[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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.jcahpo.org/clmw.
Registration Information: Registration must be completed online at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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