Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Seek, Test, Treat, and Retain Data Harmonization Coordinating Center (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. June 10, 2013 - See Companion RFA's; RFA-DA-14-009 R01 Research Project Grant , RFA-DA-14-010 R01 Research Project Grant , RFA-DA-14-011 R01 Research Project Grant and RFA-DA-14-012 R21 Exploratory/Developmental Grant.
Funding Opportunity Announcement (FOA) Number	RFA-DA-14-007
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 interdisciplinary Coordinating Center to support data harmonization and analysis activities for a subset of NIDA-funded HIV services research grants. The Coordinating Center will (1) support the existing data harmonization efforts of grantees examining the Seek, Test, Treat and Retain HIV treatment cascade; (2) identify and obtain Seek, Test, Treat and Retain relevant data from other sources; (3) conduct requested cross-site data analyses from the harmonized Seek, Test, Treat and Retain dataset; (4) develop and execute a dissemination and publication plan of results and findings from the integrated Seek, Test, Treat and Retain dataset; and (5) provide operational, administrative and logistical support for the Seek, Test, Treat and Retain data harmonization initiative.

Posted Date	May 31, 2013
Open Date (Earliest Submission Date)	July 16, 2013
Letter of Intent Due Date(s)	July 16, 2013
Application Due Date(s)	August 16, 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)	August 16, 2013, by 5:00 PM local time of applicant organization.
Scientific Merit Review	October/November 2013
Advisory Council Review	January 2014
Earliest Start Date	April 2014
Expiration Date	August 17, 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

To improve understanding of the intersection of HIV/AIDS and drug abuse, this Funding Opportunity Announcement (FOA) is part of a multipronged 2014 expansion of HIV and AIDS related research within the context of drug and alcohol abuse among understudied populations and in understudied settings that show promise for the development of effective prevention and treatment efforts.

The Seek, Test, Treat, and Retain research initiative was designed by NIDA, in collaboration with other NIH Institutes and Centers, to develop and empirically test interventions to effectively deliver an HIV continuum of care to criminal justice and vulnerable drug-abusing populations. This initiative was based on growing evidence that HIV testing followed by immediate initiation of antiretroviral treatment for HIV seropositive individuals could effectively reduce HIV transmission at a population level. The success of such a strategy depends on reaching out to high risk, hard to reach groups who have not been recently tested (seek), engaging them in HIV testing (test), initiating those testing positive in highly active antiretroviral treatment (HAART; treat), and retaining them in care (retain).

Through two related FOAs (RFA-DA-10-017 and RFA-DA-11-001), NIDA awarded 22 independent R01 applications with the expectation that all grantees would participate in a prospective effort to harmonize key data elements across these studies and contribute data to a single integrated dataset. Data harmonization is a strategy to increase the comparability of research data across independent studies. The goal of this data harmonization effort is to generate a dataset with the potential to address new and population-level research questions beyond the capacity of any individual Seek, Test, Treat and Retain project. As envisioned, the aggregate data will allow researchers to address scientific questions regarding the effectiveness of the Seek, Test, Treat and Retain model in reducing HIV incidence, infectivity, morbidity, and mortality at the systems, community, and population levels. These efforts are consistent with the goals of the National HIV/AIDS Strategy which emphasize data harmonization and improved federal coordination of HIV services. In addition, this overall effort to study and enhance testing, treatment and retention in care are consistent with the Secretary of Health and Human Services' core indicators for HIV services.

Thus far, NIDA Program and a NIDA-supported contractor have initiated the data harmonization process. Activities to date include: the identification of 12 common data domains; selection of measures to assess these domains; development of data sharing agreements; collection of baseline data; establishment of quality control procedures for the harmonized data set, and the establishment of schedule for quarterly data deposits. It is anticipated that the integrated dataset of harmonized measures will include data for approximately 70,000 individuals.

The purpose of this FOA is to fund a single interdisciplinary Coordinating Center to formalize and centralize support of the Seek, Test, Treat, and Retain data harmonization initiative. Working collaboratively with NIDA and the Seek, Test, Treat and Retain grantees, the Coordinating Center will build on the prior harmonization efforts by providing scientific, technical, legal, ethical, and logistical support in the development of state-of-the art approaches for data harmonization and data comparability standards; developing an integrated Seek, Test, Treat and Retain dataset; identifying, coordinating and integrating additional Seek, Test, Treat and Retain relevant data from national or international administrative and/or research datasets; conducting requested analyses that relate to the integrated Seek, Test, Treat and Retain dataset; developing and executing a Seek, Test, Treat and Retain publication and dissemination plan; and providing logistical support for in-person meetings, conference calls, and webinars of Seek, Test, Treat and Retain investigators.

Specific responsibilities of the Coordinating Center include:

1) Support the existing data harmonization efforts of Seek, Test, Treat and Retain grantees. This will include:

• Immediately upon award, participating in an in-person project hand off meeting to transition Seek, Test, Treat and Retain data harmonization activities, datasets, documents, etc. from the current contractor.
• Developing innovative methodological strategies to support data harmonization (e.g. data quality control, assessing and resolving cross site variation, ensuring data comparability).
• Providing a federally compliant online infrastructure to support the submission/ transmission of research data.
• Monitoring data quality and performing systematic checks for data completeness and comparability.
• Compiling integrated data sets, developed codebooks, and other data file documentation.
• Supporting requests from NIDA and Seek, Test, Treat and Retain grantees for analytic data files.
• Developing data sharing and data use agreements to support harmonization between Seek, Test, Treat and Retain grantees and the eventual creation of public use data files.
• Preparing de-identified public use data files and documents for submission into the NIDA supported repository National Addiction and HIV Data Archive Program (NAHDAP).

2) Identify and obtain access to Seek, Test, Treat and Retain -relevant data from existing HIV sources. This will include:

• Identifying candidate external datasets (expected to be less than 10) containing specific data with clear relevance to the harmonized integrated Seek, Test, Treat and Retain dataset. These might include datasets from the United States Centers for Disease Control and Prevention, HRSA Special Projects of National Significance, HSRA-funded HIV Ryan White Programs, HIV Research Network, HIV Prevention Trials Network, and Adolescent Medicine Trials Network for HIV/AIDS Interventions.
• Working with NIDA program to review the relevance, quality of the data, and level of fit and match of external datasets with the integrated Seek, Test, Treat and Retain dataset.
• Coordinating with relevant parties to obtain, extract, and integrate these datasets.
• Developing codebooks, data file documentation, data sharing agreements, etc. and public use data files that will be incorporated into the Seek, Test, Treat and Retain public use data files.

3) Conducting requested cross-site data analyses using the Seek, Test, Treat and Retain integrated dataset. This will include:

• Performing descriptive data analyses to characterize the Seek, Test, Treat and Retain harmonized study sample.
• Utilizing sophisticated statistical and analytical techniques (e.g., growth curve modeling, generalized estimating equation (GEE), Hierarchical Linear Modeling (HLM), as well as knowledge of different imputation techniques) for large complex datasets.
• Maintaining expertise on state-of-the-art and emerging study designs and methodologies relevant to scientific investigations of drug abuse and HIV, as appropriate for analyzing and interpreting the harmonized data.

4) Developing and executing a dissemination and publication plan. This will include:

• Working with NIDA and Seek, Test, Treat and Retain grantees to develop a publication and dissemination plan.
• Tracking the progress of manuscripts and/or presentations based on the integrated data.

5) Providing operational, administrative, and logistical support for the Seek, Test, Treat and Retain data harmonization 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 Seek, Test, Treat and Retain grantees 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 in-person 2-day project update meetings of Seek, Test, Treat and Retain grantees and their project managers, NIH Staff, and other scientists in the Bethesda, MD area.
• Compiling meeting minutes, delivering summary meeting reports, and coordinating post-meeting follow-up.
• Supporting meetings for workgroup and subcommittees of Seek, Test, Treat and Retain PDs/PIs involved in the use and access of the harmonized dataset, including conference calls and webinars.

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

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

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

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

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	The total amount of funds available for the award is $500,000 for fiscal year 2014, contingent upon receiving scientifically meritorious applications. One award is anticipated from this FOA.
Award Budget	Applications are limited to $500,000 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)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

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

All PDs/PIs 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: [email protected]

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

Director - DA-14-007
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.

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.

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 modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. It is expected that the Coordinating Center will encourage sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration in a timely manner. The Coordinating Center will compile aggregate data files for analysis and create de-identified public use data files with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication.
• The Coordinating Center must provide NIDA with access to all data generated under this award, subject to rules specified in any Certificates of Confidentiality obtained by awardees.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit 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-10-115.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Coordinating Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the 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 Coordinating Center address an important problem or a critical barrier to progress in the field? If the aims of the Coordinating Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the Coordinating Center provide leadership and engage relevant stakeholders in advancing scientific knowledge that identifies novel approaches to data harmonization? To what extent might successful completion of the Coordinating Center’s aims change the capability, concepts, methods, and technologies that are utilized in data harmonization?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Coordinating Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? To what extent do the investigators demonstrate the capacity to collaborate with the NIH, Seek, Test, Treat and Retain sites, and national and international HIV networks to meet the goals and objectives of this program?

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 across multi-site studies; (c) drug abuse or HIV treatment services; and (d) identified public use data files with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication?

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 for the Cooperative? Does the application challenge and seek to shift and improve current research paradigms by utilizing novel theoretical concepts, approaches, methodologies, instrumentation or tools for data harmonization?

Is a refinement, improvement or application of novel theoretical concepts, approaches, methodologies, instrumentation or tools proposed that will facilitate data harmonization broadly and between important clinical and/or public health relevant datasets?

Approach

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

If the Coordinating Center 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? Will the proposed activities facilitate flexibility and create policies, practices, algorithms, protocols, and tools to enable broad collaboration and participation?

• How well does the application demonstrate an understanding of the nuances of and challenges underlying the harmonization of large data sets?
• How well does the application evidence a capacity to manage complex, multi-site research projects including the provision of logistical support and data management?
• Does the application demonstrate a capacity to process high volumes of quantitative and qualitative data in an efficient and secure way?
• Does the application demonstrate a capacity and understanding of the procedures for eventually releasing the data for public use?
• How well does the application demonstrate a capacity to effectively facilitate secure communication, information, data, and document sharing among the project sites?
• Does the application demonstrate an ability to use state-of-the-art technological resources to enhance the efficiency of this communication?
• Does the application demonstrate an understanding of the statistical techniques necessary to conduct requested cross-site analyses?
• How well does the application demonstrate an understanding of the applicable Federal laws and the implications of these laws for aspects of project execution, including information security requirements, plain language requirements, and Section 508 compliance?
• Does the application demonstrate a familiarity with human subjects research protocols and/or an ability to provide assistance to Research Centers on IRB issues related to data sharing?

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 Coordinating Center 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact 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.
• Policies consistent with goals for resources and data sharing and sharing of software.
• Complementarity to and synergy with other funded projects
• Willingness of PD(s)/PI(s) to collaborate with the NIH and with other investigative groups participating in the program.

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(s)/PI(s) of the Coordinating Center will have the primary responsibility for:

• Integrating and managing data submitted by Seek, Test, Treat and Retain grantees
• Supporting the conduct of data analyses and defining approaches, innovations, and methods related to harmonization methods, metrics, and the harmonized Seek, Test, Treat and Retain dataset
• Providing expertise and leadership in addressing issues of broad applicability, such as informed consent, data sharing standards, analysis methodology, and dissemination, to Seek, Test, Treat and Retain Grantees in harmonizing and sharing tools, methods, strategies and approaches within and between the projects
• Facilitating comparability across the data from the Seek, Test, Treat and Retain projects when possible
• 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 the face-to-face annual meetings of the Seek, Test, Treat and Retain PIs.
• Coordinating the eventual release to the scientific and healthcare communities of methods, tools, data, results, and other resources
• A PD/PI on a U01 awarded under this RFA will be expected to maintain significant effort commitment not smaller than that stated in the application (2.4 person-months).
• 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 and apply to their research projects with minimal assistance
  

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, ensuring data comparability)
• Identify relevant Seek, Test, Treat and Retain research questions based on the harmonized dataset. He/she may cooperate with awardees in development, design, and coordination of research plans and study reports emerging from the harmonized Seek, Test, Treat and Retain dataset. 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 Seek, Test, Treat and Retain -related meeting 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.

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. 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: [email protected]

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

Shoshana Y. Kahana, Ph.D.
Services Research Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6504
Email: [email protected]

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

Maryellen Connell
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-774-3803
Email: [email protected]

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

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