Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media; Public Workshop, 34354 [2016-12684]

Download as PDF 34354 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices Dated: May 24, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–12657 Filed 5–27–16; 8:45 am] BILLING CODE 4164–01–P 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. 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. SUMMARY: 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 https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. sradovich on DSK3TPTVN1PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 20:07 May 27, 2016 Jkt 238001 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, firstserved basis. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to unmetneed2016@fda.hhs.gov. 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: https:// 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 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 https://www.fda.gov. Transcripts will also be available on the Internet at: https://wwwfda.gov/Drugs/NewsEvents/ ucm497650.htm approximately 45 days after the workshop. FOR FURTHER INFORMATION CONTACT: 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 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on August 10, 2016, from 8 a.m. to 6 p.m. ADDRESSES: Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. The hotel’s telephone number is 301–948– 8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Patricio G. Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1611, Silver Spring, MD 20993–0002, Patricio.Garcia@ fda.hhs.gov, 301–796–6875, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On August 10, 2016, the committee will discuss, make recommendations, and SUMMARY: E:\FR\FM\31MYN1.SGM 31MYN1

Agencies

[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Page 34354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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 
unmetneed2016@fda.hhs.gov. 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: https://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 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 
https://www.fda.gov. Transcripts will also be available on the Internet 
at: https://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

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