Clinical Trial Design Considerations for Malaria Drug Development Media; Public Workshop, 28876 [2016-10913]
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Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Notices
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.
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 https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. Seating is limited and
available only on a first-come, firstserved 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, firstserved 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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:33 May 09, 2016
Jkt 238001
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.
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 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. 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 https://wcms.fda.gov/FDAgov/
Drugs/NewsEvents/
ucm490084.htm?SSContributor=true
approximately 45 days after the
workshop.
SUPPLEMENTARY INFORMATION:
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1210]
Technical Considerations for Additive
Manufactured Devices; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00059
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Technical
Considerations for Additive
Manufactured Devices.’’ FDA has
developed this draft leapfrog guidance
to provide FDA’s initial thoughts on
technical considerations specific to
devices using additive manufacturing,
the broad category of manufacturing
encompassing 3-dimensional (3D)
printing. Specifically, this draft
guidance outlines technical
considerations associated with additive
manufacturing processes, and testing
and characterization for final finished
devices fabricated using additive
manufacturing. This draft guidance is
not final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 8, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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 https://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 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. 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 https://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
