[Federal Register Volume 75, Number 59 (Monday, March 29, 2010)]
[Notices]
[Pages 15443-15444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6864]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0156]
Advancing the Development of Diagnostic Tests and Biomarkers for
Tuberculosis; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) in partnership with the
Centers for Disease Control and Prevention (CDC) and the National
Institute of Allergy and Infectious Diseases (NIAID) is announcing a
public workshop entitled ``Advancing the Development of Diagnostic
Tests and Biomarkers for Tuberculosis (TB).'' The purpose of the
workshop is to provide an environment for FDA, CDC, and NIAID to engage
other interested parties in identifying intellectual and procedural
gaps in the current development of TB diagnostic tests, and in
exploring models and strategies that would expedite the development of
new diagnostic tests and biomarkers for TB.
Date and Time: The public workshop will be held on June 7 and 8,
2010, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the National Labor
College,
[[Page 15444]]
10000 New Hampshire Ave., Silver Spring, MD 20903.
Contact Person: Elizabeth Callaghan, Office of Critical Path
Programs (HF-18), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3458,
[email protected]; or Nancy Masiello, Office of Critical
Path Programs (HF-18), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1660,
[email protected].
Registration: Persons interested in attending the workshop must
register by close of business, June 3, 2010. If you wish to attend this
public workshop, you must register by e-mail at [email protected].
Those without e-mail access may register by contacting one of the
persons listed in the Contact Person section of this document. When
registering, you must provide your name, title, company, or
organization (if applicable), address, phone number, and e-mail address
(if applicable). There is no fee to register for the public workshop
and registration will be on a first-come, first-served basis. Early
registration is recommended because seating is limited. Registration on
the day of the public workshop will be permitted on a space-available
basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact one of the persons listed in the Contact Person section of this
document at least 14 days prior to the workshop.
Comments: FDA, CDC, and NIAID are holding this public workshop to
obtain information about developing new diagnostic tests and biomarkers
for TB. The deadline for submitting comments regarding this public
workshop is August 8, 2010.
Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Submit a single copy of electronic comments or two
paper copies of any mailed comments, except that individuals may submit
one paper copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
Between the mid-1980s and early 1990s, reports of TB in the United
States increased, after years of decline. This increase was associated
with a weakened network of TB services; the human immunodeficiency
virus (HIV) epidemic; increased immigration of persons from endemic
areas for TB; transmission of TB in surroundings with higher risk of
exposure (e.g., hospitals, prisons); and the emergence of drug-
resistant TB. However, reported TB cases substantially decreased in the
mid- to late 1990s with renewed efforts on TB control and prevention,
and a major focus on resources.
In 2000, The National Academy of Sciences' Institute of Medicine
(IOM) issued a report\1\ concluding that TB can be eliminated as a
public health threat in the United States with appropriate funding for
additional prevention and control programs, and development of new
tools.
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\1\ Institute of Medicine, Ending Neglect: The Elimination of
Tuberculosis in the United States, Committee on the Elimination of
Tuberculosis in the United States, Division of Health Promotion and
Disease Prevention, Institute of Medicine, 2000.
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In 2003, the Federal TB Task Force (FTBTF) issued a plan\2\ to
implement the IOM recommendations. A reconvened FTBTF issued a plan in
2009\3\ specifically for combating multidrug-resistant TB (MDR TB) and
extensively drug-resistant TB (XDR TB). Both plans addressed domestic
and global strategies, including partnerships with global agencies, as
well as detailed action steps and specific agency roles.
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\2\ The Federal Tuberculosis Task Force, Federal Tuberculosis
Task Force Plan in Response to the Institute of Medicine Report,
Ending Neglect: The Elimination of Tuberculosis in the United
States, Atlanta, GA: U.S. Department of Health and Human Services,
CDC, 2003.
\3\ ``Plan to Combat Extensively Drug-Resistant Tuberculosis:
Recommendations of the Federal Tuberculosis Task Force,'' Morbidity
and Mortality Weekly Report, Recommendations and Reports, 58 (RR-
3):1-43, February 13, 2009.
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II. Purpose of the Public Workshop
The workshop is intended to provide an environment for FDA, CDC,
and NAID to engage other interested parties in identifying intellectual
and procedural gaps in the current development of TB diagnostic tests,
and in exploring models and strategies that would expedite the
development of new diagnostic tests and biomarkers for TB. Invited
experts will address current research and its barriers; both regulatory
and scientific perspectives on the development of new diagnostic tests
and biomarkers for TB; resources for developing new TB diagnostic
tests; and components of and requirements for a TB specimen repository.
At designated times throughout the workshop, there will be short
discussions followed by question and answer sessions. Background
information on the public workshop, registration information, the
agenda, information about lodging, and other relevant information will
be posted, as it becomes available, on the Internet at http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/UpcomingEventsonCPI/ucm203262.htm.
III. 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 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.
Dated: March 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6864 Filed 3-26-10; 8:45 am]
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