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Notice

Advancing the Development of Diagnostic Tests and Biomarkers for Tuberculosis; Public Workshop; Request for Comments

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop; request for comments.

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, Start Printed Page 1544410000 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.

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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 report1 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.

In 2003, the Federal TB Task Force (FTBTF) issued a plan2 to implement the IOM recommendations. A reconvened FTBTF issued a plan in 20093 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.

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.

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Dated: March 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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Footnotes

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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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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[FR Doc. 2010-6864 Filed 3-26-10; 8:45 am]

BILLING CODE 4160-01-S