[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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