[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Notices]
[Pages 11923-11924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0696]


Current State and Further Development of Animal Models of Serious 
Infections Caused by Acinetobacter baumannii and Pseudomonas 
aeruginosa; Public Workshop

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) is announcing a public 
workshop regarding the current state and further development of animal 
models for serious infections caused by Acinetobacter baumannii and 
Pseudomonas aeruginosa. FDA is conducting this workshop in order to 
facilitate the development of narrow-spectrum antibacterial drugs, such 
as those that are active against only a single species of bacteria that 
may not occur frequently.
    This public workshop is intended to provide information for and 
gain perspective from health care providers, other U.S. Government 
Agencies, academic experts, contract research organizations, and 
industry on various aspects of development efforts pertaining to animal 
models of serious infections. The input from this public workshop will 
also help FDA in developing topics for future discussion.

DATES: The public workshop will be held on March 1, 2017, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on this 
public workshop by March 15, 2017. See the SUPPLEMENTARY INFORMATION 
section for registration information. The workshop draft Agenda will be 
made available at: http://www.fda.gov/Drugs/NewsEvents/ucm534031.htm 
prior to the meeting.

ADDRESSES: The public workshop will be held at the DoubleTree by Hilton 
Hotel Washington DC-Silver Spring, 8727 Colesville Rd., Silver Spring, 
MD 20910. The hotel's phone number is 301-589-5200.
    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 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2017-N-0696 for ``Current State and Further Development of Animal 
Models of Serious Infections Caused by Acinetobacter baumannii and 
Pseudomonas aeruginosa.'' 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 Division of 
Dockets Management 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

[[Page 11924]]

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 
Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes, 
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.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop 
regarding animal model development for infectious diseases. FDA is 
conducting this workshop in order to facilitate the development of 
narrow-spectrum antibacterial drugs, such as those that are active 
against only a single species of bacteria that may not occur 
frequently. When the species occurs infrequently, performing clinical 
trials can be extremely challenging. Therefore, animal models of 
infection may be useful to explore the activity of a candidate 
antibacterial drug and may help to predict whether the drug will be 
efficacious in humans. A discussion of the additional scientific work 
needed to evaluate current animal models of infection and evaluate 
potential animal models that may predict response in humans could 
advance the development of antibacterial drugs targeting a single 
species.
    FDA is particularly interested in infections due to Acinetobacter 
baumannii and Pseudomonas aeruginosa as pathogens because there are 
limited therapeutic options to treat patients with serious infections 
caused by these bacteria, including those resistant to currently 
available antibacterial drugs. In addition, it is difficult to enroll 
an adequate number of patients to conduct clinical trials since the 
frequency with which these organisms cause clinical disease is 
sufficiently low. Discussions will focus on the current state of animal 
models of serious infections, lessons learned from the development 
efforts for past and current animal models of infection, and scientific 
challenges and future direction and next steps in animal model 
development.
    This public workshop is intended to provide information for and 
gain perspective from health care providers, other U.S. Government 
Agencies, academic experts, contract research organizations, and 
industry on various aspects of development efforts pertaining to animal 
models of serious infections. The input from this public workshop will 
also help FDA in developing topics for future discussion. The Agency 
encourages health care providers, other U.S. Government Agencies, 
academic experts, contract research organizations, industry, and other 
interested persons to attend this public workshop.
    Registration: Interested parties are encouraged to register early. 
To register electronically, email registration information (including 
name, title, firm name, address, telephone, and fax number) to 
[email protected]. Persons without access 
to the Internet can call 301-796-1300 to register. Registration is free 
and will be on a first-come, first-served basis. However, FDA may limit 
the number of participants from each organization based on space 
limitations. Registrants will receive confirmation once they have been 
accepted. Onsite registration on the day of the meeting will be based 
on space availability.
    If you need special accommodations due to a disability, please 
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days in advance.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment 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. All requests 
to make oral presentations must be received by February 27, 2017. 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 on or before February 28, 2017. If selected for 
presentation, any presentation materials must be emailed to 
[email protected] no later than February 
28, 2017. No commercial or promotional material will be permitted to be 
presented or distributed at the public workshop.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at https://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
A transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov. Transcripts will also be available on the Internet 
at: http://www.fda.gov/Drugs/NewsEvents/ucm534031.htm approximately 45 
days after the workshop.

    Dated: February 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03751 Filed 2-24-17; 8:45 am]
 BILLING CODE 4164-01-P