and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) U.S. Food and Drug Administration (FDA) |
Office of Disesae Prevention (ODP) |
|
Funding Opportunity Title |
Mentored Research Scientist Career Development Award in Tobacco Control Regulatory Research (K01) |
Activity Code |
K01 Research Scientist Development Award - Research & Training |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-OD-13-014 |
Companion Funding Opportunity |
RFA-OD-13-015,
K22 Career Transition Award |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.077 |
Funding Opportunity Purpose |
The purpose of the Mentored Research Scientist Career Development Award in Tobacco Control Regulatory Research (K01) is to provide support and protected time (three, four, or five years) for an intensive, supervised career development experience in research 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. Participating NIH Institutes invite K01 applications from postdoctoral fellows with a research or health-professional doctoral degree in biomedical or behavioral sciences and they should be pursuing careers in research areas supported by the NIH to address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The awards under this FOA will be administered by NIH using funds made available through the CTP and the FSPTCA (P.L. 111-31). |
Posted Date |
June 28, 2013 |
Open Date (Earliest Submission Date) |
September 2, 2013 |
Letter of Intent Due Date(s) |
September 2, 2013 |
Application Due Date(s) |
(Extended to November 1, 2013 per NOT-OD-14-003), OriginallyOctober 2, 2013, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date." Use of this language is being encouraged. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
February 2014 |
Advisory Council Review |
May 2014 |
Earliest Start Date |
July 2014 |
Expiration Date |
(Extended to November 2, 2013 per NOT-OD-14-003), OriginallyOctober 3, 2013 |
Due Dates for E.O. 12372 |
Not Applicable |
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
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
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.
There is an urgent need for 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. 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. The objective of the Mentored Research Scientist Development Award in Tobacco Regulatory Science (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 or behavioral sciences that leads to research independence. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers in science that informs the regulation of tobacco products and become competitive for new research project grant (e.g. R01) funding.
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.
The FDA and NIH share interest in supporting research that could inform FDA's regulatory authorities over the manufacture, marketing, and distribution of tobacco products. 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.
The research encouraged by this FOA is expected to inform the development and evaluation of tobacco product regulations. Although a vast and sound science base exists with regard to numerous areas related to the FSPTCA, new research will provide additional science for the FDA to consider as it implements the FSPTCA.
Science will inform the FDA in regulation of the manufacture, marketing, and distribution 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 ten FDA CTP interest areas. Research consistent with the scope of this FOA includes the following ten FDA CTP interest areas. Only applications proposing research projects relevant to one or more of these ten areas will be considered for funding.
1. Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation, relapse)
2. Cigar (small, large, cigarillos) initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence and toxicity
3. Smokeless tobacco initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence and toxicity
4. E-cigarettes initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence, toxicity
5. Other tobacco product (e.g., hookah, pipes, dissolvables) initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence, toxicity
6. The impact of tobacco product characteristics, (e.g., ingredients, constituents, components, additives such as flavors, and labeling and marketing) on initiation, especially among youth and other vulnerable populations
7. Toxicity thresholds for each of the 20 harmful and potentially harmful constituents identified in the March 2012 Guidance for Industry http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm297752.htm
8. Computational/mathematical modeling and simulation and/or statistical modeling of the public health impact of FDA/CTP regulation of potential modified risk tobacco products, e.g., product standards, communications regarding risks of tobacco products
9. Consumer perceptions of tobacco products including the impact of labeling and marketing
10. Effective communication strategies regarding harmful and potentially harmful constituents and risks of tobacco products
Vulnerable populations referenced in research questions include, but are not limited to age, gender, race, ethnicity, income, occupation, geographic location, people with mental health or medical co-morbidities, the military/veterans, the lesbian, gay, bi-sexual, transgendered, questioning (LGBTQ) community, and pregnant women/women of reproductive age.
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 Conference Call
The NIH anticipates holding one or more pre-application conference calls or web-based teleconferences 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 conference calls will be available at http://prevention.nih.gov/tobacco/.
Travel
The NIH will also require awardees to travel to and participate 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. 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.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
|
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. Funds allocated by the FDA CTP for this FOA are expected to be approximately $1.0M. The NIH expects to make 6-8 awards, 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. |
Salary |
FDA will contribute up to $90,000 plus fringe benefits per year toward the salary of the career award recipient. Mentored career awards require the candidate to devote a
minimum of 9 person-months (75% of full-time professional effort) to
conducting health-related research. The remaining effort may be devoted to
other research pursuits and activities consistent with the objectives of the
award. For information regarding NIH policy on determining full-time
professional effort for career awards, see NOT-OD-04-056. |
Other Program-Related Expenses |
FDA 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 development costs may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.
|
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.
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
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.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.
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 or co-mentors 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),
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 career development awards (K awards), or the equivalent are not eligible. 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.
Candidates for this award must have a research or health-professional doctoral degree or equivalent.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Candidates may submit research project grant (RPG)
applications concurrently with the K application. However, any concurrent RPG
application may not duplicate the provisions of 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.
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.
Before submitting the application, the candidate must identify a primary mentor who will supervise the proposed career development and research experience. The primary mentor and a co-mentor may be identified to jointly supervise the candidate (the supervisory mentoring team). 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. Candidates are encouraged to identify additional mentors, i.e., to add to the mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. However, the primary mentor or if jointly supervised, the supervisory mentoring team, will have the role of and responsibility for coordinating the candidate's research and career development. All mentors should be active investigators in research relevant to the proposed areas of research, with established research productivity, and committed both to the career development of the candidate and to the direct supervision of the candidate’s research. They must document the availability of sufficient and appropriate research support for all members of the mentoring team.
The candidate must work with the mentor(s) in preparing the application. The mentor(s) should describe the career development plan for the candidate (coordinated with the candidate’s research strategy). The description of the career development plan should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g., grant-writing and making effective presentations, is required. The mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, etc.) must also be described.
The mentor(s) should clearly describe how they will coordinate mentoring of the candidate. If any 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 personal meetings. The application must include a statement from the mentor or co-mentors providing a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the Scholar’s scientific and professional independence will be promoted.
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 and behavioral 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.
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.
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.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
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
Email: [email protected]
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Candidate Information
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate s Background
Career Goals and Objectives
Career Development/Training Activities During Award Period
Training in the Responsible Conduct of Research
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.
Statements of Support
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Statements by Mentor, Co-mentor(s), Consultants, Contributors
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
Research Plan
All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:
Research Strategy
Resource Sharing Plan
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 research data are cited publically, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in Revised Circular A-110 (http://www.whitehouse.gov/omb/circulars_a110/).
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.
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). 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.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
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.
This initiative is not subject to intergovernmental review.
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.
Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the
application due date. Section III. Eligibility
Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying
Electronically.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by FDA and components of participating organizations, NIH. Applications that are incomplete and/or non-responsive will not be reviewed. Applicants are strongly encouraged to discuss whether their research ideas are responsive to this FOA with a Scientific/Research Contact listed in Section VII, and to review Frequently Asked Questions associated with this FOA at http://prevention.nih.gov/tobacco.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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.
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 score.
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? 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? Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?
Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring
What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading 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?
Research Plan
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 stage of research development and as a vehicle for
developing the research skills described in the career development plan? If
applicable, are there adequate plans for data and safety monitoring of clinical
trials? Are the overall strategy, methodology, and analyses well-reasoned and
appropriate to accomplish the specific research aims of the project? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and are risky aspects addressed? Does the
project address an important issue or a critical barrier in the field? If
the aims of the project are achieved, how will scientific knowledge and/or
technical capability be improved? How will successful completion of the aims
affect the concepts, methods, and technologies related to the manufacture,
distribution, and marketing of tobacco products?
Mentor(s), Co-Mentor(s),
Consultant(s), Collaborator(s)
Are the primary mentor's research qualifications in
the area of the proposed research appropriate? Do(es) 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, collaborator’s previous experience in fostering the
development of independent investigators? Is there evidence of previous 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?
Environment & Institutional
Commitment to the Candidate
Is there clear commitment of the sponsoring
institution to ensure that the required minimum of the candidate’s effort will
be devoted directly to the research 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 scientific and professional development of
the candidate of high quality? Is there assurance that the institution intends
the candidate to be an integral part of its research program?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: (1) risk to
subjects, (2) adequacy of protection against risks, (3) potential benefits to
the subjects and others, (4) importance of the knowledge to be gained, and (5)
data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: (1) the justification for the exemption, (2) human
subjects involvement and characteristics, and (3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Training in the Responsible Conduct of Research
Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research and travel requirements.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned 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. Council approved applications will be provided to FDA by the NIH Tobacco Regulatory Science Program (TRSP) in Impact score order in a Funding Plan. TRSP will notify the NIH ICs of approved applications for funding. The following will be considered in making funding decisions:
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.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
Any application awarded in response to this FOA will also
require awardees to participate in conference calls or webinars as needed.
Telephone conferences and/or webinars will be set up by the NIH awarding
institutes with awardees on an as needed basis in order to keep all awardees
informed of progress, events, issues, or new resources for tobacco regulatory
research and career development.
Awardees will also be asked to travel to and participate 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. This workshop will be on tobacco regulatory research and/or career development, which NIH and the Tobacco Regulatory Science Program (TRSP) will organize, with the timing of the workshop at the discretion of the Government. Funds from the award must be used for this travel. Awardees will be informed as early as possible to allow them to reserve time in their schedule, make necessary travel arrangements, and prepare for posters. Awardees must also plan to travel to and participate in at least one conference or workshop annually where in latter years they will be expected to present their research. Funds from the award must also be used for annual travel to a conference or workshop.
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.
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 publically, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in Revised Circular A-110 (http://www.whitehouse.gov/omb/circulars_a110/) and section 2.3.11.2.3 of the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch2.htm#info_confidentiality).
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.
Requirement for Interim Reports
In addition to the annual reports, Interim Reports will be due six months following the project start date and six months from the beginning of the budget period every year of award. Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The Interim Report will use the Non-Competing Continuation Progress Report; PHS 2590 (Revised 06/2009) http://grants.nih.gov/grants/funding/2590/2590.htm. The Interim Report should include: Form Page 1, Form Page 1-Continuation, Project/Performance Site Format Page - use only if additional space is needed; Form Page 5: Progress Report Summary (which must include the Mentors' Report) and Continuation Page as needed. The scientific summary should be a maximum of two (2) pages.
Other Reporting Requirements
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Telephone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Beth Babecki
National Institue on Drug Abuse (NIDA)
Telephone: 301-435-0899
Fax: 301-594-6043
Email: [email protected]
Jeanette F. Korczak, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5642
Email: [email protected]
Abraham P. Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9737
Email: [email protected]
Carol Shreffler, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1445
Email: [email protected]
Raymond Jacobson, Ph.D.
Center fpr Scientific Review (CSR)
Telephone: 301-996-7702
Email: [email protected]
Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]
Tracie H. McGraw
National Cancer Institute (NCI)
Telephone: 301-631-3020
E-mail: [email protected]
Carol Alderson
National Institute on Drugy Abuse (NIDA)
Telephone: 301-933-6196
Email: [email protected]
Wanda Boggs
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4638
E-mail: [email protected]
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.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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NIH Funding Opportunities and Notices
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