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clinical information systems;

Ability to overcome reimbursement and other policy challenges to achieve sustainability of their networks;

Comprehensive evaluation strategy and implementation as evidenced by publications, especially ones that address effectiveness, costs, and productivity; Experience in maintaining a strong and efficient operational/management structure; and

Experience in developing and implementing strategic/business plans.

LPGP

The LPGP seeks projects that can clearly serve as national models and have implications for overcoming State statutory and regulatory licensure barriers to cross-state practice of telemedicine for all the health professions, with an emphasis on projects proposed by boards or national organizations of professional licensing that have demonstrated success in pioneering creative programs to address these issues. As a result, grantees must display a clear understanding of the barriers to cross-state practice and a realistic, feasible approach to overcome legislative, regulatory, or administrative barriers to cross-state practice and the clarity of the proposed goals and objectives and their relationship to the identified project.

For FY 2010, non-competing continuation funding for Telehealth grantees will be based upon an evaluation of each of the grantees first two years of performance, the third year program design, and expenditure justifications.

93.212 CHIROPRACTIC DEMONSTRATION PROJECT GRANTS FEDERAL AGENCY:

Health Resources and Services Administration, Department of Health and Human Services

AUTHORIZATION:

Public Health Service Act, Title VII, Section 755(b)(3), 42 U.S.C. 294e(3)as amended; Health Professions Education Partnerships Act of 1998; Public Law 105-392.

OBJECTIVES:

Grants are awarded to carry out demonstration projects in which chiropractors and physicians collaborate to identify and provide effective treatment for spinal and lower-back conditions. The project requirements include: (1) The project must address the identification and treatment of spinal and/or lower-back conditions; (2) the project must be founded on collaborative efforts between chiropractors and allopathic or osteopathic physicians; (3) each project must include a strong research protocol which will result in a significant expansion of documented research in the area addressed and which is suitable for publication in referred health professions journals, including research oriented publications; (4) the project must include an explicit strategy for case-finding and a strategy for making direct comparisons to other forms of treatment. The results must be generalizable to patients cared for in a clinical practice addressing spinal and/or lower-back conditions; and (5) whenever feasible, minorities and women should be included in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. TYPES OF ASSISTANCE:

PROJECT GRANTS

USES AND USE RESTRICTIONS:

Grant and contract funds may be used for personnel, equipment, supplies, domestic travel, consultants and guest lecturers, rental of space, renovations, and other costs directly related to the project as described in the approved application. Program funds may not be used for construction of facilities, acquisition of land, foreign travel, or support of students, including fellowships, stipends, tuition, fees, or travel allowances. Program funds may not be used to support patient care costs.

Applicant Eligibility:

To be eligible for a Chiropractic Demonstration Project, the applicant shall be: a health professions school, an academic health center, or public or private nonprofit accredited schools of chiropractic.

Beneficiary Eligibility:

Health professionals will benefit.

Credentials/Documentation:

Applicants should review the individual HRSA Guidance documents issued under this CFDA program for any required proof or certifications which must be submitted prior to or simultaneous with submission of an application package. This program is excluded from coverage under OMB Circular No. A-87.

Preapplication Coordination:

Preapplication coordination is required. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.

Application Procedures:

This program is excluded from coverage under OMB Circular No. A-102. OMB Circular No. A-110 applies to this program. HRSA requires all applicants to apply electronically through Grants.gov.

All qualified applications will be forwarded to an objective review committee. Based on the advice of the objective review committee, the HRSA program official with delegated authority is responsible for final selection and funding decisions.

Award Procedure:

Notification is made in writing by a Notice of Grant Award.
Deadlines:

Contact the headquarters or regional office, as appropriate, for application deadlines.

Range of Approval/Disapproval Time:

From 5 to 6 months from receipt of application.
Appeals:

Not Applicable. Renewals:

At the end of the initial project period, competing continuation applications
may be submitted for up to five years of support.
Formula and Matching Requirements:

This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.
Length and Time Phasing of Assistance:

Project periods are for 3 years. See the following for information on how assistance is awarded/released: Grantee drawdown funds, as necessary, from the Payment Management System (PMS). PMS is the centralized web based payment system for HHS awards.

Reports:

No program reports are required. No cash reports are required. The Uniform Progress Report (UPR) must be submitted annually. Financial status reports are required within 90 days after the end of each budget period. A final progress report and financial status report must be submitted within 90 days after the end of the project period. No expenditure reports are required. No performance monitoring is required.

Audits:

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:

Grantees are required to maintain grant accounting records 3 years after the date they submit the FSR. If any litigation, claim, negotiation, audit or other action involving the award has been started before the expiration of the 3-year period, the records shall be retained until completion of the action and resolution of all issues which arise from it, or until the end of the regular 3-year period, whichever is later.

Account Identification:

75-0350-0-1-550.

Obligations:

(Project Grants) FY 08 $1,817,438; FY 09 est $1,827,000; FY 10 est $1,945,000

Range and Average of Financial Assistance:

$280,000 to $360,000; $320,000.

PROGRAM ACCOMPLISHMENTS:

Fiscal Year 2008: In FY08, four continuation awards were made. Fiscal Year 2009: In FY 09, 4 new awards are anticipated. Fiscal Year 2010: No Current Data Available

REGULATIONS, GUIDELINES, AND LITERATURE:

This program is subject to the provisions of 45 CFR Part 92 for State, local and tribal governments and 45 CFR Part 74 for institutions of higher education, hospitals, other nonprofit organizations and commercial organizations, as applicable.

Regional or Local Office:

See Regional Agency Offices. Catherine Rupinta, Program Officer, Division of
Medicine and Dentistry, Bureau of Health Professions, Health Resources and
Services Administration, Parklawn Building, Room 9A-27, 5600 Fishers Lane,
Rockville, MD 20857. Telephone: (301) 443-1070.
Headquarters Office:

Catherine Rupinta 5600 Fishers Lane, Room 9A-27, Rockville, Maryland
20857 Phone: (301) 443-1070

Website Address:

www.hrsa.gov.

RELATED PROGRAMS:

Not Applicable.

EXAMPLES OF FUNDED PROJECTS:

Fiscal Year 2008: Funded projects include research projects addressing interdisciplinary evaluation of elderly back pain treatment outcomes by medical doctors and chiropractors; chiropractic treatment and exercise for geriatric patients with low back pain; and chiropractic treatment and exercise for geriatric patients with neck pain. Fiscal Year 2009: No Current Data Available Fiscal Year 2010: No Current Data Available

CRITERIA FOR SELECTING PROPOSALS:

All applications will be evaluated by an Objective Review Committee to determine the extent to which the applicant documents the following criteria: (1) Need; (2) Response; (3) Evaluative Measures; (4) Impact; (5) Resources/Capabilities; and (6) Support Requested.

93.213 RESEARCH AND TRAINING IN COMPLEMENTARY AND ALTERNATIVE MEDICINE

National Center for Complementary and Alternative Medicine
FEDERAL AGENCY:

National Institutes of Health, Department of Health and Human Services
AUTHORIZATION:

Public Health Service Act, Section 485D,, Title VI, Section 601, Public Law 105-277, 112 Stat. 2681-387, 42 U.S.C 281 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) 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 National Center for Complementary and Alternative Medicine (NCCAM)

regularly examines and redefines its research priorities. In setting research priorities, NCCAM considers its existing research portfolio, its 5-year strategic plan, the recommendations of the National Advisory Council for Complementary and Alternative Medicine, current scientific advances, the plans of other NIH institutes and centers, and input from expert panels and stakeholders. Research constituting a rigorous evidence base for CAM practices will be developed through a range of research strategies including basic and translational research, and clinical investigation.

Current research priorities are shaped by the following considerations regarding Research Approaches, Areas of Special Interest, and Areas of Lower Program Priority.

Research Approaches

Basic and Translational Research

NCCAM's support of basic research emphasizes and encourages in vitro and in vivo studies of the biological effects and mechanisms of action underlying complementary and alternative medicine (CAM) approaches, as well as studies characterizing the active elements of an intervention, Studies should use state-of-the-art techniques in areas such as imaging, pharmacognosy, proteomics and epigenomics, and employ optimal animal models and methodology.

NCCAM's support of translational research addresses the need for valid, reliable, and relevant research tools, outcome measures, and innovative methodology to enhance the rigor or CAM clinical studies and to ensure that they are maximally informative. Studies intended to identify and validate objective endpoints or biomarkers, assess and measure adherence or treatment fidelity, and otherwise strengthen the design of subsequent CAM clinical trials are emphasized.

Observational Studies and Clinical Investigations

NCCAM's clinical research portfolio utilizes clinical trial, case-control, observational, qualitative, and other experimental methodologies to determine safety and estimate the efficacy of CAM approaches. The clinical research portfolio also includes studies of the contribution to improved health and wellness made by CAM interventions as they are practiced in "real-world" settings.

Studies should be designed to inform decision making about the design of and/or the need for subsequent investigations. Important areas of investigation include examination of pharmacology, bioavailability, and ADME (absorption, distribution, metabolism, and excretion) of biologically based interventions; optimizing dosing of all types of CAM interventions; refinement and validation of outcome measures (including patient-reported outcomes that are particularly relevant to CAM modalities); optimizing control groups, masking strategies, and other methodological enhancements; obtaining preliminary data on safety and efficacy; and conducting early phase clinical investigations to elucidate mechanisms of action and to test models.

In general phase III clinical trials will be supported under the cooperative agreement mechanism after careful consideration by NCCAM Staff. Investigators interested in proposing phase III studies are strongly encouraged to contact a relevant NCCAM Program Officer.

Areas of Special Interest

Although a wide range of research topics are of interest to NCCAM, studies focusing on CAM interventions used frequently by the American public, and on the conditions for which they are most frequently used are particularly encouraged. These would include, but not be limited to, investigations of the impact of CAM modalities in alleviating chronic pain syndromes and inflammatory processes, and improving health and wellness. Among all types of studies, attention to a range of endpoints meaningful to improved health, well-being, and quality of life is strongly encouraged.

Investigators are urged to discuss applications with a relevant NCCAM Program Officer.

Areas of Lower Program Priority

NCCAM is already investing substantial resources in the following areas of research. We will continue to fund novel and significant research on these topics. However, until results of the currently funded studies are available, applications in these areas are likely to be considered of lower program priority. Investigators are strongly urged to contact the relevant NCCAM Program Officer before submitting an application in any of the following areas:

Clinical trials of saw palmetto and African plum (Pygeum) for benign prostatic hypertrophy

Clinical efficacy or effectiveness studies of low-carbohydrate diets for weight loss

Clinical studies of silymarin for chronic liver diseases
Clinical studies using probiotics

Early Stage and New Investigators

NCCAM is strongly committed to assisting new and early stage investigators in establishing a research career. Early stage investigators are those within 10 years of completing their terminal research degree, or their medical residency, or its equivalent. New investigators are those who have yet to compete successfully for a substantial (e.g., R01) NIH research grant. Each Advisory Council round, based on available funds, NCCAM: 1) will consider early stage or new investigator status as one of the criteria for designating grant applications as being of high program priority and 2) may make additional R01 grant awards to new and early stage investigators with percentiles or scores beyond the formal payline.

NCCAM continues to accept applications in areas not listed. All investigators are urged to discuss potential applications with the relevant NCCAM Program Officer.

TYPES OF ASSISTANCE:

PROJECT GRANTS; TRAINING

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.

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. OMB Circular No.
A-87 applies to this program.
Preapplication Coordination:

Preapplication coordination is required. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.

Application Procedures:

This program is excluded from coverage under OMB Circular No. A-102. This program is excluded from coverage under OMB Circular No. A-110. NIH is in the process of converting to SF424 (Research and Related (R&R)) forms and electronic submission through Grants.gov. Information on this plan and on registering for electronic submission is available at

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html. Updates regarding the transition process are at http://era.nih.gov/Electronic Receipt/. 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 (10) to worst (90) 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:

Contact the headquarters or regional office, as appropriate, for application deadlines.

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.

Formula and Matching Requirements:

This program has no statutory formula.

Matching requirements are not applicable to this program.

MOE requirements are not applicable to this program.

Length and Time Phasing of Assistance:

Grants and cooperative agreements: Average 3 to 4 years, maximum of 5 years with prior approval before submission. Renewals may be awarded for additional periods of up to 5 years (with prior approval before submission) based on competitive peer review. Funds are provided through Monthly Demand Payment System or an Electronic Transfer System. Method of awarding/releasing assistance: lump sum.

Reports:

No program reports are required. No cash reports are required. Type 5 progress reports are required. Expenditure reports on a quarterly basis are sent to the data warehouse. Performance monitoring is not applicable.

Audits:

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. 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.

Account Identification:

75-0896-0-1-552.

Obligations:

(Project Grants) FY 08 $88,371,000; FY 09 est $88,547,000; FY 10 est not reported.

Range and Average of Financial Assistance:

range from low to high: R21, $200,000 to U19 1.955 million. PROGRAM ACCOMPLISHMENTS:

Fiscal Year 2008: NCCAMS approach to research on meditation illustrates on

how the Center develops a comprehensive research agenda and identified promising research direction. Meditation, a generic term for a variety of mind/body practices, induces a set of integrated psychological and physiological changes purported to be beneficial in a number of health conditions. Using state of the art imaging, NCCAM funded investigators are characterizing functional activity in the brain during meditation. Other investigators have demonstrate that meditative practices are associated with augmented response to vaccination, suggesting important linkage between medication, positive emotional states, local brain response, and improved immune function.

NCCAM, in collaboration with the National Institute on Aging, sponsored a new initiative, New Interventions for Menopausal Symptoms, to study alternative to menopausal hormone therapy. NCCAM continues to work with the National heart, Lung and Blood Institute on the Trial to Assess Chelation Therapy in heart attack patients, and with the National Institute of Diabetes, Digestive and Kidney Diseases to support multi-center clinical trials of milk thistle for liver disease.

To explore the biological basis for differences in individual response to CAM modalities, NCCAM launched the initiative, Omics and Variable Responses to CAM. NCCAM funded two new Centers of Excellence in CAM Research. Using animal models investigators at the Mount Sinai School of Medicine in New York, and the Center for CAM Research on Autoimmune and Inflammatory Disease the University of South Carolina Research Foundation conduct mechanistic studies of grape based compounds, such as resveratrol, for Alzheimers dieses and multiple sclerosis. Fiscal Year 2009: Basic research clarifies fundamental biological effects that are central to the development of the evidence base in CAM and underpins the design of clinical research. To address these needs, NCCAM will continue investigator-initiated basic research and will increase, through targeted initiatives, its support for translational research on CAM.

NCCAM added two new basic research centers to its cornerstone Centers of Excellence for Research on Complementary and Alternative Medicine (CERC) program during FY 2008 (nccam.nih.gov/training/centers). The University of Chicago's Center for Herbal Research on Colorectal Cancer is studying the biological effects of two forms of ginseng and their potential in preventing cancer. The CERC at Montana State University is exploring the potential for certain biologically based therapies to alter the inflammatory response to infections in the lung and intestines. Several basic research awards were funded under the FY 2007 initiative, Mechanisms of Immune Modulation, studies the ability of various interventions to affect inflammatory processes that underlie many conditions, for which Americans frequently use CAM, such as chronic pain and allergy.

The NCCAM extramural research program funds multidisciplinary clinical investigations at leading U.S. biomedical and CAM research institutions on various CAM modalities. Clinical CAM research ranges from small pilot studies to large-scale clinical trials and epidemiological studies supported through solicited research initiatives, collaboration between NIH Institutes and Centers, and investigator-initiated research.

In FY 2008, NCCAM added two new centers on mind-body research to its CERC program. The University of California, San Francisco center is studying the effects of mindfulness-based stress reduction on obesity and the metabolic syndrome. The University of Wisconsin CERC is examining how different forms of meditation affect the brain's regulation of emotion. NCCAM also funded two new projects on Outcomes and Cost Effectiveness studying use of naturopathic care to treat diabetes and CAM approaches to the treatment of chronic fatigue syndrome. NCCAM continued to work collaboratively with other Institutes to support research on pain management.

To define research needs, priorities, and future directions for CAM research, it is essential to characterize and understand the patterns and trends in use of CAM by Americans. NCCAM leads a trans-NIH initiative to obtain the most comprehensive and reliable information available about CAM use in the United States through the National Health Interview Survey (NHIS). The NHIS, carried out by the CDC, is a national survey that annually monitors the Nation's health through personal interviews of a representative sample of the civilian, non-institutionalized U.S. population. In 2007, CAM-related questions were

posed to about 30,000 randomly selected NHIS participants. Data from the survey, which became available late in FY 2008, provide insights into the types of CAM people use, the reasons for which they turn to CAM, and the patterns of use. The 2007 data included information on CAM use among children.

Important observations from the data include the following:

Almost 40 percent of adults surveyed reported using some form of CAM during the previous 30 days.

Back pain was, by far, the most frequently cited reason for CAM use. Pain and pain-related problems make up half of the top 20 reasons for using CAM. Among specific CAM modalities, the largest increases in use compared to the 2002 NHIS data were reported for meditation, massage, and yoga. CAM use in the previous 30 days was more common among Whites, Asians, and Native Americans (ranging from 40-50%) than among African American and Latino groups (approximately 25%).

The largest increases in CAM use were among Americans over 85 years of age.

CAM use remains more common among individuals with chronic or serious illness, those with higher educational levels, and those between the ages of 50-59.

Preliminary data indicate that CAM use by children was less than and different in type than adult use, and that children were more likely to use CAM approaches if their parents did also.

Herbal medicines, dietary supplements, and probiotics are the most frequently used and widely available CAM products in the United States. However, evidence from rigorous preclinical and clinical research and development to support their use is often lacking. Research on the safety, efficacy, and mechanisms of action of these products present many challenges. First, natural products are inherently variable and may consist of complex mixtures containing many individual components. For example, the time and location of plant growth or harvesting may affect significantly the composition of herbal medicines, which in turn may influence the ultimate biological effects of the product. Second, natural products can be contaminated by substances that alter metabolism or cause adverse effects. For these and other reasons, careful attention to documentation of the sources, composition, and integrity of these products are essential in ensuring that they are safe and that research with them yields validand importantlyreproducible results.

To address these challenges, NCCAM has established a quality control program for herbal medicines, dietary supplements, probiotics, and similar products used in NCCAM-supported research. Prior to funding of research grant awards, NCCAM requires that investigators submit information documenting the source, composition, and process of production of the product to be studied. These building blocks of information, critical to the integrity of the research, are reviewed by a panel of scientific experts, the NCCAM Product Integrity Working Group (PIWG). The PIWG's mission is to ensure that the particular product to be used in NCCAM-funded research meets specific criteria of analysis and quality before a grant is issued. Investigators are also required to present a plan to reserve samples for future verification or analyses, should it be needed.

From its establishment in 2006 through the end of FY 2008, NCCAM's product integrity initiative has evaluated product information for more than 220 research projects. The program is now widely recognized for its rigor, and for the standard of excellence that it sets for the field of natural product research. Most important, the program ensures that the ensuing research will be optimally designed, rigorously conducted, and maximally authoritative. Fiscal Year 2010: In FY 2010 NCCAM will make awards under a new initiative (to be released in FY 2009) entitled Program for Translational Tools for CAM Clinical Research, which will fund research on metrics, standard protocols, and outcome measures aimed at improving the quality, consistency, and comparability of clinical CAM research. The Center will also fund studies under its initiatives Dietary Supplements Research Centers: Botanicals; Exploratory/Developmental Grant for Complementary and Alternative Medicine Studies using Cells, Tissues, and Animal Models of Disease; and Biology of Manual Therapies.

In FY 2010, NCCAM will continue to fund a portfolio of investigator-initiated

clinical research, including new research projects under its initiatives Effectiveness ResearchCAM Interventions and Chronic Back Pain; Exploratory/Developmental Grant for Complementary and Alternative Medicine Studies of Humans; Outcomes, Cost-Effectiveness, and the Decision Making Process to Use Complementary and Alternative Medicine; and Omics and Variable Research Responses to CAM: Secondary Analysis for CAM Clinical Trials.

REGULATIONS, GUIDELINES, AND LITERATURE:

Not Applicable.

Regional or Local Office:

None.

Headquarters Office:

Martin Goldrosen 6707 Democracy Blvd

suite 401

, Bethesda, Maryland 20817 Email: goldrosm@mail.nih.gov Phone: 3015942014

Website Address:

http://nccam.nih.gov.

RELATED PROGRAMS:

Not Applicable.

EXAMPLES OF FUNDED PROJECTS:

Fiscal Year 2008: No Current Data Available Fiscal Year 2009: No Current
Data Available Fiscal Year 2010: No Current Data Available
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.

93.220 CLINICAL RESEARCH LOAN REPAYMENT PROGRAM FOR
INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS
(NIH Clinical Research Loan Repayment Program; CR LRP)
FEDERAL AGENCY:

National Institutes of Health, Department of Health and Human Services
AUTHORIZATION:

Publich Health Service Act, Title IV, Part G, Section 41631, Public Law
100-43, 288-5 U.S.C.

OBJECTIVES:

To recruit and retain health professionals from disadvantaged backgrounds to conduct clinical research at the National Institutes of Health (NIH) by providing for the repayment of educational loans for participants with substantial amounts of educational debt relative to income, who agree by written contract to engage in clinical research as employees of the NIH for a minimum two-year period. TYPES OF ASSISTANCE:

PROJECT GRANTS

USES AND USE RESTRICTIONS:

To provide repayment of extant educational loans incurred by health professionals engaged, as employees of the NIH, in clinical research. Recipients must agree by written contract to engage in such research, initially, for a minimum of 2 years; individuals who have conflicting service obligations may not participate in this program until those obligations are satisfied or have been deferred during the period of program service. One-year continuation contracts are available, dependent upon the level of debt and continued involvement in clinical research. Maximum program benefit is $35,000 per year in loan repayments and $13,650 per year in Federal tax reimbursements. Recipients must have qualified educational debt in excess of 20 percent of their annual salary, which is referred to as their "debt threshold." An amount equal to half

of this "debt threshold" will not be repaid by NIH and must be paid by the Program participants.

Applicant Eligibility:

Eligible applicants must: (1) Be a citizen, national, or permanent resident of the United States; (2) possess a M.D., Ph.D., D.O., D.D.S., D.M.D., D.V.M., D.P.M., A.D.N., B.S.N., or equivalent degree; or hold the position of Physician Assistant; (3) come from a disadvantaged background as determined by the Secretary of Health and Human Services; (4) have qualified educational debt, which results from governmental or commercial loans obtained to support their undergraduate and/or graduate education, in excess of 20 percent of their annual NIH salary on the program eligibility date; (5) be appointed under any temporary or permanent employment mechanism in the Intramural Research Program of the NIH, so long as their employment has the potential to last a minimum of 2 years; (6) are not eligible to participate in the CR-LRP if they have an existing service obligation to Federal, State, or other entities, until such obligation is discharged or unless it is deferred during the period of program service; (7) submit an application to participate in the CR-LRP; and (8) sign and submit to the Secretary of Health and Human Services, at the time of agreeing to accept repayment of educational loans, a contract agreeing to engage in clinical research as an employee of the NIH for a minimum of 2 years.

Beneficiary Eligibility:

Clinical researchers from disadvantaged backgrounds who have unpaid educational loans will benefit from this program.

Credentials/Documentation:

Applicants must submit documentation of the following, as appropriate: (1) Copies of loan applications and agreements from governmental or commercial educational loans which are being submitted for repayment; (2) copies of the standard student budget from each school attended during period when debt was incurred; (3) copies of recommendations, special skills, certifications, or other copies of loan documentation; (4) certification from the school(s) attended that the applicant qualified for participation in an educational assistance program for individuals from disadvantaged backgrounds which are sponsored by the Secretary of Health and Human Services or self-certification describing circumstances which qualify him/her under the Secretary's definition of an individual from a disadvantaged background; and (5) other documentation as may be required by law. This program is excluded from coverage under OMB Circular No. A-87.

Preapplication Coordination:

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:

This program is excluded from coverage under OMB Circular No. A-102. This program is excluded from coverage under OMB Circular No. A-110. Applicants must access and submit the Loan Repayment Program application electronically via the website www.lrp.nih.gov; seek qualified employment with a sponsoring Institute or Center (IC) of the NIH. Once an application has been submitted, the Loan Repayment Committee reviews it at a regularly scheduled review meeting and a determination of loan repayment recipients is made.

Award Procedure:

The NIH Loan Repayment Committee (LRC) will review, rank, and approve or disapprove applications recommended for program participation by each Institute or Center (IC). Applications approved for program participation by the LRC will be notified by the Program Director. The Secretary, or his designee, will sign the service contract of program participants, provide a copy to the participant, and notice of the amount of approved loan repayment. Deadlines:

Contact the headquarters or regional office, as appropriate, for application deadlines.

Range of Approval/Disapproval Time:

From 90 to 120 days. The approximate time for approval/disapproval is 3 months.

Appeals:

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