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

Identification of Gene Variants for Addiction Related Traits by Next-Gen Sequencing in Model Organisms Selectively Bred for Addiction Traits (UH2/UH3)

Activity Code

UH2/UH3 Phase Innovation Awards Cooperative Agreement

Announcement Type

New

Related Notices
  • January 31, 2014 - NIH and AHRQ Extend Due Dates for Applications Due Jan 31-Feb 3 to Feb 4. See Notice NOT-OD-14-047.
Funding Opportunity Announcement (FOA) Number

PAR-14-010

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

The goals of this initiative are to: 1) develop strategies and methodologies for the sequencing, mapping and genomic analyzing of established phenotypes of selectively bred animal models with addiction traits, and 2) identify, from new or existing selectively bred animal models, genetic variants with implications for addiction related traits.  

Key Dates
Posted Date

November 22, 2013

Open Date (Earliest Submission Date)

December 31, 2013

Letter of Intent Due Date(s)

30 days prior to application due date

Application Due Date(s)

Extended to February 4, 2014 per NOT-OD-14-047 (previously January 31, 2014); June 30, 2014; October 31, 2014; June 30, 2015; October 31, 2015; June 30, 2016; by 5:00 PM local time of applicant organization.

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)

Not Applicable

Scientific Merit Review

June 2014, October 2014, February 2015, October 2015, 

February 2016, October 2016

Advisory Council Review

August 2014, January 2015, May 2015, January 2016, May 2016, January 2017

Earliest Start Date

September 2014, April 2015, July 2015, April 2016, July 2016, April 2017

Expiration Date

July 1, 2016

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.


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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

Classic behavior studies have shown that alleles influencing addiction-related phenotypes can be enriched by selection in model organisms, providing the basis for the discovery of genes influencing the complex trait.  Selectively bred animals have also provided an opportunity to identify aspects of physiology and brain function that influence behavior, and the phenotype-genotype relationships. The selected model organisms are useful for interventional studies elucidating effects of environmental exposures and drug treatments on animals of defined genotype. However, the identities of gene variants that mediate behavioral differences in selectively bred organisms remain largely unknown, greatly limiting the interpretation of physiologic differences and the design of interventional studies, and hindering translation of genetic findings to the human and to other model organisms.  New technologies in Next-Gen Sequencing, array-based genotyping, functional genomics and informatics now enable the genome-wide survey, discovery and validation of functional loci and gene variants responsible for the heritability of these traits.

Research Scope and Objectives

This announcement encourages applications for projects aimed at discovery of gene variants in either new or previously developed selectively bred animal models through the use of Next-Gen Sequencing technologies. The proposed projects should be based on data demonstrating the relevance of the selected traits to addiction and the practicality of the selective breeding either directly, for example by the existence of the selected strain, or indirectly. The applicants may employ previously selectively bred animals, re-derived strains, or strains selected for some new phenotype or beginning with a novel progenitor population. Investigators with existing established selectively bred animal models may also propose mapping strategies for gene variations in combination with Next-Gen Sequencing. 

The goals of this FOA are divided into two phases: UH2 and UH3. The first phase, UH2, supports selective breeding or mapping with the duration of up to two years.

Traits suitable for selective breeding or mapping include but are not limited to the following:

Drug preference

High and low preference for saccharin

Somatic and affective Withdrawal

Novelty seeking

Impulsivity

Delay discounting

Reversal learning

Punishment resistant responses for drug

Relapse and reinstatement

Stress response

Circadian rhythms

Neurostructural differences

Neurochemical differences

Electrophysiological and other brain functional differences

Modifiers of knockout and knock-ins of drug associated phenotypes when bred into different genetic backgrounds

In the UH3 phase, limited to one year, applicants propose sequencing strategies of the samples associated with the phenotype of interest collected during the UH2 phase to identify the causative gene variant. 

Transition from UH2 to UH3 is contingent upon successful completion of the UH2 milestones and administrative review to ensure the UH3 fulfills NIDA programmatic needs.  Investigators who meet the milestones of the UH2 phase, but do not transition to the UH3 phase due to programmatic considerations, may have the option of applying to an X01 announcement to use The Center for Addiction Genomics (TCAG) in the NIDA/NIAAA intramural program to complete the proposed work.

Investigators are strongly encouraged to discuss their applications with the Scientific/Research contact listed in this FOA before submission.

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.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.  Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:  NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org).  Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details. 

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Resubmission
Revision

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

The project period is not to exceed three years and direct costs are limited to $125,000 per year.

Award Project Period

The maximum project 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 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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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

A letter of intent is required. The applicants are strongly encouraged to discuss the intent and plan of research with NIDA program officials before the application submission.

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 - UH2/UH3 PAR
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD  20892-9550

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

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.

Project Summary/Abstract: The Abstract should be a self-contained description of the project and should contain a statement of objectives for the UH2 and UH3 phases.

Facilities & Other Resources: Upload a statement of the facilities to be used for the conduct of the research. Included a brief description of the capabilities of the institution, including faculty and infrastructure, and the commitment of the institution to the proposed research.

Equipment Upload a statement if needed. List major items of equipment already available for this project and, if appropriate identify location and pertinent capabilities.

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Applicants are expected to budget funds for depositing strains, dna samples, and tissue samples, and data in a public repository. Applicants should request a budget for the UH3 phase.

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:

Specific Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved.

Research Strategy:

a) Literature Review. Complete a review researching current field of phenotyping and genetyping research for addiction and addiction risk factors. Propose valid strategies to identify, rank, and prioritize molecular targets for substance dependence to be identified though genomic sequencing of selectively bred animal models with identified traits of substance abuse and dependence.

Describe research approaches and tactics to support or refute current research approaches, and articulate a strategy to address the most basic and high impact issues.

b) Significance. Address the following questions. 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? Is the rationale for the choice of the phenotype provided? Do the selected traits have the properties of generalizability and interpretability?

c) UH2/UH3 Research Plan. Propose a hypothesis driven research plan. The application should address the following:

For the UH2 phase: 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? Is the stability of the trait demonstrated, and are sufficient details provided about collection of the phenotype?  Is the starting point for breeding selection strategy justified?  Is there sufficient power to identify the gene variant associated with the selected trait? Are genotypes tracked as breeding progresses?  Does the application provide data supporting the map-ability of traits? This may include results from crosses not necessarily from the model, or validated in similar means. Are the analytical plans for data analysis and interpretation provided and are the plans valid?

The milestones for the successful completion of the UH2 phase are 1) Demonstration that selection for the desired trait has been achieved and the successful treatment of the problems of random fixation and providing strategies has been dealt with them.  2) Phenotype database with samples available and accessible.  3) Demonstrated validity of analytic method to measure phenotype. 4) Demonstrated heritability of phenotype. 5) Demonstrated of stability of the phenotypic measurement. 6) Provided valid strategy for following up any identified sequence hits. 7) Investigators proposing mapping strategies using existing established selectively bred lines should have collected sufficient DNA or tissue samples for genomic or genetic sequencing. 8) A photograph of an agarose gel to show DNA integrity (no smearing) and high molecular weight that is greater than 20Kb with no RNA contamination together with a spectrophometrically defined concentration and a 260/280 ratio in the range of 1.7 to 1.9.  9) If RNA-seq is proposed RNA should have a RIN >8 for RNAseq . 10) Deposited strains in a public repository.

In the UH3 phase, the applicant should propose sequencing strategies of the samples associated with the phenotype of interest collected during the UH2 phase to identify the causative gene variant.  Applicants should define the strategy and scope of sequencing, genotyping, and other studies to be performed.  In addition, the Next-Gen sequencing platform should be described, the methods of data cleaning detailed, and the analytic methods for associating a gene variant with the phenotype of interest explained.   Applicants should define how result will be interpreted. 

For the UH3 phase the DNA sequencing the sequencing approach (whole genome/exome/targeted) should be defined, the method and product used for sub-genome enrichment if exome or targeted approaches are to be used, and the sequencing platform should be defined. The average coverage for the sequencing should also be specified.  Applicant proposing targeted capture experiments the coverage is expected to be >40x coverage.  If whole genome sequencing is proposed applicants are expected to propose at least 20x coverage.  The method for variant calling, sequence alignment, and efficiency of querying gene variants should be described. The method used to assess sequence quality and accuracy should also be described.  The applicant should also describe the analyses and tools to store reads, assemblies, variants, and annotation of sequence data.  Applicants are expected to deposit sequence data in a public data base.  The location of the public data base of where the sequence data will be deposited should be explained. Applicants should define how results will be interpreted.

e) A discussion of the implications of successful accomplishment of these goals in UH2 phase for the proposed UH3 study.

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:

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

Investigators are expected to deposit selectively bred strains in an appropriate repository and register these strains and any research resources supported by this FOA in the Neuroscience Information Framework  http://neuinfo.org.

In addition, investigators are expected to deposit sequence data in a public repository. 

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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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 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? Is the rationale for the choice of the phenotype provided? Do the selected traits have the properties of generalizability and interpretability? 

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/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? Is the stability of the trait demonstrated, and are sufficient details provided about collection of the phenotype?  Is the starting point for breeding selection strategy justified?  Is there sufficient power to identify the gene variant associated with the selected trait?  Does the application provide data supporting the map-ability of traits?  This may include results from crosses not necessarily from the model, or validated in similar means.   Are the analytical plans for data analysis and interpretation provided and are the plans valid?   

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?   Does the applicant demonstrate the necessary resources and environments for all aspects of any required selective breeding, arranged crosses and phenotyping? 

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 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 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

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 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 NIDA, 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:

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 National Advisory Council on Drug Abuse. The following will be considered in making funding decisions:

At the end of the of the UH2 awards, there will be an administrative review to determine which of the cooperative agreements will continue to the UH3 phase.  The administrative review will be conducted by the NIDA staff and NIDA Advisory Council, who will consider several factors, including both the progress made in UH2 and potential for achieving the goals of the program, i.e. to review criteria for transition planning phase (UH2) to execution phase (UH3).

The criteria that will be used to determine which of the UH2 projects will make the transition to the UH3 phase will include:

The milestones include but are not limited to the following:

1) Demonstration that selection for the desired trait has been achieved and the successful treatment of the problems of random fixation and providing strategies has been dealt with them.  2) Phenotype database with samples available and accessible.  3) Demonstrated validity of analytic method to measure phenotype. 4) Demonstrated heritability of phenotype. 5) Demonstrated of stability of the phenotypic measurement. 6) Provided valid strategy for following up any identified sequence hits. 7) Investigators proposing mapping strategies using existing established selectively bred lines should have collected sufficient DNA or tissue samples for genomic or genetic sequencing. 8) A photograph of an agarose gel to show DNA integrity (no smearing) and high molecular weight that is greater than 20Kb with no RNA contamination together with a spectrophometrically defined concentration and a 260/280 ratio in the range of 1.7 to 1.9.  9) If RNA-seq is proposed RNA should have a RIN >8 for RNAseq . 10) Deposited strains in a public repository.

At the end of the UH2 phase, applicants have the option of requesting access to Next-Gen sequencing and genotyping resources of The Center for Addictions Genomics (TCAG) in the NIDA/NIAAA intramural program through an X01 announcement to be published at a later date.   Investigators wishing to use the resources of TCAG instead of performing next-gen sequencing using extramural resources should apply for the X01 announcement at the same time they submit the progress report on completing he milestone for UH2.  Applicants applying for the X01 announcement will be evaluated based on their achievement of the milestones in their UH2 application. 

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 the DUNS, SAM 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

NIH staff have substantial programmatic and scientific involvement that is above and beyond the normal stewardship role in awards, as described below:

A NIDA Project Scientist will be substantially involved as an active partner in those aspects of the scientific management of the project indicated by the Terms and Conditions, including protocol development, quality control, interim data monitoring, final analysis, and selection of animal models for sequencing. This level of involvement will be above and beyond the levels typically required for administration of traditional research grants and is vital to the success of this program. However, the lead responsibility for refining the design of the project and carrying it out will rest with the Principal Investigators.

In adition, a NIDA program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIDA Program Official, who will not participate in the research or the preparation of publications, will be responsible for monitoring the conduct of the project. The Program Official carries primary responsibility for: (1) periodic review and monitoring and approval of the progress of the research plans in relation to their stated objectives, including consistent communication with the PI and requests for additional reports or documentation; and (2) making recommendations regarding continuance of the program. The Program Official will receive all required progress reports to determine that satisfactory progress is being made and will work collaboratively with the NIDA Grants Management Specialist to assure high quality business management of the program, including the most effective use of grant money provided through this cooperative agreement.

Areas of Joint Responsibility include:

None; all responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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 Commons Help Desk (Questions regarding 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)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
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

Scientific/Research Contact(s)

Da-Yu Wu, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-4649
Email: wudy@nida.nih.gov

Peer Review Contact(s)

Mark Swieter, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1389
Email: mswieter@mail.nih.gov

Financial/Grants Management Contact(s)

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