Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 14125-14127 [2021-05202]
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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
are no substantial changes to the forms,
only minor changes such as to reflect a
temporary change in the Federal
Financial Participation rate.
Respondents: State and tribal agencies
with approved title IV–E plans.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
Form CB–496 ..................................................................................................
67
4
23
6,164
Estimated Total Annual Burden
Hours: 6,164.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 671(a)(6), 42 U.S.C.
671(a)(7), 42 U.S.C. 673(a)(8)(B), and 42
U.S.C. 674(a) and (b).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–05157 Filed 3–11–21; 8:45 am]
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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
SUMMARY:
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award of the priority review voucher.
FDA has determined that NULIBRY
(fosdenopterin), manufactured by Origin
Biosciences, 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: 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 NULIBRY
(fosdenopterin), manufactured by Origin
Biosciences, Inc., meets the criteria for
a priority review voucher.
NULIBRY (fosdenopterin) is indicated
to reduce the risk of mortality in
patients with Molybdenum Cofactor
Deficiency Type A.
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 NULIBRY
(fosdenopterin), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05207 Filed 3–11–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1440]
Oncologic Drugs 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) announces a
forthcoming public advisory committee
meeting of the Oncologic 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
document.
SUMMARY:
The meeting will be held on
April 27, 2021, from 1 p.m. to 3:45 p.m.
Eastern Time, on April 28, 2021, from
9 a.m. to 3 p.m. Eastern Time, and on
April 29, 2021, from 9 a.m. to 5:30 p.m.
Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing 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–2020–N–1440.
The docket will close on April 26, 2021.
Submit either electronic or written
comments on this public meeting by
April 26, 2021. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 26,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
DATES:
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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
at the end of April 26, 2021. 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 April
20, 2021, 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 cancelled, 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–
2020–N–1440 for ‘‘Oncologic Drugs
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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., Monday through
Friday. Please call 240–402–7500 ahead
of the meeting time to verify access.
• 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
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:
Joyce Yu and Takyiah Stevenson, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, email:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
PO 00000
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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
FDA’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: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform.
The committee will hear updates on
certain supplemental biologics license
applications (sBLAs) approved under 21
CFR 601.40 (subpart E, accelerated
approval regulations) with confirmatory
trial(s) that have not verified clinical
benefit. These updates will provide
information on: (1) The status and
results of confirmatory clinical studies
for a given indication; and (2) any
ongoing and planned trials.
Confirmatory studies are post-marketing
studies to verify and describe the
clinical benefit of a drug after it receives
accelerated approval. Based on the
updates provided, the committee will
have a general discussion focused on
next steps for each product including
whether the indications should remain
on the market while additional trial(s)
are conducted.
On April 27, 2021, the committee will
receive updates on the following
product: BLA 761034/S–018, for
TECENTRIQ (atezolizumab), submitted
by Genentech, Inc., indicated in
combination with paclitaxel proteinbound for the treatment of adult patients
with unresectable locally advanced or
metastatic triple-negative breast cancer
(TNBC) whose tumors express PD–L1
(PD–L1 stained tumor-infiltrating
immune cells (IC) of any intensity
covering ≥1% of the tumor area), as
determined by an FDA-approved test.
On April 28, 2021, the committee will
receive updates on the following
products: (1) BLA 125514/S–017, trade
name KEYTRUDA (pembrolizumab),
submitted by Merck Sharpe & Dohme
Corp., indicated for the treatment of
patients with locally advanced or
metastatic urothelial carcinoma who are
not eligible for cisplatin-containing
chemotherapy; and (2) BLA 761034/S–
001, trade name TECENTRIQ
(atezolizumab), submitted by
Genentech, Inc., indicated for patients
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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
with locally advanced or metastatic
urothelial carcinoma who are not
eligible for cisplatin-containing
chemotherapy.
On April 29, 2021, the committee will
receive updates on the following
products: (1) BLA 125514/S–024, trade
name KEYTRUDA (pembrolizumab),
submitted by Merck Sharpe & Dohme
Corp., indicated for the treatment of
patients with recurrent locally advanced
or metastatic gastric or gastroesophageal
junction adenocarcinoma whose tumors
express PD–L1 [Combined Positive
Score (CPS) ≥1] as determined by an
FDA-approved test, with disease
progression on or after two or more
prior lines of therapy including
fluoropyrimidine- and platinumcontaining chemotherapy and if
appropriate, HER2/neu-targeted therapy;
(2) BLA 125514/S–042, trade name
KEYTRUDA (pembrolizumab),
submitted by Merck Sharpe & Dohme
Corp., indicated for the treatment of
patients with hepatocellular carcinoma
(HCC) who have been previously treated
with sorafenib; and (3) BLA 125554/S–
041, trade name OPDIVO (nivolumab),
submitted by Bristol-Myers Squibb
Company, indicated as a single agent for
the treatment of patients with
hepatocellular carcinoma (HCC) who
have been previously treated with
sorafenib.
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 at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference meeting room 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 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 submitted to the
Docket (see ADDRESSES) on or before
April 20, 2021, will be provided to the
committee. Oral presentations from the
public will be scheduled from
approximately 2:55 p.m. to 3:15 p.m.
Eastern Time on April 27, 2021. Oral
presentations from the public will also
be scheduled between approximately
10:55 a.m. to 11:15 a.m., and 2:10 p.m.
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to 2:30 p.m. Eastern Time on April 28,
2021. Oral presentations from the public
will also be scheduled between
approximately 10:50 a.m. to 11:10 a.m.,
1:55 p.m. to 2:15 p.m., and from 4:40
p.m. to 5 p.m. Eastern Time on April 29,
2021. 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
requested to make their presentation on
or before April 12, 2021. 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 April 13, 2021.
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 Joyce Yu and
Takyiah Stevenson (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. app. 2).
Dated: March 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05202 Filed 3–11–21; 8:45 am]
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14127
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2143]
Withdrawal of Approval of Five
Abbreviated New Drug Applications for
Bacitracin for Injection
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is withdrawing approval of five
abbreviated new drug applications
(ANDAs) from multiple holders. Akorn
Inc. (Akorn), Mylan ASI LLC (Mylan),
Pfizer Inc. (Pfizer), X–GEN
Pharmaceuticals, Inc. (X–GEN), and
Fresenius Kabi USA, LLC (Fresenius)
have requested withdrawal of approval
of their respective applications and have
waived their opportunity for a hearing.
DATES: Approval is withdrawn as of
March 12, 2021.
FOR FURTHER INFORMATION CONTACT:
Sungjoon Chi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3600,
Sungjoon.Chi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 31, 2020, FDA requested that all
application holders of bacitracin for
injection voluntarily request withdrawal
of approval of their applications under
§ 314.150(d) (21 CFR 314.150(d)).
Bacitracin for injection is an antibiotic
for intramuscular administration, the
use of which is limited to the treatment
of infants with pneumonia and
empyema caused by staphylococci
shown to be susceptible to the drug.
Bacitracin for injection poses serious
risks, including nephrotoxicity and
anaphylactic reactions. Healthcare
professionals generally no longer use
bacitracin for injection to treat infants
with pneumonia and empyema because
other effective FDA-approved
treatments are available that do not have
these risks.
In April 2019, FDA’s Antimicrobial
Drugs Advisory Committee met and
discussed the safety and effectiveness of
bacitracin for injection. The advisory
committee voted almost unanimously,
with one abstention, that the benefits of
bacitracin for intramuscular injection do
not outweigh its risks, including
nephrotoxicity and anaphylactic
reactions, for the drug’s only approved
indication. Based on FDA’s review of
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14125-14127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05202]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1440]
Oncologic Drugs 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) announces a forthcoming
public advisory committee meeting of the Oncologic 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 document.
DATES: The meeting will be held on April 27, 2021, from 1 p.m. to 3:45
p.m. Eastern Time, on April 28, 2021, from 9 a.m. to 3 p.m. Eastern
Time, and on April 29, 2021, from 9 a.m. to 5:30 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing 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-2020-N-1440. The docket will close on April
26, 2021. Submit either electronic or written comments on this public
meeting by April 26, 2021. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before April 26, 2021. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time
[[Page 14126]]
at the end of April 26, 2021. 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 April 20, 2021, 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 cancelled, 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-2020-N-1440 for ``Oncologic Drugs 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., Monday through Friday. Please call 240-402-7500 ahead of
the meeting time to verify access.
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
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: Joyce Yu and Takyiah Stevenson, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,
email: [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 FDA'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: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform.
The committee will hear updates on certain supplemental biologics
license applications (sBLAs) approved under 21 CFR 601.40 (subpart E,
accelerated approval regulations) with confirmatory trial(s) that have
not verified clinical benefit. These updates will provide information
on: (1) The status and results of confirmatory clinical studies for a
given indication; and (2) any ongoing and planned trials. Confirmatory
studies are post-marketing studies to verify and describe the clinical
benefit of a drug after it receives accelerated approval. Based on the
updates provided, the committee will have a general discussion focused
on next steps for each product including whether the indications should
remain on the market while additional trial(s) are conducted.
On April 27, 2021, the committee will receive updates on the
following product: BLA 761034/S-018, for TECENTRIQ (atezolizumab),
submitted by Genentech, Inc., indicated in combination with paclitaxel
protein-bound for the treatment of adult patients with unresectable
locally advanced or metastatic triple-negative breast cancer (TNBC)
whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune
cells (IC) of any intensity covering >=1% of the tumor area), as
determined by an FDA-approved test.
On April 28, 2021, the committee will receive updates on the
following products: (1) BLA 125514/S-017, trade name KEYTRUDA
(pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for
the treatment of patients with locally advanced or metastatic
urothelial carcinoma who are not eligible for cisplatin-containing
chemotherapy; and (2) BLA 761034/S-001, trade name TECENTRIQ
(atezolizumab), submitted by Genentech, Inc., indicated for patients
[[Page 14127]]
with locally advanced or metastatic urothelial carcinoma who are not
eligible for cisplatin-containing chemotherapy.
On April 29, 2021, the committee will receive updates on the
following products: (1) BLA 125514/S-024, trade name KEYTRUDA
(pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for
the treatment of patients with recurrent locally advanced or metastatic
gastric or gastroesophageal junction adenocarcinoma whose tumors
express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an
FDA-approved test, with disease progression on or after two or more
prior lines of therapy including fluoropyrimidine- and platinum-
containing chemotherapy and if appropriate, HER2/neu-targeted therapy;
(2) BLA 125514/S-042, trade name KEYTRUDA (pembrolizumab), submitted by
Merck Sharpe & Dohme Corp., indicated for the treatment of patients
with hepatocellular carcinoma (HCC) who have been previously treated
with sorafenib; and (3) BLA 125554/S-041, trade name OPDIVO
(nivolumab), submitted by Bristol-Myers Squibb Company, indicated as a
single agent for the treatment of patients with hepatocellular
carcinoma (HCC) who have been previously treated with sorafenib.
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 at
the time of the advisory committee meeting. Background material and the
link to the online teleconference meeting room 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 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 submitted to the Docket (see
ADDRESSES) on or before April 20, 2021, will be provided to the
committee. Oral presentations from the public will be scheduled from
approximately 2:55 p.m. to 3:15 p.m. Eastern Time on April 27, 2021.
Oral presentations from the public will also be scheduled between
approximately 10:55 a.m. to 11:15 a.m., and 2:10 p.m. to 2:30 p.m.
Eastern Time on April 28, 2021. Oral presentations from the public will
also be scheduled between approximately 10:50 a.m. to 11:10 a.m., 1:55
p.m. to 2:15 p.m., and from 4:40 p.m. to 5 p.m. Eastern Time on April
29, 2021. 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 requested to make their presentation
on or before April 12, 2021. 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 April 13,
2021.
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 Joyce Yu and Takyiah Stevenson (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. app. 2).
Dated: March 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05202 Filed 3-11-21; 8:45 am]
BILLING CODE 4164-01-P
