Small Business Innovation Research (SBIR) Program at NIAMS

Small Business Innovation Research (SBIR) Program at NIAMS is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). This grant funds innovative biomedical research with commercial potential in musculoskeletal, rheumatic, and skin disease areas.

Expired RFA-AR-14-005: Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating National Institute of Arthritis and Musculoskeletal and Funding Opportunity Title Small Business Innovation Research on Rare Musculoskeletal, Rheumatic and Skin Diseases (SBIR) (R43) R43 Small Business Innovation Research (SBIR) Grant - Phase I only April 11, 2017 - This RFA has been reissued as RFA-AR-18-005 .

August 21, 2013: Removed reference to ASSIST in section IV. 3, since ASSIST is currently only available for multi-project applications. Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity 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 at http://www.

niams. nih. gov/About_Us/Mission_and_Purpose/long_range.

asp . Open Date (Earliest Submission Date) Letter of Intent Due Date(s) August 1, 2013, by 5:00 PM local time of applicant AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in (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 Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description 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. The 2010 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 ) called for active involvement and collaboration by the public and private sectors, and emphasized the role of NIH in integrating various stake holders into a comprehensive strategy for supporting all phases of rare diseases research.

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 diseases 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 support and enhance research and development conducted by SBCs that may lead to important biomarkers and/or treatments for rare musculoskeletal, rheumatic or Specific Areas of Research Interest There are many rare diseases and conditions (with a prevalence of fewer than 200,000 affected individuals in the United States) within the NIAMS mission, including chondrodysplasias, cutis laxa, epidermolysis bullosa, familial Mediterranean fever, genetic rickets, inflammatory myopathies, muscular dystrophies, nemaline myopathies, osteogenesis imperfecta, pachyonychia congenita, pediatric rheumatic diseases, pemphigus, pseudoxanthoma elasticum, scleroderma, and vasculititis, as well as conditions such as chronic wounds unique to a rare disease(s), etc. The NIH Office of Rare Diseases Research provides a listing of many other rare diseases ( http://rarediseases.

info. nih. gov/RareDiseaseList.

aspx? PageID=1 ), but only those within the NIAMS mission should be the focus of research projects supported by 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.

If the proposed project focuses on FDA-designated orphan products for a disease/condition in the NIAMS mission with a prevalence of more than 200,000 persons (i.e., not a rare disease), the application can also be considered responsive to this FOA, but the applicant must provide documentation of Orphan Product Designation from the FDA no later than September 30, 2013 ( http://www. fda.

gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default. htm ). Applications primarily focused on one or more rare diseases are not required to provide documentation of Orphan Product Designation.

However, all applications 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 in the PHS 398 Research Plan. More information on this requirement can be found in Section IV. 2.

Content and Form of Application Submission. 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 mainly to overcome the inherent scientific risks and market limitations caused by the small number of individuals affected by a rare disease, approaches that are also likely to find applications in the large markets associated with common diseases may receive a lower funding priority.

Research topics that would be responsive to this FOA include Development of therapies such as drugs, biologics, devices, cells, genes or behavioral interventions Development of innovative strategies for the delivery of existing Biomarker studies focusing on changes in disease-associated biochemistry, imaging, physiology or other measures that would facilitate screening, diagnosis or outcome measures Development of outcomes measures and methodologies that are tailored for rare diseases and would enhance future observational studies and Development of FDA-designated orphan products 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 subjects' 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; however, applications that propose to conduct intervention studies will not be considered responsive to the FOA and 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 future clinical NIH supports several innovation platforms that can facilitate and accelerate therapy development including the NIH Molecular Libraries Program ( http://mli. nih. gov/mli/ ), Bridging Interventional Development Gaps (BrIDGs, http://www.

ncats. nih. gov/research/reengineering/bridgs/bridgs.

html ), the Therapeutics for Rare and Neglected Diseases program (TRND, https://rarediseases. info. nih.

gov/TRND/ ), 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.

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 of the PHS 398 Research Plan in a separate paragraph with the heading Therapy/Biomarker Development Plan . This plan may include the future utilization of the NIH-supported research resources described above, or other established public or private resources or partnerships that will increase the likelihood of successful clinical testing of the biomarkers or therapies.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed 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 NIAMS intends to commit $ 1,000,000 in FY 2014. Budgets up to $ 225,000 total costs per year for Phase I Durations up to one year for Phase I may be requested. 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 must be less than 50 percent participation by foreign business entities in the joint venture; 3. (i) SBIR and STTR.

Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any (ii) SBIR-only.

Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section.

A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121. 705(b) concerning registration and proposal 4. Has, including its affiliates, not more than 500 If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV.

Application and Submission Information for additional instructions regarding required application certification. If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.

Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)).

The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity Private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C.

1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. Venture capital operating company means an entity described in 121.

103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State. 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.

business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the STTR program. Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , may be allowed.

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 Award Management (SAM) must maintain an active entity registration(formerly CCR registration), to be renewed at least annually. Use the Sam.

gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM. gov for additional information.

SBA Company Registry New requirement. See Section IV. Application and Submission Information , SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package.

Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants. gov or eRA Commons registration.

All Program Directors/Principal Investigators (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 6 weeks prior to the application due date. Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Under the SBIR program, for both Phase I and Phase II, 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 PDs/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 . 3.

Additional Information on Eligibility 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 NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

Contractual/Consortium Arrangements 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 A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C.

3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C.

3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS 398 Research Plan component of SF424 (R&R) application forms.

Additional details are contained in the SF424 (R&R) SBIR/STTR and Submission Information 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 It is critical that applicants follow the instructions in (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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed research Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: SBIR/STTR Program Coordinator National Institute of Arthritis and Musculoskeletal 6701 Democracy Blvd, Suite 800 All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

Required and Optional Components The forms package associated with this FOA includes all applicable components, required 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) SBIR/STTR Application Guide to ensure you complete all appropriate optional All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions: All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and . pdf file.

If applicants have previously registered, you are still required to attach proof of registration. The SBA Company Registry recommends verification with SAM , but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM.

If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.

b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided. Identify your company and click Proceed to Registration .

c. If you are a first time applicant, click the New to the SBIR Program? link on lower right of registry screen.

d. Fill out the required information on the Basic Information and Eligibility Statement screens. e.

Press Complete Registration on the lower right of the Eligibility Statement screen and follow all instructions. f. Download and save your SBA registry PDF locally.

The name will be in the format of SBC_123456789. pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID. DO NOT CHANGE OR ALTER THE FILE NAME.

Changing the file name may cause delays in the processing of your application. g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking Add Attachments located to the right of Other Attachments on the Research and Related Other Project Information form.

For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir. gov/feedback? type=reg .

SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at the time of their application submission per the SBIR Policy Directive .

Follow the Applicants small business concerns who are more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package.

a. Download the SBIR Application VCOC Certification. pdf at the NIH SBIR Forms webpage.

b. Answer the 3 questions and check the certification c. The authorized business official must sign the d.

Save the certification using the original file name. The file must be named SBIR Application VCOC Certification. pdf .

DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application. e.

When you are completing the application package, attach this certification as a separate file by clicking Add Attachments located to the right of Other Attachments on the Research and Related Other Project Information form. SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.

All instructions in the SF424 (R&R) SBIR/STTR Application All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) SBIR/STTR Application Guide 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 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 September 30, 2013.

Applications that propose research on orphan products for common diseases within NIAMS mission need to submit documentation for Orphan Product Designation from the FDA. Documentation of this designation can be submitted after the application receipt date, but must be provided by September 30, 2013, or the application will not be reviewed.

Applications that propose research on orphan products for rare diseases need not submit this documentation.

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, Bridging Interventional Development Gaps (BrIDGs), 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 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.

Do not use the Appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide, with the following modification: Note that Phase I SBIR/STTR Appendix materials are not permitted. Part I.

Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. Organizations must submit applications to 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 responsible for viewing their application before the due date 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. 4. Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement . 6. Other Submission Requirements Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions.

Paper applications will 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 All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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 System for Award Management (SAM). Additional information may be found in the SF424 (R&R) SBIR/STTR Application Guide. 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.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 with the following modification: Applications that propose research on orphan products for common diseases need to submit FDA Orphan Product Designation by September 30, 2013. Section V. Application Review Information 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 Reviewers will provide an overall impact 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 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. 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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New