and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
Office of Disease Prevention (ODP) |
|
Funding Opportunity Title |
Pathway to Independence Award in Tobacco Control Regulatory Research (K99/R00) |
Activity Code |
|
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-OD-13-016 |
Companion Funding Opportunity |
RFA-OD-13-014,
K01 Mentored Research Scientist Award |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.077 |
Funding Opportunity Purpose |
The purpose of the Pathway to Independence Award in Tobacco Control Regulatory Research (K99/R00) is to increase and maintain a strong cohort of new and talented independent investigators conducting research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. The program is designed to facilitate a timely transition from a mentored postdoctoral research position to a stable independent research position with independent NIH or other independent research support at an earlier stage than is currently the norm. 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 and Centers invite K99/R00 applications from postdoctoral researchers no more than 4 years from having received their doctorate at the time of application (with a research or health-professional doctoral degree or equivalent) in biomedical or behavioral sciences who are 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. |
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.
The objective ofthe Pathway to Independence Award in Tobacco Control Regulatory Research (K99/R00) award is to support postdoctoral investigators during their transition to independent research positions. NIH believes that the creativity and innovation of new independent investigators in their early career stages play an integral role in addressing our Nation s biomedical, behavioral, social science and clinical research needs. The intent of the K99/R00 program is to assist new investigators who have no more than 4 years of postdoctoral research training experience at the time of initial application and do not already have a full-time tenure track assistant professor position (or equivalent). The goal is to transition to stable, independent research positions at an earlier age and with an enhanced probability of success in obtaining independent NIH or other independent research support conducting research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. These include investigators at domestic extramural institutions/organizations, as well as investigators working in Federal research groups.
The expectation is that, through this sustained period of research career development and transition, awardees will launch independent research careers in science that informs the regulation of tobacco products and become competitive for new research project grant (R01 or equivalent) 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 Family Smoking Prevention and Tobacco Control Act (FSPTCA).
Program Scope and Research Objectives
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.
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. 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.
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 K99/R00 applications from postdoctoral investigators who are no more than 4 years postdoctorate and who are 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 Pathway to Independence 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 $1.5M. The NIH expects to make 10-12 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 |
Allowable Costs: Mentored Phase (K99) FDA will contribute up to $90,000 per year toward the salary of the K99 award recipient. Applicants may request higher salary in cases of individuals with exceptional salary needs. Candidates (intramural or extramural) are required to commit a minimum of 75% of full-time professional effort (i.e. minimum of 9 person-months) to the pursuit of their career development and research experience during the mentored phase. This experience may also include activities such as completing research publications and searching for an independent research position. Candidates may engage in teaching and/or clinical duties as part of the remaining 25% of the candidate’s 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. Intramural: The requests by NIH intramural scientists will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to research support or administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). Applicants should indicate the number of person-months devoted to the project. If selected, appropriate funding will be provided by the FDA Center for Tobacco Products. The intramural scientist should submit a separate request for intramural funding as described above. Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory Institute/Center and salary will be consistent with that offered new scientists in similar positions. Extramural: Mentored candidates in an extramural sponsoring institution/organization will be supported by NIH extramural funds. Salary must be consistent with the established salary structure at the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. Fringe benefits should be requested based on the sponsoring institution’s rate. The extramural sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may additional PHS funds beyond those provided in the K99 award be used for salary supplementation. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary paid from NIH funds, however, may not exceed the legislatively mandated salary cap. See http://grants.nih.gov/grants/policy/salcap_summary.htm. For information regarding NIH policy on determining full-time professional effort for career awards see NOT-OD-04-056. The requested salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members with equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure. Confirmation of salary is required prior to the issuance of an award. Fringe benefits based on the sponsoring institution’s rate and the percent of effort are provided in addition to the salary. Allowable Costs: Independent Phase (R00) The total cost for the independent investigator phase (R00) may not exceed $249,000 per year. This amount includes salary, fringe benefits, research support allowance and applicable indirect costs. Indirect costs will be reimbursed at the extramural sponsoring institution’s indirect cost rate. Indirect costs requested by consortium participants are included in the total cost limitation. The salary requested should be based on the person-months effort to be devoted to the R00 project, as is the case for other research grant awards. The candidate is required to devote a total of 75% of their full-time, 12 month professional effort to research (i.e., a full-time 9 person-months). See eligibility below. However, it may not be feasible to support this entire effort through the R00 project alone. Recipients of the R00 phase awards may devote effort to other research projects and may reduce effort on the R00 award if they receive additional independent research support. Please note that a reduction of time devoted to a project by 25% or more from the level in an approved application will require NIH prior approval as described in the NIH Grants Policy Statement. |
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 expenses may include (a) tuition and fees related to career development; (b) supplies, equipment and technical personnel; c) travel to research 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 |
For the extramural K99 phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. For the R00 phase, indirect costs will be reimbursed at the extramural sponsoring institution’s indirect cost rate. |
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
Governments
The applicant institution will be the mentored phase (K99) institution. All institution/organization types listed above are eligible for both the mentored and independent phase, with one exception: eligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase.
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 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), or for non-U.S.
citizen/permanent residents, requirements are described below.
For non-U.S. citizen/permanent residents, the applicant U.S.
institution for each phase of the application (K99 or R00) is responsible for
determining and documenting in the application that the applicant
investigator’s visa will allow him or her to remain in this country long enough
to (a) transition to an independent research career in the U.S. during the
proposed mentored (K99) phase and/or (b) be productive on the research project
in the U.S. for the duration of the proposed independent research (R00) phase.
Individuals are NOT eligible if they:
Candidates must have a clinical or research doctorate (including PhD, MD, DO,
DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees). Clinicians
(including those with MD, DDS, DVM and other licensed health professionals) in
a clinical faculty position that denotes independence in clinical
responsibilities but not in research may also be eligible for the K99/R00
award.
Some institutions appoint postdoctoral fellows in positions with other titles
although they are still in non-independent training positions. Candidates in
such positions are encouraged to obtain confirmation of their eligibility
before they begin to prepare their applications. It is incumbent upon the
candidate to provide evidence that the position he/she is in complies with the
intent of this eligibility requirement. Evidence for non-independence may
include:
Conversely, evidence for independence, and therefore lack of eligibility, includes:
Clinicians (including those with MD, DDS, DVM and other licensed professionals)
in positions not designated as postdoctoral positions: Following clinical
training or fellowship training periods, clinicians often obtain a clinical
faculty position that denotes independence in clinical responsibilities but not
in research. A clinical faculty member who does not hold an independent
research faculty position may be eligible for the K99/R00 award and should
contact a Program Director at the relevant NIH Institute for guidance.
Clinicians in such positions are encouraged to obtain confirmation of their
eligibility before they begin to prepare their applications. Such individuals
may also wish to consider other career awards (e.g., K08, K23) available for
junior faculty development.
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.
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.
Project Summary/Abstract
Include a description of your current research and the research you propose to continue in the independent phase.
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.
Awardees will 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 (the last R00 year). Awardees must also plan to travel to and participate in at least one conference or workshop annually. Applications should request funds for this required travel.
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.
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.
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
What is the candidate's record of research
productivity, including the quality of peer-reviewed scientific publications?
Based on the postdoctoral candidate's experience, track record and prior
research training, does the candidate have the potential for becoming a
successful independent investigator who will contribute significantly to a
chosen health-related research field? Will the research experiences in the
mentored phase prepare the candidate to implement successfully the independent
phase research project?
Career Development Plan/ Career Goals
& Objectives
Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate including his/her successful transition to independence? To what extent are the plans for evaluating the K99 awardee’s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award? Are the contents and duration of the proposed plan, and the timeline for the transition to the independent phase of the award appropriate for the candidate's current stage of scientific and professional development and the career development proposed for the K99 phase of the award?
Research Plan
Is the proposed K99 phase research significant? Are the scientific and technical merits of the K99 research question, experimental design and methodology appropriate for the candidate's level of training, an appropriate vehicle for developing the research skills described in the career development plan, and appropriate for developing a highly successful R00 research program? Is the proposed R00 phase research scientifically sound and a logical extension of the K99 phase research? Is there evidence of long-term viability of the proposed R00 phase research plan? To what extent is the proposed R00 phase research likely to foster the career of the candidate as an independent investigator in tobacco regulatory research?
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Are the 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?
To what extent does the mentor have a strong track
record in training future independent researchers?
To what extent are the mentor's research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant's career development needs in order to foster his/her development into a productive tobacco regulatory science researcher?
Is the proposed supervision that will occur during the mentored phase of support adequate, and is the commitment of the mentor(s) to the applicant's continued career development appropriate?
Does the mentor have a comprehensive plan to support the proposed K99 phase career development and research plans as well as the candidate’s efforts to transition to independence?
Is this plan adequate and appropriate? When applicable, are the consultants'/collaborators' research qualifications appropriate for their roles in the proposed K99 phase of the award?
Environment & Institutional Commitment to the Candidate
What evidence is provided that the K99 sponsoring institution is strongly committed to fostering the candidate’s development and transition to the independent (R00) phase?
Is there clear commitment of the sponsoring institution to ensure that the required minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research training, career development and research activities described in the proposed career development and research plans?
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?Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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.
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 for the Pathway to Independence Award in Tobacco Control Regulatory Research K99/R00 award will be assigned to the appropriate participating NIH Institute or Center on the basis of established PHS referral guidelines. 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 respective NIH Advisory Councils. Council approved applications will be provided to FDA by the NIH Tobacco Regulatory Science Program (TRSP) by impact score order in a Funding Plan. TRSP will notify the NIH ICs of approved applications for funding.
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.
If selected for funding, a Notice of Award (NoA) will be issued and the mentored training phase will begin. Transition to the independent R00 phase is not automatic. Upon securing a tenure-track faculty position, or its equivalent, an updated R00 application for the independent phase with a revised budget will be submitted by the new sponsoring institution to NIH. NIH together with the FDA CTP will review the R00 application to ensure that all programmatic requirements have been met prior to issuance of the independent R00 phase award.
There will not be a formal Notice of Award (NoA) associated with the K99 phase of the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which will include the terms and conditions of the NIH intramural K99 award, as well as expectations for the transition to the R00 phase of the award.
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.
Transition from the mentored phase to the independent phase
is intended to be continuous in time and, except in unusual circumstances, the
awarding NIH Institute/Center will not extend the K99 phase beyond the 2-year
limit. To activate the independent phase of the grant, individuals must have
been offered and accepted a tenure-track, full-time assistant professor position
(or equivalent) at an eligible institution with appropriate infrastructure to
support the proposed research program and a history of external research
funding. Applicants are free to apply for independent phase positions within
the NIH intramural research program (IRP). However, should the individual
accept such a position in the IRP, the independent phase of the award will not
be activated. This is because NIH intramural scientists are supported directly
by NIH intramural funds and are not eligible for NIH extramural grant awards. Such
outcomes are consistent with the goals of the K99/R00 award initiative.
The application for the R00 phase of the award must be submitted no later than
2 months prior to the proposed activation date of the R00 award by the R00
phase grantee organization. However, to avoid potential problems in activation,
applicants are strongly encouraged to contact their NIH program official as
soon as plans to assume an independent position develop, and not later than 6
months prior to the termination of the K99 phase of the award, to discuss plans
for transition to, and the application for, the R00 phase.
The independent phase institution will submit an application on behalf of the
candidate for the R00 award using the PHS 398
Application.
The R00 application must include:
In addition, a letter from the R00 Department or Division Chairman describing the R00 institution’s commitment to the candidate and plans for his/her career development should be submitted (see below), as well as a final evaluation statement by the K99 phase mentor, if not already provided.
These materials should be sent directly to the awarding
Institute or Center (IC). Details are available at the NIH New
Investigator Program website. The original application plus one copy
(preferably in a PDF format) are to be mailed to the Financial or Grants
Management contact person of the awarding NIH Institute or Center listed in the
Notice of Grant Award. The R00 application will be evaluated by extramural
program staff of the awarding component for completeness and responsiveness to
the program.
An institutional commitment agreement will be required at the time of
activation of the independent phase of the award. This agreement should satisfy
the criteria described in the Career Development Award Section of the SF424
(R&R) Application Guide.
In addition to space, facilities, resources, and other support needed to
conduct the proposed research, the sponsoring institution must provide
protected research time (minimum of 9 person-months [75% full time professional
effort]) at least for the duration of the R00 award. The start-up package and
other institutional support must be described and should be comparable to that
given to other faculty recently hired into tenure-track or equivalent positions.
Institutions must provide a startup and salary package equivalent to that
provided to a newly hired faculty member who does not have a grant; R00 funds
may not be used to offset the typical startup package or to offset the usual
institutional commitment to provide salary for tenure-track (or equivalent)
assistant professors who are hired without grant support. The R00 sponsoring
institution should describe the candidate’s academic appointment, bearing in
mind that it must be tenure-track assistant professor (or equivalent), and
confirm that the appointment is not contingent on the transfer of the award to
the institution. The R00 phase institution must foster and support the
awardee’s ability to apply for and secure independent research grant (R01)
support.
The R00 award requires that a minimum of 9 person-months (75% full time
professional effort) be devoted to research activities. Consequently, teaching,
clinical duties and other non-research activities should be minimal during the
R00 award period. NIH staff may review start-up packages and other commitments
between the institution and candidate prior to activating the independent phase
of the award. It is suggested that the applicant and/or the hiring institution
discuss the institutional commitment with the relevant NIH institute program
official prior to submission of the R00 application. NIH will not activate the
independent phase if the institutional commitment is deemed inadequate.
Applicants who are approved to transition will receive a Notice of Award for
the R00, the dollar amount, and the new recipient organization (if applicable).
The K99/R00 award is intended to facilitate successful transition to
independence. Consequently, a requirement for activation of the R00 phase is
successful completion of this transition. Applicants are encouraged (but not
required) to apply for independent positions at departments and institutions
different from where they conducted their mentored research. It is important
for all applicants, but especially so for applicants who intend to stay at the
mentored phase institution for the independent phase, to provide a plan by
which they will separate from their mentor and advance to independence. Awardees
are also encouraged to include a plan and timeline for submitting an
independent research grant application in a research area relevant to the
mission of an NIH awarding component.
Candidates who are not approved to transition will receive written notification
from the awarding component communicating the rationale for the disapproval. This
letter typically will be sent within 60 days of receipt of the R00 application.
Although the financial plans of the NIH Institute or Center provide support for
this program, awards pursuant to this funding opportunity are contingent upon
the availability of funds.
If transition from the K99 phase at an extramural institution to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary. If the transition occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award. Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase may be permitted.
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.
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]
Jeannette 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]
Lynne Haverkos, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
Telephone: 301-435-6881
Email: [email protected]
Beth Babecki
National Institue on Drug Abuse (NIDA)
Telephone: 301-435-0899
Fax: 301-594-6043
Email: [email protected]
Lynn King, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
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 for Scientific Review
Telephone: 301-996-7702
Email: [email protected]
Tracie H. McGraw
National Cancer Institute (NCI)
Telephone: 301-631-3020
E-mail: [email protected]
Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]
Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]
Carol Alderson
National Institute on Drugy Abuse (NIDA)
Telephone: 301-933-6196
Email: [email protected]
Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]
Wanda Boggs
National Institute of Environmental
Health Sciences (NIEHS)
Telephone: 919-316-4638
Email: [email protected]
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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