Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Not Allowed)

Activity Code

K01 Research Scientist Development Award - Research & Training, Activity Code

Announcement Type

Reissue of RFA-OD-13-014

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-OD-18-005

Companion Funding Opportunity

RFA-OD-18-006, K01 Research Scientist Development Award - Research & Training

RFA-OD-18-007, K99/R00 Career Transition Award/Research Transition,

RFA-OD-18-008 K99/R00 Career Transition Award/Research Transition  

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

93.077

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA RFA-OD-18-006.

The purpose of the Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01) is to provide support and protected time (three, four, or five years) for an intensive, supervised career development experience in biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing and that will lead to research independence. Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using funds made available through the CTP and the FSPTCA (P.L. 111-31).

Key Dates

 

Posted Date

May 15, 2018

Open Date (Earliest Submission Date)

June 19, 2018

Letter of Intent Due Date(s)

Note, for the first round, because of the application due date, the LOIs are due 30 days prior to the first application date.  Subsequent  LOI due date is 60 days prior to the application due date.  

Application Due Date(s)

July 19, 2018, November 8, 2018, July 19, 2019, November 8, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2018, February 2019, October 2019, February 2020

Advisory Council Review

January 2019, May 2019, January 2020, May 2020

Earliest Start Date

April 2019, July 2019, April 2020, July 2020

Expiration Date

November 9, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Career Development (K) 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. 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. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

    The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of "protected time" (3-5 years) for intensive research career development, under the guidance of an experienced mentor, or sponsor in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.

    Investigators who have the quality and breadth of training necessary to conduct cutting-edge research related to the regulation, manufacture, distribution and marketing of tobacco products are needed. All applicants responding to this FOA are expected to propose research that responds to the priorities of the FDA Center for Tobacco Products as outlined in the Program Scope and Research Objectives.

    Background

    The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The NIH and the FDA have formed an interagency partnership to foster research that can inform FDA's regulatory authorities over the manufacture, marketing, and distribution of tobacco products within the framework of the Tobacco Control Act, the Tobacco Regulatory Science Program.

    Program Scope and Research Objectives

    The FDA and NIH share interest in supporting research that could inform FDA's tobacco regulatory authorities. To that end, the research encouraged by this FOA is expected to provide additional scientific data to the research base to inform regulation of tobacco products to protect public health.

    Science will inform the FDA in regulation of tobacco products in order to reduce the public health toll from tobacco product use in the United States.This FOA is focused on the following seven FDA CTP interest areas. Only applications proposing research projects relevant to one or more of these seven areas will be considered for funding.

    SCIENTIFIC INTEREST AREAS

    Toxicity - Understanding how tobacco products and changes to tobacco product characteristics affect their potential to cause morbidity and mortality, including animal and cell culture models as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke, aerosols, or specific constituents in tobacco. Given the chronic nature of the human health effects of tobacco products, the assessment of both chronic and acute tobacco product toxicity is important.  Assays that can address chronic toxicity resulting from long term tobacco use are a priority and an important piece of the evaluation of the human health effects of tobacco products.  Priorities include toxicological assays (in vivo and in vitro) to compare toxicity across different types of tobacco products within the same class including electronic nicotine delivery systems (ENDS), cigars, waterpipes and smokeless tobacco; how product design characteristics (and changes in those characteristics) impact constituent exposure and toxicity from tobacco products; biomarkers to assess exposure, as well as biomarkers to assess harm or toxicity of non-cigarette tobacco products, including ENDS.

    Addiction - Understanding the effect of tobacco product characteristics on addiction and abuse liability. Priorities include impact of changes in tobacco product characteristics (such as flavors, product design) on dependence; differences in dependence and tobacco use patterns with use of low nicotine content cigarettes in context with other tobacco products; the amounts of nicotine delivered to ENDS users during experimentation, regular ENDS use, dual use of ENDS and cigarettes, and cigarette smoking quit attempts; correlation of ENDS use behaviors with pharmacokinetic and pharmacodynamics effects of nicotine and other HPHCs delivered by ENDS.

    Health Effects - Understanding the short and long term health effects of tobacco products. Highest priority areas include cardiovascular or respiratory health effects, including inflammation. Other health effects including cancer, oral health or reproductive health may be included within projects but should not be the primary focus of the application. Priorities include impact of changes in tobacco product characteristics (such as flavors, product design) on human health; biomarkers to assess short and long-term effects of non-cigarette tobacco products; clinical evaluations to distinguish changes in cell function/physiology specific to tobacco exposure (e.g., ENDS aerosol exposure) known to indicate longer term disease development and progression.

    Behavior - Understanding the knowledge, attitudes, and behaviors related to tobacco product use and changes in tobacco product characteristics. Priorities include changes in tobacco product characteristics (such as flavors, product design, packaging) impact on tobacco use behaviors including experimentation, initiation, dual/poly use, transition to non-flavored products, and cessation; innovative methods and measures to assess tobacco use behaviors; measures, methods, or study designs to assess the likely impact of novel and/or potential modified risk tobacco products on tobacco behavior, including perceptions, susceptibility, experimentation, adoption, switching, and use (including dual use); measures (e.g., attitudes, perceptions, intentions) to best predict future behaviors of non-cigarette tobacco product use, including current and established users of cigars, waterpipe, and ENDS.

    Communications – Understanding how to effectively communicate to the public and vulnerable populations regarding nicotine and the health effects of tobacco products, including media campaigns, and digital media. Priorities include messages to effectively communicate about nicotine and the harms of non-cigarette tobacco product use; methods and messages for communicating complex scientific concepts to the general public, including risk and harms of tobacco use taking into account unintended consequences.

    Marketing Influences – Understanding why people become susceptible to using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation to regular use and dual use. Topics may include tobacco industry marketing such as advertising, point-of-sale, digital media, and promotions. Priorities include methods, measures, and study designs to best assess the impact of tobacco product advertising, and promotion restrictions on users and non-users of tobacco including marketing of novel and/or potential modified risk tobacco products ; impact of potential marketing restrictions on youth experimentation, initiation, use and cessation.

    Impact Analysis – Understanding impact of potential FDA regulatory actions. Priorities include evaluation of policies at the state and community level that fall within FDA CTP regulatory authorities; methods and measures (e.g., behavioral economics, population modeling) to estimate the range of potential impacts on behavior and health of potential FDA regulatory actions such as products standards addressing toxicity, appeal, and addiction.

    The term "characteristic" used above, encompasses materials, ingredients (including additives and flavors), design, composition, heating source and other features of a tobacco product including harmful and potentially harmful constituents. Product characteristics can be incorporated into all of the above topics. 

    Applications may focus on one or more classes of tobacco products. If a vulnerable population will be included, applicants will be expected to identify the population and how the population is important to the research question, taking into account the impact on population health. Vulnerable populations include:

    • Youth and young adults
    • Race/ethnicity
    • Low SES
    • Rural populations
    • People with mental health or medical co-morbidities
    • Military/veterans
    • The LBGTQ community
    • Pregnant women/women of reproductive age

    NON-RESPONSIVE RESEARCH TOPICS

    Although the following research topics may be within FDA CTP's regulatory authorities to fund, they are not covered by this FOA and will be deemed non-responsive:

    • Studies of short term health effects and/or acute topography/clinical pharmacology testing of early generation ENDS products
    • Mechanistic studies/basic science of disease development unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome
    • Short-term studies of the acute effects of reduced nicotine content cigarettes
    • When addressing chronic toxicity, short-term studies (i.e., 90 days or less) of acute or subchronic toxicity without a rationale explaining how shorter studies are relevant to long-term effects
    • Graphic health warnings for cigarette packages and advertisements
    • Communicating harmful and potentially harmful constituents to the public
    • Impacts of marketing restrictions on adults
    • Descriptive studies of demographics and/or risk perceptions that describe only exposure to advertising without linking exposure to tobacco use behaviors

    Projects must propose research aims that are within the regulatory authority of FDA CTP and the scientific interest areas identified in this FOA in order to be considered responsive to this FOA. Research proposed must be specific to the United States population and provide information that will be useful to United States regulations. As such, investigators are strongly encouraged to discuss whether their application is responsive to this FOA with a Scientific/Research Contact, listed in Section VII, prior to submission of their application. Additional information, including research priorities and a Frequently Asked Questions document can be found at: http://prevention.nih.gov/tobacco/.

    SPECIAL CONSIDERATIONS

    Applicants should keep the following special considerations in mind as they prepare their applications:

    • Data Harmonization for Tobacco Regulatory Research via the PhenX Toolkit: NIH and FDA encourage 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 Tobacco Regulatory Research Collection of the PhenX Toolkit (www.phenxtoolkit.org).
    • Tobacco Industry Funding of Applicants: The FDA CTP has adopted the following guidance regarding tobacco industry funding of applicants responding to this FOA.
    • The National Advisory Council on Drug Abuse (NACDA) has set forth points 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 (https://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-tobacco-industry-funding-nida) for details. While this guidance was originally issued for NIDA applicants, it is relevant for all applications submitted under this FOA.
    • Recommended Guidelines for the Administration of Drugs to Human Subjects: NACDA also 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 https://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

    See Section VIII. Other Information for award authorities and regulations.

    Special Note

    The NIH participating institutes invite K01 applications from candidates interested in pursuing careers in regulatory science as it relates to the regulation of tobacco products and the FDA's new authorities under the Family Smoking Prevention and Tobacco Control Act. Applicants are strongly encouraged to discuss whether their research ideas are responsive to this FOA with a Scientific/Research Contact listed in Section VII. Agency Contacts, and to review Frequently Asked Questions associated with this FOA at http://prevention.nih.gov/tobacco.

    Pre-Application Webinars

    The NIH anticipates holding one or more pre-application webinar to which all interested prospective applicants are invited.  NIH Program and Review staff persons will explain the goals and objectives of the Mentored Research Scientist Career Development Award in Tobacco Control Regulatory Research for research relevant to the FSPTCA, discuss the application peer review process, and answer questions.  Information about the pre-application webinars will be available at http://prevention.nih.gov/tobacco/.

    Travel

    The NIH will require awardees to travel to and participate in up to one workshop in the Washington D.C. area per year beginning in the first year and continuing through the last year of the award. The tobacco regulatory research and/or career development workshop will be organized by NIH and FDA, with the timing of the workshop at the discretion of the Government. Funds from the award must be used for this travel.

    Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA RFA-18-OD-006.

    See Section VIII. Other Information for award authorities and regulations.

    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
    Resubmission

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

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. FDA intends to commit $1 million to support 6-10 awards to this FOA and its Clinical Trial Required FOA Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Not Allowed) and Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01 - Independent Clinical Trial Required).  Awards are contingent upon funds available from the FDA 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

    FDA CTP will contribute up to $ 90,000 per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.See also NOT-OD-17-094

    The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap.  See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

    The sponsoring institution may supplement the FDA 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 HHS 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

    FDA CTP will contribute $60,000 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.

    Research expenses may include (a) tuition and fees related to career development activities; (b) supplies, equipment and technical personnel; c) travel to research and grantee meetings or training; and (d) statistical services including personnel and computer time.

    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 from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

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

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    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.

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any 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 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).

    Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), sub-projects of program project (P01), sub-projects of center grants (P50), other major individual career development awards (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), or the equivalent are not eligible. Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible, as do PD/PIs of Transition Scholar (K38) awards and individuals appointed to institutional K programs (K12, KL2).

    Candidates for the K01 award must have a research or health-professional doctoral degree.

    This funding opportunity may support individuals who propose to train in a new field or individuals who have had a hiatus in their research career because of illness or pressing family circumstances.

    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, and each is from a different candidate.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

    Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the career award application. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

    Level of Effort

    At the time of award, the candidate must have a "full-time" appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development during the mentored phase. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

    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.

    After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-09-036 for more details.  

    Mentor(s)

    Before submitting the application, the candidate must identify a mentor(s) who will supervise the proposed career development and research experience. The mentor should be an active investigator 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. At least one member of the supervisory mentoring team must have expertise in the field of tobacco research as it relates to the regulation of tobacco products and FDA's regulatory authorities. The mentor must document the availability of sufficient research support and facilities for high-quality research. 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 primary mentor who will coordinate the candidate's research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate's career stage. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

    Institutional Environment

    The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research. The institution must demonstrate a commitment to the development of the candidate as a productive, independent investigator with research projects that address research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The institution must also be willing to allow the protected time needed by the candidate. The candidate, mentor(s), and institution must describe a research career development program that will maximize the use of this environment, including available facilities and resources.

    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

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

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

    Letter of Intent

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

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

    Descriptive title of proposed activity

    Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

    Names of other key personnel

    Participating institution(s)

    Number and title of this funding opportunity

    The letter of intent should be emailed to:

    Tobacco Regulatory Science Program
    Email: TRSP@nih.gov

    Or if you prefer you may mail it to:

    Tobacco Regulatory Science Program
    Office of Disease Prevention
    6100 Executive Blvd.
    Room 3B01, MSC 7530
    Bethesda, MD 20892-7530 (use Rockville, MD 20852 for Express Mail) 
    Telephone: 301-451-7464
    Fax: 301-480-2230

    Page Limitations

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF 424 (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.   

    Other Project Information

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

    Keep the text below for K22 (mentored and independent) and K99.  For other activity codes, modify, delete, or add instructions as needed.  Do not add information already in SF424:

    SF424(R&R) Senior/Key Person Profile Expanded

    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

    PHS 398 Cover Page Supplement

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

    PHS 398 Career Development Award Supplemental Form

    The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

    •         Candidate
    •         Research Plan
    •         Other Candidate Information
    •         Mentor, Co-Mentor, Consultant, Collaborators
    •         Environment & Institutional Commitment to the Candidate
    •         Other Research Plan Sections
    •         Appendix

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

    Candidate Section

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

    Candidate Information and Goals for Career Development

    Candidate's Background

    • Describe the candidate's commitment to a career in tobacco regulatory science. Describe all the candidate's professional responsibilities in the grantee institution and elsewhere and describe their relationship to the proposed activities on the career award.
    • Describe prior training and how it relates to the objectives and long-term career plans of the candidate.
    • Describe the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
    • Provide evidence of the candidate's potential to develop into an independent investigator.
    • Describe the candidate's commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIH and tobacco regulatory science as it relates to the FDA CTP tobacco regulatory authorities.

    Career Goals and Objectives

    Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status;    (2) justifies the need for further career development to become an independent investigator in tobacco regulatory science; and (3) utilizes the relevant research and educational resources of the institution.

    Candidate's Plan for Career Development/Training Activities During Award Period

    • The candidate and the mentor are jointly responsible for the preparation of the career development plan.  A career development timeline is often helpful. The mentor and any co-mentor may form a mentoring team to assist with the development of a program of study or to monitor the candidate's progress through the career development program.
    • The didactic (if any) and the research aspects of the plan must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals.
    • Describe the professional responsibilities/activities including other research projects beyond the minimum required 9 person-months (75% full-time appointment ) commitment to the career award.  Explain how these responsibilities/activities will help ensure career progression to achieve independence as a tobacco regulatory science investigator.
    • The career development plan must be tailored to the needs of the individual candidate and the ultimate goal of achieving independence as a tobacco regulatory science researcher.
    • The career development plan must be tailored to the needs of the individual candidate with the ultimate goal of achieving independence as a researcher and must include travel and participation in one workshop in the Washington D.C. area per year beginning in the first year and continuing through the last year of the award with the timing of the workshop at the discretion of the Government. Awardees must also plan to travel to and participate in at least one conference or tobacco regulatory science workshop annually where in later years they will be expected to present their research.
    • A plan should be presented to assist the candidate in preparing an application for independent research support in the third year of the award.

    Research Plan Section

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

    Research Strategy

    • A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate the quality of the candidate's research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
    • In order to be considered responsive, the proposed research must focus on one or more of the seven FDA Center for Tobacco Products (CTP) research interest priorities. As this FOA is funded by the NIH via support from the FDA CTP, all research conducted through this mechanism must fall within the regulatory authority of the FDA CTP. Indicating how your career plan will address one or more of the seven FDA CTP research priorities is strongly advised.
    • The research should address an important problem or a critical barrier to progress in the field of tobacco regulatory science.
    • The application must also describe the relationship between the mentor's research and the candidate's proposed research plan.If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

    Training in the Responsible Conduct of Research

    • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

    Mentor, Co-Mentor, Consultant, Collaborators Section

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

    Plans and Statements of Mentor and Co-mentor(s)

    • The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program.  The candidate may also nominate co-mentors as appropriate to the goals of the program. 
    • The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
    • The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
    • Include a statement that the candidate will commit at least 9 person-months (75% of full-time appointment ) to the career development program and related career development activities.
    • The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of his/her career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate's research, publications, and progression towards independence.
    • The primary mentor should have research expertise in tobacco as it relates to the regulation of tobacco products and FDA's regulatory authorities.  Or if co-mentors are identified to jointly supervise the candidate, at least one mentor should have research expertise in the field of tobacco research as it relates to the regulation of tobacco products and FDA's regulatory authorities.
    • Similar information must be provided by any co-mentor.  If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described.  Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
    • The mentor must agree to provide evaluations of the candidate's progress as required in the mid-year and annual progress reports.
    • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

    Letters of Support from Collaborators, Contributors and Consultants

    • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
    • Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

    Environmental and Institutional Commitment to the Candidate

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

    Description of Institutional Environment

    • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
    • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

    Institutional Commitment to the Candidate's Research Career Development

    • The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent tobacco regulatory science investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
    • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest and also specifically to tobacco regulatory research that will inform CTP regulatory authorities, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
    • The applicant institution must demonstrate or give reasonable assurances that it has the capacity to prepare the applicant for a career in tobacco regulatory science.
    • Provide assurances that the candidate will be able to devote the required effort to activities under this award.The remaining effort should be devoted to activities related to the development of the candidate's career as an independent scientist.
    • Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.

    Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. The research findings generated from this FOA may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.  If the research data are cited publicly in support of regulation, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in 2 CFR 200 (http://gpo.gov/fdsys/pkg/CFR-2015-title2-vol1/pdf/CFR-2015-title2-vol1-part200.pdf) and Section 2.3.11.2.2 of the NIH Grants Policy Statement.

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

    Appendix

    Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

    PHS Human Subjects and Clinical Trials Information              

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    • Do not complete Section 4 – Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

    Delayed Onset Study

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

    PHS Assignment Request Form

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

    Reference Letters

    Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and Times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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. and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.  Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. 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.

     Awards funded under this FOA are not subject to SNAP authorities and do not have authority for the carryover of unobligated balances from budget period to any subsequent budget period without prior written approval from NIH.  Special reporting requirements also apply, as described in Section VI.3. Reporting.  

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

    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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive to the scientific interest areas identified in this FOA, and/or proposing work outside FDA-CTP's regulatory authority will not be reviewed.

    In order to expedite review, applicants are requested to notify the Tobacco Regulatory Science Program by email at TRSP@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    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.

    For this particular announcement, note the following: Reviewers should evaluate the candidate's potential for developing an independent tobacco regulatory science research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

    Overall Impact

    Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate's potential for a productive, independent scientific research career in a health-related field, 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

    • Does the candidate have the potential to develop as an independent and productive researcher?
    • Are the candidate's prior training and research experience appropriate for this award?
    • Is the candidate's academic, clinical (if relevant), and research record of high quality?
    • Is there evidence of the candidate's commitment to meeting the program objectives to become an independent investigator in research?
    • Do the reference letters address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator?

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

    • What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
    • Are the candidate's prior training and research experience appropriate for this award?
    • Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
    • Are there adequate plans for monitoring and evaluating the candidate's research and career development progress?
    • Are plans to integrate the candidate into the tobacco regulatory research community and present the research findings to the research community appropriate?
    • Are there adequate plans to assist the candidate in preparing an application for independent research support in the third year of the award?
    • If proposed, will the clinical trial experience contribute to the applicant's research career development?

    Research Plan

    • Is there a strong scientific premise for the project?
    • Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
    • Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
    • Are the proposed research question, design, and methodology of significant scientific and technical merit?
    • Is the research plan relevant to the candidate's research career objectives?
    • Is the research plan appropriate to the candidate's stage of research development and as a vehicle for developing the research skills described in the career development plan?
    • Will the proposed research lead to an independent line of research for the candidate?
    • How will successful completion of the aims affect the concepts, methods, and technologies related to the manufacture, distribution, and marketing of tobacco products?
    • If proposed, will the clinical trial experience contribute to the research project?

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

    • Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
    • Does the mentor(s) adequately address the candidate's potential and his/her strengths and areas needing improvement?
    • Is there adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate?
    • Is the mentor's description of the elements of the research career development activities, including formal course work adequate?
    • Is there evidence of the mentor's, consultant's, and/or collaborator's previous experience in fostering the development of independent investigators?
    • Is there evidence of the mentor's current research productivity and peer-reviewed support?
    • Is active/pending support for the proposed research project appropriate and adequate?
    • Are there adequate plans for monitoring and evaluating the career development awardee's progress toward independence?
    • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

    Environment & Institutional Commitment to the Candidate

    • Is there clear commitment of the sponsoring institution to ensure that a minimum of 9 person-months (75% of the candidate's full-time appointment) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities?
    • Is the institutional commitment to the career development of the candidate appropriately strong?
    • Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
    • Is the environment for the candidate's scientific and professional development of high quality?
    • Is there assurance that the institution intends the candidate to be an integral part of its research program as an independent investigator?
    Additional Review Criteria

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

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Children 

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

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

    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

    All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant's career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow's instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once 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. See also: NOT-OD-10-019.

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    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:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    •               Will receive a written critique.

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

    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:

    •         Scientific and technical merit of the proposed project as determined by scientific peer review.
    •         Availability of funds.
    •         Relevance of the proposed project to program priorities.
    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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

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

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    2. Administrative and National Policy Requirements

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor's Report must include an annual and mid-year evaluation statement of the candidate's progress.

    A final RPPR, 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.

    A mid-year report will be due every six (6) months following the project start date, as well as the annual progress report. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The scientific summary should be a maximum of two (2) pages.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    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

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    NCI Contact for Matters Concerning the K01 Mechanism

    Sergei Radaev, PhD
    National Cancer Institute (NCI)
    Telephone: 240-276-5630
    Email: sergei.radaev@nih.gov

    NCI Contact for Scientific Questions

    Rachel Grana Mayne, PhD
    National Cancer Institute (NCI)
    Telephone: 240-276-5899
    Email: rachel.mayne@nih.gov

    NIEHS Contact for Matters Concerning the K01 Mechanism

    Carol Shreffler, PhD
    National Institutes of Environmental Sciences (NIEHS)
    Telephone: 984-287-3322
    Email: carol.shreffler@nih.gov

    NIEHS Contact for Scientific Questions

    Fred Tyson, PhD
    National Institutes of Environmental Sciences (NIEHS)
    Telephone: 984-287-3334
    Email: fred.tyson@nih.gov

    NHLBI Contact for Matters Concerning the K01 Mechanism

    Lora Reineck, MD
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0222
    Email: lora.reineck@nih.gov

    NHLBI Contact for Scientific Questions

    Lisa Postow, PhD
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-877-7843
    Email: lisa.postow@nih.gov

    NIDA Contact for Matters Concerning the K01 Mechanism

    Michele Rankin, PhD
    National Institute of Drug Abuse (NIDA)
    Telephone: 301-480-3832
    Email: michele.rankin@nih.gov

    NIDA Contact for Scientific Questions

    Mary Kautz, PhD
    National Institute of Drug Abuse (NIDA)
    Telephone: 301-443-3206
    Email: mary.kautz@nih.gov

    Peer Review Contact(s)

    Weijia Ni, PhD
    Center for Scientific Review (CSR)
    Telephone: 301-594-3292
    Email: weijia.ni@nih.gov

    Financial/Grants Management Contact(s)

    Carol Perry
    National Cancer Institute (NCI)
    Telephone: 240-276-6282
    Email: carol.perry@nih.gov

    Judy Sint
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-480-1307
    Email: judy.sint@nih.gov

    Michelle Victalino
    National Institutes of Environmental Sciences (NIEHS)
    Telephone: 919-316-4666
    Email: michelle.victalino@.nih.gov

    Amy Bucheimer
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-827-6694
    Email: amy.bucheimer@nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.  

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