[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Pages 41985-41986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17337]



Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Use of Influenza Disease Models To Quantitatively Evaluate the 
Benefits and Risks of Vaccines: A Technical Workshop; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled: ``Use of Influenza Disease Models to Quantitatively 
Evaluate the Benefits and Risks of Vaccines: A Technical Workshop.'' 
The purpose of this public workshop is to provide stakeholders a forum 
to discuss the design of a model to quantitatively estimate the 
benefits and risks of a hypothetical influenza vaccine, and to seek 
from a range of experts, feedback on the current version of the model 
used by the Center for Biologics Evaluation and Research (CBER) and 
suggestions for further development.
    The public workshop will include presentations and panel 
discussions with experts from academia, regulated industry, government, 
and other stakeholders.
    Date and Time: The public workshop will be held on August 23, 2012, 
from 9 a.m. to 4 p.m.
    Location: The public workshop will be held at the Bethesda North 
Marriott Hotel & Conference Center; 5701 Marinelli Rd., Bethesda, MD 
20852; 301-822-9200.
    Contact Person: Richard Forshee, Center for Biologics Evaluation 
and Research (HFM-210), Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6042, email: 
    Registration: Mail, fax, or email your registration information 
(including name, title, firm name, address, telephone, and fax numbers, 
and email address) to Richard Forshee (see Contact Person) by August 
16, 2012. There is no registration fee for the public workshop. Early 
registration is recommended because seating is limited. Registration on 
the day of the public workshop will be provided on a space-available 
basis beginning at 8 a.m. If you need special accommodations due to a 
disability, please contact Richard Forshee (see Contact Person) at 
least 7 days in advance.

SUPPLEMENTARY INFORMATION: The workshop will provide an opportunity for 
discussions on the application of open source influenza infectious 
disease computer simulation models to generate quantitative estimates 
of the benefits and risks of influenza vaccination.
    The public workshop presentations and panel discussions will: (1) 
Discuss recent developments in open-source, agent-based, publicly 
available computer simulation tools to model influenza and other 
infectious diseases; (2) discuss and seek technical feedback on the 
CBER quantitative model of influenza vaccine benefit/risk; and (3) 
discuss possible applications of quantitative benefit/risk assessment 
methods to vaccine assessment of quantitative benefit/risk assessment 
methods to vaccine assessment.
    Transcripts: Please be advised that as soon as possible after a 
transcript of the public workshop is available, it will be accessible 
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm. 
Transcripts of the public workshop may also be requested in writing 
from the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Rockville, MD 20857.

[[Page 41986]]

    Dated: July 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17337 Filed 7-16-12; 8:45 am]