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the draft guidance for industry, ``Limited Population Pathway for 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this draft guidance for comments to be submitted for consideration 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the draft guidance before it finishes work on the final version of the 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

[[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

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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


