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 Cancer Institute (NCI)

National Institute on Aging (NIA)

National Center for Complementary and Integrative Health (NCCIH)

National Institute of Neurological Disorders and Stroke (NINDS)

r National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Funding Opportunity Title Developing the Therapeutic Potential of the Endocannabinoid System for Pain Treatment (R01)

Activity Code R01 Research Project Grant

Announcement Type New

Related Notices December 6, 2017 - This PA has been reissued as PA-18-465.

May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062.

NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)

NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)

NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)

Funding Opportunity Announcement (FOA) Number PA-15-188

Companion Funding Opportunity None

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.279, 93.393, 93.866, 93.213, 93.853, 93.273, 93.865

Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to support projects that will elucidate the therapeutic potential of the cannabinoids and endocannabinoid system in the development of mechanism-based therapies for pain.

Key Dates

Posted Date April 28, 2015

Open Date (Earliest Submission Date) September 5, 2015

Letter of Intent Due Date(s) Not Applicable

Application Due Date(s) Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) Standard AIDS dates apply by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review Standard dates apply

Advisory Council Review Standard dates apply

Earliest Start Date Standard dates apply

Expiration Date New Date December 6, 2017 per issuance of PA-18-465. (Original Expiration Date: September 8, 2018)

Due Dates for E.O. 12372 Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Pain is a substantial public health issue, where it is estimated that about 100 million Americans suffer from chronic pain. Opioids have been increasingly used to treat chronic pain, and there has been an increase in the number of opioid prescriptions, which has caused a concomitant rise in prescription opioid abuse. While opioids may be effective in treating chronic pain in some cases, other treatment options are desperately needed. One such option is to explore and develop medications that work through the cannabinoid system to help reduce pain.

Recently there has been a resurgence in interest in the potential medical utility of cannabis and its constituents. Certainly, public perception is that cannabis has therapeutic benefit, especially in the treatment of pain, and there is some preliminary epidemiological and clinical research that supports possible benefits, yet to date there have not been adequate large controlled trials to support these claims. Moreover, the use of an unprocessed plant or crude extract, in which constituents vary and dosing is difficult to control, would not be an optimal design for a medication. In contrast, cannabis constituents, especially THC and cannabidiol (CBD), or synthetic cannabinoids (e.g. CB2 agonists), and the endocannabinoid system are promising entities that are currently under investigation as potential targets for pain treatments. Despite some positive outcomes, none of the cannabinoid-based drugs have yet been approved by the FDA for pain treatment. More clinical and mechanism-based basic research is warranted to develop safe and effective cannabinoid-based pain treatments.

Several small trials have demonstrated that cannabis can reduce the sensation of pain, including additive effects over those achieved from concurrent medications. Research is needed to examine cannabis-related compounds as alternative therapies for pain management. Important in this endeavor is to develop a deeper understanding of the role of natural cannabinoids and endocannabinoids in pain perception, processes, and outcomes. Research is also needed to determine how to modulate key endocannabinoid receptors, ligands, and enzyme levels in pain conditions. This funding opportunity announcement (FOA) encourages research project grant (R01) applications that study cannabinoids (phytocannabinoids and synthetic cannabinoids) and the endocannabioid system to evaluate the therapeutic potential of the endocannabinoid system across a variety of pain conditions.

Objectives

The purpose of this NIH Pain Consortium-endorsed FOA is to support projects examining the therapeutic potential of cannabinoids and endocannabinoid system across a variety of pain conditions. Research supported under this FOA is wide-ranging. In general, the goal is to understand the role of cannabinoids in the management of chronic pain, in part, to help mitigate the high rate of use and abuse of opioids.

Applicants responding to this FOA should consider the following points: 1) If plant derived cannabis material is proposed, it should be well-justified, with a statement on where the material or compounds will be obtained, and the status of a schedule 1 license should be noted. 2) Explicit sex/gender analyses of effects are highly encouraged. 3) Role of cannabinoids in the modulation of HIV pain is also encouraged.

Areas of interest include, but are not limited to, the following:

Understand the role of cannabinoids and endocannabinoids in the transition of acute pain to chronic pain;

Understand the interactive role of cannabinoids, endocannabinoids, and opioid system in pain signaling;

Study the spatial and temporal regulation of cannabinoid receptor expression at various stages of pain processes

Understand the role of endocannabinoid ligands and ligand-metabolizing enzymes in pain conditions.

Determine if the endocannabinoid system genes are regulated differently under pain conditions (role of epigenetics, gene expression, cis-/trans-effects, etc)

Determine the potential for biased agonists, hybrid dual ligands, or allosteric modulators that include cannabinoid receptor targets with other targets (e.g. opioid receptors, TRP channels, etc) as possible mechanisms for analgesia

Study the potential therapeutic efficacy of non-psychotropic phytocannabinoids found in cannabis, such as CBD, Tetrahydrocannabivarin (THCV), or others.

Parse the effects of cannabis vs. ?9-THC vs CBD and their role in modulating the endocannabinoid system in various pain states

Understand interaction between cannabinoids, endocannabinoid system, inflammation, and pain

Understand the role of cannabinoids in co-morbid pain conditions (e.g. diabetes, depression, HIV, cancer, etc)

Use of novel approaches such as social media or hospital/clinical-based observational studies on the use of medical marijuana by patients with pain indications.

In addition to the topics listed above, additional specific areas of interest for some of the participating ICs are outlined below. Applicants are encouraged to contact the participating IC's Scientific/Research contact to discuss the submission and gauge the interest of the participating institute.

NIDA: Examine the role of various combinations and potencies of the two main cannabinoids (?9-THC and cannabidiol; CBD) and their effects on modulating the endocannabinoid system for pain perception and analgesia; effects of long-term endocannabinoid system therapies on addiction liability.

NCI: The role of cannabinoids and the endocannabinoid system in the treatment of metastatic bone pain, chemotherapy induced peripheral neuropathy, and aromatase inhibitor arthralgias.

NCCIH: The role of naturally occurring phytocannabinoids and their derivatives either alone or in conjunction with other complementary approaches (e.g. other natural products, mind-body programs) as well as their effects on modulating the biological and neural systems associated with pain perception and analgesia in relevant model organisms or human subjects.

NIA: Research on the mechanisms by which endocannabinoids influence the pain processing in older adults with pain conditions or relevant aging animal models; the therapeutic effects, pharmacodynamics, or side effects of endocannabinoids in the aged; the interaction of endocannabinoids with other commonly used medications in older adults; and research comparing the effectiveness of endocannabinoids with that of other pain treatments for older adults.

NICHD: Characterization of the cannabinoids and endocannabinoid system as potential targets

for treatment of dysmenorrhea, vulvodynia, and chronic pelvic pain due to endometriosis and other gynecologic disorders. Studies into the role of these systems in the management of spasticity, neuropathic pain, bone pain, musculoskeletal pain and pain secondary to other disabling conditions. Cannabinoids and endocannabinoid system and their therapeutic and adverse effects in pregnancy and its outcomes.

NIAAA: Alcohol abuse/dependence causes increased pain sensitivity and neuropathic pain. The role of endocannabinoids in mediating the actions of alcohol in inducing and regulating pain responses will be the primary interest.

NINDS: Interest is exclusively focused on the effect of the endogenous ligands for the cannabinoid receptors in the neural mechanisms of pain and the transition from acute to chronic pain.

Section II. Award Information

Funding Instrument Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed New

Renewal

Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

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

Award Project Period The scope of the proposed project should determine the project period. The maximum period is 4 years. Applications with a project period less than 4 years are encouraged where feasible.

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

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

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

Hispanic-serving Institutions



Historically Black Colleges and Universities (HBCUs)



Tribally Controlled Colleges and Universities (TCCUs)



Alaska Native and Native Hawaiian Serving Institutions



Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses

For-Profit Organizations (Other than Small Businesses)

Governments

State Governments

County Governments

City or Township Governments

Special District Governments

Indian/Native American Tribal Governments (Federally Recognized)

Indian/Native American Tribal Governments (Other than Federally Recognized)

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

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

Foreign Institutions

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

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

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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, including Supplemental Grant Application Instructions 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.

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

The investigators funded under this FOA will be expected to attend annual investigator meetings to discuss research progress and highlight unexpected challenges. Funds to support travel of the key investigators to attend these meetings should be included in the application budget.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

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 as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

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 SF424 (R&R) Application Guide. Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow our Post Submission Application Materials policy.

Section V. Application Review Information

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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 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(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion 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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

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 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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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. Due to the nature of the scientific area for this FOA, review of appropriate DEA schedule I licensure may be required to be in place prior to funding decision.

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’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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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. The investigators funded under this FOA will be expected to attend annual investigator meetings to discuss research progress and highlight unexpected challenges.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: https://grants.nih.gov/support/index.html

Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)

Contact CenterTelephone: 800-518-4726

Email: support@grants.gov

Scientific/Research Contact(s)

David Thomas, PhD

National Institute on Drug Abuse (NIDA)

Telephone: 301-435-1313

Email: dthomas1@nida.nih.gov

Vishnudutt Purohit, PhD

National Institute on Drug Abuse (NIDA)

Telephone: 301-594-5753

Email: vpurohit@nida.nih.gov

Wen Chen, PhD

National Center for Complementary and Integrative Health (NCCIH)

Telephone: 301.451.3989

Email: chenw@mail.nih.gov

Ann O'Mara, PhD

National Cancer Institute (NCI)

Telephone: 240-276-7050

Email: omaraa@mail.nih.gov

Soundar Regunathan, Ph.D.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Telephone: 301-443-1192

Email: soundar.regunathan@nih.gov

Lisa Halvorson, MD

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Telephone: 301-480-1646

Email: lisa.halvorson@nih.gov

Michael L. Oshinsky, Ph.D.

National Institute of Neurological disorders and Stroke (NINDS)

Telephone: 301-496-9964

Email: michael.oshinsky@nih.gov

Molly Wagster, PhD

National Institute on Aging (NIA)

Telephone: 301-496-9350

Email: wagsterm@nia.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)

Pam Fleming

National Institute on Drug Abuse (NIDA)

Telephone: 301-253-8729

Email: pfleming@nida.nih.gov

Robin Laney

National Institute on Aging (NIA)

Telephone: 301-496-1472

Email: Robin.Laney@nih.gov

Sean Hine

National Cancer Institute (NCI)

Telephone: 240-276-6291

Email: hines@mail.nih.gov

Judy S. Fox

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Telephone: 301-443-4704

Email: Judy.Fox@nih.gov

Bryan Clark, M.B.A.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) \

Telephone: 301-435-6975

Email: clarkb1@mail.nih.gov

Shelley M. Carow

National Center for Complementary and Integrative Health (NCCIH)

Telephone: 301-594-3788\

Email: carows@mail.nih.gov

Tijuanna DeCoster, MPA

National Institute for Neurological Disorders and Stroke (NINDS)

Telephone: 301-496-9231

Email: decostert@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 Part 75.