[Federal Register Volume 60, Number 103 (Tuesday, May 30, 1995)]
[Rules and Regulations]
[Pages 28065-28067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13130]
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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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