[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]               
[Page 41362-41363]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy08-96]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
Rapid Methods for Detecting Mycoplasma Contamination in the 
Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and 
Other Biological Products; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Rapid Methods for Detecting Mycoplasma 
Contamination in the Manufacture of Vaccines, Including Pandemic 
Influenza Vaccines, and Other Biological Products.'' The purpose of the 
public workshop is to provide a forum on recent scientific and 
technical achievements in the development of rapid methods for 
mycoplasma testing during the manufacture of vaccines and other 
biological products. Such discussion may help to assess how these 
methods compare with currently used methods. Expedited manufacture may 
be of particular importance to public health during an influenza 
pandemic.
    Date and Time: The public workshop will be held on September 22, 
2008, from 8:30 a.m. to 5 p.m., and September 23, 2008, from 8:30 a.m. 
to 12 noon.
    Location: The public workshop will be held at the Hilton Washington 
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Bernadette Kawaley, Center for Biologics Evaluation 
and Research (HFM-43), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-3079, e-
mail: CBERTraining@fda.hhs.gov (Subject line: Mycoplasma Workshop).

[[Page 41363]]

    Registration: Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, telephone and fax numbers) 
to the contact person by August 22, 2008. There is no registration fee 
for the public workshop. Early registration is recommended because 
seating is limited. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Bernadette Kawaley (see Contact Person) at least 7 days in 
advance.
    Submit written abstracts to the contact person by August 15, 2008 
(see section II of this document for additional information).

SUPPLEMENTARY INFORMATION:

I. Background

    FDA will explore the use of alternative methods for detecting 
mycoplasma contamination in the manufacture of vaccines, including 
pandemic influenza vaccines, and other biological products. Alternative 
methods that allow detection of mycoplasma in a shorter period, as 
compared to the current methods, could expedite the manufacture of 
vaccines and other biological products. The workshop is aimed at: (1) 
Identifying promising rapid method(s) for further validation to 
demonstrate equivalency or superiority to methods currently used for 
mycoplasma testing during the manufacture of vaccines and other 
biological products and (2) providing information that may lead to 
collaborative studies with FDA on testing for mycoplasma. The program 
agenda will be available at http://www.fda.gov/cber/scireg.htm, by 
September 5, 2008.

II. Submission of the Abstracts

    For purposes of discussion at the workshop, FDA is requesting 
submission of abstracts that describe current developments in rapid 
methods for detection of mycoplasma contamination during manufacture of 
vaccines and other biological products. FDA will select a limited 
number of abstracts for formal presentation at the workshop by the 
abstract authors. If time permits, FDA may allow additional 
presentations from interested persons attending the meeting who did not 
submit an abstract. FDA will notify authors of abstracts accepted for 
presentation at the workshop by August 25, 2008.
    Abstracts should be a maximum of 350 words, printed (typewritten or 
computer) and double-spaced. The title should be brief and capitalized. 
The authors name(s), contact information, and agency, institution, or 
facility involved should be listed. The author who intends to present 
the abstract should submit a current curriculum vitae with the 
abstract.

    Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16459 Filed 7-17-08; 8:45 am]

BILLING CODE 4160-01-S