Family Smoking Prevention and Tobacco Control Act Regulatory Research

Family Smoking Prevention and Tobacco Control Act Regulatory Research is sponsored by National Institutes of Health (NIH) / Food and Drug Administration (FDA). This program supports regulatory research to provide scientific evidence to guide the implementation of the Family Smoking Prevention and Tobacco Control Act.

Expired PAR-12-011: NIH Competitive Revision Applications for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U01) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) 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 Research Project Cooperative Agreements January 20, 2012 - See Notice NOT-HD-12-010.

Participation of NICHD. Funding Opportunity Announcement (FOA) Number PAR-12-010 R01 Research Project Grant Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.

393, 93. 399, 93. 242, 93.

113, 93. 233, 93. 865 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/ ) Open Date (Earliest Submission Date) Letter of Intent Due Date February 17, 2012, by 5:00 PM local time of applicant AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in 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 Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description 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 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 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 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.

Specific Research Objectives and Scope 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 questions consistent with the goals of this FOA include but are not limited to : 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 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? 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 What is the dependence potential of cigars (e.g., liking, What nicotine level is associated with progression to dependence among cigar smokers, including users of large or little 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? 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 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 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? Section II.

Award Information 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) Glossary and the SF 424 (R&R) Application Guide provide details on 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.

Direct costs requested for this competitive revision may not exceed $500,000 per year, and the budget should reflect actual needs of 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. 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: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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 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 Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually 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) 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 does not require cost sharing as defined in the NIH Grants Policy Statement .

3. Additional Information on Eligibility 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. Section IV. Application and Submission Information 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 (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant 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: Tobacco Control Research Branch Behavioral Research Program National Cancer Institute (NCI) 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 All page limitations described in the SF424 Application 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: 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 All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Foreign (non-US) institutions must follow policies described 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 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 This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Pre-award costs are allowable only as described in the NIH Grants 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 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. 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 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 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 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.

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?

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? 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? 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 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?

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 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 Subjects Protection and Inclusion Guidelines .

Inclusion of Women, Minorities, and 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 .

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 for Review of the Vertebrate Animal Section . 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. 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.

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 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.

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).

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 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