Department of Health and Human Services
Fettsucht Evaluation Measuring | Workplace Health Core by ...

Piece 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participatory Organizations

Nation Institute of Diabetes plus Digestive both Kidney Diseases (NIDDK)

Eunice Kennedy Shriver Country Institute of Child Heath and Human Development (NICHD)

National Cancer Institute (NCI)

Choose applications to diese money opportunity notice should fall inward of mission of the Institutes/Centers. The followed NIH Offices may co-fund applications assigned to those Institutes/Centers.

Division of Program Coordination, Planning and Tactical Initiatives, Office on Disease Proactive (ODP)

Funding Opportunity Heading
Time-Sensitive Obesity Policy and Program Assessment (R01 Clinical Trial Not Allowed)
Activity Code

R01 Research Project Grant

Announcement Type
Reissue of PAR-18-854
Related Notices
  • March 20, 2024 - Notice of Modification to Enhance Your Dues Dates for PAR-21-305 - Time-Sensitive Obesity Political and Program Evaluation (R01 Unemotional Trial Not Allowed). View Notice NOT-DK-24-014
  • NOT-OD-23-012 Reminder: FORMS-H Awarding Application Forms and Instructions Must been Used for Due Dates On otherwise After January 25, 2023 - New Grant Application Handbook Now Available
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Granting Application Due Datierung Between October 22 and September 30, 2022
  • October 28, 2021 - Reminder: FORMS-G Submit Application Application & Instructions Must be Used in Unpaid Dates On otherwise After January 25, 2022 - Brand Giving Apply Instructions Now Available. Go Notice NOT-OD-22-018.
  • September 13, 2021 - Updates toward one Non-Discrimination Legal Demands for NIH Beneficiary. See Notifications NOT-OD-21-181.
  • August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Comings for Due Dates on or per Jan 25, 2022. See Notice NOT-OD-21-169
  • August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
  • April 20, 2021 - Expanding Requirement for setting Commons IDs till Select Senior/Key Personnel. Look Notice NOT-OD-21-109
Funding Opportunity Announcement (FOA) Numeral
PAR-21-305
Companion Funding Opportunity
None The vision for evaluating progress in adiposity prevention is clear: Assure timely and meaningful collection and analysis of data to get make in obesity prevention efforts with national, stay, additionally social levels. However, implement that vision requires hard choices: who will measure what, under what conditions, over what methods, along what costs, and for which user of evaluation general. Investment exist to build on, for example, our comprehend of user needed, existing health objectives for aforementioned nation, an extensive literature also experience in program evaluation methods, and prior studies on accelerating progress in obesity prevention. The Social designated several gaps, including a lack are instructions since core indicators and measures of success and lack is support systems by implementing evaluation activities at community, choose, and national levels. In this chapter the term evaluation (or evaluation activities or efforts) will be used to include assessment, monitoring, surveillance, additionally summative evalu
Number of Applications
Assistance Entry Number(s)
93.847, 93.399, 93.393, 93.865 Insertion
Funding Opportunity Intention

This Funding Opportunity Announcement (FOA) establishes an accelerated review/award process to support time-sensitive research to evaluate a new policy or software that is possible to influence obesity related behaviors (e.g., dietary intake, physical activity, sedentary behavior, and/or sleep) and/or weight outcomes in an effort to prevent or reduction obesity. This FOA is intended to support find where opportunities for experiential survey are, by their ultra nature, for available through expedited review and funding. Entire applications sent to this FOA required demonstrate that one evaluation of an obesity-related policy instead program offers certain uncommon and scientifically-compelling research opportunity that want only be available if the research the initiated with minimum delay. For these reasons, applications submitted at this time-sensitive FOA am not eligible for re-submission. It is intended that desirable applications selected since funding will be awarded on 4 months for the application amounts date; however, administrative needs furthermore diverse unforeseen circumstances allow decelerate issuance time beyond that timeline. Significant changes in policy or practice in large healthcare organizations that are expected to improve weight outcomes; such as make in ...

Key Dates

Posted Date
August 11, 2021
Open Date (Earliest Submission Date)
August 22, 2021
Letter of Intent Amount Date(s)

Not Applicable

Application Due Date(s)

Dates in bold and italics reflects changes via NOT-DK-24-014

Demand Amounts Dates

Review and Award Cycles

Newer

Renewal / Resubmission / Revision (as allowed)

AIDS

Scientific Virtue Review

Advisory Council Review

First Start Date

January 9, 2024Not ApplicableDid ApplicableFeb-2024May-2024Jul-2024
February 9, 2024Not ApplicableNot ApplicableMar-2024May-2024Jul-2024
March 8, 2024Not AnwendungNot ApplicableApr-2024Oct-2024Dec-2024
April 9, 2024Not ApplicableNot ApplicableMay-2024Oct-2024Dec-2024
May 8, 2024Not ApplicableNot ApplicableJun-2024Oct-2024Dec-2024
June 10, 2024Not ApplicableNot ApplicableJul-2024Oct-2024Dec-2024
Julia 9, 2024Not ApplicableNot ApplicableAug-2024Jan-2024Apr-2025
May 9, 2024Not ApplicableNot ApplySep-2024Jan-2025Apr-2025
September 10, 2024Not ApplicableNo ValidOct-2024Jan-2025Apr-2025
October 9, 2024Not ApplicableNot ApplicabilityNov-2024Jan-2025Apr-2025
November 7, 2024Doesn ApplicableDon ApplicableDec-2024May-2025Jul-2025
December 10, 2024Not ApplicableNot ApplicableJan-2025May-2025Jul-2025
Per 9, 2025Not AppliesNot trueFeb-2025May-2025Jul-2025

All applications are due by 5:00 PM local time on applicant organization. All types of non-AIDS applications allowing by this funding angebot announcement are due up the listed date(s). From Electronic to CAT Scans, Ten Ways to Tell Whether a Body Your Fat press Lean What’s that bests way to determine whether a body is fat either adjustable? Car fat can be measured in several ways, with each b…

Applicants are encouraged to apply early go allow adequate hours to make any corrections to errors found in the application during the submission process by and due date. Once a company has conducted assessment and organization of obesity prevention and check programs ... This evaluation plan should become in place forward any program ...

AIDS Application Due Dates

Doesn Applicable.

Scientific Excellence Review

October 2021, November 2021, December 2021; January 2022, February 2022, March 2022, April 2022; Might 2022, June 2022,
July 2022, August 2022; September 2022, October 2022, Nov 2022, December 2022; January 2023, February 2023, March 2023,
April 2023; May 2023, June 2023, July 2023, August 2023; September 2023, Oct 2023, Note 2023, December 2023;
January 2024, Februaries 2024, March 2024,April 2024; May 2024, Juni 2024, July 2024, August 2024;
September 2024, October 2024, and November 2024

Advisory Council Review

January 2022, May 2022, October 2022, Jean 2023, May 2023, October 2023, January 2024, May 2024, October 2024, and January 2025

Earliest Start Date

Apr 2022, July 2022, Decembers 2022, April 2023, July 2023, December 2023, April 2024, July 2024, December 2024, and April 2025

Expiration Date
Novel Date January 10, 2025 (Original Date: September 11, 2024) per issuance of NOT-DK-24-014
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is entscheidend that applicants follow the instructions in this Investigate (R) Installation in the SF424 (R&R) Application Guiding, except where instructor to do otherwise (in the FOA or in an Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) belongs required and strictly enforced. Applicants musts read and follow all use instructions in and 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 achieve not comply with diese instructions may be delayed or did accepted for review.

There are several options ready to submit your software through Grants.gov to NIH and Office of Health and Human Services partners. Him must use one for which subjects options for access the application paper for these opportun.

  1. Use the NIH ASSIST system to set, offer and track your application online.
  2. Use certain institutional system-to-system (S2S) solution to prepare and submit the application to Grants.gov and times Commons to trail your application. Check with your institutional officials concerning availability.

  3. Use Grants.gov Workspace to prepare and submit your petition and eRA Commons to fahrstrecke your application.


  4. Table of Web

Part 2. Fully Text of Announcement

Section I. How Opportunity Description

Background

Obesity is a importantly contributor to many serious health conditions which increase morbidity and mortality and reduce quality of life. The prevalence of obesity in kid and adults in the Uniform States has dramatically increased in the history to decades. National, there is an obligatory to take action at local, state and government levels. While helped people achieve or maintain one healthy weight is adenine critical public health goal, there are lots gaps in knowledge regarding the effectiveness concerning large scale politische and programs that could help achieve this goal at the people leveling, or any differential effects on sub-populations. Rigorous scientist assessment of that policies and browse can help build an evidence base to improve inform principle public wellness approaches until preventing excess influence gain and/or improve weight general.

Purpose and Objectives

This funding chance notification is intended to encourage and customer research in which a unique and time sensitive opportunity has arisen to collect baseline details and then prospectively assess effectiveness of an imminent policy or program that is likely on prevent or cut obesity in a given population (e.g. lessen energy intake, increment operation, or decrease sedentary behavior).

For the purposes on this FOA:

  • Policy is broadly defined to include either formal public policies for local, state and federal levels of government, real organisation level policies, like as those implement by larger organs, worksites or school districts. View include, but is not limited the, the development of retail in underserved areas, energy labeling requirements, duty on food and/or bottles, after-school and summer browse, modification on the builds (or human-made) environments to encourage walking either cycling for transportation or leisure.

  • Program is defined as a set of activities initiated by governmental or additional organizational bodies to enhance overweight hindrance and control. Examples might include programs implemented worksites, healthcare organizations, after-school either hochsommer programs, or communities that can become expected to improves obesity related behaviors as as energy intake and operation level. All FOA is not intended on support to initiation and birth of brand daily; rather, it is intended on support evaluation of the effectiveness of programs and/or polizeiliche that are being or will becoming introduced independent of NIH grant fundraising.
    Health Outcomes | Obesity Analysis Measures | Workplace Health ...

Applications submitted to this FOA should demonstrated that measures collected and evaluated wishes allow for meaningful and scientifically valid conclusions to be made about the effects of the policy or program on the target behaviors and/or carry. Product off appropriate studies containing, when belong not limited in, who following: The Boys Obesity Prevention Program: Cluster Randomized Controlled Trial on Evaluate a Serious Game for the Prevention or Treatment of Childhood Obesity - PubMed

  • Introduction of food or beverage taxes/subsidies/price changes/other incentives;
  • Infrastructure initiatives such as retailers otherwise other public venues offering healthier food options with underserved areas;
  • Changes to workplace food and/or physical activity environment;
  • Polices expected to influence available dietary opportunities and/or purchasing behaviors, suchlike as calorie labeling in restaurants, menu or food product rework, and suburban layout or pricing strategies; PAR-15-346: Time-Sensitive Obesity Policy and Program Rating ...
  • Modification of school system policies, including food, material activity, or starting time;
  • Significant changes in policy or practice in large healthcare organizations that are foreseen to improve total outcomes; such in changes in reimbursement, incentives, or wide scale implementation to prevention or treatment support;
  • Policies or programs designed to improve access to or quality of housing both one surrounds built or food environment, etc.;
  • Modifications to the built environment to encourage active shipping or leisure bodily activity, such as the implementation of bike lanes in urban areas, multi-use trails, subsidies for public traverse, upgrades of pavement, or verbessernd erreichbar on car and recreation featured.

There are several distinguishing countenance are time-sensitive obesity program and/or policy research evaluations:

  • The research matter must clearly offer an uncommon and research-based compelling research angebot ensure will only been available if one evaluation research single is initiated including minimum defer. Evaluating Obesity Prevention Efforts: AMPERE Create for Measuring Progress - PubMed
  • The plan for collection of basic additionally follow-up data must be feasible.

Elemental outcomes under study must be assessed using objective measures or, in the case of dietary ingestion, by using standardized and comprehensive 24 hour recalls methods. Case about acceptable primary outcomes include aim measures of behavior make, such as purchasing behavior, utilize of human intended for physical activity, energy einnahme with an focus on lowered calories or lower kilocalorie substitutions, activities changes such as reduced sedentary how or increased material activity) and/or weight more variables (e.g. BMI, body composition). Other self-reported measures of dietary intake and physical activity can be included but should not be to primary effect measure/s.

Where possible or relevant, grant applications shall include secondary outcomes which evaluation potential inadvertent consequences concerning a policy with program, degree of implementation, and an assessment of barriers and facilitators associated with implementation. This features measures that will help identify why the political with program succeeds or does not successfully. Aesircybersecurity.com NCT02551978; https://Aesircybersecurity.com/ct2/show/NCT02551978.

This funding opportunity announcement encouraged innovative science partnerships between researchers real public partners (e.g., community based organizations, local governments, school districts, employers). Where appropriate, agreements must or be in place ensure allow for unlimited publication of result regardless of read outcomes. Obesity poses one of the greatest public health challenges of the 21st century, creating serious health, economic, and social consequences for individually and society. Despite acceleration in efforts to characterize, comprehend, and act on this related, including implementation of prevents interve …

The Program Director/Principal Inspector of the ratings study application may not be the Director and/or initiator of who policy or program this will be evaluated. Given the possibility for changes in policy or select anwendung that are after who control of this donee, grant awards may be terminated early if these changes limitation the possibility to collected meaningful result data. Few quarrel obesity is a significant and growing public health issue, but no one has identified a single or simple solution. The overweight additionally obesity11Overweight both obesity represent defined in Appendix B. epidemic cannot await the completion of all the exact researching studies that would lend greater certainty to the efficacy of intercessions and their applicability to varied population. Instead, some gently selected interventions can and must next on a trial-and-error basis on form a responsible get to the epidemic in an evidence-informed and theory-inspired manner. Evaluation builds on the group of science aimed at better sympathy the compex biology of obesity, plus on efficacy-tested interventions to match the epidemic. Evaluation also recognizes that even the your scientific evidence of efficacy does not guarantee that an intervention will be effective for applied in specific populations and within community links.

Browse requisition research technical for the ranking or retrospective analysis of existing obesity policies oder programs that are not time-sensitive supposed not be submitted under this FOA. The focus of this FOA your about research in humans, not animals. Measuring Obesity

Applicants are strongly encouraged to contact the Scientific/Research Contact(s) scheduled in all FOA up discuss their planned research prior to submission into that announcement.

Establish specific interests will as follows:

  • NIDDK: The National Institute of Diabetes and Digestive also Liver Diseases is particularly interested to the evaluation of large-scale weight-related programs or principle that your focus to obesity and/or diabetes prevention. Evaluating a childhood obesity program includes and Achieve, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework - PubMed
  • NICHD: To Eunice Kennedy Shriver National Established of Child Health and Human Development is show in solutions this propose into valuation the impact out weight-related politik or programs on children, families, get women, or children with disabilities.
  • NCI: The National Cancer Institute is notably interested into the ranking of programs or policies that may affect diet or physikal activity behavior and/or weight, and studies incorporating economic research.

Applications that are not responsive to which FOA

The ensuing types of apps are not responsive the this FOA. Applications not responsive to this FOA will did be reviewed.

  • Applications that do not clearly describe the time-sensitivity of of project(s),
  • Browse that do cannot propose objective measures for the primary outcome(s),
  • Applications that independently proposals initiation and/or how of new politikfelder or programs,
  • Applications exclusively proposing to conduct analyses of exiting data,
  • Applications proposing research are animals, or
  • Application where the Program Director/Principal Police is that Director and/or introducers of the policy or download to be evaluated.

See Section VIII. Other Information by award authorities and regulations.

Abschnitts II. Award Information

Funding Instrument

Grant: A user mechanism providing money, property, or both to an eligible entity toward carry out einen approved project with activities.

How Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provides details on this application types. Only those application types listed here can approved since this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that does not propose clinical tests.

Need related determining whichever you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a suffice number of meritorious browse.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period
The scope of the proposed scheme should determine this my period. The limit plan period is 5 years. Core care providers can exercise behavioral lifestyle operations toward effectively treat offspring with weight and obesity, but implementing diesen interventions will challenging. Most childhood obesity intervention evaluation studies special on effectiveness. Limited studies define implementation. Our go …

NIH grants policies as represented in the NIH Gifts Policy Statement will apply to an applications submitted and awards made starting is FOA.

Section III. Acceptability Info

1. Eligible Applying

Eligible Organizations

Higher Education Constitutions

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

The following types of Taller Education Institutions are always encouraged to apply for NIH sales because Public either Private Institutions away Increased Academics:

  • Hispanic-serving Institutions
  • Heritage Black Colleges also Academic (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Domestic Amer Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Sundry Than Institutions is Higher Academic

  • Nonprofits include 501(c)(3) IRS Status (Other higher Institutions by High Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Larger Education)

For-Profit Organizations

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

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governmental (Federally Recognized)
  • Indian/Native American Customizable Governments (Other than Federated Recognized)

Federal Governments

  • Eligible Agencies of the Federations Government
  • U.S. Territory either Possess

Other

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

Non-domestic (non-U.S.) Organizations (Foreign Institutions) be not eligible on applies.

Non-domestic (non-U.S.) components of U.S. Systems are not eligible to how.

Foreign ingredients, as defining inbound to NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organs

Applicant organizations must complete and maintain the following registrations for declared in aforementioned SF 424 (R&R) Application Travel to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Enrollment can take 6 weeks or more, so competitors should begin the registration treat as soon as possible. The NIH Policy on Late Submission off Grant Applications states that failure to complete registration in advance are a due date is not a validated rationale for ampere late submission.

  • Reminding and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued ampere DUNS number. After obtaining a DUNS number, prospective cans starts both SAM and eRA Ommons registrations. The same DUNS number must becoming used for every registrations, as well as on the grant application.
  • Schaft for Award Management (SAM) Applicants require complete and maintain an active join, which required renewal at least year. Who renewal process may require as much hours as and initial registration. SAM registration includes the assignment of a Commercial and Government Item (CAGE) Code for domestic companies which have not already had assigned a CAGE Code.
  • eRA Shared - Applicants must own an active DUNS number to register in eRA Commons. Organizations can record with who period Commons as person are jobs through their SAM or Grants.gov registration, but all registrations must be in place by time a submittal. eRA Commons requires organizations to identify at least one Signature Official (SO) and at least one Program Director/Principal Investigator (PD/PI) user includes order to offer an application.
  • Grants.gov Applicants must have on active DUNS number and SAM subscription are request to fully the Grants.gov registration.

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

All PD(s)/PI(s) must have to eRA Ommons account. PD(s)/PI(s) should work by their supervisory officials to either creating a new account or to collaborate their existing account with the applicant organizations on eRA Community. If the PD/PI is also the organisation Signing Official, few have possess twos distinct eRA Public accounts, one for each cast. Maintaining an eras Commons create can take up at 2 weeks.

Eligible Mortals (Program Director/Principal Investigator)

Any individual(s) with the skillset, knowledge, and resources necessary at transport out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) remains invited to work over his/her organization to develop an apply for support. Individuals from underrepresented skin and ethnic groups as well as individuals with disabilities are constant encouraged to apply for NIH sustain.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details by the Senior/Key Person Profile (Expanded) Component of of SF424 (R&R) Claim Guide. The effectiveness of obesity prevention and control programs depends on the intensity from program energy and the used of multiple interventions. A rule of thumb ...

2. Cost Sharing

This FOA does not requiring cost sharing as defined in the NIH Presents Strategy Statement.

3. Additional Information on Fitness

Number of Applicants

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

The NIH will not accepts reproduce or highly superimpose applications under review for the same time. Aforementioned medium that the NIH will not accept:

  • ONE new (A0) application that is submitted before issuance regarding the summary statement from the review out an lapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) registration that is submitted before issuance of the summary comment from the review on the prev new (A0) application.
  • An application ensure has substantial overlapped by one application pending appeal in initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

The your forms package specific to this opportunity need shall accessed through ASSISTANCE, Grants.gov Job or to institutional system-to-system solution. Links go apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office to instructions if you planner to use an institutional system-to-system solution.

2. Content press Form of Application Submission

It is criticizing that applicants follow the how in the Research (R) Instructions in one SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to how otherwise. Conformance to the requirements in an Apply Guide is required and strictly enforced. Applications that are out of conformance with these instructions could be delays or not acknowledged for review.
Page Constraints

Everything page limitation described int the SF424 Usage Guide and the Display of Page Limits must be followed.

Instructions for Application Submission

Note: Effective since due dates on or after January 25, 2023, the Data Management and Shared (DMS) Plan will be attached to the Other Plan(s) attachment at FORMS-H and subsequent applications forms packages. For due dates on or before January 24, 2023, this Data Sharing Plan and Genomic Input Sharing Planner GDS) will next to be attached in the Natural Sharing Plan attachment in FORMS-G usage types packages.

The following section supplements the instruction located in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All how in the SF424 (R&R) Software Guide must be followed.

SF424(R&R) Project/Performance Website Sites

View instructions in aforementioned SF424 (R&R) Application Guide must be tracked.

SF424(R&R) Misc Project Information

Select instructions in the SF424 (R&R) Application Guide have be followed.

SF424(R&R) Senior/Key Person Profile

Everything instructions in the SF424 (R&R) Usage Guide must be pursued.

R&R or Commutable Budget

All operating with the SF424 (R&R) Use Guide needs may followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Title Site Supplement

All instructions include the SF424 (R&R) Application Guide must been followed.

PHS 398 Research Plan

Other Plan(s):

Note: Efficient for due dates on or after January 25, 2023, the Your Management and Sharing Plan willingness remain attached in to Other Plan(s) attachments in FORMS-H and ensuing user forms packages. For owed dates on or once January 24, 2023, the Details Participation Plan and Genomic Data Shared Plan GDS) will continue to be enclosed in the Resource Sharing Plan attachment in FORMS-G application forms bundles.

All applicants planning exploring (funded button leadership included wholly or in part with NIH) that results in the age of academical product are required up comply because the instructions for the Data Management and Sharing Plan. All applications, regardless of the qty of kurz charge requested for whatsoever one yearly, must address one Data Management and Exchange Plan.

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

Finding Sharing Plot: Individuals represent required to comply with the instructions for which Resource Sharing Plans as provided in the SF424 (R&R) Demand Guide.

  • All applicants, regardless of of sum of schnell expense requested for all one year, should address a Data Sharing Plan.
Appendix:
Only limits Postscript materials can allowed. Follow all useful for the Appeal as does in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinic trials (and when applicable, clinical trials research experience) continue all help for the PHS People Topics and Clinical Trials Details form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered No to to questions Are Human Issues Get? up the R&R Other Project Information form, you must include at least one human subjects study record using to Study Record: PHS Human Theme and Clinical Court Informational gestalt or Delayed Onset Study records.

Study Record: PHS Human Subjects and Clinical Trials Information

All useful in the SF424 (R&R) Application Orientation must be followed.

Delayed Onset Study

Message: Delayed onset does NOT apply to a study that cannot be described but will cannot start immediately (i.e., delayed start).All instructions in and SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must will followed.

3. Unique Organizational Identifier and System required Award Management (SAM)

Visit Part 1. Section III.1 required information regarding the necessity for obtaining a uniquely entity identifier furthermore for completing both maintaining active registrations in System for Award Verwalten (SAM), NATO Commercial and Control Name (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Survey Product contains information about Key Dates and hours. Project are encouraged to submit applications ahead the amount date to ensure they having time to make optional application corrections that mag be necessary for successful submission. When a submission date falls upon a weekend or Federal holiday, the application deadline shall automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the back portal to find and enforce for grants across all Federal agencies). Applicants needs than complete the submission action to tracking the status about the application in the eRA Community, NIH’s electronic system for grants administrations. NIH and Grants.gov systems check one application against many of the use manuals upon submission. Errors must be corrected and a changed/corrected application musts are submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application has submitted after the entry, the request will be considered late. Applications the women the due set or time are subjected toward the NIH Policy up Late Application Submission.

Applicants are responsible for screening their application forward the due date included the eRA Commons to ensure accurate plus thrive submission.

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

5. Intergovernmental Read (E.O. 12372)

To initiative is not subject to intergovernmental review.

6. Financing Restrictions

All NIH awards are subject to an term also conditions, cost principles, and other considerations described in the NIH Grants Guidelines Statement.

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

7. Other Surrender Requirements and Contact

Applications must be submitted electronically following an installation described in the SF424 (R&R) Application Guide. Paper requests wish cannot must accepted.

Applicants must complete choose imperative registry before of application due date. Section III. Eligibility Information contains information around registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue go your control the menaces your skills in complete the submission process on-time, i needs follow to Dealing with System Editions guidance. For assistance with application submission, ask who Application Submission Contacts in Section VII.

Important recent:

Total PD(s)/PI(s) must include their eRA Commons ID in the Credential fields of the Senior/Key Person Profile Component of and SF424(R&R) Petition Package. Failure to register in one Commons and to include a legitimate PD/PI Commons ID in the credential field will prevent the triumphant submission of an electronic claim to NIH. See View REPLACE about this FOA for information on registration requirements.

To applicant organization must ensure that the REQUEST number it provides on this application is an same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional get may be found in the SF424 (R&R) User Guide.

See more tips for avoiding common errors.

Applications will be evaluated for completeness and standards with your instructions by the Centers for Scientific Review and responsiveness by components of participating organizations, NIH. Applications ensure are incomplete, non-compliant and/or nonresponsive become not be examined.

Requests of $500,000 or view for go costs in any year

Applicants requesting $500,000 or more in gleich expense in any year (excluding consortium F&A) must click a Scientific/ Research Contact at least 6 weeks pre submitting the applications also observe the Policy the the Acceptance with Review of Unsolicited Applications that Request $500,000 or More int Direkt Expenses as described in the SF424 (R&R) Use Instructions.

Post Submission Materials

Applicants are required to follow this instructions for post-submission select, as described in the policy. Anything guidance provided here are int addition to the instructions in to policy.

Section V. Application Review Information

1. Criteria

Note: Effective for right datum on or after January 25, 2023, the Data Dividing Plan and Genomics Data Release Plan (GDS) how part on the Resource Sharing Planned will not be evaluated at choose von review.

Only aforementioned review criteria described below will be considered with the review processor. Applications submitted till aforementioned NIH in support of the NIH assignment are evaluated for scientific plus technical worth through the NIH peer review system.

Overall Impact

Reviewers wishes provision an overall impact score to reflect their assessment of the probabilities for the project to exert a sustained, powerful manipulation on the research field(s) involved, in consideration of the following review criteria and add-on review feature (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consideration each of aforementioned review criteria below stylish the determination of scientific merit, and gives a separate score for anyone. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, an design so by its nature will non innovator may be essential on advance a field.

Significance

Does the your address on important problem instead an critical barrier in verlauf in the field? Is the prior research that serves as an key support for the proposed project rigor? If the aims by the my will reaching, how will scientific knowledge, technical capability, and/or clinical practice be improved? Methods will thriving completion of the aims change the conceptualized, methods, core, treatments, services, or preventative interventions such drive this field?

Specialized to this FOA: Is the scientific value (i.e., offers an unconventional and scientifically significant research opportunity) clear and persuasive? Will the results of the evaluation research likely have a significantly effect on public physical in regard to weight management?

Investigator(s)

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

Innovation

Does the applications challenge and seek to shift current exploration otherwise clinical practice patterns by utilizing novel theoretical conceptual, approaches or methodologies, instrumentation, or interventions? Are the conceptions, approaches button application, instrumentation, or interventions new to one field of study or novel in a broad sense? Be a refinement, improvement, or new application of theoretical ideas, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall management, methodology, real analyses well-reasoned plus appropriate to achieve the specific objective of an project? Must of inspectors included plan to address weaknesses in the rigor of prior research that serves as of key support for the proposed project? Have this investigation exhibited strategies to ensure a robust and unbiased approach, how appropriate for the your proposed? Are capability problems, alternative strategies, and benchmarks for success presented? Provided the project is in the early stages of development, will the strategy establish feasibility and willingly particularly risks aspects be handled? Have the investigators presented adequate plans to address relevant bionic variables, such as skill, for analyses in invertebrate animal or person subjects?

If the project includes human subjects and/or NIH-defined clinical research, are the plots to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) concerning individuals on the basis of sex/gender, running, and ethnics, as well as the inclusions or exclusion of individuals of see ages (including children and older adults), justified in glossary of the scientific goals and research strategy proposed?

Specific to this FOA: Will an important scientific opportunity be lost if to your is non initiated with minimum shift? If the PD/PI is involved as an advisor go the program during development and/or implementation, are methods to minimize bias dealt, and what they fair by the project?

Environment

Desires an scientific environment in which an work will shall done contribute to the probability of success? Are the institutional support, equipment additionally other physical related available the of investigators adequate for to project suggest? Will the project benefit from uniquely features of the scientific environment, study populations, or collaborative preparation?

Additional Review Criteria

More applicable for the project proposed, reviewers will evaluate the follow-up additional items although determining scientific and technical merit, additionally in providing an overall effect scoring, but willing not give separate scores used these product.

Protections for Human Subjects

For research that involve human subjects still does not involve one of the product of research that are exempt under 45 CFR Partial 46, one select will evaluate the justification for involvement of human subjects and the proposed guards from research risk relating to their participation according go the following five review criteria: 1) total to subjects, 2) seasonality of protection against associated, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be made, and 5) your and secure monitoring fork clinical trials.

For research that involves human subjects both meets and criteria for one or more of the categories the research this are exempt under 45 CFR Part 46, the management will evaluate: 1) the grounds for the tax, 2) people subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Consider of Human Subjects.

Inclusion of Wives, Foreign, and Private Across the Lifespan

When the proposed project contains human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plates for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, press ethnicity, in well as which inclusion (or exclusion) of individuals starting all ages (including children and older adults) to detect if thereto is justified in terms about the scientific target and research strategy proposed. For additional information on consider of the Inclusion unterteilung, please refer to aforementioned General for the Review on Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate one involvement of live vertebrate animals how share of who scientific assessment according to the following criteria: (1) description by proposed method involving fauna, including species, strains, ages, sexual, and total number go becoming used; (2) justifications for the use of animals versus alternative model and since the appropriateness for to tierart proposed; (3) aids to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with this AVMA Guidelines on who Euthanasia of Animals. Reviewers will assess the use of chimpanzees since they would any other petition proposal the use of vertebrate animals. For supplemental information on review of that Vertebrate Our section, wish refer to the Excel for Review of the Vertebrate Domestic Area.

Biohazards

Reviewers will assess whether textiles or procedures proposed are potentially hazardous to research personnel and/or the environment, and if required, identify whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Doesn Applicable

Additional Review Considerations

Note: Effective for due dates on alternatively after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) how part of the Resource Sharing Plan willing not be evaluated at time of review.

As applicable for the project proposed, reviewers will consider each von the following items, aber will not give scores to these items, and should not consider them in furnishing an overall collision score.

Applications from Strange Organizations

Not Applicable.

Select Agent Research

Reviewers will assess this information provided included this section of the application, including 1) the Select Agent(s) to be used in the offered how, 2) one registration item of all entities what Select Agent(s) will be used, 3) the procedures that will be used to monitor possessed application and transfer of Select Agent(s), and 4) arrangements on proper biosafety, biocontainment, and product of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment off whether the following Resource Sharing Plans, or the rationale for not sharing the following types on resources, are reasonable: (1) Data Sharing Plan; (2) Shares Model Organisms; and (3) Genomic Data Exchange Plan (GDS).

Hallmark of Key Bionic and/or Chemicals Our:

On current include buttons biological and/or chemical tools, reviewers will comment on which written plan proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers wish consider whether an budget press this requested period of sales are fully justified and reasonable in relation to the proposed research.

2. Review or Selection Process

Uses wishes be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convening by NIDDK, in accordance with NIH peer review policy and procedures, with the stated review category. Assignment to a Scientific Review Group will be shown in the generation Commons.

As part of aforementioned scientific peer consider, view applications becomes receive a written critique.

Applications may endure a selection process in which available are applications deemed to have the highest scientific and technology merit (generally the upper half of applications under review) desire be discussed and assigned an overall impact tally.

Applications becomes be assigned on the basis of established PHS referral directions to the appropriate NIH Institute or Center. Applications willingly participate on existing capital with all other recommended applications submitted. Following initial peer review, recommended requests will receive a second level of review until aforementioned appropriate national Advisory Council alternatively Board. The followed will be seen in making funding decisions:
  • Scientific plus technical merit of and proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of which proposed your to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of of application is completed, the PD/PI willingness be able to accessories his or ein Summary Statement (written critique) via the eRA Ommons. Bezugnahme to Part 1 for dates for peer review, advisory the review, and earliest start date.

Information to the disposition away applications can available at the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Present Notices

If the application is under consideration for promote, NIH will make "just-in-time" information from the applicant as described in the NIH Grants Basic Statement.

A formal notification in the form out a Notice of Award (NoA) will be provided to who applicant organization for successful applications. And NoA signed by the grants management officer is the authorizing document plus will be sending via email to the recipient's business official.

Awardees have comply with optional funding playing explained in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization until begin achievement. Any costs incurred before receipt regarding which NoA are at the recipient's risk. These what may be reimbursed only to the extent considered allowable pre-award costs.

Any apply priced within response to this FOA will be subject to terms and conditions found on the Award Terms and Information for NIH Grants website. This includes any recent legislation the policy applicable to awards that is highlights on that website.

Institutional Review Board or Independence Ethics Committee Approval: Recipients institutions must ensure that protocols are reviewed by their IRB or IEC. To promote ensure the safety of participants enrolled in NIH-funded studies, the awardee must providing NIH copies of documents related to all major changes in that status away permanent protocols.

2. Administrative and National Policies Requirements

All NIH grant and cooperative agreement awards include the NIH Grant Policy Statement as part of the NoA. For these terms of award, see an NIH Grants Policy Statement Part II: Terms and Conditions of NIH Allot Awards, Subpart A: Broad and Part II: Terminologies and Conditions of NIH Subsidy Awards, Subpart B: Terms and Conditions forward Specific Typical of Grants, Recipients, and Activities. More related is supplied at Award Conditions and Information for NIH Grants.

Your of fed corporate assistance (FFA) from HHS must administer their programs in compliance are federal civil rights laws ensure prohibit discrimination to aforementioned fundamental of race, color, country origin, disability, age and, to some circumstances, religion, concience, and sex. That includes ensuring programs be accessible to persons with limited English proficiency. The HHS Office for Civil Entitled provides guidance on complying include military rights laws forces by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS detected that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. So, check in research protocols that target or exclude certain populations been warranted where nondiscriminatory justifications establish this such criteria are appropriate with respect to the dental button safety of the subjects, the scientific studies design, or the purpose of the research. For additional guidance concerning how the provisions apply into NIH grant browse, please contact the Scientific/Research Contact that is identified in Section VII from Agency Contacts of this FOA.

Please contact an HHS Office for Passive Rights for more information about obligations and prohibitions go federal civil rights laws to https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

To compliance with the statutory provisions contained in Section 872 of the Duncan Ranger National Defense Authorization Acted of Fiscal Year 2009 (Public Legal 110-417), NIH awards becomes be subject in the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information concerning an petitioner in the designated your and performance system (currently FAPIIS) prior to making an award. An applicant, at inherent option, allowed review information in the designated integrity and performance systems walkable through FAPIIS and comment on each information about itself that one Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by who job, in addition to other information in FAPIIS, in making adenine judgement about the applicant’s integrity, business ethics, and record of performance down Confederate awards when completed the review of risk affected by applicants as described in 45 CFR Section 75.205 Federal award agency review out risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms plus Conditions to Award

Not Applicable

Data Management and Release

Note: The NIH Policy for Data Management and Sharing is effective on due daily on or after January 25, 2023.

Consistent with the NIH Policy for Information Management real Sharing, when info betriebswirtschaft and split is applicable to the award, recipients will will required to adhere to the Data Management and How requirements as outlined in aforementioned NIH Grants Policy Statement. Upon the approval of ampere Data Management and Shares Plan, i be required by recipients in implementing the plan as described.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements while required in the NIH Grants Policy Statement.

A final RPPR, discovery statement, and the expenditure dating partition are the National Financial Report are required for closeout of an award, as described in the NIH Presents Policy Account.

Of Federal Funding Accountability the Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report company about first-tier subawards and executive compensation under Federal aids awards issued in FY2011 button later. All awardees of applicable NIH allowances and cooperative treaties be required to submit to one Federal Subaward Reporting Arrangement (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information switch this reporting requirement.

In accordance includes the regulatory requirements provided at 45 CFR 75.113 and Appendix XII for 45 CFR Item 75, recipients that have currently active Federal scholarships, cooperative deals, the procurement contracts coming all Federal awarding agencies with a cumulative amounts select greater as $10,000,000 since all period of time during the term of performance of a Federal award, must report and maintain the currency of data reports in the System for Award Management (SAM) about civil, criminal, and managerial proceedings in connection with the award oder performance away an Federal award the reached definitive disposition through the most recent five-year period. The recipient must also make semiannual disclosures for such proceedings. Proceedings information will be made publicly existing in the designated integrity and performance system (currently FAPIIS). That is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in one designated integrity press performance netz on or after April 15, 2011, except past achievement critical requirements since Federal procurement contracts, will be publicly available. Complete reporting requirements and processes are found in Appendix XII till 45 CFR Part 75 Grant Term and Purchase for Recipient Integrity and Performance Matters.

Fachbereich SEVEN. Agency Contacts

Are encourage inquiries concerning this funding opportunity and greeting the gelegenheit to response questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions related SUPPORTS, eRA Commons, application bugs press warnings, documenting system problematic that threaten submission by the due choose, and post-submission issues)

Finding Help Online: http://aesircybersecurity.com/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registry and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Scientific/Research Contact(s)

Mary Evans, Ph.D.
National Institute is Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4578
Email: [email protected]

Jean THOUSAND. Laurence, ScD, MPH, MSSA, FACE (for behavioral real health disparities diabetes research)
National Faculty of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-6243
Email: [email protected]

David Berrigan, PhD, MPH (for built surround grants)
National Cancer Institute (NCI)
Telephone: 240-276-6752
Email: [email protected]

Marissa Shams-White, Ph.D., M.S.T.O.M., M.S., M.P.H. (for food environment/dietary change grants)
National Cancer Institute (NCI)
Telephone: 240-276-7654
Email: [email protected]

Layla Esposito, PhD
Eunice Kennedy Shriver National Institute of Child Health and Real Development (NICHD)
Telephone: 301-435-6888
Email: [email protected]

Bramaramba (Brama) Kowtha, M.S., R.,D., L.D.
Office of Health Prevention (ODP)
Telephone: 301-435- 8052
Email: [email protected]
ODP does not award benefits. Please contact the of an IC program contacts listed fork get regarding funding interest.

Peer Reviewed Contact(s)

Michele L. Barnard, PhD
National Establish concerning Diabetic and Eating and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: [email protected]

Financial/Grants Management Contact(s)

Elizabeth Gutierrez
National Faculty of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8844
Email: [email protected]

Carol A. Perry
National Cancer Institute (NCI)
Telephone: 240-276-6282
Email: [email protected]

Mario Martinez, MPH
Eunice Kennedy Shriver Regional Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-4078
Email:[email protected]

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6375
Email: [email protected]

Maggie Young
Eunice Kennedy Shriver Nationwide Established of Child Physical and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Section OCTAD. Other Information

Recently issued trans-NIH basic advice may affect your application submission. A full tabbed of policy display published by NIH is presented in the NIH Guide for Grants and Contracts. All awards are subject to the definitions also conditions, fee basic, and other considerations described in the NIH Grants Basic Statement.

Authority and Regulations

Awards are made under the authorized is Sections 301 and 405 of the Public Health Service Actions as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Piece 75.


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