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private nonprofit entities for projects to: (a) Plan, develop, and operate, or participate in predoctoral, graduate, or faculty development educational programs in family medicine; and (b) provide financial assistance to trainees participating in predoctoral or graduate educational programs who are in need of financial assistance and who plan to practice family medicine or to trainees in faculty development programs who plan to teach in family medicine training programs. [57 FR 45738, Oct. 5, 1992, as amended at 61 FR 6125, Feb. 16, 1996)

ciation, or is owned and operated by one or more corporations or associations, no part of the net earnings of which inures, or may lawfully inure, to the benefit of any private shareholder or individual.

Osteopathic internship program means an internship which emphasizes family medicine and is approved by the American Osteopathic Association.

Preceptorship means an educational experience in which the trainee works individually with a designated physician, the preceptor, who teaches and personally supervises clinical activity.

Predoctoral training program means an educational program in family medicine, including courses, clerkships or preceptorships in family medicine, which is part of a course of study leading to the degree of doctor of medicine or osteopathic medicine, and student assistantships in family medicine.

Residency training program means:

(a) A residency program in family practice which is fully or provisionally accredited by the Accreditation Council for Graduate Medical Education; or

(b) A postdoctoral program in osteopathic general practice which emphasizes family medicine and is approved by the American Osteopathic Association.

School of medicine or osteopathic medicine means a public or private nonprofit school in a State which provides training leading, respectively, to a degree of doctor of medicine or to a degree of doctor of osteopathic medicine and which is accredited as provided in section 799(1)(E) of the Act. Secretary

the Secretary of Health and Human Services and any other officer or employer of the Department of Health and Human Seryices to whom the authority involved has been delegated.

State means, in addition to the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, the Republic of Palau, the Republic of the Marshall Islands, and the Federated States of Micronesia.

Student assistantship means search program in family medicine for

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8 57.1602 Definitions.

Act means the Public Health Service Act, as amended.

Clerkship means supervised clinical training in a specific field of medicine for predoctoral medical (M.D. or D.O.) students.

Faculty development program means a systematic training program to increase faculty competence in teaching skills and in other areas related to academic responsibilities.

Family medicine means the field of medicine, including osteopathic general practice, in which the physician:

(a) Serves as a physician of first contact with families and with patients of all ages and provides a means of entry into the health care system;

(b) Evaluates the patient's total health needs, provides personal medical care within one or more fields of medicine, and refers the patient, when indicated, to appropriate sources of care while preserving the continuity of care;

(C) Assumes responsibility with the patient for comprehensive and continuous health care and acts as a leader or coordinator of others providing health services; and

(d) Considers the patient's total health care within the context of his or her environment, including the community and the family or comparable social units.

Hospital means a public or other nonprofit hospital which is accredited by the Joint Commission on Accreditation of Hospitals or the American Osteopathic Association.

Nonprofit refers to the status of an entity which is a corporation or asso

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predoctoral medical (M.D. or D.O.) students.

Trainee means a medical (M.D. or D.O.) student, intern, resident, or physician participating in a training program supported by a grant under these regulations. [45 FR 68895, Oct. 16, 1980, as amended at 49 FR 11613, Mar. 26, 1984; 57 FR 45738, Oct. 5, 1992; 61 FR 6125, Feb. 16, 1996)

$57.1603 Who is eligible to apply for a

grant? (a) For predoctoral training programs, an applicant must be a school of medicine or osteopathic medicine located in a state.

(b) For graduate and faculty development training programs, an applicant must be located in a State and be a school of medicine or osteopathic medicine, a hospital, or a public or private nonprofit entity which provides either health or educational programs as one of its major functions.

(c) Each eligible applicant desiring a grant under this subpart shall submit an application in the form and at such time as the Secretary may prescribe. [45 FR 68895, Oct. 16, 1980, as amended at 57 FR 45738, Oct. 5, 1992)

quate portion of the clinical training is conducted.

(5) Each project, other than a faculty development project, must have a family medicine curriculum which:

(i) Is appropriate for the academic level of the trainees and the specific length and nature of the educational program;

(ii) Supplements any practical (including clinical) experiences with related education activities; and

(iii) Emphasizes subjects pertinent to:

(A) Ambulatory care;

(B) Psychosocial skills and topics: and

(C) Related nonclinical areas relevant to the practitioner of family medicine.

(b) Additional requirements for predoctoral training programs. In addition to the requirements of paragraph (a) of this section, projects for predoctoral training programs must also meet the following additional requirements:

(1) The training program must be sponsored and supervised by an appropriate administrative unit in family medicine, the faculty of which participates in the preparation of the preclerkship curriculum and required courses and activities, for which faculty may be interdisciplinary, such as physical diagnosis and clinical pathological conferences, and which coordinates the predoctoral offering of clerkships and other clinical experi ces oriented to family medicine.

(2) Each training program must be part of an integrated institutional strategy to provide education and training in family medicine designed to encourage an appropriate percentage of its graduates, annually, to seek graduate training in family medicine and eventually to enter a career in family medicine.

(3) For projects which include preceptorships in family medicine:

(i) The project must provide medical (M.D. or D.O.) students with ambulatory care training in a community setting.

(ii) Preceptors must have practices which are consistent with the principles of family medicine and must be

$57.1604 What requirements must a

project meet? (a) General requirements. A project supported under this subpart must meet the following requirements:

(1) Each project must have a project director who works at the grantee institution or training site institution, has relevant training and experience, and has been approved by the Secretary to direct the project.

(2) Each project must have an appropriate administrative and organizational plan and appropriate faculty, staff, and facility resources for the achievement of stated objectives.

(3) Each project must systematically evaluate the educational program including trainees and faculty preceptors, the administration of the program and the degree to which program and educational objectives are met.

(4) Each project, other than a faculty development project, must use ambulatory care settings where family medicine is practiced and in which an ade

: selected by the administrative unit in family medicine.

(iii) Stipend support from grant funds may be given to trainees who are not receiving academic credit for the preceptorship only if they (A) need it; (B) indicate an interest in working in the field of family medicine; and (C) engage in the preceptorship full time for at least 4 consecutive weeks. Stipend support from grant funds may be given to trainees who are receiving academic credit for the preceptorship only when the three conditions above are met and, additionally, when the trainee incurs extraordinary living expenses due to participation in the preceptorship.

(4) For projects for student assistantships:

(i) A family medicine faculty member of the administrative unit, identified

under paragraph (b)(1) of this section, : must supervise each student assistant. I (ii) The grantee must give preference

in admission to the training program i to applicants considering a career in academic family medicine.

(iii) Stipend support from grant funds may be given to trainees who are not receiving academic credit for the assistantship only if they (A) need it;

(B) indicate an interest in working in 1 the field of family medicine; and (C)

engage in the assistantship full time for at least 8 consecutive weeks. Stipend support from grant funds may be given to trainees who are receiving academic credit for the assistantship only when the three conditions above are met and, additionally, when the

trainees incurs extraordinary living ex$

penses, due to participation in the assistantship.

(c) Additional requirements for graduate training projects (except faculty development). In addition to the requirements of paragraph (a) of this section, projects for approved or accredited residency training programs must meet the following additional requirements:

(1) Each program must have a supervisor of training with appropriate experience and training who is responsible for coordination and supervision of training in the program.

(2) Each program must use an appropriate resident or intern recruitment and selection process which assures that residents and interns in the pro

gram have applied specifically for training in the approved graduate training program.

(3) Each program must provide education for a sufficient number of interns or residents to provide an adequate collegial environment for the educational program and to enhance cost efficiency.

(4) Each program must have an adequate number of qualified faculty with training and experience in family medicine, behavioral sciences, and liaison specialties, for the number of interns or resident in the program. The faculty of the program must engage in periodic educational activities to improve their teaching skills.

(5) Each program must provide an appropriate amount of clinical training for each intern or resident in ambulatory care settings emphasizing family medicine in each year of the training program. This training will be for the purpose of assuring an adequate education in the principles of the practice of family medicine throughout the program. In addition, each training program must provide clinical training in other ambulatory care settings relevant to family medicine, such emergency units.

(6) Each program must have adequate facilities for the provision of the educational activities and, in particular, have family medicine ambulatory care space sufficient to provide an adequate clinical experience for the interns or residents.

(7) Each intern or resident must serve a sufficient number of families and individual patients with a variety of health care needs to provide the trainee with a broad clinical experience.

(d) Additional requirements for faculty development programs. (1) Each project must have a curriculum which:

(i) Directly applies to family medicine training programs;

(ii) Emphasizes improvement of pedagogical skills for clinical and classroom settings; and

(iii) Uses didactic and nondidactic teaching strategies.

(2) Only physicians who teach or intend to teach in family medicine are eligible to participate as trainees in the program.

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(3) Each program must have a sufficient number of trainees participating during the conduct of any educational activities to provide a collegial environment and to make the program cost efficient.

(4) Stipend support from grant funds may be no longer than 24 cumulative months for any trainee.

(5) To be eligible for financial assistance from grant funds, a trainee must:

(i) Intend to teach in family medicine training program on a full-time basis; and

(ii) Be a full-time participant in the training program for at least 3 months.

(45 FR 68895, Oct. 16, 1980, as amended at 49 FR 11613, Mar. 26, 1984; 54 FR 50374, Dec. 6, 1989; 57 FR 45738, Oct. 5, 1992)

$57.1606 How long does grant support

last? (a) The notice of grant award specifies the length of time the Secretary intends to support the project without requiring the project to recompete for funds. This period, called the project period, will not exceed 5 years.

(b) Generally, the grant will initially be funded for 1 year, and subsequent continuation awards will also be for 1 year at a time. Decisions regarding continuation awards and the funding levels of these awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by the Secretary that continued funding is in the best interest of the Federal Government.

(c) Neither the approval of any application nor the award of any grant shall commit or obligate the United States in any way to make any additional, supplemental, continuation or other award with respect to any approved application or portion of an approved application. For continuation support, grantees must make separate application at such times and in such a form as the Secretary may prescribe. [45 FR 68895, Oct. 16, 1980, as amended at 57 FR 45739, Oct. 5, 1992]

8 57.1605 How will applications be

evaluated? (a) As required by section 798(a) of the Act, each application for a grant under this subpart shall be submitted to a peer review group, composed principally of non-Federal experts, for an evaluation of the merits of the proposals made in the application. The Secretary may not approve such an application unless a peer review group has recommended the application for approval. The Secretary will approve projects which best promote the purposes of section 747 of the Act and these regulations. The Secretary will consider, among other factors:

(1) The degree to which the proposed project provides for the project requirements in $ 57.1604;

(2) The administrative and management ability of the applicant to carry out the proposed project in a cost-effective manner; and

(3) The potential of the project to continue on a self-sustaining basis.

(b) In determining the funding of projects approved under paragraph (a) of this section, the Secretary will consider any special factors relating to national needs as the Secretary may from time to time announce in the FEDERAL REGISTER.

857.1607 For what purposes may grant

funds be spent? (a) A grantee shall only spend funds it receives under this subpart according to the approved application and budget, the authorizing legislation, terms and conditions of the grant award, applicable cost principles specified in subpart Q of 45 CFR part 74, and these regulations.

(b) Grantees may not spend grant funds for sectarian instruction or for any religious purpose.

(c) Any balance of federally obligated grant funds remaining unobligated by the grantee at the end of a budget period may be carried forward provided specific approval is granted by the Secretary. If at any time during a budget period it becomes apparent to the Secretary that the amount of Federal funds awarded and available to the grantee for that period, including any

(45 FR 68895, Oct. 16, 1980, as amended at 49 FR 11613, Mar. 26, 1984; 53 FR 14792, Apr. 26, 1988; 61 FR 6125, Feb. 16, 1996)

quirements of 45 CFR part 74 concerning audit and inspection. (61 FR 6125, Feb. 16, 1996; 61 FR 51020, Sept. 30, 1996]

unobligated balance carried forward from prior periods, exceeds the grantee's needs for the period, the Secretary may adjust the amounts awarded by withdrawing the excess. A budget period is an interval of time (usually 12 months) into which the project period is divided for funding and reporting purposes. (45 FR 68895, Oct. 16, 1980, as amended at 57 FR 45739, Oct. 5, 1992)

$57.1610 Additional conditions.

The Secretary may impose additional conditions on any grant award before or at the time of an award if he or she determines that these conditions are necessary to assure or protect the advancement of the approved activity, the interest of the public health, or the conservation of grant funds.

(45 FR 68895, Oct. 16, 1980. Redesignated at 49 FR 11613, Mar. 26, 1984)

Subpart R-Grants for the Estab

lishment of Departments of Family Medicine

AUTHORITY: Sec. 215, Public Health Service Act, 58 Stat. 690, as amended by 63 Stat. 35 (42 U.S.C. 216); sec. 780, Public Health Service Act, 90 Stat. 2311, as amended by 95 Stat. 221 and 102 Stat. 3146 (42 U.S.C. 295g); renumbered as sec. 747, as amended by Pub. L. 102– 408, 106 Stat. 2042-2043 (42 U.S.C. 293k).

8 57.1608 What additional Department

regulations apply to grantees? Several other regulations apply to these grants. They include, but are not limited to: 42 CFR part 50, subpart D-Public Health

Service grant appeals procedure 45 CFR part 16—Procedures of the Depart

mental Grant Appeals Board 45 CFR part 46—Protection of human sub

jects 45 CFR part 74-Administration of grants 45 CFR part 75 Informal grant appeals pro

cedures 45 CFR part 76_Governmentwide Debarment

and Suspension (nonprocurement) and Governmentwide Requirements for Drug-Free

Workplace (Grants) 45 CFR part 80-Nondiscrimination under

programs receiving Federal assistance through the Department of Health and Human Services effectuation of title VI of

the Civil Rights Act of 1964 45 CFR part 81-Practice and procedure for

hearings under part 80 of this title 45 CFR part 83—Regulation for the adminis

tration and enforcement of Sections 794

and 855 of the Public Health Service Act 45 CFR part 84—Nondiscrimination on the

basis of handicap in programs and activities receiving or benefiting from Federal

financial assistance 45 CFR part 86—Nondiscrimination on the

basis of sex in education programs and activities receiving or benefiting from Fed

eral financial assistance 45 CFR part 91-Nondiscrimination on the

basis of age in HHS programs or activities

receiving Federal financial assistance 45 CFR part 93—New restrictions on lob

bying. (49 FR 38113, Sept. 27, 1984; 49 FR 40406, Oct. 16, 1984, as amended at 57 FR 45739, Oct. 5, 1992; 61 FR 6125, Feb. 16, 1996)

857.1701 To what programs do these

regulations apply? These regulations apply to the award of grants under section 747 of the Public Health Service Act (42 U.S.C. 293k) to schools of medicine and osteopathic medicine to meet the costs of projects to establish, maintain, or improve academic administrative units to provide clinical instruction in family medicine. These projects may include:

(a) The planning and development of model predoctoral, faculty development, and graduate medical education programs; and

(b) Academic and clinical activities relevant to the field of family medicine. (48 FR 20215, May 4, 1983, as amended at 57 FR 45739, Oct. 5, 1992; 60 FR 28067, May 30, 1995]

$57.1609 What other audit and inspec.

tion requirements apply to grant

ees? Each entity which receives a grant under this subpart must meet the re

$57.1702 Definitions.

Academic administrative unit or unit means a department, division, or other formal academic unit of a school of medicine or osteopathic medicine or clinical campuses of such schools that

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