18586 Federal Register / Vol. 74, No. 77 / Thursday, April 23, 2009 / Notices 

they possess properties from both of its 

parental compounds, etoposide and 

ellipticine. They act by stabilizing the 

top2–DNA cleavage complex, like 

etoposide does, instead of inhibiting 

top2 catalytic activity, the mechanism 

by which ellipticine acts. With regard to 

DNA cleavage activity, azatoxins show 

similar activity to etoposide. In addition 

to acting as a top2 inhibitor, azatoxin is 

also a potent inhibitor of tubulin 

polymerization. 

The anti-cancer activity of azatoxins 

has been validated by cell line 

screening. The Developmental 

Therapeutics Program (DTP) of the 

National Cancer Institute (NCI) has 

tested azatoxins in its tumor cell panel 

and established their effectiveness 

against disseminated leukemia and 

localized tumors, such as non-small cell 

lung and colon cancer. These results are 

very encouraging showing that certain 

azatoxin derivatives are 100 times more 

active than etoposide, which is the 

common top2 inhibitor used in 

chemotherapy. Azatoxins are a novel 

class of potent top2 and/or tubulin 

inhibitors that could outperform current 

chemotherapeutic agents. 

Technology Description 

Topoisomerase enzymes are critical 

for normal cell division because they 

prevent tangles and knots from forming 

during DNA replication by cleaving and 

religating DNA. Several compounds 

have been discovered that block 

topoisomerases and stop its ability to 

religate DNA resulting in an increased 

number of double strand DNA breaks 

that kill the cell. These inhibitors are 

especially effective against rapidly 

dividing malignant cells that express 

high levels of top2, which represents a 

main reason these top2 enzymes have 

become an important therapeutic target. 

The problem is that currently used 

drugs are limited by their toxicity, 

insolubility, and their susceptibility to 

induce drug resistance. 

In an effort to produce top2 inhibitors 

with increased therapeutic efficiency, 

well established top2 inhibitors were 

compared by molecular modeling to 

produce a composite top2 inhibitor 

pharmacophore of the diverse 

inhibitors. Based on this model, 

azatoxin was designed as an analogue 

hybrid of etoposide and ellipticine. 

Subsequently, several modifications of 

azatoxin have been synthesized to 

generate derivatives, such as 

anilinoazatoxins, which have improved 

pharmacological profiles. 

Market 

Despite further discoveries leading to 

a greater understanding and treating of 

cancer, it continues to be a burden to 

the public health. After heart disease, 

cancer is the most common cause of 

death in the United States. In 2008, it 

was estimated that about 565,650 

Americans were expected to die of 

cancer. Although, the incidence of 

cancer has been dropping over the 

years, it was estimated that over 1.4 

million Americans would be diagnosed 

with cancer in 2008. 

Cancer is not only a health burden but 

also a financial burden to the country. 

The NIH estimated the overall cost of 

cancer in 2007 to be $219.2 billion 

dollars with $89 billion attributable to 

direct medical costs. It is expected that 

cancer will continue to be a public 

health problem for the foreseeable 

future which prompts the need for the 

development of new therapeutics. 

Chemotherapy is still the standard 

approach for treating cancers even 

though there were high expectations 

that targeted therapeutics would become 

the preferred drugs in cancer treatment. 

Current topoisomerase inhibitors have 

demonstrated to be effective 

chemotherapy drugs and they continue 

being developed for use in combination 

therapy with targeted therapeutics. 

However, top2 inhibitors need to be 

improved in order to overcome their 

limitations. A next-generation top2 

inhibitor like azatoxins has potential in 

meeting this need. 

Patent Estate 

The National Institutes of Health 

holds a substantial portfolio of patents 

in U.S., Europe, Canada, and Australia 

which claim compositions of azatoxin 

and its derivatives, pharmaceutical 

formulations, and methods of use for 

chemotherapy. 

The portfolio includes the following 

issued patents: 

I. United States Patent No. 5,622,960 

entitled ‘‘Topoisomerase II inhibitors 

and therapeutic uses therefor’’ issued 

April 22, 1997 (HHS Ref. No. E–119– 

1992/1–US–01). 

II. United States Patent No. 5,747,520 

entitled ‘‘Topoisomerase II inhibitors 

and therapeutic uses therefor’’ issued 

May 5, 1998 (HHS Ref. No. E–119–1992/ 

1–US–17). 

III. European Patent No. 0665846 

entitled ‘‘Topoisomerase II inhibitors 

and therapeutic uses therefor’’ issued 

July 29, 1998 (HHS Ref. No. E–119– 

1992/1–EP–10) validated in Austria, 

Belgium, Denmark, France, Germany, 

Great Britain, Ireland, Italy, 

Luxembourg, Switzerland, and The 

Netherlands. 

IV. Canadian Patent No. 2147608 

entitled ‘‘Topoisomerase II inhibitors 

and therapeutic uses therefor’’ issued 

December 12, 2006 (HHS Ref. No. E– 

119–1992/1–CA–06). 

V. Australian Patent No. 676511 

entitled ‘‘Topoisomerase II inhibitors 

and therapeutic uses therefor’’ issued 

June 13, 1997 (HHS Ref. No. E–119– 

1992/1–AU–04). 

Next Step: Teleconference 

There will be a teleconference where 

the principal investigator, Dr. Yves 

Pommier, will explain this technology. 

Licensing and collaborative research 

opportunities will also be discussed. If 

you are interested in participating in 

this teleconference please call or e-mail 

Samuel Bish; (301) 435–5282; 

bishse@mail.nih.gov. The NIH Office of 

Technology Transfer (OTT) will then email you the date, time, and number for 

the teleconference. 

Dated: April 16, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–9344 Filed 4–22–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[Docket No. USCBP–2006–0037] 

Expansion of Global Entry Pilot 

Program 

AGENCY: U.S. Customs and Border 

Protection; Department of Homeland 

Security. 

ACTION: General notice. 

SUMMARY: U.S. Customs and Border 

Protection (CBP) is currently conducting 

an international trusted traveler pilot 

program, referred to as Global Entry, at 

seven U.S. airports. This document 

announces that pursuant to an 

arrangement between the United States 

and the Netherlands, CBP is expanding 

eligibility for participation in the Global 

Entry pilot to include citizens of the 

Netherlands who participate in Privium, 

an expedited travel program in the 

Netherlands, and who otherwise satisfy 

the requirements for participation in 

Global Entry. Currently, eligibility is 

limited to U.S. citizens, U.S. nationals, 

and U.S. lawful permanent residents 

(LPRs). Pursuant to this same 

arrangement, U.S. citizens who 

participate in the Global Entry pilot will 

have the option to also apply for 

participation in Privium. 

DATES: Effective Dates: Applications for 

the Global Entry pilot are currently 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 74, No. 77 / Thursday, April 23, 2009 / Notices 18587 

being accepted from U.S. citizens, U.S. 

nationals, and U.S. lawful permanent 

residents and will be accepted for the 

duration of the pilot. The expansion of 

eligibility to qualified citizens of the 

Netherlands will occur on April 23, 

2009. Applications will be accepted 

from qualified citizens of the 

Netherlands beginning April 23, 2009. 

Comments concerning this notice and 

all aspects of the announced pilot may 

also be submitted throughout the 

duration of the Global Entry pilot. 

ADDRESSES: You may submit comments, 

identified by ‘‘USCBP–2006–0037,’’ by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Border Security Regulations 

Branch, Regulations and Rulings, Office 

of International Trade, U.S. Customs 

and Border Protection, Mint Annex, 799 

9th Street, NW., Washington, DC 20229. 

Instructions: All submissions received 

must include the agency name, 

document title, and docket number 

(USCBP–2006–0037) for this notice. All 

comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received go to http:// 

www.regulations.gov. Submitted 

comments may also be inspected during 

regular business days between the hours 

of 9 a.m. and 4:30 p.m. at the Office of 

Regulations and Rulings, Office of 

International Trade, U.S. Customs and 

Border Protection, 799 9th Street, NW., 

5th Floor, Washington, DC. 

Arrangements to inspect submitted 

comments should be made in advance 

by calling Mr. Joseph Clark at (202) 325– 

0118. 

Applications for the Global Entry 

pilot are available through the Global 

On-Line Enrollment System (GOES) at 

http://www.globalentry.gov. 

Applications must be completed and 

submitted electronically. 

FOR FURTHER INFORMATION CONTACT: 

Fiorella Michelucci, Office of Field 

Operations, (202) 344–2564. 

SUPPLEMENTARY INFORMATION: 

Background 

In a notice published in the Federal 

Register (73 FR 19861) on April 11, 

2008, CBP announced an international 

trusted traveler pilot program, then 

referred to as International Registered 

Traveler (IRT) program, which was 

scheduled to commence operations at 

three initial U.S. airports on June 10, 

2008. In a subsequent notice published 

in the Federal Register (73 FR 30416) on 

May 27, 2008, CBP changed the name of 

the pilot program from IRT to Global 

Entry and moved up the starting date to 

June 6, 2008. 

The Global Entry pilot program allows 

for the expedited clearance of preapproved, low-risk travelers into the 

United States. The initial Federal 

Register notice published on April 11, 

2008 contained a detailed description of 

the program, the eligibility criteria and 

the application and selection process, 

and the initial airport locations: John F. 

Kennedy International Airport, Jamaica, 

New York, Terminal 4 (JFK); the George 

Bush Intercontinental Airport, Houston, 

Texas (IAH); and the Washington Dulles 

International Airport, Sterling, Virginia 

(IAD). CBP chose these initial airports 

due to the large numbers of travelers 

that arrive at those locations from 

outside the United States. 

On August 13, 2008, in a notice 

published in the Federal Register (73 

FR 47204), CBP announced that the 

pilot had expanded to include all 

terminals at JFK and four additional 

airports: Los Angeles International 

Airport, Los Angeles, California (LAX); 

Hartsfield-Jackson Atlanta International 

Airport, Atlanta, Georgia (ATL); Chicago 

O’Hare International Airport, Chicago, 

Illinois (ORD); and Miami International 

Airport, Miami, Florida (MIA). 

Operations 

The Global Entry pilot project allows 

pilot participants expedited entry into 

the United States at any of the 

designated airport locations by using 

automated kiosks located in the Federal 

Inspection Services (FIS) area of each 

airport. Global Entry uses fingerprint 

biometrics technology to verify a 

participant’s identity and confirm his or 

her status as a participant. 

After arriving at the FIS area, 

participants proceed directly to the 

Global Entry kiosk. A sticker affixed to 

the participant’s passport at the time of 

acceptance in Global Entry will provide 

visual identification that the individual 

can be referred to the kiosk. Global 

Entry participants need not wait in the 

regular passport control primary 

inspection lines. 

After arriving at the kiosk, 

participants activate the system by 

inserting into the document reader 

either a machine-readable passport or a 

machine-readable U.S. permanent 

resident card. On-screen instructions 

guide participants to provide 

fingerprints electronically. These 

fingerprints are compared with the 

fingerprint biometrics on file to validate 

identity and confirm that the individual 

is a member of the program. Participants 

are also prompted to look at the camera 

for a digital photograph and to respond 

to several customs declaration questions 

by use of a touch-screen. 

When the procedures at the kiosk 

have been successfully completed, 

participants are issued a transaction 

receipt. This receipt must be provided 

along with the passport or permanent 

resident card to the CBP Officer at the 

exit control area who will examine and 

inspect these documents. CBP Officers 

stationed in booths next to the kiosk 

lanes also oversee activities at the kiosk. 

Declarations 

When using the Global Entry kiosks, 

Global Entry participants are required to 

declare all articles being brought into 

the U.S. pursuant to 19 CFR 148.11. 

If a Global Entry participant declares 

any of the following, the kiosk redirects 

that user to the head of the line at the 

nearest, open passport control, primary 

inspection station: 

(a) Commercial merchandise or 

commercial samples, or items that 

exceed the applicable personal 

exemption amount; 

(b) More than $10,000 in currency or 

other monetary instruments (checks, 

money orders, etc.), or foreign 

equivalent in any form; or 

(c) Restricted/prohibited goods, such 

as agricultural products, firearms, mace, 

pepper spray, endangered animals, 

birds, narcotics, fireworks, Cuban goods, 

and plants. 

Global Entry participants may also be 

subject to further examination and 

inspection as determined by CBP 

Officers at any time during the arrival 

process. 

For a more detailed description of the 

Global Entry pilot program, please refer 

to the April 11, 2008 Federal Register 

notice, 73 FR 19861. 

Expanded Eligibility 

Eligibility criteria for participation in 

the Global Entry pilot are set forth in 

detail in the April 11, 2008 Federal 

Register notice. To date, only U.S. 

citizens, U.S. nationals, and U.S. LPRs 

are eligible to participate in the pilot. 

However, as explained in the April 11, 

2008 Federal Register notice, CBP is 

working with other countries to 

recognize comparable programs 

operated by these countries and, as 

these arrangements are finalized, CBP 

will expand its eligibility criteria. The 

notice stated that such expansions of the 

pilot would be announced by 

publication in the Federal Register. 


sroberts on PROD1PC70 with NOTICES
18588 Federal Register / Vol. 74, No. 77 / Thursday, April 23, 2009 / Notices 

1Section 7208 of the Intelligence Reform and 

Terrorism Prevention Act of 2004 (IRPTA), 118 Stat. 

3638, as amended by section 565 of the 

Consolidated Appropriations Act, 2008, 121 Stat. 

1844, codified at 8 U.S.C. 1365b, directs the 

Secretary to establish an international registered 

traveler program in coordination with US–VISIT, 

other prescreening initiatives, and the Visa Waiver 

Program. See 8 U.S.C. 1365b(k)(3). 

Expansion of Global Entry to Certain 

Citizens of the Netherlands 

The United States has entered into an 

arrangement with the Netherlands 

concerning Global Entry. Pursuant to 

this arrangement, CBP is expanding 

eligibility for the Global Entry pilot. 

Specifically, citizens of the Netherlands 

who participate in Privium, an 

expedited travel program in the 

Netherlands, will now be able to apply 

for participation in the Global Entry 

pilot. In order to participate, these 

citizens of the Netherlands will be 

required to complete the on-line 

application, pay the non-refundable 

$100 per person applicant processing 

fee, and satisfy all the requirements of 

the Global Entry pilot. Based on the 

terms of the arrangement reached with 

the Government of the Netherlands, 

these citizens will be permitted to 

participate in the Global Entry pilot 

only upon successful completion of a 

thorough risk assessment by both U.S. 

Customs and Border Protection and the 

Government of the Netherlands. 

No person who is inadmissible to the 

United States under U.S. immigration 

law is eligible to participate in the 

Global Entry pilot. Applications from 

such individuals will automatically be 

rejected. Applications for the Global 

Entry pilot may also be rejected if the 

applicant has ever been convicted of a 

criminal offense, or the individual has 

ever been found in violation of the 

customs or immigration laws of the 

United States, or of any criminal law. 

Additionally, no applicant will be 

accepted for participation in the Global 

Entry pilot if CBP determines that the 

individual presents a potential risk for 

terrorism, criminality or smuggling, or if 

CBP cannot sufficiently determine that 

the applicant meets all the program 

eligibility criteria. CBP will be accepting 

applications from eligible citizens of the 

Netherlands beginning April 23, 2009. 

Additional information on eligibility 

will be announced at http:// 

www.globalentry.gov. 

The Netherlands is also a participant 

in the Visa Waiver Program (VWP). The 

VWP enables citizens and nationals 

from participating countries to travel to 

and enter the United States for business 

or pleasure purposes for up to 90 days 

without obtaining a visa.1 VWP travelers 

are now required to obtain a travel 

authorization via ESTA (Electronic 

System for Travel Authorization) prior 

to traveling to the United States under 

the VWP. ESTA is accessible online at 

https://esta.cbp.dhs.gov. The ESTA 

requirements will continue to be 

applicable to Global Entry applicants 

who are VWP travelers. Global Entry 

applicants from the Netherlands who 

wish to travel to the United States under 

the VWP who have not already received 

a travel authorization via ESTA will be 

able to do so as part of the Global Entry 

application and enrollment process. 

During the Global Entry enrollment and 

interview phase the applicant will be 

asked whether he or she is in possession 

of an ESTA authorization number. If not 

in possession of an ESTA authorization 

number, the applicant will be asked 

questions from which it can be 

determined whether the applicant is 

VWP-eligible, and a determination 

regarding ESTA authorization will be 

made. 

All other aspects of the program as 

described in the April 11, 2008 notice 

are still in effect. 

U.S. Citizen Participation in Privium 

Pursuant to the reciprocal 

arrangement with the Government of the 

Netherlands, U.S. citizens who 

participate in the Global Entry pilot will 

have the option to also apply for 

participation in Privium. Privium is an 

automated border passage system in the 

Netherlands that provides expedited 

entry and exit at Amsterdam Airport 

Schiphol. It uses iris scans to provide 

quick and secure biometric confirmation 

of a traveler’s identity. Enrollment 

includes an eligibility assessment by the 

Dutch border police. Upon a positive 

determination of eligibility, pictures of 

each iris are taken and stored on a 

personalized smart card. Upon entry 

and exit, Privium members place their 

Privium smart card into a reader and a 

passport validity check is performed 

with the Dutch authorities and valid 

membership is verified. The 

individual’s iris information is then 

compared against the iris information 

stored on the card. This border passage 

process takes approximately twelve 

seconds. 

Additional fees and information 

sharing beyond CBP’s Global Entry 

requirements are needed for U.S. 

citizens who wish to participate in 

Privium through Global Entry. If 

approved, U.S. citizens would be able to 

take advantage of expedited travel into, 

and out of, the Netherlands at 

Amsterdam Airport Schiphol. More 

information about how to apply for 

Privium membership is available at 

http://www.globalentry.gov. 

Dated: April 16, 2009. 

Susan T. Mitchell, 

Acting Assistant Commissioner, Office of 

Field Operations. 

[FR Doc. E9–9221 Filed 4–22–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5285–N–14] 

Notice of Proposed Information 

Collection: Comment Request; FHA 

Insured Title I Property Improvement 

and Manufactured Home Loan 

Programs 

AGENCY: Office of the Assistant 

Secretary for Housing—Federal Housing 

Commissioner, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

will be submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 

DATES: Comments Due Date: June 22, 

2009. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

Control Number and should be sent to: 

Lillian Deitzer, Departmental Reports 

Management Officer, QDAM, 

Department of Housing and Urban 

Development, 451 7th Street, SW., 

Washington, DC 20410; e-mail or 

telephone (202) 402–8048. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Burns, Director, Office of 

Single Family Program Development, 

Department of Housing and Urban 

Development, 451 7th Street, SW., 

Washington, DC 20410, telephone (202) 

708–2121 (this is not a toll free number) 

for copies of the proposed forms and 

other available information. 

SUPPLEMENTARY INFORMATION: The 

Department is submitting the proposed 

information collection to OMB for 

review, as required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

Chapter 35, as amended). 

This Notice is soliciting comments 

from members of the public and affected 

agencies concerning the proposed 

collection of information to: (1) Evaluate 

whether the proposed collection is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 


sroberts on PROD1PC70 with NOTICES