Lapse or Relapse to Drug Abuse and Other Chronic Conditions
RFA Number: RFA-DA-05-004
Announcement Type
New
Catalog of Federal Domestic Assistance Number(s)
93.279-NIDA
Key Dates
Release Date: November 3, 2004
Letters Of Intent Receipt Date(s): December 27, 2004
Application Receipt Dates(s): January 25, 2005
Peer Review Date(s): May-June 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 2005
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: January 26, 2005
Due Dates for E.O. 12372
Not Applicable
Executive Summary
The National Institute on Drug Abuse (NIDA) invites applications in which a behavioral, cognitive, social cognitive or neurobiological approach is used to advance our understanding of the causes, consequences and treatment of drug abuse relapse. The purpose of this RFA is to stimulate research that will lead to an improved understanding of the relapsing nature of drug addiction. This RFA particularly encourages interdisciplinary research that fosters collaboration between basic and applied researchers, between those studying humans in laboratory settings and those studying clinical populations. In addition, researchers who study other chronic, relapsing conditions (e.g., obesity, depression, anxiety disorders) are encouraged to apply their research approaches or paradigms to the problem of drug abuse and addiction. To the extent that relapse is a common feature of many chronic diseases, an understanding of drug abuse relapse will have considerable generalizability beyond the phenomenon of drug addiction.
NIDA intends to commit approximately $2.0 million in FY 2005 to fund 6-8 new grants in response to this RFA. An applicant may request for the R01 a project period of up to 5 years and a budget for direct costs of up to $500,000 per year. For the R03, the project period is 2 years and direct costs up to $50,000 for each of those years. (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html) This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
You may submit (an) application(s) if your institution has any of the following characteristics:
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. There is no limit to the number of applications an applicant may submit under this announcement. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
Telecommunications for the hearing impaired: TTY 301-451-0088
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
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
A. Receipt and 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
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilites
4. Arbitration Process
3. Award Criteria
4. 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
Purpose of this RFA
Drug addiction is a chronic relapsing disorder characterized by compulsive, often uncontrollable, drug seeking and drug use in the face of negative consequences. Relapse is a problem common to a wide variety of drugs of abuse including alcohol, nicotine (tobacco), heroin, cocaine, and marijuana. Relapse to drug addiction is a complex phenomenon that is affected by neurobiological, biobehavioral, individual, environmental, social, and cultural variables. The purpose of this RFA is to stimulate research that will lead to an improved understanding of the relapsing nature of drug addiction. This RFA particularly encourages interdisciplinary research that fosters collaboration between basic and applied researchers, between those studying humans in laboratory settings and those studying clinical populations. In addition, researchers who study other chronic, relapsing conditions (e.g., obesity, depression, anxiety disorders) are encouraged to apply their research approaches or paradigms to the problem of drug abuse and addiction. To the extent that relapse is a common feature of many chronic diseases, an understanding of drug abuse relapse will have considerable generalizability beyond the phenomenon of drug addiction.
An understanding of relapse and its implications for treatment interventions, therefore, may require the coordinated efforts of scientists working in collaboration at several levels of analysis across traditional boundaries of scientific specialty. For example, neurobiologists studying neural systems can provide considerable information about the neural substrates and putative antecedent neurobiological markers underlying relapse that may be useful for predicting treatment success and the likelihood of sustained abstinence. Cognitive psychologists can employ or develop sophisticated, sensitive assessment tools and other methods for studying issues such as the role of affect regulation and withdrawal in relapse, or the effect of expectation for sustained abstinence and memory for drug experiences on relapse. Clinical scientists can integrate predictions or findings arising from basic research into treatment programs to optimize success in treatment.
This RFA is meant to include the full spectrum of basic to applied research that utilizes a variety of paradigms and procedures. The research should be hypothesis driven and thematic. It is envisioned that the research will be conducted using laboratory studies, small-scale studies with human volunteers, or Stage I style clinical studies. However, it is possible that basic animal research studies may be relevant to the objective of this RFA and, as such, may be one logical component of the work plan of an application. For example, studies with animal models of relapse might be relevant to the discovery of more details regarding the mode of action of a clinically used medication, neurobiological or behavioral mechanism, knowledge that, in turn, would allow direct application to the clinical setting. For such applications the applicant will need to provide a compelling rationale that the basic research, if successful will, in fact, have direct impact on clinical research, with direct application to treatment interventions. While not exhaustive, research themes that might be investigated include: 1) the neurobiological, behavioral, cognitive antecedents, indices, and/or predictors of relapse; 2) the consequences of relapse; and 3) studies that have the potential to suggest treatment or relapse prevention strategies based on underlying mechanisms revealed by basic research. Research does not need to be conducted in drug abusing populations or involve administration of drugs, but investigators must provide a clear statement indicating either: [1] how the proposed basic research would advance the understanding and/or treatment of drug abuse relapse; or [2] how the proposed clinical research tests a basic research model of drug abuse relapse in an ecologically valid setting.
1. Research Objectives
Like many neuropsychiatric conditions, addiction is a chronic relapsing disorder characterized by compulsive, often uncontrollable, drug seeking and drug use in the face of negative consequences. Despite the availability of many forms of effective treatment, the problem of relapse remains the major challenge to achieving sustained abstinence from drugs. Relapse is a problem common to a wide variety of drugs of abuse including alcohol, nicotine (tobacco), heroin, cocaine, and marijuana. Furthermore, the relapse phenomenon may occur at any time during or after a course of treatment, and it may occur many times, leading to repeated cycles of drug use and abstinence. Understanding relapse, therefore, would appear to be a necessary component of any successful treatment program for drug addiction. Moreover, the chronic relapsing nature of drug addiction appears similar to other conditions characterized by a relapsing course such as eating disorders, gambling, depression and various anxiety disorders. To the extent that relapse is a common feature of many chronic diseases, an understanding of drug abuse relapse will have considerable generalizability beyond the phenomenon of drug addiction.
Relapse to drug addiction is a complex phenomenon that is affected by neurobiological, biobehavioral, individual, environmental, social, and cultural variables. An under-standing of relapse and its implications for treatment interventions, therefore, may require the coordinated efforts of scientists working in collaboration at several levels of analysis across traditional boundaries of scientific specialty. For example neurobiologists studying neural systems can provide considerable information about the neural substrates and putative antecedent neurobiological markers underlying relapse and predicting treatment success. Behavioral, cognitive and social psychologists can employ or develop sophisticated and sensitive methods for studying issues such as the role of affect regulation and withdrawal in relapse, the effect of social support or alternative reinforcers on relapse prevention, the effect of expectation for sustained abstinence and memory for drug experiences on relapse. Clinical scientists can integrate predictions or findings arising from basic research into treatment programs to optimize success in treatment.
This RFA is meant to include the full spectrum of basic to applied research that utilizes a variety of paradigms and procedures. The research should be hypothesis driven and thematic. It is envisioned that the research will be conducted using laboratory studies, small-scale studies with human volunteers, or Stage I style clinical studies. However, it is possible that basic animal research studies may be relevant to the objective of this RFA and, as such, may be one logical component of the work plan of an application. For such applications, the applicant will need to provide a compelling rationale that the basic research, if successful will, in fact, have direct impact on clinical research, with direct application to treatment interventions. In vitro studies will not be considered responsive to this RFA.
1. Mechanism(s) of Support Section III. Eligibility Information
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
Cost sharing is not required.
3. Other-Special Eligibility Criteria
N/A
Section IV. Application and Submission Information
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 at the beginning of this document.
The letter of intent should be sent to:
Director - DA-05-004
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 PHS 398 research grant application instructions and forms as described above. 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)
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:
Director - DA-05-004
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
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review.
The NIH will not accept any application in response to this RFA 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 an RFA, it is to be prepared as a NEW application. That is, the application for the RFA 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.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All 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 (See also Section VI.3. Award Criteria)
6. Other Submission Requirements
N/A
Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html 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
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy 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 and http://www.ott.nih.gov/policy/rt_guide_final.html . 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 data sharing plan and the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Award Criteria.
Section V. Application Review Information
As part of the initial merit review, all applications will:
3. Merit Review Criteria
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
2. 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?
3. 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?
4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
5. 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?
3.A. Additional Review Criteria:
In addition to the above criteria, the following items will 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).
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 E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
3.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.
3.C. Sharing Research Data
1. 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
3.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. NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps and http://www.ott.nih.gov/policy/rt_guide_final.html. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible
The adequacy of the resources sharing plan 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 Principal Investigator 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. Award Criteria.
Section VI. Award Administration Information
If the grantee organization is set up to receive e-mailed awards from NIH, the award will be e-mailed to the authorized business official of the grantee institution. If the organization is not e-mailed enabled, one copy of the Notice of Award will be mailed to the authorized business official. The business official's office is responsible for sending a copy of the award to the Principal Investigator.
2. Administrative Requirements
All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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.
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
3. Award Criteria
The following will be considered in making funding decisions:
4. 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.
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:
Gary Fleming, J.D.
Chief, 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: gfleming@nida.nih.gov
Section VIII. Other Information
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects : The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. 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 Home Page at http://www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.
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 PA 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.
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