Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This FOA is a Common Fund initiative (http://commonfund.nih.gov) through the NIH Office of the Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). The FOA will be administered by a trans-NIH team led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Funding Opportunity Title

Genome Sequencing Center for the Gabriella Miller Kids First Pediatric Research Program (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

RFA-RM-16-001

Companion Funding Opportunity

None

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

93.310  

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish one or two centers that can rapidly generate high quality whole genome sequence and variant data from a large number of human specimens representing two types of pediatric conditions - structural birth defects and childhood cancers.  The generated data will become a part of a data resource under The Gabriella Miller Kids First Pediatric Research Program, which will allow researchers to investigate the genetic etiology of structural birth defects, and to further elucidate the genetic contribution to childhood cancers.

Key Dates
Posted Date

January 13, 2016

Open Date (Earliest Submission Date)

March 1, 2016

Letter of Intent Due Date(s)

March 1, 2016

Application Due Date(s)

March 31, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2016  

Advisory Council Review

August 2016

Earliest Start Date

September 2016

Expiration Date

April 1, 2016  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

In response to The Gabriella Miller Kids First Act (https://www.govtrack.us/congress/bills/113/hr2019/text), NIH, through the Common Fund, has established the Gabriella Miller Kids First Pediatric Research Program (Kids First Program).  This program is intended to support a ten-year effort to develop an integrated Gabriela Miller Kids First Pediatric Data Resource (Kids First Data Resource) populated by genomic and phenotypic data that will be of high value for the pediatric research community.  This resource will allow data mining across diverse conditions to uncover shared developmental pathways.  The overall goal is to help researchers understand the underlying mechanisms of disease, leading to more refined diagnostic capabilities and ultimately more targeted therapies or interventions. 

As the first step toward building the Kids First Data Resource, the Kids First Program published the Funding Opportunity Announcement, PAR-15-259, "Discovery of the Genetic Basis of Structural Birth Defects and of Childhood Cancers: Gabriella Miller Kids First Pediatric Research Program (X01)", to solicit project/sample proposals to use whole genome sequencing to investigate the genetics of structural birth defects and the genetic contributions to childhood cancers.  Future calls will be published to continue the solicitation of similar types of projects and samples, pending availability of funds.

This FOA invites applications for sequencing center(s) that will produce whole genome sequence and variant data from the solicited samples (X01 samples) to contribute to the Kids First Data Resource.  It is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite 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.

Goals

The goals of this FOA are as follows:

  • Generation of whole genome sequence data and variant data from cohorts for structural birth defects and childhood cancers that the Kids First Program will provide.
  • Submission of sequence and variant data to the controlled public database of Genotypes and Phenotypes (dbGaP), and databases that may be designated by the Kids First Program, and providing the same data to the project/sample Program Directors/Principal Investigators (PDs/PIs) (X01 PDs/PIs). 
  • Coordination with X01PDs/PIs who will submit the phenotypic data of the sequenced samples to the same databases.  

The FOA expects high quality sequence and variant data to be generated from the largest number of cases and samples possible with available funds.  It is anticipated that costs will decrease over the course of the award while data quality is maintained or improved, so the number of cases that can be sequenced and analyzed per dollar spent is expected to increase. 

Coordination and Governance 

The center(s) under this FOA will be funded using a cooperative agreement.  The center(s) will be required to closely interact with project/sample PDs/PIs on sample transfer and QC, project design, data transfer, and public data release.  If two centers are funded, coordination between the centers will be necessary to assure comparable data quality, standards, and formats, and to avoid unnecessary duplication of efforts.  Close interactions with the NIH program staff will also be required to assure appropriate and timely project assignments to the funded center(s) and satisfactory progress toward the FOA goals.  In addition, the Kids First Program plans to fund a component to establish and manage the Kids First Data Resource, with which the funded center(s) are expected to closely coordinate.  The activities to be coordinated include, but are not limited to, establishing data standards and formats, data transfer, as well as public release of sequence, variant, and phenotypic data.

A Steering Committee will be the main governing body of the Kids First Program.  The Steering Committee will be composed of the PIs of the Sequencing Center(s), Kids First Data Resource, representatives of project/sample PDs/PIs, and NIH program staff.  Major scientific and administrative decisions will be determined by majority vote of the Steering Committee.

An independent group of External Scientific Advisors (ESAs) will be appointed by the NIH to evaluate the progress of the program and to provide advice to the Steering Committee about scientific direction.

See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument

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. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIH intends to fund one or two awards from this FOA, contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. The total amount of funds available for these awards is $12.6M for fiscal year 2016. In FY2017-FY2018, $8.0M per year is anticipated, although future year amounts will depend on annual appropriations.

Award Budget

Application budgets for fiscal year 2016 should not exceed $12.6M in total costs.  For fiscal years 2017 and 2018, annual budgets should not exceed $8M in total costs.

Award Project Period

The total award period for this FOA is 3 years (FY2016 - FY2018).    

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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
Foreign Institutions

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

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Lu Wang, Ph.D.
National Human Genome Research Institute, NIH
Telephone: 301-594-7303
Email: wanglu@mail.nih.gov
 

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.     

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Up to 2% of the total budget can be devoted to custom analysis and validation of a selected set of variants in collaboration with project/sample PIs after the generation of VCF files.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

Applicants should address the following aspects. 

Genome Sequencing and Variant Identification

  • Sample processing

This should include receipt, QC, verification, tracking, and storage of de-identified DNA, blood, and tissues.  Protocols for isolating DNA from tumor (frozen or paraffin embedded) and blood specimens, and DNA quality and yield, should be described.  

  • Whole genome sequencing and identification of variants

Applicants should describe the facilities and sequencing platform(s) that will be used for the proposed activities.  Protocols for 1) generation of libraries, 2) sequence data generation, 3) storage and transfer of BAM and alternative files, 4) generation, storage, and transfer of Variant Call Format (VCF) files, and 5) quality metrics, should be described. 

This FOA anticipates that the following types of cohorts will be sequenced and analyzed: 1) structural birth defects in “trios”(proband, mother, father); 2) childhood cancers in “quads” (proband, tumor from proband, mother, father).  In addition, the sample/project PDs/PIs may propose other types of cohorts to be sequenced and analyzed by the funded center(s).  Applicants should propose plans for 1) appropriate whole genome sequence coverages for these two types of cohorts, and 2) methods for identifying germline or somatic genomic variants from the sequence data.  Types of variants to be identified should include SNVs, indels, and structural variants.  Applicants should propose timelines from having samples in house through delivering the sequence data and VCF files to project/sample PDs/PIs.  The flexibility of the sequencing and variant calling pipeline to accommodate possible fluctuation of sample availabilities should be described as well.  

After the delivery of sequence and variant data, the next step may be custom analysis and validation of variants for a subset of cases by the center(s) or between the centers and the project/sample PIs, if both parties are interested in pursuing such collaborations.  The funded center(s) may spend a small portion of the total budget(s) for this type of scientific collaboration (see the instruction for R&R Budget).  Applicants interested in pursuing such collaboration should describe the methods that will be applied and products that will be delivered. 

Finally, to demonstrate the readiness for performing all of the above activities, applicants should describe relevant examples of previous success. 

  • Computational and bioinformatics capacity

Computational and bioinformatics capacity to support sample processing, sequence generation and processing, variant calling, variant validation, data storage, data transfer to project/samples PIs, and public data release, should be included.

  • Costs

Applicants should provide the following itemized costs.

Cost per genome.  Applicants should estimate the cost for whole genome sequencing and variant identification per sample.  This should factor in, but are not limited to, the following items:

Sample processing and DNA isolation

Library preparation
Sequencing
Generation of VCF files
QC
Experimental failures
Equipment
Computational and bioinformatics costs
Labor
Indirect costs

Cost reduction.  Plans for decreasing all of the above costs over the three funded years while improving efficiency and quality should be proposed.

Total number of samples to sequence and analyze.  The applicant should estimate the minimum number of samples for which the proposed center can generate whole genome sequence and variant data, with annual breakdowns that factor in the cost reduction plan.  For the sake of the application, assume equal number of samples in each of the two cohort types.  For reference, the Kids First Program so far has identified approximately 6,000 samples.  It is anticipated that a similar number of samples will be solicited each year in the next three years.   

  • Complementary genomic approaches

While this FOA clearly prefers high throughput and cost-effective whole genome sequencing, complementary approaches may be considered.  For example, some whole exome sequencing may be used for cost effectiveness.  In addition, applicants are encouraged to consider the role of long-read sequencing technologies in analyzing the sample types discussed above.  Although these technologies are not cost-effective for the main purposes of this FOA currently, it is possible that advances in these technologies will soon make it particularly desirable to apply to some Kids First samples, particularly where complex structural variation is suspected to underlie the phenotype under study.  Plans for deploying long-read technologies should include a rationale that considers both costs and added scientific value for specific sample and variant types.     

Management Plan

A management plan for the proposed center should be proposed. The plan should describe the organization, reporting, and communication structure within the proposed center including the roles of key center members and decision-making processes. The plan must assure adequate personnel for 1) the generation, delivery, and public release of sequence and variant data; and 2) coordination within the Kids First Program.  Overall, the plan should discuss how the proposed organization and management structure will likely lead to success in attaining the goals of the proposed center and the Kids First program.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.   

The Resource Sharing Plan should include:

1) How methods, tools, and standard practice developed under this FOA will be made publically available.

2) A data release plan that describes the release of sequence and variant data, as well as coordination with project/sample PDs/PIs who will submit phenotypic data for the sequenced samples, which must be consistent with the NIH Genomic Data Sharing Policy (see http://gds.nih.gov).

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

 
3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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. 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:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NHGRI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

 
Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PDs/PIs have successful experience in performing large-scale whole genome sequencing and variant identification for human structural birth defects and cancers using state-of-the-art technologies and methods?  Do the PDs/PIs have successful experience in managing multiple collaborative projects simultaneously?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

Will the proposed approaches lead to large volume and high quality sequence and variant data from Kids First samples in a highly efficient and cost-effective way?  Will the management plan enable the proposed center and the program as a whole to meet the FOA goals?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items. 

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, the committee 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, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (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.

Biohazards

Reviewers 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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.   

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHGRI, NIH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. 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.

2. Administrative and National Policy Requirements

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

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the awardees' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific responsibilities and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Accept close coordination, cooperation, and participation of the NIH staff in the aspects of scientific and technical management of the project as described below.
  • Provide the funded center’s goals as requested by NIH staff, with associated throughput, quality, and cost information. These are usually requested at the outset of the award and annually thereafter, but can also be at other times.
  • Determine the approaches for sequence data generation and variant identification, and carrying out those efforts.
  • Ensure that all center goals are met.
  • Determine ways to establish and disseminate the best practices for sequence data generation and variant identification from Kids First samples.
  • Ensure effective interaction with project/sample PIs, the planned Kids First Data Resource, the NIH staff, and the other sequencing center if two centers are funded.
  • Adhere to the NIH policies regarding intellectual property, data release and other applicable resource sharing policies that might be established during the funded period as appropriate.
  • Ensure that the sequence and variant data are deposited into appropriate public databases, and that developed resources are made publicly available according to NIH policies.
  • Accept and implement any procedures and guidelines developed and approved for the Kids First Program.
  • Accept and participate in the cooperative nature of the Kids First Program, including
  • Attend the Steering Committee meetings;
  • Coordinate and collaborate within the Kids First Program as described above;
  • Where opportunities are identified, participate in collaborations with other NIH research networks.
  • Submit data for quality assessment in any manner specified by the Steering Committee.
  • Inform the Program staff of all major interactions with members of the External Advisory Committee.
  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access.
     

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH staff will have the role of Project Scientists through technical assistance, advice, and coordination.  However, the role of the Project Scientists will be to facilitate but not to direct the activities.

Project Scientists' responsibilities are defined as follows:

  • Make decisions about assignment of projects, and the final project design, to a sequencing center.
  • Participate (with other Steering Committee members) in the group process of setting project priorities and making decisions on joint activities and standard practice of the Kids First Program. The Project Scientists will assist and facilitate the group process but not direct it.
  • Negotiate goals and timelines with the awardees, as necessary.
  • Serve as liaisons between the awardees and the External Advisory Committee (EAC), NIH, and the larger scientific community in helping the Kids First Program to achieve its goals.
  • Coordinate the efforts of the Kids First Program with others engaged in similar and related activities.
  • Attend all Steering Committee meetings and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.
  • Periodically report progress to the Director of NIH.
  • Lend relevant expertise and overall knowledge of NIH sponsored research to facilitate the selection of scientists not affiliated with the awardee institutions who are to serve on the EAC.
  • Serve on subcommittees of the Kids First Steering Committee, as appropriate.
  • Assist in promoting the availability of the data source developed by the Kids First Program to the scientific community at large.
  • Where warranted, co-author publications about the goals of this FOA, and of results of studies funded under this FOA.

Additionally, an agency program official or institute program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as the NIH Project Scientist.

Areas of Joint Responsibility include:

A Steering Committee will be the main governing body of the Kids First Program.  The Steering Committee will be composed of the PDs/PIs of the Sequencing Center(s), Kids First Data Resource, representatives of sample/project PDs/PIs (one from structural birth defects community and one from the pediatric cancer community), and the NIH program staff.  The Steering Committee Chair will not be an NIH staff member.  Each full member (limited to one person per award) will have one vote except NIH Project Scientists, who will have one collective vote.  Additional members may be added by action of the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions.  Major scientific and administrative decisions will be determined by majority vote of the Steering Committee. 

The Steering Committee will:

  • Establish the milestones under this FOA.
  • Develop uniform procedures and policies necessary to meet the Program goals.
  • Provide information to the External Scientific Advisors (ESA), who will be appointed by the NIH.  The ESAs will evaluate the progress of the Kids First Program and the Program’s awardees, and provide advice to the NIH about scientific direction. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the ECHO awards) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The panel members will be a designee of the ECHO Steering Committee, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

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

Application Submission Contacts

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 CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Lu Wang, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-594-7303
Email: wanglu@mail.nih.gov

Peer Review Contact(s)

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301 402-0838
Email: pozzattr@exchange.nih.gov

Financial/Grants Management Contact(s)

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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