Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

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

Components of Participating Organizations

National Cancer Institute (NCI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS
National Institute of Neurological Disorders and Stroke (NINDS)
U.S. Food and Drug Administration, Center for Tobacco Control (CTP)

Funding Opportunity Title

Tobacco Control Regulatory Research - R21

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

  • June 20, 2013 - This PAR has been reissued as RFA-OD-13-010.
  • April 19, 2013 - See Notice NOT-OD-13-055. Notice of Change in Expiration Date.
  • October 5, 2012 - See Notice NOT-DA-13-002. Notice of Availability of Nicotine Research Cigarettes through NIDA's Drug Supply Program.
  • September 6, 2012 - See Notice NOT-HD-12-029. Participation of NICHD.

Funding Opportunity Announcement (FOA) Number

PAR-12-266

Companion Funding Opportunity

PAR-12-267, R01 Research Project Grant
PAR-12-268, R03 Small Grant Program

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.077

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing.  Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research results from this FOA are expected to generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. 

Key Dates
Posted Date

August 23, 2012

Open Date (Earliest Submission Date)

October 1, 2012  

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

November 1, 2012; January 16, 2013; June 18, 2013; January 15, 2014;  June 17, 2014; January, 16, 2015, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

March 2013; July 2013; October 2013; July 2014; October 2014; July 2015

Advisory Council Review

May 2013; Aug 2013; Jan 2014; Aug 2014; Jan 2015; Aug 2015  

Earliest Start Date(s)

July 2013; October 2013; April 2014; October 2014; April 2015; October 2015

Expiration Date

(New Date June 19, 2013 per NOT-OD-13-055), Originally January 17, 2015

Due Dates for E.O. 12372

Not Applicable. 

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose:

This Funding Opportunity Announcement (FOA) encourages biomedical, behavioral, and social science research that informs the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing.  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 (http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM237080.pdf).

The research findings generated from this FOA are expected to provide scientific underpinnings to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

Consistent with the FDA CTP mission, this FOA encourages research applications that address such aspects as: understanding the diversity of tobacco products, reducing addiction to tobacco products, reducing toxicity and carcinogenicity of tobacco products and smoke, understanding the adverse health consequences of tobacco use, understanding communications about tobacco products, understanding tobacco product marketing, and understanding how economics and policies affect tobacco product use (http://cancercontrol.cancer.gov/nih-fda/).

Background:

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.

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 at the FDA are coordinated by the Center for Tobacco Products (CTP) and at NIH by the Office of the Director. The FDA and NIH share interest in supporting research that could inform the development and evaluation of tobacco product regulations.  To that end, the research encouraged by this FOA is expected to provide additional scientific data to the research 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 applications that address priority research areas including: diversity of tobacco products; toxicity, carcinogenicity and use of new and emerging tobacco products;  effective methods to substantially reduce the toxicity of tobacco products and smoke;  effective methods to substantially reduce the overall addictiveness of cigarettes and other tobacco products; communications regarding tobacco products; marketing, economics and policies of tobacco products; and consumer perceptions and behaviors related to tobacco products, and claims (http://cancercontrol.cancer.gov/nih-fda/)

Program Scope and Research Objectives:

The research encouraged by this FOA is expected to inform the development and evaluation of tobacco product regulations.  Although a vast and sound science base exists with regard to numerous areas related to the FSPTCA, new research will provide additional science for FDA to consider as it implements the FSPTCA. 

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance tobacco regulatory-related research. Another example could include the unique and innovative use of an existing methodology to explore regulatory research. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel agents or applications that could have a major impact on a field of tobacco control regulatory research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Research consistent with the scope of this FOA includes the following:

The research plan must state how it will inform the development and evaluation of tobacco product regulations.  Additional information, including a detailed list of 56 FDA CTP research priorities can be found at: http://cancercontrol.cancer.gov/nih-fda/research.htm

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon funds available from the FDA, and the submission of a sufficient number of meritorious applications.

The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science.

Award Budget

The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.

Award Project Period

The total project period may not exceed 2 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

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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

All Program 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 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) 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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed,

PHS 398 Research Plan Component

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

Detailed budgets must be submitted; modular budgets will not be accepted.

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 SF424 (R&R) Application Guide,  In addition, the research findings generated from this FOA may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. If research data are cited publically in support of regulation, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in 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.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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.

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by FDA and components of participating organizations, NIH. Applications that are incomplete and/or non-responsive will not be reviewed.

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

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation.   As such, these requests 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 administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits. 

If selected, appropriate funding will be provided by the NIH Intramural Program.  NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA.  Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application.  The intramural scientist may submit a separate request for intramural funding as described above.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Overall Impact

Reviewers will provide an overall impact/priority 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

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 regulatory authority over tobacco products?  If the aims of the project are achieved, how will regulatory science research be informed or regulation affected? How will successful completion of the aims have affect on the concepts, methods, technologies, or regulation 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Will the project aid in advancement of developing and evaluating regulations pertaining to the manufacture, distribution, and marketing of tobacco products in order to protect public health?  Will the outcomes of the project provide new information addressing regulatory authority over tobacco products?

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?  Is the project directly relevant to a specific section in the Family Smoking Prevention and Tobacco Control Act? If the project is in the early stages of development, will the strategy establish feasibility and are risky aspects addressed?

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources. 

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted to the FDA Center for Tobacco Products Program. 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(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

The research findings generated from this FOA may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.  If the research data are cited publically in support of regulation, institutions of higher education, hospitals, and other non-profit organizations are subject to the Freedom of Information Act (FOIA) as outlined in Revised Circular A-110 (http://www.whitehouse.gov/omb/circulars_a110/).

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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.

An Interim Report will be due at the end of six (6) months follow the project start date.  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.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Robert Vollinger, M.S.P.H.
National Cancer Institute (NCI)
Telephone: 301-496-0275
Email: vollingb@mail.nih.gov

Abraham P. Bautista, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-9737
E-mail: bautista@mail.nih.gov

Kay Wanke, Ph.D., M.P.H.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-0036
E-mail: wankek@nida.nih.gov

Antonello Punturieri, M.D., Ph.D.
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-435-0230
E-mail: punturieria@nhlbi.nih.gov

Srikanth Nadadur, M.Sc., Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-5327
E-mail: nadadurs@niehs.nih.gov

Randall R. Stewart, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
E-mail stewartr@ninds.nih.gov

Peer Review Contact(s)

Tomas Drgon
Center for Scientific Review
Telephone: 301-437-7056
E-mail: tdrgon@mail.nih.gov

Financial/Grants Management Contact(s)

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

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
E-mail: jfox@mail.nih.gov

Deborah Wertz
National Institute on Drug Abuse (NIDA)
Telephone: 301-649-1715
E-mail: dwertz@nida.nih.gov

Tawana McKeither
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-402-3842
E-mail: mckeitherta@nhlbi.nih.gov

Dorothy Duke
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2749
E-mail: duke3@niehs.nih.gov

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
E-mail: decostert@ninds.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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