[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Page 28876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10913]
[[Page 28876]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Clinical Trial Design Considerations for Malaria Drug Development
Media; 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 clinical trial design considerations for malaria
drug development. FDA is interested in discussing the scientific
challenges pertaining to malaria drug development and malaria parasite
detection methods used as endpoints in clinical trials. 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 the design of clinical trials evaluating new drugs to treat malaria.
The input from this public workshop will also help in developing topics
for future discussion.
Dates and Times: The public workshop will be held on June 30, 2016,
from 8:30 a.m. to 4 p.m.
Location: The public workshop will be held at FDA's White Oak
campus, 10903 New Hampshire Ave., Bldg. 31 Great Rm., 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Seating
is limited and available only on a first-come, first-served basis.
Contact Persons: Ms. Lori Benner and/or Ms. Jessica Barnes, Center
for Drug Evaluation and Research, Food and Drug Administration, Bldg.
22, Rm. 6221, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1300.
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. Persons needing a sign language
interpreter or other special accommodations should notify Ms. Jessica
Barnes or Ms. Lori Benner (see Contact Persons) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding scientific and regulatory considerations in the design of
clinical trials of antimalarial drugs. Discussions will focus on
developing two or more drugs used in combination, human challenge
studies, issues/challenges associated with current detection methods,
use of polymerase chain reaction, and other emerging rapid diagnostic
tests in clinical trials.
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. A
transcript will also be available in either hard copy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, Rm. 6-30, Rockville, MD 20857. Transcripts will also be available
on the Internet at http://wcms.fda.gov/FDAgov/Drugs/NewsEvents/ucm490084.htm?SSContributor=true approximately 45 days after the
workshop.
Dated: May 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10913 Filed 5-9-16; 8:45 am]
BILLING CODE 4164-01-P