Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 63839 

relating to the safety of regulated 

medical devices and radiation-emitting 

products. FDA must conduct needed 

research to ensure that such programs 

have the highest likelihood of being 

effective. Improving communications 

about medical devices and radiationemitting products will involve many 

research methods, including individual 

indepth interviews, mall-intercept 

interviews, focus groups, selfadministered surveys, gatekeeper 

reviews, and omnibus telephone 

surveys. 

The information collected will serve 

three major purposes. First, as formative 

research it will provide critical 

knowledge needed about target 

audiences to develop messages and 

campaigns about medical device and 

radiation-emitting product use. 

Knowledge of consumer and health care 

professional decisionmaking processes 

will provide the better understanding of 

target audiences that FDA needs to 

design effective communication 

strategies, messages, and labels. These 

communications will aim to improve 

public understanding of the risks and 

benefits of using medical devices and 

radiation-emitting products by 

providing users with a better context in 

which to place risk information more 

completely. 

Second, as initial testing, it will allow 

FDA to assess the potential effectiveness 

of messages and materials in reaching 

and successfully communicating with 

their intended audiences. Testing 

messages with a sample of the target 

audience will allow FDA to refine 

messages while still in the 

developmental stage. Respondents will 

be asked to give their reaction to the 

messages in either individual or group 

settings. 

Third, as evaluative research, it will 

allow FDA to ascertain the effectiveness 

of the messages and the distribution 

method of these messages in achieving 

the objectives of the message campaign. 

Evaluation of campaigns is a vital link 

in continuous improvement of 

communications at FDA. 

Annually, FDA projects about 30 

studies using a variety of research 

methods and lasting an average of 0.17 

hours each (varying from 0.08–1.5 

hours). The operating and maintenance 

costs include contractor expenses for 

designing and conducting information 

collection activities, specifically, 

drawing samples, training interviewers, 

collecting and analyzing information, 

and reporting and disseminating 

findings. FDA estimates the burden of 

this collection of information based on 

prior recent experience with the various 

types of data collection methods 

described earlier. FDA is requesting this 

burden so as not to restrict the Agency’s 

ability to gather information on public 

sentiment for its proposals in its 

regulatory and communications 

programs. 

In the Federal Register of July 13, 

2010 (75 FR 39952), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment, however it was not related to 

the collection of information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Anticipated data collection methods Number of respondents 

Annual frequency per response 

Total annual 

responses 

Hours per response Total hours 

Individual indepth interviews .............................................. 360 1 360 .75 270 

General public focus group interviews .............................. 144 1 144 1 .5 216 

Intercept interviews: Central location ................................. 600 1 600 .25 150 

Intercept interviews: Telephone ......................................... 10,000 2 1 10,000 .08 800 

Self-administered surveys .................................................. 2,400 1 2,400 .25 600 

Gatekeeper reviews ........................................................... 400 1 400 .50 200 

Omnibus surveys ............................................................... 2,400 1 2,400 .17 408 

Total (general public) .................................................. 16,304 16,304 2,644 

Physician focus group interviews ...................................... 144 1 144 1 .5 216 

Total (physician) ......................................................... 144 ........................ 144 .......................... 216 

Total (overall) ....................................................... 16,448 ........................ 16,448 .......................... 2,860 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1–800 number. 

Dated: October 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26119 Filed 10–15–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel: Notice of Charter 

Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel, Centers 

for Disease Control and Prevention, 

Department of Health and Human 

Services, has been renewed for a 2-year 

period through September 18, 2012. 

For information, contact Gladys G. 

Lewellen, M.B.A, M.P.A., Designated 

Federal Officer, Disease, Disability, and 

Injury Prevention and Control Special 

Emphasis Panel, Centers for Disease 

Control and Prevention, Department of 

Health and Human Services, 1600 

Clifton Road, NE., Mailstop E11, 

Atlanta, Georgia 30333, telephone (404) 

498–1519 or fax (404) 498–1541. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

mstockstill on DSKH9S0YB1PROD with NOTICES

63840 Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: October 8, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–26114 Filed 10–15–10; 8:45 am] 

BILLING CODE 4163–18–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. 

Prevention and Treatment of Herpes 

Virus Infection by Inhibition of the 

JMJD2 Family of Histone Demethylases 

Description of Invention: Investigators 

at the NIH have discovered a potential 

means for preventing or treating a 

herpes virus infection by inhibiting the 

activity of the host cell’s histone 

demethylases. When herpesviruses 

enter a cell, they are inactivated by 

cellular defense mechanisms that wrap 

the viral genome in repressive 

chromatin structures. In order for viral 

replication to progress, the host’s own 

histone demethylases are recruited to 

the viral genome to reverse this 

repression. In a preceding invention, the 

laboratory disclosed that viral 

replication and reactivation can be 

significantly reduced through inhibition 

of the histone demethylase LSD1 using 

Mono-Amino Oxidase Inhibitors 

(MAOIs); drugs that are in clinical use. 

The current invention further discloses 

that inhibition of a second set of histone 

demethylases (JMJD2 family) using a 

specific JMJD2 inhibitor, 

dimethyloxaloylglycine (DMOG), also 

results in significant repression of 

herpes viral replication. 

Either alone or in combination, small 

molecule inhibition of LSD1 and the 

JMJD2 family present novel approaches 

for preventing herpes virus infection 

and halting viral reactivation that can 

lead to a disease that ranges from mild 

core sores to herpesvirus keratitis and 

life-threatening encephalitis. 

Additionally, chromatin-mediated 

repression of viral genomes and the 

requirement to de-repress these 

genomes for productive infection 

appears to be general to herpesviruses. 

Therefore, this treatment could also be 

applicable to chicken pox, shingles, 

CMV disease, mononucleosis, and 

Kaposi’s sarcoma. 

Applications: Prevention or treatment 

of infection by herpes simplex virus and 

other diseases caused by herpesviruses 

(i.e. Epstein-Barr virus, 

cytomegalovirus, varicella zoster, and 

Kaposi’s sarcoma-associated 

herpesvirus). 

Advantage: Inhibition of histone 

demethylases provides an alternative 

pathway for repressing herpes virus 

infection as compared to purine analog 

antivirals. While purine analogs are the 

most widely prescribed treatment for 

herpes infection, drug resistance is 

prevalent. Additionally, inhibition of 

histone demethylases results in no 

expression of viral gene products; in 

contrast to DNA replication inhibitors. 

Development Status: 

• Early-stage development 

• Pre-clinical data available for mice 

• Further pre-clinical and clinical 

development is needed 

Market: 

• Genital herpes can result from 

infection with either HSV type 2 or type 

1, mainly by HSV type 2 in the U.S., 

which typically causes more recurrent 

and severe manifestations of the disease. 

• According to the Centers for Disease 

Control and Prevention, nationwide, 

16.2%, or about one out of six, people 

14 to 49 years of age have genital HSV– 

2 infection. 

• HSV keratitis is the most frequent 

cause of corneal blindness in the United 

States. 

Inventors: Thomas Kristie et al. 

(NIAID) 

Publications: None related to this 

invention available at this time. 

Patent Status: U.S. Provisional 

Application No. 61/366,563 filed 22 Jul 

2010 (HHS Reference No. E–184–2010/ 

0–US–01). 

Related Technologies: ‘‘Use of MonoAmine Oxidase Inhibitors to Prevent 

Herpes Virus Infections and 

Reactivation from Latency’’—HHS 

Reference No. E–275–2008/2–PCT–02. 

Licensing Status: Available for 

licensing. 

Licensing Contacts: 

• Eric W. Odom, PhD; 301–435–5009; 

odome@mail.nih.gov. 

• Susan O. Ano, PhD; 301–435–5515; 

anos@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID Laboratory of Viral Diseases 

is seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize 

prevention and treatment of viral 

diseases. Please contact Thomas Kristie, 

PhD at 301.496.3854 or 

tkristie@niaid.nih.gov for more 

information. 

Treatment of Inflammatory Bowel 

Disease (IBD) Using IL–13 Modulators 

and Inhibitors 

Description of Invention: Ulcerative 

colitis (UC), a chronic inflammatory 

disease of the colorectum, affects 

approximately 400,000 people in the 

United States. The cause of UC is not 

known, although an abnormal 

immunological response to bacterial 

antigens in the gut microflora is thought 

to be involved. Available for licensing 

are broad claims covering (1) treatments 

preventing the inflammatory response of 

colitis by modulating IL–13 and Natural 

Killer T cell (NKT) activity and (2) 

methods for screening for therapeutic 

compounds effective for colitis. NIH 

scientists and their collaborators have 

used a mouse model of experimental 

colitis (oxazolone colitis, OC) to show 

that IL–13, a Th2 cytokine, is a 

significant pathologic factor in OC and 

that neutralizing IL–13 in these animals 

effectively prevents colitis. 

Inflammation in this mouse model has 

also been shown to be effectively 

blocked by neutralizing IL–13 or by 

inhibiting the activation of NK–T cells 

through CD1. 

Oxazolone colitis (OC) is a colitis 

induced by intrarectal administration of 

a relatively low dose of the haptenating 

agent oxazolone subsequent to skin 

sensitization with oxazolone. A highly 

reproducible and chronic colonic 

inflammation is obtained that is 

histologically similar to human 

ulcerative colitis. Studies show that 

NKT cells, rather than conventional 

CD4+T cells, mediate oxazolone colitis, 

mstockstill on DSKH9S0YB1PROD with NOTICES