Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute on Aging (NIA) National Cancer Institute (NCI) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Office of Behavioral and Social Sciences Research (OBSSR)
Funding Opportunity Title	Time-Sensitive Obesity Policy and Program Evaluation (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	September 17, 2015 - This PA has been reissued as PAR-15-346. June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PAR-12-257
Companion Funding Opportunity	Not Applicable.
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847,93.866, 93.399, 93.865
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) is issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Cancer Institute (NCI), National Institute on Aging (NIA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the Office of Behavioral and Social Sciences Research (OBSSR), at the National Institutes of Health (NIH). This announcement establishes an accelerated review/award process to support time-sensitive research to evaluate a new policy or program expected to influence obesity related behaviors (e.g., dietary intake, physical activity, or sedentary behavior) and/or weight outcomes in an effort to prevent or reduce obesity. This FOA is intended to support research where opportunities for empirical study are, by their very nature, only available through expedited review and funding. All applications to this FOA must demonstrate that the evaluation of an obesity related policy and /or program offers an uncommon and scientifically compelling research opportunity that will only be available if the research is initiated with minimum delay. For these reasons, applications in response to this time-sensitive FOA are eligible for only one submission. It is intended that eligible applications selected for funding will be awarded within 3-4 months after the application submission/receipt date. However, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline.

Posted Date	August 8, 2012
Open Date (Earliest Submission Date)	September 10, 2012
Letter of Intent Due Date	September 12, 2012, October 17, 2012, November 13, 2012, December 13, 2012, January 14, 2013, February 11, 2012, March 14, 2013, April 11, 2013, May 13, 2013, June 12, 2013, July 17, 2013, August 13, 2013, September 17, 2013, October 17, 2013, November 13, 2013, December 17, 2013, January 14, 2014, February 11, 2014, March 17, 2014, April 14, 2014, May 13, 2014, June 12, 2014, July 17, 2014, August 13, 2014, September 12, 2014, October 13, 2014, November 13, 2014, December 15, 2014, January 13, 2015, February 10, 2015, March 17, 2015, April 13, 2015, May 13, 2015, June 12, 2015, July 15, 2015, August 13, 2015.
Application Due Date(s)	October 10, 2012, November 14, 2012, December 11, 2012, January 10, 2013, February 11, 2013, March 11, 2013, April 11, 2013, May 10, 2013, June 10, 2013, July 10, 2013, August 14, 2013, September 10, 2013, (Extended to November 1, 2013 per NOT-OD-14-003), Originally October 10, 2013, November 14, 2013, December 11, 2013, January 10, 2014, February 11, 2014, March 11, 2014, April 11, 2014, May 12, 2014, June 10, 2014, July 10, 2014, August 14, 2014, September 10, 2014, October 10, 2014, November 10, 2014, December 10, 2014, January 12, 2015, February 10, 2015, March 10, 2015, April 14, 2015, May 11, 2015, June 10, 2015, July 10, 2015, August 12, 2015, September 10, 2015, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	December, 2012, January, 2013, February, 2013, March, 2013, April, 2013, May, 2013, June, 2013, July, 2013, August, 2013, September, 2013, October, 2013, November, 2013, December, 2013, January, 2014, February, 2014, March, 2014, April, 2014, May, 2014, June, 2014, July, 2014, August, 2014, September, 2014, October, 2014, November, 2014, December, 2014, January, 2015, February, 2015, March, 2015, April, 2015, May, 2015, June, 2015, July, 2015, August, 2015, September, 2015, October, 2015, November, 2015.
Advisory Council Review	January, 2013, May, 2013, October, 2013, January, 2014, May, 2014, October, 2014, January, 2015, May, 2015, October, 2015, January 2016.
Earliest Start Date(s)	January, 2013, February, 2013, March, 2013, April, 2013, May, 2013, June, 2013, July, 2013, August, 2013, September, 2013, October, 2013, November, 2013, December, 2013, January, 2014, February, 2014, March, 2014, April, 2014, May, 2014, June, 2014, July, 2014, August, 2014, September, 2014, October, 2014, November, 2014, December, 2014, January, 2015, February, 2015, March, 2015, April, 2015, May, 2015, June, 2015, July, 2015, August, 2015, September, 2015, October, 2015, November, 2015, December, 2015.
Expiration Date	September 11, 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.

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

Obesity is a major contributor to many serious health conditions that increase morbidity and mortality and reduce quality of life. The prevalence of obesity in children and adults in the United States has dramatically increased in the past four decades. While helping people achieve and maintain a healthy weight is a critical public health goal, little is known about the effectiveness of large scale policies and programs that could help achieve this goal. Nationally and internationally there is an imperative to take action at local, state and federal levels, especially related to obesity in children. Some of the policies or programs being implemented offer investigators the opportunity to perform natural experiments . A natural experiment is not a randomized controlled experiment as the allocation of intervention is not within the researcher's control. As noted in the 2010 IOM report, Bridging the Evidence Gap in Obesity Prevention: A Framework to Inform Decision Making, rigorous scientific evaluation of these policies and programs can help build an evidence base to measure advances toward preventing excess weight gain or improving weight management and to ensure that future resources are directed towards those interventions shown to be effective.

This FOA is intended to encourage and support research in which a unique and time sensitive opportunity has arisen to collect baseline data and then prospectively assess effectiveness of an imminent policy or program designed to prevent or reduce obesity in a given population (e.g. designed to reduce energy intake, increase activity, or decrease sedentary behavior).

For the purposes of this FOA:

• Policy is broadly defined to include both formal public policies at local, state and federal levels of government, as well as organizational level policies, such as those implemented by organizations, schools or worksites. Examples include but are not limited to the development of supermarkets in underserved areas, calorie labeling requirements, added tax on food or beverage, school-based BMI measurement and reporting, modification of transportation pathways to facilitate more walking or bicycle riding, or the implementation of multi-use trail/s.
• Program is defined as a set of activities initiated by governmental or other organizational bodies to enhance obesity prevention and control. Examples might include programs implemented in schools, worksites, or communities designed to improve obesity related behaviors such as energy intake and activity level. This FOA is not intended to support the initiation and delivery of new programs; rather, it is intended to support time sensitive evaluations of the effectiveness of programs and/or policies that will be implemented imminently and regardless of the outcome of a research application in response to this FOA.

Several distinguishing features of the obesity program and/or policy research evaluation must be articulated in the grant application:

1. It must be clear that the research question offers an uncommon and scientifically compelling research opportunity that will only be available if the evaluation research component is initiated with minimum delay.

2. Expedited review and funding are required in order for the scientific question to be addressed and for the research design to be carried out. It should be clear that the knowledge gained from the study could not be obtained through the traditional NIH cycle of application submission, review and award. Therefore, as noted above, applications in response to this time-sensitive mechanism are eligible for only one submission. Resubmission applications are not permitted under this FOA.

3. The plan for collection of baseline and follow-up data is feasible.

The obesity program or policy to be evaluated should reasonably be expected to affect behaviors relevant to obesity such as reduced energy intake, reduced sedentary behavior, or increased physical activity in the target population. Further, research proposed in response to this FOA should demonstrate that measures collected and evaluated will allow for meaningful and scientifically valid conclusions to be made about the effects of the policy or program on the target behaviors or weight.

Examples of appropriate studies include, but are not limited to, the following:

• Examine the effect of imminent policy or programs intended to improve dietary intake or activity levels such as:
  • Introduction of new taxes/subsidies/price changes/other incentives;
  • Infrastructure Initiatives such as the introduction of new aspects of the built environment such as retailers offering healthier food options in underserved areas;
  • Changes to school or workplace food and/or physical activity environment;
  • Polices designed to influence available options and purchasing, such as calorie labeling in restaurants, menu or food product reformulation, and supermarket layout or pricing strategies;
  • Introduction of active transportation options such as the implementation of bike lanes in urban areas, multi-use trails, or subsidies for public transit on activity of citizens; and community-level changes, e.g., upgrades of sidewalks, modification of transportation pathways to facilitate more walking or bicycle riding, implementation of multi-use trail/s, or traffic calming measures.

Primary outcomes under study must be assessed using objective measures, or in the case of dietary intake, by using standardized and comprehensive 24hr recall methods. Examples of acceptable primary outcomes include objective measures of behavior change (purchasing behavior, use of resources intended for physical activity, energy intake with a focus on lowered calories or lower calorie substitutions, activity changes such as reduced sedentary behavior or increased physical activity) and/or weight related variables (e.g. BMI, body composition). Other self-reported measures of dietary intake and physical activity can be included but should not be the primary outcome measure/s.

Where possible or relevant, grant applications should include secondary outcomes that evaluate potential unintended consequences of a policy or program, degree of implementation, and an assessment of barriers and facilitators associated with implementation. This includes measures that will help identify why the policy or program succeeds or does not succeed.

This funding opportunity announcement encourages innovative scientific partnerships between researchers and public partners (e.g., community based organizations, local governments, school districts, employers). Where relevant, applicants must provide letters of support from those who hold ownership or management of the program and/or policy that indicate their full cooperation with the research team. This must include support for access to the data required for the evaluation. Where appropriate, agreements must also be in place that allow for unrestricted publication of findings regardless of study outcomes. Research applications that include comparison group/s must include letters of support/agreement for access to the comparison group. The Program Director/Principal Investigator of the evaluation study should not be the initiator of the policy or director of the program to be evaluated.

Applicants are strongly encouraged to contact the program staff listed on this FOA to discuss their planned research prior to submission to this announcement.

Applications requesting research support for the evaluation or retrospective analysis of existing obesity policies or programs that are not time sensitive should not be submitted under this FOA. Rather, such applications should be submitted under PA-10-027, Obesity Policy Research: Evaluation and Measures (R01) or PA-10-052, School Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes (R01).

Given the possibility for changes in policy or program implementation that are beyond the control of the grantee, grant awards may be terminated early if these changes limit the possibility to collect meaningful outcome data.

Funding Instrument	Grant
Application Types Allowed	New 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 NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project.
Award Project Period	The maximum project period is five years.

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

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the 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.

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.

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
• Number and title of this funding opportunity

The letter of intent should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: [email protected]

AND

Christine M. Hunter, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-4728
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.

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.

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/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, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

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.

Is the scientific value (offers an uncommon and scientifically significant research opportunity) clear and compelling? Is the feasibility clear--e.g., can the measures be collected, are the appropriate partnerships in place, etc., to complete the project successfully? Are rapid review and funding required in order for the scientific question to be approached and for the research design to be carried out? Is it accurate that the knowledge gained from the study cannot be obtained through the traditional NIH cycle of application submission, review and award? It should be clear that the research question can only be answered if the project is initiated with minimum delay.

Is the policy or program designed to meaningfully reduce calorie consumption, increase activity, or decrease sedentary behavior? Will the results of the evaluation research likely have a meaningful effect on public health in regard to weight management?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

Applications from Foreign Organizations

Not Applicable..

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK, 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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

Not Applicable.

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 Service Desk (Questions regarding ASSIST, 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]

Christine M. Hunter, Ph.D.
Director of Behavioral Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4728
Email: [email protected]

John G. Haaga, Ph.D.
Deputy Director, Division of Behavioral and Social Research
National Institute on Aging (NIA)
Telephone: 301-496-3131
Email: [email protected]

Robin A. McKinnon, PhD, MPA
Health Policy Specialist
Division of Cancer Control & Population Sciences
National Cancer Institute (NCI)
Telephone: 240-276-6921
Email: [email protected]

Layla Esposito, Ph.D.
Program Director
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6888
Email: [email protected]

Michele L. Barnard, Ph.D.
Deputy Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: [email protected]

Natasha Loveless
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8853
Email: [email protected]

John Bladen
Grants Management Specialist
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: [email protected]

Carol A. Perry
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 240-276-6282
E-mail: [email protected]

Bryan S. Clark, MBA
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
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.