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(3) A description of the present employment of any graduates of the program, to the extent available, and a description of the methods to be used by the program in placing its graduates. (Approved by the Office of Management and Budget under control number 0915-0060) (44 FR 36178, June 21, 1979, as amended at 49 FR 38112, Sept. 27, 1984; 52 FR 24160, June 29, 1987; 57 FR 45736, Oct. 5, 1992; 61 FR 6124, Feb. 16, 1996)

(2) The project must provide on an annual basis, upon request and in a format acceptable to the Secretary, information in the aggregate regarding the employment of its graduates including place of employment. (Approved by the Office of Management and Budget under control number 09150060) (37 FR 20543, Sept. 30, 1972, as amended at 45 FR 41420, June 19, 1980; 52 FR 24160, June 29. 1987; 57 FR 45736, Oct. 5, 1992)

$57.705 Project requirements.

A project supported under this subpart must be conducted in accordance with the following requirements:

(a) The project must conduct its program for the training of physician assistants in accordance with the requirements in 42 CFR 57.803.

(b) The program must (1) be accredited as an Educational Program for the Physician Assistant by the American Medical Association's Committee on Allied Health Education and Accreditation, or (2) have received a Letter of Review from the Accreditation Review Committee on Education for the Physician Assistant.

(c) The program must be operational no later than 12 months after the award of a grant under this subpart.

(d) The project must be conducted under the direction of the project director who must be employed full-time at the grantee institution(s). If the project director becomes unable to function in this capacity, the Secretary must be notified as soon as possible.

(e) The project must evaluate the supervised clinical practice conducted by the program with respect to:

(1) The variety of patient contact and care experiences afforded to participating students;

(2) The adequacy and quality of supervision provided to participating students; and

(3) The adequacy of the physical setting or settings in which the supervised clinical practice takes place.

(f)(1) The project must provide on an annual basis, upon request and in a format acceptable to the Secretary, information in the aggregate regarding student characteristics, student attrition rate and student performance.

$57.706 Evaluation of applications.

(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 or disapprove all applications filed in accordance with $57.704, taking into consideration:

(1) The degree to which the project plan adequately provides for meeting the requirements set forth in $57.705 and 42 CFR 57.803;

(2) The potential effectiveness of the project in carrying out the purposes of section 750 of the Act and this subpart;

(3) The capability of the applicant to carry out the proposed project;

(4) The local, regional, and national needs the project proposes to serve;

(5) The adequacy of the project's plan for placing graduates in health professional shortage areas;

(6) The soundness of the fiscal plan for assuring effective use of grant funds;

(7) The potential of the project to continue on a self-sustaining basis after the period of grant support; and

(8) The adequacy of the project's plan to develop and use methods designed to attract and maintain minority and disadvantaged students to train as physician assistants.

(b) In determining the funding of applications 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. [44 FR 36178, June 21, 1979, as amended at 52 FR 24160, June 29, 1987; 53 FR 14792, Apr. 26, 1988; 57 FR 45736, Oct. 5, 1992; 61 FR 6124, Feb. 16, 1996)

portion of any grant award, either in advance or by way of reimbursement. [44 FR 36178, June 21, 1979]

857.707 Grant award.

(a) General. (1) Within the limits of funds available for this purpose, the Secretary may award grants to those applicants whose projects will, in his or her judgment best promote the purposes of section 750 of the Act as determined in accordance with $57.706.

(2) 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.

(3) Neither the approval of any project nor any grant award shall commit or obligate the United States in any way to make any additional, supplemental, continuation,

or

other award with respect to any approved project or portion of an approved project. For continuation support, grantees must make separate application at such times and in such a form as the Secretary may prescribe.

(b) The Secretary will determine the amount of any award on the basis of his or her estimate of the sum necessary for the cost (including both direct and indirect costs) of the project.

(c) 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, existence of legislative authority, 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.

$57.709 Purposes for which grant

funds must be spent. (a) Grant funds must be spent solely for carrying out the approved project under section 750 of the Act, these regulations, the terms and conditions of the grant award, and applicable cost principles specified in subpart Q of 45 CFR part 74.

(b) Grant funds may not be spent 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 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. [44 FR 36178, June 21, 1979, as amended at 52 FR 24160, June 29, 1987; 57 FR 45736, Oct. 5, 1992; 61 FR 6124, Feb. 16, 1996]

8 57.710 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

(44 FR 36178, June 21, 1979, as amended at 57 FR 45736, Oct. 5, 1992; 61 FR 6124, Feb. 16, 1996)

$57.708 Grant payments.

The Secretary will from time to time make payments to a grantee of all or a

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 of 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. (52 FR 24161, June 29, 1987, as amended at 57 FR 45736, Oct. 5, 1992; 61 FR 6124, Feb. 16, 1996)

for programs for the training of physician assistants. The purpose of this subpart is to comply with this requirement.

(b) The regulations in this subpart apply to all programs for the training of physician assistants supported under title VII of the Public Health Service Act. (44 FR 36177, June 21, 1979, as amended at 52 FR 24160, June 29, 1987; 61 FR 6124, Feb. 16. 1996)

$57.711 What other audit and inspec

tion requirements apply to grant

ees? Each entity which receives a grant under this subpart must meet the requirements of 45 CFR part 74 concerning audit and inspection. [61 FR 6124, Feb. 16, 1996; 61 FR 51020, Sept. 30, 1996)

$57.712 Additional conditions.

The Secretary may with respect to any grant award impose additional conditions prior to or at the time of any award when, in his or her judgment, these conditions are necessary to assure or protect advancement of the grant, the interest of the public health, or the conservation of grant funds. (44 FR 36177, June 21, 1979. Redesignated at 52 FR 24161, June 29, 1987)

$57.802 Definitions.

For purpose of this subpart:

Academic year means the approximately 9-12 month period of time during which the program is in session.

Disease prevention is the health strategy which emphasizes the development of individual and community measures to protect against disease or environmental hazards and their harmful consequence.

Full-time student means a student who is enrolled in a program and pursuing a course of study which constitutes & full-time academic workload, as determined by the program, and which leads to a degree, diploma, or certificate of completion.

Geriatric medicine is the prevention, diagnosis, care and treatment of illness and disability as required by the distinct needs of the elderly.

Health professional shortage ате means an area designated under section 322 of the Public Health Service Act.

Health promotion is the health strategy which emphasizes individual responsibility for one's health, and community efforts to maintain and enhance well-being through lifestyle changes.

Home health care is the provision of medical and other health care services to maintain or restore the health of an ill or disabled person in their place of residence.

Medical director means the individual responsible for providing competent medical direction of the program.

Physician assistant means an individual who is qualified by academic and clinical training to provide patient care services under the supervision and responsibility of a doctor of medicine

Subpart Programs for the Training of Physician Assistants

AUTHORITY: Sec. 215 of the Public Health Service Act, 58 Stat. 690, as amended by 63 Stat. 35 (42 U.S.C. 216); sec, 701(8)(B), 90 Stat. 2247, as amended by 95 Stat. 913 and 99 Stat. 525-526 (42 U.S.C. 292a(8)(B)); renumbered as sec. 750, as amended by Pub. L. 102-408, 106 Stat. 2044 (42 U.S.C. 293n).

857.801 Purpose and scope.

(a) Section 750 of the Public Health Service Act (42 U.S.C. 293n) requires the Secretary to develop regulations

guidance and responsibility of a physician who holds a full and unrestricted license in the State in which the supervised clinical practice is located.

(44 FR 36177, June 21, 1979, as amended at 52 FR 24160, June 29, 1987; 57 FR 45737, Oct. 5, 1992]

or osteopathic medicine. At a minimum, the physician assistant is competent to:

(1) Do the initial and follow-up evaluation of patients of various age groups in any setting to elicit a detailed and accurate history, perform an appropriate physical examination, and record and present pertinent data, including interpretive recommendations, in a manner meaningful to the physician;

(2) Perform or assist in the performance of routine laboratory and related

studies as appropriate for a specific : practice setting, such as blood studies, urinalyses, and electrocardiographic E tracings;

(3) Perform routine therapeutic pro- cedures such as injections, immuniza

tions, and the assessment, suturing, and care of wounds;

(4) Instruct and counsel patients regarding physical and mental health, including matters such as nutrition, illness, treatment, normal growth and development, and age, sex, or lifestyle risk factors;

(5) Perform the following functions in a hospital setting: patient work-ups, making patient rounds, recording patient progress notes, accurately and appropriately transcribing or executing standing orders and other specific orders at the direction of the supervising physician, and compiling and recording detailed progress reports and narrative case summaries;

(6) Deliver or assist in the delivery of services, including the review and monitoring of treatment and therapy plans, to patients requiring initial or continuing care in settings other than a hospital, such as the home, nursing homes, and extended care facilities;

(7) Evaluate and treat life-threatening emergency situations;

(8) Interact with those community health services and other community resources which will facilitate the patient's care and continuity of care.

Primary care means primary care, as defined in 42 CFR 57.702.

Supervised clinical practice means direct participation in patient care by observation, examination, and performance of procedures as are appropriate for the assigned role of the student for the purposes of instruction under the

$57.803 Requirements.

A program for the training of physician assistants must:

(a)(1) Be accredited as an Educational Program for the Physician Assistant by the American Medical Association's Committee on Allied Health Education and Accreditation; or

(2) Have received a Letter of Review from the Accreditation Review Committee on Education for the Physician Assistant for its plans for a program for the training of physician assistants;

(b) Have a medical director who is licensed to practice medicine or osteopathic medicine in the State in which the program is located (or any State if the program is conducted by a Federal health facility) and who is experienced in the delivery of the type of health care services for which the program provides training;

(c) Have an enrollment of not less than eight full-time students in each class;

(d) Be a minimum of 1 academic year in length;

(e) Consist of supervised clinical practice and at least 4 months (in the aggregate) of classroom instruction;

(f) Provide training to students in the areas of primary care, health promotion, disease prevention, geriatric medicine and home health care;

(g) Develop and use methods designed to encourage graduates of the program to work in health professional shortage areas, such as periods of supervised clinical practice in those areas;

(h) Develop and use methods for placing graduates in positions for which they have been trained, including methods for placing graduates in positions in health professional shortage areas; and

(i) Develop and use a method for evaluating the effectiveness of the program in training physician assistants, including:

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sistance and who plan to practice general dentistry. (52 FR 19145, May 21, 1987, as amended at 57 FR 45737, Oct. 5, 1992; 61 FR 6124, Feb. 16. 1996)

(1) Evaluation by faculty and students of the program in relation to its objectives;

(2) Evaluation of student performance in classroom instruction and supervised clinical practice; and

(3) Evaluation of the number of graduates employed and the characteristics of their employment, such as geographical location, setting, and functions performed; and

(4) Award a degree, diploma, or certificate of completion to individuals who have successfully completed the program.

(44 FR 36177, June 21, 1979, as amended at 52 FR 24160, June 29, 1987; 57 FR 45737, Oct. 5, 1992]

Subparts J-K [Reserved]

K

Subpart L-Grants for Residency

Training and Advanced Education in the General Practice of Dentistry

AUTHORITY: Sec. 215 of the Public Health Service Act, 58 Stat. 690, as amended by 63 Stat. 35 (42 U.S.C. 216); sec. 786(b) of the Public Health Service Act, 90 Stat. 2317, as amended by 99 Stat. 540-541 (42 U.S.C. 295g6(b)); redesignated as sec. 785 and amended by 102 Stat. 3130_3131 (42 U.S.C. 295g-5); renumbered as sec. 749, as amended by Pub. L. 102-408, 106 Stat. 2043 2044 (42 U.S.C. 293m).

857.1102 Definitions.

As used in this subpart:

Accredited postgraduate dental training institution means a public or private nonprofit institution which operates a postgraduate dental training program that has received an accreditation classification of "accreditation eligible," "preliminary provisional approval." “provisional approval," "conditional approval, or "approval" by the Commission on Dental Accreditation.

Act means the Public Health Service Act, as amended.

Approved residency training program, approved advanced educational program, or program means a general practice residency program or an advanced educational program in general dentistry which has received an accreditation classification of "accreditation eligible,” "preliminary provisional approval," "provisional approval," "conditional approval,” or “approval" by the Commission on Dental Accreditation.

Budget period means an interval of time into which the project period is divided for budgetary purposes, as specified in the grant award document.

Nonprofit refers to the status of an entity which is a corporation or association, or is owned or 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.

Practice of general dentistry means a practice of dentistry in which the dentist:

(1) Serves as a patient's first contact with the dental care system and provides the means of timely entry into that system;

(2) Evaluates the patient's general medical status and relates this to anticipated dental treatment;

(3) Assumes continuing responsibility for the patient's dental care and provides a comprehensive range of services

857.1101 To what projects do these

regulations apply? These regulations apply to the award of grants under section 749 of the Public Health Service Act (42 U.S.C. 293m) to public or private nonprofit schools of dentistry and to accredited postgraduate dental training institutions to meet the costs of projects to:

(a) Plan, develop and operate an approved residency training program in the general practice of dentistry or an approved advanced educational program in the general practice of dentistry; and

(b) Provide financial assistance (in the form of traineeships and fellowships) to participants in such a program who are in need of financial as

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