Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61457 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21158 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

MicroArray Quality Control Project 

Meeting on MicroArray Quality Control; 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘MicroArray 

Quality Control (MAQC) Project 

Meeting on MicroArray Quality 

Control.’’ The focus of the 2-day 

meeting will be to review the datasets 

generated by the MAQC study. 

Date and Time: The meeting will be 

held on Thursday, December 1, 2005, 

from 8 a.m. to 5 p.m. and Friday, 

December 2, 2005, from 8 a.m. to 2 p.m. 

Location: The meeting will be held at 

the Crowne Plaza Cabana Portofino 

Room on December 1, 2005, and the St. 

Tropez Room on December 2, 2005, 

4290 El Camino Real, Palo Alto, CA 

94306, 650–857–0787, FAX: 650–496–

1939, Web site: http:// 

www.cppaloalto.crowneplaza.com/. 

(FDA has verified the Web site address, 

but is not responsible for subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

Contact: Leming Shi, National Center 

for Toxicological Research, Food and 

Drug Administration, 3900 NCTR Rd., 

Jefferson, AR 72079, 870–543–7387, 

FAX: 870–543–7686, e-mail: 

leming.shi@fda.hhs.gov. 

Registration: There will be no 

registration fee for attending the 

meeting. However, interested parties 

should send registration information 

(including name, title, firm name, 

address, telephone, and fax number), 

and written material and requests to 

make oral presentations, to the contact 

person (see Contact) at least 15 days in 

advance of the meeting. Participants are 

responsible for their own costs of travel, 

lodging, and meals. 

FDA welcomes the attendance of the 

public at this meeting and will make 

every effort to accommodate persons 

with physical disabilities or special 

needs. If you require special 

accommodations due to a disability, 

please contact Jeannette Coleman at 

870–543–7087, e-mail: 

jeanette.coleman@fda.hhs.gov, at least 7 

days in advance of the meeting. 

SUPPLEMENTARY INFORMATION: FDA’s 

critical path initiative (http:// 

www.fda.gov/oc/initiatives/criticalpath/ 

) identifies pharmacogenomics as a key 

opportunity in advancing medical 

product development and personalized 

medicine. FDA issued the ‘‘Guidance for 

Industry: Pharmacogenomic Data 

Submissions’’ (http://www.fda.gov/cder/ 

guidance/6400fnl.pdf) to facilitate 

scientific progress in the field of 

pharmacogenomics and to facilitate the 

use of pharmacogenomic data in drug 

development and medical diagnostics. 

A microarray is a tool for analyzing gene 

expression that consists of a small 

membrane or glass slide containing 

samples of many genes arranged in a 

regular pattern. Microarrays represent a 

core technology in pharmacogenomics; 

however, before this technology can 

successfully and reliably be applied in 

clinical practice and regulatory 

decisionmaking, standards and quality 

measures need to be developed. 

The MAQC project involves six FDA 

centers, major providers of microarray 

platforms and ribonucleic acid (RNA) 

samples, government agencies, 

academic laboratories, and other 

stakeholders. The MAQC project aims to 

evaluate quality control metrics and 

thresholds for objectively assessing the 

performance achievable by various 

microarray platforms, and evaluating 

the advantages and disadvantages of 

various data analysis methods. Two 

RNA samples will be selected for three 

species (i.e., human, rat, and mouse), 

and differential gene expression levels 

between the two samples will be 

calibrated with microarrays and other 

technologies (e.g., quantitative real timepolymerase chain reaction (qRT–PCR)). 

The resulting microarray datasets will 

be used for assessing the precision and 

crossplatform/laboratory comparability 

of microarrays, and the qRT–PCR 

datasets will enable evaluation of the 

nature and magnitude of any systematic 

biases that may exist between 

microarrays and qRT–PCR. The 

availability of the calibrated RNA 

samples and the resulting microarray 

and qRT–PCR datasets, which will be 

made readily accessible to the 

microarray community, will allow 

individual laboratories to identify and 

correct procedural failures more easily. 

The MAQC project will help improve 

the microarray technology and foster its 

proper applications in discovery, 

development and review of FDAregulated products. For more 

information about the MAQC project, 

please visit http://www.fda.gov/nctr/ 

science/centers/toxicoinformatics/ 

maqc/. 

At the public meeting, each 

participating platform provider will give 

a 15-minute presentation to summarize 

the datasets generated by its test sites 

and to describe its analysis results. Each 

analysis site will also give a 15-minute 

presentation on its analysis results. 

Other interested parties may present 

data, information, or views, orally or in 

writing, on issues related to microarray 

quality control and data analysis. Those 

desiring to make formal oral 

presentations should notify the contact 

person (see Contact) before November 4, 

2005, and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present with an 

indication of the approximate time 

requested to make the presentation. 

Dated: October 17, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21152 Filed 10–21–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Injuries Among Youth With 

Developmental Disabilities 

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 Institute of Child Health and 

Human Development (NICHD), 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: Injuries Among Youth with 

Developmental Disabilities. Type of 

Information Collection Request: New. 

Use of Information: The proposed study 

seeks (1) to determine if children with 

disabilities are at increased risk of 

injury compared to typically developing 

children, and (2) to identify which 

injuries children with developmental 

disabilities are at particular risk of 

sustaining. Existing data on this topic 

are scarce and equivocal. Results will 

help inform prevention efforts. NICHD 

proposes to collect information about 

disabilities among children with 

injuries through phone interviews with 

61458 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 

parents/guardians of children who were 

seen in an emergency department for an 

injury. This information will be 

collected in conjunction with the 

Consumer Product Safety Commission’s 

(CPSC’s) National Electronic Injury 

Surveillance System (NEISS). The 

NEISS is part of CPSC’s routine data 

collection. Through this system, trained 

abstractors code information from all 

injury-related emergency department 

visits in the participating hospital. 

Additional information will be collected 

through ‘‘follow-back’’ phone interviews 

with parents/guardians of injured 

children seen in participating hospitals. 

NICHD will collect information on 

developmental disabilities among 

injured children e.g., cerebral palsy, 

blindness, deafness or trouble hearing, 

autism, and mental retardation), 

medical/psychological conditions e.g. 

epilepsy/seizures, ADHD), medication 

use, and other potential risk factors for 

injury including family structure, 

sibling characteristics, and caregiver 

supervision practices. Finally, NICHD 

would like to determine if typically 

developing children who have a sibling 

with a developmental disability, who 

may compete for supervisory time, are 

at a greater risk of injury than other 

children. This Interagency Agreement 

provides funds from NICHD to CPSC to 

complete 8000 telephone interviews 

with parents/guardians of injured 

children. The sample of interviewees 

will be derived from a larger sample of 

children who will be systematically 

selected from the NEISS system. 

Sampling will cover an entire year to 

account for seasonal variations in injury 

rates. Two thousand interviews will be 

conducted in 4 different age groups: 0–

4 years, 5–9 years, 10–14 years, and 15–

19 years. Intentional injuries will not be 

included in the sampling pool. Further, 

deaths and hospitalizations will be 

excluded. Interviews will be limited to 

those who can complete an interview in 

English or Spanish. Frequency of 

Response: One interview; Affected 

Public: Individuals or households; Type 

of Respondents: Parents or Guardians; 

The annual reporting burden is as 

follows: Estimated Number of 

Respondents: 8000. Estimated Number 

of Responses per Respondent: 1; 

Average Burden Hours Per Response 

0.33; and Estimated Total Annual 

Burden Hours Requested: 2640. There 

are no Capital Costs, Operating Costs 

and/or Maintenance Costs to report. 

Type of respondents 

Estimated 

numbers of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

Parents/guardians ............................................................................................ 8000 1 .33 2640 

Request for Comments 

Written comments and/or suggestions 

from the public and affected agencies 

should address one or more of the 

following points: (1) Evaluate whether 

the proposed collection of information 

is necessary for the proper performance 

of the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate 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) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) 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: Gitanjali Saluja, 

Ph.D., 6100 Executive Blvd. Suite 7B03, 

Rockville, MD 20852. Phone: 301–435–

6917. E-mail: salujag@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 the date of this publication. 

Dated: October 13, 2005. 

Paul L. Johnson, 

Project Clearance Liaison, NICHD, National 

Institutes of Health. 

[FR Doc. 05–21116 Filed 10–21–05; 8:45 am] 

BILLING CODE 4140–01–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, DHHS. 

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. 

NIH3T3 Cell Lines Carrying c-Met 

Mutations Including G3906A, G3522A, 

G3810T, T3936C, T3936G, T3997C, 

C3528T, C3564G, C3831G, A3529T, and 

T3640C 

Laura S. Schmidt (NCI). 

HHS Reference No. E–327–2005/0—

Research Tool. 

Licensing Contact: John Stansberry; 301/ 

435–5236: stansbej@mail.nih.gov. 

MET is over expressed in a variety of 

cancers including hereditary papillary 

renal cell carcinoma and non-small cell 

lung cancer. These cell lines carry 

naturally-occurring Met mutations and 

were derived from the germline of 

patients with hereditary papillary renal 

cell carcinoma. These cell lines can be 

used as drug discovery research 

reagents. 

These cell lines were described in 

part in Schmidt et al., ‘‘Novel mutations 

of the MET proto-oncogene in papillary 

renal carcinomas. Oncogene. (1999) 

18:2343–2350 and Jeffers et al., 

‘‘Activating mutations for the met 

tyrosine kinase receptor in human 

cancer.’’ PNAS (1997) 94:11445–11450. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors.