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 Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

Senior Scientist Research Award (K05)

Activity Code

K05 Research Scientist Award

Announcement Type

Reissue of PA-09-076

Related Notices
  • June 1, 2012 - NIDA and NIAAA are Terminating PA-12-148. See Notice NOT-DA-12-016.
Funding Opportunity Announcement (FOA) Number

PA-12-148

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.273, 93.279

FOA Purpose

The purpose of the Senior Scientist Research (K05) is intended to provide protected time for outstanding senior scientists who have demonstrated a sustained high level of productivity conducting biomedical research relevant to the scientific mission of the appropriate institute to focus on their research and to provide mentoring of new investigators.    

Key Dates
Posted Date

March 30, 2012

Open Date (Earliest Submission Date)

May 12, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

(Updated - See NOT-DA-12-016) Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

(Updated - See NOT-DA-12-016) Standard dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply.

Advisory Council Review

Standard dates apply.

Earliest Start Date(s)

Standard dates apply.

Expiration Date

January 8, 2013 per NOT-DA-12-016 (Original date: May 8, 2015)

Due Dates for E.O. 12372

Not Applicable http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch10.htm#construction_grants_intergovernmental_review

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially 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.

The objective of the NIH Senior Scientist Research Award (K05) is to provide partial salary support for a sustained period of “protected time” (3-5 years) to outstanding senior scientists to focus on and enhance their research and to carry out mentoring of new investigators. Candidates for the K05 should be recognized leaders in their respective research fields who have demonstrated a sustained, high level of productivity and a distinguished record of original contributions in their field, and whose expertise and contributions to these research fields will continue to be critical to the mission of the NIAAA or NIDA.

Each candidate must demonstrate both the need for protected time to further their field of research and a commitment to serve as a mentor to new investigators or junior faculty who are currently performing or will begin to perform alcohol, drug abuse, or related research. Mentored junior investigators should have an independent, full-time appointment at their institution; this can be in either non-tenure or tenure-track positions.

The award provides salary support for the K05 applicant for up to five years and may be renewed for one additional five-year period. The applicant must commit a total of 75 percent effort to the proposed program, with at least 25 percent of that effort to the mentoring activities proposed under this award. K05 applicants are expected to have independent, peer-reviewed research grant funding (such as an R01, P01, U01, or an equivalent grant in excess of $125,000 direct costs per year) at the time of submitting the K05 application to support the proposed research activities. An exception may be considered if the applicant is conducting primarily theoretical work. NIAAA will provide up to $25,000 per year for the following expenses: (a) research expenses, such as supplies, equipment and technical personnel for the PD/PI and up to five mentees per year; (b) travel to research meetings or training; (c) statistical services including personnel and computer time.  NIDA will provide up to $25,000 per year for research-related and/or mentoring support incurred only by those mentored investigators who are engaged in predominantly theoretical research, such as modeling or computer simulation.

The NIAAA and NIDA acknowledge the following in offering the Senior Scientist Research Award (K05).

First, the NIAAA and NIDA are committed to the development of the next generation of exceptionally talented new scientists who are committed to conducting basic, clinical and/or behavioral research on the health risks and benefits of alcohol consumption, or the health risks of drug abuse, and the prevention and treatment of alcohol, drug abuse, or related disorders. Towards this goal, NIAAA and NIDA support several programs designed to address the research training and career development needs of alcohol [http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/#About] and of drug abuse [http://www.nida.nih.gov/researchtraining/traininghome.html] early career researchers, respectively. However, mentoring and supervision should continue beyond these programs. New investigators and junior faculty members may also benefit from mentoring as they begin to establish their own research programs. These junior, independent investigators are potential innovators of the future. They will bring fresh ideas and technologies to tackle biomedical and behavioral research problems, and will pioneer new areas of investigation. NIAAA and NIDA believe that junior investigators can benefit from skilled advice and guidance - such as that provided by senior scientists - as they establish their own independent research programs; from strategizing scientific problems and developing research directions to obtaining guidance in grant writing skills and identifying funding opportunities in their pursuit of independent grant support for their research ideas and interests.

Second, NIAAA and NIDA recognize the achievements that outstanding senior scientists have made in alcohol, drug abuse, and related research and encourage the continued productivity of these investigators. NIAAA and NIDA also recognize that senior scientists have much to offer new investigators. Therefore, NIAAA and NIDA offer the Senior Scientist Research Award as a mechanism to provide recognized and well-respected leaders in alcohol, drug abuse, or related research with protected time to continue and to enhance their research programs and to disseminate their expertise and wisdom in the mentoring of junior investigators. In addition to their proposed research activities, the applicant will be expected to commit to mentoring from two to five junior investigators through this award. Senior scientists in all areas of alcohol, drug abuse, or related research are encouraged to apply for this award.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

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 5 years.

Other Award Budget Information
Salary

NIAAA and NIDA will provide salary for a level of effort equivalent to 9 person-months (or 75% full-time professional effort). Salary for NIDA K05 awards, however, is capped at $90,000 for each award year; and salary for NIAAA K05 awards is capped at $140,000 for each award year.

Recipients of a NIAAA K05 award may also derive additional salary compensation for effort associated with all other federal sources or awards, including any NIH research grant, provided the total salary derived from all Federal sources does not exceed the current legislatively-mandated Federal salary rate limit, and their total percent effort does not exceed 100 percent. Direct salary is exclusive of fringe benefits, indirect costs/facilities, and administrative expenses.

Recipients of a NIDA K05 award may not derive additional salary compensation from PHS funds.

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

NIAAA will provide up to $25,000 per year for the following expenses: (a) research expenses, such as supplies, equipment and technical personnel for the PD/PI and up to five mentees per year; (b) travel to research meetings or training; (c) statistical services including personnel and computer time.

NIDA will provide up to $25,000 per year for research-related and/or mentoring support incurred only by those mentored investigators who are engaged in predominantly theoretical research, such as modeling or computer simulation.

The amount requested should be based on a maximum of $5,000 per mentee and a maximum of 5 mentored investigators per year. Expenses could include: (a) tuition and course fees, (b) travel to research meetings or to obtain training, or c) research supplies and equipment for the mentored investigators. Funds provided for mentoring expenses cannot be rebudgeted for any other purpose.

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

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

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

Eligible Individuals (Program Director/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 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 Principal Investigators 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). Individuals on temporary or student visas are not eligible.

Candidates must be outstanding established senior scientists and recognized leaders in their field of research, and be able to demonstrate the need for a period of intensive research focus as a means of enhancing their research career and a need for protected time to conduct their mentoring activities. Senior scientists are expected to mentor from two to five new investigators or junior faculty members per year. Mentored investigators should hold an independent, non-tenure or tenure-track faculty appointment equivalent to the instructor level or above, and must conduct research relevant to the scientific mission of the awarding Institute while under the mentorship of the K05 award recipient.

Candidates must also have a research or health-professional doctoral degree or its equivalent, and are expected to have peer-reviewed, independent research support from any federal agency at the time of submitting a new (Type 1) K05 application. Eligible research grant support includes investigator-initiated research project (R01) grants, P01 grants, center grants, cooperative agreement (U01) awards, or similar NIH grants supported in excess of $125,000 direct costs per year, and comparable awards from other granting agencies. NIH small research grants (R03), NIH exploratory/developmental grants (R21), or small grants of less than $100,000 direct costs per year from other granting agencies are not considered independent support for purposes of eligibility for the K05 award support.

One exception to the requirement for peer-reviewed, independent research support is made for scientists whose work is primarily theoretical. These individuals may apply for a K05 award in the absence of research grant support if the institutional commitment includes stability of salary and research support, and the candidate’s record of publications, recognition of scientific leadership, and capacity for mentoring are strong.  

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. An individual may not have two or more competing NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.  

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

Renewals

K05 awardees may apply for a one-time renewal for an additional three to five years of support if the K05 recipient continues to have independent peer-reviewed research support at the time of submission of the renewal application. Eligible research grant support includes investigator-initiated research project (R01) grants, P01 grants, center grants, cooperative agreement (U01) awards, or similar NIH grants supported in excess of $125,000 direct costs per year, and comparable awards from other granting agencies. NIH small research grants (R03), NIH exploratory/developmental grants (R21), or small grants of less than $100,000 direct costs per year from other granting agencies are not considered independent support for purposes of eligibility for the K05 renewal. Candidates should clearly demonstrate their continuing need for protected time to further their field and to conduct their mentoring activities.

Peer Reviewed Research Support

Candidates are expected to continue to hold independent peer-reviewed research support for the period of this award. Candidates losing this support during the award period must document in their annual Progress Reports efforts to replace this support and demonstrate that they continue to meet all other requirements of the K05 award.

Institutional Environment

The applicant institution must have a strong, well-established record of research career development activities and demonstrate a commitment to the K05 candidate as a productive, senior scientist and an integral part of its research and academic program. The applicant and institution must certify that the candidate will be released from other duties and be able to devote effort equivalent to 9 person-months (or 75% full-time professional effort) to achieve the research and mentoring objectives of this award. The applicant and institution must assure that there is an adequate pool of candidates for mentoring..

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 SF 424 (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.

Other Project Information Component

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

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.

Mentoring Plan (Component of Candidate Information)

Statements by 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.

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review . 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-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 maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority 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

Is the candidate an outstanding scientist who is making significant contributions to the field?

Is there evidence of ongoing, high quality alcohol, drug abuse, or related research productivity as evidenced by contributions to the scientific literature and success in obtaining independent funding that is likely to continue during the award?

Has the candidate demonstrated the ability to conceptualize and organize a long-term research approach?

Is there evidence of the candidates capabilities and commitment to serve as a mentor?

Is the candidates level of training, experience, and competence commensurate with the purposes of the award?

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

What is the likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate?

Is there evidence that the award will enable the candidate to devote full time (at least the required minimum percentage of full-time professional effort) to research mentoring by release from teaching, administration, clinical work, and other responsibilities?

Are the plans to provide mentoring to new or junior investigators adequate?

Have past and current mentoring activities been adequately described?

Is an appropriate level of effort proposed for the mentoring component?

Research Plan

Is the research plan of high quality, and does it have potential for advancing the field of study? Is the research plan relevant to the candidate’s research career objectives and appropriate to the stage of research development?

Are the scientific and technical plans of the proposed research of significant merit? If applicable, are there adequate plans for data and safety monitoring of clinical trials?

Are adequate resources available to conduct the research program? This includes adequacy of plans for continued support of the research during the funding period of the grant.

Candidates are expected to have independent, peer reviewed research support at the time the career award is made. Reviewers should not re-evaluate the components of the research plan that have already been peer reviewed. Rather, the reviewers should evaluate how the research and career development plans together further the candidate’s research career, and whether it has the potential for advancing the field of study.

Consultant(s), Collaborator(s)

Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality?

Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration? Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate’s project? Do the proposed consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project?

Environment & Institutional Commitment to the Candidate

Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate?

Is the level of assurance from the institution that the candidate is an integral part of its research program adequate?

Are the research facilities, resources and educational opportunities available to the candidate appropriate and adequate?

Are the size and quality of the pool of investigators to be mentored by the PD/PI  adequate?

Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing research appropriate and adequate?

 Is the commitment from the sponsoring institution to provide protected time for the candidate to conduct the research and mentoring program adequate?

Is the level of commitment of the candidate’s institution to the career development of new investigators mentored by the candidate adequate?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.   

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period. In addition, candidates seeking renewal through NIDA must have been awarded a NIDA-funded research grant (R01), center grant, P01, cooperative agreement (U01) award, or similar NIDA grant in excess of $125,000 direct costs per year, at the time the application is submitted.

Revisions

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

Additional Review Considerations

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

Training in the Responsible Conduct of Research

 Taking into account the circumstances of the candidate, including the senior level of experience of candidates for this award, 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 that the candidate will participate in?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, and laboratory safety?  Do the plans adequately describe the candidate’s role in the participation in instruction in RCR? 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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications 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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

Because of the difference in individual Institute requirements for this FOA, prior consultation with NIH staff is strongly encouraged.

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

NIAAA

Gary J. Murray, Ph.D.
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2037, MSC 9304
Bethesda, MD 20892-9304
Telephone: 301-443-9940
FAX: 301-594-0673
Email: gary.murray@nih.gov

NIDA

Mimi M. Ghim, Ph.D.
Office of Science Policy and Communications
National Institute on Drug Abuse
6001 Executive Blvd., Room 5232, MSC 9591
Bethesda, MD  20892-9591
Telephone: (301) 443-6071
E-mail: ghimm@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date). For general peer review questions or questions prior to review assignment:

Financial/Grants Management Contact(s)

NIAAA

Judy Fox 
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Rm 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-4704
FAX: (301) 443-3891
Email: jfox@mail.nih.gov

NIDA

Carol Alderson 
Deputy Chief Grants Management Officer 
Grants Management Branch/OM
National Institute on Drug Abuse
6001 Executive Boulevard, Rm 4128, MSC 9560
Bethesda, MD 20892-9560
Telephone: (301) 933-6196
Email: ca10h@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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