Antibacterial Resistance and Diagnostic Device and Drug Development Research for Bacterial Diseases; Public Workshop, 33317 [2010-14048]
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Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Antibacterial Resistance and
Diagnostic Device and Drug
Development Research for Bacterial
Diseases; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop jointly sponsored by
the National Institute of Allergy and
Infectious Diseases and the Infectious
Diseases Society of America (IDSA)
regarding scientific and potential
research issues in antibacterial drug
resistance, rapid diagnostic device
development for bacterial diseases, and
antibacterial drug development. The
workshop will address antibacterial
drug resistance, mechanisms of
resistance, epidemiology of resistance,
and issues in the development of rapid
diagnostic devices and antibacterial
drugs for the diagnosis and treatment of
bacterial diseases. The input from this
public workshop will help in
developing topics for further discussion.
Dates and Times: The public
workshop will be held on July 26, 2010,
from 8 a.m. to 5:30 p.m. and on July 27,
2010, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Crowne Plaza Hotel, 8777
Georgia Ave., Silver Spring, MD 20910.
Seating is limited and available only on
a first-come, first-served basis.
Contact Persons: Chris Moser or Lori
Benner, Center for Drug Evaluation and
Research, Food and Drug
Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave.,
Bldg. 22, rm. 6209, Silver Spring, MD
20993–0002, 301–796–1300.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited. Seating will be
available on a first-come, first-served
basis. To register electronically, e-mail
registration information (including
name, title, firm name, address,
telephone, and fax number) to
arworkshop@fda.hhs.gov. Persons
without access to the Internet can call
Chris Moser or Lori Benner at 301–796–
1300 to register. Persons needing a sign
language interpreter or other special
accommodations should notify
Christine Moser or Lori Benner (see
Contact Persons) at least 7 days in
advance.
VerDate Mar<15>2010
15:04 Jun 10, 2010
Jkt 220001
FDA is
announcing a public workshop, jointly
sponsored by the National Institute of
Allergy and Infectious Diseases and the
Infectious Diseases Society of America,
regarding scientific issues in
antibacterial drug resistance and
product development for bacterial
diseases. Topics for discussion include
the following: (1) An overview and
discussion of the scale of the current
bacterial resistance problem, (2) current
understanding of the science and
mechanisms of bacterial resistance, (3)
the use of rapid diagnostics in the
diagnosis and management of bacterial
infections, and (4) the science of
antibacterial drug development. The
input from this workshop will help in
the further consideration of potential
areas of research in antibacterial
resistance and help in developing topics
in antibacterial drug development and
rapid diagnostic development for
further discussion.
The agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Webcasting: The workshop will be
simultaneously webcast. The public
may view the live webcast free by
registering through IDSA’s Web site at
https://www.idsociety.org until 24 hours
prior to the workshop. IDSA will do its
best to accommodate members of the
public who register after this time.
Videotaped workshop presentations will
also be available free on IDSA’s Web site
following the 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 20852. A transcript
will also be available in either hardcopy
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://www.fda.gov/FDAgov/
Drugs/NewsEvents/ucm211146.htm
approximately 45 days after the
workshop.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–14048 Filed 6–10–10; 8:45 am]
BILLING CODE 4160–01–S
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33317
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information (RFI) on the
National Institutes of Health Plan To
Develop the Genetic Testing Registry
ACTION:
Notice.
SUMMARY: The National Institutes of
Health, an agency within the
Department of Health and Human
Services (HHS), is seeking input and
feedback on its plan to develop the
Genetic Testing Registry (GTR); a
centralized public resource that will
provide information about the
availability, scientific basis, and
usefulness of genetic tests. Submission
of test information to the GTR will be
voluntary, and the NIH expects to
receive wide interest and participation
from researchers, test developers, and
manufacturers.
SUPPLEMENTARY INFORMATION:
I. Background
The last decade has seen tremendous
advances in our knowledge of the
genomic and genetic factors involved in
health and disease. This increased
knowledge has been accompanied by a
rapid rise in the availability of genetic
tests. Although more than 2,000 genetic
tests are available, there is no single
public resource that provides
information about the validity and
usefulness of these tests. The NIH
believes that transparent access to such
information is vital to facilitate research
and to enable informed decision making
by patients, caregivers, health care
providers, clinical laboratory
professionals, payers, and policymakers.
Therefore, the NIH is initiating the
development of the GTR, an online
resource that will provide a centralized
location for researchers, test developers,
and manufacturers to submit
information voluntarily about genetic
tests, such as their intended use,
validity, and utility. The Registry will
serve as a resource for health care
providers and patients interested in
learning about the tests and easily
locating laboratories offering particular
genetic tests. By using standard
identifiers for genetic tests, GTR can
facilitate Health Information
Technology (HIT) exchange. The GTR
will be a repository of information about
genetic tests, not a repository of test
results.
On March 18, 2010, the NIH
announced that it would be creating the
GTR (see https://www.nih.gov/news/
health/mar2010/od-18.htm). This RFI
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 75, Number 112 (Friday, June 11, 2010)]
[Notices]
[Page 33317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14048]
[[Page 33317]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Antibacterial Resistance and Diagnostic Device and Drug
Development Research for Bacterial Diseases; 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 jointly sponsored by the National Institute of Allergy and
Infectious Diseases and the Infectious Diseases Society of America
(IDSA) regarding scientific and potential research issues in
antibacterial drug resistance, rapid diagnostic device development for
bacterial diseases, and antibacterial drug development. The workshop
will address antibacterial drug resistance, mechanisms of resistance,
epidemiology of resistance, and issues in the development of rapid
diagnostic devices and antibacterial drugs for the diagnosis and
treatment of bacterial diseases. The input from this public workshop
will help in developing topics for further discussion.
Dates and Times: The public workshop will be held on July 26, 2010,
from 8 a.m. to 5:30 p.m. and on July 27, 2010, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Crowne Plaza
Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited
and available only on a first-come, first-served basis.
Contact Persons: Chris Moser or Lori Benner, Center for Drug
Evaluation and Research, Food and Drug Administration, Office of
Antimicrobial Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209,
Silver Spring, MD 20993-0002, 301-796-1300.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early because space is
limited. Seating will be available on a first-come, first-served basis.
To register electronically, e-mail registration information (including
name, title, firm name, address, telephone, and fax number) to
arworkshop@fda.hhs.gov. Persons without access to the Internet can call
Chris Moser or Lori Benner at 301-796-1300 to register. Persons needing
a sign language interpreter or other special accommodations should
notify Christine Moser or Lori Benner (see Contact Persons) at least 7
days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop, jointly
sponsored by the National Institute of Allergy and Infectious Diseases
and the Infectious Diseases Society of America, regarding scientific
issues in antibacterial drug resistance and product development for
bacterial diseases. Topics for discussion include the following: (1) An
overview and discussion of the scale of the current bacterial
resistance problem, (2) current understanding of the science and
mechanisms of bacterial resistance, (3) the use of rapid diagnostics in
the diagnosis and management of bacterial infections, and (4) the
science of antibacterial drug development. The input from this workshop
will help in the further consideration of potential areas of research
in antibacterial resistance and help in developing topics in
antibacterial drug development and rapid diagnostic development for
further discussion.
The agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
Webcasting: The workshop will be simultaneously webcast. The public
may view the live webcast free by registering through IDSA's Web site
at https://www.idsociety.org until 24 hours prior to the workshop. IDSA
will do its best to accommodate members of the public who register
after this time. Videotaped workshop presentations will also be
available free on IDSA's Web site following the 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 20852.
A transcript will also be available in either hardcopy 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://www.fda.gov/FDAgov/Drugs/NewsEvents/ucm211146.htm approximately 45 days after the workshop.
Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14048 Filed 6-10-10; 8:45 am]
BILLING CODE 4160-01-S
