hpsa criteria 2003 notice

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Pike, Rockville, MD 20852, 301–
827–5349.
SUPPLEMENTARY INFORMATION:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D–5047]

Guidance for Industry on
Pharmacokinetics in Patients With
Impaired Hepatic Function: Study
Design, Data Analysis, and Impact on
Dosing and Labeling; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Pharmacokinetics in Patients
With Impaired Hepatic Function: Study
Design, Data Analysis, and Impact on
Dosing and Labeling.’’ This guidance
provides recommendations to sponsors
planning to conduct studies to assess
the influence of hepatic impairment on
the pharmacokinetics and, where
appropriate, the pharmacodynamics of
drugs or therapeutic biologics.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, or to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
Submit written comments on the
guidance to the Dockets Management
Branch (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Mehul U. Mehta, Center for Drug
Evaluation and Research (HFD–
860), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–
2567; or
David Green, Center for Biologics
Evaluation and Research (HFM–
579), Food and Drug
Administration, 1401 Rockville

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I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Pharmacokinetics in Patients With
Impaired Hepatic Function: Study
Design, Data Analysis, and Impact on
Dosing and Labeling.’’ This document
provides guidance on: (1) When
pharmacokinetic studies in patients
with hepatic impairments should be
conducted; (2) the recommended design
and conduct of studies to characterize
the effects of impaired hepatic function
on the pharmacokinetics of a drug; (3)
inclusion criteria for patient
populations to be studied; (4) analysis,
interpretation, and reporting of the
results of the studies; and (5) the
description of study results in drug
labeling.
In the Federal Register of December 7,
1999 (64 FR 68357), FDA published a
notice announcing the availability of a
draft version of this guidance. A number
of comments were received in the
docket for the 1999 draft guidance. After
careful consideration of the comments,
the draft guidance was revised.
Although we made a number of
clarifying edits and tried to make the
guidance more user friendly, the only
substantive change to the draft guidance
was to correct the implication that
certain drugs should be studied in
patients with concurrent hepatic and
renal impairment.
This level 1 final guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The guidance represents the
agency’s current thinking on
pharmacokinetic studies in patients
with impaired hepatic function. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Dockets Management Branch (see
ADDRESSES) written or electronic
comments on the guidance at any time.
Two copies of mailed comments are to
be submitted, except that individuals
may submit one copy. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. The guidance and received
comments are available for public
examination in the Dockets
Management Branch between 9 a.m. and
4 p.m., Monday through Friday.

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III. Electronic Access
Persons with access to the Internet
may obtain the document at http://
www.fda.gov/cder/guidance/index.htm,
http://www.fda.gov/cber/
guidelines.htm, or http://www.fda.gov/
ohrms/dockets/default.htm.
Dated: May 22, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03–13477 Filed 5–29–03; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Criteria for Determining Priorities
Among Health Professional Shortage
Areas
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice.
SUMMARY: In accordance with the
requirements of section 333A(b)(1) of
the Public Health Service (PHS) Act, as
amended by the Health Care Safety Net
Amendments of 2002, 42 U.S.C. 254f–
1(b)(1), the Secretary of HHS shall
establish the criteria which he will use
to make determinations under section
333A(a)(1)(A) of the health professional
shortage areas (HPSAs) with the greatest
shortages. This notice sets forth the
current greatest shortage criteria for
primary care,dental and mental health
HPSAs, which will be used pending the
adoption of new criteria through
rulemaking.
EFFECTIVE DATE:

May 30, 2003.

FOR FURTHER INFORMATION CONTACT:

Andy Jordan, Acting Chief, Shortage
Designation Branch, National Center for
Health Workforce Analysis, Bureau of
Health Professions, Health Resources
and Services Administration, 5600
Fishers Lane, Parklawn Building, Room
8C–26, Rockville, Maryland 20857,
(301–594–0816).
SUPPLEMENTARY INFORMATION: Section
332 of the PHS Act, 42 U.S.C. 254e,
provides that the Secretary shall
designate HPSAs based on criteria
established by regulation. HPSAs are
defined in section 332 to include (1)
urban and rural geographic areas with
shortages of health professionals, (2)
population groups with such shortages,
and (3) facilities with such shortages.
The required regulations setting forth
the criteria for designating HPSAs are
codified at 42 CFR Part 5.

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Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices

Section 333A(a)(1)(A) of the PHS Act
requires that the Secretary give priority
in assignment of NHSC personnel to
entities serving HPSAs with the greatest
health professional shortage. Section
333A(c) of the PHS Act requires that the
Secretary establish criteria specifying
the manner in which he determines
HPSAs of greatest shortage and
published in the Federal Register.
The Secretary is developing a new
method for designating HPSAs and
determining HPSAs of greatest shortage.
A Notice of Proposed Rulemaking
(NPRM), relating to primary care
HPSAs, was initially published in 1998.
Major revisions were made in response
to the comments received, and the
Secretary anticipates publishing a new
NPRM this year. Subsequent to the
adoption of a new rule relating to
primary care HPSAs, the Secretary
intends to propose new methods for
designating dental care and mental
health care HPSAs and to publish new
criteria for determining HPSAs of
greatest shortage for primary care,
dental care and mental health care
HPSAs. In the interim, to determine
HPSAs of greatest shortage, the
Secretary will continue to use the
current criteria set forth in this notice.
Approach for Determining Greatest
Shortages
1. Three factors (population-toprovider ratio, poverty rate, and travel
distance/time to nearest accessible
source of care) are applicable to all
categories of HPSAs (primary care,
dental and mental health).
2. Additional factors specifically
related to each HPSA category are
included (e.g., infant mortality/low birth
weight rates (IMR/LBW) for primary
care; presence of fluoridated water for
dental; ratios of the population under 18
and over 65 and the prevalence of
alcohol or substance abuse for mental
health).
3. A scale is developed for scoring
each factor. The scale generally includes
five scoring levels, and reflects different
patient utilization patterns for primary
care, dental and mental health services.
4. Relative weights for the various
factors are established, based on the
significance of the factors in
determining a shortage.
5. Each HPSA is scored on each
factor.
6. The factor scores are weighted and
summed for each HPSA.
7. The total scores for each HPSA are
ranked from highest to lowest for each
HPSA category.
8. A level is selected annually to
identify the boundary between the

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HPSAs of greatest shortage and all other
HPSAs.
9. Those HPSAs with total scores
equal to or greater than the selected
boundary level within each category are
identified as the HPSAs of greatest
shortage.
Criteria for Determining Primary Care
HPSAs of Greatest Shortage
Note: GE is defined as greater than or equal
to.

1. Score for population-to-full-timeequivalent primary care physician (PCP)
ratio:
Ratio > 10,000:1, or No PCPs and
Population GE 2500 = 5 points
10,000:1 > Ratio GE 5,000:1, or No PCPs
and Population GE 2000 = 4 points;
5,000:1 > Ratio GE 4,000:1, or No PCPs
and Population GE 1500 = 3 points;
4,000:1 > Ratio GE 3,500:1, or No PCPs
and Population GE 1000 = 2 points;
3,500:1 > Ratio > 3,000:1, or No PCPs
and Population GE 500 = 1 point.
2. Score for percent of population
with incomes below poverty level (P):
P GE 50% = 5 points;
50% > P GE 40% = 4 points;
40% > P GE 30% = 3 points;
30% > P GE 20% = 2 points;
20% > P GE 15% = 1 point;
P < 15% = 0 points.
3. Infant Health Index:
IMR GE 20 or LBW GE 13 = 5 points;
20>IMR>18 OR 13>LBW>11 = 4 points;
18>IMR>15 or 11>LBW>10 = 3 points;
15>IMR>12 or 10>LBW>9 = 2 points;
12>IMR>10 or 9>LBW>7 = 1 point;
IMR<10 or LBW<7 = 0 points.
4. Score for travel distance/time to
nearest source of accessible care outside
the HPSA:
Nearest Source of Care is defined as
the closest location where the residents
of the area or population that is
designated have access to
comprehensive primary care services.
Time GE 60 minutes or Distance GE 50
miles = 5 points;
60 min > Time GE 50 min or 50 mi >
Dist GE 40 mi = 4 points;
50 min > Time GE 40 min or 40 mi >
Dist GE 30 mi = 3 points;
40 min > Time GE 30 min or 30 mi >
Dist GE 20 mi = 2 points;
30 min > Time GE 20 min or 20 mi >
Dist GE 10 mi = 1 point;
Time < 20 min or Dist < 10 mi = 0
points.
Criteria for Determining Dental HPSAs
of Greatest Shortage
1. Score for population-to-full-timeequivalent provider ratio:
Ratio GE 10,000:1, or no dentists and
population GE 3,000 = 5 points;

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10,000:1 > Ratio GE 8,000:1, or no
dentists and population GE 2,500 = 4
points;
8,000:1 > Ratio GE 6,000:1, or no
dentists and population GE 2,000 = 3
points;
6,000:1 > Ratio GE 5,000:1, or no
dentists and population GE 1,500 = 2
points;
5,000:1 > Ratio GE 4,000:1, or no
dentists and population GE 1,000 = 1
point.
2. Score for percent of population
with incomes below poverty level (P):
P GE 50% = 5 points;
50% > P GE 40% = 4 points;
40% > P GE 30% = 3 points;
30% > P GE 20% = 2 points;
20% > P GE 15% = 1 point;
P < 15% = 0 points.
3. Score for travel distance/time to
nearest source of accessible care outside
the HPSA:
Nearest Source of Care is defined as
the closest location where the residents
of the area or population that is
designated have access to dental care
services.
Time GE 90 minutes or Distance GE 60
miles = 5 points;
90 min > Time GE 75 min or 60 mi >
Dist GE 50 mi = 4 points;
75 min > Time GE 60 min or 50 mi >
Dist GE 40 mi = 3 points;
60 min > Time GE 45 min or 40 mi >
Dist GE 30 mi = 2 points;
45 min > Time GE 30 min or 30 mi >
Dist GE 20 mi = 1 point;
Time < 30 min or Dist < 20 mi = 0
points.
4. Score for Fluoridation:
Fluoridated Water Available for ≥50%
of Population = 0 points;
Fluoridated Water Available for <50%
of Population = 1 point.
For primary care and dental care
HPSAs, the population-to-practitioner
ratio is double weighted, as it is a
primary factor in the designation of
HPSAs under section 332 of the PHS
Act. The poverty rate is also doubled.
The poverty rate is widely
acknowledged in professional literature
as a key measure of need for primary
health services, and income levels have
been shown to correlate directly with
access to health care and with health
status measures. This results in a
maximum possible score of 26 points.
Criteria for Determining Mental Health
HPSAs of Greatest Shortage
1. Score for population-to-full-timeequivalent provider ratio:
The reporting of the number of
psychiatrists present is required in all
mental health HPSA applications; the

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Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices
(c) Substance Abuse prevalence:
Area’s rate is in worst quartile for
nation/region/or state:
Yes = 1 point;
No = 0 points.
(d) Alcohol Abuse prevalence: Area’s
rate is in worst quartile for nation/
region/or state:
Yes = 1 point;
No = 0 points.
Since a larger number of factors are
considered in the mental health HPSA
scoring methodology, there is no
doubling of the weights. The possible
points for the population to provider
ratio, 8, is greater than for any of the
Score
other factors, in recognition of its
primary importance as mentioned
8 above. The maximum score is 26.

reporting of other mental health
professionals is optional. Other mental
health professionals include: clinical
psychologists, clinical social workers,
marriage and family therapists, and
psychiatric nurse specialists. Depending
upon the data reported, the scales
utilize a population-to-psychiatrist ratio
and/or a population-to-core mental
health provider ratio. (Core mental
health providers include psychiatrists
and other mental health professionals.)
The table below defines the various
provider to population ratios and
related scores:
Psychiatrist ratio

Core mental
health ratio

GT 45,000:0 and

GT 4,500:0 ........
GT 4500:1 and
LT 6000:1.
GT 6000:1 and
LT <9,000:1.

LT 20,000:1 and
GT 15,000:1
and.
LT 30,000:1 and
GT 15,000:1
or.
LT 45,000:1 and
GT 20,000:1
and.
GT 20,000:1 and
GT 30,000:1 ......

7
6

GT 4,500:1 and
LT 6,000:1.

5

GT 4,500:0 and
LT 6,000:0.

4

GT 6,000:1 ........
...........................
GT 9,000:1 ........

3
2
1

2. Score for percent of population
with incomes below poverty level (P)
P GE 50% = 5 points;
50% > P GE 40% = 4 points;
40% > P GE 30% = 3 points;
30% > P GE 20% = 2 points;
20% > P GE 15% = 1 point;
P < 15% = 0 points.
3. Score for travel distance/time to
nearest source of accessible care outside
the HPSA:
Nearest Source of Care is defined as
the closest location where the residents
of the area or population that is
designated have access to mental health
care services.
Time GE 60 minutes = 5 points;
<60 min and >50 minutes = 4 points;
<50 minutes and >40 minutes = 3
points;
<40 minutes and >30 minutes = 2
points;
<30 minutes and >20 minutes = 1 point.
4. Scores for Additional Factors
(a) Youth Ratio: Ratio of Children
under 18 to Adults 18–64:
≥60% = 3 points;
<60 and >40 = 2 points;
<40 and >20 = 1 point.
(b) Elderly Ratio: Ratio of Adults over
65 to Adults 18–64
≥25% = 3 points;
<25 and >15 = 2 points;
<15 and >10 = 1 point.

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Facility HPSA Scores
All geographic and population group
HPSAs are scored using the above
methodologies. In general, public or
nonprofit private facilities designated as
HPSAs based on the provision of
services to a geographic or population
group HPSA receive the score of the
HPSA they serve. The exception is for
Federally Qualified Health Centers and
Rural Health Centers which are
automatically designated under the
Health Care Safety Net Amendments of
2002. These facilities will be scored as
an entity, using the same factors used
for the designation of areas and
populations described above, but
applied to the entity itself. Designated
facilities which serve interned
populations (Federal and State
correctional facilities and State/county
mental hospitals) are designated based
on internee/inpatient data that differs
from the data used in geographic and
population group HPSAs. Poverty rate
and travel distance/time to nearest
accessible source of care are not data
reported or required under the facility
HPSA designation criteria and, likewise,
do not appear to be directly applicable
in determining HPSA scores for these
institutionalized populations.
Consequently, correctional facility/
mental hospital HPSA scores are
extrapolated from the degree-of-shortage
(DOS) groups determined in the HPSA
designation process. See 42 CFR part 5,
Appendices A, B and C. The
determination of DOS groups for these
facilities is based primarily on internee/
inpatient-to-provider ratios, which is
similar to the first factor used for
determining HPSAs of greatest shortage
(population-to-provider ratio).
For all correctional facilities, the
following scores apply: DOS group 1 =
21, DOS group 2 = 15, and DOS group
3 = 9. These were derived by dividing

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the HPSA score range (1–25) into
quartiles, then setting the HPSA score at
the midpoints, respectively.
Correctional facilities only have DOS 1–
3, so the midpoints for the top three
quartiles were used. For State and
county mental hospitals, this approach
was adjusted due to the different
distribution of mental health facilities
among the DOS groups , with DOS
group 1 = 20, DOS group 2 = 16, DOS
group 3 = 12, and DOS group 4 = 8.
Paperwork Reduction Act: The criteria
used to make determinations under
section 333A(a)(1)(A) of the health
professional shortage areas (HPSAs)
with the greatest shortages described in
this announcement will not involve data
collection activities that fall under the
purview of the Paperwork Reduction
Act of 1995. If the methods for
determining health professional
shortage area with the greatest shortages
fall under the purview of the Paper
work Reduction Act, the Program will
assist HRSA in seeking OMB clearance
for proposed data collection activities.
Dated: May 22, 2003.
Elizabeth M. Duke,
Administrator.
[FR Doc. 03–13478 Filed 5–29–03; 8:45 am]
BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Advisory Child Health and
Human Development Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which

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