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

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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 ofsociallyandeconomicallydisadvantagedsmallbusiness 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.

Research Grants: In fiscal year 2007, a total of 1,261 noncompeting and competing research grants were funded, including 40 SBIR and STTR awards. The fiscal year 2008 estimate is 1,258 research grant awards, including 40 SBIR and STTR awards. The fiscal year 2009 estimate is 1,269 grants, including 40 SBIR and STTR awards. National Research Service Awards (NRSA): In fiscal year 2007, 319 trainees were funded. The estimates for fiscal year 2008 and 2009 are 319 trainees each year.

Uses and Use Restrictions

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.

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Eligibility Requirements

Applicant Eligibility

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

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

Requirements are specified in the application form. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. 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.

Aplication and Award Process

Preapplication Coordination

None.

This program is excluded from coverage under E.O.

12372.

Application Procedures

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 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 Office of Research Manpower, Center for Scientific Review, Grants, National Institutes of Health, Bethesda, MD 20892. 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 Procedures

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

New Applications: February 5, June 5, and October 5. Competing continuation applications: March 5, July 5, and November 5. Individual NRSA Applications: April 8, August 8, and December 8 Institutional NRSA: January 25, May 25, and September 25. Small Business Innovation Research: April 5, August 5, and December 5. STTR: December 1, only.

Authorization

Public Health Service Act, Sections 301, 437, and 487, as amended, Public Laws 78-410 and 99-158, 42 U.S.C. 241, as amended; 42 U.S.C. 285d-2; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

Range of Approval/Disapproval Time

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

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 www.nih.gov/grants/guide/1997/97.11.21/n2.html.

Renewals

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 Considerations

Formula and Matching Requirements

None.

Length and Time Phasing of Assistance

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.

Post Assistance Requirements

Reports

Research grants: Annual and final progress reports.

Also annual reports of inventions and financial status reports.

Annual certification with respect to research involving human subjects.

National Research Service Awards: Reports are required during and after termination of National Research Service Awards to ascertain compliance with service and payback provisions.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.

Records

Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.

Financial Information

Account Identification

75-0888-0-1-552.

Obigations

Research Grants: FY 07 $396,238,000; FY 08 $395,093,000; and FY 09$394,305,000. National Research Service Awards (NRSAs): FY 07 $15,446,000; FY 08 $15,446,000; and FY 09 $15,585,000.

Range and Average of Financial Assistance

Research Grants: $2,000 to $2,100,000; $314,200. National Research Service Awards: $12,300 to $448,000; $138,000. SBIR/STTR: Phase I awards - approximately $100,000; Phase II awards - up to $750,000.

Regulations, Guidelines, and Literature

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

Regional or Local Office

None.

Headquarters Office

Program Contact: Research Grants: Dr. Madeline Turkeltaub, Division of Extramural Research Activities, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Public Health Service, Department of Health and Human Services, NIAMS, Extramural Program, National Institutes of Health, 6701 Democracy Blvd., Suite 800, Bethesda, MD 20892. Telephone: (301) 594-2463. Small Business Innovation Research Grants and Grants Management Contact: Ms. Melinda Nelson, Grants Management Officer, Grants Management Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Public Health Service, Department of Health and Human Services, NIAMS, 6701 Democracy Blvd., Suite 800, Bethesda, MD 20892, Bethesda, MD 20892. Telephone: (301) 5435-5278. Use the same numbers for FTS.

Criteria for Selecting Proposals

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.