Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NIH Basic Behavioral & Social Science Opportunity Network (OppNet) on behalf of its constitutent organizations:

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Advancing Translational Sciences (NCATS)
Office of AIDS Research (OAR)
Office of Research Infrastructure Programs (ORIP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)

Funding Opportunity Title

Short-term Mentored Career Enhancement Awards in the Basic Behavioral and Social Sciences: Cross-Training at the Intersection of Animal Models and Human Investigation (K18)

Activity Code

K18 Career Enhancement Award

Announcement Type

New

Related Notices

  • June 24, 2013 - See Notice NOT-DA-13-040. Notice of Change to Earliest Start Date for Applications Submitted.

Funding Opportunity Announcement (FOA) Number

RFA-DA-14-002

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.113, 93.121, 93.142, 93.143, 93.172,93.173, 93.213, 93.233, 93.242, 93.273 ,93.279 ,93.286 ,93.307, 93.350, 93.361, 93.389,93.393, 93.394, 93.395,93.396, 93.399, 93.837, 93.838, 93.846, 93.847, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879, 93.989

Funding Opportunity Purpose

This funding opportunity announcement (FOA), issued by the NIH Basic Behavioral & Social Science Opportunity Network (OppNet), invites applications for short-term mentored career enhancement (K18) awards in basic behavioral and social sciences research (b-BSSR). This funding mechanism will support development of research capability in b-BSSR, with specific emphasis on cross-training and establishing collaborations between researchers with expertise in animal models of basic behavioral and social processes and those studying similar or related processes in human subjects. Basic research using any non-human species or with human subjects in laboratory- or field-based settings is appropriate for this FOA. Eligible candidates for this K18 will be either: (a) scientists conducting b-BSSR in animal models who seek training in the study of similar or related behavioral or social processes in humans; or (b) investigators conducting b-BSSR in human subjects who seek training in the study of similar or related processes in animal models. Candidates may be at any rank or level of research/academic development beyond three years of postdoctoral experience.

Key Dates
Posted Date

March 1, 2013

Open Date (Earliest Submission Date)

November 11, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

December 11, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2014

Advisory Council Review

August 2014

Earliest Start Date

(New Date September 2014 per NOT-DA-13-040), Originally December 2014

Expiration Date

December 12, 2013

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, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), 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

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

This funding opportunity announcement (FOA), issued by the NIH Basic Behavioral & Social Science Opportunity Network (OppNet), invites applications for short-term mentored career enhancement (K18) awards in basic behavioral and social sciences research (b-BSSR). This funding mechanism will support development of research capability in b-BSSR, with specific emphasis on cross-training and establishing collaborations between researchers with expertise in animal models of basic behavioral and social processes and those studying similar or related processes in human subjects. Basic research using any non-human species or with human subjects in laboratory- or field-based settings is appropriate for this FOA. Eligible candidates for this K18 will be either: (a) scientists conducting b-BSSR in animal models who seek training in the study of similar or related behavioral or social processes in humans; or (b) investigators conducting b-BSSR in human subjects who seek training in the study of similar or related processes in animal models. Candidates may be at any rank or level of research/academic development beyond three years of postdoctoral experience.

About OppNet

OppNet is a trans-NIH initiative that funds activities to 1) build the collective body of knowledge about the nature of behavior and social systems, and 2) deepen our understanding of basic mechanisms of behavioral and social processes. All 24 NIH Institutes and Centers that fund research and four Program Offices within the NIH Office of the Director (ICOs) co-fund and co-manage OppNet. All OppNet initiatives invite investigators to propose innovative research that will advance basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and life course-related research. Applicants should understand that the NIH Institute or Center (IC) that made this FOA available to the public is not necessarily the NIH IC that ultimately will manage a funded OppNet project. For more information about OppNet and all its funding opportunities, visit http://oppnet.nih.gov.

OppNet uses the NIH definition of b-BSSR (http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx) to determine application responsiveness. Consequently, OppNet strongly encourages prospective investigators to consult this definition, in addition to OppNet’s answers to frequently asked questions (FAQs) about b-BSSR (http://oppnet.nih.gov/about-faqs.asp), and FAQs regarding this specific FOA (http://oppnet.nih.gov/pdf/FAQsRFA-DA-14-002.pdf). Prospective applicants are encouraged to reach out to the NIH Scientific/Research Contacts listed under Section VII. Agency Contacts for additional guidance about this FOA.

Background

The use of animal models to understand and predict human behavior and the environmental or social factors affecting behavior, provides several distinct advantages over human subjects approaches. These include tighter control of experimental subjects and their environments, the use of invasive techniques to study otherwise inaccessible tissues and test mechanistic hypotheses, and shorter life-spans that allow for longitudinal and intergenerational studies, among others. While these approaches have provided valuable information, failures of translatability or generalizability are many. Challenges to translation from animal findings to the human condition may be due to species differences, the use of artificial versus naturalistic environments, lack of cross-validation of behavioral/social phenomena between human and non-human organisms, non-equivalence of metrics and measurement systems, and the difficulty of modeling complex human processes (e.g., decision-making, self-regulation, empathy, transmission of behaviors among individuals, social adversity, population dynamics, and vocal communication). Additional complexity arises because behavioral and social processes occur in dynamic environments that are influenced by physical, social and developmental contexts factors not often taken into account in studies using animal models.

Scientific experts who participated in a 2010 meeting, OppNet: Expanding Opportunities in Basic Behavioral and Social Science Research (http://oppnet.nih.gov/news-events.asp) and an OppNet workshop, Improving Animal Models of Behavioral and Social Processes in July, 2012 (http://oppnet.nih.gov/news-07232012.asp) identified the need for increased collaboration between researchers working with animal models and those working with human subjects, in order to improve the back-and-forth translation of b-BSSR findings between animal studies and the human condition. This FOA begins to address this need using a career enhancement strategy. Its goal, to develop a cadre of researchers who will be better equipped to work across species, will help address the challenges of modeling complex human social and behavioral processes in non-human organisms.

Purpose

The opportunities afforded by this FOA are as follows:

It is anticipated that this interaction on multiple levels including mentoring, discussion, shared research participation, and an academic enrichment plan (if appropriate) will improve both the development of animal models for human processes and the design of human subject research that draws from, and is amenable to, modeling in experimental animals. It is also expected that cross-training will facilitate future collaborative endeavors between researchers working with human subjects and those employing animal models to study similar behavioral and social processes, thus improving forward-and-back translation between these two approaches.

For the purposes of this FOA, individuals conducting research in animal models may mentor investigators studying similar basic behavioral or social processes in human subjects; conversely, investigators conducting research on basic behavioral or social processes in humans may mentor animal model researchers. This FOA is not intended as a substitute for research project support. It is expected that either the candidate or the mentor has sufficient research funding to support the proposed shared research project, in excess of the allowable costs of this award. It is not a requirement that the candidate or the proposed mentor receive his/her primary research funding from the NIH. Candidates for K18 support may be at any rank or level of research/academic development beyond three years of postdoctoral experience.

Applicants must propose a mentored career enhancement program that includes a collaborative research project that will meet the goal of this FOA. Candidates are expected to devote 3-6 person-months of full time professional effort to a career enhancement program that will be from three months to one year in duration. The career enhancement activities are to be conducted in a host department or institution different from that of the applicant’s current primary appointment. An academic enrichment plan of coursework, seminars, journal clubs, etc. may also be included, if appropriate. The host program is expected to demonstrate the availability of appropriate resources to provide research experiences that will meet the goals of this FOA and the applicant’s career enhancement plan. In most cases, the candidate and the proposed mentor will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate the FOA goal in a manner that could not be accomplished through a research grant mechanism or current collaborative efforts.

The relevant administrators (e.g., department chairs, deans) of the candidate s home institution must provide a clear and unambiguous statement of assurance that during the active period of the K18 award the candidate will be released from all administrative, teaching and/or clinical duties that infringe on his/her commitment to the award, and that he/she will be able to devote 3-6 person-months of full time professional effort to the research career enhancement program in b-BSSR. The home institutional representatives should also indicate what, if any, duties or commitments the candidate will continue to maintain, including grant-related responsibilities. In addition, the mentor(s) and host institution should provide documentation of any requisite commitments to the candidate during the career enhancement program.

Any topical area that fits the definition of b-BSSR, as defined by NIH (http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx), is appropriate for support through this FOA. According to this definition, these topics include, but are not limited to the following:

(A). Research on basic behavioral and social processes.

Research on behavioral and social processes involves the study of human or animal functioning at the level of the individual, small group, institution, organization, community, or population; the study of the interactions within and between these levels of aggregation; and the study of how environmental factors affect behavioral and social functioning.

(B). Research on interactions among biological, behavioral and social processes.

This topic includes the identification of interacting biological and behavioral or social variables, including studies to determine how these different processes affect each other (i.e., bi-directional, multilevel relationships).

(C). Research on methodology and measurement in the behavioral and social sciences.

This category encompasses the development of new approaches for research design, data collection, measurement, and data analysis. Of particular interest is the development of measures that are comparable across human and animal populations.

In addition, OppNet has identified topics that may be particularly amenable to this type of career enhancement activity, examples of which are listed below. Note, however, that while a need has been identified for collaborations between animal modelers and human subject researchers on these topics, this is not an all inclusive listing of appropriate topics for the FOA.

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

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

Funds Available and Anticipated Number of Awards

OppNet intends to commit $1 million in Fiscal Year 2014 to support an estimated 10 awards.

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period

The total project period may not exceed 1 year.

Other Award Budget Information
Salary

NIH will contribute a minimum of 3 up to a maximum of 6 person-months of full-time professional effort per year toward the salary of the career award recipient.

The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses

NIH will contribute $20,000, maximum, in direct costs per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

NIH grant 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 not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (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 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor(s) and 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. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

This award is intended for researchers early in their careers through established investigators holding a research or health professional doctorate who are at any rank or level of research/academic development beyond three years of postdoctoral experience. Applicants should have established records of b-BSSR experience using animal models and be seeking an intense, mentored career development experience which will substantially improve their understanding of similar phenomena in humans and their ability to design animal studies that will be more translatable to humans. Alternatively, applicants should have established records of b-BSSR experience in humans and be seeking an intense, mentored career development experience which will substantially improve their understanding of similar phenomena in animals and their ability to design human studies that draw on, or inform, animal research.

Candidates (i.e., applicants) must identify one or more mentors willing to sponsor the short term research career enhancement experience. If the candidate works in humans, the mentor(s) should have expertise in researching a similar behavioral or social process in non-human organisms. Alternatively, if the candidate works in animals, the mentor(s) should have expertise in researching a similar behavioral or social process in humans. It is expected that the proposed career enhancement plan will represent a novel extension of the research of the candidate. In most cases, the candidate and the proposed host laboratory/research program will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate the goals of this FOA in a manner that could not be achieved solely through a research grant mechanism or current collaborative arrangement.

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:

Level of Effort

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Mentor(s)

Before submitting the application, the candidate must identify a mentor or mentoring team who will supervise the proposed career development and research experience. The mentor(s) should be active investigator(s) in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor(s) must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor(s) should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g., grant-writing and making effective presentations, is strongly encouraged. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described.

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.

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 the 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 (R&R) Application Guide and the Table of Page Limits must be followed.

Budget

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

Other program-related expenses: Applicants may request up to $20,000 in direct costs to cover other program-related expenses, such as tuition and fees for short-term courses, travel to scientific meetings or training, and research-related costs, primarily supplies and technical or computational services.

PHS 398 Career Development Award Supplemental Form

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

Candidate’s Background (Component of Candidate Information)

Career Goals and Objectives (Component of Candidate Information)

Career Development/Training Activities During Award Period (Component of Candidate Information)

Training in the Responsible Conduct of Research (Component of Candidate Information)

Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as provided in Chapter 7 of the SF424 (R&R) Application Guide.

Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

Research Strategy (Component of Research 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.

Letters of Reference

Letters of reference are not required. However, the mentor(s) should submit a letter outlining support of the application.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before 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 before the deadline 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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers should provide their assessment of the likelihood for the candidate to strengthen his/her research program, taking into consideration the criteria below in determining the overall impact score.

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.

Candidate

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

Research Plan

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Environment & Institutional Commitment to the Candidate

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

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), 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:

Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’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. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. .

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.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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 301-710-0267
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)

Minda Lynch, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1322
Email: mlynch1@mail.nih.gov

Melissa S. Gerald, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging/National Institutes of Health
Phone: 301-402-4156
Email: melissa.gerald@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
Chief, Grants Management Branch
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@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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