and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|
Funding Opportunity Title |
Ancillary Studies to Large Ongoing Clinical Projects (R21) |
Activity Code |
R21 Exploratory/Developmental Research Grant Award |
Announcement Type |
Reissue of RFA-AR-11-013 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-AR-13-011 |
Companion Funding Opportunity |
RFA-AR-13-010, R01 Research Project Grant |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.846 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) solicits applications that propose to conduct time-sensitive ancillary studies related to the NIAMS mission in conjunction with privately or publicly funded, large, ongoing clinical projects. The ongoing parent project can be a large clinical trial or observational study, or a disease registry that can provide a sufficient cohort of well-characterized patients, infrastructure, data, and biological samples. Applications submitted in response to this FOA will undergo an accelerated review and award process. Each application must include a timeline to demonstrate that the parent project has adequate time left to accommodate the proposed ancillary study. In addition, it must justify the time-sensitive nature of the ancillary study and the need for an expedited review and award process. It must also document permission from the parent project to use the patient cohorts, data, and biological materials. The objective of this FOA is to provide a flexible mechanism to leverage established resources and maximize the return on existing investments in parent projects. Successful ancillary studies will enhance the scientific content and value of the parent projects, improve the research community s understanding of a disease or organ system in the NIAMS portfolio, and thus identify novel targets for diagnosis, treatment, and prevention of disease. |
Posted Date |
July 20, 2012 |
Open Date (Earliest Submission Date) |
November 3, 2012 |
Letter of Intent Due Date |
November 3, 2012; March 15, 2013 |
Application Due Date(s) |
December 3, 2012; April 16, 2013, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
December 3, 2012; April 16, 2013, by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
February/March 2013; June/July 2013 |
Advisory Council Review |
May 2013; August 2013 |
Earliest Start Date(s) |
May 2013; September 2013 |
Expiration Date |
April 17, 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.
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
Clinical studies, whether clinical trials, observational studies, or disease registries, often represent a substantial financial commitment from the sponsors and enormous effort from the investigators who establish an infrastructure for patient recruitment, examination, and follow-up. These large clinical projects, particularly clinical trials, offer unique experimental windows to human disease that are largely under-exploited. Additional studies that go beyond the core activities of the original clinical project can explore the research opportunities offered in the established cohorts and generate new information to enhance the scientific content of the original project. Such studies that are not part of the original parent project are referred to as ancillary studies.
This FOA uses the NIH Exploratory/Developmental Research Grant (R21) award mechanism. Applications in response to this announcement will support innovative, ground breaking projects with potential for significant impact. Such projects may also develop novel technology or tools that have the potential to significantly accelerate research fields; or may apply methods, technologies or approaches from outside this field of research in a novel way to conduct an important ancillary study. 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 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 for NIAMS R01 grants for ancillary studies (RFA-AR-13-010). 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 this 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 in the relevant fields of research.
Objectives
This FOA will provide support for time-sensitive ancillary studies related to the NIAMS mission that will be conducted in conjunction with privately or publicly funded, large, ongoing clinical projects. These large, ongoing, parent projects can be clinical trials, observational studies, or disease registries that can provide sufficient cohorts of well-characterized patients, infrastructure, data, and biological samples. The parent projects must be independently funded by the NIAMS, other NIH institutes or government agencies, or private sponsors; they will not receive support from this FOA. Unlike those of the ancillary studies, the objectives of the parent study need not relate to the NIAMS mission, so long as the parent study provides an appropriate venue for the proposed ancillary study. Information about clinical trials currently supported by a variety of public and private entities can be obtained from http://www.clinicaltrials.gov/.
The ancillary studies supported under this FOA should focus on areas that are not studied in the parent project and address new research questions that are related to the mission of NIAMS (http://www.niams.nih.gov/About_Us/Mission_and_Purpose/mission.asp) in the venue of a parent project. The parent project can provide existing resources to facilitate the research and make it more efficient than initiating the same research de novo.
The following are examples of research that might be proposed under this FOA. These are only examples and are not meant to be inclusive:
Ancillary studies must document permission from the parent project to use the patient cohorts, data, and biological materials. Ancillary studies must not interfere with the parent project or unduly burden participants. Applicants must document that proper informed consent to conduct ancillary studies has been or will be obtained, and must agree to follow the procedures and policies established by the parent project. Ancillary studies may involve the entire cohort of participants in a parent study or selected subsets, depending on the scientific questions posed and the sample size required to answer them. The ancillary studies may also draw patients from two or more parent projects if they are able to obtain approval from these parent projects and if their research plan is feasible. In general, this FOA will not support the recruitment of patients who are not already enrolled in the parent study or studies; however, recruitment of a small number of normal controls is acceptable provided that the cost is minimal (e.g., no more than one budget module).
Once a parent project clinical protocol is finalized, its investigators often are ready to begin recruiting patients as soon as they obtain Institutional Review Board approval. This time-sensitive feature demands a robust administrative system within NIAMS that is compatible with the timeline of the parent project to avoid any missed research opportunities; an accelerated review and award process would allow the initiation of ancillary studies in a timely fashion to take advantage of the unique resources and well-characterized cohorts being established in the parent project. Applications submitted to this FOA will be subject to an accelerated peer review and award process.
An ancillary study may begin any time during the course of the parent project, but ideally should begin in the early stages of the parent project, and before recruitment in completed. Each application must include a timeline to demonstrate that the parent project has adequate time left to carry out the proposed ancillary study. Each application must justify the time-sensitive nature of the ancillary study and clearly explain on a separate and clearly identifiable paragraph titled "Time-Sensitivity Justification" why an expedited review and award process is essential to its feasibility. This information will be disclosed in the approach of the Research Strategy section of the application.
Examples of characteristics that would support the case for time-sensitivity include (1) the need for support to collect samples or data prior to end of recruitment, (2) the need to perform analysis on soon-to-be-collected fresh specimens, or (3) the need for collecting post-intervention data from research participants in a trial that will end. If the proposed research does not need to be concurrent with the parent project (e.g., secondary analysis of existing datasets); or is a sample collection that is already part of the parent study; or a data collection by the parent study is completed before the beginning of the ancillary study, then the application will be considered non-responsive to this FOA, unless the existing data set has to be analyzed at the same time with soon-to-be-collected samples.
Applicants will have to carefully justify this case and any other time-sensitivity rationale in the Research Approach Section. Investigators who could complete the same work using the standard application process should not apply to this FOA.
This FOA encourages collaboration between basic and clinical investigators and partnership with private entities. In addition, this FOA encourages junior investigators to take a leading role in clinical research with the support and collaboration of senior investigators. The prospective applicants are not necessarily investigators in the parent study. However, collaborations in which a senior investigator from the parent study mentors a junior investigator on an ancillary study are encouraged.
Applicants are invited to visit the NIAMS Ancillary Studies website for answers to commonly asked questions: http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/Ancillary_Studies_FAQs.asp.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Funding Instrument |
Grant |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
The NIAMS intends to commit approximately $1.5 million total costs in FY2013 to support a total of four to six new awards combined from the two companion FOAs for R01s (RFA-AR-13-010) and R21s (RFA-AR-13-011). Awards issued under this FOA are contingent upon the availability of funds 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 a single year. |
Award Project Period |
A project duration for up to two years may be requested. |
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
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.
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.
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.
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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
All ancillary study applications MUST include a letter or statement from one of the parent study leadership committees (i.e., Steering Committee, Scientific Advisory Board, Data and Safety Monitoring Board or Observational Study Monitoring Board, or other equivalent oversight committees) documenting its approval of the proposed ancillary study. This letter of approval must explicitly indicate that the required patients, samples, data, and materials from the parent project are accessible to the ancillary study. The letter should also provide the details of any agreement reached between the parent and ancillary study if there are requirements for limited data access and distribution. It must provide assurance that there is adequate time left in the parent study to carry out the ancillary study. This letter should be included as an upload in Item 14 of the PHS398 Components Letters of Support. Applications missing such documentation will be considered non-responsive to this FOA. Applications in which the critical time lines for the parent study and ancillary study are incompatible or ambiguous may not be reviewed.
All ancillary study applications must include a paragraph with the heading "Time-Sensitivity Justification" under Approach to explicitly justify the time-sensitive nature of the proposed ancillary study. The intent of this FOA is to fund scientifically meritorious applications that demonstrate the need for expedited review and award in order to complete the proposed work. Applications that do not demonstrate the need for accelerated review and award are encouraged to submit through the regular NIH submission process. (http://grants.nih.gov/grants/guide/pa-files/PA-11-261.html).
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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:
Anna Nicholson
Clinical Coordinator, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800
6701 Democracy Blvd.
Bethesda, MD 20892-4872
Telephone: (301) 451-6513
Fax: (301) 480-4543
Email: [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 submission of applications for this FOA. 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.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Protection of Human Subjects
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 modification:
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 modification:
The clinical protocol of the parent project may be submitted as appendix materials.
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.
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.
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.
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 and responsiveness by NIAMS, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIAMS Referral 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.
Due to the expedited review time, no post submission materials are permitted.
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.
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? Does the proposed ancillary study enhance the scientific content and value of the parent project(s)?
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? Does the application describe how the PD(s)/PI(s) of the ancillary study and the parent project interact on a regular basis and work cooperatively to ensure the successful completion of the ancillary study while maintaining the integrity of the parent 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?
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.
Time Sensitivity Justification
The committee will evaluate the adequacy of the justification for time-sensitivity of the proposed project.
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.
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by the NIAMS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. The following will be considered in making funding decisions:
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.
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.
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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]
Ricardo Cibotti, Ph.D.
Program Director
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin
Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone: (301) 451-5888
Email: [email protected]
Charles N. Rafferty, Ph.D.
Chief, Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin
Diseases
6701 Democracy Blvd., Suite 818, MSC 4872
Bethesda, MD 20892
Telephone: 301-594-5019
FAX: 301-402-2406
Email: [email protected]
Katie Joffee
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin
Diseases
Telephone: 301-594-5891
Email: [email protected]
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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