Post date: Apr 7, 2015 12:27:21 AM

Behavioral & Integrative Treatment Development Program (R01)

gomojoaidsfreegeneration.blog

Department of Health and Human Services

Part 1. Overview Information

Key Dates

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support athttp://www07.grants.gov/contactus/contactus.jsp.

Table of Contents

Part 1. Overview Information

Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the Office of Behavioral and Social Sciences (OBSSR) are seeking research grant applications on the development and testing of behavioral and integrative treatments for drug and alcohol abuse and dependence. This Funding Opportunity Announcement (FOA) reaffirms NIDA's, NIAAA's and OBSSR's continued commitment to major programs of research on behavioral and integrative treatments. The term "behavioral treatments" is used here in a broad sense and includes but is not limited to psychotherapies, cognitive, relapse prevention, remediative, rehabilitative, skills training, counseling, family, and exercise therapies and includes screening, brief, computerized, adherence, and HIV prevention interventions, as well as intervention that target therapist training and fidelity. Integrative refers to combinations with other treatments, including medications or complementary and alternative (CAM) treatments. The development of putative mechanisms of behavior change, and the use and development of valid and reliable assessment tools, are crucial to the three Stages of treatment research supported under this initiative:

• Stage I (Intervention generation and refinement) encompasses all activities related to the creation of a new behavioral intervention. This stage also includes the modification, adaptation, or refinement of an existing intervention (Stage IA). Stage I culminates in feasibility and pilot testing (Stage 1B). Finally, note that one can conduct Stage I studies in research settings, with research therapists and research subjects; or in community settings with community providers.
• Stage II (“Efficacy”) research consists of experimental testing of promising behavioral interventions in research settings, with research-based therapists/providers.
• Stage III (“Efficacy in Real World”) research consists of experimental testing of promising behavioral interventions in community settings, with community-based therapists/providers and patients, while maintaining a high level of control necessary to establish internal validity.

Stages I, II, and III all include a focus on theory-derived, putative moderators, mediators, and change mechanisms that underlie the treatment.

Significance

Behavioral treatments play a critical role in most evidence-based substance abuse interventions, and often constitute the entire treatment. This funding opportunity announcement (FOA) is intended to promote Stage I treatment and intervention development research. This FOA (in conjunction with the parallel FOAs using the R34 and R03 mechanisms) will support Stages I through Stage III of behavioral and integrative intervention research so that better interventions are developed as the science advances, and so that these treatments and interventions are better tailored to individuals and more readily transported to the community. Over the past two decades, numerous evidence-based behavioral and integrative treatments for substance abuse and addiction have been created. With recent advances in science and neuroscience, it is evident that in order to improve clinical outcome, more can be done to incorporate new scientific discoveries into behavioral treatment and intervention development. In addition, as we learn about how these treatments work, and as new technologies become available, more can be done to make treatments and interventions more easily transportable to community settings. To achieve these goals, the Behavioral Therapies Development Program, renamed the Behavioral and Integrative Treatment Development Program, is continued.

For alcohol abuse and dependence, most of the treatments available in the U.S. also have been behavioral in nature. A large number of clinical trials have demonstrated effectiveness for several types of behavioral therapies, including cognitive behavioral therapy, motivational enhancement therapy, marital family therapy, brief interventions, and the community reinforcement approach. Although progress has been made in a broad range of behavioral interventions to treat alcohol abuse and dependence, many alcoholics do not respond adequately to currently available behavioral therapies. For alcohol abuse and dependence, this FOA supports research to develop new innovative behavioral therapies or modify existing treatments to improve their effectiveness and devise ways to improve the engagement, retention, adherence, and outcome of alcoholism treatment across various populations of alcohol dependent and abuse subjects.

Behavioral and integrative treatment and intervention research has been conceptualized within a Stage Model consisting of six Stages. Under this FOA, intervention development is viewed as iterative, recursive, and bidirectional. Three Stages are supported under this FOA.

Stage I: Stage I encompasses all activities related to the creation of a new behavioral intervention, or the modification, adaptation, or refinement of an existing intervention (Stage IA), as well as feasibility and pilot testing (Stage 1B). Stage I may involve translational basic to applied (sometimes referred to as “T1”) research. Stage I may also involve the modification or adaptation of interventions for ease of implementation in real-world settings. It can be conducted in: research settings, with research therapists/providers, but it can also be done in “real world” or community settings, with community therapists/providers. One goal of a Stage I project is to provide necessary materials and information to proceed to a later phase Stage I, Stage II or Stage III project. An equally important goal is to obtain scientific knowledge of the processes that lead to behavior change (i.e., behavioral, cognitive, social or biological change mechanism).

Stage I research is iterative and may involve: 1) identifying promising basic or clinical scientific findings relevant to the development or refinement of an intervention; 2) generating/ formulating theories relevant to intervention development and putative change mechanisms; 3) operationally defining, and standardizing new or modified principle-driven interventions; 4) initial or pilot testing of the intervention; 5) experimentally testing the mechanisms and principles of behavior change of the intervention; and 6) as necessary, further refining the intervention.

This Stage Model presumes that intervention development is incomplete if no materials and methods are available to ensure faithful administration of an intervention. Therefore, therapist/provider training and fidelity assessment and enhancement methods are an integral part of behavioral intervention development. Research on the generation, modification, and pilot-testing of training and fidelity intervention/procedures for community providers are important Stage I activities, whether conducted prior to taking intervention to an efficacy study, or after an intervention has proven efficacious.

Stage I research can be conducted to generate, modify, refine, adapt, or pilot-test: 1) behavioral treatment interventions; 2) HIV prevention interventions; 3) medication adherence interventions; 4) components of a behavioral intervention; 5) therapist/provider training and supervision interventions; 6) interventions to ensure maintenance of the fidelity of intervention.

Stage II: Stage II research consists of testing of promising behavioral interventions in research settings, with research therapists/providers while maintaining a high level of control necessary to establish internal validity. It also involves examining mechanisms of behavior change. Stage II does not specify a particular research design. Testing of interventions may be done in randomized clinical trials, but may also be conducted using other methodologies as appropriate (e.g., adaptive designs, multiple baseline single-case designs, A-B-A designs, etc.). Stage II studies may include exploration of intervention components, dose-response, and theory-derived moderators.

Proceeding from Stage I to Stage II (or Stage III in the case of an intervention developed in or ripe for a community setting) presumes that promising pilot data exist. If sufficiently strong evidence of promise does not exist, but if there is a good rationale for additional modification of the intervention, such modification can be proposed in a subsequent Stage I study.

Information obtained from Stage II studies may be used to inform future Stage I studies. For example, if it is shown that an intervention works for some people, but not for others, especially if such moderator effect makes conceptual sense, a Stage II study may lay the groundwork for a Stage I application aimed at developing an intervention (or modifying the intervention) for people who were unresponsive to the initial intervention.

Stage III: Stage III research determines efficacy in community settings, with community therapists/providers. Although Stage III occurs in real-world settings, investigators should maintain a high level of control to establish internal validity. Proceeding directly from Stage I to Stage III requires Stage I research to be promising, and requires the existence of methods to ensure fidelity of delivery of an intervention, along with therapist training materials (as required by the intervention).

Stage III does not specify a particular research design. Testing of interventions may be done in randomized clinical trials, but may also be conducted using other methodologies (e.g., adaptive designs, multiple baseline single-case designs, A-B-A designs, etc.). Stage III studies may include examinations of intervention components, dose-response, and theory-derived moderators.

Information obtained from Stage III – or Stage II – studies may be used to inform future Stage I studies. For example, if it is shown in Stage III that an intervention works for some people, but not for others, a Stage III study may lay the groundwork for a Stage I application aimed at developing an intervention (or modifying the intervention) for people who were unresponsive to the initial intervention.

Examination of the mechanism of action of interventions is considered to be an integral part of all Stages of intervention development research.

The objective of this and the accompanying two other announcements is to ensure sufficient emphasis and support for Stages I through III of behavioral and integrative treatment research, so that scientific knowledge can be incorporated into newer and better behavioral, combined behavioral and pharmacological, integrative and CAM treatments, and so that treatments can be effectively transported from research to the community.

Specific Areas of Research Interest

This FOA encourages research on behavioral and integrative treatments or any medication/treatment adherence interventions for any substance abusing population or populations with pain. For this FOA, this primarily includes Stage II and Stage III efficacy studies (randomized clinical trials, adaptive designs, SMART designs, etc.) of behavioral, combined, or integrated treatment interventions, adherence interventions, and HIV prevention interventions. This includes treatment dose-response studies, and studies of the optimal sequencing of treatment, adherence, and HIV prevention interventions. Also of interest are integrated or sequential treatments for populations with substance use disorder(s) and co-occurring medical and/or psychiatric condition(s). Research on the treatment of any substance of abuse, including illicit drugs, prescription medications, nicotine, alcohol and multiple drugs is encouraged. Of particular interest, and relevant to most examples listed below, are studies that seek to determine basic mechanisms of behavior change, within the context of behavioral treatment research. Therefore, applicants are strongly encouraged to include (and if necessary develop) measures of proposed mediators, moderators, and mechanisms of behavior change relevant to their intervention. This may include, for example, behavioral, cognitive, social, affective, and/or neurobiological measures.

Specific areas of interest include, but are not limited to:

1. Research to explicate purported mechanism of action of behavioral interventions at multiple levels of analysis. This includes determination of underlying biological and/or neurobiological mechanism (e.g., as measured by imaging methodologies, skin conductance, or other biological/physiological indices) of the interventions associated with the behavioral, cognitive, affective, or social mechanisms of interventions.

2. Research that uses innovative technologies (web-based interventions, smart phone technology, virtual reality, wireless monitoring and biofeedback, video games, imaging tools for biofeedback) to develop and improve on behavioral interventions including the use of imaging methods to predict outcomes from behavioral interventions.

3. Research that incorporates genetic/epigenetic methodologies to help understand the variability in outcomes as result of therapeutic interventions.

4. Research that evaluates the use of medications to improve the efficacy or effectiveness of behavioral interventions.

5. Research on the essential components of a behavioral treatment, adherence or therapist training intervention.

6. Stage III intervention development research aimed at facilitating the implementation of an intervention

7. Stage III intervention development research aimed at testing behavioral interventions within primary care settings.

8. Research testing the efficacy of treatment interventions for psychiatric conditions that are co-occurring with substance abuse, such as research on treatments for people who smoke and have a diagnosis of schizophrenia.

9. Research to promote adherence to medications, such as HAART, in substance abuse treatment populations

Special Considerations

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

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

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Section II. Award Information

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

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

State Governments

County Governments

City or Township Governments

Special District Governments

Indian/Native American Tribal Governments (Federally Recognized)

Indian/Native American Tribal Governments (Other than Federally Recognized)

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the SAM.gov “Manage Entity” function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided atGrants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

Regardless of the stage of intervention development, investigators should include the development of theory-derived, putative moderators, mediators, and change mechanisms that underlie the treatment.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grantswebsite.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)

Contact Center Phone: 800-518-4726

Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)

Telephone 301-435-0714

TTY 301-451-5936

Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)

Phone: 301-402-7469 or 866-504-9552 (Toll Free)

TTY: 301-451-5939

Email: commons@od.nih.gov

Scientific/Research Contact(s)

Lisa Onken, Ph.D.

Chief, Behavioral and Integrative Treatment Branch

Associate Director for Treatment

Division of Clinical Neuroscience and Behavioral Research

National Institute on Drug Abuse

National Institutes of Health

6001 Executive Boulevard, Room 3172 MSC 9593

Bethesda, MD 20892-9593

(301) 443-2235

E-mail: Lisa_Onken@nih.gov

Daniel E. Falk, Ph.D.

Health Scientist Administrator

Division of Treatment and Recovery Research

National Institute on Alcohol Abuse and Alcoholism

NIH/DHHS

5635 Fishers Lane, Rm 2040, Rockville, MD 20892-9304

Voice: 301-443-0788

Fax: 301-480-8774

Email: falkde@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Debra Dudley

Grants Management Branch

National Institute on Drug Abuse/NIH/DHHS

6101 Executive Blvd., Room 270

Bethesda, MD 20892

Telephone: (301) 443-6710

FAX: (301) 594-6849

E-mail: ddudley@nida.nih.gov

Judy Fox

Chief, Grants Management Branch

National Institute on Alcohol Abuse and Alcoholism

5635 Fishers Lane, Rm 3023, MSC 9304

Bethesda, MD 20892-9304

Telephone: (301) 443-4704

FAX: (301) 443-3891

Email: jfox@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

Weekly TOC for this Announcement

NIH Funding Opportunities and Notices