FEDERAL AGENCY:

NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES

AUTHORIZATION:

Public Health Service Act, Sections 222 and 404E; Public Law 103-43, 42 U.S.C. 217a and 283g, as amended; Public Law 92- 463, as amended.

OBJECTIVES:

To evaluate alternative, complementary, or unconventional medical treatments. The following objectives support this goal: (1) Coordinate and facilitate the investigation of alternative medical practices through peer-reviewed grant solicitations; (2) Interface with the Center's National Advisory Council; (3) Conduct technology assessment conferences for the purpose of establishing areas of Clinical and Pre-clinical research that need to be further developed within Alternative Medicine; (4) Maintain a comprehensive bibliographic data base in conjunction with the National Library of Medicine; (5) Develop and continue contacts with international programs in complementary and alternative medicine (CAM); and (6) Establish an intra- and extra-mural clinical research fellowship program focusing on broad areas of clinical, scientific, and administrative training in CAM. The major purpose of all of these programs is to foster collaborations between practitioners of CAM and individuals knowledgeable in biomedical research.

TYPES OF ASSISTANCE:

Project Grants. Place Cursor Here for Definition

Training. Place Cursor Here for Definition

USES AND USE RESTRICTIONS:

Project grants and cooperative agreements may be made to eligible institutions for the support of various projects in CAM. The grants may be used for personnel, consultant costs, equipment, supplies, travel, patient costs, animals miscellaneous items, and indirect costs. For the individual post-doctoral training grant, support is for salary of the trainee, tuition and fees, self-only health insurance, research supplies, equipment, travel to scientific meetings, and related items.

ELIGIBILITY REQUIREMENTS:

Applicant Eligibility:   The awardee will be either a university, college, hospital, public agency, nonprofit research institution, or for-profit organization that submits an application and receives a grant or cooperative agreement for support of research by a named principal investigator.

Beneficiary Eligibility:   Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation:   For-profit organizations costs are determined by in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. Costs will be determined in accordance with HHS Regulations 45 CFR 74, Subpart Q.

Pre-application Coordination:   No preapplication is required. This program is excluded from coverage under E.O. 12372.

Application Procedure:   Application form PHS-398 is the standard form that can be obtained from the NIH homepage on the Internet at: http://grants.nih.gov/grants/forms.htm Application forms may also be obtained by contacting the NCCAM Division of Extramural Research, Training, and Review at 301-496-4792. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92 for State and local governments, must be used for this program. For the postdoctoral training program, application form PHS- 416-1 should be used.

Award Procedure:   Award Procedure: All accepted 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 ranging from the best (100) to worst (500) compete for available funds based on scientific merit, program relevance, and program balance and are made annually. Initial award provides funds for the first budget period (usually 12 months) and Notice of Grant Award (Form PHS 1533) indicates support recommended for remainder of project period, allocation of Federal funds by budget categories, and special conditions, if any.

Deadlines:   New Grants and Cooperative Agreements: February 1, June 1, and October 1. Renewals and Supplements: March 1, July 1, and November 1. Postdoctoral Training, April 5, August 5, and December 5.

Range of Approval/Disapproval Time:   Grants and Cooperation Agreement: Approximately 10 months. Training: For 9 months.

Appeals:   A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Office. A description of the NIH Peer Review Appeal procedures is available on the NIH homepage www.nih.gov/grants/guide/1997/97.11.21/n2.html.

Renewals:   Applications submitted for renewal are reviewed and selected for funding on a competitive basis.

ASSISTANCE CONSIDERATIONS:

Formula and Matching Requirements:   This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance:   Grants and cooperative agreements: Average 3 to 4 years, maximum of 5 years. Renewals may be awarded for additional periods of up to 5 years based on competitive peer review. Funds are provided through Monthly Demand Payment System or an Electronic Transfer System.

POST ASSISTANCE REQUIREMENTS:

Reports:   Progress reports are required each year. Annual financial status report is required 90 days after the end of the budget period. Special reports may be requested by the DHHS. Terminal reports are required 6 months after the end of the project.

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 financial status report for the report period.

FINANCIAL INFORMATION:

Account Identification:   75-0896-0-1-552.

Obligations:   (Grants) FY 01 $66,000,000; FY 02 est $74,000,000; and FY 03 est $80,000,000.

Range and Average of Financial Assistance:  
Range from low to high: R34 $12,132 to U19 $2,063,091 Average financial assistance is $397,987.

In fiscal year 2001, 110 total grants were funded. It is estimated that 117 grants will be funded in fiscal year 2002 and 124 grants in fiscal year 2003. In fiscal year 2001, 16 centers were funded using the Specialized Centers mechanism. Topics for these centers include arthritis, botanicals, cancer, cardiovascular disease, neurology, and pediatrics Several large clinical trials were in progress: Hypericum for Depression; Acupuncture for Symptomatic Relief from Osteoarthritis; Ginkgo biloba for Preventing Dementia; Shark Cartilage as an adjunctive therapy for non-small Cell Lung Cancer; and Glucosamine/Chondroitin for Osteoarthritis. Numerous investigator-initiated research grants were studying the breath of CAM modalities including clinical and basic studies of acupuncture, botanicals, chiropractic, distant healing, homeopathy, massage therapy, magnet therapy and naturopathy to name a few. Finally, individual postdoctoral and predoctoral fellows and two institutional training awards were funded under National Research Service Awards (NRSA).

REGULATIONS, GUIDELINES, AND LITERATURE:

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.

NFORMATION CONTACTS:

Regional or Local Office:   None. Project Grants: Program Analyst; Division of Extramural Research, National Center for Complementary and Integrative Health, National Institutes of Health; 6707 Democracy Blvd, Suite 401, Bethesda, MD, 20892-5475; email: NCCIHDERINQUIRIES@MAIL.NIH.GOV. Small Business Innovation Research Grants Contact: John Williamson PhD; Division of Extramural Research, National Center for Complementary and Integrative Health, National Institutes of Health; 6707 Democracy Blvd, Suite 401, Bethesda, MD, 20892-5475; Telephone: (301) 496-2583. Training Portfolios: John Williamson, Ph.D.; Division of Extramural Research, National Center for Complementary and Integrative Health, National Institutes of Health; 6707 Democracy Blvd, Suite 401, Bethesda, MD, 20892-5475; Telephone: (301) 496-2583.

Headquarters Office:   Martin Goldrosen, 6707 Democracy Blvd, Suite 401, Bethesda, Maryland 20817 Email: goldrosm@mail.nih.gov Phone: (301) 594-2014.

Web Site Address:  
http://nccih.nih.gov

EXAMPLES OF FUNDED PROJECTS:

The Centers program is supporting a variety of on-going or planned studies including the chiropractic treatment of temporomandibular joint disease and lower back pain, the use of gingko biloba to treat stroke, tibetan medicine for the treatment of metastatic breast cancer, the evaluation of Korean ginseng for chemopreventive activity, a multi-site randomized clinical trial of homeopathy for the treatment of fibromyalgia, a pilot study of Kudzu for the treatment of alcoholism, the efficacy of oral immunotherapy to reduce allergic rhinitis and asthma, music therapy as an adjunct to conventional care for traumatic brain injury, and basic science studies of acupuncture analgesia. Also supported through investigator-initiated grants are basic research investigations of chiropractic and traditional Chinese medicine, clinical applications of alternative medicine for the treatment of alcoholism, allodynia, Alzheimer's disease, attention deficient syndrome, and autism.

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; (6) the relevance and importance to the announced program objectives; and (7) the interfacing of conventional researchers and technology with unconventional/alternative clinicians for the purpose of providing clinical and scientific collaborations when and where appropriate.