Issues in the Design of Clinical Trials of Antibacterial Drugs for the Treatment of Non-Cystic Fibrosis Bronchiectasis; Public Workshop, 49450 [2012-20106]
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Federal Register / Vol. 77, No. 159 / Thursday, August 16, 2012 / Notices
with a check or money order payable to
‘‘SoCRA’’. Mail to: SoCRA (see Contact
for address). To register via the Internet,
go to https://www.socra.org/html/
FDA_Conference.htm. (FDA has verified
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Payment by major credit card is
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only). For more information on the
meeting registration, or for questions on
the workshop, contact SoCRA (see
Contact).
The
public conference helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, IRB inspections,
electronic record requirements, and
investigator initiated research. Topics
for discussion include the following: (1)
What FDA Expects in a Pharmaceutical
Clinical Trial; (2) Adverse Event
Reporting—Science, Regulation, Error,
and Safety; (3) Part 11 Compliance—
Electronic Signatures; (4) Informed
Consent Regulations; (5) IRB
Regulations and FDA Inspections; (6)
Keeping Informed and Working
Together; (7) FDA Conduct of Clinical
Investigator Inspections; (8) Meetings
With FDA: Why, When, and How; (9)
Investigator Initiated Research; (10)
Medical Device Aspects of Clinical
Research; (11) Working With FDA’s
Center for Biologics Evaluation and
Research; (12) The Inspection Is Over—
What Happens Next? Possible FDA
Compliance Actions; (13) Ethical Issues
in Subject Enrollment; (14) Medical
Device Aspects of Clinical Research;
and (15) Are We There Yet? An
Overview of the FDA Good Clinical
Practice Program.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393), which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The public workshop also is
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Pub. L. 104–121) as outreach
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SUPPLEMENTARY INFORMATION:
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activities by Government Agencies to
small businesses.
Dated: August 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19852 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Issues in the Design of Clinical Trials
of Antibacterial Drugs for the
Treatment of Non-Cystic Fibrosis
Bronchiectasis; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop focusing on the design
of clinical trials of antibacterial drugs
for the treatment of non-cystic fibrosis
(non-CF) bronchiectasis. This public
workshop is intended to provide
information for, and gain perspective
from, health care providers, patients and
patient advocacy organizations,
academia, and industry on various
aspects of the design of clinical trials.
The input from this public workshop
will useful in developing topics for
further discussion.
Date and Time: The public workshop
will be held on September 7, 2012, from
8 a.m. to 3:30 p.m.
Location: 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. Seating is limited and
available on a first-come, first-served
basis.
SUMMARY:
interpreter or other special
accommodations should notify
Christine Moser or Lori Benner (see
CONTACT PERSON FOR MORE INFORMATION)
at least 7 days in advance.
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 hardcopy or
on CD–ROM after submission of a
Freedom of Information request. Written
requests should be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be
available on the Internet (https://
www.fda.gov/Drugs/NewsEvents/
ucm305463.htm) approximately 45 days
after the workshop.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop focusing
on scientific considerations in the
design of clinical trials of antibacterial
agents for the treatment of non-CF
bronchiectasis. Discussions will focus
on natural history; patient populations
for enrollment in clinical trials; current
standard of care and unmet need;
clinical trial endpoints, including
exacerbation and patient-reported
outcomes; and clinical trial design
elements, including duration of
treatment and patient followup.
FDA encourages individuals, patient
advocates, industry, consumer groups,
health care professionals, researchers,
and other interested persons to attend
this public workshop.
Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20106 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
CONTACT PERSON FOR MORE INFORMATION:
Christine Moser or Lori Benner, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6204,
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 your registration information
(including name, title, firm name,
address, telephone, and fax number) to
bronchiectasisworkshop@fda.hhs.gov.
Those without access to the Internet
may call 301–796–1300 to register.
Persons needing a sign language
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
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[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Page 49450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20106]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Issues in the Design of Clinical Trials of Antibacterial Drugs
for the Treatment of Non-Cystic Fibrosis Bronchiectasis; 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 focusing on the design of clinical trials of antibacterial
drugs for the treatment of non-cystic fibrosis (non-CF) bronchiectasis.
This public workshop is intended to provide information for, and gain
perspective from, health care providers, patients and patient advocacy
organizations, academia, and industry on various aspects of the design
of clinical trials. The input from this public workshop will useful in
developing topics for further discussion.
Date and Time: The public workshop will be held on September 7,
2012, from 8 a.m. to 3:30 p.m.
Location: 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. Seating is limited and available on a
first-come, first-served basis.
CONTACT PERSON FOR MORE INFORMATION: Christine Moser or Lori Benner,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, rm. 6204, 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 your registration information (including name,
title, firm name, address, telephone, and fax number) to
bronchiectasisworkshop@fda.hhs.gov. Those without access to the
Internet may call 301-796-1300 to register. Persons needing a sign
language interpreter or other special accommodations should notify
Christine Moser or Lori Benner (see CONTACT PERSON FOR MORE
INFORMATION) at least 7 days in advance.
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 hardcopy or on CD-ROM after
submission of a Freedom of Information request. Written requests should
be sent to Division of Freedom of Information (ELEM-1029), Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD
20857. Transcripts will also be available on the Internet (https://www.fda.gov/Drugs/NewsEvents/ucm305463.htm) approximately 45 days after
the workshop.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop focusing
on scientific considerations in the design of clinical trials of
antibacterial agents for the treatment of non-CF bronchiectasis.
Discussions will focus on natural history; patient populations for
enrollment in clinical trials; current standard of care and unmet need;
clinical trial endpoints, including exacerbation and patient-reported
outcomes; and clinical trial design elements, including duration of
treatment and patient followup.
FDA encourages individuals, patient advocates, industry, consumer
groups, health care professionals, researchers, and other interested
persons to attend this public workshop.
Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20106 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P
