Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Translational Research on Interventions for Adolescents in the Legal System: TRIALS (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	October 5, 2012 - See Notice NOT-DA-13-001. Notice to Clarify Page Limits.
Funding Opportunity Announcement (FOA) Number	RFA-DA-13-009
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
Funding Opportunity Purpose	The National Institute on Drug Abuse (NIDA) invites applications for cooperative agreement participants (multiple Research Centers and one coordinating center) to collaborate in developing and testing implementation strategies and associated measures to improve the continuum of substance abuse prevention and treatment services delivered to youth under juvenile justice supervision. Awardees will develop and execute collaborative multisite studies across a variety of community-based supervision settings including juvenile probation, truancy and teen courts, and adolescent drug courts. Research undertaken by the cooperative is expected to contribute both to implementation science and to the effective delivery of evidence-based substance abuse interventions within real-world practice settings. These goals will be accomplished through the development and testing of measures and methods to support the successful implementation of substance abuse and HIV prevention and treatment services in juvenile justice settings.

Posted Date	July 13, 2012
Open Date (Earliest Submission Date)	October 28, 2012
Letter of Intent Due Date	October 28, 2012
Application Due Date(s)	November 28, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	February/March 2013
Advisory Council Review	May 2013
Earliest Start Date(s)	July 2013
Expiration Date	November 29, 2012
Due Dates for E.O. 12372	Not Applicable

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.

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

Virtually all youth in the juvenile justice system could benefit from prevention or treatment interventions for drug abuse. Although a number of evidence-based drug abuse screening, assessment, prevention, and treatment practices for adolescents exist, implementation of these within juvenile justice settings is variable, incomplete, and non-systematic. Implementation is further stymied by inadequate strategies for measuring and addressing organization, system, and environmental factors that impact the uptake of evidence-based approaches. The National Institute on Drug Abuse (NIDA) invites applications for cooperative agreement participants (multiple Research Centers and one coordinating center) to collaborate in developing and testing implementation strategies and associated measures to improve the continuum of substance abuse prevention and treatment services delivered to youth under juvenile justice supervision. Awardees will develop and execute collaborative multisite studies across a variety of community-based supervision settings including juvenile probation, truancy and teen courts, and adolescent drug courts. Research undertaken by the cooperative is expected to contribute both to implementation science and to the effective delivery of evidence-based substance abuse interventions within real-world practice settings. These goals will be accomplished through the development and testing of measures and methods to support the successful implementation of substance abuse and HIV prevention and treatment services in juvenile justice settings.

This initiative is intended to support a program of research on how juvenile justice systems can effectively implement a continuum of evidence-based substance abuse and HIV prevention and treatment services for youth under community supervision. As envisioned, this continuum would reach every juvenile in the system in some manner. Systems would screen all youth for alcohol and drug use, mental and behavioral problems, HIV risk behaviors, and delinquent and criminal behavior. Results of this screening would be used to link adolescents to evidence-based prevention services or further assessment to determine indicated treatment. Assessments should at minimum address substance abuse severity, HIV risk behaviors, and delinquent/criminal risk. The results of the assessment should determine the adolescent’s treatment plan, including substance abuse treatment (broadly defined to include individual or group counseling, pharmacotherapy, family-based therapy, and recovery management); HIV prevention, testing, and/or care; services to address delinquent behavior; mental and physical healthcare; family interventions; etc. Effective linkage strategies must be developed and tested to ensure that youth actually receive the prevention and treatment services that have been deemed appropriate and necessary, and related strategies are needed to promote engagement and retention of youth and families in these processes. Research to facilitate the implementation of the services continuum may involve a range of activities, such as improving knowledge about the elements of effective prevention and treatment for youth; improving coordination between a juvenile assessment center, service providers, and juvenile probation/supervision; and improving availability of and access to prevention, treatment, family, and other support services.

This cooperative program of research will be carried out by multiple Research Centers working collaboratively with one another, a Coordinating Center, and NIDA. This FOA solicits applications for multiple Research Centers as well as for one Coordinating Center. The expected structure of the cooperative is described further in Section I.3.

Research Center applicant organizations must: demonstrate strong expertise in prevention and/or treatment services for adolescents and in implementation research; have established collaborative relationships with one or more juvenile justice systems committed to engaging in implementation research supporting the continuum of care described above (this juvenile justice partner must be designated as Key Personnel in the U01 application); and have identified and partnered with appropriate and available community-based substance abuse and HIV service providers to facilitate linkage to care for youth needing such services.

Coordinating Center applicants must demonstrate capacity and expertise for carrying out the logistical, data management, and survey support for the Cooperative as specified below.

The cooperative will carry out a program of research to (a) identify, develop, or refine a set of measures to assess existing services along with key organizational and environmental factors that may facilitate or impede the implementation of the services continuum; (b) deploy those measures in their partnering juvenile justice systems and service provider agencies; (c) based on the data obtained, design one or more multi-site implementation projects to address identified gaps in the services continuum; and (d) identify, develop, or refine a set of measures to systematically assess implementation outcomes.

It is not the objective of this cooperative to develop and test the clinical efficacy or effectiveness of discrete prevention or treatment interventions or services per se, although individual-level outcomes may be collected to demonstrate the reach or effectiveness of the tested implementation strategies. Effective screening, assessment, and prevention and treatment interventions already exist, and efforts under this research initiative should focus on developing measures and implementation strategies to facilitate the uptake of a comprehensive, evidence-based services continuum to address substance abuse and HIV needs of adolescents within the participating organizations and systems.

Research undertaken by the cooperative should, at minimum, attend to the following:

• Theoretical framework. The cooperative should identify and adopt a single, comprehensive implementation framework to guide the selection or development of measures, methods, and outcomes.
• Instrument development and testing. In order to develop tests of implementation interventions, it is necessary to have valid and reliable measures of implementation outcomes and their predictors, mediators, and moderators. Measures should be directly related to the theoretical framework, and may be adopted, adapted, or developed as needed. Qualitative and mixed-methods approaches are valuable components of implementation research and should be strongly considered.
• Implementation strategies. One or more implementation strategies should be developed, adopted, or adapted. These should be selected in consideration of the implementation targets (i.e., components of the comprehensive services continuum), implementation settings, theoretical framework, and significance of their potential contribution to implementation science, public health, and public safety.
• Innovative study designs. Research studies fielded by the cooperative should emphasize innovative approaches that will be completed within the project s performance period and would be sustainable after the performance period ends. Research Centers should be prepared to rapidly develop and adopt salvage strategies for addressing contingencies raised by unforeseen changes in the environment (e.g., state budget cuts).
• Implementation outcomes. Measures of implementation outcomes should be identified and adapted if need be, or developed and tested. These should be consistent with the theoretical model. A plan for data collection and processing must ensure that outcomes can be analyzed and prepared for publication within the project’s performance period.

The cooperative will encompass 3 to 5 Research Centers, one Coordinating Center, a Steering Committee Chairperson, and NIDA. Each of the 3 to 5 regional Research Centers will partner with at least one juvenile justice system and community-based treatment provider. One Coordinating Center will oversee data management and cross-site coordination, meeting logistics, and communications. One Steering Committee Chairperson, with expertise in juvenile justice and substance abuse, will be selected by NIDA to coordinate the activities of the Steering Committee (described below). NIDA will have an active role in the activities of the cooperative, including the development and approval of the research protocol(s), through the involvement of an appointed Project Scientist and a Program Official.

A. Research Centers. Research Centers will develop and conduct implementation research projects to promote effective uptake and sustainability of the services continuum described above. Research Centers will work together to select a theoretical model, identify measures, collect pre-implementation data, identify appropriate implementation targets, develop protocols and study designs, and execute one or more multi-site studies. The number and scope of the studies will depend on the characteristics of the partner agencies, the identified gaps in the service continuum, and the results of the pre-implementation data collection activity. NIDA’s expectation is that all Research Centers will participate in all protocols designed by the cooperative. Participating Research Centers must include at least one juvenile justice agency partner providing supervision to adolescents within the community (see Section C below). A representative from the juvenile justice agency must be named as a Key Personnel in the U01 application. Partnerships that exclusively involve juvenile detention facilities will not be considered responsive to this FOA. Research Centers are also expected to identify one or more substance abuse and HIV prevention and treatment service providers serving the communities in which the juvenile justice partners are located (see Section D below).

Research Center responsibilities include:

• Establishing, through contractual or collaborative arrangements, partnerships among researchers, juvenile justice professionals, and substance abuse prevention, treatment, and HIV practitioners with the capacity and willingness to conduct multiple implementation research protocols to be developed by the Cooperative. Teams should include both substantive and methodological expertise, including both qualitative and quantitative methods.
• With other Research Centers and the NIDA Project Scientist, collaboratively identifying, adopting, adapting, and testing measures of organizational resources, structure, and readiness for implementation of a continuum of care, and for collecting these measures in a standardized fashion from their affiliated juvenile justice partners and service providers in order to inform subsequent development of implementation protocols. (The Coordinating Center is responsible for data processing and development of analytic files associated with this activity.)
• In partnership with the other funded Research Centers, the Coordinating Center, the NIDA Project Scientist, the juvenile justice partner agencies, and substance abuse and HIV service providers, and based on the findings of the pre-implementation data collection, developing and coordinating one or more multi-site implementation research protocols focused on optimizing the continuum of care for adolescents under community supervision. Applicants should note that the primary focus of implementation research is at the system or organizational level; studies are unlikely to use randomization at the client level. However, client-level data collection may be necessary to measure the reach, effectiveness, or sustainment of the implementation intervention effects.
• Providing juvenile justice and substance abuse and HIV services partners with the necessary data collection infrastructure to participate in study protocols, including a data management information system, staff support, consultation, training, supervision, and other resources as needed.
• Providing a management and committee structure that invites and ensures participation by juvenile justice partners and substance abuse and HIV services providers in the design, planning, and conduct of the research.
• Participating in semi-annual in-person meetings of the Cooperative’s Steering Committee. For planning purposes, assume 2 two-day meetings per project year in Bethesda, Maryland. Research Centers are to cover the travel expenses of the Program Director(s)/Principal Investigator(s), the juvenile justice partner agency representative, and up to 3 additional project staff as appropriate given agenda topics.
• Participating in the study protocols developed by the Cooperative. Applicants should anticipate participating in multiple implementation research protocols addressing system change in the areas of screening and assessment and substance abuse and/or HIV prevention and/or treatment. Research Centers must coordinate with other participating Research Centers, the Steering Committee, and the Coordinating Center to ensure timely conduct of the cross-site research activities.
• Working with the Steering Committee and the Coordinating Center, collaborate to establish procedures for conducting periodic protocol reviews to examine sample accrual, data accuracy and timeliness, and compliance with study plans. Research Centers are responsible for ensuring full protocol compliance and adequate accrual and follow-up rates within their own sites, and to participate in collectively monitoring progress across the cooperative and implementing corrective action plans to ensure timely completion of the protocols.
• With the Coordinating Center, establishing and implementing procedures that ensure data collection and management are: a) adequate for quality control and analysis, b) efficiently designed to encourage participation of juvenile justice personnel and service providers, c) in accordance with procedures and requirements established by NIDA and the Steering Committee, and d) sufficiently uniform across all participating sites.
• As appropriate, monitoring adverse events and reporting on all ongoing studies to the Data Safety Monitoring Board in accord with policies and procedures to be determined by the Board.
• Ensuring that any organizations engaged in prisoner research as defined by the Office for Human Research Protections (OHRP) obtain an OHRP assurance and IRB review and approval before conducting human subjects research. Note that all research protocols involving OHRP-defined prisoners must be reviewed and approved by an OHRP panel before they can be implemented.
• Establishing a mechanism for interim monitoring of progress and results to be reported at least semi-annually to the Steering Committee and to NIDA.
• Submitting annual progress reports to the NIDA Program Official. Research Center funding is contingent on progress, including collaborative contributions and satisfactory site and/or subject accrual.
• Publishing major findings in a timely manner, in accordance with procedures established by the Cooperative’s Steering Committee. Publication or oral presentation of work done under this agreement requires acknowledgement of support from NIDA and any other Federal agencies as specified. Research Centers must agree not to report findings prior to collaborative reporting or approval by the Steering Committee and the NIDA Project Scientist.

Note: The PD/PI of a Research Center application is expected to commit a minimum of 2.4 person months annually over the life of the grant award.

B. Coordinating Center. The Cooperative will have one Coordinating Center. The Coordinating Center will be responsible for facilitating cross-site activities of the participating Research Centers, partner agencies, and NIDA. This includes organizing and convening grantee meetings; maintaining a project website; maintaining a secure internet-based infrastructure for cross-site communication and document sharing; creating a data repository; monitoring cross-site progress on the implementation studies; ensuring that the Cooperative’s policies and procedures are documented, up-to-date, and accessible; and maintaining records of research dissemination activities. In addition, the Coordinating Center will be responsible for conducting a representative survey of juvenile justice agencies regarding service availability (see below). The Coordinating Center will not directly participate in the implementation research protocols being conducted by the Research Centers.

Specific areas of responsibility for the Coordinating Center include:

• Collaborating with Research Centers, the NIDA Project Scientist and the Federal government to facilitate cross-site data comparability. This includes developing standard formats for data collection instruments using measures identified by the Research Centers; distributing forms, data entry screens, or other data collection instruments to Research Centers and receiving completed instruments from them; monitoring and calculating response rates; providing state-of-the art software and methods for accurately and efficiently processing received data; compiling integrated data sets; and developing codebooks and other data file documentation. The Coordinating Center will serve as a repository for data collected under this cooperative, prepare public use data files, and provide other reports required for oversight of the Cooperative.
• Developing and maintaining a public project website to facilitate dissemination of plain-language study protocols, progress reports and research findings to multiple audiences, including juvenile justice system personnel and substance abuse and HIV service providers. The Coordinating Center shall ensure that this website is in compliance with all applicable Federal and NIH requirements, including Section 508 compliance and plain language requirements.
• Providing a secure internet-based infrastructure to support cross-site communications and document sharing among the Cooperative. Within or in addition to this platform, the Coordinating Center is required to provide a secure method for transmitting raw data files to and from the Research Centers. The Coordinating Center shall ensure that this platform is in compliance with all applicable Federal information security requirements.
• Maintaining up-to-date versions of the policies and procedures developed by the Steering Committee and making these readily available to the Cooperative.
• Coordinating logistical functions associated with in-person meetings of the Steering Committee. This includes working with the NIDA Program Official to coordinate dates and locations; communicate with all relevant parties about the meeting dates and logistics; maintain participant lists; secure room blocks at area hotels for meeting participants (note: Research Centers are responsible for their own travel expenses); compile meeting minutes; and coordinate any post-meeting follow-up. The Coordinating Center will be responsible for travel expenses of the Steering Committee Chairperson. For planning purposes, the Coordinating Center should assume that 2 two-day Steering Committee meetings will be held per project year at NIDA or other NIH offices in Bethesda, Maryland.
• Providing technical or logistical support for meetings of subcommittees and workgroups to be formed by the Cooperative, including providing conference call lines and webinar support.
• Providing operational support for the Data and Safety Monitoring Board, if a DSMB is convened. This may include collection and synthesis of reports from research sites, and preliminary data analyses to identify and monitor adverse events across Research Centers; making reports to the DSMB; and working with an independent DSMB coordinator to ensure that DSMB functions are carried out.

The Coordinating Center is also responsible for two significant data collection activities:

• Coordination of Pre-Implementation Data Collection. Research Centers are responsible for collaboratively identifying, adopting, adapting, and testing measures of organizational resources, structure, and readiness for implementation of a continuum of care, and for collecting these measures from their affiliated juvenile justice partners and service providers in order to inform subsequent development of implementation protocols. The Coordinating Center is responsible for working with the Research Centers to ensure that these measures are collected using standardized forms and procedures; that all human subjects protocols and consent forms ensure access to data by all members of the cooperative and that follow-up data may be collected by the Research Center or other cooperative research entities; and that data collected by the Research Centers are processed into analysis-ready files. The Coordinating Center will provide analyses to inform Steering Committee deliberations about appropriateness and validity of measures, and development of protocols. The Research Centers are responsible for collecting the data; the Coordinating Center is responsible for ensuring consistency of measures and methods across sites; creation and distribution of survey forms or data entry screens as needed; and merging, cleaning, and analysis of the cross-site data file. Timely completion of this activity is essential to support the development and conduct of study protocols.
• Survey of juvenile justice systems. Since little is known about the substance abuse and HIV prevention and treatment services available to youth under community supervision of the juvenile justice system and their families, the Coordinating Center will work closely with the NIDA Project Scientist and the Steering Committee to carry out a representative survey of juvenile justice agencies. The survey will be designed to determine what services are available to youth (including community-based resources that are typically available to justice-involved youth), how youth receive services, what administrative data systems are in place to monitor outcomes, and what resources are available to staff in these agencies and to the youth and their families. The primary sample for this survey should be juvenile community correctional agencies (including juvenile probation agencies, adolescent drug courts, teen and truancy courts, etc.), but may also include youth detention centers if scientifically justified and if resources are sufficient for this purpose. The Coordinating Center is also responsible for analyzing these data and developing a publication plan which may involve Research Center members and NIDA staff; delivering one or more high-quality peer-reviewed journal articles; making the aggregate data file available to the Cooperative and to NIDA for further analysis; and delivering a de-identified public-use data file. This survey will be conducted while the implementation protocols are underway.

C. Juvenile Justice Partner Agencies. Each Research Center must designate a representative from a partnering juvenile justice agency as Key Personnel on the U01 application. Juvenile justice partner agency representatives are generally individuals with oversight responsibility for juvenile probation, or other correctional supervision programs for youth in the community (actual terminology may vary by state or locality). The juvenile justice partner agency representative should be a change leader in their organization i.e., someone able to influence agency practices and policies. The application should describe the representative s role within the juvenile justice organization. Juvenile justice partner agency representatives responsibilities include:

• Obtaining agency support for research on the implementation of evidence-based substance abuse and HIV prevention and treatment services delivered within a comprehensive continuum of care described above (screening, assessment, linkage to prevention and treatment services, and engagement in prevention or treatment services);
• Participating in development of study designs and protocols as part of the Steering Committee or study workgroups;
• Agreeing to participate in research studies approved for the Cooperative;
• Agreeing to be randomly assigned to a delayed implementation, control, or services as usual condition if this is part of the study design;
• Providing access to agency staff and/or to juvenile justice-involved youth with substance abuse or addiction disorders, as required by the study protocol;
• Maintaining records required for each study protocol;
• Adhering to the study protocol and to guidelines set by the Research Center, the Steering Committee, and NIDA;
• Agreeing not to report data prior to collaborative reporting.

D. Substance Abuse and HIV Prevention and Treatment Service Providers. Substance abuse and HIV prevention and treatment service providers may be formally associated with the juvenile justice agency or may be community-based programs that provide services to juvenile justice-involved youth. The Research Center is responsible for identifying and recruiting providers who are willing and able to participate in collaborative research on the implementation of a continuum of screening, assessment, prevention and treatment services for supervised youth. Service provider responsibilities may differ depending on the protocols developed by the Cooperative, but generally include:

• Obtaining agency support for research on the implementation of evidence-based substance abuse and HIV prevention and treatment services delivered within a comprehensive continuum of care described above (screening, assessment, linkage to prevention and treatment services, and engagement in prevention or treatment services);
• Participating in development of study designs and protocols as part of the Steering Committee or study workgroups;
• Agreeing to participate in research studies approved for the Cooperative;
• Agreeing to be randomly assigned to a delayed implementation, control, or services as usual condition if this is part of the study design;
• Providing access to agency staff and/or to juvenile justice-involved youth with substance abuse or addiction disorders, as required by the study protocol;
• Maintaining records required for each study protocol;
• Adhering to the study protocol and to guidelines set by the Research Center, the Steering Committee, and NIDA;
• Agreeing not to report data prior to collaborative reporting.

E. Steering Committee. The Steering Committee will constitute the primary governing body of the Cooperative. It will consist of the Principal Investigator of each Research Center, the juvenile justice representative named in the application as Key Personnel from each Research Center, and the NIDA Project Scientist, each of whom will be a voting member. Each Research Center has a maximum of two Steering Committee votes one for the PD(s)/PI(s) regardless of whether the Multiple PD(s)/PI(s) mechanism is used, and one for the juvenile justice partner(s) regardless of number. The NIDA Project Scientist has one vote. Neither the Coordinating Center nor the Steering Committee chairperson (see below) is a voting member of the Steering Committee.

The Steering Committee will determine the policies and procedures used to govern the Cooperative; identify the research studies to be undertaken (subject to NIDA approval); monitor progress across all sites and protocols; develop plans for monitoring data quality, conduct data analyses, and review results prior to dissemination. All Steering Committee members are collectively responsible for the quality of research protocols, data, findings and publications of all studies conducted by the Cooperative.

Steering Committee meetings will be led by a Chairperson who is selected by NIDA. This person will have significant scientific expertise in the areas of the research conducted by the Cooperative, but will not be affiliated with any of the Research Centers, Coordinating Center, or Federal participants. The Chairperson will provide leadership for meetings and activities of the Steering Committee but will not be a voting member.

The Steering Committee may establish subcommittees and workgroups to assist it in carrying out its functions, and these groups may comprise individuals affiliated with the Research Centers or affiliated service provider agencies. The Steering Committee may elect to establish an advisory body consisting of juvenile justice representatives and substance abuse and HIV prevention and treatment provider representatives from the Centers' research sites. This advisory body will review proposed research concepts and plans, comment upon their feasibility and practical importance, assist in the implementation of research, and carry out other activities determined by the Steering Committee. If such an advisory board is not established, the Steering Committee should ensure representation of juvenile justice and service provider agencies on protocol development workgroups.

F. Data Safety Monitoring Board (DSMB). After the research protocols are developed, the NIDA Program Official will determine whether a DSMB is warranted, and if so, will convene one. A DSMB is an independent expert board appointed by and reporting to the NIDA Director, which will monitor the conduct of studies to ensure the safety of participants and the validity and integrity of the data. Research Centers are responsible for following protocols established for reporting data for review by DSMB. The Coordinating Center is responsible for providing reports as needed for DSMB review. The DSMB will also make independent assessment of whether a study will continue.

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 seehttp://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.

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.

Funding Instrument	Cooperative Agreement
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIDA intends to commit approximately $5 million in FY 2013 to fund 3-5 Research Centers and 1 Coordinating Center.
Award Budget	Direct costs are limited to $500,000 per year for a 5-year period.
Award Project Period	All projects should be for a period of 5 years.

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.

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)
• 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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(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 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

NOTE: For institutions/organizations proposing multiple PD(s)/PI(s), at least one PD/PI must commit at least 2.4 person months annually to the funded U01 grant.

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

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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 at Grants.gov.

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.

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to: [email protected]

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Director - DA-13-009
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

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.

All page limitations described in the SF424 Application Guide and must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 30 pages.
• Specific Aims are limited to 1 page and should include the applicant’s understanding of the mission of the cooperative.
• The total length of the Research Plan should not exceed 30 pages. No more than 12 of the 30 pages should be allocated to description of the proposed research concept (for Research Center applicants) or the national survey of juvenile justice facilities (for the Coordinating Center), as described below. No specific page limits apply to the Human Subjects section; Gender, Child, and Minority inclusion sections; data safety and monitoring plans; or Consortium and Contractual arrangements, but these sections should not be used to avoid the Research Plan page limits.

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

Other Requirements Research Center Applicants

Research Center applicants should include budget estimates and plans for participating in the Cooperative, organized around the areas of core functions (Center administration, management, staffing, Steering Committee participation), and research activities (i.e., conducting the implementation interventions, data collection, analysis, publication, dissemination). The total budget should include: 1) infrastructure to enable the Center to provide core functions (e.g., personnel, facilities, equipment, supplies, training costs, logistic support, travel, etc.); 2) research project specific costs such as research assistants, study implementation costs, staff for data collection, management, and analysis; and any laboratory costs, monitoring costs, publications costs. As noted above, funds for travel should be included to provide for the PD(s)/PI(s), the juvenile justice agency representative named as Key Personnel, and up to 3 additional project staff to participate in 2 in-person Steering Committee meetings each year in Bethesda, MD.

For Research Center applicants, the Research Strategy section should be organized as follows:

A. Research Capacity

The application should document the scientific expertise within the Research Center and its partnering organizations to collaboratively design, implement, and analyze the results of studies conducted under this Cooperative.

Substantial support and input from juvenile justice agencies and substance abuse and HIV prevention and treatment service providers will be necessary to undertake research protocols on the implementation of a continuum of care for adolescents under community supervision. Thus, applications should name and describe the partnering programs, agencies, or institutions expected to collaborate in the Cooperative and in what capacity. The application should provide evidence, where possible, of successful collaborations with these or similar entities in research activities.

In addition, the ability and willingness of juvenile justice agencies and service providers to participate in this research should be documented and should include the potential number of study participants (including program staff as well as offenders/patients), and plans to recruit and retain subjects in studies. Thus, applications should describe the partnering programs, agencies, or institutions expected to collaborate in the Cooperative, including relevant program/system and offender/patient characteristics (e.g. organizational characteristics, services offered, client/patient flow, staff structure and characteristics).

Letters of Support must be provided by each of the institution, agency, or program directors agreeing to participate in the Cooperative. Letters should demonstrate an understanding of the scope of research to be undertaken through the Cooperative and the capacity and commitment to work collaboratively with other participating investigators in implementing research studies to improve delivery of the continuum of care for adolescents under community supervision. Letters should include explicit acceptance of the parameters of the research noted earlier, including possible randomization to study conditions. Letters of Support do not count against Research Strategy page limits, but no letter of support should exceed 2 pages in length.

The application should document the ability of the Research Center and its partners to implement system- and organizational-level modifications where specified by the study protocols, and to deliver needed substance abuse and HIV prevention and treatment services. Plans to recruit subjects and implement the research should be described, and the application should attempt to anticipate and address problems and challenges in conducting research in real-world settings.

Note that Section A focuses on the capacity of each entity for engaging in implementation research. Section B addresses mechanisms through which inter-organizational relationships will be managed.

B. Internal Administration and Collaborative Plans

The administrative and managerial qualifications and experience of the PD(s)/PI(s) must be described to provide evidence of skills in managing and coordinating research endeavors of this scope. The skills of other personnel involved in administration and management of the research should also be clear. Evidence of participation in relevant multisite studies is desirable. The PD(s)/PI(s) must commit 2.4 person-months or more to this grant award annually. The substantive contribution of the juvenile justice representative named as Key Personnel must be detailed.

Partnerships among collaborating components of the Research Center are essential to the success of the Cooperative and should be described in detail. Applicants should describe how juvenile justice and treatment providers are expected to function in true partnership with the Center and the Cooperative in terms of research development, protocol design, research project implementation, and administrative support services. Communication and coordination plans for working with involved agencies (e.g., juvenile justice agencies, parole boards, treatment providers) should be given, as well as plans for developing such relationships as appropriate. Applicants should anticipate potential problems and challenges that may arise in during the project and propose mechanisms for collaborative resolution among Center participants.

Plans should describe capabilities and plans for intra-center decision making, project management, coordination and communication, data management, and procedures for oversight of studies. Plans for functioning as a Research Center in the context of a cooperative research program should be described.

An approach should be provided for coordinating implementation of studies across sites, providing training, and monitoring progress. Plans should be provided for collecting, managing, sharing, and analyzing data, including strategies for pooling data, addressing measurement issues across studies, implementing CONSORT guidelines if appropriate, as well as plans for monitoring research progress and data quality across study sites, and disseminating findings.

C. Research Concept

Applicants are requested to develop and propose a research concept that lays out a theoretically grounded, hypothesis-driven study design using implementation strategies to address gaps in the continuum of care for adolescents under community supervision. The proposed study concept should account for the need for systems to reach all adolescents under their supervision with some form of substance abuse and HIV intervention either prevention or treatment. The research concept should describe how the Research Center would measure and assess a system’s current service delivery capacity in the areas of screening, comprehensive assessment, and delivery of substance abuse and HIV prevention and treatment services to adolescents based on the outcomes of the screening and assessment services. The research concept should further demonstrate how the results of such measurement would inform the selection of implementation strategies and targets (i.e., the evidence-based practices to be implemented). The research concept should identify at least one implementation framework to guide the concept’s design and proposed approach, and to anchor the selection of predictor, outcome, mediator and moderator variables. The concept should describe the Center’s approach to site selection, subject recruitment, data collection, and quality assurance. The concept should further demonstrate how such a study could be undertaken as part of a multi-site collaborative. The research concept proposed should exemplify the applicant's approach to designing and undertaking hypothesis-driven implementation research in the context of juvenile justice systems.

Applicants should note that the study protocols ultimately selected for the Cooperative will be based on actual data obtained from the participating study sites, and therefore the concepts proposed in these applications may not be adopted. Therefore, rather than propose detailed research protocols, applicants should write these concepts as examples of how such research might be approached. The application should discuss how the proposed concept would contribute to implementation science, and how it would capitalize on the Cooperative’s resources and structure.

The research goals of the Collaborative are not intended to develop new preventive or treatment interventions, nor to conduct client-level effectiveness research. Therefore, applications proposing such studies for the research concept will be considered non-responsive to this FOA.

Other Requirements Coordinating Center Applicants

Coordinating Center applicants should include budget estimates and plans for participating in the Cooperative, organized around the areas of logistical support, data collection, and data processing. The total budget should include 1) logistical support costs (e.g., personnel, equipment, travel costs, communications tools, etc., to support the work of the Steering Committee and any subcommittees or workgroups); 2) data collection costs associated with the national survey of juvenile justice agencies; and 3) data processing costs (e.g., development and tracking of data collection forms or data entry screens for web-based surveys; equipment and software for processing collected data into analytic files; personnel for data processing and cleaning; delivering de-identified public use files to NIDA, etc.). As noted above, the Coordinating Center reimburses the travel costs of the Steering Committee Chairperson; Research Centers are responsible for their own travel costs associated with the semi-annual Steering Committee meetings.

For Coordinating Center applications, the Research Strategy section should be organized as follows:

A. Research Capacity

The applicant must demonstrate the expertise, experience, and capacity necessary to conduct a representative survey of juvenile justice agencies in the U.S., as described in Section I.3.b. The application should describe the proposed approach to developing the survey, securing IRB approvals, sample selection, survey administration, data processing, development of analytic and public-use files, analysis, and publication/dissemination. An estimated timeline should be proposed that allows completion of this activity within the project performance period and concurrent with other Coordinating Center responsibilities.

The application should also propose an approach to coordination of cross-site collection of pre-implementation data from participating juvenile justice agencies and substance abuse and HIV treatment and prevention service provider organizations. (Note that the Research Centers are responsible for developing measures and for collecting the data from their partner agencies.) The Coordinating Center applicants should propose an approach for centralizing development of data collection forms, data entry screens, or other methods of survey administration; providing secure channels for transmitting raw data files between Research Centers and the Coordinating Center; using state-of-the-art systems and approaches for efficient data processing; quality control methods; compiling aggregate data files for analysis; and making de-identified public use data files available.

No more than 6 of the 12 pages of the Research Strategy should be devoted to the Research Capacity section.

B. Data Management Capacity

In addition to the national survey and the pre-implementation data collection described above, the Coordinating Center will also be responsible for ongoing data processing in support of the implementation research protocols developed by the Steering Committee. Research Centers are responsible for ongoing collection of data for these protocols, which is likely to include cross-sectional and recurring surveys (i.e., repeated measures from the same respondents), extraction of existing data from client records or administrative systems, and other data. Data are likely to be collected at the organizational or service delivery unit level, and from front-line service provider staff. It is not expected that studies will include randomization at the client level. Coordinating Center applications should describe an overall approach to managing the flow of data from multiple Research Centers across multiple concurrent research protocols; receiving secure transmissions of raw data from Research Centers and communicating about discrepancies or errors; implementing efficient data processing and appropriate quality controls; compiling, checking, and delivering aggregate data files for analysis by the Research Centers; and delivering de-identified, integrated data files to NIDA for eventual release as public use data files. Applicants should also propose an approach for interim data analysis to support the work of a Data Safety Monitoring Board, should one be required for any or all study protocols.

C. Logistical Support Capacity

Coordinating Center applicants should describe their capacity, experience, and expertise at providing logistical support for a multi-site cooperative. Applications should describe an overall approach, with details as necessary, to facilitating communication among NIDA, the funded Research Centers and partnering agencies on the Steering Committee, subcommittees, and workgroups. Logistical support includes support for convening semi-annual in-person Steering Committee meetings (at NIDA or NIH facilities in Bethesda, MD); communications support for subcommittees and workgroups (including conference call lines, webinar hosting, and secure document sharing); and maintaining a public project website. The applicant should demonstrate familiarity and compliance with any applicable Federal information technology security requirements.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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.

This initiative is not subject to intergovernmental review.

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.

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 Central Contractor Registration (CCR). 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

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.

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).

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?

In the context of this FOA, significance will be evaluated based on the entire application, including:

For Research Centers:

• Could the applicant’s proposed vision of implementation research lead to scientific knowledge that would significantly advance practice and treatment within the juvenile justice system?
• Would this Research Center make unique contributions that would increase the likely scientific yield of the research conducted?

For Coordinating Center:

• How well does the application demonstrate an understanding of key issues in the juvenile justice system and relevant issues that might be part of research conducted by this cooperative?

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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In the context of this FOA:

For Research Centers:

• What is the quality of the scientific expertise and productivity within the Research Center, with respect to (a) treatment, prevention, and HIV services for adolescents; (b) services research in the juvenile justice context; (c) implementation science; and (d) qualitative and quantitative methodologies?

For Coordinating Centers:

• What is the quality of the scientific expertise and productivity within the Coordinating Center, with respect to (a) survey research; (b) the juvenile justice system, (c) large-scale multisite studies; and (d) data management?

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?

In the context of this FOA:

For Research Centers:

• How innovative is the application's approach to implementation research to deliver evidence-based practices for youth with substance abuse problems in juvenile probation or under community supervision?
• How innovative is the application in capitalizing on the structure of the Cooperative to advance the FOA's scientific goals?
• Because this FOA calls for research concepts concerning the implementation of evidence-based practices, those evidence-based practices will not themselves be evaluated for innovation.

For Coordinating Centers:

• How innovative is the proposed approach to logistical support, communication, and data management for the Cooperative?

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?

In the context of this FOA:

For Research Centers:

• How well does the proposed research concept demonstrate an effective approach to mounting conceptually grounded and hypothesis driven implementation studies?
• How much would the proposed research concept contribute to our knowledge of the implementation of evidence-based interventions for youth with substance abuse problems in juvenile probation or under community supervision?
• How well would the concept capitalize on the Cooperative’s resources and structure?

For Coordinating Center:

• How well does the application demonstrate capacity to both conduct and coordinate large-scale survey research within the juvenile justice system?
• How well does the application demonstrate a capacity to manage a complex, multisite research project including the provision of logistical support and data management? Does the application demonstrate a capacity to process high volumes of quantitative and qualitative data in an efficient and secure way? Does the application demonstrate a capacity and understanding of the procedures for eventually releasing the data for public use?
• How well does the application demonstrate a capacity to effectively facilitate secure communication, information, data, and document sharing among Research Centers? Does the application demonstrate an ability to use state-of-the-art technological resources to enhance the efficiency of this communication?
• How well does the application demonstrate an understanding of the applicable Federal laws and the implications of these laws for aspects of project execution, including information security requirements, plain language requirements, Data and Safety Monitoring Boards, and Section 508 compliance?
• Does the application demonstrate a familiarity with human subjects protocols for research in juvenile justice (or similar) settings, a capacity to obtain IRB approval for the survey, and an ability to provide assistance to Research Centers on IRB issues?

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?

In the context of this FOA:

For Research Centers:

• How strong are the applicant’s plans for collaboration and involvement of juvenile justice, prevention, and treatment partners?
• How clear and feasible are plans for intra-center decision making, project management, coordination and communication, and data management, and how adequate are procedures for oversight of studies?

For Coordinating Center:

• How well does the application document availability of state-of-the-art technological infrastructure to support the data collection, coordination, and communication activities required?

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

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Not Applicable.

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 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.

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug Abuse. 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.

After the peer review of the application is completed, the Program Director(s)/Principal Investigator(s) 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.

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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Researchers should be knowledgeable of the additional human subjects protections required for "prisoners," a term defined by the Department of Health and Human Services (DHHS) as any individual involuntarily confined or detained in a penal institution. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial. All investigators proposing research involving prisoners or individuals who may enter prisoner status during study involvement should be familiar with OHRP guidance on prisoners as human subjects, which is available on the web at the following URL address: http://www.hhs.gov/ohrp/policy/prisoner.html.

Pursuant to Title 45 of the Code of Federal Regulations, Part 46 Subpart C, Section 46.306, OHRP requires review and approval of research protocols prior to implementation.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• The Program Director/Principal Investigator has primary responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies in collaboration with other awardees, and with assistance from the NIDA Project Scientist. Awardees shall participate in the Steering Committee and abide by decisions of the Steering Committee and the policies and procedures adopted by the Steering Committee.
• Awardees shall develop research plans in conjunction with participating juvenile justice professionals, service providers, and other awardees and submit them for approval by the Steering Committee. Awardees shall take lead responsibility for implementation of selected plans as determined by the Steering Committee and shall participate in studies that are under the leadership of other sites. Implementation of studies shall be in accord with Steering Committee policies and procedures, including policies and procedures pertaining to instrumentation, data collection, data and safety monitoring, and publication. Awardees shall conduct research in partnership with juvenile justice professionals and treatment practitioners, assure quality of care, assure that research findings and adverse events are communicated to research partners and to NIDA, and assure that the study is conducted in accordance with established protocols.
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• A PD/PI on a U01 awarded under this RFA will be expected to maintain significant effort commitment not smaller than that stated in the application (2.4 person-months).

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIDA Project Scientist. A designated NIDA Program Official(s) acting as a Project Scientist(s) will have the following responsibilities:

• A NIDA Project Scientist will help to identify research questions that will have fundamental and timely significance for addressing service delivery in the target settings. He/she may cooperate with awardees in development of research plans and preparation of study reports. In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIDA Project Scientist may cooperate with awardees as coauthor in preparing publications of data resulting from the research. In this regard, he/she will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIDA staff require internal clearances.
• The NIDA Project Scientist will serve as a resource for specific information on NIDA's programmatic intentions and priorities, and will help to foster collaborations between researchers, juvenile justice partners, and service providers to increase the value of research to these participants.
• The NIDA Project Scientist will be a voting member of the Steering Committee, but will not hold the position of chair. He/she will participate in the development of instrumentation, development of study plans, in quality control, and in coordination of projects, but will not participate in activities that directly involve assessment, testing, or treatment of human subjects.

NIDA Program Official. A NIDA program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIDA Program Official, who will not participate in the research, publications, or Steering Committee, will be responsible for the oversight of each cooperative agreement. The Program Official carries primary responsibility for: (1) periodic review and approval of the progress of the research plans in relation to their stated objectives, and (2) making recommendations regarding continuance of the program. The NIDA Program Official will be responsible for monitoring the conduct of the project and overseeing the individual Research Centers. The Program Official will receive all required progress reports to determine that satisfactory progress is being made and will work collaboratively with the NIDA Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement.

DSMB. If warranted by the studies developed by the Cooperative, NIDA will appoint an independent Data Safety Monitoring Board (DSMB) which will oversee and monitor the conduct of research studies to ensure the safety of participants and the validity and integrity of the data. The DSMB will also make independent assessments of treatment effectiveness and whether a study will continue. One or more NIDA staff will serve as nonvoting members on the DSMB.

Other NIDA staff. Subject to Steering Committee invitation, other NIDA staff may attend and participate as non-voting resources to the Steering Committee and/or its subcommittees.

Other Federal staff. The Cooperative will enable cross-Institute and cross-agency collaboration of several types, including facilitating access to juvenile justice system participants, co-funding research studies of particular interest, and providing systems-level expertise. Representatives from Federal agencies that provide resources, assistance, or expertise may be invited to join a panel constituted by NIDA. NIDA will convene meetings of this panel to ensure that these Federal agencies are kept informed of the Cooperative s progress and findings and to provide a venue for their participation in the Cooperative. Members of the panel may be consulted for advice by the Steering Committee. The NIDA Project Scientist will serve on the Federal panel.

Areas of Joint Responsibility include:

Steering Committee. The Steering Committee constitutes the primary governing body of the Cooperative. Awardees must participate in the Steering Committee. The Steering Committee reviews and approves the research agenda, monitors policies and procedures guiding the research activities, and oversees communications. Awardees agree to abide by those procedures and policies.

Study Plan Development and Implementation. The study plan is a document mutually acceptable to the research site(s), the Steering Committee, and NIDA. Communication at the various stages of development is essential. The NIDA Project Scientist will contribute to study plan design as appropriate by providing information regarding implementation models and methods that can be tested within the Cooperative. NIDA will also review the scientific rationale, programmatic relevance, priority, design, statistical requirements, and implementation of proposed studies.

Data Management, Analysis, and Access. Data generated are the property of the awardee. However, the Coordinating Center and all Research Centers must provide NIDA with access to all data generated under this award, subject to rules specified in any Certificates of Confidentiality obtained by awardees. Data must be shared upon request with the Steering Committee, subcommittees reporting to the Steering Committee, and the Data Safety Monitoring Board. As governed by any Certificates of Confidentiality, data may also be available for external monitoring if required by NIDA's agreements with other Federal agencies.

As the Cooperative is intended to be a national resource, sites must be prepared to share their data under provisions that safeguard the privacy and confidentiality of respondents. Thus, each proposing Research Center should include explicit indications of how they will make their data available for broad use and on what timetable. The awardee will provide for data sharing consistent with its data sharing plan, as approved by NIDA.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

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

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TTY 301-451-5936
Email: [email protected]

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: [email protected]

Redonna K. Chandler, Ph.D.
Chief, Services Research Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: [email protected]

Mark Swieter, Ph.D.
Chief, Extramural Affairs Branch
Office of Extramural Affairs
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: [email protected]

Edith Davis
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 410-360-4734
Email: [email protected]

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.

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.