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

Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • August 19, 2013 - This PAR has been reissued as PAR-13-334.
  • July 18, 2013 - See Notice NOT-DA-13-042. Notice to Expire this FOA.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAS-12-122

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.279

Funding Opportunity Purpose

NIDA grant-funded research programs aiming to develop medications for the treatment of Substance Use Disorders (SUDs) are often hindered by a lack of both human and financial resources.  Drug development is a long process that requires teams of people with a wide range of individual skill sets.  Consequently, individual grantees with the skills to get through the preclinical stages of drug development often fail to transition their project through the clinic and into the market place.  Grantees frequently lack both real world experience of the drug development process and the financial resources to advance a medication to the market place in the necessary timeframe.  The purpose of this Funding Opportunity Announcement (FOA) is to help support these efforts to meet these objectives by leveraging the strengths of two or more organizations toward a common goal of medications development.  Targeted organization types include both for-profit and not-for-profit entities, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, and small businesses.  Applications from single entities (private for-profit, not-for-profit, or academic institutions) who possess considerable resources for medications development will also be considered, provided the entity demonstrates a significant resource commitment to the proposed project.  It is anticipated that in comparison with traditional grant-funded research, strategic alliances will increase the pace at which medications to treat SUDs move through the drug development process.  Both the term (up to three years) and budget (up to $2,000,000/year) of the grant are consistent with the objective of accelerating the pace of medications development compared to traditional research project grant funding.  Project aims can range from the development of a new molecular entity to the expansion of an existing medications’ clinical indication(s), but each project should have a defined entry and exit point with the objective of advancement in the approval process.  It is hoped that support for these collaborations will accelerate the rate of medications development for Substance Use Disorders.

Key Dates
Posted Date

March 21, 2012

Open Date (Earliest Submission Date)

07/07/2012

Letter of Intent Due Date

07/07/2012, 11/07/2012, 06/17/2013, 11/04/2013, 02/24/2014, 11/04/2014

Application Due Date(s)

08/07/2012, 12/07/2012, 07/17/2013, 12/04/2013, 03/24/2014, 12/04/2014, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Same as above.

Scientific Merit Review

October/November 2012, February/March 2013, October/November 2013, February/March 2014, October/November 2014, February/March 2015

Advisory Council Review

January 2013, May 2013, January 2014, May 2014, January 2015, May 2015  

Earliest Start Date(s)

April 1, 2013, July 1, 2013, April 1, 2014, July 1, 2014, April 1, 2015 and July 1, 2015

Expiration Date

(Now Expired July 18, 2013 per NOT-DA-13-042) , Originally December 5, 2014

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

Drug development is a long process that requires teams possessing a wide range of individual skill sets.  Frequently grantees with the skills to get through the preclinical stages of drug development fail to transition their project through the clinic to the market place.  Grantees often lack both experience of the drug development process and the financial resources to advance a medication to the market place in the necessary timeframe.  Consequently,the National Institute on Drug Abuse (NIDA) is seeking research grant applications which propose the discovery and development of safe and effective medications for the treatment of Substance Use Disorders (SUDs) through the establishment of  tactical alliances , collaborations between researchers at for profit or non-profit organizations (including, but not limited to, academic institutions,  pharmaceutical companies, biotech companies, private or public foundations).  NIDA anticipates that through the leveraging of resources,  Strategic Alliances will accelerate the pace of grant-funded medications development for SUDs. Applications may be focused at any point along the drug development continuum including, but not limited to, the advanced development of new chemical entities (e.g., lead optimization), investigational new drug (IND)-enabling studies (e.g., preclinical toxicology, GMP manufacturing), and Phase I, II or III clinical trials of either a new chemical entity or an already marketed therapeutic. The studies funded proposed should be directed at advancing a medication to treat SUDs toward FDA approval.

Applications from a single entity (private for-profit, non-profit, or academic) will be considered, but the entity would be expected to contribute considerable, specific resources sufficient to cover major costs associated with the proposed project. Examples of such contributions would be financial resources, manpower and equipment.  

The development of safe and effective medications for the treatment of SUDs and nicotine dependence is a public health priority. According to the National Survey of Drug Use and Health (NSDUH) of 2010, an estimated 69.6 million Americans aged 12 or older are current users of tobacco products and 22.6 million Americans aged 12 or older are current drug users (defined as having had used an illicit drug during the last month). Illicit drugs include marijuana, cocaine, heroin, hallucinogens, inhalants as well as the nonmedical use of prescription-type pain relievers, tranquilizers, stimulants, and sedatives. The overall use of illicit drugs has not increased since 2002, but the abuse of prescription opiate analgesics has more than doubled over the past 10 years significantly (P<0.05) higher in both 2009 and 2010 than in every year from 2002 to 2007.   

Over the past 20 years, basic research has identified neural substrates and pathways implicated in reward and addiction. However, the application of this basic knowledge to the development of effective medications to treat SUDs has largely been unsuccessful in both preclinical and early clinical stage development, hindered by the high cost and attrition rates of compounds. Later stage clinical development also presents formidable challenges, with prospective SUD medications failing due to lack of efficacy, tolerability and unexpected toxicity, as well as “human” issues such as difficulties in recruitment, medication compliance and subject loss during the trial and prior to follow up.

While there are medications approved for nicotine and opiate dependence, the efficacy of these drugs is far from ideal.  For example, the abstinence rates after 1 year with nicotine replacement therapy (NRT) or bupropion is 6% compared with placebo.  Moreover, there are currently no FDA approved medications for the treatment of cocaine, methamphetamine, or cannabis use disorders. By providing funds well beyond a traditional research project grant, this Strategic Alliances FOA will accelerate medications development, fostering collaborative ventures between entities such that each offers financial resources , in-kind resources, and/or expertise toward the development of  safe and effective medications for SUDs. Examples of in-kind resources include toxicology assays, analytical support, providing clinical trial material, clinical support (e.g., monitoring, site support), and/or statistical analyses.

This FOA encourages, but is not limited to, the following medications development stages:

Lead optimization of new chemical entities identified through assay screens as having promise as SUD treatments;

Preclinical characterization of pharmacological or biological-based therapies, within appropriate animal models of behavior, and / or IND enabling studies including toxicity and pharmacokinetic (PK) / pharmacodynamic (PD) studies

Clinical development

Phase I clinical trials (e.g., safety and interaction studies, human laboratory studies assessing subjective effects of a medication on targeted drug of abuse)

Pilot or proof-of-concept studies to assess efficacy

Phase II clinical trials to assess efficacy

Phase III clinical trials for NDA requirements

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.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Revision
Resubmission

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

Funds Available and Anticipated Number of Awards

During Fiscal Year 2013, the estimated amount of funds available to support projects under this FOA is $6,000,000.  Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.  Given the likely range of budgets, it is anticipated that 2 to 4 awards could be made during Fiscal Year 2013.  The availability of funds and the number of awards in future years will depend upon Institutional annual budget appropriations.

Award Budget

Budgets for direct costs may be up to $2,000,000 per year.

Award Project Period

The maximum period is 3 years. 

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

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

Required Registrations

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

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

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

Director - Strategic Alliances FOA
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

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

Appendix

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

Foreign Institutions

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

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

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

For grant applications which propose a grantee and one or more collaborating organization(s), the resources to be contributed by the collaborating organization(s) should provide a significant contribution to the project. The application should contain a specific description of each resource, how it will facilitate the project goals, and an outline of the projected timeline for resource receipt and utilization.  Letter(s) of support from the collaborating organization(s) should be provided.  The application must also provide a clear organizational plan of governance and describe how communications between entities will be conducted and maintained. All of this information should be included in "Consortium/Contractual Arrangements" (Section 13) of the PHS 398 Research Plan component.

Grant applications which do not propose a collaborating entity must specifically describe the resources which the grantee would bring to the project. The proposed resources (e.g comparable funds, manpower, in-kind resources) are expected to provide a significant contribution to the project and should be described in the Research Strategy section of the PHS 398 Research Plan component.

Applications must be in compliance with SF 424 guidelines. Inclusion of inappropriate materials in the Human Subjects section may result in withdrawal of an application from the review process (NOT-OD-11-080).

Applications for clinical projects should include a timeline for the clinical trial(s) proposed, a timeline that is consistent with both the project aims and the drug development schedule.  This section should describe the number of subjects to be recruited and a description of how the recruitment target will be achieved. The explanation should describe the racial, ethnic and gender breakdown of the subjects and how NIH mandates for these requirements will be achieved. If more than one site will be recruiting subjects, a section should also be included to describe how communication between sites and investigators will be coordinated. All applications should include a chart or timeline that describes the development pathway for advancement to FDA approval. These sections should be added under the PHS SF424 (R&R) "4.4 Other Project Information Component” under item 12 “Other Attachments”.  An application which does not include such a chart or timeline will be considered incomplete and would not be considered for review. Inclusion of inappropriate materials and substantial excess information may result in withdrawal of an application from the review process (NOT-OD-11-080).

In addition, if the project is intended to ultimately result in a commercializable product, a Commercialization Plan, (not to exceed 6 pages), should also be included.  This plan should succinctly describe the commercial, societal and scientific benefits of the project in comparison with current existing therapies and provide a timeline for the entry and exit points of the project. The corporate objectives, core competencies and history of product development of the Commercial partners should be described, as should a vision of how research / clinical success will be translated into a successful commercial therapeutic. Any partnerships or licensing agreements that will be required to get FDA approval or successfully market and sell the product should be described, as should plans for protecting market space, whether by Intellectual Property protection or by employing a temporal “first in class” solution. Intellectual property rights issues are to be decided by the grantee and their collaborator(s) and are not part of the Commercialization plan

The plan should include designs to raise the requisite financing, as demonstrated by letters indicating commitment of funding, Letters of Intent, or documentation of negotiations to provide funding. The plan should also include a section covering Production and Marketing, describing how the final product will be manufactured and taken to market.    The Commercialization Plan section should be added under the PHS SF424 (R&R) “4.4 Other Project Information Component” under item 12 “Other Attachments”. 

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(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the application adequately address communication plans, the processes governing the scientific direction of the project, the appropriateness of the procedures for resolving conflicts? Is there a clear delineation of the administrative, technical, and scientific roles of PD/PIs and collaborators?  

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.

Competency of Alliance

In addition to the applicant organization, collaborating organizations may also choose to designate PD(s)/PI(s). The success of Strategic Alliances will be critically dependent on the organization of the collaboration(s), and so this aspect of the application will receive special scrutiny.  Does the application adequately address plans for communication between the organizations? Is the inter-organizational leadership structure for the project clearly defined, both with regards to scientific direction and conflict resolution? Is there a clear delineation of the administrative, technical, and scientific roles of collaborators?

Commercialization Plan

Does the project have a defined entry and exit point with the objective of advancement toward FDA approval?  If applicable, does the commercialization plan adequately address the commercial, societal and scientific benefits of the project in comparison with current existing therapies? Are the corporate objectives, core competencies and history of product development of the commercial partners adequately described? Is a vision of how research / clinical success will be translated into a successful commercial therapeutic adequately described? Are any partnerships or licensing agreements that will be required to get FDA approval or successfully market and sell the product adequately described?  Are plans for protecting market space, whether by Intellectual Property protection or a temporal “first in class” solution described? Does the plan adequately include designs to raise the requisite financing, as demonstrated by letters indicating commitment of funding, Letters of Intent, or documentation of negotiations to provide funding? Does the Production and Marketing plan adequately describe how the final product will be manufactured and marketed?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

Revisions

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

Additional Review Considerations

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

Chart or Timeline for Development Pathway.

Does the application describe a complete and satisfactory chart or timeline addressing the development pathway?

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 National Institute on Drug Abuse, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Jamie Biswas, Ph.D.
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse (NIDA)
Telephone: (301) 443-8096
Email: jb168r@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Deborah Wertz
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
Telephone: 301-649-1715
Email: dwertz@nih.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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NIH Funding Opportunities and Notices



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