9010 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 

Regulation citation Number of 

respondents 

Frequency of 

responses 

Hours per 

response 

(minutes) 

Total burden 

hours 

60.11(a)(7) Requests by Researchers for Aggregated Data ...................... 100 1 30 50 

60.14(b) Practitioner Places a Report in Disputed Status .......................... 666 1 5 55 

60.14(b) Practitioner Statement ................................................................... 2,563 1 45 1,922 

60.14(b) Practitioner Requests for Secretarial Review ............................... 117 1 480 936 

60.3 Entity Registration—Initial ................................................................... 500 1 60 500 

60.3 Entity Registration—Update ................................................................ 643 1 5 54 

60.11(a) Authorized Agent Designation—Initial .......................................... 500 1 15 125 

60.11(a) Authorized Agent-Update .............................................................. 86 1 5 7 

60.12(c) Account Discrepancy Report ......................................................... 300 1 15 75 

60.12(c) Electronic Funds Transfer Authorization ....................................... 363 1 15 91 

60.3 Entity Reactivation ............................................................................... 100 1 60 100 

Total ...................................................................................................... ........................ .......................... ........................ 293,644 

Numbers in the table may not add up exactly due to rounding. 

Send comments to Susan Queen, PhD, 

HRSA Reports Clearance Officer, Room 

10–33, Parklawn Building, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

Written comments should be received 

within 60 days of this notice. 

Dated: February 22, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–3446 Filed 2–27–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Commission on 

Childhood Vaccines (ACCV). 

Date and Time: March 7, 2007, 1 p.m.–5 

p.m., EST. March 8, 2007, 9 a.m.–3:30 p.m., 

EST. 

Place: Audio Conference Call and 

Parklawn Building, Conference Rooms G & H, 

5600 Fishers Lane, Rockville, MD 20857. 

The ACCV will meet on Wednesday, 

March 7, from 1 p.m. to 5 p.m., and on 

Thursday, March 8, from 9 a.m. to 3:30 p.m. 

The public can join the meeting in person at 

the address listed above or by audio 

conference call by dialing 1–888–947–9967 

on March 7 and 8 and providing the 

following information: 

Leader’s Name: Dr. Geoffrey Evans. 

Password: ACCV. 

Agenda: The agenda items for the March 

meeting will include, but are not limited to: 

A discussion of VICP outreach activities; an 

overview of the Vaccine Adverse Event 

Reporting System, including the 

requirements for the reporting of adverse 

events; a report from the ACCV Futures 

Workgroup; and updates from the Division of 

Vaccine Injury Compensation (DVIC), 

Department of Justice, National Vaccine 

Program Office, Immunization Safety Office 

(Centers for Disease Control and Prevention), 

National Institute of Allergy and Infectious 

Diseases (National Institutes of Health), and 

Center for Biologics and Evaluation Research 

(Food and Drug Administration). Agenda 

items are subject to change as priorities 

dictate. 

Public Comments: Persons interested in 

providing an oral presentation should submit 

a written request, along with a copy of their 

presentation, to: Ms. Cheryl Lee, Principal 

Staff Liaison, DVIC, Healthcare Systems 

Bureau (HSB), Health Resources and Services 

Administration (HRSA), Room 11C–26, 5600 

Fishers Lane, Rockville, MD 20857 or e-mail: 

clee@hrsa.gov. Requests should contain the 

name, address, telephone number, and any 

business or professional affiliation of the 

person desiring to make an oral presentation. 

Groups having similar interests are requested 

to combine their comments and present them 

through a single representative. The 

allocation of time may be adjusted to 

accommodate the level of expressed interest. 

DVIC will notify each presenter by mail or 

telephone of their assigned presentation time. 

Persons who do not file an advance request 

for a presentation, but desire to make an oral 

statement, may announce it at the time of the 

comment period. These persons will be 

allocated time as it permits. 

For Further Information Contact: Anyone 

requiring information regarding the ACCV 

should contact Ms. Cheryl Lee, Principal 

Staff Liaison, DVIC, HSB, HRSA, Room 11C–

26, 5600 Fishers Lane, Rockville, MD 20857; 

telephone (301) 443–2124 or e-mail: 

clee@hrsa.gov. 

Notification: Due to inclement weather, the 

requirement that the public be notified of this 

meeting at least 15 calendar days in advance 

was not met. 

Dated: February 22, 2007. 

Alexandra Huttinger, 

Acting Director, Division of Policy Review 

and Coordination. 

[FR Doc. E7–3559 Filed 2–27–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Request for 

Genetic Studies in a Cohort of U.S. 

Radiologic Technologists 

SUMMARY: Under the provisions of 

section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute, the National Institutes 

of Health (NIH) has submitted to the 

Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on December 29, 2006, pages 

78445–78446 and allowed 60 days for 

public comment. No public comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. The National 

Institutes of Health may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 

Proposed Collection 

Title: Genetic Studies in a Cohort of 

U.S. Radiologic Technologists (formerly 

known as ‘‘Generic Clearance to Collect 

Medical Outcome and Risk Factor Data 

from a Cohort of U.S. Radiologic 

Technologists’’). Type of Information 

Collection Request: Renewal with 

change of a previously approved 

collection (OMB No. 0925–0405, 

expiration 02/28/2007). Need and Use 

of Information Collection: The primary 

aim of this collection is to substantially 

increase knowledge about the possible 

modifying role of genetic variation on 

the long-term health effects associated 

with protracted low-to moderate-dose 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 9011 

radiation exposures. With this 

submission, the NIH, Office of 

Communications and Public Liaison, 

seeks to obtain OMB’s approval to 

collect biospecimens and risk factor 

data in this ongoing cohort study of U.S. 

radiologic technologists to assess 

genetic and molecular risk factors for 

cancer, and to evaluate possible 

modifying effects of genetic variation on 

radiation-cancer relationships. 

Researchers at the National Cancer 

Institute and The University of 

Minnesota have followed a nationwide 

cohort of 146,000 radiologic 

technologists since 1982, of whom 

110,000 completed at least one of three 

prior questionnaire surveys and 18,400 

are deceased. This cohort is unique 

because estimates of cumulative 

radiation dose to specific organs (e.g. 

breast) are available and the cohort is 

largely female, offering a rare 

opportunity to study effects of low-dose 

radiation exposure on breast and 

thyroid cancers, the two most sensitive 

organ sites for radiation carcinogenesis 

in women. Overall study objectives are: 

(1) To quantify radiation dose-response 

for cancers of the breast, thyroid, and 

other radiogenic sites, and selected 

benign conditions related to cancer (e.g. 

thyroid nodules); (2) to assess cancer 

risk associated with genotypic, 

phenotypic, or other biologically 

measurable factors (e.g. serum levels of 

C-reactive protein, insulin growth 

factors or binding proteins); and (3) to 

determine if genetic variation modifies 

the radiation-related cancer risk. A third 

follow-up of this cohort was completed 

during the past three years. During 

2003–2005, the ‘‘Third Survey’’

questionnaire was mailed or 

administered by telephone to 101,694 

living cohort members who had 

completed at least one prior survey; 

73,838 technologists (73% response) 

completed the survey. The 

questionnaire elicited information on: 

Medical outcomes to assess radiationrelated risks; detailed employment data 

to refine the occupational radiation dose 

estimates; and behavioral and 

residential histories for estimating 

lifetime ultraviolet (UV) radiation 

exposure. Analyses of these data are 

currently underway and findings will 

address an important gap in the 

scientific understanding of radiation 

dose-rate effects, i.e., whether 

cumulative exposures of the same 

magnitude have the same health effects 

when received in a single or a few doses 

over a very short period of time (as in 

the atomic bomb or therapeutic 

exposures) or in many small doses over 

a protracted period of time (as in 

medical or nuclear occupational 

settings). 

There are few, if any, other study 

populations in which both quantified 

breast radiation doses and blood 

samples are available for individuals 

with protracted low-dose radiation 

exposures. The current petition is for 

renewal with change of the previous 

clearance to administer a Genetic 

Studies Questionnaire and collect 

biospecimens from 10,000 cohort 

members who completed at least one 

prior survey. These individuals would 

serve as a comparison group for casecohort studies of gene main effects and 

gene-radiation interactions. To improve 

statistical power to detect such 

associations, we plan to select the 

comparison sample based on dose; this 

is to ensure inclusion of sufficient 

numbers of high-dose individuals. The 

Genetic Studies Questionnaire will 

collect information on: Family history of 

cancer; reproductive history in women 

(e.g. pregnancy outcomes, menopause); 

personal medical radiation exposures 

(e.g. diagnostic x-rays, therapeutic 

irradiation); and personal history of 

chemotherapy. The survey will be in 

optical-read format for computerized 

data capture. A blood collection kit will 

be mailed to technologists along with 

the Genetic Studies Questionnaire; they 

will be asked to take the kit to a 

phlebotomist to have a single tube of 

blood drawn and returned to the study 

laboratory by pre-paid Federal Express 

overnight delivery. Ongoing efforts to 

medically validate self-reported cancers 

and other medical outcomes will 

continue. The annual reporting burden 

is as follows: Frequency of Response: 

On occasion. Affected Public: U.S. 

radiologic technologists who willingly 

participated in earlier investigations to 

quantify the carcinogenic risks of 

protracted low-to moderate-dose 

occupational radiation exposures. 

Estimated Number of Respondents: 

4,233. Estimated Number of Responses 

per Respondent: 1. Average Burden 

Hours per Response: 1.3. Annual 

Burden Hours Requested: 5,630. Total 

cost to respondents is estimated at 

$157,471. There are no capital costs, 

operating costs and/or maintenance 

costs to report. 

RESPONDENT AND BURDEN ESTIMATE—OMB NO. 0925–0405 

Type of respondent 

Number of 

respondents 

(3 yr) 

Frequency 

of response 

Total 

respondents 

(3 yr) 

Average 

hours per 

response 

Total hours 

(3 yr) 

Annual hour 

burden 

Genetic Studies/Risk Factor Survey and Blood Collection 

Sub-Cohort ............................................................... 10,000 1 10,000 1.66666 16,666 5,555 

Medical Validation 

Hospitals/ Physicians ............................................... 2,700 1 2,700 0.08333 225 75 

Total: ................................................................. 12,700 .................... 12,700 .................... 16,891 5,630 

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 proper 

performance of the functioning of the 

National Cancer Institute, 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. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 


sroberts on PROD1PC70 with NOTICES
9012 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Michele 

M. Doody, Radiation Epidemiology 

Branch, National Cancer Institute, 

Executive Plaza South, Room 7040, 

Bethesda, MD 20892–7238, or call nontoll-free at 301–594–7203 or e-mail your 

request, including your address to: 

doodym@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: February 16, 2007. 

Rachelle Ragland-Greene, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. E7–3435 Filed 2–27–07; 8:45 am] 

BILLING CODE 4104–01–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. 

Methods of Determining the Prognosis 

of Hepatocellular Carcinoma 

Description of Technology: 

Hepatocellular carcinoma (HCC) 

represents an extremely poor prognostic 

cancer that remains one of the most 

common and aggressive malignancies 

worldwide. A major hallmark of HCC is 

intrahepatic metastasis and postsurgical reoccurrence. With current 

diagnostic methods, HCC patients are 

often diagnosed with end-stage cancer 

and have poor survival. Thus, there is 

a need for an accurate method to 

identify HCC and its proclivity for 

metastases/relapse, particularly at early 

stages of this disease. 

The inventors have discovered a 

unique set of microRNA (miRNA) 

biomarkers that are associated with HCC 

metastasis/recurrence. This miRNA 

signature was validated in an 

independent cohort of 110 HCC samples 

as an independent predictor of HCC 

prognosis and likelihood of metastasis 

and relapse. In particular, the inventors 

provide evidence that these miRNA 

markers can predict HCC metastasis in 

the early stages of cancer. This 

methodology may enable clinicians to 

effectively stratify patients for 

appropriate cancer treatment and 

prioritize liver transplantation 

candidates. 

Applications: (1) Method to prognose 

HCC, patient survival and likelihood of 

HCC metastasis/relapse; (2) Diagnostic 

tool to aid clinicians in determining 

appropriate cancer treatment; (3) 

Compositions that inhibit miRNA HCC 

biomarkers such as siRNA; (4) Method 

to treatment HCC patients with 

inhibitory miRNA compositions. 

Market: (1) Primary liver cancer 

accounts for about 2% of cancers in the 

U.S., but up to half of all cancers in 

some undeveloped countries; (2) Postoperative five year survival rate of HCC 

patients is 30–40%. 

Development Status: This technology 

is currently in the pre-clinical stage of 

development. 

Inventors: Xin Wei Wang et al. (NCI). 

Publication: Budhu et al. A Unique 

Metastasis-related MicroRNA 

Expression Signature Predicts Survival 

and Recurrence in Hepatocellular 

Carcinoma, manuscript in preparation. 

Patent Status: U.S. Provisional 

Application No. 60/884,052 filed 09 Jan 

2007 (HHS Reference No. E–050–2007/ 

0–US–01). 

Licensing Availability: Available for 

exclusive or non-exclusive licensing. 

Licensing Contact: Jennifer Wong; 

301/435–4633; wongje@mail.nih.gov. 

A Varicella-Zoster Virus Mutant that is 

Markedly Impaired for Latent Infection 

Available for the Development of 

Shingles Vaccines and Diagnostics 

Description of Technology: 

Reactivation of latent Varicella-Zoster 

virus (VZV) infection is the cause of 

shingles, which is prominent in adults 

over the age of 60 and individuals who 

have compromised immune systems, 

due to HIV infection, cancer treatment 

and/or transplant. Shingles is a 

worldwide health concern that affects 

approximately 600,000 Americans each 

year. The incidence of shingles is also 

high in Europe, South America, and 

India; the latter having an estimated two 

million individuals affected, yearly. 

Recent research studies show that VZV 

vaccines have a significant effect on 

decreasing the incidence of shingles in 

elderly. 

The current technology describes 

compositions, cells and methods related 

to the production and use of a mutant 

VZV and the development of vaccines 

against the infectious agent. Latent VZV 

expresses a limited repertoire of viral 

genes including the following six open 

reading frames (ORFs): 4, 21, 29, 62, 63, 

and 66. The present invention describes 

an ORF29 mutant VZV that 

demonstrates a weakened ability to 

establish latency in animal studies. The 

current technology provides methods 

for using the mutant in the development 

of live vaccines and diagnostic tools. A 

related invention is described in PCT/ 

US05/021788 (publication number 

WO2006012092). 

Applications: Development of 

vaccines and diagnostics for prevention 

of shingles. 

Development Status: Pre-clinical 

studies have been performed to 

demonstrate the reduced latency of the 

ORF29 mutant VZV in animals. 

Inventors: Jeffrey Cohen (NIAID) and 

Lesley Pesnicak (NIAID). 

Patent Status: U.S. Provisional 

Application No. 60/857,766 filed 09 

Nov 2006 (HHS Reference No. E–029–

2007/0–US–01). 

Licensing Availability: Available for 

licensing and commercial development. 

Licensing Contact: Chekesha 

Clingman, Ph.D.; 301/435–5018; 

clingmac@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID Laboratory of Clinical 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize vaccine strains of VZV 

vaccine with impaired latency. Please 

contact Kelly Murphy, J.D., M.S., at 301/ 

451–3523 or murphykt@niaid.nih.gov 

for more information. 


sroberts on PROD1PC70 with NOTICES