Grants for the Establishment of Departments of Family Medicine

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 57

RIN 0905-AE17

Grants for the Establishment of Departments of Family Medicine

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final rule.

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SUMMARY: This final regulation amends the existing regulations

governing the program for Grants for the Establishment of Departments

of Family Medicine authorized by section 747(b) of the Public Health

Service Act (the Act), to bring the regulations into conformity with

technical amendments made by the Health Professions Extension

Amendments of 1992 and to include other changes for consistency with

current grant program policies.

EFFECTIVE DATE: This regulation is effective May 30, 1995.

FOR FURTHER INFORMATION CONTACT: Marc L. Rivo, M.D., Director, Division

of Medicine, Bureau of Health Professions, HRSA, Room 9A-27, Parklawn

Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301)

443-6190.

SUPPLEMENTARY INFORMATION: This final rule amends the existing

regulations for Grants for the Establishment of Departments of Family

Medicine, authorized under section 747(b) of the Public Health Service

Act (the Act) (42 U.S.C. 293k). The Health Professions Education

Extension Amendments of 1992 (Pub. L. 102-408) amended and renumbered

former section 780 of the Act (42 U.S.C. 295g) to section 747.

Section 747(b) of the Act, as amended, authorizes the Secretary to

make grants to and enter into contracts with accredited schools of

medicine or osteopathic medicine to meet the costs of projects to

establish, maintain, or improve academic administrative units (which

may be departments, divisions, or other units) to provide clinical

instruction in family medicine. The primary purpose of the program is

to assist family medicine academic administrative units to achieve

comparability in status, faculty, and curriculum with those of other

clinical units at the applying schools.

The Notice of Proposed Rulemaking (NPRM), published on July 19,

1994 in the Federal Register (59 FR 36733), proposed amendments to

implement several statutory provisions made by Pub. L. 102-408 to

section 747(b) by: (1) Revising the definitions of ``academic

administrative unit'' and ``other major clinical units'', and add the

term ``clinical campus''; (2) revising and clarifying some program

requirements--to permit a program applicant to use a program director

from the clinical campus rather than the parent medical school, to

extend a requirement to control a residency program to the clinical

campus program, and to clarify that training to all medical students

can be met by the combined effort of the parent family medicine

administrative unit and the clinical campus administrative unit.

The public comment period on the proposed regulations closed August

18, 1994. The Department received 4 public comments. The comments

received on the proposed rule to section 747 and the Department's

responses to the comments are discussed below according to the section

numbers and the headings of the regulations affected.

Section 57.1702 ``Definitions''

The Department proposed to revise the following terms in this

section:

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 provides clinical

instruction in family medicine.

The Department received positive response to this definition.

Clinical campus means a geographically separate educational entity

of an accredited medical school that has been given the responsibility

to coordinate or provide all clinical training for at least 10 percent

of the school's third-year students.

The Department received 2 comments on this definition. One

respondent favorably indicated that this definition ``would give small

programs the [[Page 28066]] autonomy necessary to respond to the demand

for primary care practitioners in rural America.''

Another respondent requested that the clinical training requirement

of 10 percent for third-year students be changed to 8 percent.

In response to this comment, the Department has reexamined this

definition and has removed the phrase ``for at least 10 percent of the

school's third-year students''. The Department has subsequently

determined that there is a potential for a serious problem in

determining and monitoring the eligibility of those clinical campuses

that apply for funding based on the 10 percent criteria. The NPRM

proposed that in order to be considered eligible for funding as a

clinical campus, at least 10 percent of the third-year class must be in

training at that clinical campus. The Department now believes that this

criterion does not constitute an adequate basis for the identification

of a clinical campus. This 10 percent of a small third-year class in a

small school would not constitute a critical mass of students and

educational structures necessary for the resources to plan an academic

unit, comparable to other units, and therefore, the Department is

removing this phrase from the definition.

The Department further modified this definition by adding the

requirement that the clinical campus must be ``recognized and

identified as such by the American Academy of Family Physicians,''

after the words ``accredited medical school'' as an objective method of

determining those eligible. The American Academy of Family Physicians

(AAFP) publishes annually the activities and status of family medicine

teaching and training programs at medical schools. The publication is

used as a valid reference work on the accreditation status of family

medicine programs. Over the last several decades, PHS has relied upon

the accessibility and accuracy of information on the current status of

accreditation of family practice training and teaching programs through

the AAFP data base.

Other major clinical units means formal academic units at the

applicant school or its clinical campus that offer clinical instruction

in internal medicine, obstetrics and gynecology, pediatrics,

psychiatry, or surgery.

The phrase ``or its clinical campus'' was added to reflect the

change to the definition of ``academic administrative unit'' cited

above.

Section 57.1704 ``Program Requirement.''

The Department revised paragraph (a) of this section. The phrase

``in an administrative unit'' was added to permit a program applicant

to use a program director from the clinical campus rather than the

parent medical school. In many instances the level of medical school

involvement in the remote campus is not sufficient to exercise

effective management of the training provided at the clinical campus.

The Department deleted a parenthetical phrase in paragraph (d) of

this section, ``(or in the case of a school of osteopathic medicine,

have control over or be closely affiliated with)'', to remove the

redundancy within this paragraph. The phrase ``or clinical campus'' was

added to extend the requirement to control a residency program so that

a residency program controlled by the parent medical school department

would meet the residency requirement for an application for assistance

for a clinical campus.

The parenthetical phrase in paragraph (e) of this section was

added, ``(or units in the case of schools with one or more

decentralized units)'', to clarify that the requirement to provide

training to all medical students can be met by the combined efforts of

the parent family medicine administrative unit and the clinical campus

administrative unit.

The Department added the phrase ``or clinical campus'' in paragraph

(f) of this section to clarify that in comparing numbers of clinical

faculty, the clinical campus family medicine administrative unit should

be compared to other clinical campus units.

In addition to the changes proposed above, a number of technical

and ministerial revisions were included to conform the existing

regulations with amendments made by Pub. L. 102-408. The following

changes were made to the regulations:

1. The section number of the Act was revised from ``780'' to

``747'' wherever it appeared in subpart R, as renumbered, and the

United States Code citation was revised from ``(42 U.S.C. 295g)'' to

``(42 U.S.C. 293k)'', in accordance with Pub. L. 102-408.

2. Section 57.1702, entitled ``Definitions.'', was amended to

revise the section number of the Act in the definition of ``School of

medicine or school of osteopathic medicine'' from ``701(5)'' to

``799(1)(E)'', in accordance with Pub. L. 102-408.

3. Section 57.1704, entitled ``Program requirements.'', was amended

to revise the section number ``786(a)'' in paragraph (h) to ``747'', in

accordance with Pub. L. 102-408.

4. Section 57.1705, entitled ``How will applications be

evaluated?'', was further revised to reflect current statutory

language, as required by section 798(a) of the Act, regarding the

evaluation and recommendation process of awarding grant applications by

removing the reference to the National Advisory Council on Health

Professions Education and the section of the Act which established it.

Pub. L. 102-408 repealed the Advisory Council effective October 1,

1992.

The Department further revised Sec. 57.1709, entitled ``What other

audit and inspection requirements apply to grantees?'', to:

(a) Remove the reference to ``section 705 of the PHS Act''

concerning audit and inspection requirements because it is redundant to

the requirements that are already covered under 45 CFR part 74; and

(b) Remove the parenthetical phrase at the end of the section text

citing the OMB approval number regarding information collection

requirements as no longer necessary.

Further, PHS strongly encourages all grant recipients to provide a

smoke-free workplace and to promote the nonuse of all tobacco products,

and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking

in certain facilities that receive Federal funds in which education,

library, day care, health care, and early childhood development

services are provided to children.

Economic Impact

Executive Order 12866 requires that all regulations reflect

consideration of alternatives, of costs, of benefits, of incentives, of

equity, and of available information. Regulations must meet certain

standards, such as avoiding unnecessary burden. Regulations which are

``significant'' because of cost, adverse effects on the economy,

inconsistency with other agency actions, effects on the budget, or

novel legal or policy issues, require special analysis.

This final rule governs a financial assistance training grant

program in which participation is voluntary. The Department believes

that the resources required to implement the requirements in these

regulations are minimal. Because this final rule makes minor changes in

an existing grant program, and in accordance with the Regulatory

Flexibility Act of 1980, the Secretary certifies that this rule will

not have a significant economic impact on small entitites. For the same

reasons, the Secretary has also determined that this

[[Page 28067]] rule is not a ``significant'' rule under Executive Order

12866.

Paperwork Reduction Act of 1980

This final rule does not affect the recordkeeping or reporting

requirements in the existing regulations for the Grants for the

Establishment of Departments of Family Medicine.

List of Subjects in 42 CFR Part 57

Aged, Dental health, Education of disadvantaged, Educational

facilities, Education study programs, Grant programs--education, Grant

programs--health, Health facilities, Health professions, Loan

programs--health, Medical and dental schools, Reporting and

recordkeeping requirements, Scholarships and fellowships, Student aid.

(Catalog of Federal Domestic Assistance, No. 93.984, Grants for the

Establishment of Departments of Family Medicine)

Dated: April 4, 1995.

Philip R. Lee,

Assistant Secretary for Health.

Approved: May 19, 1995.

Donna E. Shalala,

Secretary.

Accordingly, 42 CFR part 57, subpart R is amended as set forth

below:

PART 57--GRANTS FOR CONSTRUCTION OF TEACHING FACILITIES,

EDUCATIONAL IMPROVEMENTS, SCHOLARSHIPS AND STUDENT LOANS

1. The authority citation for subpart R is revised to read as

follows:

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).

Sec. 57.1701 [Amended]

2. Section 57.1701 introductory text is amended by revising the

section number of the Act ``780'' to read ``747'' and the United States

Code ``(42 U.S.C. 295g)'' to read ``(42 U.S.C. 293k)''.

3. Section 57.1702 is amended by revising the section number of the

Act ``701(5)'' in the definition of ``School of medicine or osteopathic

medicine'' to read ``799(1)(E)''; by revising the definitions of

``Academic administrative unit or unit'' and ``Other major clinical

units''; and by adding the definition ``Clinical campus'' to read as

follows:

Sec. 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 provides clinical

instruction in family medicine.

* * * * *

Clinical campus means a geographically separate educational entity

of an accredited medical school that is recognized and identified as a

clinical campus by the American Academy of Family Physicians and that

has been given the responsibility to coordinate or provide all clinical

training for that clinical campus.

* * * * *

Other major clinical units means formal academic units at the

applicant school or its clinical campus that offer clinical instruction

in internal medicine, obstetrics and gynecology, pediatrics,

psychiatry, or surgery.

* * * * *

4. Section 57.1704 is amended by revising the section number

``786(a)'' in paragraph (h) to read ``747''; and by revising paragraphs

(a), (d), (e), and (f) to read as follows:

Sec. 57.1704 Program requirements.

* * * * *

(a) Each project must have a project director, who works at the

grantee institution in an administrative unit of the grantee

institution on an appointment consistent with other major departments,

heads or will head the unit, and has relevant training and experience

in family medicine.

* * * * *

(d) The unit must have control over a residency training program.

The program must have the capacity to enroll a total of at least 9

interns or residents annually. A unit whose applicant school or

clinical campus does not have a residency program accredited under its

direct authority will be considered as meeting this requirement if it

has a written affiliation agreement with a hospital which conducts a

residency program as described.

(e) The unit (or units in the case of schools with one or more

decentralized units) must have responsibility for providing instruction

to each member of the student body who is engaged in an education

program leading to a degree in doctor of medicine or doctor of

osteopathic medicine. The amount of mandatory and elective curriculum

must be comparable to the amount of mandatory and elective curriculum

time required for other major clinical units at the school.

(f) The unit must have, in the judgment of the Secretary, a

sufficient number of full-time faculty to conduct the instruction. The

number of family medicine faculty in the unit must be comparable to

that of full-time faculty responsible for conducting the instruction of

one of the other major clinical units either at the school or at the

clinical campus, whichever is the same as the unit receiving the grant

funds.

* * * * *

5. Section 57.1705 is amended by revising the introductory text to

read as follows:

Sec. 57.1705 How will applications be evaluated?

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 award grants to

applicants whose projects will best promote the purposes of section 747

of the Act and this subpart. The Secretary will consider, among other

factors:

* * * * *

6. Section 57.1709 is revised to read as follows:

Sec. 57.1709 What other audit and inspection requirements apply to

grantees?

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

requirements of 45 CFR part 74 concerning audit and inspection.

(Approved by the Office of Management and Budget under conrol number

0915-0060)

[FR Doc. 95-13130 Filed 5-26-95; 8:45 am]

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