Newborn Screening and Genetics Education for Nurses

Newborn Screening and Genetics Education for Nurses is sponsored by National Institutes of Health (NIH). Offers grants to develop educational materials and programs to enhance nurses' knowledge and skills in newborn screening and genetics.

Expired RFA-HD-13-010: Genomic Sequencing and Newborn Screening Disorders (U19) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Kennedy Shriver National Institute of Child Health and Human National Human Genome Research Institute ( NHGRI ) Funding Opportunity Title Genomic Sequencing and Newborn Screening Disorders (U19) U19 Research Program Cooperative Agreements 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 Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose 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 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.

Letter of Intent Due Date AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in 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.

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 Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I. Funding Opportunity Description 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 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.

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 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 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: 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?

B) What knowledge about conditions not currently screened for in newborns could genomic sequencing of newborns provide? 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 Component 1) acquisition and analysis of genomic datasets that expand considerably the scale of data available for analysis in the newborn Component 2) clinical research that will advance understanding of specific disorders identifiable via newborn screening through promising new Component 3) research related to the ethical, legal and social implications (ELSI) of the possible implementation of genomic sequencing of 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.

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 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: Applying existing sequencing technologies with appropriate sensitivity, accuracy, high throughput, speed and low cost to obtain high-quality large genomic sequence dataset from newborns; Developing new sequencing technologies with appropriate sensitivity, accuracy, high throughput, speed and low cost to obtain high-quality large genomic sequence dataset from newborns; Comparing the quality of comprehensive sequence data obtained by using DNA isolated from dried blood spots, to that from fresh blood or other relevant samples of demonstrated quality.

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: Correlating genetic, genomic, and/or pharmacogenomic information with phenotypic data to determine prognostic factors in disease presentation, progression, and response to therapy for disorders identified through newborn Identifying the relevance of genetic variants; Developing an analysis pipeline that improves quality and interpretation of newborn genomic data as a function of the availability of one or both parents genomic information.

This component of the FOA focuses on the ethical, legal and social implications of genetic and genomic research for individuals, families 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 Possible research topics may include but are not limited to: Examining how the possible return of DNA-based newborn screening results affects health behaviors and psychosocial well-being of both parents Investigating decision-making frameworks (especially ethical and legal factors) for clinicians and other providers in deciding whether and how to return DNA-based results to individuals and their families; Exploring perspectives of parents and clinicians regarding their goals for and expectations about DNA-based newborn screening; Identifying and addressing the challenges related to informed consent for population-based newborn screening with potential lifelong implications, such as carrier status; Examining the issues regarding the ethical and legal status of the newborn undergoing DNA-based screening; Exploring the legal, economic, social and institutional challenges of the possible use of genomic screening technologies by existing newborn screening programs.

Section II. Award Information Application Types Allowed Glossary and the PHS398 Application Guide provide details on these application Funds Available and Anticipated Number of Awards NICHD and NHGRI intend to commit an estimated total of $25,000,000. Application budgets should not exceed total costs of $1.

25 million dollars per year, and must reflect actual needs of proposed research project. The scope of the proposed project should determine the project period. The maximum period is 5 years.

Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations 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 Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually 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 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. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement .

3. Additional Information on Eligibility 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 Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 2. Content and Form of Application Submission It is critical that applicants follow the instructions in 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.

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 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 research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity The letter of intent should be sent to: Intellectual and Developmental Disabilities Branch Kennedy Shriver National Institute of Child Health and Human 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 Director, Division of Scientific Review Kennedy Shriver National Institute of Child Health and Human 6100 Executive Boulevard, Room 5B01, MSC 7510 Rockville, MD 20852 (for express/courier service; non-USPS described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements: Overview of Project (Specific aims, 1 page; Overview, 6 pages) Component Project 1: Analysis and Assembly of Genomic Datasets (Research Component Project 2: Clinical Research of Disorders Identifiable through Newborn Screening (Research Strategy - 12 pages) Component Project 3: Ethical and Social Implications of Research related to DNA-based analysis associated with Newborn Screening (Research Include the number and title of this FOA in item/line 2 of 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 One in-person meeting involving research projects funded under this FOA and the External Scientific Panel.

Two research project steering committee meetings (in-person or 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. 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. All instructions in the PHS398 Application Guide must be followed, with the following additional instructions: 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. Describe the aims of the overall research project and outline how the component projects will contribute to these aims.

Program Objectives (6 pages) Items 1, 2 and 3 below are to be included in the six 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 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 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.)

Program Objectives should also address the following: Identify which research question(s) is/are being addressed by the 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?

A detailed description of and interdependent associations between Component Projects 1, 2, and 3, including a description of how each component project will be integrated into the overall research project.

A description of management structure, leadership roles, and mechanisms of communication; A detailed description of the informed consent or re-consent process, including consent for genomic sequencing, data sharing, and return of A description of institutional human subject's protections and Specific Aims for the overall research project and each component Potential relevance to newborn screening programs.

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 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 Description of specimen processing and tracking.

Justification for and description of the genomic sequencing strategy description of the proposed study sample, including details on study design, sample size, selection, and plans for obtaining appropriate informed consent or re-consent of individuals for genomic sequencing and data deposition.

Description of genomic sequence generation, the facilities and instrumentation to be utilized for sequence generation or, if sequencing is to be subcontracted, the sequence provider.

Detailed description of genomic sequencing experience and demonstration of quality data production at the scale required to achieve component project goals; it is suggested that a report on the prior quarter’s sequencing production and quality measures employed be included. Detailed description of bioinformatics infrastructure/capabilities to securely transmit and store genomic data files for the research project.

Description of the pipeline from acquisition of specimens through sequencing data generation, including time components. A clear statement of the scientific question(s) being addressed related to technology development for collecting a large genomic dataset in the newborn screening context, if applicable.

B) Genomic Sequence Analysis Description of computational and analysis resources Description of anticipated analysis strategy, including file hierarchy and structure, and primary sequence data quality assessments Description of variation calling strategy, including algorithm An itemized breakdown of costs per patient for genomic sequencing Component Project 2 - Clinical Research of Disorders Identifiable through Newborn Screening 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 A clear statement of the research question(s) being addressed by use of a large genomic dataset, and how that information will enhance understanding of a disorder identifiable via newborn screening, particularly with regard to disease presentation, progression, and/or response to therapy For individuals with a confirmed positive NBS disorder, a specific plan for coordination with State Newborn Screening Programs, if appropriate to the research question.

A detailed description of the analysis tools and the methodologies to address the research questions posed, including an algorithm to determine whether genetic or genomic variants are relevant or clinically actionable and integration of parental genomic information, if appropriate.

A detailed description of the clinical approach to phenotypic assessment, evaluation, and follow-up for individuals with a condition identifiable Applicants are required to present a plan for return of results describing which results would be returned and the procedures for doing so. If no results are returned, a detailed rationale must be provided.

Clear description of the expertise available to carry out research related to clinical and phenotypic evaluation, as well as experience related to state newborn screening programs, their principles, practices and A description of anticipated challenges in the analysis plan, and strategies to overcome these challenges. An estimate of cost per patient for clinical evaluation, phenotypic evaluation, and return of results.

Component Project 3 - Ethical and Social Implications of Research Related to DNA-based Analysis Associated 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: A clear statement of the specific research questions being addressed, and how addressing these questions will enhance understanding of the implications of the possible implementation of broad DNA-based screening of A detailed description of and rationale for the approaches and methodologies that will be used to study these questions.

A concise description of how this component project will be integrated into the development and implementation of the overall study design, including the informed consent process and return of results. Clear description of the expertise available to design, lead and carry out the ELSI Research component project, and how this expertise will be utilized in the development and implementation of the overall study.

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 Inclusion of Women, Minorities and 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.

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: The NHGRI large-scale sequencing program has long championed the concept of rapid pre-publication data release.

However, privacy issues associated with clinical research, such as in the program described in this FOA, can provide a rationale for exception to those long-held precepts. Some genomic sequencing and variation data sets generated as a result of this research may become a part of an individual patient’s medical record.

However, sequence and phenotype data resulting from this research may have value beyond that intended by the submitting investigators.

Therefore, submission of study data sets to the database of Genotype and Phenotype (dbGaP), while not required before publication, is encouraged, and should be released at the time of publication, within the rules and regulations of the controlling IRB and local jurisdiction and with informed consent to permit broad data release via an NIH database.

Applications to this FOA are expected to include a discussion of how release to dbGaP will be authorized in the informed consent for the study, consistent with achieving the goals of the program. Any restrictions on data use (such as limitations to a specific disease or condition) should be described.

Although this information is expected to be included in the application, the plans for data sharing will not be factored into the Overall The general NIH data sharing policy is available at http://grants. nih. gov/grants/policy/data_sharing .

All investigators responding to this funding opportunity and requesting $500,000 or more per year in direct costs are expected to include a description of how research data will be shared. 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.

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 Applicants may track the status of the application in the eRA Commons , NIH’s electronic system for grants Intergovernmental Review (E.

O. 12372) This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Pre-award costs are allowable only as described in the NIH Grants Policy Statement . Requirements and Information