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Arthritis, Musculoskeletal and Skin Diseases Research

Number: 93.846
Agency: Department of Health and Human Services
Office: National Institutes of Health

Program Information 

Program Number/Title (010):
93.846 Arthritis, Musculoskeletal and Skin Diseases Research
Federal Agency (030):
National Institutes of Health, Department of Health and Human Services
Authorization (040):
Public Health Service Act, Section 301, 437, 487, Public Law 78-410, 42 U.S.C 241.
Objectives (050):
To support research relevant to arthritis, musculoskeletal and skin diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports research training and basic and clinical investigations including epidemiology and clinical trials in the areas of skin and rheumatic diseases and musculoskeletal diseases. The Division of Skin and Rheumatic Diseases promotes and supports basic, epidemiological, and clinical studies of skin and rheumatic and related diseases. Studies range from determining the underlying basis and mechanisms of disease (including large genetic studies), to translational and clinical research aimed at the diagnosis, treatment, prediction, and/or prevention of disease. The skin program supports research in normal and diseased skin including keratinocyte biology and wound healing, and disorders such as psoriasis, atopic dermatitis and other chronic inflammatory skin disorders; the vesiculobullous diseases such as pemphigus, bullous pemphigoid, and epidermolysis bullosa; acne, alopecia areata, vitiligo, and skin neoplasia. The rheumatic disease program supports research in the systemic autoimmune diseases and arthritides, including systemic lupus erythematosus (SLE), systemic scleroderma, autoimmune myositis, rheumatoid arthritis, juvenile idiopathic arthritis, spondyloarthropathies, vasculitis, gout, Sjogren's syndrome, and fibromyalgia syndrome. In addition, the Division supports studies on the extracellular matrix, including research on Marfan syndrome, keloid formation, and pseudoxanthoma elasticum. The Division also supports biopyschosocial research related to rheumatic, musculoskeletal, or skin diseases. Topics include behavioral interventions, pain mechanisms, neuroendocrine and neuroimmune mechanisms, behavioral and social research, and epidemiology. The Division of Musculoskeletal Diseases supports studies of the skeleton and associated connective tissues. Broad areas of interest include skeletal development, metabolism, mechanical properties, and responses to injury. Among these diseases and skeletal disorders are osteoporosis; osteogenesis imperfecta; Paget's disease of bone; vitamin D refractory diseases; and rickets and osteochondrodysplasias. Other areas of interest include treatment of acute and chronic injuries, including carpal tunnel syndrome, repetitive stress injury, low back pain and clinical and epidemiological studies of osteoarthritis. The Division supports development of new technologies with the potential to improve treatment of skeletal disorders and facilitate the repair of trauma in the normal skeleton. These include drugs and nutritional interventions, joint replacement, bone and cartilage transplantation, biomarkers and gene therapy. In addition, bioengineering, sports medicine and musculoskeletal fitness are areas of special research emphasis. This Division also encourages and supports research on skeletal muscle, its diseases and disorders, and its central role in human physiology and exercise. Topics include the molecular structure of muscle and the molecular mechanisms that produce force and motion. Muscle biophysics, cell biology, muscle biology, muscle disorders and therapies, musculoskeletal development, tissue reengineering, and regenerative medicine are encompassed in this area as well. The Division also supports research into the biology of cartilage, tendons, ligaments, mensisci, and interveterbral discs, including pre-clinical studies on injury and disease conditions affecting these tissues. NIAMS participates in the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. The SBIR program is intended to increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. The STTR program is intended to stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
Types of Assistance (060):
PROJECT GRANTS
Uses and Use Restrictions (070):
Research Grants provide funds for salaries, equipment, supplies, travel, and other expenses associated with scientific investigation relevant to program objectives. Individual National Research Service Awards (NRSAs) are made to individuals for research training in specified biomedical shortage areas. In addition, grants may be made to institutions to enable them to make NRSAs to individuals selected by them. Each individual who receives a NRSA is obligated upon termination of the award to comply with certain service and payback provisions. Small Business Innovation Research Phase I grants (of approximately 6-months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of the research initiated in Phase I that are likely to result in commercial products or processes. Only Phase I awardees are eligible to receive Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential on Phase II application.
Eligibility Requirements (080)
Applicant Eligibility (081):
Research Grants: Individuals and public and private institutions, both nonprofit and for-profit, who propose to establish, expand, and improve research activities in health sciences and related fields. National Research Service Awards: Individuals must be nominated and sponsored by a public or private, for-profit or nonprofit institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.D.S., D.O., D.V.M., Sc.D., D. Eng., or equivalent domestic or foreign degree). Nonprofit domestic organizations may apply for the Institutional National Research Service grant. Small Business Innovation Research grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more that 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
Beneficiary Eligibility (082):
Research Grants: Although no degree of education is either specified or required, nearly all successful applicants have doctoral degrees in one of the sciences or professions. National Research Service Awards: Predoctoral awardees must have completed the baccalaureate degree and postdoctoral awardees must have a professional or scientific degree.
Credentials/Documentation (083):
Requirements are specified in the application form. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulations 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Grant forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively. OMB Circular No. A-87 applies to this program.
Application and Award Process (090)
Preapplication Coordination (091):
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
Application Procedures (092):
This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. Research grants: Applications must be prepared either electronically through grants.gov (http://www.grants.gov) using the SF 424 (Research and Research-Related) or on paper using the PHS 398 research grant application instructions and forms (Rev. 11/2007). Individual funding opportunity announcements will indicate the appropriate application format to be used. A listing of NIAMS and other funding opportunities can be found through the NIAMS web site (http://www.niams.nih.gov/Funding/Funding_Opportunities/filter.asp), through the Grants.gov web site (http://www.grants.gov/), or on the NIH Guide to Grants and Contracts (http://grants1.nih.gov/grants/guide/index.html). For those few types of applications that require the PHS 398, the most recent version of the form and instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Electronic applications are submitted through the Grants.gov website. Completed PHS 398 applications should be submitted to the National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710 or Bethesda, MD 20817 (for express/courier service). For assistance contact GrantsInfo, Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov. National Research Services Awards: Completed application forms should be submitted to the Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, Md. 20892-7710 (regular USPS or USPS Express mail)or Bethesda, Md. 20817 (other courier/express mail delivery) Phone: 301-435-0715. This program is subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Research Funding Opportunities" web page at http://grants1.nih.gov/grants/funding/sbir.htm . A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: Telephone: (301) 206-9385; Fax: (301) 206-9722; E-mail: a2y@cu.nih.gov. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710. Application forms for SBIR and STTR grants may be obtained through the SBIR/STTR funding announcements posted on the Grants.gov sites and the NIH Guide to Grants and Contracts (see URLs listed above). All SBIR and STTR applications must be submitted electronically. Electronic applications are submitted through the Grants.gov website. Completed PHS 398 applications should be submitted to the National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710 or Bethesda, MD 20817 (for express/courier service). This program is subject to the provisions of 45 CFR Part 92 for State and local governments, OMB Circular No. A-110 for nonprofit organizations, cost principles of A-21 for educational institutions, and 42 CFR Part 42.
Award Procedure (093):
Following review by the appropriate study section and council, the successful applicant is notified by the National Institute of Arthritis and Musculoskeletal and Skin Diseases through a Notice of Grant Award. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.
Deadlines (094):
Contact the headquarters or regional office, as appropriate, for application deadlines.
Range of Approval/Disapproval Time (095):
From 120 to 180 days. Research grants: From 6 to 9 months. National Research Service Awards: From 6 to 9 months. SBIR/STTR applications: About 7-1/2 months.
Appeals (096):
A principal investigator may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants.nih.gov/grants/guide/notice-files/not97-232.html and at http://grants.nih.gov/grants/guide/notice-files/not-od-11-064.html .
Renewals (097):
Research grants: renewals by competitive application and review. Extension by request and administrative action. National Research Service Awards: individual awards may be made for 1, 2, or 3 years. No individual may receive NIH fellowship support at the postdoctoral level for more than 3 years.
Assistance Consideration (100)
Formula and Matching Requirements (101):
Statutory formulas are not applicable to this program.
Matching requirements are not applicable to this program.
MOE requirements are not applicable to this program.
Length and Time Phasing of Assistance (102):
Research grants: Awards may be recommended for up to 5 years. Awards usually are made for 12-month budget periods. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years. See the following for information on how assistance is awarded/released: A formal notification in the form of a Notice of Grant Award (NoGA) will be provided to the applicant organization.
Post Assistance Requirements (110)
Reports (111):
No reports are required.
Audits (112):
In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. Records must be available for review or audit by appropriate officials of the Federal agency, pass-through entity, and Government Accountability Office (GAO). In accordance with 45 Code of Federal Regulations, Part 74.26, for-profit (commercial) organizations are subject to audit requirements for a non-Federal audit if, during its fiscal year, it expended $500,000 or more under HHS awards and at least one award is a HHS grant or subgrant. The regulation incorporates the thresholds and deadlines of OMB Circular No. A-133, but provides for profit organizations with two options for the type of audit that will satisfy the audit requirement: 1. a financial related audit of the HHS awards in accordance with Government Auditing Standards, or 2. an audit that meets the requirements of OMB Circular No. A-133. In accordance with NIH grants policy, Foreign grantees are subject to the same audit requirements as for-profit (commercial) organizations.
Records (113):
Grantees generally must retain financial and programmatic records, supporting documents, statistical records, and all other records that are required by the terms of a grant, or may reasonably be considered pertinent to a grant, for a period of 3 years from the date the annual FFR is submitted. For awards under SNAP (other than those to foreign organizations and Federal institutions), the 3-year retention period will be calculated from the date the FFR for the entire competitive segment is submitted. Those grantees must retain the records pertinent to the entire competitive segment for 3 years from the date the FFR is submitted to NIH. Foreign organizations and Federal institutions must retain records for 3 years from the date of submission of the annual FFR to NIH. See 45 CFR 74.53 and 92.42 for exceptions and qualifications to the 3-year retention requirement (e.g., if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims, or audit findings involving the records have been resolved and final action taken). Those sections also specify the retention period for other types of grant-related records, including F&A cost proposals and property records. See 45 CFR 74.48 and 92.36 for record retention and access requirements for contracts under grants. In accordance with 45 Code of Federal Regulations, Part 74.53(e), the HHS Inspector General, the U.S. Comptroller General, or any of their duly authorized representatives have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to awards in order to make audits, examinations, excerpts, transcripts, and copies of such documents. This right also includes timely and reasonable access to a recipientís personnel for the purpose of interview and discussion related to such documents. The rights of access are not limited to the required retention period, but shall last as long as records are retained.
Financial Information (120)
Obligations (122):
(Project Grants) FY 12 $418,898,000; FY 13 est $398,060,000; and FY 14 est $421,631,000 - Research Grants: FY 12 $418,898,000; FY 13 $398,060,000; FY 14 $421,631,000. National Research Service Awards (NRSAs): FY 12 $15,085,000; FY 13 $15,085,000; FY 14 $15,513,000.
Range and Average of Financial Assistance (123):
Research Grants: $7,883 to $1,623,290; $327,908. National Research Service Awards: $6,158 to $516,686; $135,301. SBIR: Phase 1 awards -- approximately $150,000; Phase II awards --approximately $1,000,000. STTR: Phase 1 awards -- approximately $150,000; Phase II awards --approximately $1,000,000.
Program Accomplishments (130):
Fiscal Year 2013: No Current Data Available Fiscal Year 2014: Research Grants: The fiscal year 2014 estimate is 1,245 grants, including 35 SBIR and STTR awards. National Research Service Awards (NRSA): The estimate for fiscal year 2014 is 296 trainees. Fiscal Year 2015: No Current Data Available
Regulations, Guidelines, and Literature (140):
Research Grants: 42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant Applications.
Information Contacts (150)
Regional or Local Office (151) :
See Regional Agency Offices.
Headquarters Office (152):
Laura K. Moen, 6701 Democracy Boulevard, Ste 800, Bethesda, Maryland 20892 Email: moenl@mail.nih.gov Phone: (301) 451-6515.
Website Address (153):
http://www.hhs.gov .
Examples of Funded Projects (170):
Not Applicable.
Criteria for Selecting Proposals (180):
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment.