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
Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Notices 49777 

next-generation smallpox vaccines in 

humans; (3) discuss the most 

appropriate methods to bridge 

immunogenicity of next-generation 

smallpox vaccines to licensed smallpox 

vaccines in clinical trials; and (4) 

discuss viable methods of extrapolating 

clinical efficacy of next-generation 

smallpox vaccines from 

immunogenicity and efficacy data from 

relevant animal models. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Division of Freedom of 

Information Office (ELEM–1029), Food 

and Drug Administration, 12420 

Parklawn Dr., Element Bldg., Rockville, 

MD 20857, approximately 15 working 

days after the public workshop at a cost 

of 10 cents per page. A transcript of the 

public workshop will be available on 

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

BiologicsBloodVaccines/NewsEvents/ 

WorkshopsMeetingsConferences/ 

TranscriptsMinutes/default.htm. 

Dated: August 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20367 Filed 8–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301– 

496–7057; fax: 301–402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Tumor Markers for Potentially 

Predicting Outcome of Antiangiogenesis Therapy 

Description of Technology: During the 

past decade, anti-angiogenesis therapy 

has evolved as a promising approach to 

the treatment of cancer. However, a 

significant fraction of patients do not 

benefit from anti-angiogenesis therapy, 

either by itself or in combination with 

chemotherapy. A significant need 

remains for a means of predicting 

clinical benefit from anti-angiogenesis 

therapy. 

Researchers at the National Cancer 

Institute, NIH, have identified tumor 

cell apoptosis, p53, and HER2 as having 

potential predictive significance for 

treatment outcome in breast cancer 

patients who received anti-angiogenesis 

therapy in combination with 

chemotherapy. The researchers have 

developed a quantitative antibody-based 

testing method for correlating 

expression of p53 and HER2 and tumor 

apoptosis with clinical outcome. These 

markers can be potentially applied to 

predict which patients should receive 

anti-angiogenesis therapy plus 

chemotherapy. 

Potential Commercial Applications: 

• A diagnostic kit for predicting 

benefit of anti-angiogenesis therapy plus 

chemotherapy in breast cancer patients. 

• A testing service for breast cancer 

patients. 

Competitive Advantages: 

• The clinical predictive markers p53, 

HER2 and tumor apoptosis indicators 

are easily and readily evaluated using 

the new assay. 

• The new assay is potentially useful 

to determine which patients should or 

should not receive anti-angiogenesis 

therapy plus chemotherapy for longer 

survival and progression-free survival in 

patients with breast cancer. 

• A study with a large sample size 

will be planned by the inventors and 

potential collaborators. 

Development Stage: 

• Pilot. 

• In vivo data available (human). 

Inventors: Sherry Yang (NCI), Seth 

Steinberg (NCI), et al. 

Publication: Yang S, et al. p53, HER2 

and tumor cell apoptosis correlate with 

clinical outcome after neoadjuvant 

bevacizumab plus chemotherapy in 

breast cancer. Int J Oncol. 2011 May; 

38(5):1445–1452. [PMID 21399868] 

Intellectual Property: HHS Reference 

No. E–096–2011/0—U.S. Patent 

Application No. 61/448,092 filed 01 

March 2011 

Licensing Contact: Patrick McCue, 

Ph.D.; 301–435–5560; 

mccuepat@mail.nih.gov 

Collaborative Research Opportunity: 

The National Clinical Target Validation 

Laboratory, DCTD, NCI, NIH, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize p53, tumor apoptosis, 

and HER2 as markers for antiangiogenesis therapy. For collaboration 

opportunities, please contact John 

Hewes, Ph.D. at hewesj@mail.nih.gov. 

TRRAP and GRIN2A Mutations for the 

Diagnosis and Treatment of Melanoma 

Description of Technology: Using 

whole-exome sequencing of matched 

normal and metastatic tumor DNAs, 

researchers at the NIH have identified 

several novel somatic (e.g., tumorspecific) alterations, many of which 

have not previously been known to be 

genetically altered in tumors or linked 

to melanoma. In particular, the 

researchers identified a recurrent 

‘‘hotspot’’ mutation in the 

transformation/transcription domainassociated protein (TRRAP) gene, found 

the glutamate receptor ionotropic Nmethyl D-aspartate 2A (GRIN2A) gene as 

a highly mutated in melanoma, and 

have shown that the majority of 

melanoma tumors have alterations in 

genes encoding members of the 

glutamate signaling pathway. Therefore, 

this technology not only provides a 

comprehensive map of genetic 

alterations in melanoma, but has 

important diagnostic and therapeutic 

applications. Mutations in the TRRAP 

and GRIN2A genes can be used as 

diagnostic markers for melanoma and 

may serve as therapeutic targets in the 

treatment of melanoma. In addition, 

glutamate antagonists have previously 

been shown to inhibit proliferation of 

human tumor cells, and therefore 

further investigation of the pathway in 

melanoma could allow for the 

identification of new therapeutic 

proteins that target this pathway. 

Potential Commercial Applications: 

• Diagnostic array for the detection of 

TRRAP and GRIN2A mutations. 

• Method of identifying TRRAP and 

GRIN2A inhibitors as therapeutic agents 

to treat malignant melanoma patients. 

• Method of selecting a therapy based 

on the presence of TRRAP and GRIN2A 

mutations. 

Competitive Advantages: 

• Complete analysis of melanoma 

exome alterations. 

• TRRAP, GRIN2A, and the other 

identified mutations are highly frequent 

and/or highly mutated in melanomas. 

• Glutamate antagonists have already 

been shown to inhibit tumor growth. 

Thus, this technology may prove useful 


srobinson on DSK4SPTVN1PROD with NOTICES