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	May 31, 2019 - This RFA has been reissued as RFA-DA-20-016. 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.

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.

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

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:

• Identifying 8-10 experts to: advise in the conduct of the project; provide guidance on establishing procedures for harmonizing data from different sources and jurisdictions; provide guidance on procedures for presentation, interpretation and analysis of data within and across sentinel sites; provide guidance in establishing methods for assessing trends over time, and identify opportunities and novel methods for collecting data to enhance understanding of emerging drug abuse trends.
• Convening internet-assisted or in-person meetings of the Scientific Advisory Group and sub-committees, as needed, but at least once a year. In-person meetings should be held in the Rockville/Bethesda, Maryland area.

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:

• Identification of common data domains relevant to drug supply/market factors, drug use and associated consequences including transmission of pathogens such as HIV and Hepatitis C. Vulnerable populations such as pregnant women should be considered.
• Selection of measures to assess these domains
• Identifying candidate external data sources containing specific data with clear relevance for the early identification of emerging drug issues and monitoring trends in availability, use and associated consequences of illicit drugs (including nonmedical use of prescription drugs) and emerging new synthetic psychoactive substances. These might include data from the Drug Enforcement Agency, Substance Abuse and Mental Health Services Administration, Centers for Disease Control and Prevention, Medical Examiners, and Poison Centers.
• Working with the NIDA Scientific Officer to review the relevance, quality of the data, and level of fit and match of external data
• Coordinating with relevant parties to obtain, extract, and integrate these datasets.
• Establishment of quality control procedures for the harmonized data set.

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

• Consideration of data from the Internet and social media
• Exploration of open source analytic tools such as Google News/Trends for utility
• Utilize 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.

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

• Establishing annual sentinel site profiles based on descriptive analyses of key indicators, establish parameters for assessing trends (changes over time) using multiple data sources.
• Considering regional and socio-demographic factors, including gender and race/ethnicity, in analyzing data

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

• Development of an annual report briefly and concisely summarizing findings for multiple audiences to maximize public health benefit.
• Developing and maintaining a public project website to facilitate dissemination of data and findings to multiple audiences, including the general public, substance abuse service providers and researchers. For example, an approach could include an interactive website enabling simple display of and access to annual data through tables and spreadsheets, and utilizing data visualization techniques such as graphs or maps showing trends over time. Video interviews might also be used to disseminate information.
• Tracking the progress of manuscripts and/or presentations based on the Coordinating Center data set.

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

• Maintaining a web-based project collaboration and document management system that meets applicable federal requirements (e.g., Live Link; SharePoint) to facilitate: (a) communication between coordinating Center, Scientific Advisory Group, NIDA-NEWS Network and NIDA staff; (b) document sharing and storage; and (c) dissemination of relevant data collection forms, research findings, timelines, and other documents.
• Planning, organizing and conducting annual 1-2 day project update meetings of the Scientific Advisory Group.
• Planning, organizing and conducting semi-annual 1-2 day Internet-facilitated project meetings of the NIDA-NEWS Network. More frequent shorter conference calls may be established in response to emerging drug abuse issues.
• Compiling meeting minutes, delivering summary meeting reports, and coordinating post-meeting follow-up.

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

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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

Applicant Organizations

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

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.

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

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

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

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

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

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

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

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

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

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.

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.

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

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

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

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

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

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

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• The Coordinating Center must provide NIDA with access to all the data generated under this award, subject to rules specified in any Certificate of Confidentiality obtained by the awardee.

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.

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

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

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.

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the 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.

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

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

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

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

Significance

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

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?

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

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.

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:

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

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

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

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

After the peer review of the application is completed, the 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.

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.

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:

• Integrating and managing data acquired.
• Supporting the conduct of data analyses and defining approaches, innovations, and methods related to harmonization methods.
• Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination.
• Facilitating comparability across the data from sentinel areas.
• Facilitating data quality monitoring through rigorous data management and identifying data biases and errors as they arise.
• Agreeing to accept close coordination, cooperation, and management of the project with NIH, including those outlined under NIH Responsibilities .
• Participating in group activities, including annual project update meetings.
• Providing integrative, organizational, and logistical support for the entire program, including tracking, scheduling, facilitating work group meetings and conference calls, and preparing concise minutes or summaries of meetings for distribution.
• Planning and hosting annual meetings of the Scientific Advisory Group.
• Providing timely notification to the NIDA Project Scientist of emerging psychoactive substances, new drug use patterns or sudden increases in consequences detected.
• Coordinating dissemination of methods, tools, data, results, and other resources.
• A PD/PI on a U01 awarded under this FOA will be expected to maintain significant effort commitment not smaller than that stated in the application (2.4 person-months).
• Providing high-quality documentation as needed, particularly of protocols or approaches that have broad applicability across the program that will be sufficient for outside users to understand.

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:

• Serve as a resource for specific information on NIDA's programmatic intentions and priorities, and will help to foster collaborations between researchers, public health, and public policy partners both within and across other Federal agencies to increase the value of research to these participants.
• Play an active role in developing innovative methodological strategies to support data harmonization (e.g. data quality control, assessing and resolving cross site variation) comparability).
• Identify relevant research questions. He/she may cooperate with awardees in development, design, and coordination of research plans and study reports.
• In instances where significant involvement in the design of studies and/or analysis of results has occurred, the NIDA Project Scientist may cooperate with awardees as coauthor in preparing publications of data resulting from the research. In this regard, he/she will be subject to the publication/authorship policies governing all participants. In addition, publications involving NIDA staff require internal clearances.

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:

• Awardee and NIDA Project Scientist will jointly propose and select members of Scientific Advisory Group and NEWS Network participants. The Awardee and NIDA staff will jointly plan agenda for Scientific Advisory Group meetings.
• Awardee, the NIDA Project Scientist, and other relevant NIDA staff will participate together in Scientific Advisory Group meetings, NEWS Network meetings and additional conference calls as needed, to facilitate development of the network and exchange of information on emerging drug abuse issues.
• Awardee and NIDA Scientist will provide input on emerging issues and new psychoactive substances to be monitored.
• The dissemination plan will be jointly developed and mutually acceptable to the both awardee and NIDA.
• Status reports in the format of conference calls with NIDA program staff will take place on a monthly basis, or more frequently, as needed. These reports will include information concerning project progress, obstacles and steps taken to remedy them. Status reports will also discuss the results of studies 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 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.

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.

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

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 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

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

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

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

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