Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Funding Opportunity Title

Identification and Analysis of Causal Variants: Follow-Up on Genome-Wide Association Studies for Arthritis and Musculoskeletal and Skin Diseases (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

New

Related Notices

  • July 25, 2013 - See Notice NOT-AR-13-023. Notice of Change in Application Due Date.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-12-230

Companion FOA

PAR-12-236, R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.846  

FOA Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, encourages applications that are exploratory/developmental and highly innovative in nature, and aim to characterize the genetic variations in human genomic regions that have been putatively associated with complex diseases relevant to the NIAMS mission. The purpose is to accelerate the discovery of causal genes and variants that influence the risk for disease; and conduct follow-up studies of particular genetic variants to gain novel insights into the functions of these variants and the mechanisms by which they may contribute to disease. Genomic regions of interest are primarily those identified by genome-wide association studies (GWAS) although other types of evidence may also inform the rationale for a given study. These studies are essential for the translation of initial GWAS finding into biological insights, and ultimately important for improving our understanding of the molecular mechanisms of disease that could lead to predictive, diagnostic, and therapeutic advances.

Key Dates
Posted Date

July 10, 2012

Open Date (Earliest Submission Date)

October 20, 2012, April 20, 2013, (Changed to January 20, 2014 per NOT-AR-13-023), Originally October 20, 2013

Letter of Intent Due Date

October 20, 2012, April 20, 2013, (Changed to January 20, 2014 per NOT-AR-13-023), Originally October 20, 2013

Application Due Date(s)

November 20, 2012, May 20, 2013, (Changed to February 20, 2014 per NOT-AR-13-023), Originally November 20, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February/March 2013, October/November 2013, (Changed to June/July 2014 per NOT-AR-13-023), Originally February/March 2014

Advisory Council Review

May 2013, January 2014, (Changed to October 2014 per NOT-AR-13-023), Originally May 2014

Earliest Start Date(s)

July 1, 2013, April 1, 2014, (Changed to December 1, 2014 per NOT-AR-13-023), Originally July 1, 2014

Expiration Date

(Extended to February 21, 2014 per NOT-AR-13-023), Originally November 21, 2013

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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), encourages applications that aim to characterize the genetic variations in human genomic regions that have been putatively associated with complex diseases relevant to the NIAMS mission and conduct follow-up functional studies of particular genetic variants. The purpose is to accelerate the discovery of causal genes and variants that influence the risk for disease; and gain novel insights into the functions of these variants and the mechanisms by which they may contribute to disease. This knowledge will facilitate development of tools for risk prediction and early treatment of disease. The disease-associated regions are primarily those identified by genome-wide association studies (GWAS) although other types of evidence may also inform the rationale for a given study. These studies are expected to be undertaken by a multidisciplinary collaborative effort. This FOA will not support initial discovery GWAS efforts or simple replication of GWAS findings. Awards under this FOA will provide support for personnel, sequencing, genotyping, analyses and other costs, as justified by the study design.

This FOA uses the NIH Exploratory/Developmental Research Grant (R21) award mechanism to support innovative, ground breaking projects with potential for significant impact. Such projects may test a novel scientific idea; or may also develop novel technology, tools or model systems that have the potential to significantly accelerate research in the identification and functional analysis of causal variants; or may apply methods, technologies or approaches from outside this field of research in a novel way to conduct the proposed studies. Projects not suitable for this program are ones specifically to develop preliminary data for longer-term projects in a well established research area, or pilot projects that are less than highly innovative. Projects of limited time and scope that do not meet these characteristics of innovative, ground breaking research should consider applying for a Research Project Grant (R01) instead, through the accompanying FOA (PAR-12-236 for the NIAMS R01 grants for Identification and Analysis of Causal Variants: Follow-up on GWAS. The R21 is not a starter grant for new investigators, and such investigators may be better served by applying for an R01 (for the definition of new investigators and additional information on point please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-013.html). Potential applicants are strongly encouraged to contact the appropriate NIAMS Program Director prior to application to determine the suitability of the project for the R21 mechanism. Preference in funding decisions will be given to projects within NIAMS mission areas that are especially innovative, ground breaking and have a high potential impact on the relevant fields of research. 

Background

The GWAS have proven to be powerful in systematically identifying common genetic variants of modest effect that influence the risk of many complex diseases. There are many areas of the NIAMS mission (http://www.niams.nih.gov/About_Us/Mission_and_Purpose/long_range.asp) in which GWAS could furnish novel insights; and significant advances have been made in rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, psoriasis, vitiligo, alopecia areata and osteoporosis, as a result of GWAS. While the potential of GWAS to identify risk loci in complex diseases is becoming evident, it is clear that many challenges lie ahead.

While GWAS in a number of areas have yielded promising results, follow-up studies are needed to translate initial findings of GWAS into the biological insights that could lead to predictive, diagnostic, and therapeutic advances. For instance, in the regions of confirmed associations, the causal variants will only occasionally be among those that are directly genotyped. Moreover, GWAS detect almost exclusively the effects of common SNPs, but offer limited power to capture any rare variants (<1% population frequency) and structural variants, such as insertions, deletions, inversions and translocations. Detailed sequencing may be necessary to further characterize the genetic variations in the disease-associated regions to enhance the identification of causal variants. Furthermore, in many cases, the functions of identified genes and their variants as well as the mechanisms by which they may contribute to disease are largely unknown. Different approaches may be pursued to improve knowledge about the potential biological impact of different genetic variations. Currently, very few existing groups can bridge from genetics to molecular biology or cell physiology and to disease or novel therapy; multidisciplinary collaborations become critical in accelerating translation. 

Objectives

This FOA intends to facilitate studies that aim to characterize the genetic variations in human genomic regions that have been putatively associated with complex rheumatic, musculoskeletal and skin diseases to accelerate discovery of causal genes and variants that influence the risk for disease; and conduct follow-up studies of particular genetic variants to gain novel insights into the functions of these variants and the mechanisms by which they may contribute to disease. For this FOA, the term causal variant is defined as the functional genetic variant that influences the risk for disease and explains the observed association. The disease-associated genomic regions are primarily those identified by GWAS and other human genetic mapping approaches. Diseases of interest include, but are not limited to: rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, gout, scleroderma, juvenile idiopathic arthritis, psoriasis, vitiligo, alopecia areata, osteoporosis, and osteoarthritis. An application may propose, for example, fine-mapping and sequencing of a targeted region(s), and/or functional validation to understand the biological impact of a genetic variant(s) at the levels of gene expression, protein function, cell and tissue functions, their upstream regulation, and/or their potential contribution to disease. Since different variants, i.e. common/rare or coding/non-coding, often require very different approaches to study them, this program will not be limited to any specific experimental approaches and the investigators are expected to employ the most amenable for the variants to be studied. For instance, variants in protein-coding region may involve characterization of protein product in vitro, in cell lines, or in transgenic animals. The interrogation of variants in non-coding regions may involve the analysis of sequence conservation, expression quantitative loci (eQTL), and chromatin modifications at regulatory sites. Computational approaches may be used to prioritize the discovered variants for potentially time-consuming functional follow up. In addition, integrative analyses may facilitate the identification of key signatures, specific cell subsets or biological pathways for further functional validation. The proposed research is expected to include the study of human subjects or utilize human tissues or cells from well-characterized cohorts. Animal studies, if included, must be complementary to the proposed human research and address mechanistic or therapeutic questions that cannot be addressed directly in humans.

Applicants are strongly encouraged to seek multidisciplinary collaborations to ensure the inclusion of appropriate expertise for the proposed studies. Applications are expected to reflect integration of relevant groups such as clinicians, geneticists, basic biologists or immunologists, computational scientists, systems biologists, statisticians and bioinformaticians. Such an integrated effort will ensure that the complexities of phenotypic definition, the study design, the technical approaches, methods and model systems, the power and statistical genetic analysis are adequately considered. Each application should clearly define the rationale for the proposed fine-mapping, sequencing and functional studies, provide a sufficient summary of the GWAS that identified the genomic regions associated with a particular disease or trait, and explain why those regions should be assigned priority for the proposed interrogation. For sequencing and fine-mapping studies, applications should also describe the rationale for the proposed study design, including the extent and scope of resequencing efforts, efficient fine-mapping strategies, the choice of statistical methods for data analysis, and the costs associated with sequencing and genotyping.

For projects that require sequencing, genotyping, or other genetic/genomic services, access to high quality and cost-effective services is a priority. The NIAMS is currently a participating Institute in the Center for Inherited Disease Research (CIDR, http://www.cidr.jhmi.edu/) which offers a variety of genetic and genomic services, including genome-wide and custom SNP genotyping, methylation profiling, and custom-targeted and whole exome sequencing. Investigators should plan to apply for access to CIDR services (http://grants1.nih.gov/grants/guide/pa-files/PAR-11-210.html) in parallel with an application submitted in response to this FOA. Scientific/research contacts listed here can assist in this process. However, because access to CIDR resources cannot be assured in advance, applications responding to this FOA should include fully budgeted costs for required genetic/genomic services, based on costs at a non-CIDR provider. In the event of an award, final selection of the source will be based on quality and cost considerations.

Examples of research may include, but not limited to:

Awards under this FOA will provide support for personnel, sequencing, genotyping, analyses and other costs, as justified by the study design. This FOA will not support initial discovery GWAS efforts or simple replication of GWAS findings.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Revisions
Resubmission

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 submission of a sufficient number of meritorious applications.

Award Budget

Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year.  

Award Project Period

The total project period may not exceed two 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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

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 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 least 4-6 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 SF 424 (R&R) Application Guide.

The decision of whether to apply for a grant with a single PD(s)/PI(s) or multiple PD(s)/PI(s) grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD(s)/PI(s) will be factored into the assessment of the overall scientific merit of the application. Multiple PD(s)/PI(s) on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PD(s)/PI(s), please see http://grants.nih.gov/grants/multi_pi.

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. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted to the second or third receipt date of this FOA, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

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

The letter of intent should be sent to:

Justine Buschman
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800
6701 Democracy Blvd.
Bethesda, MD 20892-4872
Telephone: 301-496-4811
Email: buschmanj@mail.nih.gov

Required and Optional Components

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 submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

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, with the following modifications:,

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/)

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.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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.

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 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 the application due date. Section III. Eligibility Information contains information about registration.

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

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

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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

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

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

Not Applicable

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.

Additional Review Considerations

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

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 Center for Scientific Review and, 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the NIAMS Scientific Advisory Council.l 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

Not Applicable.

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

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

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

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

Scientific/Research Contact(s)

Yan Wang, M.D., Ph.D.
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800
6701 Democracy Blvd.
Bethesda, MD 20892-4872
Telephone: 301-594-5032
Fax: 301-480-1284
Email: wangy1@mail.nih.gov

William J. Sharrock, Ph.D.
Division of Musculoskeletal Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800
6701 Democracy Blvd.
Bethesda, MD 20892-4872
Telephone: 301-594-5055
Fax: 301-480-4543
Email: ws19h@nih.gov

Peer Review Contact(s)

Richard Panniers, Ph.D.
Center for Scientific Review, NIH
6701 Rockledge Drive MSC7890
Bethesda, MD 20892-7720
Telephone: 301-435-1741
Fax: 301-480-2067
Email: Pannierr@csr.nih.gov

Financial/Grants Management Contact(s)

Jamie M. Thompson
Grants Management Specialist
National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
Bethesda, MD  20892-4872
Phone: 301-594-3535
Fax: 301-480-5450
Email: thompsonja@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.