Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/).  The FOA will be administered by the National Human Genome Research Institute (NHGRI) on behalf of the NIH.
Funding Opportunity Title	Gene Function Studies to Investigate Rare and Undiagnosed Diseases (Admin Supp)
Activity Code	Administrative Supplement Additional funds may be awarded as supplements to parent awards using the following Activity Code(s): P01 Research Program Projects P30 Center Core Grants P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants P41 Biotechnology Resource Grants P50 Specialized Center P51 Primate Research Center Grants P60 Comprehensive Center PN2 Research Development Center R24 Resource-Related Research Projects U19 Research Program – Cooperative Agreements U24 Resource-Related Research Projects – Cooperative Agreements U41 Biotechnology Resource Cooperative Agreements U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements U54 Specialized Center- Cooperative Agreements U56 Exploratory Grants – Cooperative Agreements UM1 Multi-Component Research Project Cooperative Agreements DP1 NIH Director’s Pioneer Award (NDPA) DP2 NIH Director’s New Innovator Awards DP4 NIH Director’s Pathfinder Award- Multi-Yr Funding DP5/UP5 Early Independence Award/Cooperative Agreement R01 Research Project Grant R33 Exploratory/Developmental Grants Phase II R37 Method to Extend Research in Time (MERIT) Award R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track R41/R42 Small Business Technology Transfer (STTR) Grant - Phase I and Phase II R42 Small Business Technology Transfer (STTR) Grant - Phase II only R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I and Phase II R44 Small Business Innovation Research (SBIR) Grant - Phase II only U01 Research Project – Cooperative Agreements UH2/UH3 Phase Innovation Awards Cooperative Agreement UH3 Exploratory/Developmental Cooperative Agreement Phase II UL1 Linked Specialized Center Cooperative Agreement
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	PA-13-076
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.310
Funding Opportunity Purpose	This Administrative Supplement Program intends to support gene function studies in collaboration with the NIH Undiagnosed Diseases Program (UDP) to investigate the underlying genetics, biochemistry and pathophysiology of newly diagnosed diseases identified through the UDP. In recent years, gene function studies combined with genetic and genomic analyses and metabolic studies have greatly improved diagnoses of these very rare diseases and advanced scientific knowledge of the underlying pathogenesis. This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact.

Posted Date	January 7, 2013
Open Date (Earliest Submission Date)	January 26, 2013
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	February 26, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Not Applicable
Advisory Council Review	Not Applicable
Earliest Start Date	April 2013
Expiration Date	February 27, 2013
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.

A compatible version of Adobe Reader is required for download. For Assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://www07.grants.gov/contactus/contactus.jsp.

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

This Administrative Supplement Program is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives encourage investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

The purpose of this Funding Opportunity Announcement (FOA) is to support gene function studies in collaboration with the NIH Undiagnosed Diseases Program (UDP) to investigate the underlying genetics, biochemistry and pathophysiology of newly diagnosed diseases identified through the UDP. In recent years, gene function studies combined with genetic and genomic analyses and metabolic studies have greatly improved diagnoses of these very rare diseases and advanced scientific knowledge of the underlying pathogenesis.

Over the past decade, the NIH Office of Rare Diseases Research (ORDR) has received thousands of inquiries regarding patients’ undiagnosed diseases. Of those individuals seeking assistance, 6% were found to have an undiagnosed disorder. The NIH intramural Undiagnosed Diseases Program (UDP) began in May 2008 and has received approximately 6,300 inquiries over a four-year period. From these inquiries, the investigators were able to evaluate 2,300 medical records and admit 450 patients to the NIH Clinical Center for thorough, one-week evaluations.  Over the four-years, diagnoses were made in approximately 100 patients. The UDP discovered and described two unknown diseases and identified 15 genes not previously associated with human disease. The ability to diagnose these rare and yet to be described diseases has been revolutionized by the use of genetic and genomic analyses combined with gene function studies that uncover the links among gene defects, patient phenotypes, and diseases.

The UDP has demonstrated that it can, in some cases, overcome the obstacles impeding traditional methods of diagnoses, capitalize on new technologies to reveal novel mechanisms of diseases, and expand the spectrum of explained human phenotypes and successfully diagnose patients with rare diseases.  Building on the early successes of the UDP, the NIH is planning to expand the UDP into a network of clinical sites containing the Intramural Research Program (IRP-UDP) and extramural clinical sites.  These clinical sites together with the planned UDP Coordinating Center will comprise the Undiagnosed Diseases Network (UDN). The goals of the Network are to diagnose both rare and new diseases, to advance laboratory and clinical research by building upon the experience and expertise of the IRP-UDP and other similar programs, to enhance coordination and collaboration among laboratory and clinical researchers across multiple centers, and to share resulting data and approaches widely throughout the scientific community.

A critical step in the process leading to diagnosis and potential treatment of patients with these rare diseases is the investigation of gene function in order to provide the causal link between the genetic defects and patient phenotypes. Over the last four years, the IRP-UDP has identified more than 15 gene variants and associated diseases as starting points for gene function studies. Over half of the newly diagnosed diseases from the UDP involve neurological dysfunction or developmental delay; the remaining phenotypes span metabolic, skeletal and inflammatory disease among others. The current list of these genes and the diseases of interest to the UDN is provided on the UDP website.

With expansion of the UDP, the need for gene function studies will substantially increase.  This Gene Function UDP Administrative Supplement will be the first step in an expanding, multi-faceted approach to meet this growing demand. Administrative Supplements provide funds to augment existing grants supporting investigation of the relevant gene, biological pathway, disease or disease model.  Supplement applications will be awarded based on scientific merit, demonstrated track record of the investigative team and ability to perform investigations in a timely way as reviewed by NIH staff of the awarding component. 

Applications should not be limited to particular experimental methods but should employ a wide variety of investigative approaches. Applicants are expected to conduct integrated studies of individual genes in the relevant physiological/pathophysiological environment across any of several levels including molecular, cell, tissue, organ, and whole animal. Before submitting an application, investigators are strongly encouraged to contact the IRP-UDP (genefunction@mail.nih.gov) to establish collaborations and/or gain detailed information about the gene variant and associated clinical phenotype of the disease of interest. In addition, applicants can inquire about the availability of patient bio-specimens and other available resources for gene function studies.

The goal of this administrative supplement program is to obtain mechanistic understanding of (1) what these genes do in the context of physiology and/or pathophysiology of the disease of interest, (2) whether and how the genetic variation affects gene expression and function particularly as it relates to the disease phenotype, and (3) whether and how particular genes and their specific variants are involved in the disease pathogenesis.  Several of the genes on the list may have pleiotropic functions or function in known pathways that may or may not be relevant to the newly diagnosed disease of interest.  Highest priority will be given to those applications that can provide new mechanistic insight into gene function relevant to the disease of interest. 

Examples of research may include, but are not limited to:

• Functional characterization of the genes and their variants using integrated –omic approaches (genomics, transcriptomics, proteomics, metabolomics, phenomics, etc.) to examine the mechanism leading to the disease phenotype (gene x gene, gene x environment, epigenetics, etc.).
• Examination of spatiotemporal expression patterns of the genes and their protein products, their upstream and downstream regulation, and the potential contribution of the gene variants to diseases of interest.
• Use of model organisms (including mice, flies, zebrafish, worms, and yeast) to assess the contribution of the gene variant to the disease phenotype. 
• Exploration of the contribution of the disease-related gene variants to abnormalities in gene expression or function in patient bio-specimens or animal disease models.

Gene function research often requires building investigative teams that cross scientific disciplines. This program encourages applications from teams or interdisciplinary teams of investigators representing multiple scientific disciplines (genetics, informatics, biochemistry, molecular and cellular biology, physiology, pharmacology, etc.).  Investigators who are interested in applying to this program should contact a program official using the contact information provided at the UDP website to discuss strategy for gene function studies within the scope of the parent grant and to link potential applicants with the investigators of UDP to discuss scientific and technical issues prior to submission of an application.

Applications should include a data and research resources sharing plan. Data from the UDN are expected to be handled so as to increase the value of the significant public investment in the creation and operation of the Network. Consistent with achieving the goals of the program, NIH expects that the project datasets (phenotypic, environmental, covariate, process, and other relevant data) and associated genotyping data from the Network will be widely shared with the scientific community for research, while carefully observing standards of patient privacy, confidentiality, and management of health information.  The data sharing plan should describe how final research information such as study protocols, descriptions, bioinformatic tools, and publications will be shared among the UDN, made available through an open access section of a database such as dbGAP, other public websites, as well as with the research community at large, or state why this is not possible. For additional information on the NIH Data Sharing Policy, see http://grants.nih.gov/grants/policy/data_sharing/. 

The NIH also expects the timely sharing of biomedical resources by grant recipients. The resources sharing plan should also describe how unique research resources will be distributed, e.g., through the institution, a repository, or national coordinating center. For information regarding research resources sharing, see http://grants.nih.gov/grants/sharing.htm.  Information regarding the sharing of model organisms can be found at http://grants.nih.gov/grants/policy/model_organism/.   

Funding Instrument	The funding instrument will be the same as the parent award.  Grant: 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. This announcement is intended to support 2-4 supplements for a period of one year.
Award Budget	Supplement requests for up to $150,000 total costs will be accepted in Fiscal Year 2013. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the project, or the cost increases are for unanticipated expenses within the original scope of the project. Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes.
Award Project Period	The project and budget periods must be within the currently approved project period for the existing parent award. This supplement program is designed to provide one year of support in Fiscal Year 2013.

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:

• 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
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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

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

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

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

• System for Award Management (SAM) – must maintain an active entity registration (formerly CCR registration), to be renewed at least annually.  Use the Sam.gov “Manage Entity” function to manage your entity registrations.  See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov (required for all electronic application submissions)
• eRA Commons

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

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

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

For supplements to parent awards that include multiple 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.   

Because there may be institute-specific practices about supplementing particular grant mechanisms, a particular parent grant using one of the above mechanisms (see the list of Activity Code in Part I. Overview Information) may not be eligible. Applicants are strongly encouraged to contact the program and grants management officials responsible for the parent grant to confirm eligibility for this supplement program.

Applicants are required to prepare applications according to the current application forms in accordance with the Application Guide.

For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this announcement, or use the eRA Commons streamlined submission process.

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

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

All page limitations described in the Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• The Research Strategy section of the application is limited to 6 pages.

The process for submitting an application varies depending on whether the activity code of the parent award requires electronic submission (as of the submission date of the supplement application). Visit the list of Activity Codes Processed Electronically by eRA to determine if the activity code of the parent award has transitioned to electronic submission.

• If the parent award’s activity code has not transitioned to electronic submission, then you must use the PHS 398 Application Forms and follow the PHS 398 Application Guide.
• If the parent award’s activity code has transitioned to electronic submission, then you may either (A) electronically submit using the SF424 (R&R) Application Forms and Grants.gov/Apply, (B) electronically 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.

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

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

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

NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons, identify the parent award, and prepare an administrative supplement request. 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, including the checklist, and two signed photocopies in one package to:

Ms. Monika Christman
Lead Grants Management Specialist
Grants Administration Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 3058, MSC 9307
Bethesda, MD 20892-9307
Rockville, MD 20852 (express/courier)
Telephone: 301-435-7860
Email: nhgrigab@mail.nih.gov

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

Project Director/Principal Investigator (PD/PI) name

Parent grant number and title

Gene and Disease of interest in the application

Amount of the requested supplement

Name and title of the institutional official, and

Phone, email, and address information for both the PD/PI and institutional official.

The cover letter must be signed by the authorized organizational representative/institutional official.

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.

In addition, the Research Strategy should include:

• The Gene and Disease of Interest selected from the project list provided on the UDP website.
• A justification of how the aims of the supplement request fit within the scope of the overall parent project.
• A description of research design, methods and data analysis, and how the supplement application will advance our understanding of the gene and its role in the disease of interest.
• A description of how the research team plans to collaborate with the IRP-UDP, if at all, in characterizing the gene of interest.
• Any differences in the involvement or use of human subjects or specimens between the administrative supplement activity and the parent grant will be determined in most cases to be a change in scope and will not be eligible for administrative supplement funds.
• Plans for sharing data with the UDP Network through the future UDP Coordinating Center (award planned for Fall 2013).

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.

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

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 budget should include personnel, research supplies, cost for data deposition to the future UDP Coordinating Center and public databases and travel for collaborator principles to visit the IRP-UDP.  Budget requests for equipment are not allowed. Provide justification that details the items requested.

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.

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.

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

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

Organizations must submit applications as described above. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline 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 before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (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 by the awarding Institute or Center. Applications that are incomplete and/or nonresponsive will not be reviewed.

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. The distribution of the supplemental funds will be determined based on scientific merit and on promise of the application to inform patient diagnosis and/or care. Applications will be reviewed by the staff of the NIH awarding component.  The following questions will be considered in the review:

• Will the administrative supplement application significantly advance our understanding of the underlying genetics, biochemistry and/or pathophysiology of the disease of interest; will the application lead to new mechanistic insights of the role of the gene variant in the disease phenotype?
• Does the application propose to use novel, innovative and/or powerful approaches to characterize the gene and associated disease of interest?  Does the proposed research team have the necessary methodological and technological expertise to conduct the relevant gene function and disease phenotype studies to achieve the proposed goals?
• What is the level of rigor and appropriateness of the proposed methodology and are the proposed methods the right approach to achieve success?
• What is the status of progress on the parent grant and will lack of progress on the parent grant impact the success of this application?  
• Are power calculations and statistical analyses appropriate for an informative study?
• What is the feasibility and appropriateness of the supplemental research plan to accomplish the goals within the proposed timeframe?
• How does the research team plan to collaborate with the IRP-UDP, if at all, to characterize the gene(s) of interest?
• Is there an adequate data sharing plan?
• How will patient confidentiality be maintained during the course of these studies?

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

Protections for Human Subjects:

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Cooperative Agreement Terms and Conditions of Award

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  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.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

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

Yong Yao, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7175, MSC 9641
Bethesda, MD 20892-964
Telephone: (301) 443-6102
Email: yyao@mail.nih.gov

Laura Mamounas, Ph.D.
DER-NEUROGENETICS
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, MSC 9525
Bethesda, MD 20892-9525
Telephone: (301) 496-5745
Email: mamounal@ninds.nih.gov

Carson R. Loomis, Ph.D.
Division of Genomic Medicine
National Human Genome Research Institute
5635 Fishers Lane, Ste. 4076, MSC 9305
Bethesda, MD  20892-9306
Telephone: (919) 541-7592
Email:  LoomisC@mail.nih.gov

Not Applicable

Ms. Monika Christman
Lead Grants Management Specialist
Grants Administration Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 3058, MSC 9307
Bethesda, MD 20892-9307
Rockville, MD 20852 (express/courier)
Telephone: (301) 435-7860
Email: nhgrigab@mail.nih.gov

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

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

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

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