Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Notices 24317 

As explained in detail in the 

guidance, there have been repeated 

instances of DEG poisoning that have 

led to the development of this guidance. 

Between 1990 and 1998, DEG poisoning 

has been reported in Haiti, Argentina, 

Bangladesh, India, and Nigeria. More 

recently, in October 2006, there were 

cases of illness and death in Panama 

due to DEG poisoning. 

The cases involving DEG 

contamination reveal the following 

similarities: 

<bullet≤ The pharmaceutical 

manufacturers did not perform full 

identity testing on the glycerin raw 

material, including tests to quantify the 

amount of DEG present and to verify the 

purity of the glycerin received. 

<bullet≤ The pharmaceutical 

manufacturers of the contaminated 

products relied on the certificate of 

analysis (COA) provided by the 

supplier. 

<bullet≤ The origin of the product 

was not easily apparent from the COA. 

FDA has no reason to believe that the 

U.S. supply of glycerin is affected at the 

present time. However, because of the 

serious nature of this potentially fatal 

problem and the global nature of the 

pharmaceutical supply chain, FDA is 

emphasizing in this guidance the 

importance of testing glycerin for DEG. 

We are issuing this level 1 guidance 

for immediate implementation, 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The agency is not seeking comment 

prior to implementing this guidance 

because of the potential for a serious 

public health impact if DEGcontaminated glycerin were to enter the 

domestic market. The guidance 

represents the agency’s current thinking 

on this issue. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one copy. Comments are to be 

identified with the 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. 

III. 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.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: April 16, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8389 Filed 5–1–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the OMB for review under 

the Paperwork Reduction Act of 1995: 

Proposed Project: Bureau of Primary 

Health Care (BPHC) Uniform Data 

System (OMB No. 0915–0193)— 

Extension for 2007 UDS Data Collection 

The Uniform Data System (UDS) 

contains the annual reporting 

requirements for the cluster of primary 

care grantees funded by HRSA. The 

UDS includes reporting requirements 

for grantees of the following primary 

care programs: Community Health 

Centers, Migrant Health Centers, Health 

Care for the Homeless, Public Housing 

Primary Care, and other grantees under 

Section 330. The authorizing statute is 

Section 330 of the Public Health Service 

Act, as amended. 

HRSA collects data in the UDS which 

is used to ensure compliance with 

legislative mandates and to report to 

Congress and policy makers on program 

accomplishments. To meet these 

objectives, HRSA requires a core set of 

data collected annually that is 

appropriate for monitoring and 

evaluating performance and reporting 

on annual trends. 

Estimates of annualized reporting 

burden are as follows: 

Type of report Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Universal Report .................................................................. 1,055 1 1,055 28 29,540 

Grant Report ........................................................................ 145 1 145 18 2,610 

Total .............................................................................. 1,055 ........................ 1,100 ........................ 32,150 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to: 

Karen Matsuoka, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503. 

Dated: April 25, 2007. 

Caroline Lewis, 

Acting Associate Administrator for 

Administration and Financial Management. 

[FR Doc. E7–8379 Filed 5–1–07; 8:45 am] 

BILLING CODE 4165–15–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. 

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24318 Federal Register / Vol. 72, No. 84 / Wednesday, May 2, 2007 / Notices 

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. 

Diagnosing and Treating Cancer Using 

Beta-Catenin Splice Variants 

Description of Technology: This 

application discloses and claims 

inventions which may be used alone or 

together. One group of inventions 

relates to early detection diagnostic, 

prognostic and patient monitoring 

methods (‘‘Diagnostic Methods’’). The 

other group of inventions relates to 

methods of treatment. Both groups of 

inventions have particular application 

with respect to esophageal squamous 

cell cancers (ESCC) or other types of 

adenocarcinomas and squamous cell 

carcinomas. 

The Diagnostic Methods are useful in 

evaluating the status of preneoplastic 

lesions as well as tumor tissue. Because 

of this, the methods can be used to track 

the progression or regression of disease 

in many types of cell samples from 

normal to dysplasia to cancer. 

The Diagnostic Methods involve 

measuring the level of one or more pairs 

of transcripts or the protein products of 

these pairs of transcripts or the cellular 

localization of the transcripts or 

proteins. The primary transcripts or 

protein products useful in this method 

are those of the beta-Catenin gene 

(CTNNB1). In particular, the levels of 

the 16A and 16B CTNNB1 transcripts or 

protein products are of importance in 

carrying out the methods of this patent 

application. Other gene transcripts or 

protein products that may be used in 

conjunction with CTNNB1 16A and 16B 

to provide additional information are 

WAF1 (p21) and cMYC. 

The treatment methods include 

employing small interfering RNA 

molecules (siRNAs) as a means to alter 

the expression of one or more of these 

particular CTNNB1 transcripts. More 

specifically, preferred siRNA molecules 

can be used to alter the expression of 

the CTNNB1 transcripts 16A and/or 

16B. These siRNA molecules may be 

single-stranded (ss) or double-stranded 

(ds) and may be delivered using a 

construct capable of producing the 

siRNA molecule upon delivery to the 

target cell. 

Applications: Diagnostic or prognostic 

methods for squamous cell cancers and 

adenocarcinomas; Monitoring 

therapeutic response during and after 

patient treatment; Development of 

cancer treatments; Basic research to 

further elucidate the role of beta catenin 

in signal transduction pathways and 

carcinogenesis. 

Development Stage: The use of beta 

catenin transcripts to provide prognostic 

or diagnostic information remains the 

subject of research but early patient data 

is found in the article in Genes 

Chromosomes & Cancer listed below. 

Work related to the use of siRNA as a 

treatment strategy remains in its early 

stages of research and has not yet 

progressed to clinical trials. 

Inventors: Mark J. Roth and Konrad 

Huppi (NCI). 

Publications: 

1. The patent application has been 

published as WO 2006/086772 A2 on 17 

August 2006. 

2. MJ Roth et al. beta-Catenin splice 

variants and downstream targets as 

markers for neoplastic progression of 

esophageal cancer. Genes Chromosomes 

Cancer. 2005 Dec;44(4):423–428. 

3. SE Martin et al. Multiplexing 

siRNAs to compress RNAi-based screen 

size in human cells. Nucleic Acids Res. 

2007 Mar 28; E published ahead of 

print, doi:10.1093/nar/gkm141. 

4. A Thiele et al. AU-rich elements 

and alternative splicing in the betaCatenin 3’ UTR can influence the 

human beta-Catenin mRNA stability. 

Exp Cell Res. 2006 Jul;312:2367–2378. 

Patent Status: 

PCT/US2006/05032 filed 10 Feb 2006 

and published as WO 2006/086772 on 

17 Aug 2006, currently pending, 

entitled ‘‘Method of Diagnosing and 

Treating Cancer Using Beta Catenin 

Splice Variants’’ (HHS Reference No. E– 

018–2005/2–PCT–01); 

U.S. Provisional Application No. 60/ 

667,084 filed 30 Mar 2005, now 

abandoned (HHS Reference No. E–018– 

2005/1–US–01); 

U.S. Provisional Application No. 60/ 

652,154 filed 10 Feb 2005, now 

abandoned (HHS Reference No. E–018– 

2005/0–US–01). 

Biological Materials Availability: 

Biological materials related to this 

technology are available and include 

those referred to in the following 

publications as well as a series of 

recently established aptamers capable of 

specific binding to the CTNNB1 protein. 

1. MJ Roth et al. Cytologic detection 

of esophageal squamous cell carcinoma 

and precursor lesions using balloon and 

sponge samplers in asymptomatic adults 

in Linxian, China. Cancer. 1997 Dec 

1;80(11):2047–2059. 

2. Q–J Pan et al. Cytologic detection 

of esophageal squamous cell carcinoma 

and its precursor lesions using balloon 

samplers and liquid-based cytology in 

asymptomatic adults in Linxian, China. 

ACTA Cytologica (In Press). 

3. MJ Roth et al. A study of betacatenin splice variants and associated 

downstream targets as markers for 

neoplastic progression of squamous cell 

carcinoma of the esophagus. Genes 

Chromosomes Cancer. 2005 

Dec;44(4):423–428. 

4. PJ Limburg et al. Randomized, 

placebo-controlled esphogeal squamous 

cell cancer chemoprevention trial of 

selenomethionine and celecoxib. 

Gastroenterology. 2005 Sept;129(3):863– 

873. 

Licensing Availability: This 

application is available for license on a 

non-exclusive or exclusive basis. 

Licensing Contact: Susan S. Rucker, 

Esq.; 301/435–4478; 

ruckersu@mail.nih.gov 

Collaborative Research Opportunity: 

The National Cancer Institute, Division 

of Cancer Epidemiology and Genetics, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize a 

method of diagnosing and treating 

cancer using beta-Catenin splice 

variants. Please contact John D. Hewes, 

PhD at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 8356 

Dated: April 25, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E7–8356 Filed 5–1–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Fogarty International Center; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

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