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	Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (R43)
Activity Code	R43 Small Business Innovation Research (SBIR) Grant - Phase I only
Announcement Type	New
Related Notices	March 1, 2013 - This RFA has been reissued as RFA-AR-14-005.
Funding Opportunity Announcement (FOA) Number	RFA-AR-12-006
Companion FOA	None
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) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose preclinical studies to advance the development of biomarkers or treatments for rare musculoskeletal, rheumatic or skin diseases. Rare diseases have a prevalence of fewer than 200,000 affected individuals in the United States. Also eligible for potential funding through this initiative are studies of FDA-designated orphan products for musculoskeletal, rheumatic or skin diseases. See the NIAMS Long-Range Plan for more information about NIAMS research interests (http://www.niams.nih.gov/About_Us/Mission_and_Purpose/long_range.asp).

Posted Date	June 10, 2011
Open Date (Earliest Submission Date)	September 11, 2011
Letter of Intent Due Date	September 12, 2011
Application Due Date(s)	October 11, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not applicable.
Scientific Merit Review	February/March, 2012
Advisory Council Review	May, 2012
Earliest Start Date(s)	July, 2012
Expiration Date	October 12, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR 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

The purpose of this funding opportunity announcement (FOA) is to advance translational research for rare musculoskeletal, rheumatic or skin diseases by supporting preclinical projects conducted by small business concerns (SBCs) to develop biomarkers and/or therapies. There are many rare diseases and conditions (with a prevalence of less than 200,000 affected individuals in the United States) within the NIAMS mission, including genetic rickets, chondrodysplasias, osteogenesis imperfecta, inflammatory myopathies, pediatric rheumatic diseases, cutis laxa, pseudoxanthoma elasticum, muscular dystrophies, nemaline myopathies, scleroderma, vasculititis, familial mediterranean fever, genodermatoses such as epidermolysis bullosa and pachyonychia congenita, pemphigus, chronic wounds unique to a rare disease(s), and many others. Research projects supported by this FOA may also focus on drugs, biologics, devices, or medical foods that have been designated as orphan products by the FDA, even if the relevant musculoskeletal, rheumatic or skin disease/condition affects more than 200,000 persons in the United States. However, if the proposed project focuses on a disease/condition with a prevalence of more than 200,000 persons (not a rare disease) the applicant must provide documentation of Orphan Product Designationfrom the FDA no later than Feb 15, 2012 to be considered responsive to this FOA.. (http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm). Applications primarily focused on one or more rare diseases do not require Orphan Product Designation to be considered for funding through this FOA. The NIAMS Long-Range Plan (http://www.niams.nih.gov/About_Us/Mission_and_Purpose/long_range.asp) provides a more complete description of NIAMS research interests. The NIH Office of Rare Disease Research provides a listing of rare diseases (http://rarediseases.info.nih.gov/RareDiseaseList.aspx?PageID=1), but only those within the NIAMS mission will be the focus of research projects supported by this FOA. The NIAMS supports research on rare diseases and orphan drugs through various grant mechanisms including research project grants, center awards and training/career development awards. SBCs play an important role in disease research by developing innovative technologies and increasing the commercial application of Federally supported research results. However, it can be more challenging for SBCs to achieve profitability in rare disease research and development due to inherent scientific risks and market limitations caused by the small number of individuals affected by each disease. With this FOA, NIAMS intends to focus SBIR funds to support rare disease research and development that may lead to important biomarkers and/or treatments for these diseases. Therapies for rare diseases within the NIAMS mission may include drugs, biologics, devices, cells, genes or behavioral interventions, and may also include FDA designated orphan products. Development of innovative strategies for the delivery of existing or new drugs for rare diseases within the NIAMS mission would also be responsive to this FOA. Biomarker studies could focus on changes in disease-associated biochemistry, imaging, physiology or other measures that would facilitate screening, diagnosis or outcome measures for rare diseases. The development of platforms for validation of rare disease biomarkers would also be considered responsive to this FOA. The testing of rare disease therapies in clinical trials will likely require new outcomes measures and innovative clinical trial designs. The development of outcomes measures and methodologies tailored for rare diseases within the NIAMS mission that enable future clinical trials would be responsive to this FOA. One of the considerations in funding applications in response to this FOA will be the potential of the project to decrease the burden of disease on patients or families affected by that disease/condition. Because the intent of this FOA is to overcome the inherent scientific risks and market limitations caused by the small number of individuals affected by a rare disease, approaches that are likely to find application also in the large markets associated with common diseases may receive a lower funding priority.

Each application should include a paragraph with the heading Justification for Rare Disease or Orphan Product Designation within the six-page limit of the Research Strategy section (Item 5.4.3 of the PHS 398 Research Plan). This paragraph should provide one or more references confirming that the disease/condition that is the primary focus of the research proposal has prevalence of 200,000 or less in the US. Alternatively, the paragraph can indicate that the applicants expect to have received Orphan Product Designation from the FDA by Feb. 15, 2012. Applications that do not include this information will be determined non-responsive to the FOA and will not be reviewed. If the application depends on Orphan Designation to be responsive to this FOA, documentation of this designation can be submitted after the application receipt date, but must be provided by Feb. 15, or the application will not be reviewed.

Applicants are strongly encouraged to develop partnerships with the appropriate patient advocacy groups and/or foundations. These groups are a valuable source of scientific and medical expertise that can help guide product development and provide access to research subjects for clinical testing.

The Institute of Medicine report "Rare Diseases and Orphan Products: Accelerating Research and Development" (http://www.iom.edu/Reports/2010/Rare-Diseases-and-Orphan-Products-Accelerating-Research-and-Development.aspx), released in 2010, emphasizes the need for integrating various stake holders, including small businesses, into a comprehensive strategy for supporting all phases of rare disease research. NIH supports several innovation platforms that can facilitate and accelerate therapy development including the NIH Molecular Libraries Program (http://mli.nih.gov/mli/), Rapid Access to Interventional Development (RAID, http://commonfund.nih.gov/raid/), the Therapeutics for Rare and Neglected Diseases (TRND, https://rarediseases.info.nih.gov/TRND/) program, and the Rare Diseases Clinical Research Network (RDCRN, http://rarediseasesnetwork.epi.usf.edu/). Small business concerns should consider utilizing these resources to enhance their efforts in developing and testing biomarkers and treatments for rare diseases. This FOA encourages applications for studies that will better position the applicants to leverage these innovation platforms.

This FOA is designed to stimulate translational research on rare diseases and is therefore limited to Phase I SBIR awards. Applications for this FOA may include human subject research; however, clinical trials are excluded. Applicants could propose to analyze samples from affected subjects and controls, conduct subject interviews or other procedures of clinical research. But, applications that propose to conduct intervention studies will not be considered responsive to the FOA and will not be reviewed.

Beyond the work proposed for this early stage of translation, applications should briefly describe the plan for following through on the results of the Phase I SBIR award to develop the biomarker, therapy, or other proposed methodologies and approaches to the point of readiness for clinical studies or clinical trials. This plan should be included in the Research Strategy section (Item 5.4.3 of the PHS 398 Research Plan) within the six-page limit

in a separate paragraph with the heading Therapy/Biomarker Development Plan . This plan may include the utilization of the NIH-supported research resources described above, or other established public or private resources that will increase the likelihood of successful clinical testing of the biomarkers or therapies.

Funding Instrument	Grant
Application Types Allowed	New (Phase I) The OER Glossary and the SF424 (R&R) SBIR/STTR 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. NIAMS intends to commit $1,500,000 in FY 2012..
Award Budget	Budgets up to $300,000 total costs per year for Phase I may be requested.
Award Project Period	Durations up to one year for Phase I 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.

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;

2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;

3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;

4. Has, including its affiliates, not more than 500 employees.

SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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 Project 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.

Under the SBIR program, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR 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 similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

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

In Phase I, normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee).

The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR 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) SBIR/STTR Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Xibin Wang, Ph.D.
SBIR/STTR Program Coordinator
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892-4872
Phone: 301-594-5055
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 application submission. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

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

Justification for Rare Disease or Orphan Status

Each application should include a paragraph within the six-page limit of the Research Strategy section with the heading Justification for Rare Disease or Orphan Status . This paragraph should provide one or more references confirming that the disease/condition that is the primary focus of the research proposal has prevalence of 200,000 or less in the US. Alternatively, the paragraph can indicate that the applicants expect to have received Orphan Product Designation from the FDA by Feb. 15, 2012. Applications that do not include this information will be determined non-responsive to the FOA and will not be reviewed. If the application depends on Orphan Designation to be responsive to this FOA, documentation of this designation can be submitted after the application receipt date, but must be provided by Feb. 15, or the application will not be reviewed. Applications focused primarily on one or more rare disease do not require Orphan Product Designation in order to be considered responsive to this FOA.

Therapy/Biomarker Development Plan

Beyond the work proposed for this early stage of translation, applications should briefly describe the plan for following through on the results of the phase I SBIR award to develop the biomarker, therapy, or other proposed methodologies and approaches to the point of readiness for clinical studies or clinical trials. This plan should be included in the application within the six-page limit of the Research Strategy section, in a separate paragraph with the heading Therapy/Biomarker Development Plan . This plan may include the utilization of NIH-supported research resources such as the NIH Molecular Libraries Program, Rapid Access to Interventional Development (RAID), the Therapeutics for Rare and Neglected Diseases (TRND) program, and the Rare Diseases Clinical Research Network (RDCRN), or other established public or private resources that will increase the likelihood of successful clinical testing of the biomarkers or therapies.

Resource Sharing Plans

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) SBIR/STTR Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Note that Phase I SBIR/STTR Appendix materials are not permitted, unless requested specifically by NIH SBIR/STTR

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) SBIR/STTR 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 SF424 (R&R) SBIR/STTR Application Instructions. 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/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) SBIR/STTR 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.

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

• Applicants may provide a letter with a one paragraph description documenting FDA Orphan Product Designation after the application receipt date, but no later than Feb. 15, 2012. This letter can be sent to the Peer Review Contact listed below in Section VII ( Agency Contacts ).

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? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization? What is the potential for the study to decrease the burden of disease for affected patients and families? Is this study likely to significantly accelerate progress towards markedly improved screening, diagnosis or treatments?

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?

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 arrangement?

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.

Phase II Applications

Not Applicable

Phase I/Phase II Fast-Track Applications

Not Applicable

Translational Research Plan

Does the application provide an adequate plan for key steps beyond the phase I SBIR that will further develop the biomarker, therapy, or other proposed methodologies and approaches to the point of readiness for clinical studies or clinical trials? Does this plan consider leveraging existing research resources such as the NIH Molecular Libraries Program, Rapid Access to Interventional Development, the Therapeutics for Rare and Neglected Diseases Program, the Rare Diseases Clinical Research Network, or other resources in the public or private sector that would enhance the likelihood of biomarkers or therapies being testing in clinical studies? Does the plan include partnerships with appropriate patient advocacy groups and foundations that could provide scientific and medical expertise as well as research subjects for clinical testing?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable..

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.

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 National Institute of Arthritis and Musculoskeletal and Skin Diseases (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:

• May undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

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 NAMS Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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 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.

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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

• Expenditure Data Portion of the Federal Financial Report
• Final Progress Report
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Final Cash Transaction Report (PSC 272)
• Phase II Data Collection Requirement for Government Tech-Net Database

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF424 (R&R) SBIR/STTR Application Guide.

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]

Xibin Wang, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-5055
Email: [email protected]

Charles Rafferty, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301 594-5019
Email: [email protected]

Mr. Erik (Timothy) Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-3968
Fax: 301-480-5450
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.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) and P.L. 102-564 (Small Business Research and Development Act).The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.