Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
National Cancer Institute (NCI)
U.S. Food and Drug Administration, Center for Tobacco Products (CTP)

Funding Opportunity Title

Center for Evaluation and Coordination of Training and Research (CECTR) in Tobacco Regulatory Science (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

  • October 18, 2013 - See Notice NOT-OD-14-005. Notice Announcing Rescheduled Pre-Application Webinar.
  • September 30, 2013 - See Notice NOT-OD-13-124. Notice Announcing FAQ Page and Pre-Application Webinar.

Funding Opportunity Announcement (FOA) Number

RFA-OD-13-117

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.077 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for a Center for Evaluation and Coordination of Training and Research (CECTR) in Tobacco Regulatory Science.  The CECTR will become a national resource in tobacco regulatory science, will support and conduct an evaluation of the scientific programs funded by the Food and Drug Administration (FDA) Center for Tobacco Products (CTP), and will facilitate coordination and communications of research and scientific training within those programs. The overall objective of the CECTR is to evaluate and support training and research programs that can inform the FDA CTP in the development and evaluation of tobacco product regulatory activities and actions.  Through leadership, evaluation, coordination, and facilitation of collaborative efforts, the CECTR can accelerate the advancement of science relevant to the Family Smoking Prevention and Tobacco Control Act (FSPTCA). 

The NIH and the FDA have formed an interagency partnership to foster research relevant to FDA's tobacco regulatory authorities. The award 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.

Key Dates
Posted Date
Letter of Intent Due Date(s)

November 10, 2013

Application Due Date(s)

December 10, 2013  

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2014  

Advisory Council Review

May 2014

Earliest Start Date

July 2014

Expiration Date

December 11, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and  NIH’s Applying Electronically website for more information.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Purpose

The purpose of this funding opportunity announcement (FOA) is to solicit applications for a Center for Evaluation and Coordination of Training and Research (CECTR) in Tobacco Regulatory Science. The overall objective of the CECTR is to support and evaluate training and research programs that can assist the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) in the development and evaluation of tobacco product regulations.  Through leadership, coordination, evaluation, and facilitation of communication and collaborative efforts among tobacco regulatory science investigators, the CECTR can accelerate the identification, integration and advancement of research findings relevant to the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

CECTR evaluation and coordination will focus on the scientific programs funded by the FDA CTP, which includes the portfolio of the NIH Tobacco Regulatory Science Program  (TRSP; http://prevention.nih.gov/tobacco/portfolio.aspx), such as the Tobacco Centers of Regulatory Science (TCORS) and the awardees of the K- and R-mechanism grants (http://prevention.nih.gov/tobacco/funding.aspx), as well as other FDA CTP-funded programs such as research supported at the Centers for Disease Control and Prevention (CDC), FDA's National Center for Toxicological Research (NCTR), and research contract organizations. The objective of the overarching CTP-funded research program is to conduct research programs that will aid the development and evaluation of tobacco product regulations and address the research priorities related to the regulatory authority of the FDA CTP. The CECTR, in conjunction with the NIH and FDA CTP Program Staff and Project Scientists, will facilitate communication, evaluation, scientific coordination and collaboration, and communications among the CTP-funded programs and awardees, including, but not limited to, TCORS and other TRSP awardees, and CDC, NCTR and research contract projects.  The CECTR will support communications and operations, provide logistical support and coordination, facilitate collaboration among investigators and training awardees, and facilitate the conduct of cross-site analyses including the coordination of harmonized data collection through facilitation of secondary, translational, or other data analyses.

The award made 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 research coordinated by the CECTR is expected to provide scientific underpinnings for the FDA to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

Background

Role of the FDA in the Family Smoking Prevention and Tobacco Control Act (FSPTCA)

With the passage of the FSPTCA in June 2009, the FDA acquired the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. A tobacco product is defined as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory or a tobacco product)”.  As of June 2013, FDA’s jurisdiction of tobacco products included all cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.  It is anticipated that FDA will assert jurisdiction over all other tobacco products currently not under its jurisdiction that meet the statutory definition of “tobacco product.” (Regulation Identification Number 0910-AG38, Regulation of E-Cigarettes and Other Tobacco Products). 

Partnership between FDA and NIH in the Context of the FSPTCA

Within the framework of the Tobacco Control Act, the NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulations. These activities are coordinated by the FDA CTP and by the Tobacco Regulatory Science Program (TRSP) in the Office of Disease Prevention (ODP) at the NIH. The FDA and NIH share an interest in supporting research that could inform the development and evaluation of tobacco product regulatory activities and actions.  To that end, the research supported through TRSP and other CTP-funded research is expected to contribute to a science base to inform the FDA’s regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.  Consistent with the FDA CTP mission, this FOA seeks CECTR applications that coordinate research across seven research areas, below.

FDA Center for Tobacco Products Research Areas

The CECTR will provide evaluation, coordination and facilitation of tobacco regulatory science.  The 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.  The research studies across the CTP-funded program will be focused on the following seven CTP research areas:

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.

Projects conducted within or through the CECTR must propose research that is within the regulatory authority of the FDA CTP in order to be considered responsive to this FOA.  The research plan(s) must state how it will inform the development and evaluation of tobacco product regulatory activities and actions.   Applications that are incomplete and/or nonresponsive will not be reviewed.  As such, investigators are strongly encouraged to discuss whether their application is responsive to this FOA with a Scientific/Research Contact, listed in Section VII, prior to submission of their application. Additional information, including research priorities and a Frequently Asked Questions document can be found at: http://prevention.nih.gov/tobacco/.  

Specific Research Objectives and Requirements for the CECTR

The CECTR funded as a result of this FOA is expected to serve as the national scientific research coordinator for the establishment and advancement of a broad base of tobacco regulatory research, supporting excellence in evaluation, research, training, and leadership that will contribute to the science base FDA CTP can use to inform the development of product regulatory activities and actions to reduce tobacco-related disease, disability, and death in the United States. Within this program, the CECTR and its PD(s)/PI(s), in cooperation with NIH and FDA CTP scientific, administrative, and program staff, will serve as the nationally recognized evaluator, coordinator and facilitator of this research program, building a broad base of knowledge and resources for the advancement, dissemination and translation of tobacco regulatory science. 

The CECTR will have substantial responsibility for the evaluation of TCORS and other CTP-funded programs in tobacco regulatory science.  In consultation with the NIH and FDA CTP scientific, administrative, and program staff, the CECTR will establish an evaluation plan and desirable outcomes to determine the successful programs and research mechanisms within the CTP-funded research portfolio.  The CECTR evaluation program will also provide ongoing evaluation of research programs and feedback to enable self-correcting actions within the CTP-funded research programs and projects. 

The CECTR will encourage and support networks among CTP-funded tobacco regulatory scientists that foster communication, collaboration, and high-quality research that address the research priorities related to the regulatory authority of the FDA CTP (http://prevention.nih.gov/tobacco/research.aspx).  The CECTR will have an important role in coordinating and integrating the efforts of the TCORS to be funded under RFA-DA-13-003, including the TCORS training programs, and will also enable collaboration and consultation with other CTP-funded training awardees, investigators, and other experts conducting tobacco regulatory research.  The CECTR will be expected to provide intellectual scientific leadership as well as logistic support infrastructure for the TCORS, the TRSP program, and other CTP-funded research.  

The CECTR will work with the CTP-funded awardees and the NIH and FDA CTP scientific, administrative, and program staff to bring together expertise and data relevant to the funded research programs. The CECTR must be able to connect and build upon available expertise and infrastructure to integrate activities of the awarded research projects so as to minimize duplication, maximize the use of existing resources, and establish new resources when necessary to facilitate collaboration, data integration, and the dissemination of research findings and outcomes, and to enable new, novel research questions that can be developed and answered with integrated data.

The applicants must have appropriate professional expertise and experience in the areas defined above. The applicant institution must have the necessary facilities to meet the special requirements mentioned in the FOA.

Strategic Objectives for the CECTR

The CECTR applicant team must address the following strategic objectives and responsibilities:

1. Facilitate and support communications among and between CTP-funded research awardees and NIH and CTP scientific, administrative, and program staff. 

2.  Create and manage relevant logistic infrastructure to support all meetings and communications, including monthly or quarterly TCORS conference calls and/or web-based meetings, training symposia, and meetings of the Steering Committee, Data Coordination Committee, and other working groups and committees as established.  A key requirement for the CECTR is to plan, coordinate, convene and fund the biannual scientific meetings.

3. Support and conduct the evaluation of the scientific programs funded by the FDA CTP in conjunction with the NIH. This includes, but is not limited to, awardees of center grants (TCORS), K- and R-mechanisms, and other CTP-funded programs (e.g., CDC, FDA's NCTR); Provide the evaluation expertise and infrastructure to establish metrics, collect and analyze data, and report outcomes.

4. Coordinate and support cross-disciplinary training of CTP-funded tobacco regulatory scientists at every stage in their careers.  This will include the creation of collegial and collaborative networks among the awardees and training programs, sharing of training modules developed under these programs, and facilitating web-based participation across CTP-funded mechanisms with training components

5. Facilitate collaborative research and scientific integration across multiple research institutions and/or disciplines.  This should include the identification, adoption, and support for the use of consensus measures for shared scientific topic areas across CTP-funded research projects.  The expected outcome of this effort is to generate increased research collaborations and the generation of new, novel research questions and findings

6. Provide methodological support and expertise for data coordination, analysis, and synthesis across the TCORS and other CTP-funded research projects

7. Consolidate data and disseminate results across multiple venues, including scientific reports, workshops, seminars, websites, and collaborative manuscripts, and work with NIH and FDA CTP staff to employ the use of new technologies for collaboration and data sharing as they become available

NIH and FDA will be substantially involved with the CECTR awardees in a partnership role.  The NIH and FDA CTP scientific, administrative, and program staff will collaborate on developing procedures and management protocols, monitoring study progress, ensuring disclosure of conflicts of interest and adherence to FDA and NIH policies, and participating in data analysis and manuscript preparation as appropriate. 

Governance of the CECTR

The CECTR will be governed by the Steering Committee, to be established. The Steering Committee will oversee the activities of the CECTR, including the policies, procedures, and strategies that pertain to its work with the TCORS and other CTP-funded research programs and awardees.  These activities include, but are not limited to, identifying the approach for the evaluation plan, encouraging collaboration and pursuit of priority research topics within TCORS developmental and pilot projects, and coordinating and facilitating training and educational programs. The Steering Committee will have the ability to establish sub-committees to advise the Steering Committee. The Steering Committee will work collaboratively across its membership, comprised of representatives of the CECTR (PD(s)/PI(s)), CTP-funded PD(s)/PI(s), NIH and FDA CTP scientific, administrative, and program staff, and selected outside expert(s). The Steering Committee will also work collaboratively with any established sub-committees and working groups, including the Data Coordination Committee. The Steering Committee will identify and develop opportunities for initiatives and projects that capitalize on unique strengths and expertise of the TCORS program and the broader CTP-funded tobacco regulatory science program, and that address the needs of the FDA CTP. Examples of initiatives that could be identified include, but are not limited to, time-sensitive research opportunities, training projects, white papers, topics for annual scientific meetings, and website development and other dissemination activities.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH and FDA staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIH, via support from the FDA Center for Tobacco Products (CTP), intends to fund one award, corresponding to a total of $2 million, for fiscal year 2014. Future year amounts will depend on annual appropriations.

Award Budget

Applicants may request a budget (in total cost) up to $2 million per year.

Award Project Period

Applicants may request a project period up to five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 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.

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 (ODP)
Telephone: 301-451-7464
FAX: 301-480-2230
Email: TRSP@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Modify Form Page 3 of the PHS 398 to replace standard sub-sections of Section 3 “Research Strategy” of the PHS 398 Research Plan with the following new sub-sections A-E:

A. Overview of the Proposed Center

B. Leadership and Administrative Core

C. Evaluation Core

D. Education and Training Core

E. Analytics and Synthesis Core

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed. Provide the total budget for the initial budget period for the entire Center application by summing the individual budgets of each of the components (Leadership and Administrative Core, Evaluation Core, Education and Training Core, Analytics and Synthesis Core); i.e., the budget presented in the Overall Component should be the cumulative budget for the entire CECTR.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed. Provide the total budget for the entire proposed budget period for the entire Center application, by summing the individual budgets of each of the components (Leadership and Administrative Core, Evaluation Core, Education and Training Core, Analytics and Synthesis Core); i.e., the budget presented in the Overall Component should be the cumulative budget for the entire CECTR.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  The Specific Aims for the Overall Component should be the overall vision for the Center.  These Specific Aims should not be the same as the specific aims of the other components, but should be overarching and at a high level.

Research Strategy: Provide a concise description of the vision and proposed plan for the Center.  This section should include a concise description of the structure of the Center, including a brief management plan and organization chart with the role of the Administrative Core defined.  Explain how the CECTR cores, including key personnel, will interact, how their activities will contribute to the accomplishment of the overall Center goals, and how the organization of the components into a Center will create an entity that will result in a resource useful and important for the greater tobacco regulatory research community.

Resource Sharing Plan:Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide with the following modification:

Leadership and Administrative Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Leadership and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Leadership and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Table of Contents (Leadership and Administrative Core

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Detailed Budget for Initial Budget Period (Leadership and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Budget for Entire Proposed Period of Support (Leadership and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Biographical Sketch (Leadership and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Resources (Leadership and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Research Plan (Leadership and Administrative Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims of the Leadership and Administrative core.    

Research Strategy:  The CECTR must be able to support and coordinate the efforts of investigators, training awardees, and programs in tobacco regulatory science, and in particular provide close coordination of communication and collaborative research among the TCORS. Details on the composition and functions of TCORS are provided in RFA-DA-13-003.  This role will require strong leadership, scientific insight, capacity to bring diverse teams together, and expertise in the art and science of organization and management of science teams.  This includes connecting with other existing research initiatives and data resources outside of TCORS program (e.g., the PATH Study, CTP-funded NIH extramural and intramural research and training grants, and other CTP-funded projects via CDC, NCTR and research contract projects). 

Because of the program requirement for interactions across the TCORS research centers, the CECTR Leadership and Administrative Core will be responsible for the following activities:

a) Providing scientific leadership and serving as an intellectual/scientific hub for the TCORS Research Centers, and the broader CTP-funded research program

b) Providing leadership for the Steering Committee and helping to bring together appropriate experts to advise Steering Committee members

c) Providing expertise and support to establish topical “Working Groups” (e.g., e-cigarette working group, a mathematical or computational modeling working group, or a specimen collection and biomarkers working group) relevant to the CTP-funded research programs and scientific needs

d) Facilitating and mediating contacts between awardees and NIH and CTP professional staff to allow for efficient interactions, consultations, and oversight functions

e) Providing expertise and logistical infrastructure supporting TCORS research centers and facilitating trans-CTP-funded functions and activities

f) Providing expertise and logistical and administrative support for all the activities of the Steering Committee and its subcommittees, including Working Groups or other established committees

g) Organizing and providing logistical support for the annual or biannual meetings of TCORS investigators and training awardees (in cooperation with the NIH and CTP representatives), annual scientific meetings, and meetings of topical scientific work groups

h) Coordinating the evaluation of the TCORS and other CTP-funded research programs (see more detail below under Evaluation Core).

i) Providing and supporting state-of-the-art cross-site communication tools for TCORS and other CTP-funded awardees, which may include public and/or internal website(s), web meetings and seminars, and video-conferencing

j) Coordinating and/or facilitating development of specific collaborative time-sensitive research proposals

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Evaluation Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Table of Contents (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Detailed Budget for Initial Budget Period (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Budget for Entire Proposed Period of Support (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Biographical Sketch (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Resources (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Research Plan (Evaluation Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims of the Evaluation Core.    

Research Strategy: The proposed CECTR must have the expertise, capacity, and institutional support to conduct an evaluation of the research programs funded by the FDA CTP. The entire CTP-funded tobacco regulatory research program will be subject to evaluation coordinated by the CECTR, in cooperation with the Steering Committee and NIH and CTP scientific, administrative and program staff. Therefore, the application must outline the applicant's experience and capability to evaluate large and/or complex research programs. The approach for the program evaluation and desirable outcomes will be determined in consultation with the Steering Committee, the NIH and CTP scientific, administrative and program staff, and consultation with evaluation and tobacco-control experts. As such, applicants are expected to propose an overarching evaluation framework. The application should describe the expertise and capacity to lead, oversee, and conduct a multi-component evaluation that is informed by the recommendations of outside experts and through consultation with the Steering Committee, and NIH and CTP staff.

The CECTR must have a well-developed capacity to enable timely evaluation mechanisms promoting effective self-correcting actions across the TCORS and other CTP-funded programs. For instance, the Evaluation Core must have the capability to track the relevant performance benchmarks of each TCORS Research Center and compare its performance to that of other TCORS Research Centers. The outcomes will help the Steering Committee and individual awardees to take corrective steps and optimize their performance. The evaluation conducted by the CECTR awardee (and the activities of this Core) will be essential for facilitating and enhancing the development of future tobacco regulatory research programs. 

The Evaluation Core will be expected to cooperate with NIH and FDA in the evaluation process. The Evaluation Core will evaluate the quality and innovativeness of the science conducted by the TCORS Research Centers as well as other CTP-supported research assessing critical intermediate indicators of success such as infrastructure development and capacity building, career development, linkages and resource sharing arrangements within and among the TCORS initiative, and the cross disciplinary and multilevel nature of the research. The evaluation shall be designed to assess near and mid-term indicators of collaborative and scientific success. The evaluation should consider process factors (e.g., collaborative readiness, communication, and networking opportunities) and how they impact outputs and outcomes (e.g., new collaborations, publications, new methods or models, submission to the FDA CTP docket). The CECTR will closely collaborate with the Steering Committee, individual Research Centers, and NIH and CTP scientific, administrative and program staff in the implementation of the evaluation plan. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Education and Training Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Education and Training Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Education and Training Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Table of Contents (Education and Training Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Detailed Budget for Initial Budget Period (Education and Training Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Budget for Entire Proposed Period of Support (Education and Training Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Biographical Sketch (Education and Training Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Resources (Education and Training Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Research Plan (Education and Training Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims of the Education and Training Core.    

Research Strategy:  The CECTR is expected to take a leadership role in coordinating and integrating the training programs across the TCORS research centers and with other CTP-funded training awardees, including awardees of the K-mechanism funding opportunity announcements, and to support continuing education in tobacco regulatory science among training awardees, junior investigators, and cross-training senior investigators. The goal is to aid in the development of a new cadre of tobacco regulatory scientists and a program to disseminate research findings and data sharing. Such training should expose investigators to the multiple levels of research that address tobacco regulatory related issues.  Because tobacco research scientists are widely dispersed by geography and discipline, this type of training has been difficult to obtain. As such, a unique opportunity is afforded the CECTR to create collegial and collaborative networks among the training awardees and training programs across the CTP-funded awardees, and with other training awardees and investigators who are conducting research in tobacco regulatory science. 

Plans for this Core must include the following activities, which will be conducted in collaboration with the TCORS Training Programs:

a) Facilitating collaboration across TRSP K-mechanism awardees and TCORS training programs, creating networks of training directors and training awardees, and facilitating communication and collaboration among CTP-funded training awardees and investigators with expertise to complement individuals' training programs

b) Developing and disseminating training modules and curricula in diverse disciplines and topical areas relevant to the regulatory authority of the FDA CTP (e.g., nicotine dependence thresholds, tobacco product constituents and toxicology, and smoking topography and other measurement technologies for assessment of tobacco use and dependence);  this may include professional development training activities (e.g., grantsmanship, public speaking, leadership) or participating in team science activities across disciplines and settings (e.g., training in leading, managing, and participating in team science collaborations, using transdisciplinary research approaches) to support transfer of knowledge across disciplines

c) Sharing of training modules and curricula, including those developed under the TCORS and other relevant training programs, and facilitating web-based participation across CTP-funded mechanisms with training components for events such as speakers, presentations, workshops, and other educational opportunities that, for example, may be developed or hosted at one training program and shared with others

d) Disseminating and promoting CTP-funded research findings of training awardees and junior investigators, by facilitating the organization of sessions to present TCORS training and TRSP K-training awardee research outcomes at annual investigator meetings and relevant national meetings and conferences, actively synthesizing and disseminating relevant results, and disseminating tobacco regulatory science information to the larger tobacco control, public health, policy, and biomedical research community

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Analytics and Synthesis Core

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Analytics and Synthesis Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Analytics and Synthesis Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Table of Contents (Analytics and Synthesis Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Detailed Budget for Initial Budget Period (Analytics and Synthesis Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Budget for Entire Proposed Period of Support (Analytics and Synthesis Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Biographical Sketch (Analytics and Synthesis Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Resources (Analytics and Synthesis Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions.

Research Plan (Analytics and Synthesis Core)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims:  Describe the specific aims of the Analytics and Synthesis Core.    

Research Strategy:  The main goals of this Core are to facilitate data sharing, support and/or conduct collaborative analyses, and provide results dissemination across TCORS and CTP-funded research programs through the provision of data analytic and research synthesis expertise. The Analytics and Synthesis Core must

a) provide infrastructure and scientific expertise for data transfer, merging, and analysis

b) facilitate use of common or consensus measures, data harmonization/integration, data sharing, data comparison, and results validation and replication

c) conduct and/or provide expertise and support for meta analyses, secondary data analyses, data integration, and methodology/approaches

d) identify data to inform mathematical or statistical models and system science approaches that inform the regulatory decisions relevant to the CTP

e) identify commonalities in research directions and specific questions being explored across the TCORS Research Centers to promote cross-TCORS collaborative efforts

f) identify scientific problems in tobacco regulatory science that could be jointly explored across TCORS, and/or other CTP-funded research projects and programs

g) provide the methodological support and expertise to facilitate cross-project data linking, integration, and harmonization

h) support cross-center resource-development projects (e.g., evaluate common measures, or develop new methodologies that can be validated at multiple centers and in larger populations, etc)

i) have the capacity to facilitate rapid, coordinated data collection in response to ongoing, changing and urgent needs

j) identify the proposed/planned/ongoing TCORS developmental and pilot projects to facilitate NIH and FDA review and approval of the research projects to 1) ensure alignment with FDA CTP regulatory authority, 2) ensure risks and protections for human subjects are addressed in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan, 3) ensure provision of plans for data and safety monitoring consistent with NIH DSMP policies

The CECTR will play a leadership and coordination role to facilitate the adoption and use of standardized measures, methods, and data management whenever feasible to facilitate data aggregation and collaborative activities. The use of common study variables, criteria, and protocols among the TCORS awardees and other CTP-funded investigators is expected to facilitate future analyses of the data aggregated across studies. For example, investigators may be required to adopt consensus measures for nicotine dependence or the biochemical validation of smoking abstinence. The variable naming and data coding conventions for TCORS and/or CTP-funded databases may be shared to develop common coding and naming conventions across research projects to facilitate data harmonization and aggregation. This may include the identification of one or more data sharing repositories, and the creation of a tobacco regulatory science ontology, for CTP-funded data and outcomes, to facilitate data and resource sharing, secondary analysis, and efficient searching and quick access to publications and other products created through CTP-funded awards. Consensus measures and data and products repositories will serve as a resource for the tobacco regulatory science community to enhance communication and collaboration across the CTP-funded program. They will also be critical to program assessment of scientific progress in the field, identification of new research opportunities, and formation of collaborations to promote discovery and to resolve areas of scientific controversy.  The CECTR will facilitate these collaborations in conjunction with the NIH and FDA CTP scientific, administrative, and program staff.

It is expected that this Core will strongly involve resources and personnel at individual TCORS research centers, and the data management functions will involve, as appropriate, a distributed model, e.g., without having to centralize all data to one repository site. As such, the CECTR will establish and operate a Data Coordination Committee to include NIH and FDA CTP staff, and investigators from the CECTR, the TCORS and other selected CTP-funded programs that will advise the establishment of sharing standards, resources, and repositories, and will evaluate requests for data access from investigators outside of established CTP-funded investigator networks. Standards for common data systems and future data repositories should be addressed within the Data Coordination Committee. Consistent with ongoing data-harmonization efforts that promote the use of common measures (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html), the CECTR  must aim to achieve compatibility with shared resources like the measures from the Substance Abuse and Addiction Collection of the PhenX Toolkit (http://www.phenxtoolkit.org) or data- and publication-sharing repositories (http://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html) like the Neuroscience Information Framework (NIF, http://www.neuinfo.org/).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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 nonresponsive will not be reviewed. Prior to submitting their application, 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.

Pre-Application Conference Call

The NIH anticipates holding a pre-application conference call to which all interested prospective applicants are invited. NIH and FDA CTP Scientific/Research staff, and NIH Peer Review and Financial/Grants Management staff will explain the goals and objectives of the CECTR, the CTP-funded tobacco regulatory research programs, and the funding opportunity announcement (FOA), and will discuss the application and peer review process and answer questions. Information about this pre-application conference call will be available at http://prevention.nih.gov/tobacco.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in

NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

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

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

Innovation

Does the application challenge and seek to shift current research in the field of tobacco science as it relates to the manufacture, distribution, and marketing of tobacco products? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed? Will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific 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 will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

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?       

Additional Review Criteria - Overall

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.

Review Criteria for Leadership and Administrative Core

Organizational Structure

What is the quality of the organizational structure of the CECTR proposal and does this structure indicate an ability to integrate the full range of Center functions to achieve the specified goals? Is the coordination between the CECTR's administrative core and other cores adequate and well documented?

Leadership and Managerial Capacity

Is there evidence of strong leadership and managerial capacity to bring diverse teams together across the TCORS and other CTP-funded programs? Is there evidence of expertise in organizational, management, and/or team sciences? 

Plans for Communication and Cooperation

Are there adequate plans for communication and cooperation among investigators?

Program Directors/Principal Investigators

Is/Are the PDs/PIs appropriately experienced in coordinating large multi-site programs and well-suited to carry out the proposed administrative, professional, and scientific leadership across the CTP-funded program?  If the CECTR is a multi-PD/PI application, do the investigators have complementary and integrated expertise? Are their leadership approaches, governance, and organizational structure appropriate for the proposed CECTR? Does the proposed CECTR team demonstrate evidence for potential broad mastery of tobacco regulatory science; knowledge of investigators with content, methodological, and related disciplinary expertise; and a vision for advancing the state of tobacco regulatory science? 

Leadership and Management of Logistic Support

Does the proposed CECTR demonstrate experience in and clear leadership for the provision and management of logistics support services?  Do the qualifications, experience, and commitment of the logistics lead ensure he/she is well suited to provide administrative, managerial, and professional leadership within the TCORS and across the CTP-funded research programs? 

Quality Control

Are adequate quality control procedures in place?  Is the proposal for long-term management and periodic evaluation of goal attainment adequate?

Plans for Facilitation

Does the proposal identify an adequate plan for facilitating the Steering Committee, NIH and FDA review and approval of the TCORS developmental and pilot research projects to 1) ensure alignment with FDA CTP regulatory authority, 2) address risks and protections for human subjects in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan, 3) provide plans for data and safety monitoring consistent with NIH DSMP policies?

Review Criteria for Evaluation Core

Capacity for Evaluation

Does the proposed CECTR have the expertise, capacity, and institutional support to conduct an evaluation of multi-component, complex research programs? Does the proposed evaluation framework reflect understanding of approaches to the evaluation of complex and large initiatives?  How well does the application demonstrate the capacity of the CECTR to collaborate with and provide feedback and input to the TCORS and other CTP-funded awardees, and to the NIH and FDA CTP scientific, administrative, and program staff on critical evaluation of scientific progress, peer-reviewed publications, evidence-based dissemination, and/or new collaborations and partnerships?

Investigators

Does the evaluation core include staff with expertise in evaluation studies of collaborations, management, organization and/or teams in science, including experience engaging scientists in large initiatives in qualitative and survey data collection related to evaluations of scientific programs/projects?

Review Criteria for Education and Training Core

Training Leadership

Does the application propose training core leadership experienced in mentoring, cross-site training, and multi-disciplinary research training leadership, with evidence of trainees' career advancement and scientific contributions?

Plan for Training Coordination

Does the plan for the training core to work in concert with the TCORS training programs ensure creative maximization of the potential for a shared foundation of learning and minimization of redundancies and duplicative efforts across centers? 

Capacity to Develop and Implement Training Programs

Does the plan for training coordination demonstrate the capability and creativity to effectively develop and implement educational curricula, programs, and activities that support cross-site training in tobacco regulatory science?

Review Criteria for Analytics and Synthesis Core

Plan to Facilitate the Adoption of Shared Protocols

Does the application have a well-described process that demonstrates the capacity to facilitate the adoption of shared measurement protocols?  

Commitment to Facilitation of the Use of Standardized Measures and Collaborative Activities

Does the application indicate a commitment to ongoing facilitation of the use of standardized measures, methods, and data management whenever feasible to support data aggregation and collaborative activities across Centers? 

Capacity to Coordinate Analyses

Does the proposed CECTR have the capacity to coordinate analyses of the shared data elements and/or conduct meta-analyses, systems science methodologies, or secondary data analyses? 

Plan for a Data Coordination Committee

Does the application plan for establishing and operating a Data Coordination Committee demonstrate the capacity forfacilitiation and establishment of data-sharing conventions, measures, tools, and resources, and evaluation of requests for data access from investigators outside of the TCORS or other established CTP-funded research networks?

Plan for Identifying Research Gaps and Opportunities

How well does the application propose to identify research gaps and opportunities to encourage proposals that advance tobacco regulatory science?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves 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 Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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 of initial peer review will not be accepted for applications submitted response to this FOA.

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Prior Approval of Pilot Projects

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation. 

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH and FDA as defined below.

The CECTR PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) will have the primary responsibility to define objectives and approaches of the CECTR and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the evaluation program. The primary responsibilities of the awardees are to:

NIH and FDA staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH and FDA CTP Project Scientists will:

Areas of Joint Responsibility include:

The CECTR PD(s)/PI(s) funded under this FOA, the NIH and FDA CTP scientific, administrative, and program staff, and selected CTP-funded PD(s)/PI(s) will be responsible for forming a Steering Committee.  The Steering Committee will act as the main governing board across the multiple awards and will review the progress of the evaluation, research activities, development of collaborative protocols, identification and development of shared protocols and resources, and identify opportunities for sharing techniques and tools developed across the TCORS and the broader CTP-funded research programs.

The Steering Committee will:

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of four members will be convened. It will have four members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, one FDA CTP designee and a fourth designee with expertise in the relevant area who is chosen by the other three; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems. An Interim Report will be due every six (6) months following the project start date, as well as the annual progress report.  Electronic copies should be sent to the Grants Management Specialist listed on the Notice of Grant Award. The scientific summary should be a maximum of two (2) pages.

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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Scientific/Research Contact(s)

Glen Morgan, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6787
Email: gmorgan@nih.gov

Peer Review Contact(s)

Boris P. Sokolov, PhD
Brain Disorders and Clinical Neuroscience IRG
Center for Scientific Review (CSR)
Telephone: 301-408-9115
Email: bsokolov@csr.nih.gov

Financial/Grants Management Contact(s)

Carol A. Perry
National Cancer Institute (NCI)
Telephone: 301-496-7205
Email: perryc@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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