National Center for Advancing Translational Sciences; Notice of Closed Meeting
| Published date | 05 August 2021 |
| Citation | 86 FR 42868 |
| Record Number | 2021-16668 |
| Section | Notices |
| Court | National Institutes Of Health |
42868
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
Dated: July 30, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–16705 Filed 8–4–21; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; 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 cooperative agreement
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the cooperative agreement applications,
the disclosure of which would
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EN05AU21.036</GPH>
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Page 8 - Genentech, Inc.
•
Be
accompanied
by
the
authorized labeling,
if
the
promotional materials are not
subject
to
Section 502(n)
of
the Act.
• Be.submitted
to
FDA
accompanied
by
Fortn FDA:2253
at
the time
of
initial
dissemination
or
fast
use.
lfthe
Agency notifies Genentech
that
any
descriptive printed matter, advertising
or
promotional materials do
not
meet
the terms
set
forth
in
conditions Q-S
of
this EUA;
Genentech
must
cease distribution
of
such
descriptive printed matter, advertising,-0r
promotional materials
in
accordance with
the
Agency's
notificati-On.
Furthermore, as part
of
ifs
notification, the Agency
may
also require Genentecht-0 issue rorrective
communication(s
).
R
No
descriptive printed matter, advertising,
or
promotional materials relating
to
the
use
of
Actemra
underthis authorization
may
represent
or
suggest
that
Actemra
is
safe
or
effective
when
used
for
:the treatment
of
COVID-19
in
hospitalized adults and pediatric patients (2
years
of
age
and
older)
who
are receiving systemic c-0rticosteroids
and
require
supplemental oxygen,non-invasiveorinvasivemechamcal ventilation,
or
ECMO.
S. Ail descriptive printed matter, advertising, and promotional material, relating
to
the
use
of
Actemra under this authorization clearly and ronspicuously shall state that:
• Actemra.has
not
been approved,
but
has
been
authorized
for
emergency use
by
FDA
under
an
EU
A,
to
treat COVID-19
in
hospitalized adults
and
pediatric
patients (2 years
of
age and older)
who
are receiving systemic corticosteroids
and require supplemental oxygen,non-invasive
or
invasive mechanical
ventilation,
or
ECMO; and
••
Theemergencyuse
of
Actemrais
only
anthorizedforthe
durationofthe
declaration that circumstances existjustifying the authorization
of
the
emergency use
of
drugs
and
biological products during the COVID-19
pandemic
under
Section 564(b X 1)
of
the Act, 2
lU.S.C.
§ 36dbbb-3(b
Xl
),
unless the declaration is terminated
or
authorization revoked sooner;
IV.
Duration ofAuthorb.ation
This
EU
A
will
be
effective until
the
declaration
that
circumstances exist
justifying
the
authorization
of
the
emergency
use
of
drugs
and
biological products
during
the
COVID-19
pandemic
is
terminated
under
Section
564(b
)(2)
of
the
Act
or
the
EUA
is
revoked
under
Section
564(g)
ofthe
Act.
Sincerely,
--JS!--
RADM
Denise
M.
Hinton
Chief
Scientist
Food_
ancl
Drug
Administration
42869
Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA Review.
Date: September 9, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1037, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Victor Henriquez, Ph.D.,
Scientific Review Officer, National Center for
Advancing Translational Sciences, National
Institutes of Health, 6701 Democracy
Boulevard, Room 1037, Bethesda, MD 20817,
301–435–0813, henriquv@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: July 30, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–16668 Filed 8–4–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Draft NTP Developmental and
Reproductive Toxicity Technical
Reports on 2-Hydroxy-4-
methoxybenzophenone and 2-
Ethylhexyl p-Methoxycinnamate;
Availability of Documents; Request for
Comments; Notice of Peer-Review
Meeting
AGENCY
: National Institutes of Health,
Health and Human Services (HHS).
ACTION
: Notice.
SUMMARY
: The Division of the National
Toxicology Program (DNTP) announces
the availability of the Draft NTP
Developmental and Reproductive
Toxicity Technical Reports on 2-
hydroxy-4-methoxybenzophenone and
2-ethylhexyl p-methoxycinnamate
scheduled for peer review. The peer-
review meeting will be held remotely
and will be available to the public for
veiwing. Oral and written comments
will be accepted; registration is required
to access the webcast and to present oral
comments.
DATES
: Meeting: October 14, 2021, 10
a.m. Eastern Daylight Time (EDT) to
adjournment. The meeting may end
earlier or later than 5:00 p.m. EDT.
Document Availability: The two draft
NTP reports will be available by August
16, 2021 at https://ntp.niehs.nih.gov/go/
36051.
Written Public Comment
Submissions: Deadline is September 30,
2021.
Registration for Oral Comments:
Deadline is October 7, 2021.
Registration to View the Webcast:
Deadline is October 14, 2021.
ADDRESSES
: Meeting web page: The draft
reports, preliminary agenda,
registration, and other meeting materials
will be available at https://
ntp.niehs.nih.gov/go/36051. Webcast:
The URL for viewing the peer-review
meeting will be provided to registrants.
FOR FURTHER INFORMATION CONTACT
:
Email NTP-Meetings@icf.com. Dr.
Sheena Scruggs, NIEHS/DNTP, is the
Designated Federal Official. Phone:
(984) 287–3355. Email: sheena.scruggs@
nih.gov.
SUPPLEMENTARY INFORMATION
:
Meeting Attendance Registration: The
meeting is available for viewing by the
public with time set aside for oral
public comment. Registration to view
the webcast is by October 14, 2021, at
https://ntp.niehs.nih.gov/go/36051. The
URL for the webcast will be provided in
the email confirming registration.
Individuals with disabilities who need
accommodation to view the webcast
should contact Canden Byrd by phone:
(919) 293–1660 or email: NTP-
Meetings@icf.com. TTY users should
contact the Federal TTY Relay Service
at (800) 877–8339. Requests should be
made at least five business days in
advance of the event.
Request for Comments: DNTP invites
written and oral public comments on
the draft reports that address scientific
or technical issues. Guidelines for
public comments are available at
https://ntp.niehs.nih.gov/ntp/about_
ntp/guidelines_public_comments_
508.pdf.
The deadline for submission of
written comments is September 30,
2021, to enable review by the peer-
review panel and DNTP staff prior to the
meeting. Written public comments
should be submitted through the
meeting website at https://
ntp.niehs.nih.gov/go/36051. Persons
submitting written comments should
include name, affiliation, mailing
address, phone, email, and sponsoring
organization (if any). Written comments
received in response to this notice will
be posted on the NTP website and the
submitter will be identified by name,
affiliation, and sponsoring organization
(if any). Comments that address
scientific/technical issues will be
forwarded to the peer-review panel and
DNTP staff prior to the meeting.
Oral public comment at this meeting
is welcome, with time set aside for the
presentation of oral comments on the
draft reports. The agenda will allow for
two oral public comment periods—one
comment period per report (up to 6
commenters, up to 5 minutes per
speaker). Persons wishing to make an
oral comment are required to register
online at https://ntp.niehs.nih.gov/go/
36051 by October 7, 2021. Registration
is on a first-come, first served basis.
Each organization is allowed one time
slot per report. The access number for
the teleconference line will be provided
to registrants by email prior to the
meeting. Commenters will be notified
approximately one week before the
peer-review meeting about the actual
time allotted per speaker.
If possible, oral public commenters
should send a copy of their slides and/
or statement or talking points to Canden
Byrd by email: NTP-Meetings@icf.com
by October 7, 2021. Written statements
can supplement and may expand the
oral presentation.
Meeting Materials: The draft NTP
reports and preliminary agenda will be
available on the NTP website at https://
ntp.niehs.nih.gov/go/36051 prior to the
meeting. NTP expects that the draft
reports should be available on the
website by August 16, 2021. Additional
information will be posted when
available or may be requested in
hardcopy from Canden Byrd by phone:
(919) 293–1660 or email: NTP-
Meetings@icf.com. Individuals are
encouraged to access the meeting web
page to stay abreast of the most current
information regarding the meeting.
Following the meeting, a report of the
peer review will be prepared and made
available on the NTP website.
Background Information on NTP Peer-
Review Panels: NTP panels are
technical, scientific advisory bodies
established on an ‘‘as needed’’ basis to
provide independent scientific peer
review and advise NTP on agents of
public health concern, new/revised
toxicological test methods, or other
issues. These panels help ensure
transparent, unbiased, and scientifically
rigorous input to the program for its use
in making credible decisions about
human hazard, setting research and
testing priorities, and providing
information to regulatory agencies about
alternative methods for toxicity
screening. DNTP welcomes nominations
of scientific experts for upcoming
panels. Scientists interested in serving
on an NTP panel should provide their
name and best form of contact to
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