Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Drug Abuse (NIDA)
Funding Opportunity Title	Development and Testing of Novel Interventions to Improve HIV Prevention, Care, and Program Implementation (R34)
Activity Code	R34 Clinical Trial Planning Grant Program
Announcement Type	New
Related Notices	May 28, 2015 - This PA has been reissued as PA-15-268. 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.
Funding Opportunity Announcement (FOA) Number	PA-12-231
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.279
Funding Opportunity Purpose	This FOA is issued by the National institute on Drug Abuse (NIDA), National Institutes of Health for R34 applications, and provides resources to support (a) pilot or feasibility studies of new or adapted interventions to prevent HIV infection among populations where substance use may be a contributing factor; (b) pilot or feasibility studies of new or adapted interventions to improve the care of HIV infection among populations where substance use is prevalent, including interventions that integrate treatment for substance use disorders and HIV infection; or (c) pilot or feasibility studies to increase the scale, uptake, delivery, and/or quality of HIV prevention or care interventions with established evidence of efficacy. Both primary and secondary prevention will be supported. The full range of substance use will be considered including problematic episodic use and substance use disorders, as well as a full range of substances and modes of administration. The most important consideration is that substance use may affect transmission directly as in the case of injection drug use or may affect transmission risk behavior. Domestic and overseas populations will be considered, with particular attention to populations with disproportionate burden of HIV infection and those where HIV infection and/or drug use are emergent.

Posted Date	July 6, 2012
Open Date (Earliest Submission Date)	August 7, 2012
Letter of Intent Due Date	Not Applicable.
Application Due Date(s)	Not Applicable.
AIDS Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	May 8, 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.

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

In 2011, almost 1.5 million people were living with HIV in the US and it is estimated that 56,000 adults and adolescents have become infected annually. The annual number of new cases has remained stable in recent years despite advances in prevention and treatment and efforts to increase the reach of effective interventions. Globally, an estimated 33.3 million people were living with HIV in 2009, with an estimate of 2.6 million new infections each year. The global burden of disease has shown variations across nations, with notable reductions in some areas, while new cases have increased in others. Substance use contributes to the disproportionate burden of disease in many populations and regions in the US and overseas. Areas of emergent HIV epidemics such as Eastern Europe and East Asia often have coincided with the changes in the patterns of substance use, including opiate injection and the use of stimulant drugs.

Many of those living with HIV are unaware of their diagnosis and these individuals are likely to account for a disproportionate share of new infections. There is considerable variation across countries in terms of the specific risk factors and populations affected by HIV. Within countries HIV incidence and prevalence often varies by age, gender, sexual orientation, race/ethnicity, geographic location and risk behavior. Disparities often exist which disadvantage populations that are marginal in terms of income, resources, gender, sexuality, race/ethnicity or geography. Consequently, novel approaches are needed to ensure that interventions address the particular needs within different groups of at-risk individuals. Interventions also need to address the range of settings where at-risk individuals can be found and the different service delivery systems which may be available to them. Similarly, HIV seropositive individuals have needs that differ from those who are HIV negative. For those individuals living with HIV, interventions are needed that ensure they continue practicing risk reduction behaviors, remain adherent to their HIV medication, receive consistent HIV medical care, and maintain a high quality of life free of problematic substance use, co-occurring disorders (infectious disease and psychiatric), stigma, and discrimination.

Progress has been made in the development of efficacious HIV-related interventions, including seek/test/treat/retain approaches, new HIV testing technologies, new interventions for prevention and HIV treatment adherence, and development of biomedical prevention modalities and efforts are increasing to broaden the reach, intensity, and integration of these interventions. Nonetheless, incident infections remain unacceptably high in many US and global populations, and persons living with HIV still need better access to HIV testing, preventive interventions, optimal HIV care, and management of co-morbidities such as substance use disorders. In addition, a great many HIV-seropositive individuals are not adequately linked, engaged or retained in care, treatment compliance may be inconsistent or otherwise inadequate to suppress viral load. Attention to problematic, episodic and ongoing consistent use of substances also needs further attention. Therefore, the development of innovative behavioral, social, and integrated behavioral/biomedical approaches remains critical in order to address the HIV pandemic.

HIV prevention and care are recognized to be long-term objectives and not likely to be ameliorated by one-time interventions. This makes it important to consider ways to improve intervention durability and integration into existing systems of public health, health care, and other systems of human service delivery. Disparities in HIV morbidity are evident in the US and in many other nations; hence, novel interventions which address the root causes of these disparities is of particular importance Attention to social/environmental and structural factors that affect individual and population health, as well as developmental considerations may enhance the uptake and effect of existing interventions, as well as address root causes of disparity. Innovative research is encouraged that engages multidisciplinary teams, including researchers from the fields of public health, primary care, epidemiology, public policy, behavioral and social science, systems science, health disparities, organizational behavior, demography, and decision sciences.

The R34 mechanism is designed to conduct pilot and feasibility studies that, if successful will lead to applications using the R01 or similar mechanisms for evaluating large scale efficacy (for novel interventions or adaptations) or effectiveness (in the case of implementation research). Applications to this R34 FOA are not required to present pilot data in support of the proposed hypotheses and aims; rather a well defined theory of change or logic model and associated hypotheses are expected. Thus, applications should not be penalized for a lack of preliminary data supporting the proposed hypotheses and aims. Applicants are encouraged to provide strong evidence of their capability to conduct the proposed study, through documenting the availability of needed resources, the training and experience of the investigator team, and/or the conduct of related studies.

The NIDA R34 mechanism does not support the development of intervention protocols, manuals, or the standardization of protocols as interventions by themselves. This FOA provides resources to support (a) pilot or feasibility studies of new or adapted interventions to prevent HIV infection among populations where substance use is a contributing factor; (b) pilot or feasibility studies of new or adapted interventions to improve the care of HIV infection among populations where substance use is prevalent, including interventions that integrate treatment for substance use disorders and HIV infection; or (c) pilot or feasibility studies to increase the scale, uptake, delivery, and/or quality of HIV prevention or care interventions with established evidence of efficacy. Both primary and secondary prevention will be supported. The full range of substance use will be considered including problematic episodic use and substance use disorders, as well as a complete range of relevant substances (including alcohol and tobacco) and modes of administration. The most important consideration is that substance use may affect transmission directly as in the case of injection drug use or may affect transmission risk behavior. Domestic and overseas intervention studies will be considered with particular attention to populations with disproportionate burden of HIV infection. Adaptation of interventions with known efficacy or effectiveness to novel populations, settings, or systems of delivery should represent significant potential contributions to the understanding of how to appropriately adapt and tailor interventions to new circumstances.

Specific Areas of Research Interest

Technology-based exploratory/pilot studies may be submitted under this FOA, although a fuller description of NIDA interests in this area is available under Technology-Based Interventions to Promote Engagement in Care and Treatment Adherence and For Substance Abusing Populations with HIV (R34; PA-12-118).

Exploratory or pilot research studies for purposes other than collecting pilot or feasibility data for use in later, larger-scale intervention studies should not be submitted under this FOA. However, they may be appropriate for submission to other NIDA R21 FOAs for HIV/AIDS such as HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R21; PA-09-237) or Drug Abuse Aspects of HIV/AIDS (R21; PA-10-130).

Examples of research questions that may help move the HIV intervention field forward, under this FOA, include (but are not limited to) the following:

Studies to advance HIV prevention:

• Studies to identify and test interventions that incorporate components to increase the durability of effective prevention strategies and enhance long term maintenance of risk reduction practices.
• Interventions which make use of innovative approaches to engaging high risk populations through venues, networks, etc. and utilize new testing modalities to identify recent infection, or identify co-factors for HIV transmission
• Interventions that take a syndemic approach to HIV prevention with consideration of substance use and comorbidities such as psychiatric disorder or infectious disease, and contributing conditions such as intimate partner violence, childhood sexual abuse, stigma, or discrimination based on race/ethnicity, sexual minority membership or injection drug use.
• Studies using new and expanding technological approaches to recruit, enroll, and retain high risk groups (e.g., young men and women, MSM) who are difficult to reach by other means.
• Studies to identify and test interventions that integrate HIV prevention into primary care settings.
• Pilot feasibility evaluations of biological and combination biological/behavioral prevention modalities among substance using populations.
• Research that translates basic behavioral, cognitive, and social science findings about risky behavior (e.g., impulsivity, decision-making, risk-taking, sexual development, partner and peer relationships, etc.) into strategies for preventing HIV acquisition among drug users.
• Research addressing drug use among MSM, particularly young ethnic/racial minority MSM in the US and applicable MSM populations in international locations, particularly in countries with emergent HIV epidemics among substance using MSM.
• Efforts to integrate HIV/AIDS prevention and drug use prevention into settings that routinely serve adolescents and youth (including non-clinic settings) particularly MSM youth and members of ethnic/racial minorities;
• Prevention interventions directed at youth that use advances in knowledge about the prevention of drug use and other factors that contribute to HIV/AIDS risk in this population.
• Development and evaluation of HIV/AIDS prevention interventions which make use of new technologies to identify recent infection, assess community-level risk for transmission, or identify co-factors for HIV transmission;
• Development and evaluation of culturally competent interventions that integrate HIV/AIDS prevention with substance use prevention in the criminal justice system; and
• Development and evaluation of HIV/AIDS prevention interventions that incorporate reduction in stigma toward persons living with HIV/AIDS and persons at elevated risk.

Studies to Advance Treatment and Adherence Research

• Studies to optimize the provision of brief, evidence-based interventions to treat or reduce substance use in HIV at-risk populations.
• Studies to develop novel approaches for augmenting the impact of interventions to promote HIV treatment adherence and persistence.
• Clinical trials of integrated drug abuse treatment (behavioral or pharmacological) and HIV prevention interventions that address risky sexual behavior, risky injection practices, and overall risk reduction behaviors for adolescent and adult vulnerable populations (e.g., minorities, criminal justice populations, MSM, dually diagnosed individuals, etc.)
• Clinical trials of HIV risk reduction interventions for use during treatment, including those that target stress responses or other mental health variables likely to affect HIV risk behavior and which examine the mechanism of action of the intervention
• Feasibility testing of new treatments for drugs of abuse which directly affect motivational systems related to risky sexual behavior (e.g., hyperarousal associated with stimulant use).
• Feasibility and acceptability evaluations of interventions that incorporate technological tool(s) to promote patient engagement in HIV care (including early and efficient linkage to HIV care, treatment adherence behaviors, and long-term retention in care) among drug-using populations diagnosed with HIV.

Studies to Advance Program Implementation and Health Services Research

• Assessing the delivery of substance use treatment services for HIV at-risk populations in non-traditional settings such as schools, criminal justice, settings, primary care practices, and AIDS service organizations.
• Identifying and assessing programs that provide integrated and holistic approaches to service delivery to HIV+ persons with comorbid substance abuse and/or mental health disorders (e.g., depression, PTSD, schizophrenia, and other disorders);
• Testing integrated universal HIV testing and counseling approaches among high risk vulnerable drug abusing groups (e.g., racial/ethnic and sexual minorities) both in and outside of the drug abuse treatment system;
• Improving access and quality of prevention or treatment services for HIV+ drug users from vulnerable populations, including women, adolescents, racial/ethnic minorities, sexual minorities, and those with other co-occurring disorders (e.g., psychiatric disorder, HBV, HCV);
• Conducting implementation and dissemination research and developing innovative implementation models of treatment and care for vulnerable HIV+ persons within primary care systems or the drug treatment system.
• Interventions that that target and address structural, organizational or policy interventions to address barriers to and facilitators of, the implementation of science-based HIV/AIDS treatment and/or prevention.
• Developing interventions that influence organizational structure, climate, and culture in order to promote organizational readiness and capacity for dissemination and adoption of evidence based practices.
• Evaluations of the adaptation process, and subsequent effectiveness of evidence-based interventions when implemented in real-world community and clinical settings.

Investigators are encouraged, when appropriate, to utilize the Clinical Trials Network (CTN) (http://www.drugabuse.gov/CTN/Index.htm) infrastructure as a platform for their studies.

Additional information about NIDA’s HIV/AIDS priority research areas is available at: http://www.nida.nih.gov/about/organization/arp/. This Web site also lists NIDA AIDS Workgroup members and their program areas. Workgroup members can provide programmatic guidance to applicants.

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.

Funding Instrument	Grant
Application Types Allowed	New Resubmission 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	Direct costs are limited to $450,000 over a three-year period, with no more than $225,000 direct costs allowed in any single year.
Award Project Period	The maximum period is 3 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

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 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.

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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.

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.

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 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.

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.

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.

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

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 (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.

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.

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 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.

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.

For this particular announcement note the following:

Applications to this R34 FOA are not required to present pilot data in support of the proposed hypotheses and aims; rather a well defined theory of change or logic model and associated hypotheses are expected. Thus, applications should not be penalized for a lack of preliminary data supporting the proposed hypotheses and aims. Applicants are encouraged to provide strong evidence of their capability to conduct the proposed study, through documenting the availability of needed resources, the training and experience of the investigator team, and/or the conduct of related studies.

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).

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

Significance

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

Investigator(s)

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?

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?

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

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/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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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:

• 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/priority score.
• Will receive a written critique.

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:

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

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

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.

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

Not Applicable.

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.

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

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

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: [email protected]

Richard A. Jenkins, PhD
Prevention Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd.
Rm. 5185 MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-1923
Fax: (301) 480-2542
E-mail: [email protected]

Shoshana Y. Kahana, Ph.D.
Services Research Branch
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd., Rm 5180, MSC 9589
Bethesda, MD 20892-9589
Telephone: (301) 443-2261
E-mail: [email protected]

Will M. Aklin, Ph.D.
Behavioral & Integrative Treatment Branch
Division of Clinical Neuroscience & Behavioral Research
National Institute on Drug Abuse (NIDA)
National Institutes of Health
6001 Executive Boulevard, Rm. 3152, MSC 9593
Bethesda, Maryland 20892-9551
Telephone: (301) 443-3207
Fax: (301) 443-6814
E-mail: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Maryellen Connell
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: (301) 774-3803
E-mail: [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.