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

Systems Biology Approaches in HIV/AIDS and Substance Use (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DA-12-009

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.279

FOA Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage systems biology approaches to address critical questions in HIV/AIDS and the potential impact of substance use.   

 
Key Dates
Posted Date

April 21, 2011

Open Date (Earliest Submission Date)

July 17, 2011

Letter of Intent Due Date

July 18, 2011

Application Due Date(s)

August 17, 2011, by 5:00 PM local time of applicant organization

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

October/November 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 2012

Expiration Date

August 18, 2011

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.

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

Nature of the Research Opportunity

The purpose of this Funding Opportunity Announcement (FOA) is to solicit systems biology research proposals that address critical questions in HIV/AIDS and the potential impact of substance use.   Substance use and abuse, as well as co-infections and co-morbidities that are prevalent in drug using populations, present unique challenges for HIV prevention and treatment and are likely to affect host-virus interactions in ways that affect disease progression, medical consequences, and responses to vaccines or treatment drugs.  Understanding the complex biological intersection of HIV/AIDS and substance use is a major challenge for public health and the central theme of this FOA.

Background

Despite the many advances made in our understanding of HIV/AIDS, this disease remains a serious health problem.  In resource-limited countries, there is still significant mortality due to limited access to antiretroviral treatment.  In wealthier countries, HIV has become a chronic, manageable disease for many patients, creating a new set of health issues regarding variability in treatment response and pathogenesis, effects of aging, long-term treatment toxicity, and co-morbidities.  Development of an effective vaccine as well as strategies for long-term medication--free control of infection (“functional cure”) remain elusive goals.  Genetic diversity in humans and in HIV itself contributes to differences in susceptibility to infection and disease outcomes, but other factors including transcriptional regulation, protein modifications and interactions, and co-morbid conditions (including substance use) are likely to play a major role, particularly as patients are living longer with long-term treatment. 

Substance abuse and HIV/AIDS.  Chronic exposure to drugs of abuse and co-occurring conditions, such as infections prevalent in drug using populations, present unique challenges for HIV prevention and treatment across the globe.  Drug and alcohol users are at high risk for acquisition and transmission of HIV, and multiple emerging HIV epidemics have been reported in association with intravenous drug use.  Ongoing and/or past substance use is likely to affect host-virus interaction and result in altered consequences and disease progression at multiple levels, particularly in the era of highly active antiretroviral treatment (HAART).  Clinical studies suggest that cocaine use is associated with enhanced HIV progression as well as increased neuropathology and other biochemical and physiological consequences; these effects may be partially but not completely explained by poor adherence to antiretroviral treatment.  Experimental evidence shows that certain drugs of abuse may directly affect HIV replication, adaptive and innate immune function (including mucosal immunity), and neuronal and glial function in specific brain areas that may impact HIV-associated cognitive impairment.  Opioids have been shown to have complex and dichotomous effects on HIV infection and replication, whereas recent reports indicate that cannabinoids inhibit HIV replication in vitro, and may have beneficial effects on AIDS morbidity and mortality in a non-human primate model.  As individuals are living longer with HIV, it will be important to understand the effects of past or continuing chronic substance use, including smoking and polysubstance use, on factors that impact disease progression and responses to current therapies as well as responses to potential vaccines or new treatment strategies.

The Value of Systems Biology Approaches.  Technological advances have dramatically increased the throughput of DNA sequencing while dramatically reducing the cost.  These changes have had concomitant effects on other assays (gene expression, epigenomic, etc) dependent upon next generation sequencing platforms.  Similar technological advances have led to striking improvements in the ability to perform proteomic, metabolomic, and other assays.  Thus, comprehensive data sets now can be generated for many data types, and computational approaches can be used to interrogate these data sets to identify SNPs, transcripts, molecular entities, and pathways important in a particular biological or disease process.  Systems biology approaches, which include this combination of data set generation and computational analysis, have great potential to generate new and unexpected hypotheses.  Once validated, these discoveries may significantly alter our understanding of biological and disease mechanisms and lead to the development of new biomarkers, diagnostics, and therapeutic agents to improve human health.    

Systems Biology Approaches in HIV/AIDS and Substance Abuse.   Systems biology approaches have tremendous potential to open new avenues for both HIV/AIDS and substance abuse research.  Systems approaches currently are being used to identify: 1. biological pathways critical for HIV replication, 2. potential new targets for antiretroviral treatment, 3. factors that provide natural immunity against infection, and 4. processes involved with viral latency and reactivation.  Substance abuse researchers are exploiting systems biology approaches to identify new molecules and pathways involved in addictive processes.  Strategies interrogating epigenomic, transcription factor binding, and gene expression data sets have been used to identify new and unexpected signaling pathways that regulate cocaine-taking behavior in rodents.  Systems genetics approaches interrogating genetic variation, gene expression, and a suite of behavioral assays have identified quantitative trait loci and genes for a number of drug abuse relevant phenotypes.  Although systems biology approaches have been independently fruitful for HIV/AIDS and substance abuse research, studies combining these areas of focus have been uncommon.  This current initiative is designed to stimulate the use of systems biology approaches to answer questions and generate hypotheses of significance to both HIV/AIDS and substance abuse.

Scientific Research Scope and Objectives

The overarching purpose of this FOA is to solicit research applications utilizing systems biology approaches to interrogate multiple complex data sets in order to discover new and unanticipated paradigms of significance to HIV/AIDS and substance use and abuse.  Studies using human, animal, or in vitro data would be appropriate to address a wide range of HIV/AIDS questions.  To achieve maximum success, collaborative multidisciplinary teams will need to share expertise in areas such as HIV/AIDS, substance abuse, systems approaches, and/or computational analysis.  Studies which leverage ongoing genetic or clinical studies are encouraged. 

Many existing HIV cohorts, networks, and specimen repositories include individuals with histories of substance use (e.g., methamphetamine, inhalants, cocaine, opiates, marijuana, nicotine, alcohol, and polydrug use). The extent to which substance use has been characterized in these samples has been variable, and relatively little research has addressed the impact of substance use history on host and viral factors known to impact susceptibility to infection and pathogenesis.  Examples of relevant cohorts and networks include but are not limited to: MACS, WIHS, ALIVE, Urban Health Study, PHACS, ATN, and NNTC, as well as others through NA-ACCORD, IeDEA, and CNICS.  Additional resources include the Forum for Collaborative HIV Research Project on HIV Cohorts and Databases (http://www.hivforum.org/index.php?option=com_content&task=view&id=183&Itemid=61) and the Los Alamos National Laboratory HIV Databases (www.hiv.lanl.gov).  Use of data from existing cohorts or from newly developed cohorts reflecting current aspects of the HIV/AIDS epidemic may be appropriate, depending on the specific research questions addressed, and the ability to obtain measurable substance use data and relevant HIV/AIDS phenotype information.  Applicants are encouraged to contact program staff for guidance on existing samples and sources of data that may be appropriate.    

Four key points must be addressed to be considered responsive to this FOA:

1. Studies MUST focus on a significant scientific question in the field of HIV/AIDS relevant to either U.S. or international populations.  In addition to human studies/samples, non-human primate or other accepted HIV models may be appropriate depending upon the research question.  The choice and use of model system should be justified in light of the proposed research. 

2. Applicants MUST use a systems biology approach.  This approach may be used to interrogate data sets already in existence or, if appropriate data sets do not exist, the applicant may propose to generate new data sets.  Examples of some data types of interest include proteomic, protein interaction, metabolomic, pharmacological, behavioral, electrophysiological, imaging, neural connectivity, clinical, phenotypic, anatomical, gene variant, RNA interference, epigenomic, non-coding RNA, and gene expression data.  Applicants should propose a strategy to validate one or more of the hypotheses generated through their investigation.

3. The proposed studies MUST include at least one specific aim with a significant focus on substance use, such as analysis of samples from drug using populations relevant to current or emerging aspects of the HIV/AIDS epidemic (e.g., cocaine, methamphetamine, opioids, cannabinoids, nicotine, or polydrug use) OR by exposure to one or more substances in a relevant and appropriate model system.  Applications that include studies on alcohol in combination with other substances will be considered responsive to this FOA, but studies addressing alcohol use alone will NOT be considered responsive.  Substance use parameters and/or exposure should be well defined; applicants lacking substance abuse expertise are encouraged to collaborate with experienced substance abuse researchers.

4. Studies submitted to this FOA are unlikely to be maximally successful unless they are carried out by a multi-disciplinary team.  To allow meaningful data analysis and biological interpretation, collectively this team should have expertise in the areas of HIV/AIDS, substance abuse, systems biology/computational approaches, and other scientific areas pertinent to the research topic proposed. 

Applications which do not adequately address these four key points will be considered non-responsive to this FOA and will be administratively withdrawn without review.  Unlike a standard investigator-initiated R01 application, a key goal of applications submitted to this FOA will be to generate hypotheses.  Thus applicants only need to provide preliminary data and/or other supporting evidence indicating that the research team has the ability to complete the proposed work.  The proposed budget should be commensurate with the research proposed.

Applicants with high-risk, potentially high-impact projects might be appropriate for PAR-09-022, Cutting-Edge Basic Research Awards (CEBRA) (R21--see http://grants.nih.gov/grants/guide/pa-files/PAR-09-222.html) if the project tests a highly novel and significant hypothesis for which there is scant precedent or preliminary data and which, if confirmed, would have a substantial impact on current thinking; and/or develop or adapt innovative techniques or methods.  Alternatively, PA-11-034, Functional Genetics, Epigenetics, and Non-coding RNAs in Drug Addiction might be appropriate for R21 projects (see http://grants.nih.gov/grants/guide/pa-files/PA-11-034.html).

Examples of topics appropriate for this FOA include, but are not limited to, the following: 

Viral latency and reservoirs

Host immune and inflammatory responses

Viral determinants of pathogenesis

Neurologic and other medical consequences

Additional information about the NIDA AIDS Research Program and funding priorities is located at https://www.drugabuse.gov/AIDS

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIDA intends to commit $3,000,000 in FY 2012.

Award Budget

Direct costs are limited to no more than $650,000 per year.

Award Project Period

 The total project period for an application submitted in response to this funding opportunity may not exceed five years.    

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations 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 Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 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.

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.

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:

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

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

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

Director - DA-12-009
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 application submission. 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 modifications:

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 Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations 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/PIs 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 and responsiveness by the National Institute on Drug Abuse, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.     

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-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? If fully successful, will the discoveries made by the applicant significantly improve our understanding of HIV/AIDS, substance use or abuse, or the intersection of the two? 

Investigator(s)    

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

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? How well does the applicant demonstrate the ability of the team to complete the proposed aims?  How well does the applicant utilize a systems biology strategy to investigate one or more key issues in HIV/AIDS and substance use or abuse? 

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?        

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

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/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 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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Drug abuse. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Not Applicable.

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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)

Diane M. Lawrence, Ph.D.
Associate Director, AIDS Research Program
National Institute on Drug Abuse (NIDA)
Telephone: (301) 594-3225
Email: lawrencedi@nida.nih.gov 

John Satterlee, Ph.D.
Program Director, Epigenetics, Model Organism Genetics, Functional Genomics
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA) 
Telephone: (301) 435-1020
Email: satterleej@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)

Pam Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@mail.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

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 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.nida.nih.gov/about/organization/nacda/CouncilStatement.html


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