Document ID: FDA-2010-N-0156-0001
Agency: fda
Document Type: Notice
Title: Public Workshops: Advancing the Development of Diagnostic Tests and Biomarkers for Tuberculosis
Posted Date: 2010-03-29T04:00Z

[Federal Register: March 29, 2010 (Volume 75, Number 59)]
[Notices]               
[Page 15443-15444]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr10-71]                         

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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, 
Elizabeth.Callaghan@fda.hhs.gov; 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, 
Nancy.Masiello@fda.hhs.gov.
    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 tbdiagmtg@fda.hhs.gov. 
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]
BILLING CODE 4160-01-S