Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)
 

Funding Opportunity Title

Medications Development Centers of Excellence Cooperative Program (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of  RFA-DA-14-004

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DA-15-003

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

This FOA solicits Specialized Center Cooperative Agreement (U54) applications to provide support for Medications Development Centers of Excellence (MDCE) with emphasis solely on clinical research directed towards the identification, evaluation, and development of safe and effective medications and biologics for treatment of substance use disorders (SUDs). Research may focus on both currently approved or novel investigational products. Centers may have a translational  project to reinforce rationale of medications for testing. Any preclinical work proposed must be specifically devoted to the reinforcement of rationale of medications planned for clinical testing during the life of the project.  

Key Dates
Posted Date

January 31, 2014

Letter of Intent Due Date(s)

March 25, 2014

Application Due Date(s)

April 25, 2014

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2014  

Advisory Council Review

October 2014

Earliest Start Date

December 2014

Expiration Date

April 26, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and  NIH’s Applying Electronically website for more information.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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


Purpose

The purpose of this FOA is to solicit cooperative agreement U54 applications to provide support for research centers (Medications Development Centers of Excellence (MDCEs)) dedicated to clinical research directed towards the identification, evaluation and development of safe and effective medications, including biologics, for treatment of substance use disorders (SUDs).  Research may focus on both currently approved and/or novel, investigational medications.  Under this FOA, applicants may focus on pilot Phase I safety/tolerability or Phase II or III efficacy studies; human laboratory studies on medication interactions with other drugs; pharmacokinetic or pharmacodynamic studies; or, if justified, multisite efficacy studies.  Applications may also propose a translational project if doing so would strengthen the rationale for medications for testing.  Any preclinical work proposed must be specifically devoted to the reinforcement of rationale of medications planned for clinical testing during the life of the project. 

Because the treatment of SUDs necessitates a multidisciplinary approach, pharmacological treatments often may require a behavioral intervention strategy.  Therefore, applications may propose the concurrent evaluation of pharmacotherapy and behavioral treatment approaches in an integrated design. 

Background

As part of NIDA’s strategic plan to significantly reduce SUDs, the discovery of safe and effective medications for the treatment of disorders related to the abuse of cocaine and other stimulants, as well as opioid, cannabis, and club drug related disorders, remains a top priority.  This FOA solicits research on medications to treat a variety of aspects of the immediate and long-term effects of drug abuse and dependence, such as drug use, craving, relapse, and the physiological and behavioral consequences resulting from SUDs.  Examples of the NIDA Medications Development Program interests include pharmacotherapies that affect neurotransmitter systems involved in drug use, craving, and relapse.  Such drug actions include dopamine, glutamate, GABA and serotonin receptor orthosteric and allosteric as well as endocrine system modifiers that affect these neurotransmitters.  These are illustrative examples; any target medication justified as potentially effective through other targets would also be appropriate.

Another therapeutic strategy is the use of biologics.  Biologics are large molecules which do not cross the blood brain barrier, but either prevent or markedly restrict the access of the abused drug to the brain. Biologics include immunotherapies, such as vaccines or antibodies, as well as enzymes. The MDCE may focus on improved products and technologies to advance the discovery and development of biologics to treat addictions.  The MDCE may focus on the studies of biologics alone or in combination with other medications.

Objectives and Scope

The major goal of this FOA is to provide support for MDCEs focused on research directed towards the development of pharmacotherapies for the treatment of substance use disorders.  The top priority is in the areas of unmet clinical needs (stimulant- and cannabis-use disorders).  The following are some examples of research themes that the MDCE might utilize:

Research Projects

The purpose of the MDCE is to foster collaboration on cutting edge questions in the pharmacological treatment of SUDs.  Preclinical research can only be proposed in response to this FOA if it is meant to provide data to support a clinical trial, and only as a single project within the Center, with the expectation that the clinical trial would be initiated and completed during the project period.  Some examples of research  projects may include, but are not limited to:

Special Program Requirements

NIDA provides support for research center grants to foster an innovative, synergistic and thematically coherent approach to drug abuse and addiction research and to enable studies that would not occur without the climate, facilities and research resources that a research center can uniquely provide. NIDA encourages the application of multiple scientific perspectives and approaches to the problem of addiction.  NIDA's research Centers program is intended to support the highest quality, multidisciplinary programs of innovative research.

NIDA Centers are expected to have three essential and defining qualities.  First, they are expected to be scientifically innovative.  Centers are expected to provide the next generation of ideas and approaches.  Incremental work, though valuable, should not be the focus of Center activities.  Rather, new and creative directions are required, and it is expected that a Center will transform knowledge in the sciences it is studying.  Second, each NIDA Center is expected to be thematically coherent and is expected to demonstrate the highest caliber of multidisciplinary scientific work.  The uniqueness of each Center emerges from the confluence of thematic integration and multidisciplinary involvement.

The third quality of a NIDA Center is synergy.  Taken as a whole, a NIDA Center is expected to enable a level of achievement that exceeds that expected on the basis of "the sum of its parts."  Research supported at a NIDA research Center is expected to reflect an inter-dependence of the individual research projects that would not occur simply from the collection of the individual components. Center support should be essential to the achievement of the proposed work.

A cadre of experienced, independent and productive investigators should be present with active collaborations in place or planned.  These investigators should evidence productivity, stature and leadership, or a potentially strong leadership role, in their respective fields.  A broad range of expertise relevant to the center's goals should be present.  Investigative efforts may encompass researchers with primary appointments at the applicant institution as well as to other collaborating sites.  Investigators are expected to commit to data sharing and ongoing communications with other investigators in the center.

In addition, NIDA research Centers are expected to serve as national research resources in the drug abuse research field.  They are expected to attract established and promising investigators into drug abuse research. Center applications are expected to provide opportunities for research training, career development, and mentoring, as well as for effective dissemination of research findings.  Through the Centers program, NIDA seeks to encourage outstanding scientists to bring a full range of expertise, approaches, technologies, and creativity to the study of problems related to drug abuse and addiction. Investigative efforts are expected to be broadly based and to encompass a variety of areas, including biological, biomedical, social, behavioral, and/or clinical sciences as well as dissemination sciences to address critical research issues.

A MDCE provides support for a broadly based, multidisciplinary, innovative research program consisting of related research endeavors and an associated administrative core infrastructure to ensure their effective and synergistic functioning.  The activities included in the supported research are expected to be innovative, thematically integrated, multidisciplinary, and synergistic.  It is important that the research supported not be simply a collection of independent research projects that are only loosely related.  Each individual research component is expected to be systematically related both to some other components and to the administrative core infrastructure.  Training and mentoring to enhance junior researchers' or other researchers' skills should be conducted in the context of the research, but funds may not be used for training stipends or training not required to conduct the research.

Special Considerations

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

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

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://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-) 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
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDA intends to fund an estimate of 2 awards, corresponding to a total of $ 3M, for fiscal year 2014.

Award Budget

Application budgets are limited to $1M in direct costs per year and need to reflect the actual needs of the proposed project.

Award Project Period

Applicants may apply for up to five years of support.

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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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 allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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(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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 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:

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 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.

Letter of Intent

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:

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov

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-15-003
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Director
Office of Extramural Affairs, NIDA
6001 Executive Blvd, Room 4245, MSC 9550
Bethesda, Maryland 20892-9550
Telephone: 301-443-2755

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed.  

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Allowable Budgetary Items and Supportable Activities

Allowable costs in NIH grants are governed by rules set forth in the Public Health Service Grants Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise stated on the Notice of Award. Under these rules, the center director may exercise flexibility to meet unexpected center requirements by re-budgeting or requesting approval to re-budget among budget categories within the total direct cost budget of the center (as shown on the Notice of Award). In developing the budget for administrative core center activities, applicants should take into account funds currently available through existing collaborating grants and explain how these funds might be reconfigured to maximize efficient resource utilization. The center is intended to provide reasonable support for activities clearly related to the specialized research needs of the center, as noted below:

Center Administration

Salaries and support may be provided for a limited number of administrative and clerical personnel. However, salary and support for central administrative personnel, usually paid from institutional overhead charges, such as budget officers, grants assistants, and building personnel, are not allowable.

Administrative support services, including supplies, duplicating equipment, telephone, or maintenance contracts for equipment, when not covered by institutional overhead charges, are permitted.

Salary and support for administrative activities such as public relations, fund-raising, or educational services unrelated to the research are not allowable.

Shared Resources and Services

Shared resources and services intended to provide access to technology that enhances the research productivity of the center and provides foci for scientific interaction and consultation, as well as access to services that facilitate the research and strengthen the administrative and organizational cohesion of the center may be requested.

Costs associated with sharing data and methodologies with the scientific community and training colleagues in the use of such methodologies may also be requested.

Planning and Assessment of Progress

Costs for the use of ad hoc scientific and technical consultants when appropriate and for the conduct of seminar series designed to promote interdisciplinary interaction, education, and center cohesiveness may be requested.

Costs of center planning and evaluation, including the costs of an external advisory committee, may also be requested.

Travel

Travel of the center director and other investigators to scientific meetings justified as essential to the conduct of research under the center may be supported.  Applicants should include an estimated cost of travel to the biannual NIDA Centers meeting. During the Centers’ project period, NIDA plans to convene a biannual Centers meeting to be attended by Center Directors who may invite other Center staff at their discretion, and NIDA staff involved with administration of the Center grants.  The purpose of the meeting functions both as a reverse site visit to assess Center progress, and as an opportunity for the MDCEs to present their findings and discuss future work amongst the centers.  It is understood that some information may be proprietary and not to be disclosed outside of the meeting.  Applicants should plan travel budgets accordingly.

Travel of technical staff for training justified as essential to enhancing the quality of the research projects may be supported.  

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed with the following exceptions: All biosketches for all components should be provided in the Overall section in alphabetical order.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed.

There must be appropriate and adequate facilities dedicated to the conduct of administrative, shared resource, and research activities. While all members of the center need not be located physically in facilities controlled exclusively by the center, there must be a clearly identifiable physical location for the center which insures adequate administrative oversight for the center and the associated administrative core providing shared resources.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims of the overall MDCE.

Research Strategy:  NIDA's centers should support research activities of the highest and most innovative caliber. Research should be consistent with the aims, goals and intents of the FOA.  The application needs to justify the configuration and numbers of components proposed and to demonstrate that the proposed center infrastructure would facilitate effectively the achievement of the desired level of integration and synergy. The center mechanism is not appropriate to support a set of complex unitary investigations that would be best supported as individual R01s. Each separate project should bear an essential relationship to the integrating theme and efficiently use and contribute to center resources. Centers should enable highly innovative and important studies, whether they are developmental activities and pilot projects or more mature, complex investigations. The center should also support the education, training, and mentoring of new investigators, who should be given meaningful roles to play in the center projects.  Further, there should be evidence that the presence of a center structure is essential for the accomplishment of the research activities, and that the support of the administrative core activities enables the more efficient implementation of associated research and that this research is innovative and of the highest caliber, as well as consistent with the overall purposes of the NIDA Centers program.

Each center is expected to provide an environment that promotes the conduct of the highest quality, state-of-the-art research, innovation, and leadership in its areas of investigation. Applicants are expected to demonstrate that the center is, or would serve as, a significant national scientific research resource soon after its establishment, to provide educational and outreach activities to drug abuse research communities, educational organizations, the general public, and policy makers.

As part of serving as a national resource, a NIDA Center is expected to provide educational and outreach activities to drug abuse research communities, educational organizations, the general public, and policy makers. Training activities are also expected to recruit and nurture future generations of scientists to engage in drug abuse and addiction research. The NIH recognizes a unique and compelling need to promote diversity in the NIH-funded biomedical, behavioral, clinical and social sciences workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nations capacity to address and eliminate health disparities.  Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. The Center is strongly encouraged to provide career development programs to catalyze the participation of scientists from diverse backgrounds underrepresented in drug addiction research and to develop educational programs to eliminate health disparities.

Resource Sharing Plan: A plan for development and dissemination of assessments and methodologies and a general publication plan are also expected. The extent to which a NIDA Center is a resource to the field by developing and sharing data, methodologies and findings is a major factor in the potential value of a center and is therefore an important criterion in the funding of a center application. NIDA's MDCEs are expected to collect unique and important data, to develop innovative research assessments and methodologies, and to make critical research discoveries which lead their research fields to the next generation of ideas and approaches. These NIDA centers are supported both for their expected scientific contributions and for their role as resources to the drug abuse research community. In order to maximize the impact of their work, they are expected to make their data, methodologies, and findings available in a timely manner to the biomedical research community. In most instances, data sharing will extend beyond one's own center to the research community. This sharing can be accomplished in many ways, including posting findings in the center's website, publication, or using archival services.  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 PHS 398 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.

Administrative Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.  

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Description: The abstract should contain a brief description of how the core services will contribute towards attainment of the Center objectives.

Project/Performance Sites: List the performance sites where the Core activities and services will be conducted.

Senior/Key Personnel: List the Program Director/Principal Investigator (Center Director), followed by other key core personnel, and then other significant contributors. Multiple Center Directors are allowed; however, very strong justification for the need of such arrangement is expected to be provided.

The Administrative Core is expected to have a scientifically and administratively qualified Center Director with responsibility for the scientific, administrative, budgetary, and operational aspects of the Center. The Center Director should be an outstanding, productive, senior researcher, as documented by publications, patents, honors, and similar indices of stature.

An individual cannot serve as Center Director of a NIDA U54 MDCE grant while serving as the PD/PI of another NIDA supported research Center. In addition, it is expected that the Center Director will make a substantial commitment of time and effort to the Center.

Table of Contents (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed. In general, the total amount of money allocated to yet-to-be-conceptualized pilot projects should not exceed 15% of the center grant’s total annual direct costs, and exceptions must be strongly justified.

Although the average Center Director will commit more time to the Center and associated activities than the minimum, it is expected that the Center director will commit at least 2.4 months effort to Center administration including the administrative core and 1.8 months effort to any other core and/or research component directly supported by the Center grant, for a minimum total of 4.2 months effort. When multiple Center Directors are proposed, each one is expected to commit a minimum of 2.4 months effort to Center administration.

Budget for Entire Proposed Period of Support (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed. In general, the total amount of money allocated to yet-to-be-conceptualized pilot projects should not exceed 15% of the center grant’s total annual direct costs, and exceptions must be strongly justified.

Support for pilot projects studies should be of relatively short duration (e.g., 1 - 2 years) depending upon the nature of the research. Pilot projects, along with their corresponding budgets, should be included in the Administrative Core, for the effective management of personnel and budget resources. In addition, applicants may request funds for pilot projects that are yet to be conceptualized. 

Biographical Sketch (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed. Provide information on resources available for the core. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual support). If there are multiple performance sites, describe the resources available at each site. There should be convincing evidence of the applicant institution's commitment to the Center.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  The Administrative Core should provide for central operations, oversight activities, technical support and exercise of leadership for the overall project management, as well as integration, communication, and coordination of the MDCE.

Research Strategy:  The Center Director is responsible for overall coordination and development of the Center with the responsibility to provide leadership essential to the success of the Center program, to ensure interaction and collaboration among scientists conducting research, to monitor ongoing research and identify (with the assistance of colleagues) research and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources.

The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary research, to foster synergy, and to support planning and evaluation activities. Administrative and organizational arrangements should promote joint planning and evaluation activities as well as collaborations and interactions within, between and among programmatic elements of the center. This should include: (a) an overall programmatic structure that effectively promotes scientific interactions, provides for internal quality control of research and publications, generation of future grant applications, and also takes maximum advantage of the Center’s drug abuse research capability (the description of these attributes is particularly important when there are multiple participating institutions in the Center); (b) an administrative organization that has clear lines of authority, is managed efficiently and cost effectively, and enables effective use and leverage of resources; (c) the use of an external advisory structure that is charged to provide appropriate and objective advice and evaluation, as needed, to the Center Director; (d) an internal advisory, decision-making, and priority setting process  to support the activities of the Center; and (e) appropriate criteria and processes for determining and sustaining individual participation in the Center based on productivity, research direction, and overall contribution.

As part of the Core, each application should include a plan for protocol registration and entry to ClinicalTrials.gov (http://clinicaltrials.gov/) and designation of dedicated staff for data entry to the system. 

To promote information sharing, to facilitate collaboration, and to address issues of common concern among NIDA research Centers, NIDA may ask Center Directors to participate in meetings on an as-needed basis.

Pilot Projects

Applicants may propose and request funding for specific, already conceptualized pilot projects, which may be “research and development” pilots, feasibility studies, or other pilot work broadly defined as foundation work for further research. These pilot studies will be reviewed by the scientific review group as part of the assessment of scientific and technical merit. 

Applicants may request funds for pilot projects that are yet to be conceptualized. These projects should have the potential for developing into, or providing the foundation for, larger projects that could compete for funds on their own. Because these projects cannot be reviewed by the scientific review group, applicants must describe and provide a process for within-center scientific review of pilot projects, which must be ultimately approved by the NIDA program official. 

Whether specifically proposed in the application or developed later under center auspices, pilot projects must comply with applicable NIH policies, and the necessary human and animal welfare assurances must be submitted, as well as a Data and Safety Monitoring plan for each new study involving human subjects.

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 PHS 398 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.

Education Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Education Core)

All instructions in the PHS 398 Application Guide must be followed. 

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Education Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: 

Description: The abstract should contain a brief description of the primary function of the Education Core to provide continued education, training, and mentoring. It is expected that some junior investigators will have an active part in some of the research Projects or pilot projects.  The Education Core may also support other activities pertinent to support of Center activities (e.g., data management).

Project/Performance Sites: List the performance sites where the activities and services will be conducted.

Senior/Key Personnel: :List the Core Leader, followed by other key core personnel, and then other significant contributors and describe their involvement in training and mentoring activities.

Table of Contents (Education Core)

All instructions in the PHS 398 Application Guide must be followed. 

Detailed Budget for Initial Budget Period (Education Core)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Education Core)

All instructions in the PHS 398 Application Guide must be followed. 

Biographical Sketch (Education Core)

All instructions in the PHS 398 Application Guide must be followed. 

Resources (Education Core)

All instructions in the PHS 398 Application Guide must be followed with the following instructions:  

Provide information on resources available for the core. Describe how the scientific environment in which the research will be done contributes to the proposed educational program and the training of future investigators in the field (e.g., institutional support, physical resources, and intellectual support). If there are multiple performance sites, describe the resources available at each site. There should be convincing evidence of the applicant institution's commitment to the training activities.

Research Plan (Education Core)

All instructions in the PHS 398 Application Guide must be followed.  

Specific Aims:  Describe the specific aims of the Education Core.

Research Strategy: The Education Core should include a plan for continued education, training, and mentoring, of junior investigators wishing to pursue a career in the area of treatment for Substance Use Disorders and addiction.  Trainees should be given the opportunity to actively participate in Center Projects and should be encouraged to apply for individual grant support during their training.

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 PHS 398 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.

Other Cores

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Other Cores)

All instructions in the PHS 398 Application Guide must be followed. 

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Other Cores)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description: The abstract should contain a brief description of how the core services will contribute towards attainment of the Center objectives.

Project/Performance Sites: List the performance sites where the core activities and services will be conducted.

Senior/Key Personnel: List the Core Leader, followed by other key core personnel, and then other significant contributors.

Table of Contents (Other Cores)

All instructions in the PHS 398 Application Guide must be followed

Detailed Budget for Initial Budget Period  (Other Cores)

All instructions in the PHS 398 Application Guide must be followed. 

Budget for Entire Proposed Period of Support (Other Cores)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Other Cores)

All instructions in the PHS 398 Application Guide must be followed. 

Resources (Other Cores)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Provide information on resources available for the core. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual support). If there are multiple performance sites, describe the resources available at each site.

Research Plan (Other Cores)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims of the proposed Core.

Research Strategy: Describe the function of the core and how it will serve the Center projects.

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 PHS 398 Application Guide, with the following modifications:

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

Projects

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Projects)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Description:  

Project/Performance Sites: List the performance sites where the project activities and services will be conducted.

Senior/Key Personnel: List the Project Leader, followed by other key personnel, and then other significant contributors. Each Research Project is expected to have a scientifically and administratively qualified Leader with responsibility for the scientific, administrative, budgetary, and operational aspects of the project and for coordination with the Center Director and other Research Project/Core Leaders. The Research Project Leaders should be productive, outstanding researchers and leaders of the field. It is expected that the Research Project Leader will make a substantial commitment of time and effort to the Center, at least 1.8 months effort to research-related activities directly supported by the Research project.

Table of Contents (Projects)

All instructions in the PHS 398 Application Guide must be followed. 

Detailed Budget for Initial Budget Period  (Projects)

All instructions in the PHS 398 Application Guide must be followed. 

It is expected that the Research Project Leader will make a substantial commitment of time and effort to the Center, at least 1.8 months effort to research-related activities directly supported by the Research project.

Budget for Entire Proposed Period of Support (Projects)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Projects)

All instructions in the PHS 398 Application Guide must be followed. 

Resources (Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Provide information on resources available for the project. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual support). If there are multiple performance sites, describe the resources available at each site.

Research Plan (Projects)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims of the proposed Project.

Research Strategy:  Research may focus on any area of NIDA's mission, but must bear an essential relationship to the Center’s integrating theme and efficiently use and contribute to Center resources. Each Research Project that uses Center Research Core facilities should describe how the Core resources impact the proposed project.

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 PHS 398 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 for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.    

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 - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

Scored Review Criteria - Overall

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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 Center? 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 Center? 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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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?   

Overall Impact - Education Core, Other Cores, Projects

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the core or 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 core or project proposed). 

Scored Review Criteria - Education Core, Other Cores, Projects

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

Significance

Does the core or project address an important problem or a critical barrier to progress in the field? If the aims of the core or 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 core or 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 core or 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 core or 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 core or project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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 core or project proposed? Will the core or project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria - Overall, Education Core, Other Cores, Projects

As applicable for the Center, core or project  proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed core or project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

Additional Review Considerations - Overall, Education Core, Other Cores, Projects

As applicable for the Center, core or 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 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, 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) convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center and 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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 Grants website.

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation. 

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

These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, 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 awardee 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 Program Director/Principal Investigator (PD/PI) will have the primary responsibility for:

i) PD/PI will have the primary responsibility for all aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators. The PD/PI agrees to accept close coordination, cooperation, and participation of NIDA staff in those aspects of scientific and technical management of the study as stated in these terms and conditions.

ii) A Data and Safety Monitoring Plan (DSMP) will be developed using “Guidelines for Developing a Data and Safety Monitoring Plan” at http://www.drugabuse.gov/funding/clinical-research/guidelines-developing-data-safety-monitoring-plan and submitted to NIDA for approval for each clinical trial conducted under this award. Approval by the NIDA program official is required before any research study with human subjects is implemented. Any changes to the protocol must first be discussed with, and approved by, the NIDA program official before they are implemented. An amended DSMP incorporating approved changes and reflecting the required IRB approval will be submitted to NIDA before continuation of the study.

iii) Annual progress reports will report on the grantee's progress on each study in which it participates, including progress, obstacles and steps taken to remedy them, and a summary of any NIDA-approved changes and departures from the approved study protocol, as well as any human subjects issues.

iv) Serious Adverse Events: in addition to existing OHRP and institutional requirements, serious adverse events will be reported through the NIDA Serious Adverse Event Tracking and Reporting System (SAETRS, at https://secure.emmes.com/aes/jsp/login.jsp) within 72 hours of occurrence. Adverse Events will be reported in the annual progress report.

v) Milestones for each study will follow the timeline proposed and agreed upon between the grantee and NIDA Program staff.

vi) Awardees who do not accomplish the negotiated milestones shall submit a milestone report which will include a discussion of why the milestones were not met in the agreed- upon timeframe, and propose a corrective action plan in consultation with the Program Official and Project Scientist. The corrective action plan shall include amended milestones, plans to achieve the amended milestones and any additional items required by NIDA staff. The plan shall be provided to NIDA staff no later than 2 months following the missed milestone. The inability of the awardees to meet agreed-upon milestones may result in an adjustment of funding.

vii) Awardees are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIDA.

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

i) In addition to the Program Official who will be responsible for normal program stewardship, the cooperative agreement will be assigned a Project Scientist (PS) with expertise in medications development and clinical trial design. The PS will be substantially involved in this project beyond the normal stewardship of an NIDA Program Official by ensuring the established protocol is followed and assisting in overseeing the quality of the data and safety of the research subjects.

ii) The PS act as a resource to aid in resolving scientific and regulatory issues as they arise.

iii) NIDA will provide access to the DPMC/NIDA Serious Adverse Event Tracking and Reporting System (SAETRS https://secure.emmes.com/aes/jsp/login.jsp), as long as NIDA support for the system exists, at no cost to the grantee.

iv) Study Closure - NIDA may require that a study be closed for reasons including but not limited to: a) patient safety; b) failure to achieve enrollment and completion milestones, c) emergence of already conclusive study results and d) emergence of new information that diminishes the scientific importance of the study question. Once notified by the Grants Management Branch, NIDA, of site closure or that the study should cease, only reasonable personnel and administrative costs associated with the orderly phase-out, and/or to ensure patient safety for enrolled subjects of the study or site may be obligated or charged to the grant award.

Areas of Joint Responsibility Include:

i) The awardee and NIDA PS will confer on the most optimal strategy to ensure and monitor medication compliance.

ii) Concepts for the design and implementation of each new clinical trial will be discussed between the awardee and NIDA PS before a decision is made to proceed with the trial. Both parties shall agree on the most appropriate protocol design and outcome measures for each trial.

iii) Status reports in the format of conference calls with NIDA PS will take place on a bi-monthly basis. These reports will include information concerning recruitment, retention, and drop-out rates for each research protocol, as well as progress, obstacles and steps taken to remedy them, any changes and departures from the approved study protocol, especially any human subject issues. Status reports will also discuss the results of each study as they become available.

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Jamie Biswas, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-8096
Email: jbiswas@mail.nih.gov

Peer Review Contact(s)

Mark Swieter, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: mswieter@mail.nih.gov

Financial/Grants Management Contact(s)

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 410-254-1853
Email: wellse2@nida.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.


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