Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 60897-60899 [2024-16618]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
pulmonary-allergy-drugs-advisorycommittee/pulmonary-allergy-advisorycommittee-charter or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq.). For
general information related to FDA
advisory committees, please visit us at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16629 Filed 7–26–24; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:51 Jul 26, 2024
Jkt 262001
60897
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
You may submit comments as
follows:
Food and Drug Administration
Electronic Submissions
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
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’’).
[Docket No. FDA–2024–N–3294]
Pediatric Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency)
announces a forthcoming public
advisory committee meeting of the
Pediatric Advisory Committee (PAC).
The general function of the committee is
to provide advice and recommendations
to the FDA on pediatric regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held
virtually on September 18, 2024, from
10 a.m. to 4 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be joining this advisory committee
meeting via an online platform and
heard, viewed, captioned, and recorded
via an online and/or video conferencing
platform. Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–3294.
The docket will close on September 17,
2024. Submit either electronic or
written comments on this public
meeting by September 17, 2024. Please
note that late, untimely filed comments
will not be considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
September 17, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or the delivery service acceptance
receipt is before or on that date.
Comments received on or before
September 9, 2024, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is canceled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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 Docket No. FDA–
2024–N–3294 for ‘‘Pediatric Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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. EST, Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
E:\FR\FM\29JYN1.SGM
29JYN1
ddrumheller on DSK120RN23PROD with NOTICES1
60898
Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
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
copies to the Dockets Management Staff.
If you do not wish your name and
contact information be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify the information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Shivana Srivastava, Office of Pediatric
Therapeutics, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5152, Silver Spring,
MD 20993–0002, 301–796–8695,
shivana.srivastava@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:51 Jul 26, 2024
Jkt 262001
Agenda: On September 18, 2024, the
PAC will meet to discuss post-marketing
pediatric-focused safety reviews of the
following products:
1. Center for Biologics Evaluation and
Research
a. AGRIFLU (influenza virus vaccine)
b. CUTAQUIG (immune globulin
subcutaneous (human)-hipp,
16.5%)
c. XYNTHA (antihemophilic factor
(recombinant), plasma/albumin
Free)
2. Center for Drug Evaluation and
Research
a. AZSTARYS
(serdexmethylphenidate/
dexmethylphenidate)
b. CAFCIT (caffeine citrate)
c. CHANTIX (varenicline)
d. CIMDUO, TEMIXYS (lamivudine/
tenofovir disoproxil fumarate)
e. CLEOCIN HYDROCHLORIDE
(clindamycin hydrochloride),
CLEOCIN PHOSPHATE
(clindamycin phosphate), CLEOCIN
PHOSPHATE IN DEXTROSE 5% IN
PLASTIC CONTAINER
(clindamycin phosphate),
CLINDAMYCIN PHOSPHATE IN
0.9% SODIUM CHLORIDE
(clindamycin phosphate)
f. DYANAVEL XR (amphetamine)
g. EVEKEO ODT (amphetamine
sulfate)
h. GATTEX (teduglutide)
i. GILENYA (fingolimod) and
TASCENSO ODT (fingolimod)
j. JANUVIA (sitagliptin) and
JANUMET (sitagliptin/metformin
HCl), JANUMET XR (sitagliptin/
metformin hydrochloride extended
release)
k. KAPSPARGO SPRINKLE
(metoprolol succinate extended
release)
l. LITHIUM (lithium carbonate),
(lithium oral solution)
m. LOTEMAX (loteprednol etabonate)
n. LUMASON (sulfur hexafluoride
lipid-type A microspheres)
o. MAVYRET (glecaprevir/
pibrentasvir)
p. MIRCERA (methoxy polyethylene
glycol-epoetin beta)
q. MULTRYS (trace elements),
TRALEMENT (trace elements),
ZINC SULFATE, SELENIOUS ACID
r. MYDAYIS (mixed salts of a singleentity amphetamine)
s. NATROBA (spinosad)
t. PRADAXA (dabigatran etexilate)
u. QELBREE (viloxazine extendedrelease)
v. RIOMET ER (metformin
hydrochloride extended-release)
w. TEFLARO (ceftaroline fosamil)
x. TIROSINT–SOL (levothyroxine
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
sodium)
y. TYBOST (cobicistat)
z. ULTRAVATE (halobetasol
propionate), LEXETTE (halobetasol
propionate)
aa. VEKLURY (remdesivir)
bb. VYVANSE (lisdexamfetamine
dimesylate)
cc. XACIATO (clindamycin
phosphate)
dd. XEGLYZE (abametapir)
ee. XELSTRYM (dextroamphetamine)
ff. YERVOY (ipilimumab)
3. Center for Devices and Radiological
Health
a. CONTEGRA PULMONARY
VALVED CONDUIT (Humanitarian
Device Exemption (HDE))
b. ENTERRA THERAPY SYSTEM
(HDE)
c. FLOURISH PEDIATRIC
ESOPHAGEAL ATRESIA DEVICE
(HDE)
d. PLEXIMMUNE IN-VITRO
DIAGNOSTIC TEST (HDE)
e. PULSERIDER ANEURYSM NECK
RECONSTRUCTION DEVICE (HDE)
f. SONALLEVE MR–HIFU (HDE)
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website after the meeting. Background
material and the link to the online
meeting will be available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
meeting link. The meeting will include
slide presentations with audio and
video components to allow the
presentation of materials in a manner
that most closely resembles an in-person
advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions to the Docket (see
ADDRESSES) on or before September 9,
2024, will be provided to the committee.
Written submissions may be made to the
contact person on or before September
11, 2024. Oral presentations from the
public will be scheduled between
approximately 11 a.m. to 12 p.m.
Eastern Standard Time on September
18, 2024. Those individuals interested
in making formal oral presentations
should notify the contact person and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
E:\FR\FM\29JYN1.SGM
29JYN1
Federal Register / Vol. 89, No. 145 / Monday, July 29, 2024 / Notices
requested to make their presentation on
or before September 9, 2024. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 10, 2024.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Shivana
Srivastava (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
The conditions for issuance of a waiver
under 21 CFR 10.19 are met.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
National Agriculture and Food Defense
Strategy Survey
ddrumheller on DSK120RN23PROD with NOTICES1
[FR Doc. 2024–16618 Filed 7–26–24; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:51 Jul 26, 2024
Jkt 262001
Food and Drug Administration
[Docket No. FDA–2024–N–0846]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; National
Agriculture and Food Defense Strategy
Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by August 28,
2024.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0855. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
OMB Control Number 0910–0855—
Extension
We are seeking OMB approval of the
National Agriculture and Food Defense
Strategy (NAFDS) under section 108 of
the Food Safety Modernization Act
(FSMA). This is a voluntary survey of
State, local, territorial, and/or tribal
(SLTT) governments intended to gauge
government activities in food and
agriculture defense from intentional
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
60899
contamination and emerging threats.
The collected information will be
included in the mandatory NAFDS
followup Report to Congress. The
authority for us to collect the
information derives from the
Commissioner of Food and Drugs’
authority provided in section
1003(d)(2)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(C)).
Protecting the nation’s food and
agriculture supply against intentional
contamination and other emerging
threats is an important responsibility
shared by SLTT governments as well as
private sector partners. FSMA focuses
on ensuring the safety of the U.S. food
supply by shifting the efforts of Federal
regulators from response to prevention
and recognizes the importance of
strengthening existing collaboration
among all stakeholders to achieve
common public health and security
goals. FSMA identifies some key
priorities for working with partners in
areas such as reliance on Federal, State,
and local agencies for inspections;
improving foodborne illness
surveillance; and leveraging and
enhancing State and local food safety
and defense capacities. Section 108 of
FSMA–NAFDS requires HHS and the
U.S. Department of Agriculture (USDA),
in coordination with the Department of
Homeland Security (DHS), to work
together with SLTT to monitor and
measure progress in food defense.
In 2015, the initial NAFDS Report to
Congress detailed the specific Federal
response to food and agriculture defense
goals, objectives, key initiatives, and
activities that HHS, USDA, DHS, and
other stakeholders planned to
accomplish to meet the objectives
outlined in FSMA. The NAFDS charts a
direction for how Federal agencies, in
cooperation with SLTT governments
and private sector partners, protect the
nation’s food supply against intentional
contamination. Not later than 4 years
after the initial NAFDS Report to
Congress (2015), and every 4 years
thereafter (i.e., 2019, 2023, 2027, etc.),
HHS, USDA, and DHS are required to
revise and submit an updated report to
the relevant committees of Congress.
FDA is the agency primarily
responsible for obtaining the
information from Federal and SLTT
partners to complete the NAFDS Report
to Congress. An interagency working
group will conduct the survey and
collect and update the NAFDS as
directed by FSMA, including
developing metrics and measuring
progress for the evaluation process.
The survey of Federal and State
partners will be used to determine what
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60897-60899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16618]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3294]
Pediatric Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) announces
a forthcoming public advisory committee meeting of the Pediatric
Advisory Committee (PAC). The general function of the committee is to
provide advice and recommendations to the FDA on pediatric regulatory
issues. The meeting will be open to the public. FDA is establishing a
docket for public comment on this document.
DATES: The meeting will be held virtually on September 18, 2024, from
10 a.m. to 4 p.m. Eastern Time.
ADDRESSES: All meeting participants will be joining this advisory
committee meeting via an online platform and heard, viewed, captioned,
and recorded via an online and/or video conferencing platform. Answers
to commonly asked questions about FDA advisory committee meetings may
be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2024-N-3294. The docket will close on
September 17, 2024. Submit either electronic or written comments on
this public meeting by September 17, 2024. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 17, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or the delivery
service acceptance receipt is before or on that date.
Comments received on or before September 9, 2024, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is canceled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
You may submit comments as follows:
Electronic Submissions
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 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 Docket No.
FDA-2024-N-3294 for ``Pediatric Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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. EST, Monday
through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your
[[Page 60898]]
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 copies to the
Dockets Management Staff. If you do not wish your name and contact
information be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify the information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Shivana Srivastava, Office of
Pediatric Therapeutics, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5152, Silver Spring, MD 20993-0002, 301-
796-8695, [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On September 18, 2024, the PAC will meet to discuss post-
marketing pediatric-focused safety reviews of the following products:
1. Center for Biologics Evaluation and Research
a. AGRIFLU (influenza virus vaccine)
b. CUTAQUIG (immune globulin subcutaneous (human)-hipp, 16.5%)
c. XYNTHA (antihemophilic factor (recombinant), plasma/albumin
Free)
2. Center for Drug Evaluation and Research
a. AZSTARYS (serdexmethylphenidate/dexmethylphenidate)
b. CAFCIT (caffeine citrate)
c. CHANTIX (varenicline)
d. CIMDUO, TEMIXYS (lamivudine/tenofovir disoproxil fumarate)
e. CLEOCIN HYDROCHLORIDE (clindamycin hydrochloride), CLEOCIN
PHOSPHATE (clindamycin phosphate), CLEOCIN PHOSPHATE IN DEXTROSE 5% IN
PLASTIC CONTAINER (clindamycin phosphate), CLINDAMYCIN PHOSPHATE IN
0.9% SODIUM CHLORIDE (clindamycin phosphate)
f. DYANAVEL XR (amphetamine)
g. EVEKEO ODT (amphetamine sulfate)
h. GATTEX (teduglutide)
i. GILENYA (fingolimod) and TASCENSO ODT (fingolimod)
j. JANUVIA (sitagliptin) and JANUMET (sitagliptin/metformin HCl),
JANUMET XR (sitagliptin/metformin hydrochloride extended release)
k. KAPSPARGO SPRINKLE (metoprolol succinate extended release)
l. LITHIUM (lithium carbonate), (lithium oral solution)
m. LOTEMAX (loteprednol etabonate)
n. LUMASON (sulfur hexafluoride lipid-type A microspheres)
o. MAVYRET (glecaprevir/pibrentasvir)
p. MIRCERA (methoxy polyethylene glycol-epoetin beta)
q. MULTRYS (trace elements), TRALEMENT (trace elements), ZINC
SULFATE, SELENIOUS ACID
r. MYDAYIS (mixed salts of a single-entity amphetamine)
s. NATROBA (spinosad)
t. PRADAXA (dabigatran etexilate)
u. QELBREE (viloxazine extended-release)
v. RIOMET ER (metformin hydrochloride extended-release)
w. TEFLARO (ceftaroline fosamil)
x. TIROSINT-SOL (levothyroxine sodium)
y. TYBOST (cobicistat)
z. ULTRAVATE (halobetasol propionate), LEXETTE (halobetasol
propionate)
aa. VEKLURY (remdesivir)
bb. VYVANSE (lisdexamfetamine dimesylate)
cc. XACIATO (clindamycin phosphate)
dd. XEGLYZE (abametapir)
ee. XELSTRYM (dextroamphetamine)
ff. YERVOY (ipilimumab)
3. Center for Devices and Radiological Health
a. CONTEGRA PULMONARY VALVED CONDUIT (Humanitarian Device Exemption
(HDE))
b. ENTERRA THERAPY SYSTEM (HDE)
c. FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE (HDE)
d. PLEXIMMUNE IN-VITRO DIAGNOSTIC TEST (HDE)
e. PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (HDE)
f. SONALLEVE MR-HIFU (HDE)
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website
after the meeting. Background material and the link to the online
meeting will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee
meeting link. The meeting will include slide presentations with audio
and video components to allow the presentation of materials in a manner
that most closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before September 9, 2024, will be provided to the committee. Written
submissions may be made to the contact person on or before September
11, 2024. Oral presentations from the public will be scheduled between
approximately 11 a.m. to 12 p.m. Eastern Standard Time on September 18,
2024. Those individuals interested in making formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time
[[Page 60899]]
requested to make their presentation on or before September 9, 2024.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by September 10, 2024.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Shivana Srivastava (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. The conditions for issuance of a
waiver under 21 CFR 10.19 are met.
Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16618 Filed 7-26-24; 8:45 am]
BILLING CODE 4164-01-P
