[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Pages 11105-11106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05657]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1134]
Development of Antibacterial Drugs for the Treatment of
Nontuberculous Mycobacterial Disease; 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 ``Development of
Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial
Disease.'' The purpose of the public workshop is to discuss the
clinical trial design considerations, including endpoints, related to
the development of antibacterial drug products for treatment of
nontuberculous mycobacterial (NTM) disease.
DATES: The public workshop will be held on April 8, 2019, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on this
public workshop by May 16, 2019. 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 May 16, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on May 16, 2019. 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-1134 for ``Development of Antibacterial Drugs for the
Treatment of Nontuberculous Mycobacterial Disease.'' 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.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.
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 the development of
antibacterial drugs for the treatment of NTM disease. Discussions will
focus on clinical trial design considerations, including endpoints,
related to drug development for the treatment of NTM disease.
II. Topics for Discussion at the Public Workshop
FDA is particularly interested in discussing challenges and
considerations regarding drug development for NTM disease.
[[Page 11106]]
Discussions are planned around the following topics areas:
Trial design
Trial endpoints
Trial populations
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.
Persons interested in attending this public workshop must register
online by April 4, 2019, midnight Eastern Time. To register, please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone to https://www.eventbrite.com/e/development-of-antibacterial-drugs-for-the-treatment-of-nontuberculous-mycobacterial-disease-tickets-54145569857.
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 April 1, 2019.
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
March 29, 2019. All requests to make oral presentations must be
received by March 25, 2019. If selected for presentation, any
presentation materials must be emailed to
[email protected] no later than April 3, 2019. 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/r1s6qm9hgylr/.
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/ucm629494.htm.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05657 Filed 3-22-19; 8:45 am]
BILLING CODE 4164-01-P