``Low-Income Levels'' Used for Various Health Professions and Nursing Programs Authorized in the Public Health Service Act, 8729-8730 [2019-04407]
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Federal Register / Vol. 84, No. 47 / Monday, March 11, 2019 / Notices
treated, may lead to significant
morbidity and mortality. When
administered quickly after an opioid
overdose, naloxone, an opioid
antagonist, can save lives. Naloxone is
currently approved as a prescription
drug, but it is not approved for
nonprescription use. As part of a wide
governmental effort to address the
national crisis of opioid overdose
deaths, the Agency has identified
broader availability of naloxone,
including potential nonprescription
availability, as one means to help
reduce overdose deaths.
To support approval of a drug for
nonprescription use, the sponsor of the
drug product typically (among other
things) conducts one or more consumer
behavior studies to demonstrate that
consumers would be able to use the
drug product safely and effectively in
the nonprescription setting without the
supervision of a healthcare professional.
Some stakeholders have identified the
need to perform these studies as a
barrier to development of a
nonprescription naloxone drug product.
To help address this concern, FDA
developed a model DFL for a potential
nonprescription naloxone drug product.
The model DFL is intended to contain
adequate information (except for
individual device-specific information,
such as how to use a particular injector
or spray device, which would be added
by the product sponsor) that a consumer
would need to administer naloxone
safely and effectively for its intended
use in the nonprescription setting.
Consumer comprehension of the model
DFL has been iteratively tested by an
independent research contractor in a
prespecified research design involving
over 700 participants across a wide
range of potential nonprescription
naloxone users. These participants
included people who use heroin, people
who use prescription opioids, family
and friends of people who use opioids,
adolescents, and members of the general
public.
After completion of the label
comprehension study, an FDA review
team that was not involved in the design
or conduct of the study reviewed the
study report and determined that the
comprehension results are adequate.
FDA has determined that the model DFL
can be made publicly available so that
sponsors who wish to pursue
development of a nonprescription
naloxone product can use the model
DFL in their development program. A
sponsor would need to add its devicespecific information to the model DFL
and retest that information to
demonstrate that consumers understand
the information within the context of
VerDate Sep<11>2014
18:41 Mar 08, 2019
Jkt 247001
the overall DFL. The model DFL comes
in two versions (one for use with a nasal
spray and one for use with an injector),
but the device-specific instructions in
each version are placeholders that have
not been tested for comprehension or
human factors performance, and
sponsors will need to replace these
placeholders with their own devicespecific information and retest it
appropriately.
FDA strongly encourages sponsors of
potential nonprescription naloxone drug
products to request a meeting to discuss
their development program with the
Division of Nonprescription Drug
Products. For information on sponsor
meetings with FDA, sponsors can refer
to the draft guidance for industry
‘‘Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA
Products’’ at https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-drugsgen/documents/document/
ucm590547.pdf.
II. Electronic Access
Persons with access to the internet
may obtain the model DFLs at https://
www.fda.gov/downloads/Drugs/
DrugSafety/PostmarketDrugSafety
InformationforPatientsandProviders/
UCM629320.pdf and https://
www.fda.gov/downloads/Drugs/
DrugSafety/PostmarketDrugSafety
InformationforPatientsandProviders/
UCM629321.pdf.
Dated: March 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–04357 Filed 3–8–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
‘‘Low-Income Levels’’ Used for Various
Health Professions and Nursing
Programs Authorized in the Public
Health Service Act
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is updating income
levels used to identify a ‘‘low-income
family’’ for the purpose of determining
eligibility for programs that provide
health professions and nursing training
to individuals from disadvantaged
backgrounds. These various programs
are authorized in Titles III, VII, and VIII
of the Public Health Service Act.
SUMMARY:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
8729
HHS
periodically publishes in the Federal
Register low-income levels to be used
by institutions receiving grants and
cooperative agreements to determine
eligibility for programs providing
training for (1) disadvantaged
individuals, (2) individuals from
disadvantaged backgrounds, or (3)
individuals from low-income families.
Many health professions and nursing
grant and cooperative agreement
awardees use the low-income levels to
determine whether potential program
participants are from an economically
disadvantaged background and would
be eligible to participate in the program,
as well as to determine the amount of
funding the individual receives. Awards
are generally made to accredited schools
of allopathic medicine, osteopathic
medicine, public health, dentistry,
veterinary medicine, optometry,
pharmacy, allied health, podiatric
medicine, nursing, and chiropractic;
public or private nonprofit schools,
which offer graduate programs in
behavioral health and mental health
practice; and other public or private
nonprofit health or education entities to
assist the disadvantaged to enter and
graduate from health professions and
nursing schools. Some programs
provide for the repayment of health
professions or nursing education loans
for disadvantaged students.
A ‘‘low-income family/household’’ for
programs included in Titles III, VII, and
VIII of the Public Health Service Act is
defined as having an annual income that
does not exceed 200 percent of the
Department’s poverty guidelines. A
family is a group of two or more
individuals related by birth, marriage, or
adoption who live together.
Most HRSA programs use the income
of a student’s parents to compute lowincome status. However, a ‘‘household’’
may potentially be only one person.
Other HRSA programs, depending upon
the legislative intent of the program, the
programmatic purpose related to income
level, as well as the age and
circumstances of the participant, will
apply these low-income standards to the
individual student to determine
eligibility, as long as he or she is not
listed as a dependent on the tax form of
his or her parent(s). Each program
announces the rationale and choice of
methodology for determining lowincome levels in program guidance.
Low-income levels are adjusted
annually based on HHS’ poverty
guidelines. HHS’ poverty guidelines are
based on poverty thresholds published
by the U.S. Census Bureau, adjusted
annually for changes in the Consumer
Price Index. The income figures below
SUPPLEMENTARY INFORMATION:
E:\FR\FM\11MRN1.SGM
11MRN1
8730
Federal Register / Vol. 84, No. 47 / Monday, March 11, 2019 / Notices
have been updated to reflect the
Department’s 2019 poverty guidelines as
published in 84 FR 1167 (February 1,
2019).
LOW-INCOME LEVELS BASED ON THE
2019 POVERTY GUIDELINES FOR THE
48 CONTIGUOUS STATES AND THE
DISTRICT OF COLUMBIA
Persons in family/household *
1
2
3
4
5
6
7
8
Puerto Rico or other outlying
jurisdictions. Puerto Rico and other
outlying jurisdictions shall use income
guidelines for the 48 Contiguous States
and the District of Columbia.
Dated: March 4, 2019.
George Sigounas,
Administrator.
[FR Doc. 2019–04407 Filed 3–8–19; 8:45 am]
BILLING CODE 4165–15–P
Income Level **
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
$24,980
33,820
42,660
51,500
60,340
69,180
78,020
86,860
For families with more than 8 persons, add
$8,840 for each additional person.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
LOW-INCOME LEVELS BASED ON THE
2019 POVERTY GUIDELINES FOR SUMMARY: As stipulated by the Federal
ALASKA
Advisory Committee Act, the
Persons in family/household *
1
2
3
4
5
6
7
8
Income Level **
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
$31,200
42,260
53,320
64,380
75,440
86,500
97,560
108,620
For families with more than 8 persons, add
$11,060 for each additional person.
LOW-INCOME LEVELS BASED ON THE
2019 POVERTY GUIDELINES FOR HAWAII
Persons in family/household *
1
2
3
4
5
6
7
8
Income Level **
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
$28,760
38,920
49,080
59,240
69,400
79,560
89,720
99,880
amozie on DSK9F9SC42PROD with NOTICES
For families with more than 8 persons, add
$10,160 for each additional person.
* Includes only dependents listed on federal
income tax forms.
** Adjusted gross income for calendar year
2018.
Separate poverty guidelines figures
for Alaska and Hawaii reflect Office of
Economic Opportunity administrative
practice beginning in the 1966–1970
period since the U.S. Census Bureau
poverty thresholds do not have separate
figures for Alaska and Hawaii. The
poverty guidelines are not defined for
VerDate Sep<11>2014
18:41 Mar 08, 2019
Jkt 247001
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
on April 8, 2019, for the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (Advisory
Council). The meeting will be open to
the public via teleconference. Preregistration is required for members of
the public who wish to attend the
meeting via teleconference. Individuals
who wish to send in their public
comments should send an email to
CARB@hhs.gov. Registration
information is available on the website
https://www.hhs.gov/ash/carb/ and must
be completed by April 2, 2019.
Additional information about registering
for the meeting and providing public
comments can be obtained at https://
www.hhs.gov/ash/carb/ on the Meetings
page.
DATES: The meeting is scheduled to be
held on April 8, 2019, from 12:00 p.m.
to 2:00 p.m. ET (times are tentative and
subject to change). The confirmed times
and agenda items for the meeting will be
posted on the website for the Advisory
Council at https://www.hhs.gov/ash/
carb/ when this information becomes
available. Pre-registration for attending
the meeting is required to be completed
no later than April 2, 2019.
ADDRESSES: Instructions regarding
attending this meeting virtually will be
posted one week prior to the meeting at:
https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT:
Jomana Musmar, Designated Federal
Officer, Presidential Advisory Council
on Combating Antibiotic-Resistant
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Bacteria, Office of the Assistant
Secretary for Health, U.S. Department of
Health and Human Services, Room
L133, Switzer Building, 330 C. St. SW,
Washington, DC 20201. Phone: (202)
690–5566; email: CARB@hhs.gov.
SUPPLEMENTARY INFORMATION: Under
Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of HHS to establish the
Advisory Council, in consultation with
the Secretaries of Defense and
Agriculture. Activities of the Advisory
Council are governed by the provisions
of Public Law 92–463, as amended (5
U.S.C. App.), which sets forth standards
for the formation and use of federal
advisory committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria and the National Action Plan
for Combating Antibiotic-Resistant
Bacteria. The Advisory Council shall
function solely for advisory purposes.
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
optimizing their use; advance research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthen surveillance of antibioticresistant bacterial infections; prevent
the transmission of antibiotic-resistant
bacterial infections; advance the
development of rapid point-of-care and
agricultural diagnostics; further research
on new treatments for bacterial
infections; develop alternatives to
antibiotics for agricultural purposes;
maximize the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal
healthcare providers; and improve
international coordination of efforts to
combat antibiotic resistance.
The public meeting will be dedicated
to deliberation and vote of the report
with recommendation from the
Immediate Action Subcommittee of the
Advisory Council. The meeting agenda
will be posted on the Advisory Council
website at https://www.hhs.gov/ash/
carb/ when it has been finalized. All
agenda items are tentative and subject to
change.
Instructions regarding attending this
meeting virtually will be posted one
E:\FR\FM\11MRN1.SGM
11MRN1
]]>Agencies
[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Pages 8729-8730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04407]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
``Low-Income Levels'' Used for Various Health Professions and
Nursing Programs Authorized in the Public Health Service Act
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: HRSA is updating income levels used to identify a ``low-income
family'' for the purpose of determining eligibility for programs that
provide health professions and nursing training to individuals from
disadvantaged backgrounds. These various programs are authorized in
Titles III, VII, and VIII of the Public Health Service Act.
SUPPLEMENTARY INFORMATION: HHS periodically publishes in the Federal
Register low-income levels to be used by institutions receiving grants
and cooperative agreements to determine eligibility for programs
providing training for (1) disadvantaged individuals, (2) individuals
from disadvantaged backgrounds, or (3) individuals from low-income
families.
Many health professions and nursing grant and cooperative agreement
awardees use the low-income levels to determine whether potential
program participants are from an economically disadvantaged background
and would be eligible to participate in the program, as well as to
determine the amount of funding the individual receives. Awards are
generally made to accredited schools of allopathic medicine,
osteopathic medicine, public health, dentistry, veterinary medicine,
optometry, pharmacy, allied health, podiatric medicine, nursing, and
chiropractic; public or private nonprofit schools, which offer graduate
programs in behavioral health and mental health practice; and other
public or private nonprofit health or education entities to assist the
disadvantaged to enter and graduate from health professions and nursing
schools. Some programs provide for the repayment of health professions
or nursing education loans for disadvantaged students.
A ``low-income family/household'' for programs included in Titles
III, VII, and VIII of the Public Health Service Act is defined as
having an annual income that does not exceed 200 percent of the
Department's poverty guidelines. A family is a group of two or more
individuals related by birth, marriage, or adoption who live together.
Most HRSA programs use the income of a student's parents to compute
low-income status. However, a ``household'' may potentially be only one
person. Other HRSA programs, depending upon the legislative intent of
the program, the programmatic purpose related to income level, as well
as the age and circumstances of the participant, will apply these low-
income standards to the individual student to determine eligibility, as
long as he or she is not listed as a dependent on the tax form of his
or her parent(s). Each program announces the rationale and choice of
methodology for determining low-income levels in program guidance.
Low-income levels are adjusted annually based on HHS' poverty
guidelines. HHS' poverty guidelines are based on poverty thresholds
published by the U.S. Census Bureau, adjusted annually for changes in
the Consumer Price Index. The income figures below
[[Page 8730]]
have been updated to reflect the Department's 2019 poverty guidelines
as published in 84 FR 1167 (February 1, 2019).
Low-Income Levels Based on the 2019 Poverty Guidelines for the 48
Contiguous States and the District of Columbia
------------------------------------------------------------------------
Persons in family/household * Income Level **
------------------------------------------------------------------------
1.................................................... $24,980
2.................................................... 33,820
3.................................................... 42,660
4.................................................... 51,500
5.................................................... 60,340
6.................................................... 69,180
7.................................................... 78,020
8.................................................... 86,860
------------------------------------------------------------------------
For families with more than 8 persons, add $8,840 for each additional
person.
Low-Income Levels Based on the 2019 Poverty Guidelines for Alaska
------------------------------------------------------------------------
Persons in family/household * Income Level **
------------------------------------------------------------------------
1.................................................... $31,200
2.................................................... 42,260
3.................................................... 53,320
4.................................................... 64,380
5.................................................... 75,440
6.................................................... 86,500
7.................................................... 97,560
8.................................................... 108,620
------------------------------------------------------------------------
For families with more than 8 persons, add $11,060 for each additional
person.
Low-Income Levels Based on the 2019 Poverty Guidelines for Hawaii
------------------------------------------------------------------------
Persons in family/household * Income Level **
------------------------------------------------------------------------
1.................................................... $28,760
2.................................................... 38,920
3.................................................... 49,080
4.................................................... 59,240
5.................................................... 69,400
6.................................................... 79,560
7.................................................... 89,720
8.................................................... 99,880
------------------------------------------------------------------------
For families with more than 8 persons, add $10,160 for each additional
person.
* Includes only dependents listed on federal income tax forms.
** Adjusted gross income for calendar year 2018.
Separate poverty guidelines figures for Alaska and Hawaii reflect
Office of Economic Opportunity administrative practice beginning in the
1966-1970 period since the U.S. Census Bureau poverty thresholds do not
have separate figures for Alaska and Hawaii. The poverty guidelines are
not defined for Puerto Rico or other outlying jurisdictions. Puerto
Rico and other outlying jurisdictions shall use income guidelines for
the 48 Contiguous States and the District of Columbia.
Dated: March 4, 2019.
George Sigounas,
Administrator.
[FR Doc. 2019-04407 Filed 3-8-19; 8:45 am]
BILLING CODE 4165-15-P
