APPENDIX D SCDTDRCP 60Day FRN Published.1.23.20

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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total
responses
(2016–2018)

Average
burden per
response

Total hours
(2016–2018)

Average
annual burden
hours

60.24; revision of regulatory review period determinations ...............................
60.30; due diligence petitions ..................
60.40; due diligence hearings ..................

12
1
1

1.333
1
1

16
3
1

100
50
10

1,600
150
10

533.33
50
3.3

Total ..................................................

........................

........................

........................

........................

........................

586.63

1 There

are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimated burden for the
information collection reflects a small
increase (+7 responses) associated with
submissions received under § 60.24 in
previous years.
Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01084 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]

Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that VYONDYS 53
(golodirsen), manufactured by Sarepta
Therapeutics, Inc., meets the criteria for
a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
SUMMARY:

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Number of
responses per
respondent

Number of
respondents

21 CFR part 60—Patent term restoration

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application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that VYONDYS 53
(golodirsen), manufactured by Sarepta
Therapeutics, Inc., meets the criteria for
a priority review voucher. VYONDYS 53
(golodirsen) is indicated for the
treatment of Duchenne muscular
dystrophy (DMD) in patients who have
a confirmed mutation of the DMD gene
that is amenable to exon 53 skipping.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about VYONDYS (golodirsen), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: January 16, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01059 Filed 1–22–20; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Sickle Cell
Disease Treatment Demonstration
Regional Collaborative Program, OMB
No. 0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.

AGENCY:

ACTION:

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Notice.

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In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 23, 2020.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Sickle Cell Disease Treatment
Demonstration Regional Collaborative
Program.
OMB No.: 0906–xxxx–New.
Abstract: The Sickle Cell Disease
Treatment Demonstration Regional
Collaborative Program (SCDTDRCP) was
reauthorized and amended in 2018 by
the Sickle Cell Disease and Other
Heritable Blood Disorders Research,
Surveillance, Prevention, and Treatment
Act (Pub. L. 115–327), 42 U.S.C. 300b–
5. The purpose of the proposed data
collection is to monitor the progress of
the SCDTDRCP in improving health
outcomes in individuals living with
sickle cell disease.
The goals of the program are to
improve health outcomes in individuals
with sickle cell disease; reduce
morbidity and mortality caused by
SUMMARY:

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Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices

sickle cell disease; reduce the number of
individuals with sickle cell receiving
care only in emergency departments;
and improve the quality of coordinated
and comprehensive services to
individuals with sickle cell and their
families. The program funds five
grantees to establish regional networks
to provide leadership and support for
regional and statewide activities in
sickle cell disease. The grantees develop
and establish systemic mechanisms to
improve the treatment of sickle cell
disease, by: (1) Increasing the number of
providers treating individuals with
sickle cell disease using the National
Heart, Lung and Blood Institute (NHLBI)
Evidence-Based Management of Sickle
Cell Disease Expert Panel Report; (2)
using tele-mentoring, telemedicine and
other provider support strategies to
increase the number of providers
administering evidence-based sickle cell
care; and (3) developing and
implementing strategies to improve
access to quality care with emphasis on
individual and family engagement/
partnership, adolescent transitions to
adult life, and care in a medical home.
The SCDTDRCP is designed to improve
access to services for individuals with
sickle cell disease, improve and expand
patient and provider education, and
improve and expand the continuity and
coordination of service delivery for
individuals with sickle cell disease and
sickle cell trait. Per the statutory
requirement, the data collected will be
used to evaluate the program and will
be published in a report to Congress.
Need and Proposed Use of the
Information: The purpose of the
proposed data collection is to monitor
the progress of the SCDTDRCP in
improving care and health outcomes for
individuals living with sickle cell
disease/trait and monitor grantee
progress in meeting the goals of the
program. Each regional grantee will
conduct one quality improvement
initiative for hydroxyurea utilization

among individuals with sickle cell
disease. Grantees must conduct an
additional quality improvement
initiative on one of these topics: (1)
Pneumococcal vaccinations, (2)
Transcranial Doppler Ultrasound (TCD)
screening, or (3) transition planning.
Grantees are encouraged to conduct
additional clinical outcome quality
improvement (QI) initiatives according
to their ability. The regional grantees
will also survey providers annually to
assess provider comfort with treating
individuals with sickle cell disease,
awareness of the guidelines and
involvement in Project ECHO
(Extension of Community Health
Outcomes) and other program activities.
Pursuant to 42 U.S.C. 300b–5(b)(3)(B),
the Sickle Cell Disease Treatment
Demonstration Regional Collaborative
Program’s National Coordinating Center
(NCC) will work with the grantees to
gather data and prepare a Report to
Congress at the conclusion of the
program. Additional information
regarding the data collection activities is
below:
Provider Survey
Regional grantees will administer the
Provider Survey annually to providers
within their region. The Provider
Survey is a 13 item questionnaire that
collects information on the provider
type, their utilization of telementoring,
and aggregate de-identified patient-level
data. The number of states participating
within a region may range from 5 to 17
states. Data from the Provider Survey
will be aggregated by the regional
grantee and submitted to the NCC.
Quality Improvement
As part of the requirement for funding
under the grant, each regional grantee is
required to conduct at least two quality
improvement initiatives within their
region. All grantees are required to
conduct a quality improvement
initiative on increasing the use of
hydroxyurea. Grantees must conduct an

additional quality improvement
initiative on one of these topics: (1)
Pneumococcal vaccinations, (2) TCD
screening, or (3) transition planning.
Each regional grantee will collect QI
data from participating providers and
medical centers within their region and
aggregate the data for submission to the
NCC. Specific quality improvement data
will be extracted from patients’ charts
quarterly, either manually or via
electronic health records (EHR). This
will require an initial set-up time in
year 1 to develop data collection and
reporting protocols for manual or
electronic collection for the quality
improvement project(s) that each
regional grantee decides to measure.
This initial set-up time has been
included in the burden estimates listed
in the chart.
Likely Respondents: Providers who
treat individuals with sickle cell disease
will complete the Provider Survey. The
five regional grantees will aggregate
these data and submit to the NCC. The
grantees will also aggregate data from
medical record extraction for the quality
improvement initiatives.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purposes
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the tables below:
Provider Survey and QI Measures

TOTAL ANNUAL BURDEN ESTIMATE HOURS
Number of
respondents

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Form name

Number of
responses per
respondent
per year

Total
responses
per year

Average
burden per
response
(hrs/yr)

Total
burden hours
per year

SCDTDP Provider Survey, participant responses ...............
SCDTDP ..............................................................................
QI Measures * ......................................................................

70

1

70

1

70

50

4

200

22

4,400

Total ..............................................................................

120

........................

270

........................

4,470

* Note: Total burden hours per year shown represents the maximum number of estimated hours. Actual hours may be lower since many teams
will not be assessing all four QI initiatives.

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Federal Register / Vol. 85, No. 15 / Thursday, January 23, 2020 / Notices
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–01075 Filed 1–22–20; 8:45 am]
BILLING CODE P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; Notice of Closed
Meeting

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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Complementary and Integrative Health
Special Emphasis Panel; Exploratory Clinical
Trials of Mind and Body Interventions (MB).
Date: March 10–11, 2020.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Pamela Jeter, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, Division of Extramural Activities,
NCCIH, NIH, 6707 Democracy Boulevard,
Suite 401, Bethesda, MD 20892–547, 301–
435–2591, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)

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Dated: January 16, 2020.
Ronald J. Livingston, Jr., Program Analyst,
Office of Federal Advisory Committee Policy.
[FR Doc. 2020–01014 Filed 1–22–20; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the Council of Councils,
January 24, 2020, 8:15 a.m. to 4:00 p.m.,
National Institutes of Health, John E.
Porter Neuroscience Research Center,
Building 35A, Rooms 620/630, 35
Convent Drive, Bethesda, MD 20892
which was published in the Federal
Register December 16, 2019, 84 FR
68467.
This meeting notice is amended to
change the open and closed session
meeting times. The morning open
session will now be held from 8:15 a.m.
to 11:55 a.m.; the closed session will be
held from 12:25 p.m.–1:15 p.m.; and the
afternoon open session will be held
from 1:15 p.m. to 4:00 p.m.
Dated: January 16, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–01028 Filed 1–22–20; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Environmental Health Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting 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
the discussions could disclose

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3937

confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Environmental Health Sciences Council.
Date: February 11–12, 2020.
Closed: February 11, 2020, 8:30 a.m. to
9:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: Durham Convention Center, Durham
Marriott City Center, 301 W Morgan Street,
Durham, NC 27701.
Open: February 11, 2020, 9:15 a.m. to 5:00
p.m.
Agenda: Discussion of program policies
and issues.
Place: Durham Convention Center, Durham
Marriott City Center, 301 W Morgan Street,
Durham, NC 27701.
Open: February 12, 2020, 8:30 a.m. to 11:00
a.m.
Agenda: Discussion of program policies
and issues.
Place: Durham Convention Center, Durham
Marriott City Center, 301 W Morgan Street,
Durham, NC 27701.
Contact Person: Patrick Mastin, Ph.D.,
Chief, Cellular, Organs, and Systems
Pathobiology Branch, Division of Extramural
Research and Training, National Institute of
Environmental Health Sciences, Research
Triangle Park, NC 27709, 984–287–3285,
[email protected].
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s home page:
www.niehs.nih.gov/dert/c-agenda.htm, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to

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