81 FR 67362 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 190 (September 30, 2016)

Page Range		67362-67363
FR Document		2016-23693

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.

Federal Register, Volume 81 Issue 190 (Friday, September 30, 2016)

[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67362-67363]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23693]


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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.

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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 [email protected] 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

67362 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices

consistent with published research on FDA of its intent to use the voucher. Dated: September 26, 2016.
this subject which supports a priority Section 529(c)(4)(B) of the FD&C Act Leslie Kux,
review multiplier in the range of 1.48 to specifies that the application will be Associate Commissioner for Policy.
2.35 (Ref. 1). Using FY 2015 figures, the considered incomplete if the priority [FR Doc. 2016–23624 Filed 9–29–16; 8:45 am]
costs of a priority and standard review review user fee and all other applicable BILLING CODE 4164–01–P
are estimated using the following user fees are not paid in accordance
formula: with FDA payment procedures. In
(25 a × 1.67) + (31 a) = $289,352,000 addition, section 529(c)(4)(C) specifies DEPARTMENT OF HEALTH AND
Where ‘‘a’’ is the cost of a standard that FDA may not grant a waiver, HUMAN SERVICES
review and ‘‘a times 1.67’’ is the cost of exemption, reduction, or refund of any
a priority review. Using this formula, fees due and payable under this section Health Resources and Services
the cost of a standard review for NME of the FD&C Act. Beginning with FDA’s Administration
NDAs and BLAs is calculated to be appropriation for FY 2015, the annual
$3,977,000 (rounded to the nearest State Health Departments Coordinating
appropriation language states Center of the Jurisdictional Approach
thousand dollars) and the cost of a specifically that ‘‘priority review user
priority review for NME NDAs and To Curing Hepatitis C Among HIV/HCV
fees authorized by 21 U.S.C. 360n and Coinfected People of Color
BLAs is 1.67 times that amount, or 360ff (section 529 of the FD&C Act)
$6,642,000 (rounded to the nearest Demonstration Project Supported by
shall be credited to this account, to the Secretary’s Minority AIDS Initiative
thousand dollars). The difference
remain available until expended.’’ (Pub. Fund
between these two cost estimates, or
L. 113–235, Section 5, Division A, Title
$2,665,000, represents the incremental AGENCY: Health Resources and Services
VI).
cost of conducting a priority review Administration (HRSA), Department of
rather than a standard review. The rare pediatric disease priority Health and Human Services.
For the FY 2017 fee, FDA will need review fee established in the new fee ACTION: Notice of a deviation from
to adjust the FY 2015 incremental cost schedule must be paid for any competition requirements to make a
by the average amount by which FDA’s application that is received on or after single-source award related to the
average costs increased in the 3 years October 1, 2016. In order to comply Jurisdictional Approach to Curing
prior to FY 2016, to adjust the FY 2015 with this requirement, the sponsor must Hepatitis C (HCV) among HIV/HCV
amount for cost increases in FY 2016. notify FDA 90 days prior to submission Coinfected People of Color
That adjustment, published in the of the human drug application that is demonstration project.
Federal Register on July 28, 2016 (see the subject of a priority review voucher
81 FR 49674 at 49676), setting the FY of an intent to submit the human drug SUMMARY: HRSA’s HIV/AIDS Bureau
2017 PDUFA fee, is 1.5468 percent for application, including the date on (HAB) awarded a non-competitive
the most recent year, not compounded. which the sponsor intends to submit the single source cooperative agreement to
Increasing the FY 2015 incremental application. National Alliance of State and
priority review cost of $2,665,000 by Territorial AIDS Directors (NASTAD)
1.5468 percent results in an estimated Upon receipt of this notification, FDA
for approximately $977,400 in the
cost of $2,706,000 (rounded to the will issue an invoice to the sponsor who Secretary’s Minority AIDS Initiative
nearest thousand dollars). This is the has incurred a rare pediatric disease Funds (SMAIF) as authorized under the
rare pediatric disease priority review priority review voucher fee. The invoice Consolidated Appropriations Act, 2016
user fee amount for FY 2017 that must will include instructions on how to pay (Pub L. 114–113), Division H, Title II.
be submitted with a priority review the fee via wire transfer or check. Subject to the availability of funds and
voucher for a human drug application in As noted in section II, if a sponsor NASTAD’s satisfactory performance,
FY 2017, in addition to any PDUFA fee uses a rare pediatric disease priority HAB will also issue non-competitive,
that is required for such an application. review voucher for a human drug single-source awards of approximately
III. Fee Schedule for FY 2017 application, the sponsor would incur $750,000 each in fiscal years (FY) 2017
the rare pediatric disease priority review and 2018. This will allow NASTAD to
The fee rate for FY 2017 is set out in facilitate the participation of up to two
table 1: voucher fee in addition to any PDUFA
fee that is required for the application. Ryan White HIV/AIDS Program Part B
The sponsor would need to follow recipients in the Jurisdictional
TABLE 1—RARE PEDIATRIC DISEASE Approach to Curing Hepatitis C among
PRIORITY REVIEW SCHEDULE FOR FDA’s normal procedures for timely
payment of the PDUFA fee for the HIV/HCV Coinfected People of Color
FY 2017 demonstration project over its 3-year
human drug application.
project period.
Fee rate for V. Reference
Fee category FOR FURTHER INFORMATION CONTACT:
FY 2017
Harold J. Phillips, Director, Office of
The following reference is on display
Application submitted with a Training and Capacity Development,
in the Division of Dockets Management
rare pediatric disease pri- HAB/HRSA, 5600 Fishers Lane, Room
ority review voucher in ad- (HFA–305), Food and Drug
9N–114, Rockville, MD 20857, by email
dition to the normal Administration, 5630 Fishers Lane, Rm. at hphillips@hrsa.gov or by phone at
PDUFA fee ........................ $2,706,000 1061, Rockville, MD 20852, and is (301) 443–8109.
mstockstill on DSK3G9T082PROD with NOTICES

available for viewing by interested
SUPPLEMENTARY INFORMATION:
IV. Implementation of Rare Pediatric persons between 9 a.m. and 4 p.m., Recipient of the Award: National
Disease Priority Review User Fee Monday through Friday. Alliance of State and Territorial AIDS
Under section 529(c)(4)(A) of the 1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, Directors.
FD&C Act, the priority review user fee ‘‘Developing Drugs for Developing Period of Supplemental Funding:
is due (i.e. the obligation to pay the fee Countries,’’ Health Affairs, vol. 25, no. 2, September 30, 2016–September 29,
is incurred) when a sponsor notifies pp. 313–324, 2006. 2019.

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Document Created: 2018-02-09 13:33:52
Document Modified: 2018-02-09 13:33:52

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 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.
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 [email protected] or by phone at (301) 443-8109.
FR Citation		81 FR 67362

81 FR 67362 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 81, Issue 190 (September 30, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration