[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6549-6550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02159]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-6046]


Advancing Animal Models for Antibacterial Drug Development; 
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Advancing Animal 
Models for Antibacterial Drug Development.'' The purpose of the public 
workshop is to discuss progress and challenges in the development of 
various animal models for serious infection funded by FDA, the National 
Institutes of Health (NIH), and the Biomedical Advanced Research and 
Development Authority (BARDA) to facilitate antibacterial drug 
development, and to discuss ideas for future research. This public 
workshop is a follow up to the FDA public workshop held on March 1, 
2017, entitled ``Current Status and Future Development of Animal Models 
of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas 
aeruginosa.''

DATES: The public workshop will be held on March 5, 2020, from 8:30 
a.m. to 4 p.m. Submit either electronic or written comments on this 
public workshop by April 6, 2020. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop 
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.
    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 April 6, 2020. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time on April 6, 2020. 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-2019-N-6046 for ``Advancing Animal Models for Antibacterial Drug 
Development.'' 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.
     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

[[Page 6550]]

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.

FOR FURTHER INFORMATION CONTACT: James Byrne, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6383, Silver Spring, MD 20993-0002, 301-
796-5001.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop to discuss ongoing research 
efforts to advance the development of animal models of serious 
bacterial infection. As a follow up to the FDA public workshop held on 
March 1, 2017, entitled ``Current Status and Future Development of 
Animal Models of Serious Infections Caused by Acinetobacter baumannii 
and Pseudomonas aeruginosa,'' FDA is holding this public workshop to 
discuss research results regarding the development of various animal 
models of serious infection funded by FDA, NIH, and BARDA, and to 
discuss ideas for future research in this area. \1\
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    \1\ We support the principles of the ``3Rs,'' to reduce, refine, 
and replace animal use in testing when feasible. We encourage 
sponsors to consult with us if it they wish to use a non-animal 
testing method that they believe is suitable, adequate, validated, 
and feasible. We will consider if such an alternative method could 
be assessed for equivalency to an animal test method.
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    Animal models of serious infection are useful to explore the 
activity of a new antibacterial drug and may be further developed to 
better predict whether the drug might be efficacious in humans, and 
thus potentially contribute to the selection of drugs, dosing regimens, 
and design elements for appropriate human clinical trials. Further 
developed models may be particularly useful in settings in which the 
use of concomitant or prior antibacterial drugs in clinical trials is 
common, such as development of a new antibacterial drug with activity 
against a single species.

II. Topics for Discussion at the Public Workshop

    FDA is particularly interested in discussing challenges encountered 
in animal model development and ideas for future research. Discussions 
will focus on the following topic areas:
     An overview of urinary tract infection, abdominal 
infection, and pneumonia animal models currently used in antibacterial 
drug development;
     pharmacokinetic considerations in animal model 
development;
     animal model resources and development supported by NIH;
     progress and challenges in advancement of murine, rabbit, 
and porcine models of serious bacterial infections supported by FDA and 
BARDA; and
     potential priorities for further research and development.
    The Agency encourages health care providers, other U.S. Government 
Agencies, academic experts, industry, and other stakeholders to attend 
this public workshop.

III. Participating in the Public Workshop

    Registration: Registration is free and based on space availability, 
with priority given to early registrants. Persons interested in 
attending this public workshop must register online by March 2, 2020, 
11:59 p.m. Eastern Time. To register, please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone by visiting https://www.eventbrite.com/e/advancing-animal-models-for-antibacterial-drug-development-tickets-73803340779.
    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 workshop will be provided beginning at 7:30 a.m. We will let 
registrants know if registration closes before the day of the public 
workshop.
    If you need special accommodations due to a disability, please 
contact James Byrne (see FOR FURTHER INFORMATION CONTACT) no later than 
February 21, 2020.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session or 
participate in a specific session, and which topic(s) you wish to 
address. 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 participate in the focused sessions. 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 
February 25, 2020. All requests to make oral presentations must be 
received by February 21, 2020. If selected for presentation, any 
presentation materials must be emailed to 
[email protected] no later than March 2, 2020. No 
commercial or promotional material will be permitted to be presented or 
distributed at the public workshop.
    Persons attending FDA's workshops are advised that FDA is not 
responsible for providing access to electrical outlets.
    Streaming Webcast of the public workshop: This public workshop will 
also be webcast at the following website: https://collaboration.fda.gov/amdworkshop.
    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 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. A link to the transcript will also be available on 
the internet at https://www.fda.gov/drugs/news-events-human-drugs/advancing-animal-models-antibacterial-drug-development-03052020-03052020.

    Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02159 Filed 2-4-20; 8:45 am]
 BILLING CODE 4164-01-P