83 FR 30742 - Development of Non-Traditional Therapies for Bacterial Infections; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Non- Traditional Therapies for Bacterial Infections.'' The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30742-30744]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14048]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2398]


Development of Non-Traditional Therapies for Bacterial 
Infections; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Development of Non-
Traditional Therapies for Bacterial Infections.'' The purpose of the 
public workshop is to discuss the general development considerations of 
non-traditional therapies, including pre-clinical development, early 
clinical studies, and phase 3 clinical trial designs to evaluate safety 
and efficacy.

DATES: The public workshop will be held on August 21, 2018, from 8:30 
a.m. to 4:30 p.m. and August 22, 2018, from

[[Page 30743]]

8:30 a.m. to 12 noon. Submit either electronic or written comments on 
this public workshop by August 15, 2018. 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 August 15, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight eastern 
time on August 15, 2018. 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-2018-N-2398 for ``Development of Non-Traditional Therapies for 
Bacterial Infections; Public Workshop.'' 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 of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/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.

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:

I. Background

    FDA is announcing a public workshop regarding development of non-
traditional therapies for bacterial infections. Discussions will focus 
on pre-clinical development, early stage clinical trials, and phase 3 
clinical trial designs to evaluate safety and efficacy of non-
traditional therapies intended to serve as primary or adjunctive 
therapy to existing antibacterial drugs.

II. Topics for Discussion at the Public Workshop

    FDA is particularly interested in discussing pre-clinical and 
clinical development of several types of non-traditional therapies, 
including monoclonal antibodies, immunomodulators, lysins, and other 
non-traditional therapies.
    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 August 14, 2018, 
midnight Eastern Time. To register, please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone to 
[email protected].
    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.

[[Page 30744]]

    If you need special accommodations due to a disability, please 
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION 
CONTACT) no later than August 13, 2018.
    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 or request time for a 
joint presentation. 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 will select 
and notify participants by August 10, 2018. All requests to make oral 
presentations must be received by the close of registration on August 
6, 2018. If selected for presentation, any presentation materials must 
be emailed to [email protected] no later 
than August 14, 2018. No commercial or promotional material will be 
permitted to be presented or distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast at the following site: https://collaboration.fda.gov/dcontpfbi/.
    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/NewsEvents/ucm606052.htm.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14048 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P