Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea; Public Workshop; Request for Comments, 19271-19272 [2021-07548]
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Federal Register / Vol. 86, No. 69 / Tuesday, April 13, 2021 / Notices
Our estimated burden for the
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1 request. This adjustment corresponds
to a decrease in the number of
submissions we have received over the
last few years.
Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07549 Filed 4–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0318]
Development Considerations of
Antimicrobial Drugs for the Treatment
of Gonorrhea; Public Workshop;
Request for Comments
Food and Drug Administration,
National Institute of Allergy and
Infectious Diseases, Centers for Disease
Control and Prevention, HHS.
ACTION: Notice of public workshop;
request for comments.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we),
the National Institute of Allergy and
Infectious Diseases (NIAID), and the
Centers for Disease Control and
Prevention (CDC) are announcing the
following public workshop entitled
‘‘Development Considerations of
Antimicrobial Drugs for the Treatment
of Gonorrhea.’’ The purpose of the
public workshop is to discuss the
nonclinical and clinical pharmacology
data and clinical trial design
considerations regarding developing
antimicrobial drugs for the treatment of
gonorrhea.
DATES: The public workshop will be
held virtually on April 23, 2021, from 9
a.m. to 5 p.m., Eastern Time. Submit
either electronic or written comments
on this public workshop by June 1,
2021. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held in virtual format only.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before June 1, 2021. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 1, 2021. Comments received by
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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17:42 Apr 12, 2021
Jkt 253001
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.
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–
2021–N–0318 for ‘‘Development
Considerations of Antimicrobial Drugs
for the Treatment of Gonorrhea.’’
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, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
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19271
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.’’ The
Agency 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 to 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 this 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: Lori
Benner and/or Antoinette Ziolkowski,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6221, Silver Spring,
MD 20993–0002, 301–796–1300.
I. Background
FDA, NIAID, and CDC are announcing
a public workshop regarding the
development considerations of
antimicrobial drugs for the treatment of
gonorrhea. As such, discussions will
focus on the current state of diagnosis
and treatment of gonorrhea and
nonclinical and clinical trial design
considerations for drug development.
II. Topics for Discussion at the Public
Workshop
The workshop will focus on
discussing challenges and clinical trial
E:\FR\FM\13APN1.SGM
13APN1
19272
Federal Register / Vol. 86, No. 69 / Tuesday, April 13, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
considerations regarding antimicrobial
drug development for gonorrhea.
Discussions are planned around the
following topic areas:
• Animal models;
• Clinical pharmacology
considerations; and
• Trial design considerations for
gonorrhea, such as enrollment
strategies, choice of comparators, and
site of infection.
The Agency encourages healthcare
providers, other U.S. Government
Agencies, academic experts, industry,
and other stakeholders to attend this
public workshop.
III. Participating in the Public
Workshop
Registration: Persons interested in
attending this public workshop must
register online, using the internet link
noted in the Transcripts section below,
by April 21, 2021, 11:59 p.m. Eastern
Time. Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Registrants will receive
confirmation when they have been
accepted.
If you need special accommodations
due to a disability, please contact
Antoinette Ziolkowski or Lori Benner
(see FOR FURTHER INFORMATION CONTACT)
no later than April 20, 2021.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during
the virtual public comment session and
which topic(s) you wish to address. All
requests to make oral presentations
must be received by April 15, 2021. We
will do our best to accommodate
requests to make public comments.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations and request time for a
joint presentation. We will determine
the amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin and
will select and notify participants by
April 16, 2021. If selected for
presentation, any presentation materials
must be emailed to
ONDPublicMTGSupport@fda.hhs.gov
no later than April 19, 2021. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast at the following site:
https://collaboration.fda.gov/
cderond042321/.
VerDate Sep<11>2014
17:42 Apr 12, 2021
Jkt 253001
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available on the internet at
https://www.fda.gov/drugs/news-eventshuman-drugs/developmentconsiderations-antimicrobial-drugstreatment-gonorrhea-0423202104232021.
Dated: April 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07548 Filed 4–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1302]
Pediatric Oncology Subcommittee of
the 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 Pediatric Oncology
Subcommittee of the Oncologic Drugs
Advisory Committee. The general
function of the subcommittee 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
virtually on May 11, 2021, from 10 a.m.
to 3 p.m. Eastern Time and May 12,
2021, from noon to 5 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
SUMMARY:
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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–1302.
The docket will close on May 10, 2021.
Submit either electronic or written
comments on this public meeting by
May 10, 2021. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 10, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 10, 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
28, 2021, will be provided to the
subcommittee. 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
E:\FR\FM\13APN1.SGM
13APN1
]]>Agencies
[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Pages 19271-19272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07548]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0318]
Development Considerations of Antimicrobial Drugs for the
Treatment of Gonorrhea; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, National Institute of Allergy and
Infectious Diseases, Centers for Disease Control and Prevention, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we), the
National Institute of Allergy and Infectious Diseases (NIAID), and the
Centers for Disease Control and Prevention (CDC) are announcing the
following public workshop entitled ``Development Considerations of
Antimicrobial Drugs for the Treatment of Gonorrhea.'' The purpose of
the public workshop is to discuss the nonclinical and clinical
pharmacology data and clinical trial design considerations regarding
developing antimicrobial drugs for the treatment of gonorrhea.
DATES: The public workshop will be held virtually on April 23, 2021,
from 9 a.m. to 5 p.m., Eastern Time. Submit either electronic or
written comments on this public workshop by June 1, 2021. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held in virtual format only.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 1, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 1, 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.
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-2021-N-0318 for ``Development Considerations of Antimicrobial Drugs
for the Treatment of Gonorrhea.'' 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, 240-402-7500.
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.'' The Agency 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 to 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 this 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: Lori Benner and/or Antoinette
Ziolkowski, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver
Spring, MD 20993-0002, 301-796-1300.
I. Background
FDA, NIAID, and CDC are announcing a public workshop regarding the
development considerations of antimicrobial drugs for the treatment of
gonorrhea. As such, discussions will focus on the current state of
diagnosis and treatment of gonorrhea and nonclinical and clinical trial
design considerations for drug development.
II. Topics for Discussion at the Public Workshop
The workshop will focus on discussing challenges and clinical trial
[[Page 19272]]
considerations regarding antimicrobial drug development for gonorrhea.
Discussions are planned around the following topic areas:
Animal models;
Clinical pharmacology considerations; and
Trial design considerations for gonorrhea, such as
enrollment strategies, choice of comparators, and site of infection.
The Agency encourages healthcare providers, other U.S. Government
Agencies, academic experts, industry, and other stakeholders to attend
this public workshop.
III. Participating in the Public Workshop
Registration: Persons interested in attending this public workshop
must register online, using the internet link noted in the Transcripts
section below, by April 21, 2021, 11:59 p.m. Eastern Time. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Registrants will receive confirmation when
they have been accepted.
If you need special accommodations due to a disability, please
contact Antoinette Ziolkowski or Lori Benner (see FOR FURTHER
INFORMATION CONTACT) no later than April 20, 2021.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during the virtual public comment
session and which topic(s) you wish to address. All requests to make
oral presentations must be received by April 15, 2021. We will do our
best to accommodate requests to make public comments. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations and request time for a joint
presentation. We will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin
and will select and notify participants by April 16, 2021. If selected
for presentation, any presentation materials must be emailed to
[email protected] no later than April 19, 2021. No
commercial or promotional material will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at the following site: https://collaboration.fda.gov/cderond042321/.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/drugs/news-events-human-drugs/development-considerations-antimicrobial-drugs-treatment-gonorrhea-04232021-04232021.
Dated: April 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07548 Filed 4-12-21; 8:45 am]
BILLING CODE 4164-01-P
