[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
[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://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