[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]
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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.
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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the draft guidance for industry, ``Limited Population Pathway for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this draft guidance for comments to be submitted for consideration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the draft guidance before it finishes work on the final version of the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.
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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
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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