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

National Institute on Drug Abuse National Early Warning System (NEWS) Coordinating Center (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • November 6, 2013 - See Notice NOT-DA-14-001. Notice of Website for Frequently Asked Questions.

Funding Opportunity Announcement (FOA) Number

RFA-DA-14-015

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 Funding Opportunity Announcement (FOA) solicits applications for a single Coordinating Center to support novel data acquisition strategies, data harmonization, analysis and dissemination activities on emerging and current drug abuse trends across selected communities. The Coordinating Center will (1) establish and develop key community-level indicators for monitoring drug abuse trends and early identification of new synthetic drugs and emerging issues including establishing harmonization of indicators and of presentation and analysis of indicators across the selected communities; (2) identify and develop novel sources of data including data available via the internet and obtain relevant data from various sources; (3) conduct cross-site data analyses from the harmonized Coordinating Center data; (4) develop and execute a dissemination and publication plan of results and findings from the Coordinating Center data, including development and maintenance of a website for disseminating data and findings; (5) establish an Early Warning Network composed of local experts on drug abuse data from the selected communities, as well as NIDA-supported community-based researchers, to assist in the ongoing monitoring and interpretation of data and (6) provide operational, administrative and logistical support for the Coordinating Center data harmonization and dissemination initiative.  

Key Dates
Posted Date

September 12, 2013

Open Date (Earliest Submission Date)

November 3, 2013

Letter of Intent Due Date(s)

November 3, 2013

Application Due Date(s)

December 3, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

December 3, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

February/March 2014

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

December 4, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Background

The NIDA Epidemiology Program supports research to enhance our understanding of the nature, extent, distribution, etiology, and consequences of drug use, abuse, and addiction across individuals, families, communities, and diverse population groups. Accurate characterization of the drug abuse problem is essential to the identification of priority research needs and to inform prevention and services efforts to reduce the burden of drug use, abuse, and addiction on the nation's health.

The drug abuse problem in the United States has become increasingly complex in recent years. The US continues to grapple with the epidemic of consequences associated with the nonmedical use of prescription drugs, an emerging heroin problem among youth and the threat posed by the rapidly increasing number of new psychoactive substances such as synthetic cannabinoids being introduced into the drug market. The United Nations World Drug Report 2013 described new psychoactive substances as proliferating at an unprecedented rate across the globe and posing unforeseen public health challenges, underscoring the importance of recognizing the influence of international conditions on the US drug market.

An important aspect of the complexity of the drug use situation in the U.S is the diversity in drug use patterns across communities. To address the need to monitor drug abuse problems and capture local diversity in patterns of drug use, NIDA has supported the Community Epidemiology Work Group (CEWG) for 37 years. Through the CEWG, NIDA has maintained a program on the identification and monitoring of drug abuse trends and associated consequences based on the semiannual reporting by local drug abuse experts from sentinel communities. The CEWG has tracked drug abuse problems based on secondary data available at the local level, as well as drug trends reports from researchers from other countries and regions of the world in recognition of the global nature of the drug market and implications for the US. CEWG Reports on Drug Abuse Trends have regularly been produced and disseminated to the public.

Federally supported local-level data collection efforts such as the Drug Abuse Warning Network and the Arrestee Drug Abuse Monitoring Program have yielded standardized comparable data across local areas that have served as reliable drug abuse indicators at the community level and have been an important resource for the CEWG. In recent years, however, most of these data sources have been eliminated or greatly reduced in scope. Meanwhile, the growth of the Internet has improved the accessibility of data and expanded the range of potential data which may inform our understanding of drug abuse trends and enable detection of emerging issues at an early stage.

This initiative aims to assess the current availability of data relevant to the understanding and early detection of drug abuse patterns and trends across selected sentinel areas, and to identify a set of key indicators of drug availability, use and associated consequences with the objective of developing approaches to harmonizing data, analysis and presentation across sentinel areas in order to monitor patterns of use of illicit drugs (including nonmedical use of prescription medications) and associated consequences with a particular emphasis on "leading" and real-time indicators that will facilitate the early identification of new psychoactive substances in the drug market.

This initiative expands beyond prior NIDA Epidemiology Research Program activities (e.g. CEWG) to take advantage of new opportunities and cutting edge methodological approaches. While the CEWG has only reported secondary data primarily from administrative data sets to monitor drug abuse trends, this initiative encourages consideration of a wider range of data available including data available via the Internet and social media and encourages novel approaches to collecting data such as web-based surveys, data mining and use of crowd sourcing. Qualitative methods such as focus groups may also be proposed. Strategies should be developed for the timely and effective dissemination of findings for multiple audiences to maximize public health benefit. The current initiative seeks greater innovation and direction from the scientific community in devising and directing novel approaches to data collection, harmonization, analysis and dissemination while maintaining NIDA scientific input to assure consistency with NIDA goals.

Research Objectives

The purpose of this FOA is to fund a single Coordinating Center to support NIDA's efforts to enhance and expand the NIDA Epidemiology Research Program to address emerging drug abuse trends.  Working collaboratively with NIDA, the Center will develop and implement a model utilizing multiple data sources to identify new psychoactive substances and emerging drug abuse issues, and to track drug abuse trends through regular monitoring of key data from sentinel sites and the internet while seeking to maximize potential for cross area comparison by harmonizing approaches to data collection, aggregation, analysis and presentation across areas. Novel data sources and innovative approaches to collection and dissemination are sought.

Research conducted in international settings is not sought; however, the approach proposed should consider U.S. Border and global drug issues and the impact on drug availability and drug use patterns in the U.S.

A theoretical framework should guide the selection of measures, methods and analyses.

Specific responsibilities of the Coordinating Center include:

1) Establish a Scientific Advisory Group. This will include:

2) Establish a NIDA National Early Warning System (NIDA-NEWS) Network composed of experts on illicit drug availability, illicit drug use and associated consequences from the selected community-level sentinel (for example, from Poison Centers, Medical Examiner Offices, and Treatment Programs), as well as NIDA-supported community-based researchers, to assist in the ongoing monitoring and interpretation of data. NIDA-NEWS Network should include at least one person from each sentinel site but could include more than one person from each site.

While this initiative is an outgrowth and expansion of NIDA's previous efforts monitoring drug abuse at the community level including the CEWG, applicants should propose a network model suited to the specific approach proposed.

The NIDA-NEWS Network should serve as a resource for identifying local data sources and contacts, for the interpretation of data compiled by the Coordinating Center and for ongoing communication in identifying and monitoring new psychoactive substances, patterns of use and associated consequences.

Sentinel areas should include urban areas but the approach proposed should also address drug abuse in non-urban areas. For example, a state with a large non-urban population experiencing a significant drug abuse problem might be included. An approach which proposes only U.S. states as sentinel areas would not be considered responsive to this RFA. The community level remains the focus of this initiative. It is anticipated that there would be between 12-20 sentinel sites. Sentinel areas should be selected from each of the four U.S. main Census Regions. The inclusion of states as sentinel areas must be justified and should represent no more than 2-3 of the total number of sentinel sites proposed.

3) Establish key community-level indicators for monitoring drug abuse trends and early identification of new synthetic drugs and emerging issues including establishing harmonization of indicators and of presentation and analysis of indicators across the selected communities. This will include:

4) Identify and develop novel sources of data including data available via the internet and obtain relevant data from various sources. This will include:

5) Conduct cross-site data analyses from the harmonized Coordinating Center data.  This will include:

6) Develop and execute a dissemination and publication plan of results of analysis of harmonized data and novel data sources.  This will include:

7)  Provide operational, administrative and logistical support for the Coordinating Center data harmonization and dissemination initiative.  This will include:

Providing technical or logistical support for meetings of subcommittees and workgroups including providing conference call lines and webinar support.

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 scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDA intends to commit up to $900,000 per year to fund one award.

Award Budget

The total budget may not exceed $900,000 per year.

Award Project Period

The total project period may not exceed 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.

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 not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

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-14-015
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

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

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:

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (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 SF424(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. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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.  

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

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

Scored Review Criteria

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

Significance

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

Investigator(s)    

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

Do the personnel within the Coordinating Center have the appropriate expertise, experience, and productivity related to: (a) novel methodologies and analytics related to data harmonization and the creation of integrated datasets; (b) data management; (c) novel methodologies for acquiring new psychoactive drug and drug-abuse related data from the Internet?   

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? 

Does the application include mechanisms for leveraging novel collaboration and communication strategies? Does the application indicate creativity and flexibility to innovate on an ongoing basis? How innovative is the proposed approach to logistical support, communication, and data management? How novel is the approach to developing new sources of data to identify emerging drug abuse issues at an early stage? Does the application challenge and seek to shift and improve current research paradigms by utilizing novel theoretical concepts, approaches, methodologies, and tools?   

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?

How well does the application demonstrate an understanding of community-level drug abuse data and of the nuances of and challenges underlying the harmonization of data across different sentinel sites?

Does the application demonstrate the flexibility to adapt to incorporate monitoring of new psychoactive substances which emerge during the period of support?

How well does the application demonstrate capacity to conduct Internet-based studies to inform drug abuse trends?

How well does the application demonstrate a capacity to effectively facilitate secure communication, information, data, and document sharing among the project participants?

Does the application demonstrate an ability to use state-of-the-art technological resources to enhance the efficiency of communication?

Does the application demonstrate capability of establishing and implementing novel strategies for disseminating findings in a timely fashion, including through a project website?  

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? Does the application document the availability of state-of-the-art technological infrastructure to support the data collection, coordination, data analysis, and communication activities required?  

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact 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 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 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

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 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 the 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 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:

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.

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

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/PI of the Coordinating Center will have the following responsibilities:

NIH staff has 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:

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 or the preparation of publications, will be responsible for the oversight of the cooperative agreement. The Program Official carries primary responsibility for:

 (1) periodic review and monitoring and approval of the progress of the research plans in relation to their stated objectives, including consistent communication with the PI and the Coordinating Center staff as well as requests for additional reports or documentation; 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 Coordinating Center. 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.

Additional NIH staff may participate in all project related meetings and work groups, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.

The NIH reserves the option to recommend withholding or reduction of support from activities that fail to achieve their goal or comply with the Terms and Conditions.

Areas of Joint Responsibility include:

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  Scientific Advisory Group 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

Moira O'Brien, M. Phil.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1881
Email: mobrien@nida.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Carol Alderson
Grants Management Branch
National Institute on Drug Abuse
Telephone: 301-933-6196
Email:  aldersoc@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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