Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 29520-29521 [2019-13356]
Download as PDF
<![CDATA[
29520
Federal Register / Vol. 84, No. 121 / Monday, June 24, 2019 / Notices
Electronic or written comments
must be received by August 23, 2019.
ADDRESSES: You may submit comments,
identified by CDC–2019–0016 and
NIOSH–325, by any of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
Instructions: All information received
in response to this notice must include
the agency name and docket number
[CDC–2019–0016; NIOSH–325]. All
relevant comments received will be
posted without change to https://
www.regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov. All
information received in response to this
notice will also be available for public
examination and copying at the NIOSH
Docket Office, 1150 Tusculum Avenue,
Room 155, Cincinnati, OH 45226–1998.
FOR FURTHER INFORMATION CONTACT:
Jeffrey H. Welsh, NIOSH Office of Mine
Safety and Health Research, 315 E
Montgomery Ave., Spokane, WA 99207.
Phone: 412–386–4040 (not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Background: The mining industry has
been undergoing significant changes as
companies look to adopt automation
technologies to decrease costs and
increase efficiency and, according to
some companies, improve safety. These
new technologies include automated
mobile equipment, robotics,
teleoperation, wireless communications
and sensing systems, wearable sensors
and computers, virtual and augmented
reality, and data analytics. Surface iron
ore mines in Western Australia are
moving rapidly to adopt automation
technologies, and they appear to be the
closest in achieving completely
autonomous mining. In U.S. mines, the
adoption of automation technology is
gaining momentum, with some of the
first automation having been applied to
processing facilities, drilling equipment,
underground coal mine longwalls, and
now pilot projects with automated
haulage trucks and loaders.
Information Needs: To prepare for
expanded use of automation
technologies, NIOSH seeks to both
proactively address worker health and
safety challenges that may be associated
with automation, as well as leverage
new technologies to improve miner
health and safety. To understand the
jbell on DSK3GLQ082PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:50 Jun 21, 2019
Jkt 247001
state of automation technologies, their
implementation in the United States,
and the health and safety concerns
associated with the technology, NIOSH
seeks public input on the following
questions:
1. To what extent will automation and
associated technologies be implemented
in mining and in what timeframe?
2. What are the related health and
safety concerns with automation and
associated technologies in mining?
3. What gaps exist in occupational
health and safety research related to
automation and associated
technologies?
While the above questions have
priority, NIOSH also seeks public
comment on the state of the technology
and the health and safety concerns
associated with the following specific
topics related to automation:
4. What are the major safety concerns
associated with humans working near or
interacting with automated mining
equipment? Have other organizations
addressed the safety concerns associated
with humans working near or
interacting with automated mining
equipment? If yes, please provide a
description.
5. What research has been conducted,
or approaches taken, to address the
potential for human cognitive
processing confusion,
misunderstanding, and task or
information overload associated with
monitoring or controlling automated
mining equipment or other monitoring
systems (e.g., fleet management,
environmental monitoring, safety
systems, health care systems)?
6. What is the state of the art for
display methodologies and technologies
to provide mine personnel and
equipment operators with information
on operational status, location, and
sensory and environmental feedback
from automated mining equipment or
systems?
7. What sensor technology
improvements are needed to ensure the
safety of humans working on or near
automated equipment?
8. How are existing methods of big
data analytics applied to automated
mining equipment or systems? Are there
health and safety benefits to these
applications? If yes, please describe.
9. Are there any needed
improvements to guidelines or industry
standards for automated mining system
safe design and operation practices? If
yes, please describe.
10. Are there any needed
improvements to training materials,
training protocols, and operating
procedures for system safety design
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
principles related to automated mining
systems? If yes, please describe.
NIOSH is seeking feedback on the
research areas identified above and on
any additional knowledge gaps, ideas,
innovations, or practice improvements
not addressed by these research areas, as
well as feedback on how the research
areas should be prioritized. NIOSH is
especially interested in any creative and
new ideas as they relate to protecting
the health and safety of miners today
and in the future. When possible,
NIOSH asks that commenters provide
data and citations of relevant research to
justify their comments. NIOSH is also
seeking key scientific articles addressing
worker safety and health related to
mining automation that could inform
our research activities.
References
DoD [2000]. Standard practice for system
safety. U.S. Department of Defense, MIL–
STD–882D.
Endsley MR [1995]. Toward a theory of
situational awareness in dynamic
systems. Hum Factors 37(1):32–64.
USBM [1988]. Human factors in mining. By
Sanders MS, Peay JM. Pittsburgh, PA:
U.S. Department of the Interior, Bureau
of Mines, IC 9182.
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2019–13351 Filed 6–21–19; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4609]
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 ZOLGENSMA
(onasemnogene abeparvovec-xioi),
SUMMARY:
E:\FR\FM\24JNN1.SGM
24JNN1
Federal Register / Vol. 84, No. 121 / Monday, June 24, 2019 / Notices
manufactured by AveXis, Inc., meets the
criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Shruti Modi, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: 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
upon approval of those applications.
FDA has determined that ZOLGENSMA
(onasemnogene abeparvovec-xioi),
manufactured by AveXis, Inc., meets the
criteria for a priority review voucher.
ZOLGENSMA (onasemnogene
abeparvovec-xioi) is indicated for the
treatment of pediatric patients less than
2 years of age with spinal muscular
atrophy with biallelic mutations in the
survival motor neuron 1 gene.
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/RarePediatricDiseasePriorit
yVoucherProgram/default.htm. For
further information about ZOLGENSMA
(onasemnogene abeparvovec-xioi), go to
the Center for Biologics Evaluation and
Research Cellular and Gene Therapy
Products website at https://
www.fda.gov/vaccines-blood-biologics/
cellular-gene-therapy-products/
approved-cellular-and-gene-therapyproducts.
Dated: June 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13356 Filed 6–21–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSK3GLQ082PROD with NOTICES
[Docket No. FDA–2019–N–2779]
Antimicrobial Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:50 Jun 21, 2019
Jkt 247001
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Antimicrobial Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
meeting.
SUMMARY:
The meeting will be held on
August 7, 2019, from 8:30 a.m. to 4:30
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–2779.
The docket will close on August 6,
2019. Submit either electronic or
written comments on this public
meeting by August 6, 2019. Please note
that late, untimely filed comments will
not be considered. Electronic comments
must be submitted on or before August
6, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
August 6, 2019. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
Comments received on or before July
24, 2019, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA.
You may submit comments as
follows:
DATES:
Electronic Submissions
Food and Drug Administration
AGENCY:
Notice; establishment of a
public docket; request for comments.
ACTION:
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
29521
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the FDA–2019–N–2779 for
‘‘Antimicrobial Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see the ADDRESSES section),
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Notices]
[Pages 29520-29521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13356]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4609]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 ZOLGENSMA (onasemnogene abeparvovec-xioi),
[[Page 29521]]
manufactured by AveXis, Inc., meets the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION: 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 upon approval of those
applications. FDA has determined that ZOLGENSMA (onasemnogene
abeparvovec-xioi), manufactured by AveXis, Inc., meets the criteria for
a priority review voucher. ZOLGENSMA (onasemnogene abeparvovec-xioi) is
indicated for the treatment of pediatric patients less than 2 years of
age with spinal muscular atrophy with biallelic mutations in the
survival motor neuron 1 gene.
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/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further
information about ZOLGENSMA (onasemnogene abeparvovec-xioi), go to the
Center for Biologics Evaluation and Research Cellular and Gene Therapy
Products website at https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.
Dated: June 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13356 Filed 6-21-19; 8:45 am]
BILLING CODE 4164-01-P
