Limited Population Pathway for Antibacterial and Antifungal Drugs; Public Meeting; Request for Comments, 12621-12623 [2019-06390]
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
clinical trial experience to date, use of
technology and social media, impact of
social factors), and (3) the development
of strategies to generate robust evidence
to address youth tobacco cessation (e.g.,
clinical trial design, measures of
adolescent addiction, selection of
endpoints, subpopulation and comorbidity considerations, and patient
recruitment and retention). Presenters
may include, but are not limited to, staff
from FDA’s Center for Tobacco
Products, FDA’s Center for Drug
Evaluation and Research, industry, and
academia. There will be opportunities
for the audience to ask questions during
this workshop.
amozie on DSK9F9SC42PROD with NOTICES
III. Participating in the Public Scientific
Workshop
Registration: To register for the public
scientific workshop, please visit the
following website by May 13, 2019:
https://youth-tobaccocessation.eventbrite.com. Please provide
complete contact information for each
attendee, including name, affiliation,
and email address.
Registration is free and based on
space availability. Persons interested in
attending this workshop must register
by May 13, 2019, 5 p.m. Eastern Time.
Early registration is recommended
because seating is limited; therefore,
FDA may limit the number of
participants from each organization.
Registrants will receive confirmation
when they have been accepted. You
may choose not to register, however
seating is limited, and space will be
available on a first-come, first-served
basis.
If you need special accommodations
because of a disability, please contact
Allison Hoffman (see FOR FURTHER
INFORMATION CONTACT) no later than May
8, 2019.
Persons attending FDA’s meetings are
advised that the Agency is not
responsible for providing access to
electrical outlets.
Streaming Webcast of the Public
Scientific Workshop: This public
scientific workshop will also be
webcast. To register for the streaming
webcast of the workshop, please visit
the following website by May 13, 2019:
https://youth-tobaccocessation.eventbrite.com.
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
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publishes in the Federal Register, but
websites are subject to change over time.
IV. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. U.S. Department of Health and Human
Services (2014). ‘‘The Health
Consequences of Smoking—50 Years of
Progress: A Report of the Surgeon
General, 2014.’’ Atlanta, GA: U.S.
Department of Health and Human
Services, Centers for Disease Control and
Prevention, National Center for Chronic
Disease Prevention and Health
Promotion, Office on Smoking and
Health. (Available at: https://
www.surgeongeneral.gov/library/reports/
50-years-of-progress/.)
2. Cullen, K.A., B.K. Ambrose, A.S. Gentzke,
et al. (2018). ‘‘Notes from the Field: Use
of Electronic Cigarettes and Any Tobacco
Product Among Middle and High School
Students—United States, 2011–2018.’’
MMWR Morbidity and Mortality Weekly
Report, 67:1276–1277. DOI: https://
dx.doi.org/10.15585/mmwr.mm6745a5.
(Available at: https://www.cdc.gov/
mmwr/volumes/67/wr/mm6745a5.htm.)
3. Gentzke, A.S., M. Creamer, K.A. Cullen, et
al. (2019). ‘‘Vital Signs: Tobacco Product
Use Among Middle and High School
Students—United States, 2011–2018.’’
MMWR Morbidity and Mortality Weekly
Report, 68:157–164. DOI: https://
dx.doi.org/10.15585/mmwr.mm6806e1.
(Available at: https://www.cdc.gov/
mmwr/volumes/68/wr/mm6806e1.htm.)
4. U.S. Department of Health and Human
Services (2016). ‘‘E-Cigarette Use Among
Youth and Young Adults: A Report of
the Surgeon General.’’ Atlanta, GA: U.S.
Department of Health and Human
Services, Centers for Disease Control and
Prevention, National Center for Chronic
Disease Prevention and Health
Promotion, Office on Smoking and
Health. (Available at: https://ecigarettes.surgeongeneral.gov/
documents/2016_sgr_full_report_non508.pdf.)
5. Wang, T.W., A. Gentzke, S. Sharapova, et
al. (2018). ‘‘Tobacco Product Use Among
Middle and High School Students—
United States, 2011–2017.’’ Morbidity
and Mortality Weekly Report (MMWR)
67:629–633. DOI: https://doi.org/
10.15585/mmwr.mm6722a3 (Available at
https://www.cdc.gov/mmwr/volumes/67/
wr/mm6722a3.htm).
6. Berry, K.M., J.L. Fetterman, E.J. Benjamin,
et al. (2019). ‘‘Association of Electronic
Cigarette Use With Subsequent Initiation
of Tobacco Cigarettes in US Youths.’’
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JAMA Netw Open 2(2):e187794. DOI:
https://doi.org/10.1001/
jamanetworkopen.2018.7794 (Available
at https://jamanetwork.com/journals/
jamanetworkopen/fullarticle/2723425.)
Dated: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06323 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2032]
Limited Population Pathway for
Antibacterial and Antifungal Drugs;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting entitled ‘‘Limited Population
Pathway for Antibacterial and
Antifungal Drugs.’’ The purpose of the
meeting is to provide a public forum for
FDA to listen to comments on the draft
guidance for industry, ‘‘Limited
Population Pathway for Antibacterial
and Antifungal Drugs,’’ that was
published in the Federal Register on
June 13, 2018. FDA is also reopening the
comment period on this draft guidance
for comments to be submitted for
consideration before we finish work on
the final version of the guidance.
DATES: The public meeting will be held
on July 12, 2019, from 9 a.m. to 3 p.m.
Eastern Time. Submit either electronic
or written comments by August 12,
2019, to ensure that the Agency
considers your comments on the draft
guidance before it finishes work on the
final version of the guidance. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31, Rm.
1503A (the Great Room), Silver Spring,
MD 20993. Entrance for the public
meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
SUMMARY:
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
You may submit comments on any
guidance at any time as follows:
amozie on DSK9F9SC42PROD with NOTICES
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–
2018–D–2032 for ‘‘Limited Population
Pathway for Antibacterial and
Antifungal Drugs.’’ Received comments,
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
VerDate Sep<11>2014
18:45 Apr 01, 2019
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
FOR FURTHER INFORMATION CONTACT:
Sarah Walinsky, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242,
Silver Spring, MD 20993–0002,
sarah.walinsky@fda.hhs.gov, 240–402–
4075; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register for June 13,
2018 (83 FR 27616), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Limited Population
Pathway for Antibacterial and
Antifungal Drugs.’’ 1 This draft guidance
1 https://www.fda.gov/ucm/groups/fdagov-public/
@fdagov-drugs-gen/documents/document/
ucm610498.pdf.
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provides information on the
implementation of section 506(h) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 356(h), added by
section 3042 of the 21st Century Cures
Act, which established the limited
population pathway for antibacterial
and antifungal drugs (LPAD pathway).
This draft guidance is intended to assist
sponsors in the development of certain
new antibacterial and antifungal drugs
for approval under the LPAD pathway.
This draft guidance also is intended to
assist sponsors in developing labeling,
including prescribing information,
patient labeling, and carton/container
labeling, that incorporates certain
statements required by section 506(h) of
the FD&C Act. The LPAD pathway is
intended to encourage the development
of certain antibacterial and antifungal
drugs for limited and specific
populations of patients to help address
the critical public health and patient
care concern that has resulted from the
current decline in antibacterial and
antifungal drug research and
development as serious antibacterial
and antifungal drug-resistant infections
increase.
FDA received numerous comments on
the draft guidance from a diverse group
of stakeholders. FDA also received
requests for listening meetings with
FDA to provide feedback concerning the
draft guidance on the LPAD pathway. In
view of these requests and to promote
transparency, FDA will hold a public
meeting at which stakeholders may
present or comment on the draft
guidance.
The format of the meeting involves
presentations from the public. The
Agency will not be inviting specific
presenters; rather, with this document,
FDA is soliciting presentations from
interested stakeholders. FDA also
invites interested persons to submit
written comments to the docket
established with the publication of the
draft guidance on the LPAD pathway.
FDA is also reopening the comment
period on this draft guidance for
comments to be submitted for
consideration before it finishes work on
the final version of the guidance.
Submit either electronic or written
comments by August 12, 2019, to ensure
that the Agency considers your
comments on this draft before it finishes
work on the final version of the
guidance.
II. Topics for Discussion at the Public
Meeting
FDA is holding a public meeting to
receive information and comments
concerning the draft guidance on the
LPAD pathway from a broad group of
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Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
amozie on DSK9F9SC42PROD with NOTICES
stakeholders, including patients,
researchers, healthcare providers,
manufacturers, interested industry,
professional organizations, and the
public. The Agency has determined that
a public meeting is the most appropriate
way to ensure public engagement on the
draft guidance. FDA welcomes any
relevant information that stakeholders
wish to share.
III. Participating in the Public Meeting
Registration: To register for the public
meeting, please visit the following
website: https://
fdalimitedpoppathwayantibacterial_
antifungal.eventbrite.com by July 1,
2019, at 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. Persons interested in
attending this public meeting must
register by July 1, 2019, at 11:59 p.m.
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public meeting/public workshop will be
provided beginning at 8:15 a.m. We will
let registrants know if registration closes
before the day of the public meeting/
public workshop.
If you need special accommodations
due to a disability, please contact Sarah
Walinsky (see FOR FURTHER INFORMATION
CONTACT) no later than July 1, 2019, at
11:59 p.m. Eastern Time.
Requests for Oral Presentations:
During online registration you may
indicate which topic(s) you wish to
address, and an approximate desired
length of your presentation, so that FDA
can consider this information in
organizing the presentations. 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, or submit requests for
designated representatives to present.
Following the close of registration, we
will determine the amount of time
allotted to each presenter and the
approximate time each oral presentation
is to begin, and we will select and notify
participants. All requests to make oral
presentations must be received by the
close of registration on July 1, 2019, at
11:59 p.m. Eastern Time. If selected for
presentation, any presentation materials
must be emailed to the Sarah Walinsky
VerDate Sep<11>2014
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Jkt 247001
(see FOR FURTHER INFORMATION CONTACT)
no later than 12 p.m. Eastern Time July
8, 2019. No commercial or promotional
material will be permitted to be
presented or distributed at the public
meeting. Presenters are encouraged to
submit a copy of their presentation and
related written material to the docket
(see ADDRESSES) in advance of the
public meeting.
Streaming Webcast of the public
meeting: This public meeting will also
be webcast via https://
collaboration.fda.gov/lppaadpm0719.
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
meeting 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/
DevelopmentApprovalProcess/
DevelopmentResources/
ucm631810.htm.
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06390 Filed 4–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1215]
Post-Marketing Pediatric-Focused
Product Safety Reviews;
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) is establishing a
public docket to collect comments
related to the post-marketing pediatricfocused safety reviews of products
posted between October 12, 2018, and
April 1, 2019, on FDA’s website but not
presented at the April 8, 2019, Pediatric
Advisory Committee (PAC) meeting.
SUMMARY:
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12623
These reviews are intended to be
available for review and comment by
members of the PAC, interested parties
(such as academic researchers, regulated
industries, consortia, and patient
groups), and the general public.
DATES: Submit either electronic or
written comments by April 15, 2019.
ADDRESSES: FDA is establishing a docket
for public comment on this document.
The docket number is FDA–2019–N–
1215. The docket will close on April 15,
2019. Submit either electronic or
written comments by that date. Please
note that late, untimely comments will
not be considered. Electronic comments
must be submitted on or before April 15,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 15, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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 make 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
E:\FR\FM\02APN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12621-12623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06390]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-2032]
Limited Population Pathway for Antibacterial and Antifungal
Drugs; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Limited Population
Pathway for Antibacterial and Antifungal Drugs.'' The purpose of the
meeting is to provide a public forum for FDA to listen to comments on
the draft guidance for industry, ``Limited Population Pathway for
Antibacterial and Antifungal Drugs,'' that was published in the Federal
Register on June 13, 2018. FDA is also reopening the comment period on
this draft guidance for comments to be submitted for consideration
before we finish work on the final version of the guidance.
DATES: The public meeting will be held on July 12, 2019, from 9 a.m. to
3 p.m. Eastern Time. Submit either electronic or written comments by
August 12, 2019, to ensure that the Agency considers your comments on
the draft guidance before it finishes work on the final version of the
guidance. See the SUPPLEMENTARY INFORMATION section for registration
date and information.
ADDRESSES: The public meeting will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503A (the Great Room), Silver
Spring, MD 20993. Entrance for the public meeting participants (non-FDA
employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
[[Page 12622]]
You may submit comments on any guidance at any time 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-2018-D-2032 for ``Limited Population Pathway for Antibacterial and
Antifungal Drugs.'' Received comments, will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 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.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
FOR FURTHER INFORMATION CONTACT: Sarah Walinsky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002,
[email protected], 240-402-4075; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register for June 13, 2018 (83 FR 27616), FDA
announced the availability of a draft guidance for industry entitled
``Limited Population Pathway for Antibacterial and Antifungal Drugs.''
\1\ This draft guidance provides information on the implementation of
section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 356(h), added by section 3042 of the 21st Century Cures Act,
which established the limited population pathway for antibacterial and
antifungal drugs (LPAD pathway). This draft guidance is intended to
assist sponsors in the development of certain new antibacterial and
antifungal drugs for approval under the LPAD pathway. This draft
guidance also is intended to assist sponsors in developing labeling,
including prescribing information, patient labeling, and carton/
container labeling, that incorporates certain statements required by
section 506(h) of the FD&C Act. The LPAD pathway is intended to
encourage the development of certain antibacterial and antifungal drugs
for limited and specific populations of patients to help address the
critical public health and patient care concern that has resulted from
the current decline in antibacterial and antifungal drug research and
development as serious antibacterial and antifungal drug-resistant
infections increase.
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\1\ https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm610498.pdf.
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FDA received numerous comments on the draft guidance from a diverse
group of stakeholders. FDA also received requests for listening
meetings with FDA to provide feedback concerning the draft guidance on
the LPAD pathway. In view of these requests and to promote
transparency, FDA will hold a public meeting at which stakeholders may
present or comment on the draft guidance.
The format of the meeting involves presentations from the public.
The Agency will not be inviting specific presenters; rather, with this
document, FDA is soliciting presentations from interested stakeholders.
FDA also invites interested persons to submit written comments to the
docket established with the publication of the draft guidance on the
LPAD pathway. FDA is also reopening the comment period on this draft
guidance for comments to be submitted for consideration before it
finishes work on the final version of the guidance. Submit either
electronic or written comments by August 12, 2019, to ensure that the
Agency considers your comments on this draft before it finishes work on
the final version of the guidance.
II. Topics for Discussion at the Public Meeting
FDA is holding a public meeting to receive information and comments
concerning the draft guidance on the LPAD pathway from a broad group of
[[Page 12623]]
stakeholders, including patients, researchers, healthcare providers,
manufacturers, interested industry, professional organizations, and the
public. The Agency has determined that a public meeting is the most
appropriate way to ensure public engagement on the draft guidance. FDA
welcomes any relevant information that stakeholders wish to share.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: https://fdalimitedpoppathwayantibacterial_antifungal.eventbrite.com by July 1,
2019, at 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. Persons
interested in attending this public meeting must register by July 1,
2019, at 11:59 p.m. Eastern Time. Early registration is recommended
because seating is limited; therefore, FDA may limit the number of
participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting/public workshop
will be provided beginning at 8:15 a.m. We will let registrants know if
registration closes before the day of the public meeting/public
workshop.
If you need special accommodations due to a disability, please
contact Sarah Walinsky (see FOR FURTHER INFORMATION CONTACT) no later
than July 1, 2019, at 11:59 p.m. Eastern Time.
Requests for Oral Presentations: During online registration you may
indicate which topic(s) you wish to address, and an approximate desired
length of your presentation, so that FDA can consider this information
in organizing the presentations. 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, or submit
requests for designated representatives to present. Following the close
of registration, we will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,
and we will select and notify participants. All requests to make oral
presentations must be received by the close of registration on July 1,
2019, at 11:59 p.m. Eastern Time. If selected for presentation, any
presentation materials must be emailed to the Sarah Walinsky (see FOR
FURTHER INFORMATION CONTACT) no later than 12 p.m. Eastern Time July 8,
2019. No commercial or promotional material will be permitted to be
presented or distributed at the public meeting. Presenters are
encouraged to submit a copy of their presentation and related written
material to the docket (see ADDRESSES) in advance of the public
meeting.
Streaming Webcast of the public meeting: This public meeting will
also be webcast via https://collaboration.fda.gov/lppaadpm0719.
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 meeting 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/DevelopmentApprovalProcess/DevelopmentResources/ucm631810.htm.
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06390 Filed 4-1-19; 8:45 am]
BILLING CODE 4164-01-P
