Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 49685 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: August 13, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19490 Filed 8–21–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0447] 

Achieving a Future Vision at the 2008 

Parenteral Drug Association and the 

Food and Drug Administration Joint 

Regulatory Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

meeting: Achieving a Future Vision at 

the 2008 Parenteral Drug Association 

and the Food and Drug Administration 

Joint Regulatory Conference. The topics 

to be discussed are: FDA’s 

Pharmaceutical Inspectorate and the 

Global Harmonization Task Force; Trans 

Atlantic initiative; Product 

development; and legacy products; 

Supply chain; Combination products; 

and Recall root causes. 

Date and Time: The meeting will be 

held on September 8 through 12, 2008, 

7 a.m. to 6. 

Location: The meeting will be held at 

Renaissance Hotel, 999 9th St., NW., 

Washington, DC 20001. 

Contact: Wanda Neal-Ballard, 

Parenteral Drug Association, PDA 

Global Headquarters, Bethesda Towers, 

4350 East West Hwy., Suite 200, 

Bethesda, MD 20814 or by telephone on 

301–986–0293, ext. 111. 

Registration and Meeting Information: 

See PDA Web site, www.pda.org/ 

pdafda2008 or contact Wanda NealBallard on 301–986–0293, ext. 111. 

From now until August 25, 2008, 

registration fees are as follows: 

$1,600.00 for Members, $2,000.00 for 

Non-members, $615.00 for Government/ 

Health Authority/Academic and 

$230.00 for Students. After August 25, 

2008, registration fees are as follows: 

$1,800.00 for Members, $2,200.00 for 

Non-members, $700.00 for Government/ 

Health Authority/Academic and 

$260.00 for Students. 

If you need special accommodations 

due to a disability, please contact 

Wanda Neal-Ballard at least 7 days in 

advance. 

Dated: August 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19491 Filed 8–21–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; California Health Interview 

Survey Cancer Control Module (CHIS–

CCM) 2009 (NCI) 

SUMMARY: In compliance with the 

requirement of section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: California 

Health Interview Survey Cancer Control 

Module (CHIS–CCM) 2009. Type of 

Information Collection Request: New. 

Need and Use of Information Collection: 

The NCI has sponsored four Cancer 

Control Modules in the California 

Health Interview Survey (CHIS), and 

will be sponsoring a fifth to be 

administered in 2009. CHIS is a 

telephone survey that collects 

population-based, standardized healthrelated data to assess California’s 

progress in meeting Healthy People 

2010 objectives for the nation and the 

state. The CHIS sample is designed to 

provide statistically reliable estimates 

statewide, for California counties, and 

for California’s ethnically and racially 

diverse population. Initiated by the 

UCLA Center for Health Policy 

Research, the California Department of 

Health Services, and the California 

Public Health Institute, the survey is 

funded by a number of public and 

private sources. It was first administered 

in 2001 to 55,428 adults and 

subsequently in 2003 to 42,043 adults, 

in 2005 to 43,020 adults, and in 2007 to 

48,150 adults. These adults are a 

representative sample of California’s 

non-institutionalized population living 

in households. CHIS 2009, the fifth biannual survey, is planned for 

administration to 55,000 adult 

Californians. This study will allow NCI 

to examine patterns and trends in 

cancer screening and follow-up, as well 

as to study other cancer-related topics 

such as tobacco control, diet, physical 

activity, and obesity. Additionally, CHIS 

is designed to be comparable to the 

National Health Interview Survey 

(NHIS) data in order to conduct 

comparative analyses. CHIS provides 

enhanced estimates for cancer risk 

factors and screening among racial/ 

ethnic minority populations. Frequency 

of Response: Once. Affected public: 

Individuals or households. Types of 

Respondents: U.S. adults and 

adolescents (persons 12 years of age and 

older). The total annual burden hours 

requested are 3,276.94 (see Table A). 

The annualized cost to respondents is 

estimated at: $55,071.88. There are no 

Capital Costs, Operating Costs, and/or 

Maintenance Costs to report. 

TABLE A—ANNUALIZED BURDEN ESTIMATES FOR CHIS 2009 

Type of respondent Form type Number of 

respondents 

Frequency 

of response 

Average 

time per 

response 

(hours) 

Annual hour 

burden 

Adults ........................................................ Adult Pilot ................................................. 75 1 8/60 10.00 

.............................................................. Adult Survey ............................................. 24,000.00 1 8/60 3,200.00 


jlentini on PROD1PC65 with NOTICES
49686 Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices 

TABLE A—ANNUALIZED BURDEN ESTIMATES FOR CHIS 2009—Continued 

Type of respondent Form type Number of 

respondents 

Frequency 

of response 

Average 

time per 

response 

(hours) 

Annual hour 

burden 

Adolescents .............................................. Adolescent Pilot ........................................ 8 1 2/60 .27 

Adolescent Survey ................................... 2,000.00 1 2/60 66.67 

Total ................................................... ................................................................... 26,083 .................... .................... 3,276.94 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the 

proposed performance of the function of 

the agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Nancy Breen, 

Ph.D., Project Officer, National Cancer 

Institute, EPN 4005, 6130 Executive 

Boulevard MSC 7344, Bethesda, 

Maryland 20852–7344, or call non-toll 

free number 301–496–8500 or email 

your request, including your address to: 

breenn@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of this 

publication. 

Dated: August 13, 2008. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison Office, 

National Institutes of Health. 

[FR Doc. E8–19453 Filed 8–21–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Licensing and/or Cooperative 

Research and Development Agreement 

(CRADA) Opportunities—Enhanced Tcell Activation by Costimulation: A 

Potentially Novel Approach for the 

Prevention and/or Therapy of Cancer 

(Excluding Prostate Diseases and 

Melanoma) and for Infectious Diseases 

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. Cooperative Research and 

Development Agreement (CRADA) 

opportunities are also available. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

U.S. patent applications listed below 

may be obtained by contacting Mojdeh 

Bahar, J.D., Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville MD 20852; telephone: 301/ 

435–2950; e-mail: 

baharm@mail.nih.gov. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. If interested in a 

Cooperative Research and Development 

Agreement (CRADA) Opportunity, 

please submit a statement of interest 

and capability to Kevin Brand, J.D., in 

the NCI Technology Transfer Center, 

6120 Executive Boulevard, Suite 450, 

Rockville MD 20852; telephone: 301/ 

451–4566; e-mail: kb229t@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Description of Technology 

Cancer immunotherapy is a recent 

approach where tumor associated 

antigens (TAAs), which are primarily 

expressed in human tumor cells and not 

expressed or minimally expressed in 

normal tissues, are employed to 

generate a tumor specific immune 

response. Specifically, these antigens 

serve as targets for the host immune 

system and elicit responses that results 

in tumor destruction. The initiation of 

an effective T-cell immune response to 

antigens requires two signals. The first 

one is antigen specific via the peptide/ 

major histocompatibility complex and 

the second or ‘‘costimulatory’’ signal is 

required for cytokine production, 

proliferation, and other aspects of T-cell 

activation. 

The present technology describes 

recombinant poxvirus vectors encoding 

at least three or more costimulatory 

molecules and tumor associated 

antigens (TAAs). The use of three 

costimulatory molecules such as B7.1, 

ICAM–1 and LFA–3 (TRICOM) has 

been shown to act in synergy with 

several tumor antigens and antigen 

epitopes to activate T cells. The effects 

with TRICOM were significantly 

greater than with one or two 

costimulatory molecules. Laboratory 

results support the greater effect of 

TRICOM to activate both CD4∂ and 

CD8∂ T cells. The invention also 

describes the use of at least one target 

antigen or immunological epitope as an 

immunogen or vaccine in conjunction 

with TRICOM. The antigens include 

but are not limited to carcinoembryonic 

antigen (CEA) and MUC–1. The 

combination of CEA, MUC–1, and 

TRICOM is referred to as PANVAC. 

Availability 

The technology is available for 

exclusive and non-exclusive license in 

combinations and fields of use. Some 

potential licensing opportunities 

involving recombinant poxviral vectors 

containing transgenes are as follows: 

(1) TRICOM (alone or with a 

transgene for a tumor antigen and/or an 

immunostimulatory molecule); 


jlentini on PROD1PC65 with NOTICES