81 FR 34354 - Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

Page Range		34354-34354
FR Document		2016-12684

The Food and Drug Administration (FDA) is announcing a public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. FDA is interested in discussing the scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs, and trial population. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government Agencies, public health organizations, academic experts, and industry on various aspects of drug development for new antibacterial drugs for patients with unmet need and new antibacterial drugs that target a single species. The input from this public workshop will also help in developing topics for future discussion.

Federal Register, Volume 81 Issue 104 (Tuesday, May 31, 2016)

[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Page 34354]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-12684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Facilitating Antibacterial Drug Development for Patients With 
Unmet Need and Developing Antibacterial Drugs That Target a Single 
Species Media; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop regarding antibacterial drug development for patients with 
unmet need and developing antibacterial drugs that target a single 
species. FDA is interested in discussing the scientific challenges 
pertaining to such development programs, including enrollment 
challenges, clinical trial designs, and trial population. This public 
workshop is intended to provide information for and gain perspective 
from health care providers, other U.S. government Agencies, public 
health organizations, academic experts, and industry on various aspects 
of drug development for new antibacterial drugs for patients with unmet 
need and new antibacterial drugs that target a single species. The 
input from this public workshop will also help in developing topics for 
future discussion.

DATES: The public workshop will be held on July 18, 2016, from 8:30 
a.m. to 5 p.m. and July 19, 2016, from 8:30 a.m. to 4 p.m. See the 
SUPPLEMENTARY INFORMATION section for registration information.

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 20993-0002. 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

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 antibacterial drug development for patients with unmet need 
and developing antibacterial drugs that target a single species. 
Discussions will focus on potential development pathways, aspects of 
clinical trials including patient population, trial designs, and 
endpoints, and the role of clinical trial networks in antibacterial 
drug development.
    Registration: Registration is free for the public workshop. 
Interested parties are encouraged to register early. Seating will be 
available on a first-come, first-served basis. 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.
    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.
    Agenda: The workshop draft Agenda will be made available at: http://wwwfda.gov/Drugs/NewsEvents/ucm497650.htm at least 2 days prior to the 
meeting. The Agency encourages individuals, industry, health care 
professionals, researchers, public health organizations and other 
interested persons to attend this public workshop.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://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://wwwfda.gov/Drugs/NewsEvents/ucm497650.htm approximately 45 
days after the workshop.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12684 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P

34354 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices

Dated: May 24, 2016. FOR FURTHER INFORMATION CONTACT: Lori DEPARTMENT OF HEALTH AND
Jill Hartzler Warner, Benner and/or Jessica Barnes, Center for HUMAN SERVICES
Associate Commissioner for Special Medical Drug Evaluation and Research, Food
Programs. and Drug Administration, 10903 New Food and Drug Administration
[FR Doc. 2016–12657 Filed 5–27–16; 8:45 am] Hampshire Ave., Bldg. 22, Rm. 6221 [Docket No. FDA–2016–N–0001]
BILLING CODE 4164–01–P Silver Spring, MD 20993–0002, 301–
796–1300. Clinical Chemistry and Clinical
SUPPLEMENTARY INFORMATION: FDA is Toxicology Devices Panel of the
DEPARTMENT OF HEALTH AND announcing a public workshop Medical Devices Advisory Committee;
HUMAN SERVICES regarding antibacterial drug Notice of Meeting
development for patients with unmet AGENCY: Food and Drug Administration,
Food and Drug Administration need and developing antibacterial drugs HHS.
[Docket No. FDA–2016–N–0001] that target a single species. Discussions ACTION: Notice.
will focus on potential development
Facilitating Antibacterial Drug pathways, aspects of clinical trials SUMMARY: The Food and Drug
Development for Patients With Unmet including patient population, trial Administration (FDA) announces a
Need and Developing Antibacterial designs, and endpoints, and the role of forthcoming public advisory committee
Drugs That Target a Single Species clinical trial networks in antibacterial meeting of the Clinical Chemistry and
Media; Public Workshop drug development. Clinical Toxicology Devices Panel of the
AGENCY: Food and Drug Administration, Registration: Registration is free for Medical Devices Advisory Committee.
HHS. the public workshop. Interested parties The general function of the committee is
are encouraged to register early. Seating to provide advice and recommendations
ACTION: Notice of public workshop. will be available on a first-come, first- to the Agency on FDA’s regulatory
SUMMARY: The Food and Drug served basis. To register electronically, issues. The meeting will be open to the
Administration (FDA) is announcing a email registration information public.
public workshop regarding antibacterial (including name, title, firm name, DATES: The meeting will be held on
drug development for patients with address, telephone, and fax number) to August 10, 2016, from 8 a.m. to 6 p.m.
unmet need and developing unmetneed2016@fda.hhs.gov. Persons ADDRESSES: Gaithersburg Holiday Inn,
antibacterial drugs that target a single without access to the Internet can call Ballroom, Two Montgomery Village
species. FDA is interested in discussing 301–796–1300 to register. Ave., Gaithersburg, MD 20879. The
the scientific challenges pertaining to If you need special accommodations hotel’s telephone number is 301–948–
such development programs, including due to a disability, please contact Jessica 8900. Answers to commonly asked
enrollment challenges, clinical trial Barnes or Lori Benner (see FOR FURTHER questions including information
designs, and trial population. This INFORMATION CONTACT) at least 7 days in regarding special accommodations due
public workshop is intended to provide advance. to a disability, visitor parking, and
information for and gain perspective Agenda: The workshop draft Agenda transportation may be accessed at:
from health care providers, other U.S. will be made available at: http:// http://www.fda.gov/
government Agencies, public health wwwfda.gov/Drugs/NewsEvents/ AdvisoryCommittees/
organizations, academic experts, and ucm497650.htm at least 2 days prior to AboutAdvisoryCommittees/
industry on various aspects of drug the meeting. The Agency encourages ucm408555.htm.
development for new antibacterial drugs individuals, industry, health care FOR FURTHER INFORMATION CONTACT:
for patients with unmet need and new professionals, researchers, public health Patricio G. Garcia, Center for Devices
antibacterial drugs that target a single organizations and other interested and Radiological Health, Food and Drug
species. The input from this public persons to attend this public workshop. Administration, 10903 New Hampshire
workshop will also help in developing Transcripts: Please be advised that as Ave., Bldg. 66, rm. 1611, Silver Spring,
topics for future discussion. soon as a transcript is available, it will MD 20993–0002, Patricio.Garcia@
DATES: The public workshop will be be accessible at http:// fda.hhs.gov, 301–796–6875, or FDA
held on July 18, 2016, from 8:30 a.m. to www.regulations.gov. It may be viewed Advisory Committee Information Line,
5 p.m. and July 19, 2016, from 8:30 a.m. at the Division of Dockets Management 1–800–741–8138 (301–443–0572 in the
to 4 p.m. See the SUPPLEMENTARY (HFA–305), Food and Drug Washington, DC area). A notice in the
INFORMATION section for registration Administration, 5630 Fishers Lane, Rm. Federal Register about last minute
information. 1061, Rockville, MD 20852. A transcript modifications that impact a previously
will also be available in either hardcopy announced advisory committee meeting
ADDRESSES: The public workshop will or on CD–ROM, after submission of a
be held at FDA’s White Oak campus, cannot always be published quickly
Freedom of Information request. The enough to provide timely notice.
10903 New Hampshire Ave., Bldg. 31 Freedom of Information office address is
Conference Center, the Great Room (Rm. Therefore, you should always check the
available on the Agency’s Web site at Agency’s Web site at http://
1503), Silver Spring, MD 20993–0002. http://www.fda.gov. Transcripts will
Entrance for the public workshop www.fda.gov/AdvisoryCommittees/
also be available on the Internet at: default.htm and scroll down to the
participants (non-FDA employees) is http://wwwfda.gov/Drugs/NewsEvents/
through Building 1 where routine appropriate advisory committee meeting
sradovich on DSK3TPTVN1PROD with NOTICES

ucm497650.htm approximately 45 days link, or call the advisory committee
security check procedures will be after the workshop.
performed. For parking and security information line to learn about possible
information, please refer to http:// Dated: May 24, 2016. modifications before coming to the
www.fda.gov/AboutFDA/ Leslie Kux, meeting.
WorkingatFDA/BuildingsandFacilities/ Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: Agenda:
WhiteOakCampusInformation/ [FR Doc. 2016–12684 Filed 5–27–16; 8:45 am] On August 10, 2016, the committee will
ucm241740.htm. BILLING CODE 4164–01–P discuss, make recommendations, and

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Document Created: 2016-05-28 03:57:46
Document Modified: 2016-05-28 03:57:46

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop.
Dates		The public workshop will be held on July 18, 2016, from 8:30 a.m. to 5 p.m. and July 19, 2016, from 8:30 a.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for registration 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.
FR Citation		81 FR 34354

81 FR 34354 - Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 104 (May 31, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration