and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
This is an NIH-wide initiative that is being administered by NHGRI on behalf of NIH. |
|
Funding Opportunity Title |
Center for Inherited Disease Research (CIDR) High Throughput Genotyping and Sequencing Resource Access (X01) |
Activity Code |
X01 Resource Access Award |
Announcement Type |
Reissue of PAR-08-258 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-11-210 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.172 |
FOA Purpose |
CIDR high-throughput genotyping, sequencing and supporting statistical genetics services are designed to aid the identification of genes that contribute to human health and disease. The services provided through CIDR focus primarily on needs that can t be readily handled by individual investigator laboratories. CIDR provides the most up-to-date platforms and services. This is an NIH-wide initiative that is managed by NHGRI. Information about the current services offered can be accessed via: http://www.cidr.jhmi.edu. |
Posted Date |
April 29, 2011 |
Open Date (Earliest Submission Date) |
July 1, 2011 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
Applications are accepted by continuous receipt as
described in NOT-HG-13-008 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
We expect to review applications six times a year, with one meeting in each of the following windows. August -September 2011; December 2011-January 2012 , April-May 2012, June -July 2012, August-September 2012, December 2012-January 2013, April-May 2013, June -July 2013, August-September 2013, December 2013-January 2014, April-May 2014, June -July 2014. |
Advisory Council Review |
|
Earliest Start Date(s) |
October 15, 2011, December 15, 2011, February 15, 2012, April 15, 2012, June 15, 2012, August 15, 2012, October 15, 2012, December 15, 2012, February 15, 2013, April 15, 2013, June 15, 2013, August 15, 2013, October 15, 2013, December 15, 2013, February 15, 2014, April 15, 2014, June 15, 2014, August 15, 2014 |
Expiration Date |
(Now Expired May 6, 2014 per issuance of PAR-14-207), Originally July 2, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (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.
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
With the continued advances in our ability to detect human genetic variation, there is great interest in applying state-of-the-art technology to find genetic elements important in human health and disease. For many studies this requires high-throughput genotyping technologies that cannot be efficiently carried out in individual investigator laboratories. CIDR fulfills this need for many kinds of projects including whole genome association studies (GWAS); gene searches using next-generation sequencing technology and high-throughput custom genotyping.
This FOA is to provide access to full-service high-throughput genotyping, sequencing or other genetic tools to aid the discovery of genetic elements important in health and disease. A particular focus will be on services that are not readily available in individual investigator laboratories.
CIDR offers state-of-the-art high-throughput genotyping and sequencing services. Their services include careful quality control, the ability to replace problematic samples, and data cleaning. Some statistical analysis service is also offered.
This FOA is seeking projects that show promise of identifying genetic element(s) important to human health and disease. There should be strong evidence that the project proposed is likely to have the power to detect genetic factors affecting the trait under study. In addition, there should be a clear need for the particular high-throughput service requested. Appropriate projects would include but not be limited to: Human GWAS studies for common human diseases; human and mouse genome-wide linkage analyses, whole genome sequencing, whole-exome and custom-targeted DNA sequencing, analyses of DNA methylation and custom SNP genotyping. The currently available services can be found at http://www.cidr.jhmi.edu.
Funding Instrument |
Not Applicable, this is an access award, not a grant. |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the number of meritorious applications. |
Award Budget |
Not applicable, X01 funds are not awarded via this X01. |
Award Project Period |
Maximum period 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.
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 (non-U.S.) components of U.S. Organizations are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) 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 Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.
Before submission of an application, the applicant must obtain permission from a supporting NIH Institute. It is expected that access to CIDR resources will be linked to a present or future research grant from a participating NIH institute. A list of NIH contacts for CIDR genotyping is found at www.cidr.jhmi.edu.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each 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. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Applicants must download 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.
It is critical that applicants follow the instructions in the SF424 (R&R) 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.
Contact for submission questions: [email protected]
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
R&R Budget Component and Modular Budget Component: This X01 does not award grant funds; therefore no budget information should be provided.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy:
Significance:
1) Explain the public health significance of the trait under study. Document the evidence for a genetic component and the likely strength of that component.
2) Describe the anticipated genetic complexity of the trait (e.g whether a single, few, or many genes are likely to be involved). Also discuss any likely gene-gene interactions.
3) Describe earlier genetic studies on this disorder and what risk factors have been identified so far.
4) Describe any known environmental risk factors for this trait and the evidence for their involvement. Also discuss any evidence for gene-environment interactions.
5) If the request is a follow up of a previous study, describe those results.
6) Any other background information directly relevant to the current request.
Innovation and Approach:
Description of the Disease/Trait:
Include detailed information about the phenotypic characterization of the subjects and describe any relevant endophenotypes or secondary phenotypes that have been measured. Describe relevant environmental factors that have been measured.
Study Population:
Clearly describe features of the study subjects relevant to the present study. Highlight special features of the subjects or previous studies on these samples that would enhance the chances of success. If a subgroup of families or of the population are selected for analysis, describe the basis for that selection. Inclusion of relevant pedigrees with the subjects to be genotyped clearly marked should be included in the Appendix.
Justification of Services Requested:
Provide a clear justification for why the service requested is likely to aid the discovery of genetic elements for the trait or disease under study. If the requested genotyping or sequencing requested follows up data from a previous linkage, GWAS, or other genetic study, describe those findings in detail, including the strength of any localization, any known replications, and the relationship of the samples to be analyzed to those from the earlier study or studies.
Power and Effect Size:
For genotyping studies, use power analyses to describe the range of effect sizes detectable by the study. In the analyses address relevant features of the analytic plan, such as genetic model to be tested, the extent of multiple testing and what significance level would be used for testing. Include parameters such as risk allele frequencies as well as the expected patterns of linkage disequilibrium. If the study design requires separate analysis of groups of subjects (e.g. phenotypic classes or ancestry groups) provide power analyses for each category. If there is a plan to test for gene-gene or gene-environment effects, address power for that particular design (e.g. testing these interactions separately from the main effects and/or jointly).
For targeted sequencing provide power calculations that include correction for the number of markers estimated in each region. If you plan to sequence a discovery set and then follow up via custom sequencing as part of the validation, provide association power of the validation set.
Data Analyses: Provide a thorough and detailed plan for data analyses. Examples of elements that should be included in this section: 1) the analytical approaches to be used and their justification; 2) plans for quality control analyses of genotypic data; 3) methods to account for genotypic and phenotypic uncertainty; 4) plan to control for possible confound of genotype and phenotype due to ancestry; 5) how false positive rates will be controlled ( e.g. in light of multiple testing); 6) whether and how gene-gene and/or gene-environment interactions will be evaluated and 6) If relevant, how the trait or locus will be localized. 7)If imputation will be used to combine the data obtained with earlier data, describe the imputation plan.
For sequencing requests explain plans for filtering SNPs. If the sequencing is of family members, describe previous genotyping of the samples and whether/how data will be used to infer additional genotypes in unsequenced family members to increase sample size.
Data Management: Provide a description of the institutional computing resources that will be available for this study. Describe how the data are to be managed, such as the type of data base that will be used, who will maintain and update it, and who will have access to it. Highlight experience with data management of large data sets, particularly those similar to the proposed project. Also describe strategies to maintain data security.
Plans for the Next Phase: Describe plan for follow-up studies; e.g. additional genotyping and/or DNA sequencing, replication studies, or functional testing of variants. If collaborations have been established for follow up, include letters of collaboration in 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 SF424 (R&R) Application Guide
Data Dictionary and Data Summary:
For applications where broad sharing of individual data are expected attach: 1) a data dictionary describing in some detail the phenotypic measures to be shared and 2) a data summary (in table form) showing the number of subjects with data for each measure and if appropriate, the range of measures obtained. Examples can be found at http// www.jhmi.edu.
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 with the following exception: For this FOA applicants are encouraged to include relevant pedigrees in the appendix.
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are responsible for viewing their application 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.
This initiative is not subject to intergovernmental review.
Not applicable.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before submission of the application. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD/PIs must include their eRA Commons ID in the Credential
field of the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
In order to expedite review, applicants are requested to notify the NHGRI CIDR Review Office by email at {[email protected]} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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.
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).
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? Is the trait under study significant to human health? Is there strong evidence for a genetic component and documentation of the anticipated size of the genetic effect? Does the genetic complexity of the trait support the need for the high-throughput service requested? Are the proposed studies likely to provide important new information about genetic variants important in human health or disease?
Investigator(s)
Are the PD/PIs, 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? Is the expertise for each aspect of the project in place? Is there evidence that each member of the team, including those involved in the statistical analysis, are able to expend the needed effort?
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?
Are the genetic services requested appropriate for the question addressed? Are the specific phenotypic measures and environmental measures appropriately chosen and carefully determined? Is the study design appropriate for the trait under study? Does the sample set have the power to detect the likely genetic effect? Are there strong plans for both data analysis and data management? Are there adequate plans for follow-up studies to identify specific genes or genetic variant(s) affecting the risk of the disease or influencing quantitative trait variation?
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? Is the needed infrastructure in place for the data management and data analysis?
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.
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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Renewals will only be considered for certain long term projects such as ongoing linkage projects. For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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
Not Applicable.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) at NHGRI 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:
Applications will be assigned to NHGRI for administrative management. . Following initial peer review, recommended applications will receive a second level of review by the CIDR Board of Governors. The following will be considered in making funding decisions:
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.
1. Award Notices - Not Applicable.
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. These requirements are handled by the sponsoring NIH institutes.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
Not applicable.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Camilla Day, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076, MSC9360
Bethesda, MD 20892-9306
Telephone: 301-402-8837
Email: [email protected]
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
Camilla Day, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076, MSC 9306
Bethesda, MD 20892-9306
Telephone 301-402-8837
E mail: [email protected]
A list of participating NIH Institutes and contacts can be found at http://www.cidr.jhmi.edu
Not Applicable
Not Applicable)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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