Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute on Drug Abuse (NIDA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH formerly NCCAM)
National Center for Advancing Translational Sciences (NCATS)

Funding Opportunity Title

Administrative Supplements for the U.S.-Japan Brain Research Cooperative Program (BRCP) - U.S. Entity (Administrative Supplement)

Activity Code

Administrative Supplement

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

Administrative supplement requests may be submitted electronically for the following activity codes:

R01 Research Project Grant
R21 Exploratory/Developmental Research Grant Award
R37 Method to Extend Research in Time (MERIT) Award
U01 Research Project Cooperative Agreements
UH2 Exploratory/Developmental Cooperative Agreement Phase I
UH3 Exploratory/Developmental Cooperative Agreement Phase II

Announcement Type

Reissue of NOT-NS-10-014

Related Notices

Funding Opportunity Announcement (FOA) Number

PA-14-249

Companion Funding Opportunity

None

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

93.853, 93.866, 93.286, 93.279, 93.173, 93.121, 93.113, 93.242, 93.213, 93.350

Funding Opportunity Purpose

The National Institutes of Health (NIH) announces the continuation of the U.S. entity of the U.S.-Japan Brain Research Cooperative Program (BRCP). This administrative supplement program will provide funds to research projects that are currently supported by the participating NIH Institutes and Centers.

The purpose of the BRCP is to promote scientist exchange, training, and collaborations in basic, translational and clinical research between neuroscientists from the U.S. and Japan.

The U.S. entity of the BRCP supports the following activities:

1) Visit of U.S. scientists to conduct collaborative research and/or to acquire advanced research skills in Japanese institutions.

2) Joint workshops to exchange scientific information and to foster collaborations.

Key Dates
Posted Date

June 5, 2014

Open Date (Earliest Submission Date)

August 2, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

September 2, 2014; September 2, 2015; September 2, 2016, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Not Applicable

Advisory Council Review

Not Applicable

Earliest Start Date

February, 2015; February, 2016; February, 2017

Expiration Date

September 3, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide or PHS 398 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

The National Institutes of Health (NIH) announces the continuation of the U.S. entity of the U.S.-Japan Brain Research Cooperative Program (BRCP). This administrative supplement program will provide funds to research projects that are currently supported by the participating NIH Institutes and Centers.

The purpose of the BRCP is to promote scientist exchange, training, and collaborations in basic, translational and clinical research between neuroscientists from the U.S. and Japan.

The U.S. entity of the BRCP supports the following activities:

1) Visit of U.S. scientists to conduct collaborative research and/or to acquire advanced research skills in Japanese institutions,

2) Joint workshops to exchange scientific information and to foster collaborations.

Background

An agreement on Cooperation in Research and Development in Science and Technology was signed by the President of the United States and the Prime Minister of Japan on May 1, 1980, and has subsequently been renewed and extended. Under the umbrella of this Agreement, the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute for Physiological Sciences (NIPS), Okazaki National Research Institutes, Japan, signed a Memorandum of Understanding for a Brain Research Cooperative Program (BRCP) on November 29, 2000.

Since the inception of the U.S. BRCP in 2002, the NIH has successfully supported U.S. neuroscientists collaborative activities at Japanese institutions, and joint workshops in the neurosciences.

The Japanese entity of the BRCP has been active since 2001. Details of the program are available at http://www.nips.ac.jp/jusnou/english/.

Within the funding guidelines of the BRCP program, each country supports its own scientists who participate in the aforementioned activities.

BRCP Activities Supported by the NIH

A. Collaborative Research Fund

  • The Collaborative Research Fund provides support for the travel and lodging expenses of the U.S. scientist’s visit to Japan.
  • The visit to the Japanese institution may be performed by the PD/PI, collaborators, postdoctoral fellows or students who work on the collaborative project. Support from the Collaborative Research Fund can be used for one or multiple trips.
  • The duration of the supplement is one year. The supplement may be carried over into the next fiscal year, with prior approval from NIH Program staff.

B. Workshop Fund

  • The U.S. Workshop Fund provides partial support for joint workshops.
  • The U.S. and Japanese funding agencies of the BRCP will provide parallel support for joint-workshops. Each entity will support the travel and lodging expenses of the joint-workshop participants from their own country. If the joint workshop will be held in the U.S., the U.S. entity of the BRCP will support the logistical meeting expenses. If the joint workshop will be held in Japan, the Japanese entity will support the logistical meeting expenses.
  • The proposed workshop should have at least one U.S. and one Japanese co-organizer. Co-organizers are encouraged to work together to develop the workshop applications. The U.S. co-organizer must have an active grant from a participating NIH Institute or Center. Workshop applications from U.S. co-organizers should be submitted in response to this FOA. Similarly, Japanese co-organizers should submit their application to the NIPS. See: http://www.nips.ac.jp/jusnou/
  • Applicants are encouraged to use the Workshop Fund to compensate the travel and lodging for women and underrepresented minority investigators, junior investigators, postdoctoral fellows, and graduate students.

Areas of research interests of the participating NIH Institutes and Centers

The NINDS supports basic, translational and clinical research to understand the structure and function of the nervous system and mechanisms underlying neurological disorders and stroke.

The NIA supports a broad spectrum of research and training aimed at a better understanding of age-related normal and pathological changes in the structure and function of the nervous system and how such changes affect behavior. In addition, NIA encourages cross-country collaborations on research related to the etiology, diagnosis, progression, and treatment of Alzheimer s Disease (AD). This mission includes basic and clinical studies of the nervous system, clinical trials of interventions of therapeutic modalities, and epidemiological research to identify risk factors and to establish prevalence and incidence estimates of pathologic conditions in aging and AD.

The mission of NIBIB is to improve human health by leading the development and accelerating the application of biomedical technologies. The NIBIB encourages submission of applications that support the development of bioengineering and biomedical imaging technologies.

The NIDA supports basic, clinical, and applied research on the causes, consequences, prevention and treatment of drug abuse and addiction.

The NIDCD encourages collaborative basic and clinical biomedical and bio-behavioral research in the communication sciences of hearing, balance, smell, taste, voice, speech and language.

The NIDCR supports research on molecular mechanisms regulating normal craniofacial development; genetic and environmental influences on abnormal craniofacial disorders; and the etiology and pathophysiology of chronic pain in orofacial tissues with a focus on the temporomandibular joint.

The NIEHS supports basic mechanistic and human based studies on the interplay of environmental neurotoxicant exposure in neuronal dysfunction across the life span. This includes the influence of prenatal exposure on both childhood and adult dysfunction/disease as well as adult exposures on the aging brain.

NIMH supports research to transform the understanding and treatment of mental illnesses through basic, translational, clinical, and services research, paving the way for prevention, recovery, and cure. NIMH encourages innovative thinking to ensure that a full array of novel scientific perspectives are used to further discovery in the evolving science of brain, behavior, and experience. NIMH is now focusing on an experimental medicine approach to evaluating novel interventions for mental illnesses. This strategy is designed to increase the value of the public investment in early clinical trials by ensuring informed, data-driven decisions at an early stage for behavioral, device, and pharmacologic studies.

The NCCAM supports rigorous scientific investigation, the usefulness and safety of complementary and alternative medicine interventions and their roles in improving health and health care. This includes collaborations involving neurological mechanisms of previously unexplored natural products.

The NCATS supports the development of disruptive and innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. This includes translational and early stage clinical research on rare neurologic and brain conditions.

Section II. Award Information
Funding Instrument

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

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Non-competing Administrative Supplements

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $15,000 direct cost for Collaborative Research Funds, and $35,000 direct cost for Workshop Funds.

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 peer reviewed and approved 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.

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

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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. Similarly, the scope of the proposed collaborative research activities and workshops should be well aligned with the aims of the parent award.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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 encouraged to work with their organizations to develop applications for support.

For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (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 PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator 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

Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center.

Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must prepare applications using current 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 must be completed for the supplemental activities only and must 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 PHS 398 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.

Application Submission

Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of single-project Activity Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission. Submission of requests for administrative supplements for all other activity codes must use paper.

If the administrative supplement may be submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Applicants submitting paper applications must use the PHS 398 Application Forms and the PHS 398 Application Guide.

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

For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Form. Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some forms 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 forms.

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. A User s Guide for submitting through this system is available.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the Add Other Attachments function. 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 PHS 398 Application Forms (for paper-based submissions)

Applications must be prepared using the PHS 398 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.

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.

PHS 398 Research Plan (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.

Research Strategies

Collaborative Research Fund

Submitted applications for collaboration/training must include:

  • Description of the goals of the collaboration/training and how it will enhance the research of the NIH-supported parent grant
  • Details of the supplement's specific aims, research design, methods and data analysis
  • Background and significance of the proposed research/training and its relevance to the goals of the BRCP and the mission of the participating NIH Institutes and Centers
  • The unique opportunities offered by this collaboration/training, and the reciprocal (U.S. and Japan) entity of the project should be clearly delineated
  • Description of the qualifications of the Japanese host and the research environment of the host institution

Workshop Fund

Submitted applications for joint workshops must include:

  • Description of the importance of the proposed workshop to investigators in the field and the larger neuroscience community
  • Relevance of the workshop to the goals of the BRCP and the mission of the participating NIH Institutes and Centers
  • Background and anticipated outcomes
  • Description of the meeting content, including topics, sessions, list of potential participants and a tentative agenda
  • Plans to foster potential collaborations between U.S. and Japanese participants
  • Plans to include the participation of junior investigators, women and underrepresented minorities (if not within the scope of the meeting, explain why)
  • The proposed workshop location and duration
  • Organizing committee (if applicable)
  • Plans to disseminate information generated from the proposed workshop to the larger scientific community.
Project/Performance Site Locations (Project/Performance Sites)

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

  • 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

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

  • 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. Letters of commitment from all participants should be included in the Research Plan section of the application.
  • Submitted applications for collaboration/training must include a letter of invitation from the Japanese host.
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.

  • The total direct cost of each Collaborative Research Fund request may not exceed $15,000. Up to $2,500 may be used for research supplies. Funds from the BRCP may not be used as salary support to the PD/PI, collaborators, postdoctoral fellows, students or collaborators. Travel costs associated with Collaborative Research Fund requests should not exceed the U.S. Government Foreign Per Diem Rates for Japan. See: http://aoprals.state.gov/content.asp?content_id=184&menu_id=81/

  • The U.S. Workshop Fund provides partial support for joint workshops. The total direct cost of each Workshop Fund request from the U.S. co-organizer may not exceed $35,000. The support of travel and lodging expenses should not exceed the U.S. Government Per Diem Rates (http://www.gsa.gov/portal/content/101518 ; or http://aoprals.state.gov/content.asp?content_id=184&menu_id=81/ ). No honorarium is allowed. It is recommended that investigators secure additional funding support from other sources, if needed.
Budget for the Entire Proposed Period of Support (for use with paper-based submissions)

A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

Other Project Information (for use with electronic submissions);

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)

  • If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

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

When conducting clinical research, follow all instructions for completing the Planned Enrollment Report as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing the Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date 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 before the due date 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, information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 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 form 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 (SAM). Additional information may be found in the Application Guide.

See more tips for avoiding common errors.

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

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

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:

Will the administrative supplement increase or preserve the likelihood for the parent grant to exert a sustained, powerful influence on the research field(s) involved?

The following criteria will also be evaluated:

  • Relevance of the proposed activities to the parent grant.
  • Adequate progress of the parent grant, appropriate to the current stage of the project.
  • Appropriate and well-described plan to accomplish the goals within the timeframe proposed.
  • Expertise of the collaborative research team proposed to conduct and achieve the goals of the supplemental study.
  • Significance of the collaborative research/training or workshop.
  • Qualifications of the U.S. applicant and Japanese host.
  • Environment of the Japanese host institution.
  • Relevance of the proposed work to the goals of the BRCP and to the mission of the participating NIH Institutes and Centers.

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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, SAM 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 Non-Competing Grant Progress Report, PHS 2590 or RPPR, 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.

Final Report

Within one month of the completion of all collaborative research/training efforts and workshops, U.S. BRCP supported investigators are required to submit a final report to the NIH, detailing the following information:

  • Project objectives
  • Significance
  • Results/findings including a list of publications, presentations, dissemination material or research grant applications resulting from the collaboration/training or workshop
  • Outcome of collaboration/training or workshop and how it benefits the NIH supported research plans for continued collaboration with the Japanese investigator(s)
Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 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

Scientific/Research Contact(s)

Inquiries and discussion of plans for responding to this Notice are strongly encouraged. When contacting Scientific/Research Staff, applicants should be prepared to discuss the purpose, significance and necessity of their visit to Japan and how the collaborative arrangement will benefit their NIH-supported research.

Stacey Chambers
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-0690
Email: sc395c@nih.gov

Wen G. Chen, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: chenw@nia.nih.gov

Guoying Liu, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-594-5220
Email: liug@mail.nih.gov

Da-Yu Wu, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1887
Email: wudy@nida.nih.gov

Susan L. Sullivan, Ph.D.
National Institute on Deafness & Other Communication Disorders (NIDCD)
Telephone: 301-451-3841
Email: sullivaS@nidcd.nih.gov

John Kusiak, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-7984
Email: kusiakj@mail.nih.gov

Annette Kirshner, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0488
Email: kirshner@niehs.nih.gov

Beverly Pringle, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3725
Email: bpringle@mail.nih.gov

Ashlee Tipton, PhD
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301.451.3849
Email: Ashlee.Tipton@nih.gov

Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: danilo.tagle@nih.gov

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: darbyw@mail.nih.gov

Robin Laney
National Institute on Aging (NIA)
Telephone: 301-496-1473
Email: Robin.Laney@mail.nih.gov

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: huffj@mail.nih.gov

Cheryl Nathaniel
National Institute on Drug Abuse (NIDA)
Telephone: 202-526-0108
Email: nathanic@nida.nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: myersc@mail.nih.gov

Dede Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Barbara Gittleman, M.A.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0585
Email: Barbara.Gittleman@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Shelley M. Carow
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: 301-594-3788
Email: carows@mail.nih.gov

Karen Brummett
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-6268
Email: Karen.Brummett@nih.gov

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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