Document ID: FDA-2016-N-0001-0094
Agency: fda
Document Type: Notice
Title: Facilitating Anti-Infective Drug Development for Neonates and Young
Infants; Notice of Public Workshop
Posted Date: 2016-08-15T04:00Z

[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Page 54099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19336]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Facilitating Anti-Infective Drug Development for Neonates and 
Young Infants; Notice of Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop regarding anti-infective drug development for neonates and 
young infants. FDA is interested in discussing the scientific 
challenges pertaining to development of anti-infective products for 
neonates and young infants. 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 
and currently marketed anti-infective drugs for neonates and young 
infants. The input from this public workshop will also help in 
developing topics for future discussion.

DATES: The public workshop will be held on September 15, 2016, from 
8:30 a.m. to 4:30 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration information.

ADDRESSES: The public workshop will be held at the Sheraton Silver 
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel's 
phone number is 301-589-0800.

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 anti-infective drug development for neonates and young 
infants. Discussions will focus on challenges related to enrolling 
neonates and young infants in clinical trials, strategies to assess 
central nervous system (CNS) penetration of the drug, including 
nonclinical and in vitro data, potential development pathways, and the 
role of clinical trial networks in anti-infective drug development in 
the neonatal population.
    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 
NeonatalAntibacterialWorkshop2016@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: http://www.fda.gov/Drugs/NewsEvents/ucm507958.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://www.fda.gov/Drugs/NewsEvents/ucm507958.htm approximately 45 
days after the workshop.

    Dated: August 8, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation and Analysis.
[FR Doc. 2016-19336 Filed 8-12-16; 8:45 am]
 BILLING CODE 4164-01-P