State Health Departments Coordinating Center of the Jurisdictional Approach To Curing Hepatitis C Among HIV/HCV Coinfected People of Color Demonstration Project Supported by the Secretary's Minority AIDS Initiative Fund, 67362-67363 [2016-23693]
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Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices
consistent with published research on
this subject which supports a priority
review multiplier in the range of 1.48 to
2.35 (Ref. 1). Using FY 2015 figures, the
costs of a priority and standard review
are estimated using the following
formula:
(25 a × 1.67) + (31 a) = $289,352,000
Where ‘‘a’’ is the cost of a standard
review and ‘‘a times 1.67’’ is the cost of
a priority review. Using this formula,
the cost of a standard review for NME
NDAs and BLAs is calculated to be
$3,977,000 (rounded to the nearest
thousand dollars) and the cost of a
priority review for NME NDAs and
BLAs is 1.67 times that amount, or
$6,642,000 (rounded to the nearest
thousand dollars). The difference
between these two cost estimates, or
$2,665,000, represents the incremental
cost of conducting a priority review
rather than a standard review.
For the FY 2017 fee, FDA will need
to adjust the FY 2015 incremental cost
by the average amount by which FDA’s
average costs increased in the 3 years
prior to FY 2016, to adjust the FY 2015
amount for cost increases in FY 2016.
That adjustment, published in the
Federal Register on July 28, 2016 (see
81 FR 49674 at 49676), setting the FY
2017 PDUFA fee, is 1.5468 percent for
the most recent year, not compounded.
Increasing the FY 2015 incremental
priority review cost of $2,665,000 by
1.5468 percent results in an estimated
cost of $2,706,000 (rounded to the
nearest thousand dollars). This is the
rare pediatric disease priority review
user fee amount for FY 2017 that must
be submitted with a priority review
voucher for a human drug application in
FY 2017, in addition to any PDUFA fee
that is required for such an application.
III. Fee Schedule for FY 2017
The fee rate for FY 2017 is set out in
table 1:
TABLE 1—RARE PEDIATRIC DISEASE
PRIORITY REVIEW SCHEDULE FOR
FY 2017
mstockstill on DSK3G9T082PROD with NOTICES
Fee category
Application submitted with a
rare pediatric disease priority review voucher in addition to the normal
PDUFA fee ........................
Fee rate for
FY 2017
$2,706,000
IV. Implementation of Rare Pediatric
Disease Priority Review User Fee
Under section 529(c)(4)(A) of the
FD&C Act, the priority review user fee
is due (i.e. the obligation to pay the fee
is incurred) when a sponsor notifies
VerDate Sep<11>2014
20:49 Sep 29, 2016
Jkt 238001
FDA of its intent to use the voucher.
Section 529(c)(4)(B) of the FD&C Act
specifies that the application will be
considered incomplete if the priority
review user fee and all other applicable
user fees are not paid in accordance
with FDA payment procedures. In
addition, section 529(c)(4)(C) specifies
that FDA may not grant a waiver,
exemption, reduction, or refund of any
fees due and payable under this section
of the FD&C Act. Beginning with FDA’s
appropriation for FY 2015, the annual
appropriation language states
specifically that ‘‘priority review user
fees authorized by 21 U.S.C. 360n and
360ff (section 529 of the FD&C Act)
shall be credited to this account, to
remain available until expended.’’ (Pub.
L. 113–235, Section 5, Division A, Title
VI).
The rare pediatric disease priority
review fee established in the new fee
schedule must be paid for any
application that is received on or after
October 1, 2016. In order to comply
with this requirement, the sponsor must
notify FDA 90 days prior to submission
of the human drug application that is
the subject of a priority review voucher
of an intent to submit the human drug
application, including the date on
which the sponsor intends to submit the
application.
Upon receipt of this notification, FDA
will issue an invoice to the sponsor who
has incurred a rare pediatric disease
priority review voucher fee. The invoice
will include instructions on how to pay
the fee via wire transfer or check.
As noted in section II, if a sponsor
uses a rare pediatric disease priority
review voucher for a human drug
application, the sponsor would incur
the rare pediatric disease priority review
voucher fee in addition to any PDUFA
fee that is required for the application.
The sponsor would need to follow
FDA’s normal procedures for timely
payment of the PDUFA fee for the
human drug application.
V. Reference
The following reference is on display
in the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday.
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe,
‘‘Developing Drugs for Developing
Countries,’’ Health Affairs, vol. 25, no. 2,
pp. 313–324, 2006.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–23624 Filed 9–29–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
State Health Departments Coordinating
Center of the Jurisdictional Approach
To Curing Hepatitis C Among HIV/HCV
Coinfected People of Color
Demonstration Project Supported by
the Secretary’s Minority AIDS Initiative
Fund
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of a deviation from
competition requirements to make a
single-source award related to the
Jurisdictional Approach to Curing
Hepatitis C (HCV) among HIV/HCV
Coinfected People of Color
demonstration project.
AGENCY:
HRSA’s HIV/AIDS Bureau
(HAB) awarded a non-competitive
single source cooperative agreement to
National Alliance of State and
Territorial AIDS Directors (NASTAD)
for approximately $977,400 in the
Secretary’s Minority AIDS Initiative
Funds (SMAIF) as authorized under the
Consolidated Appropriations Act, 2016
(Pub L. 114–113), Division H, Title II.
Subject to the availability of funds and
NASTAD’s satisfactory performance,
HAB will also issue non-competitive,
single-source awards of approximately
$750,000 each in fiscal years (FY) 2017
and 2018. This will allow NASTAD to
facilitate the participation of up to two
Ryan White HIV/AIDS Program Part B
recipients in the Jurisdictional
Approach to Curing Hepatitis C among
HIV/HCV Coinfected People of Color
demonstration project over its 3-year
project period.
FOR FURTHER INFORMATION CONTACT:
Harold J. Phillips, Director, Office of
Training and Capacity Development,
HAB/HRSA, 5600 Fishers Lane, Room
9N–114, Rockville, MD 20857, by email
at hphillips@hrsa.gov or by phone at
(301) 443–8109.
SUPPLEMENTARY INFORMATION:
Recipient of the Award: National
Alliance of State and Territorial AIDS
Directors.
Period of Supplemental Funding:
September 30, 2016–September 29,
2019.
SUMMARY:
E:\FR\FM\30SEN1.SGM
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mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices
Funding Amount: Up to $977,400 in
FY 2016, and subject to availability of
appropriated funds, approximately
$750,000 in FYs 2017 and 2018.
Authority: Consolidated
Appropriations Act, 2016 (Pub L. 114–
113), Division H, Title II CFDA Number:
93.928.
Justification: The Jurisdictional
Approach to Curing Hepatitis C among
HIV/HCV Coinfected People of Color
demonstration project seeks to: (1)
Increase jurisdiction-level capacity to
provide comprehensive screening, care
and treatment for HCV among HIV/HCV
co-infected people particularly in
disproportionately affected racial and
ethnic minority communities; (2)
increase the numbers of HIV/HCV coinfected people who are diagnosed with
hepatitis C, treated, and cured; (3)
identify and provide technical
assistance for jurisdictions to reach
goals (1) and (2); and, (4) develop a plan
for evaluation of the program impact.
During the original application
period, as outlined in Funding
Opportunity Announcement HRSA–16–
189, no Ryan White Part B recipients
(States) applied. This non-competitive
single source cooperative agreement
award will provide important resources
in a part of the country that would not
otherwise have any coverage.
NASTAD is a national non-profit
alliance of state health department
program directors who are responsible
for administering HIV/AIDS and viral
hepatitis health care, prevention,
education, and supportive services
programs funded by state and federal
governments. These include programs
funded by the Centers for Disease
Control and Prevention and HRSA. In
working closely with its members,
NASTAD is dedicated to reducing the
incidence of HIV/AIDS and HCV
infections in the U.S. and its territories,
and supports the provision of
comprehensive, compassionate, and
high quality care and prevention
services to all persons living with HIV/
AIDS and HCV, by ensuring responsible
and sound public policies and practices.
NASTAD’s hepatitis team provides
guidance and technical assistance to
strengthen the capacity of state and
local health departments to develop,
maintain, and enhance comprehensive
hepatitis programs that address the
continuum from prevention through
cure. This infrastructure, experience,
and strategic partnership between state
hepatitis coordinators and AIDS
directors make NASTAD the
appropriate entity to receive a singlesource funding award in an effort to
VerDate Sep<11>2014
20:49 Sep 29, 2016
Jkt 238001
facilitate engagement between the states
and HRSA’s viral hepatitis efforts.
Dated: September 26, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016–23693 Filed 9–29–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: 0990–New—60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit a new Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate
below or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before November 29,
2016.
SUMMARY:
Submit your comments to
Information.Collection
Clearance@hhs.gov or by calling (202)
690–5683.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier 0990–New—60D
for reference.
Information Collection Request Title:
Assessment of the Impact of Energy
Development on the Behavioral Health
of Women in Western North Dakota and
Eastern Montana.
Abstract: Region VIII Office of the
Assistant Secretary for Health (OASH),
Office on Women’s Health (OWH) is
requesting approval from the Office of
Management and Budget (OMB). The
Office on Women’s Health (OWH) in the
Office of the Assistant Secretary for
Health, U.S. Department of Health and
Human Services (HHS) was established
in 1991. Its mission is to provide
national leadership and coordination to
improve the health of women and girls
through policy, education and model
programs. The vision of the Office on
Women’s Health is that all women and
ADDRESSES:
PO 00000
Frm 00075
Fmt 4703
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67363
girls achieve the best possible health.
OASH/OWH has ten regional offices
located throughout the country. As a
leader in women health, OWH supports
the development of culturally-based,
gender-sensitive programs to address
health disparities. Region VIII OASH/
OWH is interested in improving
women’s behavioral health associated
with the impact of energy development
through gender based data collection
and analysis. The discovery and
subsequent development of the Parshall
Oil Field within the Bakken region of
Western North Dakota has led to
significant economic opportunity and
population growth in the region (Eastern
Montana and Western North Dakota).
Rapid population growth has many
intended and unintended consequences,
both positive and negative, on the social
and economic environment of the region
and, consequently, the population’s
health and well-being. There are welldocumented environmental health
issues associated with oil and gas
development, including air, water, soil,
noise, and light pollution. However,
there are additional social, physical and
mental health effects that are less well
documented. Current research is very
limited, but preliminary evidence
suggests that women have unmet
behavioral health needs due in part to
the energy development and population
surge in region. In 2013, The U.S.
Department of Health and Human
Services (HHS), Region VIII Offices,
including the Office of the Assistant
Secretary for Health (OASH), Office on
Women’s Health (OWH) began to have
discussions directly with state/local
contacts about the impact this was
having on public health and the specific
impacts on women. Given this history
and context, the Region VIII OASH/
OWH, is undertaking an assessment to
examine the impact of energy
development on women’s behavioral
health in Western North Dakota and
Eastern Montana.
Likely Respondents: Data for this
assessment will be collected through
three mechanisms—a survey of women
living in the assessment geography,
approximately 20 focus groups with a
cross-section of women and other key
groups living in the assessment
geography, and approximately 40
interviews with key leaders and
stakeholders across a variety of
governmental and non-governmental
sectors. Combined, these data collection
mechanisms will provide a quantitative
and qualitative portrait of women’s
behavioral health in the region.
E:\FR\FM\30SEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67362-67363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23693]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
State Health Departments Coordinating Center of the
Jurisdictional Approach To Curing Hepatitis C Among HIV/HCV Coinfected
People of Color Demonstration Project Supported by the Secretary's
Minority AIDS Initiative Fund
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice of a deviation from competition requirements to make a
single-source award related to the Jurisdictional Approach to Curing
Hepatitis C (HCV) among HIV/HCV Coinfected People of Color
demonstration project.
-----------------------------------------------------------------------
SUMMARY: HRSA's HIV/AIDS Bureau (HAB) awarded a non-competitive single
source cooperative agreement to National Alliance of State and
Territorial AIDS Directors (NASTAD) for approximately $977,400 in the
Secretary's Minority AIDS Initiative Funds (SMAIF) as authorized under
the Consolidated Appropriations Act, 2016 (Pub L. 114-113), Division H,
Title II. Subject to the availability of funds and NASTAD's
satisfactory performance, HAB will also issue non-competitive, single-
source awards of approximately $750,000 each in fiscal years (FY) 2017
and 2018. This will allow NASTAD to facilitate the participation of up
to two Ryan White HIV/AIDS Program Part B recipients in the
Jurisdictional Approach to Curing Hepatitis C among HIV/HCV Coinfected
People of Color demonstration project over its 3-year project period.
FOR FURTHER INFORMATION CONTACT: Harold J. Phillips, Director, Office
of Training and Capacity Development, HAB/HRSA, 5600 Fishers Lane, Room
9N-114, Rockville, MD 20857, by email at hphillips@hrsa.gov or by phone
at (301) 443-8109.
SUPPLEMENTARY INFORMATION:
Recipient of the Award: National Alliance of State and Territorial
AIDS Directors.
Period of Supplemental Funding: September 30, 2016-September 29,
2019.
[[Page 67363]]
Funding Amount: Up to $977,400 in FY 2016, and subject to
availability of appropriated funds, approximately $750,000 in FYs 2017
and 2018.
Authority: Consolidated Appropriations Act, 2016 (Pub L. 114-113),
Division H, Title II CFDA Number: 93.928.
Justification: The Jurisdictional Approach to Curing Hepatitis C
among HIV/HCV Coinfected People of Color demonstration project seeks
to: (1) Increase jurisdiction-level capacity to provide comprehensive
screening, care and treatment for HCV among HIV/HCV co-infected people
particularly in disproportionately affected racial and ethnic minority
communities; (2) increase the numbers of HIV/HCV co-infected people who
are diagnosed with hepatitis C, treated, and cured; (3) identify and
provide technical assistance for jurisdictions to reach goals (1) and
(2); and, (4) develop a plan for evaluation of the program impact.
During the original application period, as outlined in Funding
Opportunity Announcement HRSA-16-189, no Ryan White Part B recipients
(States) applied. This non-competitive single source cooperative
agreement award will provide important resources in a part of the
country that would not otherwise have any coverage.
NASTAD is a national non-profit alliance of state health department
program directors who are responsible for administering HIV/AIDS and
viral hepatitis health care, prevention, education, and supportive
services programs funded by state and federal governments. These
include programs funded by the Centers for Disease Control and
Prevention and HRSA. In working closely with its members, NASTAD is
dedicated to reducing the incidence of HIV/AIDS and HCV infections in
the U.S. and its territories, and supports the provision of
comprehensive, compassionate, and high quality care and prevention
services to all persons living with HIV/AIDS and HCV, by ensuring
responsible and sound public policies and practices.
NASTAD's hepatitis team provides guidance and technical assistance
to strengthen the capacity of state and local health departments to
develop, maintain, and enhance comprehensive hepatitis programs that
address the continuum from prevention through cure. This
infrastructure, experience, and strategic partnership between state
hepatitis coordinators and AIDS directors make NASTAD the appropriate
entity to receive a single-source funding award in an effort to
facilitate engagement between the states and HRSA's viral hepatitis
efforts.
Dated: September 26, 2016.
James Macrae,
Acting Administrator.
[FR Doc. 2016-23693 Filed 9-29-16; 8:45 am]
BILLING CODE 4165-15-P
