Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Notices 49775 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On September 22, 2011, the 

committee will discuss BLA 125397, 

Umbilical Cord Blood, New York Blood 

Center, indicated for hematologic 

malignancies, bone marrow failure, 

primary immunodeficiency diseases, 

beta thalassemia, Hurler syndrome, 

Krabbe disease, and X-linked 

adrenoleukodystrophy. On September 

23, 2011, the Committee will discuss 

HDE BH110018, CliniMACS CD34 

Selection System, Miltenyi Biotec, for 

processing allogeneic HLA-matched 

hematopoietic progenitor cells-apheresis 

(HPC–C) from a related donor to obtain 

a CD34+ Cell population intended for 

hematopoietic reconstitution following 

a Myeloablative preparative regimen 

without the need for additional graft-vshost disease (GVHD) prophylaxis in 

patients with acute myelogenous 

leukemia in first or second morphologic 

complete remission. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/default.

htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before September 15, 2011. 

Oral presentations from the public will 

be scheduled on September 22, 2011, 

between approximately 11 a.m. and 12 

noon and on September 23, 2011, 

between approximately 11:30 a.m. and 

12:30 p.m. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before September 7, 2011. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 8, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Gail Dapolito 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20399 Filed 8–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Food and Drug Administration/National 

Heart, Lung, and Blood Institute/ 

National Science Foundation Public 

Workshop on Computer Methods for 

Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled ‘‘FDA/NHLBI/ 

NSF Workshop on Computer Methods 

for Medical Devices.’’ FDA is 

cosponsoring the conference workshop 

with the National Heart, Lung, and 

Blood Institute (NHLBI) of the National 

Institutes of Health and the National 

Science Foundation (NSF). The purpose 

of the workshop is to facilitate 

discussion between FDA and other 

interested parties on the use of 

computational modeling in the design, 

development and evaluation of medical 

devices. 

Dates and Times: The public 

workshop will be held on September 7, 

8, and 9, 2011, from 9 a.m. to 5 p.m. An 

optional FDA Microstructure Modeling 

session will be held from 1 to 5 p.m. on 

September 6, 2011. Participants are 

encouraged to arrive early to ensure 

time for parking and security screening 

before the meeting. Security screening 

will begin at 8 a.m. Persons interested 

in attending this public workshop must 

register by 5 p.m. on August 30, 2011. 

Location: The public workshop and 

optional session will be held at the FDA 

White Oak Campus, 10903 New 

Hampshire Ave, Building 31 Conference 

Center, the Great Room (rm. 1503), 

Silver Spring, MD 20993–0002. 

Contact Persons: Donna R. Lochner, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 62, 

rm. 3220, Silver Spring, MD 20993– 

0002, 301–796–6309, e-mail: 

donna.lochner@fda.hhs.gov; or 

Tina M. Morrison, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1272, Silver Spring, 

MD 20993–0002, 301–796–6310, e-mail: 

tina.morrison@fda.hhs.gov. 

Registration: To register for the public 

workshop and optional session, please 

visit the following Web site: http:// 

www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm (or go to http://www.fda.gov 

and select the FDA Medical Devices 

News & Events—Workshops & 

Conferences calendar and select this 

public workshop from the posted events 

list). Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone number. For those 

without Internet access, please call the 

contact person to register. Registration is 

mandatory as space is limited and 

onsite registration will not be available. 

FDA may limit the number of 

participants from each organization. 

There is no registration fee for the 

public workshop. 

Registrants requesting to present 

written materials or to make oral 

presentations at the public workshop, 

please call the contact persons by 

August 23, 2011. 

If you need special accommodations 

because of a disability, please contact 

Susan Monahan, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4321, Silver Spring, 


srobinson on DSK4SPTVN1PROD with NOTICES
49776 Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Notices 

MD 20993–0002, 301–796–5661 at least 

7 days before the public workshop. 

SUPPLEMENTARY INFORMATION: 

I. Why are we holding this public 

workshop? 

The purpose of the public workshop 

is to facilitate discussion between FDA 

and other interested parties on the use 

of computational modeling in medical 

device design, development and 

evaluation. 

II. What are the topics we intend to 

address at the public workshop? 

We hope to discuss a large number of 

issues at the public workshop, with our 

overall theme being the validation of 

computer models with nonclinical 

models. Topics include, but are not 

limited to the following: 

• Advancing Computational 

Modeling Studies—how is 

computational modeling being used for 

device design, development, and/or 

evaluation? 

• Best Validation Practices—what 

validation scheme has worked for 

computational model systems? 

• Lessons Learned—what validation 

schemes have been unsuccessful for 

computational model systems? 

• Data Resources—where are data for 

boundary conditions, loading 

conditions, material properties, etc. 

obtained for model systems? 

III. Where can I find out more about 

this public workshop? 

Background information on the public 

workshop, registration information, the 

agenda, information about lodging, food 

services, and other relevant information 

will be posted, as it becomes available, 

on the Internet at: http://www.fda.gov/ 

MedicalDevices/NewsEvents/ 

WorkshopsConferences/default.htm (or 

go to http://www.fda.gov and select the 

FDA Medical Devices News & Events— 

Workshops & Conferences calendar and 

select this public workshop from the 

posted events list). 

Dated August 8, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20446 Filed 8–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

The Development and Evaluation of 

Next-Generation Smallpox Vaccines; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) Center for Biologics Evaluation 

and Research (CBER) and the National 

Institutes of Health, the National 

Institute of Allergy and Infectious 

Diseases are announcing a public 

workshop entitled ‘‘The Development 

and Evaluation of Next-Generation 

Smallpox Vaccines.’’ The purpose of the 

public workshop is to identify and 

discuss the key issues related to the 

development and evaluation of nextgeneration smallpox vaccines. The 

public workshop will include 

presentations on the human response to 

smallpox vaccines and development of 

animal models for demonstration of 

effectiveness of next-generation 

smallpox vaccines. 

Date and Time: The public workshop 

will be held on September 16, 2011, 

from 8 a.m. to 5:30 p.m. 

Location: The public workshop will 

be held at the Hilton Washington DC 

North/Gaithersburg, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Bernadette 

Williamson-Taylor, Center for Biologics 

Evaluation and Research (HFM–43), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–2000, Fax: 

301–827–3079, e-mail: 

CBERTraining@fda.hhs.gov (in the 

subject line type ‘‘Smallpox 

Workshop’’). 

Registration: Mail, fax, or email your 

registration information (including 

name, title, firm name, address, 

telephone, and fax numbers) to the 

contact person by August 23, 2011. 

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 7:30 

a.m. 

If you need special accommodations 

due to a disability, please contact 

Bernadette Williamson-Taylor (see 

Contact Person) at least 7 days in 

advance. 

SUPPLEMENTARY INFORMATION: Smallpox 

is a serious, highly contagious, and 

sometimes fatal infectious disease. 

Although the World Health 

Organization declared the disease 

eradicated in 1980, the threat of 

smallpox as a biological weapon 

remains. Vaccination is the only 

prevention for the disease and there are 

currently no FDA-approved treatments. 

First-generation smallpox vaccines 

were prepared on the skin of calves or 

other animals or in chicken eggs. 

Although these vaccines were not 

evaluated for efficacy in well-controlled 

trials, they were highly effective as 

evidenced by the successful global 

eradication of smallpox. Manufacturing 

of these vaccines has ceased and they 

are no longer licensed in the United 

States. 

In 2007, FDA licensed the first 

second-generation smallpox vaccine, 

ACAM2000. This vaccine is based on a 

single plaque-purified vaccinia virus 

derivative of Dryvax (a previously 

licensed first-generation vaccine) and is 

aseptically propagated using cell culture 

technology under modern 

manufacturing practices and standards. 

Both ACAM2000 and Dryvax are 

derived from the New York City Board 

of Health strain and produce a vesicular 

or pustular lesion (referred to as a 

‘‘vaccine take’’) that has been shown to 

correlate with protection. In clinical 

trials, ACAM2000 elicited vaccinianeutralizing antibodies and cellmediated immune responses, with both 

clinical and immunological outcomes 

similar to Dryvax. 

Because ACAM2000 may cause 

serious adverse reactions, there is a 

desire to develop safer vaccines should 

there be a need to vaccinate the general 

population due to a threat of an attack 

with the smallpox virus. Currently, the 

next-generation smallpox vaccines 

under development do not produce the 

characteristic ‘‘vaccine take.’’ In 

addition, it is not ethical or feasible to 

evaluate the effectiveness of these 

vaccines in humans as the natural 

disease has been eradicated. Therefore, 

the effectiveness of these nextgeneration smallpox vaccines may be 

based on animal efficacy data, if 

scientifically appropriate, and to 

comparative human immune response 

data. As for any biologic product, 

licensure of new smallpox vaccines 

requires demonstration of safety, purity, 

and potency. 

The public workshop will: (1) Discuss 

regulatory challenges and approaches 

related to the licensure of nextgeneration smallpox vaccines; (2) 

discuss the strengths and weaknesses of 

various animal models relative to their 

ability to mimic human disease that can 

be used to predict the effectiveness of 


srobinson on DSK4SPTVN1PROD with NOTICES