National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting, 11986-11987 [2019-06010]
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Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices
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 SYMDEKO
(tezacaftor/ivacaftor), manufactured by
Vertex Pharmaceutical, 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,
althea.cuff@fda.hhs.gov.
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
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 SYMDEKO
(tezacaftor/ivacaftor), manufactured by
Vertex Pharmaceutical, Inc., meets the
criteria for a priority review voucher.
SYMDEKO (tezacaftor/ivacaftor) is
indicated for the treatment of patients
with cystic fibrosis aged 12 years and
older who are homozygous for the
F508del mutation or who have at least
one mutation in the cystic fibrosis
transmembrane conductance regulator
gene that is responsive to tezacaftor/
ivacaftor based on in vitro data and/or
clinical evidence.
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/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about SYMDEKO
(tezacaftor/ivacaftor), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
jbell on DSK30RV082PROD with NOTICES
Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. The April
29, 2019 meeting of the Advisory
Council will focus on person-centered
planning for older adults including
information about implementation of
care plans for people living with
cognitive symptoms. There will also be
discussion about the use of
antipsychotic medication for people
with dementia and other conditions
living in community settings.
DATES: The meeting will be held on
April 29, 2019 from 9 a.m. to 4:30 p.m.
EST.
ADDRESSES: The meeting will be held in
Room 800 in the Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Washington, DC 20201.
Comments: Time is allocated on the
agenda to hear public comments. The
time for oral comments will be limited
to two (2) minutes per individual. In
lieu of oral comments, formal written
comments may be submitted for the
record to Helen Lamont, Ph.D., OASPE,
200 Independence Avenue SW, Room
424E, Washington, DC 20201.
Comments may also be sent to napa@
hhs.gov. Those submitting written
comments should identify themselves
and any relevant organizational
affiliations.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, 202–260–6075,
helen.lamont@hhs.gov. Note: Seating
may be limited. Those wishing to attend
the meeting must send an email to
napa@hhs.gov and put ‘‘April 29
Meeting Attendance’’ in the subject line
by Friday, April 19 so that their names
may be put on a list of expected
attendees and forwarded to the security
officers at the Department of Health and
Human Services. Any interested
member of the public who is a non-U.S.
citizen should include this information
at the time of registration to ensure that
the appropriate security procedure to
gain entry to the building is carried out.
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Although the meeting is open to the
public, procedures governing security
and the entrance to Federal buildings
may change without notice. If you wish
to make a public comment, you must
note that within your email.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: The April
29, 2019 meeting of the Advisory
Council will focus on person-centered
planning for older adults including
information about implementation of
care plans for people living with
cognitive symptoms. There will also be
discussion about the use of
antipsychotic medication for people
with dementia and other conditions
living in community settings.
Procedure and Agenda: This meeting
is open to the public. Please allow 30
minutes to go through security and walk
to the meeting room. The meeting will
also be webcast at www.hhs.gov/live.
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: March 22, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation, Office of Human Services Policy.
[FR Doc. 2019–06135 Filed 3–28–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meeting
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 Institute on
Deafness and Other Communication
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Federal Register / Vol. 84, No. 61 / Friday, March 29, 2019 / Notices
Disorders Special Emphasis Panel; NIDCD
Clinical Center Application Review.
Date: April 25, 2019.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center Building (NSC), 6001
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Shiguang Yang, DVM,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, NIDCD, NIH, 6001
Executive Blvd., Room 8349, Bethesda, MD
20892, 301–496–8683, yangshi@
nidcd.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research
Related to Deafness and Communicative
Disorders, National Institutes of Health, HHS)
Dated: March 25, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–06010 Filed 3–28–19; 8:45 am]
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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.
jbell on DSK30RV082PROD with NOTICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; National Cancer Institute
(NCI) Generic Clearance for
Application Information From Fellows,
Interns, and Trainees
ACTION:
Center for Scientific Review; Notice of
Closed Meeting
Name of Committee: Center for Scientific
Review Special Emphasis Panel; BRAIN
Initiative: Targeted BRAIN Circuits Projects.
Date: April 16, 2019.
Time: 2:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Kirk Thompson, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5184,
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[FR Doc. 2019–06008 Filed 3–28–19; 8:45 am]
National Institutes of Health,
HHS.
National Institutes of Health
17:48 Mar 28, 2019
Dated: March 25, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
MSC 7844, Bethesda, MD 20892, 301–435–
1242, kgt@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
SUMMARY:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Vivian Horovitch-Kelley,
Program Analyst, Office of Management
Policy and Compliance, National Cancer
Institute, 9609 Medical Center Drive,
Room 2W444, Bethesda, Maryland
20892 or call non-toll-free number (240)
276–6850 or Email your request,
including your address to:
vivian.horovitch-kelley@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
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11987
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: Generic
Clearance for Application Information
from Fellows, Interns, and Trainees,
0925–XXXX, Exp., Date XX/XXXX,
NEW, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The ‘‘Generic Clearance for
Application Information from Fellows,
Interns, and Trainees’’ request supports
research experiences for high school,
post-baccalaureate (including post
masters) individuals, graduate students,
and postdoctoral fellows, interns, and
trainees in a multidisciplinary
environment at the National Cancer
Institute (NCI). This information
collection request is for applications,
reference letters, letters of intent and
interest, and other related
documentation necessary for various
Divisions, Offices, and Centers at NCI to
evaluate the eligibility, merits, and
quality of potential candidates. The
applications will also assist in matching
potential candidates to various training
and internship programs. The
information is for internal use to make
decisions about candidates invited to
visit and attend NCI fellowships,
internships, and other training
opportunities.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden is 12,500
hours.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11986-11987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06010]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and Other Communication Disorders;
Notice of Closed Meeting
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 Institute on Deafness and Other
Communication
[[Page 11987]]
Disorders Special Emphasis Panel; NIDCD Clinical Center Application
Review.
Date: April 25, 2019.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center
Building (NSC), 6001 Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review
Officer, Division of Extramural Activities, NIDCD, NIH, 6001
Executive Blvd., Room 8349, Bethesda, MD 20892, 301-496-8683,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.173,
Biological Research Related to Deafness and Communicative Disorders,
National Institutes of Health, HHS)
Dated: March 25, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-06010 Filed 3-28-19; 8:45 am]
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