Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Human Genome Research Institute  (NHGRI)

Funding Opportunity Title

Genomic Sequencing and Newborn Screening Disorders (U19)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

New

Related Notices
  • April 19, 2013 - See Companion PAR-13-203; Methods Development for Obtaining Comprehensive Genomic Information from Human Specimens that are Easy to Collect and Store (R43/R44).
  • August 15, 2012 - Informational/Technical Assistance Pre-application Meeting for RFA-HD-13-010. See Notice NOT-HD-12-027.
Funding Opportunity Announcement (FOA) Number

RFA-HD-13-010

Companion Funding Opportunity

None  

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865  

Funding Opportunity Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and The National Human Genome Research Institute (NHGRI) invite applications that propose to explore the implications, challenges and opportunities associated with the possible use of genomic sequence information in the newborn period.  Funds will be used to stimulate research in three component projects specifically applicable to newborn screening:

  • Acquisition and analysis of genomic datasets that expand considerably the scale of data available for analysis in the newborn period;
  • Clinical research that will advance understanding of specific disorders identifiable via newborn screening through promising new DNA-based analysis; and
  • Research related to the ethical, legal and social implications (ELSI) of the possible implementation of genomic sequencing of newborns. 

Each research project will be expected to collect a comprehensive genomic dataset from infants with known newborn screening results (positive or negative) and analyze those data in the context of one or more of the following research questions:

  • For disorders currently screened for in newborns, how can genomic sequencing replicate or augment known newborn screening results?
  • What knowledge about conditions not currently screened for in newborns could genomic sequencing of newborns provide?
  • What additional clinical information could be learned from genomic sequencing relevant to the clincial care of newborns?

Applicants must include coordinated research in each of the three Component Projects and address one or more of the research questions listed to be considered responsive to the FOA.

Key Dates
Posted Date

August 9, 2012

Letter of Intent Due Date

October 19, 2012

Application Due Date(s)

November 19, 2012

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February/March 2013

Advisory Council Review

May 2013

Earliest Start Date(s)

July 1, 2013

Expiration Date

November 20, 2012 

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and The National Human Genome Research Institute (NHGRI) invite applications that propose to explore the implications, challenges and opportunities associated with the possible use of genomic sequence information in the newborn period.  Funds will be used to stimulate research in three component projects specifically applicable to newborn screening:

Each research project will be expected to collect a comprehensive genomic dataset from infants with known newborn screening results (positive or negative) and analyze those data in the context of one or more of the following research questions:

Applicants must include coordinated research in each of the three component projects and address one or more of the research questions listed to be considered responsive to the FOA.

Background

Newborn screening programs currently screen more than 4 million U.S. infants per year making them the most common form of genetic testing (testing of gene products or DNA) performed in the United States. This public health program has saved countless lives through the identification of infants who are at risk for congenital disorders for which early interventions and treatments have the potential to reduce morbidity and mortality.  States routinely screen newborns for at least 30 congenital disorders.

The role and scope of newborn screening in the United States has continually evolved since its inception in the 1960’s.  For example, the availability of new technologies such as tandem mass spectrometry has dramatically increased the number of screenable disorders, and also has allowed identification of so-called secondary targets that are typically part of the differential diagnosis for core disorders.

Traditionally, DNA-based testing has not been a primary newborn screening methodology but has been used for second-tier confirmation of the diagnosis for many disorders for which molecular testing is available (e.g., cystic fibrosis). Genomic technologies have advanced dramatically over the past decade, however, to the point where the prospect of incorporating individuals’ whole genome sequence information into their medical care is under serious discussion and careful study.  Over the next several years, genome sequencing of large numbers of individuals and application of that information in the context of specific clinical studies and ongoing medical care are expected to increase the clinical utility of whole genome data substantially.  At the same time, the costs of collecting and interpreting comprehensive genome data are falling below the costs of conducting some individual genetic tests.  These new, sophisticated and increasingly cost-effective techniques for DNA-based sequencing and analysis may make it possible to expand newborn screening in the future and substantially expand its clinical and public health value. Recognizing these trends, NICHD, NHGRI and ORDR held a workshop in December 2010 to identify elements of a trans-NIH research agenda that could inform the possible application of new genomic concepts and technologies to newborn screening and child health. (http://www.nichd.nih.gov/about/meetings/2010/121410.cfm).  This FOA represents an initial step along this path. The purpose of this initiative is to explore, in a limited but deliberate manner, opportunities to use genomic information for broadening our understanding of diseases identified in the newborn period. 

Specific Areas of Interest

In keeping with the spirit of the 2008 Newborn Screening Saves Lives Act (P.L. 110-204) that authorizes the NIH to carry out research in newborn screening, it is the intent of this initiative to encourage the exploration of specific scientific challenges and opportunities related to the use of emerging genomic technologies and concepts in the context of newborn screening.  Interested NIH institutes (including NICHD, NHGRI) intend to support studies to collect comprehensive genomic sequence datasets (that is, whole genome or whole exome) from newborns with known newborn screening results (positive or negative).  All studies will conduct research demonstrating how genomic information compares with data obtained from current commonly-applied newborn screening. 

In order to be considered responsive to the FOA, each applicant will be expected to collect a comprehensive genomic dataset from infants with known newborn screening results and analyze those data in the context of one or more of the research questions below:

Question A)  For disorders currently screened for in newborns, how can genomic sequencing replicate or augment (e.g., make more accurate, comprehensive or inexpensive) known newborn screening results?

Question B)  What knowledge about conditions not currently screened for in newborns could genomic sequencing of newborns provide?

Question C)  What additional clinical information could be learned from genomic sequencing relevant to the clinical care of newborns?

In order to be considered responsive to the FOA, each applicant must also propose a research plan that includes each of the following three component projects:

Research Component 1) acquisition and analysis of genomic datasets that expand considerably the scale of data available for analysis in the newborn period;

Research Component 2) clinical research that will advance understanding of specific disorders identifiable via newborn screening through promising new DNA-based analysis; and

Research Component 3) research related to the ethical, legal and social implications (ELSI) of the possible implementation of genomic sequencing of newborns. 

The methods and scope of the research in all three of these component projects should be tailored to focus on the newborn period and the research context in which the sequencing is performed.

Component Project 1

This FOA requires the collection and analysis, for each participant, of a “large genomic dataset” which, in this context means a collection of high-quality nucleic acid data from all or a large portion of the genome of each of the study participants.  At a minimum the scale of data that is required is whole genome or whole exome.  The types of genomic data (in addition to germline DNA sequence) that may be collected and analyzed include epigenome (DNA methylation and/or histone modification) and transcriptome data. Applications that propose to sequence individual genes or  sets of genes, that only use microarray data, or that only assay a small number of elements (e.g., PCR products), will be considered non responsive.

Component Project 1 (Large-scale data collection and analysis) would involve acquisition and analysis of a large genomic dataset that expand considerably, in comparison with current routine data collection for newborns, the scale of data available in the newborn period.

Possible research topics may include, but are not limited to:

Component Project 2

This component of the FOA focuses on disorders that are currently identified by NBS or that could potentially benefit from early identification by newborn screening.

Component Project 2 (Clinical Research) would involve studies that advance understanding of specific disorders identifiable via newborn screening through promising new DNA-based analysis

Possible research topics may include but are not limited to:

Component Project 3

This component of the FOA focuses on the ethical, legal and social implications of genetic and genomic research for individuals, families and communities.

Component Project 3 (ELSI Research) would involve studies related to the social (including ethical, psychosocial, legal, and economic) issues that may arise from the possible implementation of genomic sequencing of newborns. 

Possible research topics may include but are not limited to:

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NICHD and NHGRI intend to commit an estimated total of $25,000,000.  

Award Budget

Application budgets should not exceed total costs of $1.25 million dollars per year, and must reflect actual needs of proposed research project.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum period is 5 years.     

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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

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

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

Expertise is essential in all areas addressed by the FOA:  genomic analysis, newborn screening, clinical medicine, bioethics and social or behavioral sciences.  One PD/PI should be designated as the lead for the grant.  Designation of additional PD(s)/PI(s), with the appropriate experience and expertise to lead other components of the project, is encouraged, as suitable for the specific Research Plan.

The PD(s)/PI(s) must devote at least 1.8 person months effort to this Cooperative Agreement.    

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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, 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.

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:

The letter of intent should be sent to:

Tiina K. Urv, Ph.D.
Intellectual and Developmental Disabilities Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Blvd.
Bethesda, MD 20892-7510
Rm 4B09D, MSC 7510
Phone: 301-402-7015
Email: urvtiin@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and five identical copies of Appendix materials as CDs must be sent to:

Sherry Dupere, Ph.D.
Director, Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-496-3415
Email: duperes@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements:

Face Page (Form Page 1)

Include the number and title of this FOA in item/line 2 of the PHS 398 face page

Table of Contents (Form Page 3)

Modify PHS398 Form Page 3 to enable reviewers to find each component of the application easily. Number all pages consecutively. Because the first page of the application is the Title Page begin the next page with the numeral "2". Do not use lettered numbers (e.g., "2A", "2B" etc.). Use these referent numbers in the Table of Contents.

Detailed Budget for Initial Budget Period

Budget for Entire Proposed Period of Support

Prepare a detailed composite budget (across all subprojects) for all requested support categories for the first year using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. If applicable, provide additional budget pages for consortium/contractual arrangements.

PD(s)/PI(s) for the overall project and for each Component Project are required to devote at least 1.8 person-months of effort.

PD(s)/PI(s) and Component Project PD(s)/PI(s) are required to attend the following meetings, and should include travel funds in the budget accordingly:

Biographical Sketch

Investigators or key personnel who participate in more than one component of the project should describe and justify their different roles in the Personal Statement of the Biosketch.  

Resources

Reviewers will use information from the Resources page to evaluate the quality of the scientific environment for the research proposed. Applicants should complete separate Resources pages for all projects.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

The Research Plan must include an Overview of the Project as well as sections devoted to each of the three required Component Projects. 

Begin each section with a new PHS 398 Continuation Page. Do not use the PHS 398 Face Page.  Include the PD(s)/PI(s) name at the upper right-hand corner of each page. 

Overview of the Project

Specific Aims (1 page)

Describe the aims of the overall research project and outline how the component projects will contribute to these aims.

Overall Program Objectives (6 pages)

Items 1, 2 and 3 below are to be included in the six page limit.

1. Significance: Focusing on the research project as a whole address (i) the importance of the problem or critical barrier to progress in the field that the proposed research project addresses, (ii) how the proposed research project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved. (One to two pages recommended).

2. Innovation: Considering the research project as a whole, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Are these concepts, approaches, methodologies, instrumentation, or interventions novel to the research field or novel in a broad sense? Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?(One page recommended).

3. Approach: Include the major approaches and studies involved in the application showing how the approaches of individual component projects complement each other or are inter-dependent. Describe the mechanisms that will ensure the coherence of the overall research project and maintain a multidisciplinary focus. (Three to four pages recommended.)

Overall Program Objectives should also address the following:

Applicants are strongly encouraged to leverage existing resources such as the NICHD-funded Newborn Screening Translational Research Network (NBSTRN) https://www.nbstrn.org and the NHGRI-funded Sequencing Centers http://www.genome.gov/10001691.

Component Project 1- Analysis and Assembly of Genomic Datasets

Specific Aims (1 page)

Research Strategy (12 pages)

Following the PHS 398 Instructions, the Research Strategy for Component Project 1 should be organized into sections on: a. Significance; b. Innovation; and c. Approach.  In addition to those sections, the Research Strategy should include the following:

A) Genomic Sequencing Plan

B) Genomic Sequence Analysis

C) Costs

Component Project 2 - Clinical Research of Disorders Identifiable through Newborn Screening

Specific Aims (1 page)

Research Strategy (12 pages)

Following the PHS 398 Instructions, the Research Strategy for Component Project 2 should be organized into sections on: a. Significance; b. Innovation; and c. Approach.  In addition to those sections, the Research Strategy should include the following:

A) Clinical Interpretation and Transmission of Results

B) Cost

Component Project 3 - Ethical and Social Implications of Research Related to DNA-based Analysis Associated with Newborn Screening

Specific Aims (1 page)

Research Strategy (12 pages)

Following the PHS 398 Instructions, the Research Strategy for Component Project 3 should be organized into sections on: a. Significance; b. Innovation; and c. Approach.  In addition to those sections, the Research Strategy should include the following:

Protection of Human Subjects

List the components of the application that involve human subjects and page numbers for the relevant human subjects sections.  Follow PHS 398 Instructions for describing appropriate human subjects protections.   These descriptions may be included under each Component Project or in one composite section of the application.

Inclusion of Women, Minorities and Children

Describe the composition of the human subjects and the proactive plan to recruit women, minorities, and children (if appropriate). List the page numbers for the relevant Women, Minorities, and Children sections. Follow PHS 398 Instructions in preparing this section. These descriptions may be included under each Component Project or in one composite section of the application.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.  

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be postmarked on or before the due dates in Part I. Overview Information.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by componants of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to be considered responsive to the FOA each application must include three highly integrated Component Projects that include each of the following:

Component Project 1: Acquisition and analysis of genomic datasets that expand considerably the scale of data available for analysis in the newborn period

Component Project 2:  Clinical research that will advance understanding of specific disorders identifiable via newborn screening through promising new DNA-based analysis

Component Project 3:  Research related to the ethical, legal and social implications (ELSI) of the possible implementation of genomic sequencing of newborns 

Each research project must also address one or more of the following questions:

Question A) For disorders currently screened for in newborns, how can genomic sequencing replicate or augment (e.g., make more accurate, comprehensive or inexpensive) known newborn screening results?

Question B) What knowledge about conditions not currently screened for in newborns could genomic sequencing of newborns provide?

Question C) What additional clinical information could be learned from genomic sequencing relevant to the clinical care of newborns?

Pre-Application Information Call and On-Line Information

The NIH will hold a pre-application informational conference call on August 29, 2012, at 2:00 pm – 3:30 pm EST, to which all interested prospective applicants are invited. Program and review staff will make presentations to explain the goals and objectives of the FOA and will answer questions from call participants.

To obtain, the call-in information, please contact Dr. Tiina Urv (urvtiin@mail.nih.gov) at least 24 hours prior to the call.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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/priority 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 - Overall

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? 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

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? 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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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 - Overall

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/priority score, but will not give separate scores for these items.

Component Project 1 - Analysis and Assemby of Genomic Datasets
Component Project 2 - Clinical Research of Disorders Identifiable through Newborn Screening
Component Project 3 - Ethical and Social Implications of Research Related to DNA-based Analysis Associated with Newborn Screening

Overall

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee 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

The committee 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

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 - Overall

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/priority 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) Genome Wide Association Studies (GWAS).

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 NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 and will compete for available funds with all other recommended applications . 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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), 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 recipients' 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 tasks 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:

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches and to plan and conduct the proposed research. She/he will assume responsibility and accountability to the applicant organization and to the NICHD and NHGRI for performance and proper conduct of all research, including the NIH intramural component, if applicable, in accordance with the Terms and Conditions of Award. The PD(s)/PI(s) will be a member of the Steering Committee (see below).

Intramural research scientists participating as collaborators have the same rights and responsibilities as other members of the Group (see below for Participation of NIH Intramural Scientists).

The Awardee Institution and/or Research Project Leader's Institution will retain primary custody of and have primary rights to data as specified under the data and research resource sharing plans (described above). The Government, via the NICHD and NHGRI Project Scientist(s), will have access to data generated under this cooperative agreement and may periodically review the data consistent with current DHHS, PHS, and NIH policies. Timely publication of major findings by the Group members is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgment of NIH (NICHD and NHGRI) support, including the assigned cooperative agreement award number.

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

The Project Scientist(s) interacts scientifically with the Group and may provide appropriate assistance, including assisting in research planning, suggesting studies within the scope of the Group's objectives and research activities, presenting experimental findings to the Group from published sources or from relevant projects, participating in the design of experiments agreed to by the Group, participating in the analysis of results, and advising in management and technical performance. The Project Scientist(s) will be a member(s) of the Steering Committee. However, the total membership by NIH staff will not exceed one-third (1/3) of the membership of the Steering Committee. In all cases, the role of NICHD and NHGRI will be to assist and facilitate and not to direct activities.

Additionally, an NICHD and/or NHGRI Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including monitoring implementation of the data and research resource sharing plans and will be named in the award notice.

Areas of Joint Responsibility include:

Steering Committee

Within two months of award, a Steering Committee will be established and chaired by the PD/PI.  The Steering Committee will consist of the designated leaders for each Project, the NIH Project Scientist, other NIH scientists as identified by the PD(s)/PI(s) and/or Steering Committee, and any other key personnel identified by the PD(s)/PI(s). The NIH Project Scientist(s) will have one NIH vote.  The Steering Committee may add additional members by majority vote.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

The Steering Committee will:

The NIH Project Scientist will participate in the activities of the Steering Committee as required, providing verbal or written responses to the Steering Committee or its designated subcommittees upon request.

External Scientific Panel

An External Scientific Panel (ESP) composed of NICHD/NHGRI-appointed non-federal scientists, not affiliated with the awarded programs, will be established.  This Panel is advisory to NICHD/NHGRI and will help assess progress, evaluate whether goals are being met, identify strengths and weaknesses, and make recommendations to NICHD/NHGRI regarding the program's success. 

The ESP will meet at least once per year; a portion of which will be held jointly with a Steering Committee meeting. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, 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 Non-Competing Continuation Grant Progress Report (PHS 2590) 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

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

Scientific/Research Contact(s)

Tiina K. Urv, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone 301.402.7015
Email: urvtiin@mail.nih.gov  

Anastasia L. Wise, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-443-0585
Email: anastasia.wise@nih.gov

Peer Review Contact(s)

Sherry Dupere, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-3415
Email: duperes@mail.nih.gov

Financial/Grants Management Contact(s)

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

Cheryl Chick
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0733
Email: cc149o@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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