Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Cohort Studies of HIV/AIDS and Substance Use (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • September 17, 2014 - See Notice NOT-DA-14-046 Notice of Early Expiration of PAR-12-222 "Cohort Studies of HIV/AIDS and Substance Use (U01)"
  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • July 3, 2013 - See Notice NOT-DA-13-041. Notice to Cancel the December 11, 2013 Application Due Date.
  • October 30, 2012 - See Notice NOT-DA-13-006. Notice to Update and Clarify Budgetary Limits.

Funding Opportunity Announcement (FOA) Number

PAR-12-222

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), issued by the National Institute on Drug Abuse (NIDA), invites grant applications that propose longitudinal cohort studies to address emerging and/or high priority research on HIV/AIDS and substance abuse.  This FOA will support the development and maintenance of new cohorts or the expansion of existing cohorts to address the natural and treated history of HIV infection in at-risk populations where substance use is a central factor. The intent of the FOA is to provide a strong resource platform for current and future collaborative efforts with other investigators to address emerging questions related to HIV infection, prevention, and treatment in the context of substance abuse, as well as to foster the creativity and efficiency of investigator–initiated research goals.   

Key Dates
Posted Date

June 29, 2012

Open Date (Earliest Submission Date)

November 11, 2012

Letter of Intent Due Date

November 11, 2012, March 9, 2013, [(Date Removed per NOT-DA-13-041) November 11, 2013], March 9, 2014, and November 11, 2014

Application Due Date(s)

December 11, 2012, April 9, 2013, [(Date Removed per NOT-DA-13-041) December 11, 2013], April 9, 2014, and December 11, 2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February/March 2013, June/July 2013, February/March 2014, June/July 2014, February/March 2015

Advisory Council Review

May 2013, October 2013, May 2014, October 2014, May 2015

Earliest Start Date(s)

July 2013, December 2013, July 2014, December 2014, July 2015

Expiration Date

December 12, 2014 per NOT-DA-14-046. (Previous date: April 10, 2015)

Due Dates for E.O. 12372

Not Applicable. 

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research Objectives

Despite the overall decline in new HIV infections worldwide, substance use continues to be a major driver of global infection, in association with sexual risk behaviors as well as through parenteral transmission.  HIV prevalence among non-injecting drug users has also grown to levels similar to those observed for injecting drug users (IDU), and polysubstance use, including alcohol, marijuana, and cigarette smoking, is common among HIV-infected populations.  Lack of treatment engagement, as well as treatment failure, continue to be major challenges among those with substance abuse issues.  It therefore remains crucial to understand the role of substance use in the context of HIV diagnosis, prevention and treatment strategies, pathogenesis, and disease outcomes, as well as its role in HIV-associated co-infections, complications and co-morbidities.

Prospective, observational cohort studies in real world settings have informed current understanding of factors that impact HIV disease acquisition, prevention and progression, treatment success and clinical outcomes.  Since the start of the HIV epidemic, cohort studies of high-risk infected and uninfected populations have made crucial contributions to understanding the biology of HIV, seroconversion dynamics, the natural and treated histories of HIV-1 infection, and the impact of associated co-morbidities, co-infections, and complications.  Because HIV-infected individuals with access to antiretroviral treatment are living longer with HIV, as new prevention and treatment approaches are introduced, it will be important to better understand the complex host, viral, and environmental factors that influence disease progression and outcomes in people living with HIV.  In addition, longitudinal cohorts involving at-risk individuals can provide crucial information about transmission and acute or early phases of infection.

This initiative is intended to develop new cohorts or build on existing cohorts which include substance using individuals who are HIV positive or at risk for infection. The  applications in response to this FOA may include specific research projects that focus on the intersection of HIV/AIDS and substance use, and should serve as a platform for a wide range of research efforts by the investigator, collaborators, and other researchers utilizing data and/or specimens collected from these studies as part of independent, investigator-initiated research grants.  Research aims included in submitted  applications may be broad or narrow, given the diverse topics of interest to this FOA, such as identifying the determinants of susceptibility or resistance to infection; HIV prevention; barriers to optimal HIV care; the effects of multiple co-morbidities and co-infections, such as HBV and HCV; disease progression and response to both substance abuse and HIV treatment; the impact of aging; factors affecting adherence to antiretroviral treatment and other pharmacotherapeutic and behavioral interventions; and understanding determinants and consequences of comprehensive care for chronic comorbid diseases, substance abuse, and mental health issues. Populations of particular interest may include injection and non-injection substance users, sexual minorities (including men who have sex with men (MSM)), racial and ethnic minorities women, youth/adolescents, and high-risk heterosexual couples . 

The National Institute on Drug Abuse encourages data harmonization to increase comparability, collaboration, and scientific yield of research funded under this FOA.  The capacity of cohort studies to address both broad and specific research questions that take into account the heterogeneity among HIV-infected and at-risk individuals, the diversity of disease severity, patterns and history of substance use, comorbidities, and demographic variables, would be greatly enhanced by harmonization using a common set of core measures.  Common elements for interval data collection provide opportunities for multiple cohorts addressing a variety of issues to collaborate on priority questions of mutual interest which a single cohort may not be able to address.  Awardees funded under this FOA will be expected to participate in collaborative activities, including annual meetings to determine how to best to harmonize data. Applications in response to this FOA should include funds for investigators to attend an annual meeting in Washington, D.C. as part of the budget request.

The  application should address the following key points:

1.  A rationale and purpose for the proposed new cohort generation or the continuation or expansion of an existing cohort involving HIV and substance abuse, including characteristics of the population to be studied;

2.  Characterization of substance use in the population to be studied, such as specific drugs used, form of administration, level and history of use, and/or changing patterns over time including initiation;

3.  Measurement, technologic, and/or methodologic approaches for the design, conduct and analyses of cohort studies of HIV/AIDS and substance use, including discussion of cohort outreach and retention approaches to ensure long-term follow-up of participants;

4.  Identification and justification of the priority research domains for the cohort study and how the study aims will be achieved; 

5.  Identification of high priority research questions the investigator proposes to be explored through collaboration with other investigators, including those involved in other cohort studies. This may include but is not limited to developing standardized assessments and outcome measures that support comparative studies among substance-using populations, pooling of data across cohorts, and/or identification of complex relationships such as gene-gene and gene-environment interactions;

6.  Discussion of proposed data elements, such as clinical data, biologic specimens, socio-behavioral data, or treatment variables that will support the study aims, and a schedule for collection of these elements for prospective intervals.  In addition, the discussion should address the potential of the proposed data elements to inform a common or shared platform for priority research collaborations with other research studies, including existing or future cohorts, as well as a plan for sharing data and materials with other investigators.

Data elements of interest for this FOA include but are not limited to:  

Additional data elements as appropriate to the specific study aims as well as to key research collaboration priorities could include but are not limited to:

The scientific agenda of this FOA is the development and maintenance of a cohort that will facilitate specific or multicomponent research studies including, but not limited to, the following areas of interest:

Special Considerations

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

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

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.  Please see (http://ww2.drugabuse.gov/about/organization/nacda/points-to-consider.html) for details.

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

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Renewal
Resubmission
Revisions

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

A project duration of up to five years may be requested.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.  

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

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

Director - Cohort Studies of HIV/AIDS PAR
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix

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

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the applicant demonstrate capacity to enroll study participants representing key demographics of the HIV epidemic in the U.S. or internationally?  Has the applicant proposed a scientific agenda that maximizes data and specimen collection from the cohort in order to advance our understanding of HIV infection and disease? Does the proposed scientific agenda maximize the potential of the overall cohort through the study aims as well as through external collaboration? 

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the project team demonstrate leadership in HIV/AIDS research through a strong publication record? Do the proposed PD(s)/PI(s) possess the skills, knowledge, commitment, and professional experience in observational clinical research needed to carry out the proposed research plans?  Have the PD(s)/PI(s) demonstrated a history of productive working relationships as scientific collaborators?  Do the PD(s)/PI(s) propose an organizational structure that facilitates collaboration within the study team and with outside investigators? 

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 demonstrate flexibility to allow innovative responses to address new questions related to HIV/AIDS and substance abuse as they arise?  Does the application describe innovative measurement, technologic, or methodologic approaches to conducting and analyzing cohort studies, and/or recruiting and retaining participants?

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?  Does the applicant propose a feasible scientific research agenda for the project that also leverages collaborations to achieve significant results beyond what would be possible without collaboration? Are the proposed aims likely to foster significant scientific collaborations? Does the application demonstrate an ability to recruit and retain at-risk or infected participants with both substance use and HIV issues?  Are the scientific goals feasible given the size and make-up of the cohort?  Are core laboratory procedures and clinical assessments well-coordinated, with adequate and appropriate quality control?

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 scientific environment foster collaboration with other HIV/AIDS and substance abuse research groups?  Are efforts to access participant populations, including efforts toward community involvement and outreach, adequately described and appropriate?  

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.   

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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

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

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

Each awardee has primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.

Each awardee has primary and lead responsibility for the project as a whole, including definition of objectives, approaches, and project milestones; research design and protocol development; participant recruitment and follow-up; data collection; quality control; interim data and safety monitoring; final data analysis and interpretation; preparation of publications; and collaborations with other investigators for research projects and with other awardees.

Awardees will agree to attend and participate in annual meetings, teleconferences, and other key activities related to the development of a Collaborative Consortium of investigators, described in Collaborative Responsibilities.  Awardees will agree to abide by the policies, rules, and recommendations defined by consensus of the Collaborative Consortium.

Awardees will be expected to accept close coordination, cooperation, and participation of the NIDA in aspects of project management as described below. 

Awardees will agree to not disclose confidential information obtained from other members of the Collaborative Consortium.

Awardees retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.  Publication and copyright agreements and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH Grants Policy Statement.

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

A NIDA Project Scientist will be assigned to each of the awarded U01 projects.  This staff member is a scientist who is selected because of relevant scientific content-area expertise and experience with regard to the scientific goals and objectives of a given U01 award.  These staff members will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond the levels required normally for program stewardship of grants, as described below.  However, the role of the NIDA staff will be to facilitate and not to direct the activities.  It is anticipated that decisions in all activities will be reached by consensus of the awardees, and that NIDA staff will have the opportunity to offer input into this process.

The Project Scientist will have the following substantial involvement:

A separate Program Official will have normal scientific and programmatic stewardship of the award and will be named in the Notice of Grant Award. The Program Official will closely monitor progress of assigned projects and recommend the withholding or reduction of support from any project that fails to achieve its goals or comply with the Terms and Conditions of award. The Program Official will not serve as the Project Scientist.     

Additional NIDA staff members may be designated to have substantial involvement. The substantially involved NIDA staff members will not attend peer review meetings of renewal and/or supplemental applications. If such participation is deemed essential, these individuals will seek waivers according to the NIDA procedures for management of conflict of interest.

The NIDA reserves the right to adjust funding, withhold, suspend, or terminate the support to those awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

Areas of Joint Responsibility include:

Awardees, the NIDA Project Scientists, and other relevant staff and investigators will participate together in annual meetings and additional conference calls as needed, to facilitate development of a Collaborative Consortium of investigators. The roles and responsibilities of the Collaborative Consortium include:

Dispute Resolution:

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Jag H. Khalsa, Ph.D.
Chief, Medical Consequences Branch
Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMC)
National Institute on Drug Abuse, NIH
6001 Executive Boulevard, Room 4137, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-2159
Fax: (301) 443-2599
E-mail: jk98p@nih.gov

Katherine Davenny, M.P.H.
AIDS Research Program 
National Institute on Drug Abuse 
Telephone: (301) 443-2146
FAX: (301) 443-9127
Email:  kdavenny@nida.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Diana Haikalis
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: (301) 435-1373
Email: dhaikali@nida.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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