Document ID: FDA-2017-N-2094-0001
Agency: fda
Document Type: Notice
Title: Developing Rabies Monoclonal Antibody Products as a Component of
Rabies Post-Exposure Prophylaxis; Public Workshop; Request for
Comments
Posted Date: 2017-06-07T04:00Z

[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Pages 26494-26495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11820]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2094]

Developing Rabies Monoclonal Antibody Products as a Component of 
Rabies Post-Exposure Prophylaxis; 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 a public workshop regarding development of rabies monoclonal 
antibody products to be used in conjunction with licensed rabies 
vaccine as part of a rabies post-exposure prophylaxis (PEP) regimen. 
This public workshop is intended to provide information for, and gain 
perspective from, health care providers, other U.S. Government 
Agencies, academic experts, industry, and other stakeholders on various 
aspects of development efforts pertaining to animal models, laboratory 
assays, and clinical trials.

DATES: The public workshop will be held on July 17, 2017, from 8:30 
a.m. to 5 p.m. Submit either electronic or written comments on this 
public workshop on or before July 31, 2017. See the SUPPLEMENTARY 
INFORMATION section for registration date and information. The workshop 
draft Agenda will be made available at: http://www.fda.gov/Drugs/NewsEvents/ucm540832.htm prior to the meeting.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 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 July 31, 2017. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of July 31, 2017. 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): 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-2094 for ``Developing Rabies Monoclonal Antibody Products as 
a Component of Rabies Post-Exposure Prophylaxis.'' 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 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 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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.

[[Page 26495]]

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing a public workshop regarding development of rabies 
monoclonal antibody products to be used in conjunction with a licensed 
rabies vaccine as part of rabies PEP. Rabies immunoglobulin, in 
combination with rabies vaccine, is currently recommended for rabies 
PEP following suspected or proven rabies exposure. Rabies monoclonal 
antibody products may offer a potential alternative to rabies 
immunoglobulin as a component of rabies PEP.

II. Topics for Discussion at the Public Workshop

    FDA is conducting this workshop to discuss the scientific work 
needed to advance the development of rabies monoclonal antibodies 
targeting rabies viruses for use in a PEP regimen. Discussions are 
planned around the following topics:

 Rabies epidemiology and vectors
 Current rabies PEP standard of care
 Scientific challenges of assessing the likely effects of 
rabies monoclonal antibodies
 Potential utility of animal models and laboratory assays in 
rabies monoclonal antibody development
 Clinical trial design challenges related to the scientific 
evaluation of rabies monoclonal antibody efficacy as a component of 
rabies PEP
 Ethical considerations regarding potential clinical trial 
designs
    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 by July 12, 2017, midnight 
Eastern Time. To register, please provide complete contact information 
for each attendee, including name, title, affiliation, address, email, 
and telephone to RabiesWorkshop2017@fda.hhs.gov. 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 Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION 
CONTACT) no later than July 12, 2017.
    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. 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 July 11, 2017. All 
requests to make oral presentations must be received by July 10, 2017, 
midnight Eastern Time. If selected for presentation, any presentation 
materials must be emailed to RabiesWorkshop2017@fda.hhs.gov no later 
than July 13, 2017. 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 Web site: https://collaboration.fda.gov/r6811zievzz/.
    If you have never attended a Connect Pro event before, please 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 Web site addresses in this document, as of the date this 
document publishes in the Federal Register, but Web sites 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 Division of Dockets 
Management (see ADDRESSES). A link to the transcript will also be 
available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm540832.htm approximately 45 days after the workshop.

    Dated: May 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11820 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P