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. 

Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 61459 

Mouse Fibroblasts Stably Expressing CType Lectin Receptors DC–SIGN and L–

SIGN 

Vineet N. KewelRamani and Thomas 

Martin (NCI). 

HHS Reference Nos. E–321–2005/0 and 

E–322–2005/0—Research Tools. 

Licensing Contact: Susan Ano; 301/435–

5515; anos@mail.nih.gov. 

The NIH is pleased to offer for 

licensing mouse fibroblasts that stably 

express the C-type lectin receptors DC–

SIGN and L–SIGN (CD209 and CD209L, 

respectively). L–SIGN and DC–SIGN 

both exhibit selectivity for highly 

mannosylated glycoproteins. DC–SIGN 

is also selective for certain Lewis X 

sugar groups. These types of 

interactions allow L–SIGN and DC–

SIGN to interact with a wide spectrum 

of pathogens including HIV, hepatitis C 

virus, and SARS coronavirus, which 

appear to use L–SIGN and DC–SIGN to 

facilitate their replication. In addition to 

HIV, HCV, and SARS, pathogens such as 

Ebola virus, some herpes viruses, and 

tuberculosis interact with DC–SIGN. In 

contrast to primary cells expressing L–

SIGN and DC–SIGN, the subject 

fibroblasts are resilient, adhere to coated 

tissue culture plates, grow rapidly and 

continually express high levels of their 

respective receptor. The subject 

materials could be used to study the 

interaction of pathogens with L–SIGN or 

DC–SIGN and to screen for compounds 

that block these interactions. 

Additionally, the materials could be 

used for the development of antibodies 

or compounds through rational design 

that interacted with L–SIGN or DC–

SIGN. The NIH3T3/DC–SIGN and 

NIH3T3/L–SIGN cells are further 

described in Journal of Virology, 2002, 

vol. 26(12), pages 5905–5914. The 

subject technologies are available for 

licensing from the NIH through 

biological materials license agreements. 

Murine Mast Cell Line Useful for 

Toxicity and Immunopotency Screens 

Michael Potter (NCI). 

HHS Reference No. E–274–2005/0—

Research Tool. 

Licensing Contact: John Stansberry; 301/ 

435–5236; stansbej@mail.nih.gov. 

The technology is a mouse cell line 

(P815) that could be useful for screening 

biological and chemical agents for 

toxicity and immunopotency. 

Specifically, the cell line is useful for 

screening for toxic effects of 

immunopotentiators including 

Mycobacterium bovis, Bacillus 

Calmette-Gurerin strain, zymosan, 

lipopolysaccharide and dextran sulfate. 

The cell line may also have application 

in screening other compounds. 

The cell line may also prove useful for 

studies of cancer and tumor 

immunology as injection of mice with 

P815 leads to progressive tumors. The 

P815 tumors express cell surface 

antigens that could provide a model for 

cancer vaccine development. 

Mutated Pseudomonas Exotoxins with 

Reduced Antigenicity 

Ira H. Pastan et al. (NCI). 

U.S. Provisional Patent Application 

filed 29 Jul 2005 (HHS Reference No. 

E–262–2005/0–US–01). 

Licensing Contact: Jesse S. Kindra; 301–

435–5559; kindraj@mail.nih.gov. 

The use of Pseudomonas exotoxins 

(PE) for treatment of solid tumors, in 

particular, has been limited because of 

the development of neutralizing 

antibodies to the immunotoxin after the 

first administration. These antibodies 

develop before most protocols would 

call for a second administration of the 

immunotoxin, and therefore render 

further use of the immunotoxins 

ineffective against solid tumors in 

previously exposed patients. 

The studies underlying this novel 

invention reveal that the predominant 

immune response of patients to PEimmunotoxins is the PE portion of the 

immunotoxin. This finding indicates 

that reducing the antigenicity of the PE 

molecules used for immunotoxins 

would reduce the overall antigenicity of 

the immunotoxin, and increase their 

utility. 

Therefore, this invention relates to 

mutated Pseudomonas exotoxins (PE) 

that have reduced antigenicity 

compared to PEs containing the native 

sequence. The PEs of this invention 

have one or more individual mutations 

that reduce antibody binding to one or 

more epitopes of PE. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

Methods and Materials for Identifying 

Polymorphic Variants, Diagnosing 

Susceptibilities, and Treating Disease 

Lawrence C. Brody (NHGRI) et al. 

PCT Application No. PCT/US05/21288 

filed 16 Jun 2005 (HHS Reference No. 

E–149–2005/0–PCT–01). 

Licensing Contact: Marlene Shinn-Astor; 

301/435–4426; shinnm@mail.nih.gov. 

This invention relates to materials 

and methods associated with 

polymorphic variants in two enzymes 

involved in folate-dependent and onecarbon metabolic pathways important in 

pregnancy-related complications and 

neural tube birth defects: MTHFD1 

(5,10-methylenetrahydrofolate 

dehydrogenase, 5,10- 

methenyltetrahydrofolate 

cyclohydrolase, 10- 

formyltetrahydrofolate synthase) and 

methylenetetrahydrofolate 

dehydrogenase (NADP+ dependent) 1- 

like (MTHFD1L). These enzymes are 

extremely important in the promotion of 

DNA synthesis, a process that is critical 

for normal placental and fetal 

development. 

Recently, the inventors have 

discovered that a MTHFD1 

polymorphism is also a strong maternal 

genetic risk factor for placental 

abruption, premature separation of a 

normally implanted placenta. This 

polymorphism may also be a risk factor 

for first and second trimester 

miscarriages. Diagnostic and therapeutic 

methods are provided in this invention 

involving the correlation of 

polymorphic variants in MTHFD1 and 

other genes with relative susceptibility 

for various pregnancy-related and other 

complications such as cancer, 

cardiovascular disease, and 

developmental anomalies. Both nutrient 

status and genetic background are 

independent yet interacting risk factors 

for impaired folate metabolism. 

However, the mechanisms that lead to 

pathology or the mechanisms whereby 

folate prevents these disorders are 

unknown. Therefore, a diagnostic and 

therapeutic invention of this kind 

would significantly improve the 

detection and treatment of disorders 

associated with folate metabolism. 

For further information, see Brody 

et al., July 28, 2005, ‘‘A polymorphism 

in the MTHFD1 gene increases a 

mother’s risk of having an unexplained 

second trimester pregnancy loss,’’ Mol. 

Hum. Reprod. 10.1093/molehr/gah204. 

In addition to licensing, the 

technology is available for further 

development through collaborative 

research opportunities with the 

inventors. 

AAV5 Vector and Uses Thereof 

John A. Chiorini, Robert M. Kotin 

(NHLBI). 

U.S. Provisional Application No. 60/ 

087,029 filed 28 May 1998 (HHS 

Reference No. E–127–1998/0–US–01). 

U.S. Patent Application No. 09/717,789 

filed 21 Nov 2000 (HHS Reference No. 

E–127–1998/0–US–07). 

U.S. Patent Application Serial No. 11/ 

184,380 filed 19 Jul 2005 (HHS 

Reference No. E–127–1998/0–US–08). 

Licensing Contact: Jesse S. Kindra; 301/ 

435–5559; kindraj@mail.nih.gov. 

The invention described and claimed 

in this patent application provides for 

novel vectors and viral particles which 

61460 Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Notices 

comprise adeno-associated virus 

serotype 5 (AAV5). AAV5 is a singlestranded DNA virus of either plus or 

minus polarity which, like other AAV 

serotypes (e.g., AAV4, AAV2) requires a 

helper virus for replication. AAV type 2 

has the interesting and potentially 

useful ability to integrate into human 

chromosome 19 q 13.3-q ter. This 

activity is dependent on the nonstructural, Rep, proteins of AAV2. The 

Rep proteins of AAV types 2 and 5 are 

dissimilar and are not able to substitute 

in DNA replication of the heterologous 

serotype. 

AAV5 offers several advantages which 

make it attractive for use in gene 

therapy: 1. Increased production (10–50 

fold greater than AAV2); 2. distinct 

integration locus when compared to 

AAV2; 3. Rep protein and ITR regions 

do not complement other AAV 

serotypes; and 4. appears to utilize 

different cell surface attachment 

molecules than those of AAV type 2. 

In addition to licensing, the 

technology may be available for further 

development through collaborative 

research opportunities with the 

inventors. 

The Use of Nitroxides in the 

Prophylactic and Therapeutic 

Treatment of Cancer Due to Genetic 

Defects 

James Mitchell, Angelo Russo, Anne 

Deluca and Murali Cherukuri (NCI). 

U.S. Patent Application No. 09/424,519 

filed 03 Mar 2000, claiming priority to 

27 May 1997 (HHS Reference No. E–

167–1997/0–US–07). 

Licensing Contact: George Pipia; 301/ 

435–5560; pipiag@mail.nih.gov. 

The invention is a method for 

preventing or treating cancer, especially 

cancers associated with defects in the 

p53 gene. This gene is generally 

considered to be a tumor-suppressor 

gene, and in a large percentage of 

malignancies including pancreatic, 

colon, lung, and breast, the gene is 

found to be inactive in the cancer. It is 

believed that many individuals have 

genetic defects in p53 predisposing 

them to cancer. 

The invention involves the use of 

certain nitroxides as agents to slow the 

appearance or progression of tumors 

associated with p53 knockout. Thus, 

these compounds could serve as 

preventative agents for people 

predisposed to cancer, or as therapeutic 

agents for certain cancers. As nitroxides 

have already been identified as 

antioxidants, such agents could become 

part of a cancer prevention and antiaging regimen. A new method of use for 

these compounds now include their use 

in imaging, which correlates functional 

information about the tumor with 

magnetic resonance imaging data. 

Dated: October 13, 2005. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 05–21118 Filed 10–21–05; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed 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 the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel PAR–04–

020: Small Grants for Behavioral Research in 

Cancer Control 

Date: November 9, 2005. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications 

Place: Gaithersburg Marriott 

Washingtonian Center, 9751 Washington 

Boulevard, Gaithersburg, MD 20878 

Contact Person: C. Michael Kerwin, PhD, 

MPH, Scientific Review Administrator, 

Special Review and Logistics Branch, 

Division of Extramural Activities, National 

Cancer Institute, National Institutes of 

Health, 6116 Executive Boulevard, Room 

8057, MSC 8329, Bethesda, MD 20892–8329, 

301–496–7421, kerwinm@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: October 13, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21124 Filed 10–21–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed 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 the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel 

Large-Scale Genotyping of NHLBI Cohorts 

Date: October 20, 2005. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate contract 

proposals 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Valerie L Prenger, PhD, 

Chief, Review Branch, Division of Extramural 

Affairs, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, MSC 7924, 

Room 7214, Bethesda, MD 20892–7924, 301–

435–0270, prengerv@nhlbi.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

October 24, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–21133 Filed 10–21–05; 8:45 am] 

BILLING CODE 4140–01–M