Participating Organization(s)	National Institutes of Health (NIH)
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 Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) National Institute of Mental Health (NIMH)
Funding Opportunity Title	NIH Competitive Revision Applications for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	New
Related Notices	January 20, 2012 - See Notice NOT-HD-12-010. Participation of NICHD.
Funding Opportunity Announcement (FOA) Number	PAR-12-011
Companion FOA	PAR-12-010 R01 Research Project Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393, 93.399, 93.242, 93.113, 93.233, 93.865
FOA Purpose	This Funding Opportunity Announcement (FOA) invites cooperative agreement research (U01) Revision applications from investigators with active U01 research project awards issued by one of the participating Institute/Centers (ICs) listed in this FOA to support an expansion of the scope of approved and funded U01 projects involving smoking and tobacco-related products and/or their constituents. Revision U01 applications for projects that have not originally focused on tobacco use are welcome provided that the proposed revision addresses the research priorities related to FDA regulatory authority that are identified in the FOA. The awards under this FOA will be administered by NIH using designated funds [from the Food and Drug Administration (FDA) Center for Tobacco Products (CTP)] for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulations. Within the framework of the Tobacco Control Act, the FDA and NIH share interest in supporting research to aid the development and evaluation of tobacco product regulations. Projects resulting from this FOA are expected to serve the FDA by generating relevant findings and data needed 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 seeks competitive revision projects that address such aspects as: the toxicity 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; and consumer perceptions and behaviors related to tobacco products, claims, and communications regarding tobacco products (http://cancercontrol.cancer.gov/nih-fda/)

Posted Date	November 9, 2011
Open Date (Earliest Submission Date)	January 17, 2012
Letter of Intent Due Date	January 30, 2012
Application Due Date(s)	February 17, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July, 2012
Advisory Council Review	August, 2012
Earliest Start Date(s)	September, 2012
Expiration Date	February 18, 2012
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.

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

This Funding Opportunity Announcement (FOA) invites cooperative agreement research (U01) Revision applications from investigators with active U01 research project awards issued by one of the participating Institute/Centers (ICs) listed in this FOA to support an expansion of the scope of approved and funded U01 projects involving smoking and tobacco-related products and/or their constituents. Revision U01 applications for projects that have not originally focused on tobacco use are welcome provided that the proposed revision addresses the research priorities related to FDA regulatory authority that are identified in the FOA. The awards under this FOA will be administered by NIH using designated funds [from the Food and Drug Administration (FDA) Center for Tobacco Products (CTP)] for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulations. Within the framework of the Tobacco Control Act, the FDA and NIH share interest in supporting research to aid the development and evaluation of tobacco product regulations. Projects resulting from this FOA are expected to serve the FDA by generating relevant findings and data needed 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 seeks competitive revision projects that address such aspects as: the toxicity 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; and consumer perceptions and behaviors related to tobacco products, claims, and communications regarding tobacco products (http://cancercontrol.cancer.gov/nih-fda/)

A parallel FOA (PAR-12-010) of identical scientific scope seeks competitive Revision applications to active NIH R01 grants.

Role of FDA in FSPTCA. With the passage of FSPTCA in June 2009, the FDA has acquired authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Under Section 901 of the FSPTCA, FDA has authority to regulate tobacco products. 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 August 2011, 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).

Under Section 907 of the FSPTCA, FDA has authority to establish tobacco product standards if a tobacco product standard is appropriate for the protection of public health. As such, FDA can establish a tobacco product standard for nicotine yields of the product but cannot require the reduction of nicotine yields of a tobacco product to zero. FDA can also establish a tobacco product standard that reduces or eliminates other constituents, including smoke constituents, or harmful components of the product.

Under Section 911 of the FSPTCA, a modified risk tobacco product may be commercially marketed if is it determined that it will significantly reduce harm and risk of tobacco-related disease to individual tobacco users and will benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. A full description of the FSPTCA can be found at: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM237080.pdf

Partnership between FDA and NIH in the Context of 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 at the FDA are coordinated by Center for Tobacco Products (CTP). The FDA and NIH share interest in supporting research that could aid the development and evaluation of tobacco product regulations. Specifically, this FOA is expected to generate a rapid mechanism for the FDA to obtain data 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 seeks competitive revisions that address the toxicity 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, and consumer perceptions and behaviors related to tobacco products, claims, and communications regarding tobacco products.

Research to be supported by this FOA is expected to advance four areas relevant to the Family Smoking Prevention and Tobacco Control Act: 1) the toxicity and use of new and emerging tobacco products, 2) effective methods to substantially reduce the overall addictiveness of cigarettes and other tobacco products, 3) effective methods to substantially reduce the toxicity of tobacco products and smoke (mainstream and/or sidestream), and 4) consumer perceptions and behaviors related to communications regarding tobacco products.

Research questions consistent with the goals of this FOA include but are not limited to:

1. New and Emerging Tobacco Products

• What are the constituents, components, and design features of new and emerging tobacco products (e.g., dissolvable tobacco products, e-cigarettes, hookah tobacco); and how do these features differ within the same class of products?
• How do components and design features of emerging tobacco products affect the bioavailability of nicotine, other addictive substances, and harmful tobacco constituents?
• What are the tobacco use behaviors of individuals using new and emerging tobacco products, including the multiple use behaviors of consumers using traditional and new and emerging tobacco products?
• What are individual cognitive and affective factors (i.e. perceptions, attitudes, beliefs, and emotions) associated with new and emerging tobacco products, including product labeling and marketing?
• How do biomarkers of exposure differ between new and emerging tobacco products and traditional tobacco products?
• What are the most effective methods of conveying risk information to the public regarding new and emerging tobacco products, including potential modified-risk tobacco products?
• What are the cognitive and affective factors (i.e. perceptions, attitudes, beliefs, and emotions) related to potential modified-risk tobacco products, their labeling, and their marketing by different subpopulations; such as current smokers, former smokers, and youth?

2. Reducing Addiction to Tobacco Products

• How does reduction of nicotine in tobacco products, particularly combustible products affect addiction in youth and adults?
• Beyond nicotine, what other constituents, components and design features of tobacco products, particularly in cigarettes and other combustible products, enhance the addictive properties of reduced nicotine tobacco products?
• What is the dependence potential of cigars (e.g., liking, craving, withdrawal)?
• What nicotine level is associated with progression to dependence among cigar smokers, including users of large or little cigars and cigarillos)?
• What is the population impact (including among subpopulations) of reduced nicotine cigarettes and other tobacco products on tobacco use behavior; and the cognitive and affective factors (i.e. perceptions, attitudes, beliefs, and emotions) associated with tobacco, including initiation and cessation, switching of products and multiple product use?
• What is the tobacco use behavior of reduced nicotine cigarettes and other tobacco products in subpopulations; such as by sex, age, race/ethnicity, income and co-morbidities?

3. Reducing Toxicity of Tobacco Products and Smoke

• What methods and measures best assess biologically relevant changes in harmful and potentially harmful constituents in tobacco products and smoke in both animal models and humans?
• Are there in vitro or in vivo assays that can be used to compare overall toxicity between two different tobacco products; with special attention to cardiotoxicity, respiratory toxicity, carcinogenicity and developmental/reproductive toxicity?
• What other constituents, compounds, design features, and tobacco use behaviors may impact toxicity of tobacco products and smoke?
• What is the impact of reduced levels of harmful and potentially harmful constituents of tobacco products on measures of toxicity?
• What is the impact of reduced toxicity products on tobacco use behavior including initiation, cessation, switching tobacco products, and multiple product use?

4. Communications about Tobacco Products

• What is the impact of cigarette graphic health warnings on cognitive and affective factors (i.e., perceptions, attitudes, knowledge, beliefs, and emotions) and behaviors of specific sub-populations?
• What is the impact of the 1-800-QUIT-NOW number included as part of graphic health warnings on quit attempts and cessation, including among subpopulations?
• What is the nature and extent of tobacco product discussions and communications in non-traditional media such as social networks, online videos, blogs, and smartphone applications; which subpopulations engage in which non-traditional media involving tobacco products?
• What communication channels do specific subpopulations (such as youth and young adults, minority populations, people of low income, people with low education, people with mental health or medical co-morbidities, and the Lesbian, Gay, Bisexual, and Transgender) use to seek information and communicate about tobacco and health issues?
• How are various tobacco products being marketed to the public; how does the marketing differ for specific subpopulations?
• What is the utility gain from public education initiatives or marketing restrictions to smokers who intend to quit? For example, point-of-sale restrictions may provide smokers with self-control mechanisms that may aid them in their attempts to quit. How can the magnitude of these utility gains be measured and how might they be compared with consumer surplus loss associated with quitting?

Funding Instrument	Cooperative Agreement
Application Types Allowed	Revision U01 applications from investigators with active U01 research project awards issued by one of the participating Institute/Centers (ICs) listed in this FOA (i.e., NCI, NIMH, NIDA, NHLBI, and NIEHS) The OER Glossary and the SF 424 (R&R) 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 an estimate of 20 awards, corresponding to a total of $10 million, for fiscal year 2012, dependent on a sufficient number of meritorious applications.
Award Budget	Direct costs requested for this competitive revision may not exceed $500,000 per year, and the budget should reflect actual needs of the proposed project.
Award Project Period	Applicants may request support for up to 2 years, not to exceed the remaining number of years on the parent grant. If a no-cost extension is needed on the parent grant to incorporate the project period of the competitive Revision, the no cost extension must be in place before the revision application is submitted.

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.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Only the institutions that have an active U01 award issued by either NCI, NIMH, NIDA, NHLBI, or NIEHS are eligible for this FOA. A project period of up to 2 years may be proposed, provided the parent U01 grant remains active.

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.

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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.

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.

The eligible PD(s)/PI(s) must be the same as the PD(s)/PI(s) of the parent U01 award from the corresponding participating/cosponsoring IC on this FOA.

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

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

NIH will not accept any application 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.

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

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

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

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

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

• Descriptive title of proposed research;
• Name, address, and telephone number of the PD(s)/PI(s);
• Names of other key personnel;
• Participating institutions; and
• Number and title of this funding opportunity.

The letter of intent should be sent to:

Stephanie Land, PhD
Tobacco Control Research Branch
Behavioral Research Program
National Cancer Institute (NCI)
Telephone: 301-496-0277
Email: [email protected]

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.

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

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

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

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

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 (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.

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.

This initiative is not subject to intergovernmental review.

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

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

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(s)/PI(s) 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, NIH. Applications that are incomplete will not be reviewed.

All U01 revision applications submitted to this funding opportunity announcement must:

• Have the same Program Director(s)/Principal Investigator(s) (PD(s)/PI(s) as the parent U01 grant.
• Use the same budget format as the parent grant.
• Not exceed the funding period for the parent grant.
• No cost extensions for the parent award must be in place prior to submission of the revision application.
• Include a 1 page Introduction that describes the nature of the revision and how it will influence the specific aims, research design, and methods of the current grant.

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

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

Reviewers 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).

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 problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

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?

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

Not Applicable

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

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

NIH Cooperative Agreements are subject to terms and conditions 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.

Each competitive revision award made under this FOA will be subject to the same terms and conditions specified for the original U01 award. Applicants should consult the Notice of Award for their current U01 for the specifics of those terms and conditions.

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.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Contact the Program Officer of the parent grant.

Stephanie Land, PhD
Tobacco Control Research Branch, Behavioral Research Program
National Cancer Institute (NCI)
Executive Plaza North, Room 4044
6130 Executive Boulevard
Bethesda, MD 20892
Telephone: (301)-496-0277
Email: [email protected]

Debra Grossman, M.A.
Behavioral and Integrative Treatment Branch
Division of Clinical Neuroscience & Behavioral Research
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, Room 3157
Bethesda, Maryland 20892-9551
Telephone: (301)-443-0107
Email: [email protected]

Amy B. Goldstein, PhD
Child and Adolescent Treatment & Preventive Intervention Research Branch
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 7144, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301)-496.7227
Email: [email protected]

Daniel Shaughnessy, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
PO Box 12233, MSC K3-12
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-2506
Email: [email protected]

William Riley, Ph.D.
Clinical Applications & Prevention Branch
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, MSC 7926
Bethesda, MD 20892
Telephone: (301)-435-0407
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Contact the Grants Management Specialist assigned to the parent grant.

Carol A. Perry
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892 (for regular mail)
Rockville, MD 20852 (for hand delivered mail)
Telephone: (301)-496-7205
Email: [email protected]

Debra Dudley
Grants Management Branch
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard
Bethesda, MD 20892-9560
Telephone: (202) 722-4093
Email: [email protected]

Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
Email: [email protected]

Pamela Clark
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
PO Box 12233, MSC K3-11
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919)-541-7629
Email: [email protected]

Tawana McKeither
National Heart, Lung, and Blood Institute (NHLBI)
6701 Rockledge Drive, MSC 7159
Bethesda, MD 20892
Telephone: (301)-402-3842
Email: [email protected]

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

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