1798 Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Development of V–ATPase 

Inhibitor Compounds for the Treatment 

of Human Cancers and Osteoclastic 

Bone Diseases Excluding Rheumatoid 

Arthritis and Other Osteo-Specific 

Auto-Immune Diseases 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This is notice, in accordance 

with 35 U.S.C. 209(c)(1) and 37 CFR 

Part 404.7(a)(1)(i), that the National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of an exclusive 

patent license to practice the inventions 

embodied in the following U.S. Patents 

and Patent Applications to the 

Australian Institute of Marine Science 

(‘‘AIMS’’) located in Townsville, 

Queensland, Australia. 

Intellectual Property 

• U.S. Provisional Patent Application 

No. 60/398,092 filed July 24, 2002 

entitled ‘‘Chondropsin-Class Antitumor 

V–ATPase Inhibitor Compounds, 

Compositions and Methods of Use 

Thereof’’ [HHS Ref. No. E–191–2002/0– 

US–01]; 

• International Patent Application 

No. PCT/US03/23290 filed July 24, 2003 

entitled ‘‘Chondropsin-Class Antitumor 

V–ATPase Inhibitor Compounds, 

Compositions and Methods of Use 

Thereof’’ [HHS Ref. No. E–191–2002/0– 

PCT–02]; 

• U.S. Patent Application No. 10/ 

521,930 filed April 18, 2005 entitled 

‘‘Chondropsin-Class Antitumor V– 

ATPase Inhibitor Compounds, 

Compositions and Methods of Use 

Thereof’’ [HHS Ref. No. E–191–2002/0– 

US–03]; 

• European Patent Application No. 

03751813.1 filed February 16, 2005 

entitled ‘‘Chondropsin-Class Antitumor 

V–ATPase Inhibitor Compounds, 

Compositions and Methods of Use 

Thereof’’ [HHS Ref. No. E–191–2002/0– 

EP–04]; 

• Australian Patent Application No. 

2003269924 filed February 4, 2005 

entitled ‘‘Chondropsin-Class Antitumor 

V–ATPase Inhibitor Compounds, 

Compositions and Methods of Use 

Thereof’’ [HHS Ref. No. E–191–2002/0– 

AU–05]; 

• Canadian Patent Application No. 

2493821 filed January 24, 2005 entitled 

‘‘Chondropsin-Class Antitumor V– 

ATPase Inhibitor Compounds, 

Compositions and Methods of Use 

Thereof’’ [HHS Ref. No. E–191–2002/0– 

CA–06]; 

• U.S. Patent No. 7,521,475 issued 

April 21, 2009 entitled ‘‘ChondropsinClass Antitumor V–ATPase Inhibitor 

Compounds, Compositions and 

Methods of Use Thereof’’ [HHS Ref. No. 

E–191–2002/0–US–07]; 

• U.S. Patent Application No. 12/ 

402,560 filed March 12, 2009 entitled 

‘‘Chondropsin-Class Antitumor V– 

ATPase Inhibitor Compounds, 

Compositions and Methods of Use 

Thereof’’ [HHS Ref. No. E–191–2002/0– 

US–08]; 

• U.S. Provisional Patent Application 

No. 60/220,270 filed July 24, 2000 

entitled ‘‘Biologically Active Macrolides, 

Compositions, and Uses Thereof’’ [HHS 

Ref. No. E–203–2000/0–US–01]; 

• International Patent Application 

No. PCT/US01/23633 filed July 24, 2001 

entitled ‘‘Biologically Active Macrolides, 

Compositions, and Uses Thereof’’ [HHS 

Ref. No. E–203–2000/0–PCT–02]; 

• US Patent No. 7,144,918 issued 

December 5, 2006 entitled ‘‘Biologically 

Active Macrolides, Compositions, and 

Uses Thereof’’ [HHS Ref. No. E–203– 

2000/0–US–04]; 

• US Patent Application No. 11/ 

435,189 filed May 16, 2006 entitled 

‘‘Biologically Active Macrolides, 

Compositions, and Uses Thereof’’ [HHS 

Ref. No. E–203–2000/0–US–08]; 

• Australian Patent No. 200112808 

issued November 30, 2006 entitled 

‘‘Biologically Active Macrolides, 

Compositions, and Uses Thereof’’ [HHS 

Ref. No. E–203–2000/0–US–03]; 

• European Patent Application No. 

01959257.5 filed July 24, 2001 entitled 

‘‘Biologically Active Macrolides, 

Compositions, and Uses Thereof’’ [HHS 

Ref. No. E–203–2000/0–EP–05]; 

• Canadian Patent Application No. 

2415611 filed July 24, 2001 entitled 

‘‘Biologically Active Macrolides, 

Compositions, and Uses Thereof’’ [HHS 

Ref. No. E–203–2000/0–CA–06]; and 

• Japanese Patent Application No. 

514137/2002 filed July 24, 2001 entitled 

‘‘Biologically Active Macrolides, 

Compositions, and Uses Thereof’’ [HHS 

Ref. No. E–203–2000/0–JP–07]. 

The patent rights in these inventions 

have been assigned to the United States 

of America. 

The prospective exclusive license 

territory may be worldwide and the 

field of use may be for ‘‘use of Licensed 

Patent Rights for use and development 

of pharmaceutically suitable V–ATPase 

Inhibitor compounds for the treatment 

of human cancers, including 

osteosarcoma, and osteoclastic bone 

diseases, such as osteoporosis, 

osteopenia and Paget’s disease, ’’ in ‘‘all’’ 

geographic territories. For avoidance of 

doubt, the field of use will specifically 

exclude rheumatoid arthritis and other 

osteo-specific autoimmune diseases. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

February 12, 2010 will be considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, comments, 

and other materials relating to the 

contemplated exclusive license should 

be directed to: Sabarni K. Chatterjee, 

PhD Licensing and Patenting Associate, 

Cancer Branch, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Telephone: 

(301) 435–5587; Facsimile: (301) 435– 

4013; e-mail: chatterjeesa@od.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

technology describes the class of 

Chondropsin compounds and its 

derivatives. The compounds can be 

potentially developed into new 

therapeutics for cancer, osteoporosis, 

and Alzheimer’s diseases. 

Briefly, vacuolar type (H+) ATPase 

(V–ATPase) has been described as ‘‘a 

universal proton pump of eukaryotes’’. 

V–ATPase is responsible for 

maintaining internal acidity and is 

important in myriad of physiological 

functions, such as sorting of membrane 

proteins, proinsulin conversion, 

neurotransmitter uptake, and cellular 

degradation process. This technology 

describes a new chondropsin, 

Poecillastrin-A, a cytotoxic, 33-member 

ring, macrolide lactam, isolated from the 

sponge Poecillastra sp. It is structurally 

related to the chondropsin class of 

macrolide lactams. However, it 

possesses unique patterns of 

methylation and oxygenation, and it is 

the first member of this family of 

polyketide derivatives with a 33- 

membered macrocyclic ring. The in 

vitro anti-tumor activity of the 

compound is comparable to that of the 

chondropsins, however the new 

structural features found in 

Poecillastrin-A broaden the known 

structural diversity of this family of 

potent anti-proliferative and cytotoxic 

macrolide lantams. The chondropsins 

and poecillastrin A produce a 

distinctive pattern of differential 

cytotoxicity in the NCI’s 60 cell 

antitumor screen that directly correlates 

with selective V–ATPase inhibitors. 

This class of compounds and its’ 

derivatives have the potential of being 

used as a therapeutics against several 

cancer types and may have applicability 

as highly selective anti-cancer small 

molecule inhibitors. Additionally, it has 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 / Notices 1799 

the potential of being used for the 

treatment of several other diseases such 

as osteoporosis, and Alzheimer’s 

diseases. 

The prospective exclusive license will 

be royalty bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR part 404.7. The 

prospective exclusive license may be 

granted unless within thirty (30) days 

from the date of this published notice, 

the NIH receives written evidence and 

argument that establishes that the grant 

of the license would not be consistent 

with the requirements of 35 U.S.C. 209 

and 37 CFR part 404.7. 

Applications for a license in the field 

of use filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive license. 

Comments and objections submitted to 

this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: December 29, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–420 Filed 1–12–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Accreditation of Commercial 

Laboratories and Approval of 

Commercial Gaugers 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: 30-Day notice and request for 

comments; Extension of an existing 

information collection: 1651–0053. 

SUMMARY: U.S. Customs and Border 

Protection (CBP) of the Department of 

Homeland Security has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act: Accreditation of 

Commercial Laboratories and Approval 

of Commercial Gaugers. This is a 

proposed extension of an information 

collection that was previously 

approved. CBP is proposing that this 

information collection be extended with 

no change to the burden hours. This 

document is published to obtain 

comments from the public and affected 

agencies. This proposed information 

collection was previously published in 

the Federal Register (74 FR 58036) on 

November 10, 2009, allowing for a 60- 

day comment period. This notice allows 

for an additional 30 days for public 

comments. This process is conducted in 

accordance with 5 CFR 1320.10. 

DATES: Written comments should be 

received on or before February 12, 2010. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

this proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget. Comments should be addressed 

to the OMB Desk Officer for Customs 

and Border Protection, Department of 

Homeland Security, and sent via 

electronic mail to 

oira_submission@omb.eop.gov or faxed 

to (202) 395–5806. 

SUPPLEMENTARY INFORMATION: U.S. 

Customs and Border Protection (CBP) 

encourages the general public and 

affected Federal agencies to submit 

written comments and suggestions on 

proposed and/or continuing information 

collection requests pursuant to the 

Paperwork Reduction Act (Pub. L. 104– 

13). Your comments should address one 

of the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency/component, 

including whether the information will 

have practical utility; 

(2) Evaluate the accuracy of the 

agencies/components 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 

collections of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

techniques or other forms of 

information. 

Title: Accreditation of Commercial 

Laboratories and Approval of 

Commercial Gaugers. 

OMB Number: 1651–0053. 

Form Number: None. 

Abstract: Commercial gaugers and 

laboratories seeking accreditation or 

approval must provide the information 

specified in 19 CFR 151.12 and/or 19 

CFR 151.13 to CBP. CBP uses this 

information in deciding whether to 

approve individuals or businesses 

desiring to measure bulk products or to 

analyze importations 

Current Actions: There are no changes 

to the information collection. This 

submission is being made to extend the 

expiration date. 

Type of Review: Extension (without 

change). 

Affected Public: Businesses, 

Individuals. 

Reporting 

Estimated Number of Respondents: 

200. 

Estimated Number of Responses per 

Respondent: 1. 

Estimated Number of Total 

Responses: 200. 

Estimated Time per Response: 75 

minutes. 

Estimated Total Burden Hours: 250. 

Recordkeeping 

Estimated Number of Recordkeepers: 

200. 

Estimated Time per Recordkeeper: 60 

minutes. 

Estimated Total Burden Hours: 200. 

If additional information is required 

contact: Tracey Denning, U.S. Customs 

and Border Protection, Office of 

Regulations and Rulings, 799 9th Street, 

NW., 7th Floor, Washington, DC 20229– 

1177, at 202–325–0265. 

Dated: January 7, 2009. 

Tracey Denning, 

Agency Clearance Officer, U.S. Customs and 

Border Protection. 

[FR Doc. 2010–464 Filed 1–12–10; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2009–0299] 

Terminate Long Range Aids to 

Navigation (Loran-C) Signal 

AGENCY: U.S. Coast Guard, DHS. 

ACTION: Notice; correction. 

SUMMARY: The Coast Guard is correcting 

a notice that appeared in the Federal 

Register of January 7, 2010 (75 FR 998). 

The document announced termination 

of the Long Range Aids to Navigation 

(Loran-C) Signal commencing on or 

about February 8, 2010. The document 

had an incorrect word in the DATES

section. 

DATES: Effective January 13, 2010. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, 

contact Mr. Mike Sollosi, U.S. Coast 

Guard, Department of Homeland 

Security, telephone (202) 372–1545, 

Mike.M.Sollosi@uscg.mil. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 7, 2010, in 


srobinson on DSKHWCL6B1PROD with NOTICES