determine that threshold? What processes are important for the vulnerability to initiate, continue, abstain, or relapse to drug use?
The cognitive neuroscience of addiction – what facets of executive function are affected by drug exposure and how are they altered along the pathway to addiction, how is the neurobiological circuitry implicated in cognitive functions such as reward, inhibitory control, impulsivity, etc. affected by exposure; can cognitive measures be used to predict vulnerability to abuse and addiction or to predict treatment outcome?
The developmental neuroscience of drug abuse – how are the effects of drug exposure influenced by the developmental epoch in which exposure occurs; are there specific developmental time points in which exposure is more or less likely to lead to addiction; what are the developmental neurobiological factors that affect addiction liability; how are processes such as the development of tolerance; the emergence of withdrawal symptoms, or the efficacy of treatment affected by duration of exposure and developmental timeframe?
The neuroeconomics of addiction – how is the neurobiological circuitry implicated in valuation, choices/decisions, and subsequent outcomes affected by drug exposure and how are they altered along the pathway to addiction; can such measures be used to predict vulnerability to abuse and addiction or to predict treatment outcome?
The treatment of drug abuse and addiction – what are the neurobiological bases of treatment effects; how do behavioral and pharmacological treatments interact with brain processes; what are the neurobiological effects of different behavioral and/or pharmacological treatment approaches; what are their neurobiological mechanisms; can neurobiological changes induced by treatment be used to predict treatment success or the optimal course of treatment?
The interaction of drug abuse and HIV/AIDS – does drug exposure influence the time course and severity of the neurobiological effects of HIV infection; does HIV infection, and its psychological effects; alter the neurobiological effects of drug exposure; does antiretroviral treatment affect abuse or addiction liability?
Extrinsic and intrinsic influences on addiction and abuse – what are the interactions between drug exposure and co-morbid psychological, psychiatric, or developmental conditions; are there demonstrable genetic influences on the effects of abused drugs; how do personal and social factors (e.g., stress) affect drug abuse and addiction liability; can intrinsic (e.g., genetic factors, gender) and/or extrinsic (e.g., stress) factors explain individual differences in the effects of abused drugs?
Special Considerations
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the NIH P20 award mechanism, which provides support for developing
collaborative teams of high caliber investigators using diverse scientific
approaches to the investigation of a highly focused research problem.
Applicants may request support for only one period of up to four years; direct
costs requested may not exceed $600,000 in any one year.
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. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
NIDA intends to
commit approximately $3,000,000 in FY 2009 to fund 2 to 3 new grants in
response to this FOA. An applicant may request a project period of up to 4
years and a budget for direct costs of up to $600,000 per year. 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 NIDA provide support for this
program, awards pursuant to this FOA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
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 and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative 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. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 support.
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.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to
Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. 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
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and
number of this funding opportunity must be typed in item (box) 2 only of the
face page of the application form and the YES box must be checked.
Supplementary Instructions:
Application Format Guidelines
The primary purpose of this initiative is to support early stage development of interdisciplinary teams of investigators dedicated to the study of the impact of drug exposure, abuse, and addiction on the human brain. The application must clearly describe the hypotheses to be tested, the goals of the proposed research plan, and the approaches used in the Center.
The application should utilize PHS Form 398 and include the following components in the specified order:
Information for the Entire Center:
Research Career Development (not to exceed 2 pages)- A description of the manner in which Center activities will provide opportunities for young investigators and how the proposed center relates to existing training programs of participating institutions should be given.
Information for Each Project or Core:
For each project or core, the information should be arranged in the following order:
Other Information:
Foreign
Organizations (Non-domestic
(non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Additional information is available in the PHS 398 grant application instructions.
3.
Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent
Receipt Date: January 27, 2009
Application Receipt Date: February 27, 2009
Peer Review Date(s): June/July 2009
Council Review Date: August 2009
Earliest
Anticipated Start Date: September
2009
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:
Director
- DA-09-012
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Director -
DA-09-012
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov
3.C. Application
Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute Incomplete and/or non-responsive
applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
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. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
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: 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 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
Principal Investigators will be required to attend an annual meeting in the Washington, DC metropolitan area. The travel budget should therefore reflect appropriate allocation for this activity. The purpose of these annual meetings will be to share scientific information, assess progress, identify and solve common methodological problems, and identify new research opportunities.
Research Plan Page Limitations
The Research Plan section of the application describing the center, but not including the individual investigators' research projects and core facilities, is limited to no more than 25 pages, including all text, tables, graphs, figures, diagrams, and charts. The Research Plans for the investigators' research projects and core facilities descriptions are limited to no more than 10 pages each. These limitations do not include the sections describing Human Subject Research, Vertebrate Animals, Literature Cited, Consortium/Contractual Arrangements, Consultants, and/or supporting letters. Each Biographical Sketch is limited to no more than four pages, using the NIH format. If not specifically cited in the PHS 398 document instructions, no page limit is in place for any other section. However, applicants are strongly urged to be succinct.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance 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 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 NIH Guide 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 (such as 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, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
that are complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NIDA and in
accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a 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.
Criteria for
scientific/technical review of the proposed projects and cores will include the
following:
Significance: Does
this study address an important problem that is relevant to human
addiction? Is the project or core well integrated into the overarching
clinical neurobiologic goal of the Center? 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?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the project well integrated into the overall clinical neurobiologic focus of the Center? Are the proposed methods appropriate for answering the translational questions proposed?
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? Will the innovation in this project
contribute to the conceptual foundation of the future mature center?
Investigators: Are the investigators appropriately trained and well
suited to lead the project or core? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers? If the
proposed principal investigator does not meet the all of the expected criteria
for a principal investigator, are his or her specific qualifications for
leading the project detailed and the choice of that individual adequately
justified? Does the investigative team bring complementary and integrated
expertise to the project or core?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support?
Criteria for scientific/technical review of the proposed Center applications will include the following:
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 rating:
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 Research Plan section on Human
Subjects in the PHS 398 instructions).
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 Research Plan section on Human Subjects in the
PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. 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.
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 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 (designated in item 12 on
the Application Face Page). If a grantee is not email enabled, a hard copy of
the NoA will be mailed to the 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).
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, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
L. R. Stanford,
Ph.D.
Division of Clinical Neuroscience and Behavioral Research
National Institute of Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3165, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 402-3869
FAX: (301) 443-6814
Email: lstanfor@mail.nih.gov
Kristopher Bough, Ph.D.
Medications Research Grants Branch
Division of Pharmacotherapies and Medical Consequences of Drug
Abuse
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Blvd, Room 4143
Bethesda, MD 20892-9551
Telephone: 301-443-9800
FAX: 301- 443-9649
Email: boughk@nida.nih.gov
Minda Lynch, Ph.D.
Division of
Basic Neuroscience and Behavioral Research
National
Institute on Drug Abuse/NIH/HHS
6001
Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone:
(301) 443-1887
Fax: (301)
594-6043
Email: mlynch1@nida.nih.gov
2. Peer Review Contacts:
Teresa Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tlevitin@mail.nih.gov
3. Financial or Grants Management Contacts:
Deborah Wertz.
Grants Management Specialist
Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: dwertz@nida.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of
PHS support for activities involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health
Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human
Subjects Protection:
Federal
regulations (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).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
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/
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law (i.e.,
a regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the 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).
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008, investigators
must include the PubMed Central reference number when citing an article in NIH
applications, proposals, and progress reports that fall under the policy, and
was authored or co-authored by the investigator or arose from the
investigator’s NIH award. 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 (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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy
People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. 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
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
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