Document ID: FDA-2016-N-0001-0048
Agency: fda
Document Type: Notice
Title: Clinical Trial Design Considerations for Malaria Drug Development Media;
Public Workshop
Posted Date: 2016-05-10T04:00Z

[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 
Malariaworkshop2016@fda.hhs.gov. 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