Low Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act, 6039-6040 [2018-02707]
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Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
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with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product AKYNZEO
(netupitant/palonosetron
hydrochloride). AKYNZEO is indicated
for the prevention of acute and delayed
nausea and vomiting associated with
initial and repeat courses of cancer
chemotherapy including, but not
limited to, highly emetogenic
chemotherapy. Subsequent to this
approval, the USPTO received a patent
term restoration application for
AKYNZEO (U.S. Patent No. 6,297,375)
from Hoffmann-La Roche Inc., and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
October 30, 2015, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
AKYNZEO represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
AKYNZEO is 1,858 days. Of this time,
1,479 days occurred during the testing
phase of the regulatory review period,
while 379 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: September 10,
2009. FDA has verified the applicant’s
claim that September 10, 2009, is the
date the investigational new drug
application (IND) became effective.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: September 27,
2013. The applicant claims September
25, 2013, as the date the new drug
application (NDA) for AKYNZEO (NDA
205718) was initially submitted.
VerDate Sep<11>2014
19:23 Feb 09, 2018
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However, FDA records indicate that
NDA 205718 was submitted on
September 27, 2013.
3. The date the application was
approved: October 10, 2014. FDA has
verified the applicant’s claim that NDA
205718 was approved on October 10,
2014.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,118 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02756 Filed 2–9–18; 8:45 am]
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6039
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Low Income Levels Used for Various
Health Professions and Nursing
Programs Authorized in Titles III, VII,
and VIII of the Public Health Service
Act
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
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:
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 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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12FEN1.SGM
12FEN1
6040
Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
individuals related by birth, marriage, or
adoption who live together.
Most HRSA programs use the income
of a student’s parent(s) 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’s poverty
guidelines. HHS’s 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 have been updated to
reflect HHS’s 2018 poverty guidelines as
published in 83 FR 2642 (January 18,
2018).
LOW INCOME LEVELS BASED ON THE
2018 POVERTY GUIDELINES FOR THE
48 CONTIGUOUS STATES AND THE
DISTRICT OF COLUMBIA
Persons in family/household *
1
2
3
4
5
6
7
8
................................................
................................................
................................................
................................................
................................................
................................................
................................................
................................................
Income
level **
$24,280
32,920
41,560
50,200
58,840
67,480
76,120
84,760
For families with more than 8 persons, add
$8,640 for each additional person.
* Includes only dependents listed on federal
income tax forms.
** Adjusted gross income for calendar year
2017.
* Includes only dependents listed on federal
income tax forms.
** Adjusted gross income for calendar year
2017.
LOW INCOME LEVELS BASED ON THE
2018 POVERTY GUIDELINES
FOR HAWAII
Persons in family/household *
1
2
3
4
5
6
7
8
Income
level **
................................................
................................................
................................................
................................................
................................................
................................................
................................................
................................................
$27,920
37,860
47,800
57,740
67,680
77,620
87,560
$97,500
For families with more than 8 persons, add
$9,940 for each additional person.
* Includes only dependents listed on federal
income tax forms.
** Adjusted gross income for calendar year
2017.
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 must use the lowincome levels table for the 48
contiguous states and the District of
Columbia.
Dated: February 5, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018–02707 Filed 2–9–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
LOW INCOME LEVELS BASED ON THE
Pursuant to section 10(d) of the
2018 POVERTY GUIDELINES FOR Federal Advisory Committee Act, as
amended, notice is hereby given of the
ALASKA
daltland on DSKBBV9HB2PROD with NOTICES
Persons in family/household *
1
2
3
4
5
6
7
8
................................................
................................................
................................................
................................................
................................................
................................................
................................................
................................................
Income
level **
$30,360
41,160
51,960
62,760
73,560
84,360
95,160
105,960
For families with more than 8 persons, add
$10,800 for each additional person.
VerDate Sep<11>2014
19:23 Feb 09, 2018
Jkt 244001
following meetings of the NHLBI
Special Emphasis Panel.
The meetings 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
contract proposals 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,
PO 00000
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the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel
for Development of Transcatheter
Electrosurgical Devices.
Date: March 2, 2018.
Time: 1:30 p.m. to 3:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7196, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Stephanie J. Webb, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Suite
7196, Bethesda, MD 20892, 301–827–7992,
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel
for Non-Surgical Interventional
Cardiovascular Medical Devices.
Date: March 2, 2018.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Suite 7196, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Stephanie J. Webb, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7196, Bethesda, MD 20892, 301–827–7992,
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
NHLBI Single-Site CLTR Review.
Date: March 13, 2018.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn—Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7188, Bethesda, MD 20892–7924, 301–827–
7940, carolko@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: February 6, 2018.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–02717 Filed 2–9–18; 8:45 am]
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]]>Agencies
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6039-6040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02707]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Low Income Levels Used for Various Health Professions and Nursing
Programs Authorized in Titles III, VII, and VIII of 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 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
[[Page 6040]]
individuals related by birth, marriage, or adoption who live together.
Most HRSA programs use the income of a student's parent(s) 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's poverty
guidelines. HHS's 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 have been updated to
reflect HHS's 2018 poverty guidelines as published in 83 FR 2642
(January 18, 2018).
Low Income Levels Based on the 2018 Poverty Guidelines for the 48
Contiguous States and the District of Columbia
------------------------------------------------------------------------
Income
Persons in family/household * level **
------------------------------------------------------------------------
1.......................................................... $24,280
2.......................................................... 32,920
3.......................................................... 41,560
4.......................................................... 50,200
5.......................................................... 58,840
6.......................................................... 67,480
7.......................................................... 76,120
8.......................................................... 84,760
------------------------------------------------------------------------
For families with more than 8 persons, add $8,640 for each additional
person.
* Includes only dependents listed on federal income tax forms.
** Adjusted gross income for calendar year 2017.
Low Income Levels Based on the 2018 Poverty Guidelines for Alaska
------------------------------------------------------------------------
Income
Persons in family/household * level **
------------------------------------------------------------------------
1.......................................................... $30,360
2.......................................................... 41,160
3.......................................................... 51,960
4.......................................................... 62,760
5.......................................................... 73,560
6.......................................................... 84,360
7.......................................................... 95,160
8.......................................................... 105,960
------------------------------------------------------------------------
For families with more than 8 persons, add $10,800 for each additional
person.
* Includes only dependents listed on federal income tax forms.
** Adjusted gross income for calendar year 2017.
Low Income Levels Based on the 2018 Poverty Guidelines
for Hawaii
------------------------------------------------------------------------
Income
Persons in family/household * level **
------------------------------------------------------------------------
1.......................................................... $27,920
2.......................................................... 37,860
3.......................................................... 47,800
4.......................................................... 57,740
5.......................................................... 67,680
6.......................................................... 77,620
7.......................................................... 87,560
8.......................................................... $97,500
------------------------------------------------------------------------
For families with more than 8 persons, add $9,940 for each additional
person.
* Includes only dependents listed on federal income tax forms.
** Adjusted gross income for calendar year 2017.
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 must use the low-income levels
table for the 48 contiguous states and the District of Columbia.
Dated: February 5, 2018.
George Sigounas,
Administrator.
[FR Doc. 2018-02707 Filed 2-9-18; 8:45 am]
BILLING CODE 4165-15-P
