It is critical that applicants follow the instructions in the Application Guide (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User 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.

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

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. New and early stage investigators are encouraged to apply, as well as established neuroscientists.

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, racial/ethnic minorities, persons with disabilities, and other individuals who have been traditionally underrepresented in science, in the planning and implementation of, as well as participation in, the proposed workshop. See NOT-OD-03-0666. The support of junior investigators, postdoctoral fellows, and graduate students is also encouraged.

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.

Awardees of projects funded by the NIH BRAIN Initiative (braininitiative.nih.gov/) are encouraged to submit supplement requests for collaborative efforts that are within scope of this FOA and NIH’s goals for the BRAIN Initiative, as defined by the strategic planning report, BRAIN 2025: A Scientific Vision. Investigators are encouraged to contact potential collaborators participating in related Japan efforts such as the Brain/MINDS project (http://brainminds.jp/en/).

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 the etiology and pathophysiology of chronic pain in orofacial tissues with a focus on temporomandibular joint disorders; acute orofacial pain and mechanisms of transition from acute to chronic pain; as well as chronic pain conditions co-morbid with orofacial pain.

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 NCCIH supports rigorous scientific investigation, the usefulness and safety of complementary and integrative health approaches, and their roles in improving health and health care. This includes collaborations involving studying the neurobiological mechanisms of natural products (such as herbs, prebiotics, probiotics, and dietary supplements) and mind and body interventions (such as acupuncture, meditation, manual therapy, yoga, Tai Chi, hypnosis, music or art therapy, etc) and their effects on pain, sleep, stress, anxiety, emotional well-being, and/or behavioral changes.

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.

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

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.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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.

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

Applicant Organizations

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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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. Grants.gov registration is only required if you plan to submit using the 'Electronic Application Submission through Grants.gov' option.

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.

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.

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

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

Applicants must prepare applications using current forms in accordance with the Application Guide.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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 for their submission option (SF424 (R&R) Application Guide, eRA Commons Administrative Supplement User Guide or PHS 398 Application Guide, as appropriate) including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to documented requirements 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.

All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits must be followed,

Instructions for Electronic Application Submission through Grants.gov

Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

Prepare applications using the SF424 (R&R) forms associated with the chosen package. 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, with the following additional guidance:

• R&R Cover form: Select Revision in the Type of Application field.
• Research Plan form: 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 Location form: 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.
• Sr/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.
• Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
• R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating 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. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . 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.

PHS 398 Research Plan for electronic submissions through Grants.gov

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, and a tentative agenda
• Plans to foster potential collaborations between U.S. and Japanese participants
• Justification for the proposed workshop location and duration
• Composition and role of the organizing committee, and the name and credentials of key participants (i.e., presenters, moderators)
• Plans to disseminate information generated from the proposed workshop to the larger scientific community.
• Plans for the inclusion of junior investigators, women, racial/ethnic minorities, and persons with disabilities.

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 and biosketch from the Japanese host(s).

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 $25,000. 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.

Other Project Information (for use with electronic submissions);

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

Collaborative Research Fund

Submitted applications for collaboration/training must include:

A description of the research facilities and resources at the Japanese host institution.

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.

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

NIH 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, with the following additional guidance:

• Budget information should be entered for the grantee institution in the tabs provided for each selected budget period.
• Since there is no template or form available for subaward budget information, all subaward information must be included as a PDF attachment in the Subrecipient Budgets section showing the funds requested (by budget period) and using the same categories provided for the grantee institution. The attachment must also include any related budget justification information.
• Use the Add Other Attachments function to include the following PDF documents:
• Research Strategy including a summary or abstract of the funded parent award or project.
• If applicable, attach documents indicating 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.

PHS 398 Research Plan for electronic submissions through eRA Commons

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, and a tentative agenda
• Plans to foster potential collaborations between U.S. and Japanese participants
• Justification for the proposed workshop location and duration
• Composition and role of the organizing committee, and the name and credentials of key participants (i.e., presenters, moderators)
• Plans to disseminate information generated from the proposed workshop to the larger scientific community.
• Plans for the inclusion of junior investigators, women, racial/ethnic minorities, and persons with disabilities.

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 and biosketch from the Japanese host(s).

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 $25,000. 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.

Other Project Information (for use with electronic submissions);

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

Collaborative Research Fund

Submitted applications for collaboration/training must include:

• A description of the research facilities and resources at the Japanese host institution.

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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit electronic applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Applicants are responsible for viewing their electronic 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.

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted using the instructions specified above.

Applicants must complete all required registrations prior to submission. 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission contact the Application Submission Contacts in Section VII.

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.

Not Applicable

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 project 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.

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.

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.

NIH staff will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

Not Applicable

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. When calculating the award for additional funds, NIH will 1) prorate funding if the requested budget period is adjusted at the time of award, and 2) use the institution’s current F&A rate; i.e., the rate in effect when the new funding is provided.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes 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. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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.

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 Research Performance Progress Report (RPPR) and financial statements as required in the NIH Grants Policy Statement.

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)

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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This 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 the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)

Telephone: 301-945-7573

Stacey D. Chambers
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-0690
Email: [email protected]

Coryse St. Hillaire-Clarke, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-827-6944
Email: [email protected]

Shumin Wang, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-594-9001
Email: [email protected]

Da-Yu Wu, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1887
Email: [email protected]

Susan L. Sullivan, Ph.D.
National Institute on Deafness & Other Communication Disorders (NIDCD)
Telephone: 301-451-3841
Email: [email protected]

Yolanda F. Vallejo, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4655
Email: [email protected]

Jonathan A. Hollander, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-9467
Email: [email protected]

Ishmael Amarreh, Ph.D., MPA
National Institute of Mental Health (NIMH)
Telephone: 301-451-5132
Email: [email protected]

Wen G. Chen, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-451-3989
Email: [email protected]

Danilo A. Tagle, Ph.D., M.S.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8064
Email: [email protected]

Not Applicable

Tijuanna DeCoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

Jennifer Edwards
National Institute on Aging (NIA)
Telephone: 301-827-6689
Email: [email protected]

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: [email protected]

Cheryl Nathaniel
National Institute on Drug Abuse (NIDA)
Telephone: 202-526-0108
Email: [email protected]

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-0909
Email: [email protected]

Dede Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

James R. Williams
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1403
Email: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Shelley M. Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

Karen Brummett
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-6268
Email: [email protected]

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

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