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)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Center for Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

The Placebo Effect:  Mechanisms and Methodology (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • April 27, 2011 - See Notice NOT-DA-11-018 The purpose of this Notice is to clarify the intention to ensure that applicants understand the goals of the FOA.

Funding Opportunity Announcement (FOA) Number

RFA-DA-12-003

Companion FOA
Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279,  93.213, 93.273

FOA Purpose

This FOA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism to stimulate basic research to elucidate the underlying biological pathways that lead to placebo effects and to better understand how to recognize and enhance the therapeutic benefits of placebo effects in clinical research and practice. 

The goal of this initiative is two-fold: [1] to stimulate cross-cutting, integrative research aimed at delineating the behavioral processes and neurobiological mechanisms by which a placebo leads to its ultimate physiological and psychological effects; and [2] to stimulate clinical research that can improve detection of placebo effects, as well as an understanding of how to manipulate(i.e., reduce or enhance)  and control them.  In the context of this initiative, integrative research is defined as the combined use of approaches from several scientific disciplines such as psychology, neuroscience, physiology, genetics, and/or molecular biology to investigate the mechanisms underlying placebo effects. Further understanding of the placebo effect also has important implications for clinical trials. To determine the efficacy of pharmacological, procedural, or behavioral interventions, clinical trials methodology must be designed to account for placebo effects. In particular, it is important to distinguish placebo effects from the actual treatment being tested, as well as effects promoted by measurement and methodological factors.  Thus, the current initiative is focused on using scientific advances within the field of placebo research to ultimately improve the ability to develop effective therapies. However, the assessment of therapeutic interventions is not the goal of this initiative.  As such, applications submitted in response to the current FOA will be considered unresponsive if they propose a randomized clinical trial.

Key Dates
Posted Date

February 17, 2011

Open Date (Earliest Submission Date)

April 24, 2011

Letter of Intent Due Date

April 24, 2011

Application Due Date(s)

May 24, 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

May 25, 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

 Background

Placebo effects can be defined as the positive physiological or psychological changes associated with the use of inert medications, sham procedures, or therapeutic symbols within a healthcare encounter. Placebos also can be active substances or real procedures that produce unexpected beneficial effects. For example, antibiotics may be considered placebos when prescribed for viral respiratory illnesses that do not respond to antibiotic treatment.  Control procedures used to assess the efficacy of various types of intervention often have unexpected beneficial (placebo) or adverse (nocebo) effects that can confound the experimental study of interventions. On the one hand, the benefits of therapeutic interventions in clinical practice are often enhanced by placebo effects. On the other hand, the difference between the efficacy of the intervention and the placebo/sham control is often reduced due to placebo effects, making assessments of treatment effects difficult.

This FOA follows FOAs issued in 2002 (RFA-AT-02-001 and RFA-AT-02-002) as well as a series of meetings on placebo.  The most recent meeting was held in Jan, 2010: “The Placebo Effect:  Opportunities and Challenges.”   The purpose of this meeting was to review the state of placebo research and to develop a research agenda for the future on the science of placebo.  Workshop participants recommended three major streams of research going forward:  (1) further elucidate the behavioral and biological mechanisms of placebo effects, (2) investigate the use of placebo effects in clinical practice; and (3) study placebo effects as they relate to methodology and ethics of clinical trials. This FOA is informed by previous FOAs and previous NIH meetings.  This FOA focuses on the identification and assessment of placebo effects, their role in clinical practice and the elucidation of their biological substrate.

Goals and Scope

One  objective of this initiative is to elucidate the underlying biological pathways that lead to placebo effects. Recent progress in understanding acute pain has been made using brain imaging (i.e., fMRI and PET) and standardized placebo analgesia procedures, to identify brain circuitry, brain regions and neurotransmitter systems associated with the placebo response. Standardized behavioral assessment of “desire, ” “emotion”  and “expectation” have shown that the placebo effect is subject to manipulation.  In addition, other contextual and conditioning factors also have been shown to contribute to the placebo effect.  A number of key research needs are suggested:

Develop fMRI- or imaging-based and/or subjective signatures that are reproducibly associated with  the placebo effect (e.g.,  anticipatory brain activity; brain activity associated with positive reward; visual analog scales) and identify differences in these measures or expression of these mechanisms between healthy research participants and patients.

Study the placebo effect in relevant clinical populations with the goal of developing biomarkers or other predictive assessment tools of the placebo responder.  For example, resting state connectivity has been proposed as a biomarker for “placebo responders.”

Study the correlation between activation of neurotransmission and the placebo response.

Study prior exposure to medications or drugs (e.g., tobacco smoking) in the context of conditioning and the placebo response.

Study the role of genetic polymorphisms in modulating the neurobiological or behavioral measures of the placebo response (extant data have been mixed in showing a genetic contribution).  Study the role of epigenetic mechanisms and gene regulation involved in placebo response.

Study the psychosocial aspects (e.g., relationship between physicians/therapists and patients) in the development and maintenance of a placebo response.

Research is needed to elucidate a related question on how pharmacological or other medical treatments, complementary, alternative and conventional, interact with psychosocial effects to enhance placebo responses.

Cellular, molecular and/or immunological approaches may be needed to dissect biological components of placebo effect and to identify the signaling pathways between the endocrine, neurological and immune systems.

Additional research is needed to better characterize subjective, conditioned physiological, and neurobiological effects and cognitive expectancies associated with placebos in human drug abusers.

Research is needed to  determine whether placebo effects modulate the effects of drugs of abuse, or whether placebo effects operate in the treatment of drug abuse.

Research is needed using a balanced placebo design to investigate the extent to which "social context" modulates the pharmacodynamics of a drug effect.

Develop novel design and analysis methods for the placebo effect, such as sequential parallel comparison designs, adaptive treatment strategies, multiple placebo or control groups.

Determine how and why psychosocial factors, and associated biological factors, in the patient/healthcare practitioner relationship or in the healthcare environment are causally related to eliciting placebo effects.

A second objective of the FOA is to better understand how to recognize and enhance the therapeutic benefits of placebo effects in clinical research and practice, and to elucidate the possible mechanisms by which the placebo exerts its effects.  A number of key research needs are suggested:

Conduct secondary analyses that examine moderators and mediators of the placebo effect using anonymized datasets that are available to the research community.   (See for example www.ctndatashare.org)  Conduct natural history studies of baseline patient characteristics as related to outcome(s) in trial datasets.

Determine the usefulness of signal detection theory methodology to the study and manipulate the placebo response; explore translational use of this method in clinical populations and trials.

Develop methods for standardizing dependent and independent variables (behavioral and biological) used to assess the placebo effect alone and in conjunction with active treatments.

Explore the effects on defined outcome measures of control conditions that consider psychosocial interactions, expectation, relevance, attention, emotion, social anxiety, or other patient/environment characteristics.

Explore the utility for understanding, controlling, or enhancing the placebo effect with trial designs that include nocebo, no treatment, or retrieval of information from subjects’ routine care records.

Investigate how and why cultural beliefs and social economic systems may enhance or diminish the placebo effect in clinical settings.

Study barriers to eliciting placebo effects, including a focus on how and why these barriers impede the effects.

In addition to the above, NIAAA is interested especially in the following topics: 

A considerable number of subjects, in alcohol clinical trials, display large pre-randomization reductions in drinking. Studies are needed to characterize these subjects, explore the extent of these reductions, and determine the relationship between pre-randomization reductions and response rates during treatment and observed treatment effects.

A critical design feature in alcohol medication trials involves the decision as to whether subjects should be required/allowed to drink up to randomization versus requiring a period of abstinence prior to randomization. Studies are needed that compare how placebo response rates and treatment effects vary as a result employing and varying key aspects of these design approaches.

Develop and apply advanced longitudinal statistical techniques to describe how the placebo response changes over the course of alcohol clinical trials and explore sources of heterogeneity in these response trajectories.

Determine the extent to which assessment types, frequency, duration, and intensity affect placebo response in alcohol clinical trials.

Similarly, NCCAM is interested especially in the following topics:

Determine the extent to which the schedule of placebo/treatment modifies the placebo response.

Determine the extent to which individual differences play a role in the effects of placebo in humans. 

Develop novel animal models of placebo effects.

Determine the extent to which assessment types, frequency, duration, and intensity affect placebo response in clinical trials with natural products 

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

 The following NIH components intend to commit the following amounts in FY 2012:

NIDA will commit $1,500,000 in total cost, NIAAA will commit $750,000 in total cost and NCCAM will commit $750,000 in total cost for this FOA and accompanying RFA- DA-12-004.

Award Budget

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

Award Project Period

The maximum period is 5 years. 

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

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-12-003
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550
Rockville, MD  20852 (for express/courier service)

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.,

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 components of participating organizations, 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?   

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?  

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 the Center for Scientific Review , 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 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 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/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)

Dr. Paul Schnur
National Institute on Drug Abuse (NIDA)
Telephone: 301- 435-1316
Email: pschnur@mail.nih.gov

Dr. John Glowa
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-496-0527
Email: glowaj@mail.nih.gov

Dr. Joanne Fertig
National Institute on Alcohol Abuse and Alcoholism  (NIAAA)
Telephone: 301-443-0635
Email: jfertig@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Cheryl Nathaniel
National Institute on Drug Abuse (NIDA)
Telephone: 202-526-0108
Email: nathanic@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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