83 FR 6039 - Low Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 29 (February 12, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 29 (February 12, 2018)
| Page Range | 6039-6040 | |
| FR Document | 2018-02707 |
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)] [Notices] [Pages 6039-6040] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices 6039
with the initial submission of an However, FDA records indicate that DEPARTMENT OF HEALTH AND
application to market the human drug NDA 205718 was submitted on HUMAN SERVICES
product and continues until FDA grants September 27, 2013.
permission to market the drug product. Health Resources and Services
3. The date the application was
Although only a portion of a regulatory Administration
approved: October 10, 2014. FDA has
review period may count toward the
verified the applicant’s claim that NDA Low Income Levels Used for Various
actual amount of extension that the
Director of USPTO may award (for 205718 was approved on October 10, Health Professions and Nursing
example, half the testing phase must be 2014. Programs Authorized in Titles III, VII,
subtracted as well as any time that may This determination of the regulatory and VIII of the Public Health Service
have occurred before the patent was review period establishes the maximum Act
issued), FDA’s determination of the potential length of a patent extension.
length of a regulatory review period for AGENCY: Health Resources and Services
However, the USPTO applies several
a human drug product will include all Administration (HRSA), Department of
statutory limitations in its calculations Health and Human Services (HHS).
of the testing phase and approval phase of the actual period for patent extension.
as specified in 35 U.S.C. 156(g)(1)(B). In its application for patent extension, ACTION: Notice.
FDA has approved for marketing the this applicant seeks 1,118 days of patent
human drug product AKYNZEO SUMMARY: HRSA is updating income
term extension.
(netupitant/palonosetron levels used to identify a ‘‘low income
hydrochloride). AKYNZEO is indicated III. Petitions family’’ for the purpose of determining
for the prevention of acute and delayed eligibility for programs that provide
nausea and vomiting associated with Anyone with knowledge that any of health professions and nursing training
initial and repeat courses of cancer the dates as published are incorrect may to individuals from disadvantaged
chemotherapy including, but not submit either electronic or written backgrounds. These various programs
limited to, highly emetogenic comments and, under 21 CFR 60.24, ask are authorized in Titles III, VII, and VIII
chemotherapy. Subsequent to this for a redetermination (see DATES). of the Public Health Service Act.
approval, the USPTO received a patent Furthermore, as specified in § 60.30 (21 SUPPLEMENTARY INFORMATION: HHS
term restoration application for CFR 60.30), any interested person may periodically publishes in the Federal
AKYNZEO (U.S. Patent No. 6,297,375) petition FDA for a determination Register low-income levels to be used
from Hoffmann-La Roche Inc., and the regarding whether the applicant for by institutions receiving grants and
USPTO requested FDA’s assistance in extension acted with due diligence cooperative agreements to determine
determining this patent’s eligibility for during the regulatory review period. To eligibility for programs providing
patent term restoration. In a letter dated meet its burden, the petition must training for (1) disadvantaged
October 30, 2015, FDA advised the comply with all the requirements of individuals, (2) individuals from
USPTO that this human drug product § 60.30, including but not limited to: disadvantaged backgrounds, or (3)
had undergone a regulatory review
Must be timely (see DATES), must be individuals from low-income families.
period and that the approval of
filed in accordance with § 10.20, must Many health professions and nursing
AKYNZEO represented the first
contain sufficient facts to merit an FDA grant and cooperative agreement
permitted commercial marketing or use
investigation, and must certify that a awardees use the low-income levels to
of the product. Thereafter, the USPTO
true and complete copy of the petition determine whether potential program
requested that FDA determine the
has been served upon the patent participants are from an economically
product’s regulatory review period.
applicant. (See H. Rept. 857, part 1, 98th disadvantaged background and would
II. Determination of Regulatory Review Cong., 2d sess., pp. 41–42, 1984.) be eligible to participate in the program,
Period Petitions should be in the format as well as to determine the amount of
FDA has determined that the specified in 21 CFR 10.30. funding the individual receives. Awards
applicable regulatory review period for are generally made to accredited schools
Submit petitions electronically to of medicine, osteopathic medicine,
AKYNZEO is 1,858 days. Of this time, https://www.regulations.gov at Docket
1,479 days occurred during the testing public health, dentistry, veterinary
No. FDA–2013–S–0610. Submit written medicine, optometry, pharmacy, allied
phase of the regulatory review period,
petitions (two copies are required) to the health, podiatric medicine, nursing, and
while 379 days occurred during the
Dockets Management Staff (HFA–305), chiropractic; public or private nonprofit
approval phase. These periods of time
were derived from the following dates: Food and Drug Administration, 5630 schools which offer graduate programs
1. The date an exemption under Fishers Lane, Rm. 1061, Rockville, MD in behavioral health and mental health
section 505(i) of the Federal Food, Drug, 20852. practice; and other public or private
and Cosmetic Act (FD&C Act) (21 U.S.C. Dated: February 7, 2018. nonprofit health or education entities to
355(i)) became effective: September 10, assist the disadvantaged to enter and
Leslie Kux,
2009. FDA has verified the applicant’s graduate from health professions and
Associate Commissioner for Policy. nursing schools. Some programs
claim that September 10, 2009, is the
[FR Doc. 2018–02756 Filed 2–9–18; 8:45 am] provide for the repayment of health
date the investigational new drug
application (IND) became effective. BILLING CODE 4164–01–P professions or nursing education loans
2. The date the application was for disadvantaged students.
daltland on DSKBBV9HB2PROD with NOTICES
initially submitted with respect to the A ‘‘low-income family/household’’ for
human drug product under section programs included in Titles III, VII, and
505(b) of the FD&C Act: September 27, VIII of the Public Health Service Act is
2013. The applicant claims September defined as having an annual income that
25, 2013, as the date the new drug does not exceed 200 percent of the
application (NDA) for AKYNZEO (NDA Department’s poverty guidelines. A
205718) was initially submitted. family is a group of two or more
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![6040 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
individuals related by birth, marriage, or * Includes only dependents listed on federal the disclosure of which would
adoption who live together. income tax forms. constitute a clearly unwarranted
** Adjusted gross income for calendar year
Most HRSA programs use the income 2017. invasion of personal privacy.
of a student’s parent(s) to compute low
Name of Committee: National Heart, Lung,
income status. However, a ‘‘household’’ LOW INCOME LEVELS BASED ON THE and Blood Institute Special Emphasis Panel
may potentially be only one person. 2018 POVERTY GUIDELINES for Development of Transcatheter
Other HRSA programs, depending upon
FOR HAWAII Electrosurgical Devices.
the legislative intent of the program, the
Date: March 2, 2018.
programmatic purpose related to income Time: 1:30 p.m. to 3:00 p.m.
Income
level, as well as the age and Persons in family/household * level ** Agenda: To review and evaluate contract
circumstances of the participant, will proposals.
apply these low income standards to the 1 ................................................ $27,920 Place: National Institutes of Health, 6701
individual student to determine 2 ................................................ 37,860
3 ................................................ 47,800 Rockledge Drive, Room 7196, Bethesda, MD
eligibility, as long as he or she is not 20892 (Telephone Conference Call).
listed as a dependent on the tax form of 4 ................................................ 57,740
5 ................................................ 67,680 Contact Person: Stephanie J. Webb, Ph.D.,
his or her parent(s). Each program 6 ................................................ 77,620 Scientific Review Officer, Office of Scientific
announces the rationale and choice of 7 ................................................ 87,560 Review/DERA, National Heart, Lung, and
methodology for determining low 8 ................................................ $97,500 Blood Institute, 6701 Rockledge Drive, Suite
income levels in program guidance. 7196, Bethesda, MD 20892, 301–827–7992,
Low-income levels are adjusted For families with more than 8 persons, add
$9,940 for each additional person. stephanie.webb@nih.gov.
annually based on HHS’s poverty * Includes only dependents listed on federal Name of Committee: National Heart, Lung,
guidelines. HHS’s poverty guidelines income tax forms.
** Adjusted gross income for calendar year and Blood Institute Special Emphasis Panel
are based on poverty thresholds for Non-Surgical Interventional
published by the U.S. Census Bureau, 2017.
Cardiovascular Medical Devices.
adjusted annually for changes in the Separate poverty guidelines figures Date: March 2, 2018.
Consumer Price Index. The income for Alaska and Hawaii reflect Office of Time: 12:00 p.m. to 1:30 p.m.
figures below have been updated to Economic Opportunity administrative Agenda: To review and evaluate contract
reflect HHS’s 2018 poverty guidelines as practice beginning in the 1966–1970 proposals.
published in 83 FR 2642 (January 18, period since the U.S. Census Bureau Place: National Institutes of Health, 6701
2018). poverty thresholds do not have separate Rockledge Drive, Suite 7196, Bethesda, MD
figures for Alaska and Hawaii. The 20892 (Telephone Conference Call).
LOW INCOME LEVELS BASED ON THE poverty guidelines are not defined for Contact Person: Stephanie J. Webb, Ph.D.,
2018 POVERTY GUIDELINES FOR THE Puerto Rico or other outlying Scientific Review Officer, Office of Scientific
48 CONTIGUOUS STATES AND THE jurisdictions. Puerto Rico and other Review/DERA, National Heart, Lung, and
DISTRICT OF COLUMBIA outlying jurisdictions must use the low- Blood Institute, 6701 Rockledge Drive, Room
income levels table for the 48 7196, Bethesda, MD 20892, 301–827–7992,
Income contiguous states and the District of stephanie.webb@nih.gov.
Persons in family/household * Columbia.
level **
Name of Committee: National Heart, Lung,
Dated: February 5, 2018. and Blood Institute Special Emphasis Panel;
1 ................................................ $24,280
2 ................................................ 32,920 George Sigounas, NHLBI Single-Site CLTR Review.
3 ................................................ 41,560 Administrator. Date: March 13, 2018.
4 ................................................ 50,200 [FR Doc. 2018–02707 Filed 2–9–18; 8:45 am] Time: 8:00 a.m. to 3:00 p.m.
5 ................................................ 58,840 BILLING CODE 4165–15–P Agenda: To review and evaluate grant
6 ................................................ 67,480 applications.
7 ................................................ 76,120 Place: Residence Inn—Bethesda, 7335
8 ................................................ 84,760 Wisconsin Avenue, Bethesda, MD 20814.
DEPARTMENT OF HEALTH AND
For families with more than 8 persons, add HUMAN SERVICES Contact Person: Chang Sook Kim, Ph.D.,
$8,640 for each additional person. Scientific Review Officer, Office of Scientific
* Includes only dependents listed on federal National Institutes of Health Review/DERA, National Heart, Lung, and
income tax forms.
** Adjusted gross income for calendar year Blood Institute, 6701 Rockledge Drive, Room
2017. National Heart, Lung, and Blood 7188, Bethesda, MD 20892–7924, 301–827–
Institute; Notice of Closed Meetings 7940, carolko@mail.nih.gov.
LOW INCOME LEVELS BASED ON THE Pursuant to section 10(d) of the (Catalogue of Federal Domestic Assistance
2018 POVERTY GUIDELINES FOR Federal Advisory Committee Act, as Program Nos. 93.233, National Center for
ALASKA amended, notice is hereby given of the Sleep Disorders Research; 93.837, Heart and
following meetings of the NHLBI Vascular Diseases Research; 93.838, Lung
Income Special Emphasis Panel. Diseases Research; 93.839, Blood Diseases
Persons in family/household * level ** The meetings will be closed to the and Resources Research, National Institutes
public in accordance with the of Health, HHS)
1 ................................................ $30,360
2 ................................................ 41,160 provisions set forth in sections Dated: February 6, 2018.
3 ................................................ 51,960 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Michelle Trout,
daltland on DSKBBV9HB2PROD with NOTICES
4 ................................................ 62,760 as amended. The grant applications and
Program Analyst, Office of Federal Advisory
5 ................................................ 73,560 contract proposals and the discussions
Committee Policy.
6 ................................................ 84,360 could disclose confidential trade secrets
7 ................................................ 95,160 [FR Doc. 2018–02717 Filed 2–9–18; 8:45 am]
or commercial property such as
8 ................................................ 105,960 patentable material, and personal BILLING CODE 4140–01–P
For families with more than 8 persons, add information concerning individuals
$10,800 for each additional person. associated with the grant applications,
VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 9990 E:\FR\FM\12FEN1.SGM 12FEN1](https://thefederalregister.org/doc/83_FR_6068/page/2.svg)
Document Created: 2018-11-01 08:43:09
Document Modified: 2018-11-01 08:43:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| FR Citation | 83 FR 6039 |
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