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Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). The FOA will be administered by the National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) on behalf of the NIH.

Funding Opportunity Title

Use-Oriented Basic Research: Change Mechanisms of Behavioral Social Interventions (Admin Supp)

Activity Code

Administrative Supplement

Additional funds may be awarded as supplements to parent awards using the following Activity Code(s):

P01 Research Program Projects
P20 Exploratory Grants
P30 Center Core Grants
P50 Specialized Center
U54 Specialized Center- Cooperative Agreements
R00 Research Transition Award
R01 Research Project Grant
R15 Academic Research Enhancement Award (AREA)
R21 Exploratory/Developmental Research Grant Program
R33 Exploratory/Developmental Grants Phase II
R34 Clinical Trial Planning Grant Program
R37 Method to Extend Research in Time (MERIT) Award
U01 Research Project Cooperative Agreements

Announcement Type

New

Related Notices

  • April 18, 2012 - See Notice NOT-RM-12-017. NIH Announces the Posting of Frequently Asked Questions (FAQs) and Other Technical Assistance Resources to Assist Applicants with this PA.

Funding Opportunity Announcement (FOA) Number

PA-12-119

Companion Funding Opportunity

None

Number of Applications

Only one application per parent award is allowed. See Section III. 3. Additional Information on Eligibility.

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

93.310

Funding Opportunity Purpose

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. This announcement was developed by a Common Fund program called the Science of Behavior Change (SOBC) (http://commonfund.nih.gov/behaviorchange/). The SOBC program seeks to promote research across disciplines on the initiation, personalization, and maintenance of behavior change that leads to an improved understanding of the underlying principles of behavior change. Like all Common Fund initiatives, this SOBC initiative invites investigators to develop bold, innovative, and potentially risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. One seemingly intractable problem is the gap between practice and research, in which treatments shown to be efficacious under controlled conditions are not adopted for use, or are unsustainable, in practice settings. There is debate in the behavioral and social sciences fields about how best to bridge this gap, with some investigators focusing on modifying the intervention, and others focusing on modifying the delivery system. This announcement focuses on the former. It acknowledges that there are multiple pathways to bridging the practice-research gap, but focuses on a pathway consistent with the mission of the SOBC program. Specifically, this FOA solicits administrative supplement applications to study possible mechanisms of action of behavioral or social interventions, with the ultimate aim of informing the simplification or other modifications of behavioral or social interventions to improve use in target settings and by target interventionists.

Key Dates
Posted Date

March 19, 2012

Open Date (Earliest Submission Date)

April 15, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

May 15, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date(s)

August 1, 2012

Expiration Date

May 16, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF 424 (R&R) Application Guide or PHS398 Application Guide, as appropriate) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. This announcement was developed by a Common Fund program called the Science of Behavior Change (SOBC) (http://commonfund.nih.gov/behaviorchange/). The SOBC program seeks to promote research across disciplines on the initiation, personalization, and maintenance of behavior change that leads to an improved understanding of the underlying principles of behavior change. Like all Common Fund initiatives, this SOBC initiative invites investigators to develop bold, innovative, and potentially risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. One seemingly intractable problem is the gap between practice and research, in which treatments shown to be efficacious under controlled conditions are not adopted for use, or are unsustainable, in practice settings. There is debate in the behavioral and social sciences fields about how best to bridge this gap, with some investigators focusing on modifying the intervention, and others focusing on modifying the delivery system. This announcement focuses on the former. Specifically, this Funding Opportunity Announcement (FOA) solicits administrative supplement applications to study possible mechanisms of action of behavioral or social interventions, with the ultimate aim of informing the simplification or other modifications of behavioral or social interventions to improve use in target settings and by target interventionists.

Background

The NIH Common Fund and other interdisciplinary NIH initiatives have made concerted attempts to bridge the gap between research and practice, but there are still challenges in moving efficacious behavioral and social interventions into practice settings. More often than not, interventions deemed efficacious fail to be adopted in practice settings. Low adoption of efficacious interventions appears to be due to characteristics of the intervention and to characteristics of the delivery system. There is value both in research to modify efficacious interventions to increase use in practice settings, and in research to modify service delivery systems to accommodate efficacious interventions. This announcement focuses on research to inform the modification of interventions or the simplification thereof.

Recognizing that interventions often need to be simplified (or at least modified) for use in different practice settings, this announcement solicits research to understand how and why behavioral and social interventions work (i.e., their mechanisms of action ). When the mechanisms of action of an intervention are known, modifications can be made that preserve the intervention potency as much as possible. Without an understanding of the mechanisms of action, simplifying an intervention may inadvertently eliminate its most efficacious components, and thus may severely reduce its potency. We note that for some interventions, experimental work may yield inconclusive results that warrant further experimentation, or may indicate that the intervention is already concise and cannot be further simplified.

For the purposes of this announcement, the term mechanisms of action refers to the causal explanations for an intervention’s effects. This announcement distinguishes between mechanisms of action and mediators of an intervention’s effect, recognizing that there is healthy debate among methodologists about this point. This announcement defines a mediator as a variable that is hypothesized to be part of a causal chain between an intervention and an outcome, but for which causation has not yet been established. Until a mediator is shown to cause an outcome, it cannot be considered a mechanism of action. In contrast, a mechanism of action is a demonstrated part of a causal chain between an intervention and its effect. Following from these definitions, mediators may be tested as possible causal mechanisms of an intervention’s effect, and such tests must be designed to allow for causal conclusions. A study by Amir and colleagues illustrates this distinction [Amir et al. (2009). Attention Training in Individuals with Generalized Social Phobia: A Randomized Controlled Trial. Journal of Consulting and Clinical Psychology, 77, 961 973]. An initial study found that attention to threat cues mediated the effect of a behavioral treatment on anxiety. While this mediational analysis demonstrated a correlation between attention and anxiety outcomes, the correlational analysis was the first step toward understanding how and why the intervention worked. To test for causation, the investigators specified and manipulated attention to threat cues, the hypothesized mechanism of the behavioral intervention. Discovering the causal link between attention to threat cues and anxiety, the investigators were then able to pare the intervention down to its essential elements, and to computerize it to reduce variability in therapist fidelity and increase sustainability. This study could serve as a model of use-inspired or use-oriented basic research, and a case where a theory-derived mediator can point to a mechanism.

This administrative supplement program seeks to support the experimental manipulation of putative mechanisms to understand how interventions produce their effects, within the context of current NIH-funded research on behavioral or social interventions. Supplemental projects are expected to include four elements:

(Note that as long as causality can be inferred with a reasonable degree of certainty, experimental manipulation does not necessarily imply a 2-group design.)

Additional activities may also be appropriate, but only if they serve the purpose of facilitating an experimental study of mechanisms. For example, adding collaborators with expertise in studying mechanisms or expertise in methodology or relevant technology may be critical. In addition, investigators may need to request funds to improve measurement or the measurement schedule, add participants, or purchase software or technological aids, etc. In cases where experimental manipulation might contaminate the parent study, it may be necessary to recruit additional participants from the target population.

The proposed supplemental work should be feasible and appropriate for the stage and design of the currently-funded ( parent ) study. Parent studies must focus on the development and/or testing of a behavioral or social intervention and could be, but need not be, in the clinical trial stage. Parent studies of all stages of intervention development may also be eligible (e.g., those conducting Stages I, II, III, and IV, randomized clinical trials, effectiveness studies). Applicants are strongly encouraged to discuss potential eligibility of their funded research with the program official and grants management official responsible for the parent study.

This supplement program focuses on human behavioral and social intervention research. Studies using animal models to understand human health behaviors are not eligible for this supplement program. Studies involving animals as part of a behavioral intervention (e.g., using a service animal) to improve health, may be eligible.

Activities proposed in response to this administrative supplement announcement must fall within the scope of the peer-reviewed and approved parent project aims. For guidance in determining whether proposed activities are within scope, applicants are strongly encouraged to contact the program and grants management officials responsible for the parent study. Activities considered to fall outside the scope of peer-reviewed and approved aims will not be eligible for administrative supplement funds.

Examples of activities that likely fall outside the scope of approved, existing studies include, but are not limited to:

In addition to falling within the scope of approved aims, proposed activities must be appropriate to the purpose of this announcement. Appropriate activities are those that would involve experimental manipulation of putative mechanisms to understand how and why behavioral or social interventions exert their effects. Activities that do not focus on mechanisms of action are not appropriate for this announcement. For instance, activities solely meant to enhance statistical power, broaden sample representativeness, extend follow-up timelines, increase personnel effort, replace existing equipment, etc., are not appropriate for this announcement. Supplemental applications connected to parent projects that do not already involve behavioral or social intervention research are not appropriate to this announcement. Also, applications that do not include an experimental manipulation of variables theorized to be causally related to the outcome of an intervention are not appropriate for this announcement.

Section II. Award Information
Funding Instrument

The funding instrument will be the same as the parent award.

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The NIH plans to commit approximately $500,000 in FY2012 towards this administrative supplement program, awarding five to seven supplements, contingent upon receiving scientifically meritorious applications.

Award Budget

Application budgets are limited to no more than the amount of the current parent award, and must reflect actual needs of the proposed project.

The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.

Supplement requests for up to $75,000 direct costs will be accepted. Multiple supplement applications for a single parent grant will not be considered. This announcement is intended to support 1-year administrative supplements; however, requests for 2-year supplements may be considered, contingent upon availability of funds, if there is a compelling justification for why 2 years are needed to complete the research proposed.

Award Project Period

The project and budget periods must be within the currently approved project period for the existing parent award.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

All organizations administering an eligible parent award may apply for a supplement under this announcement.

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

This announcement is for supplements to existing projects. To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project.

Foreign Institutions

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

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

Required Registrations

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

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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

Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are invited to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PD(s)/PI(s), the supplement may be requested by any or all of the PD(s)/PI(s) (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PD(s)/PI(s) listed on the parent award. Visit the Multiple Program Director(s)/Principal Investigator(s) Policy in the SF424 (R&R) Application Guide for more information.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Multiple supplement applications for a single parent grant will not be considered. Since applications in response to this announcement will receive only administrative review by the SOBC program, and will not receive a peer review, the NIH policy on resubmissions will not apply. However, applications not accepted by the SOBC for review, or not funded by the SOBC, should not be submitted again without either responding to any written concerns or contacting the awarding Institute or Center for instructions first.

Eligibility

This announcement is for supplements to Research Project Grants including those using the following activity codes: R00, R01, R15, R21, R33, R34, R37, U01, U54, P01, P20, P30, and P50. However, because there may be institute-specific practices about supplementing particular grant mechanisms, a particular parent grant using one of the above mechanisms may not be eligible. Applicants are strongly encouraged to contact the program and grants management officials responsible for the parent grant to confirm eligibility for this supplement program.

To be eligible:

IMPORTANT: The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the scope of the original project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes. The determination of scope is the responsibility of the NIH institute that awarded the parent grant. For this reason, it is essential that applicants consult with the program and grants management officials responsible for the parent grant to ensure that the proposed activities do not constitute a change in scope from the original funded grant.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants are required to prepare applications according to the current application forms in accordance with the Application Guide.
For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process.

2. Content and Form of Application Submission

All forms should be completed for the supplemental activities only and should not reflect funding or activities for the previously awarded parent award.

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS398 Application Guide, as appropriate) 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.

Page Limitations

All page limitations described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements: The Research Plan portion of the application is limited to 6 pages.

Application Submission

The process for submitting an application varies depending on whether the activity code of the parent award requires electronic submission (as of the submission date of the supplement application). Visit the list of Activity Codes Processed Electronically by eRA to determine if the activity code of the parent award has transitioned to electronic submission. Please see NOT-OD-12-043 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-043.html) for information on the new submission procedures for applications for administrative supplements.

Instructions for Submissions using Grants.gov/Apply for electronic-based submissions

For grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some components marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional components.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions

NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request.

Budget information should be entered for the grantee institution in the fields provided. There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award. Submit a signed, typewritten original of the application, including the checklist, and two signed photocopies in one package to:

Melissa Riddle, Ph.D.
Office of Behavioral and Social Sciences Research Branch
National Institute of Dental and Craniofacial Research
National Institutes of Health
6701 Democracy Blvd, Room 646, Mail Stop 4878
Bethesda, MD 20892-4878
Telephone: 301-451-3888
Email: riddleme@mail.nih.gov

On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

PHS398 Research Plan Component (Research Plan)

All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

Project/Performance Site Locations (Project/Performance Sites)

Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

Senior/Key Personnel Form

List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each. Follow all instructions in the Application Guide.

R&R Detailed Budget Form (for use with electronic submissions)

All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

Budget for the Entire Proposed Period of Support (for use with paper-based submissions)

A proposed budget should be submitted using the PHS398 budget forms, in accordance with the PHS398 Application Guide, and should only include funds requested for the additional supplement activities.

Other Project Information Component (for applications submitted electronically); Appendix (for applications submitted on paper)

All instructions in the Application Guide must be followed, with the following additional instructions:

IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic submissions)

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Foreign Institutions

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

3. Submission Dates and Times

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

Organizations must submit applications as described above. 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.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

For paper-based application submission, iinformation on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted using the instructions specified above

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:
For applications submitted electronically on the SF424 (R&R) Application forms, 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 Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Not Applicable.

Section V. Application Review Information

1. Criteria

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below will be considered in the administrative evaluation process.

The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

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

Overall Impact

Administrative supplement requests will be reviewed administratively by NIH Staff. This is a one-time solicitation; appeals of funding decisions are not permitted. NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award.

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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, NIH staff 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

NIH Staff 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

NIH Staff 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.

2. Review and Selection Process

Administrative supplement requests will undergo an administrative evaluation by NIH staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the awarding component for the parent award and will be administratively evaluated using the criteria shown above.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. This may be as an NoA for the supplemental activities only; alternatively, it may be as either a revision to the current year NoA or included as part of a future year NoA. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

3. Reporting

Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the NIH awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the PHS Non-Competing Grant Progress Report, Form 2590, and financial statements as required 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

Inquiries and discussion of plans for responding to this PA are strongly encouraged. Interested applicants should contact the Program Officer for the parent research grant, and one of the SOBC Common Fund Working Group representatives listed below for questions relevant to the scientific scope of the request. The institute affiliations of Common Fund SOBC Working Group representatives do not imply that applications are restricted to those NIH institutes missions. The SOBC Working Group encourages applications from grantees of all participating NIH institutes, centers, and offices.

Lisa Onken, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-0107
Email: lonken@mail.nih.gov

Melissa Riddle, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-451-3888
Email: riddleme@mail.nih.gov

Varda Shoham, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-8694
Email: shohamv@mail.nih.gov

Peer Review Contact(s)

Not Applicable.

Financial/Grants Management Contact(s)

Mary Greenwood
National Institute of Dental and Craniofacial Research (NIDCR)
Grants Management Branch
Telephone: 301-594-4808
Email: md74u@nih.gov

Michael Morse
National Institutes of Health
Office of the Director
Office of Strategic Coordination (Common Fund)
Telephone: 301-435-5446
Email: morsem@mail.nih.gov

Applicants may also contact the Grants Management Officer listed on the NoA of the parent award.

Section VIII. Other Information

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

Authority and Regulations

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


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NIH Funding Opportunities and Notices



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