Document ID: FDA-2008-N-0628-0002
Agency: fda
Document Type: Notice
Title: Microbiological Testing for Contact Lens Care Products; Public Workshop
Posted Date: 2008-12-16T05:00Z

[Federal Register: December 16, 2008 (Volume 73, Number 242)]
[Notices]               
[Page 76366-76367]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de08-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0628]

 
Microbiological Testing for Contact Lens Care Products; Public 
Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Microbiological Testing for Contact Lens Care 
Products.'' FDA is co-sponsoring the public workshop with the American 
Academy of Ophthalmology, the American Academy of Optometry, the 
American Optometric Association, and the Contact Lens Association of 
Ophthalmologists. The purpose of the public workshop is to discuss test 
method parameters for evaluating the activity of contact lens care 
products against Acanthamoeba

[[Page 76367]]

and to discuss elements of microbiological test methods that simulate 
``real world'' consumer use conditions.
    Date and Time: The public workshop will be held on January 22 and 
23, 2009, from 8 a.m. to 5 p.m. Participants are encouraged to arrive 
by 7:30 a.m. to allow enough time for parking and security screening. 
Security Screening will begin at 7 a.m.
    Location: The public workshop will be held at the Food and Drug 
Administration, White Oak Conference Center, 10903 New Hampshire Ave., 
Bldg. 2 (Central Shared Use Building), Silver Spring, MD. Attendees 
should follow the directions provided in the Registration Information 
section of this document.
    Contact: Daryl L. Kaufman, Center for Devices and Radiological 
Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-4200, FAX: 240-276-4234, e-mail: 
Daryl.Kaufman@fda.hhs.gov, or
    Marc Robboy, Center for Devices and Radiological Health (HFZ-460), 
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 240-276-4200, FAX: 240-276-4234, e-mail: 
Marc.Robboy@fda.hhs.gov.
    Agenda: The purpose of the conference is to discuss test methods 
for evaluating the anti-microbial activity of contact lens care 
products.
    On January 22, 2008, we hope to reach consensus on critical test 
method parameters for evaluating the activity of contact lens care 
products against Acanthamoeba. These parameters include organism 
species and strain, trophozoite culture and cyst production, microbial 
challenge level, and assay method for survivors.
    On January 23, 2008, we hope to present and discuss critical 
elements for new or modified disinfection efficacy test methods that 
simulate ``real world'' consumer use conditions. These elements include 
contact lens and lens case uptake of preservative and other solution 
ingredients, solution evaporation, minimal consumer compliance, biofilm 
formation and clinical isolates as challenge organisms.
    Background information on the public workshop, registration 
information, the agenda, information about lodging, and other relevant 
information will be posted on the Internet at www.jcahpo.org/clmw.
    Registration Information: Registration must be completed online at 
www.jcahpo.org/clmw. Please pre-register no later than January 8, 2009 
(see instructions in this paragraph). There will be no onsite 
registration. Non-U.S. citizens are subject to additional security 
screening and should pre-register at least 3 weeks in advance. There is 
a registration fee of $250 for this workshop. Early registration is 
recommended because seating is limited.
    If you need special accommodations due to a disability, please 
contact Ms. Janice Prestwood at 800-284-3937, ext. 229 (toll free), 
651-731-7229 (direct) or 651-731-0410 (fax) at least 7 days before the 
public workshop. Lodging, travel, and security clearance information 
are also available from the registration Web site. Persons without 
Internet access may contact Ms. Janice Prestwood for help in completing 
the registration form.

    Dated: December 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29741 Filed 12-15-08; 8:45 am]

BILLING CODE 4160-01-S