Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Notices 14575 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Orally Active Synthetic 

Estrogens for Fertility Control, 

Hormone Replacement Therapy, and 

Endometriosis 

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 

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

Institutes of Health (NIH), Department 

of Health and Human Services, is 

contemplating the grant of an exclusive 

patent license to practice the invention 

embodied in United States Patent No. 

5,554,603, issued September 10, 1996, 

entitled ‘‘Orally Active Derivatives of 1, 

3, 5(10)–Estratriene’’ (HHS Ref. No. E– 

137–1993/0–US–01); PCT Application 

No. PCT/US94/10393, filed September 

15, 1994, now expired, entitled ‘‘Orally 

Active Derivatives of 1, 3, 5(10)– 

Estratriene’’ (HHS Ref. No. E–137–1993/ 

0–PCT–02); Australian Patent No. 

700576, issued April 22, 1999, entitled 

‘‘Orally Active Derivatives of 1, 3, 

5(10)–Estratriene’’ (HHS Ref. No. E– 

137–1993/0–AU–03); Canadian Patent 

No. 2171740, issued July 26, 2005, 

entitled ‘‘Orally Active Derivatives of 1, 

3, 5(10)–Estratriene’’ (HHS Ref. No. E– 

137–1993/0–CA–04); European Patent 

No. 719276, issued November 26, 1997, 

entitled ‘‘Orally Active Derivatives of 1, 

3, 5(10)–Estratriene’’ (HHS Ref. No. E– 

137–1993/0–EP–05) and validated in 

Austria, Switzerland, Germany, 

Denmark, Spain, France, Greece, 

Ireland, Italy, Luxembourg, Monaco, the 

Netherlands, Portugal, Sweden, 

Belgium, and Great Britain; and 

Japanese Patent No. 3993228, issued 

August 3, 2007, entitled ‘‘Orally Active 

Derivatives of 1, 3, 5(10)–Estratriene’’ 

(HHS Ref. No. E–137–1993/0–JP–06) to 

Evestra, Inc., having a place of business 

in San Antonio, Texas. The patent rights 

in this invention have been assigned to 

the United States of America. 

The contemplated exclusive license 

territory may be worldwide, and the 

field of use may be limited to the use 

of CDB–3701 (11b, 17b– 

dinitratoestradiol 3-acetate) for all 

indications where estrogen is prescribed 

as a treatment, including fertility 

control, hormone replacement therapy 

(‘‘HRT’’), and endometriosis. 

DATES: Only written comments and/or 

application for a license which are 

received by the NIH Office of 

Technology Transfer on or before June 

1, 2009 will be considered. 

ADDRESSES: Requests for copies of the 

patents, inquiries, comments, and other 

materials relating to the contemplated 

license should be directed to: Tara L. 

Kirby, Ph.D., Licensing and Patenting 

Manager, Office of Technology Transfer, 

National Institutes of Health, 6011 

Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Telephone: 

301–435–4426; Facsimile: 301–402– 

0220; E-mail: tarak@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The utility 

of estrogenic substances in the practice 

of medicine is well documented. 

Estrogens may be used for the 

replacement of the natural hormone 

estradiol in hypogonadism, and 

following the removal of the ovaries or 

cessation of ovarian activity during 

menopause. They are also widely 

employed as a component of oral 

contraceptives. However, available 

orally-active synthetic estrogens are 

associated with a number of potential 

side effects, including cancer, blood 

clots, heart attack, elevated blood 

pressure, and reduced glucose tolerance. 

This technology relates to a family of 

novel, active estrogens that are nitrate 

esters of estradiol. These nitrate esters 

possess enhanced estrogenic activity 

following oral administration and lack a 

17-ethynyl alcohol, which has been 

implicated in many side effects 

attributed to other synthetic estrogens. It 

is anticipated that these esters could be 

used in all instances where estrogen is 

prescribed as a treatment. 

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 404.7. The prospective 

exclusive license may be granted unless, 

within 60 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 404.7. 

Applications for a license in the 

prospective 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 in 

response 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: March 24, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–7210 Filed 3–30–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5307–N–01] 

Notice of Web Site Availability: 

Allocations, Application Procedures 

and Requirements for Homelessness 

Prevention and Rapid Re-Housing 

Program Grantees Under the American 

Recovery and Reinvestment Act of 

2009 

AGENCY: Office of the Assistant 

Secretary for Community Planning and 

Development, HUD. 

ACTION: Notice. 

SUMMARY: Through this notice, HUD 

announces the availability on its Web 

site of the allocation formula, allocation 

amounts, list of grantees, statutory and 

regulatory program requirements, 

submission deadlines, and other 

requirements for the Homelessness 

Prevention and Rapid Re-Housing 

Program (HPRP) authorized by Title XII 

of the American Recovery and 

Reinvestment Act of 2009 (Pub. L. 111– 

05, approved February 17, 2009). HPRP 

funding is focused on providing shortand medium-term rental assistance to 

individuals and families who are 

currently in housing, but at risk of 

becoming homeless, and individuals 

and families who are homeless. 

Approximately $1.489 billion will be 

allocated for these purposes to states, 

metropolitan cities, urban counties and 

territories. State sub-grantees and nonprofit sub-grantees are also eligible to 

receive HPRP funds from grantees. The 

notice establishing the program and 

application requirements for these 

funds, allocation information, and 

eligibility criteria is available on the 

HUD Web site at: http://www.hud.gov/ 

recovery/homeless-prevention.cfm. 

FOR FURTHER INFORMATION CONTACT: Ann 

Marie Oliva, Director, Office of Special 

Needs Assistance Programs, Office of 

Special Needs Assistance, Office of 

Community Planning and Development, 

Department of Housing and Urban 

Development, 451 7th Street, SW., 

Room 7262, Washington DC 20410– 

3000; telephone 1–800–998–9999. 

Hearing- or speech-impaired individuals 

may access the voice telephone number 

listed above by calling the toll-free 


tjames on PRODPC61 with NOTICES
14576 Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Notices 

Federal Information Relay Service 

during working hours at 800–877–8339. 

Dated: March 25, 2009. 

Nelson R. Brego ́n, 

General Deputy Assistant Secretary for 

Community Planning and Development. 

[FR Doc. E9–7182 Filed 3–30–09; 8:45 am] 

BILLING CODE 4210–67–P 

DEPARTMENT OF THE INTERIOR 

Minerals Management Service 

[Docket No. MMS–2008–OMM–0041] 

MMS Information Collection Activity: 

1010–0048 Geological and Geophysical 

(G&G) Explorations of the OCS, 

Extension of a Collection; Comment 

Request 

AGENCY: Minerals Management Service 

(MMS), Interior. 

ACTION: Notice of extension of an 

information collection (1010–0048). 

SUMMARY: To comply with the 

Paperwork Reduction Act of 1995 

(PRA), MMS is inviting comments on a 

collection of information that we will 

submit to the Office of Management and 

Budget (OMB) for review and approval. 

The information collection request (ICR) 

concerns the paperwork requirements in 

the regulations under 30 CFR part 251, 

Geological and Geophysical (G&G) 

Explorations of the Outer Continental 

Shelf. 

DATES: Submit written comments by 

June 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Cheryl Blundon, Regulations and 

Standards Branch at (703) 787–1607. 

You may also contact Cheryl Blundon to 

obtain a copy, at no cost, of the 

regulation and form that require the 

subject collection of information. 

ADDRESSES: You may submit comments 

by either of the following methods listed 

below. 

• Electronically: Go to http:// 

www.regulations.gov. Under the tab 

More Search Options, click Advanced 

Docket Search, then select Minerals 

Management Service from the agency 

drop-down menu, then click submit. In 

the Docket ID column, select MMS– 

2008–OMM–0041 to submit public 

comments and to view supporting and 

related materials available for this 

rulemaking. Information on using 

Regulations.gov, including instructions 

for accessing documents, submitting 

comments, and viewing the docket after 

the close of the comment period, is 

available through the site’s User Tips 

link. The MMS will post all comments. 

• Mail or hand-carry comments to the 

Department of the Interior, Minerals 

Management Service, Attention: Cheryl 

Blundon, 381 Elden Street, MS–4024, 

Herndon, Virginia 20170–4817. Please 

reference Information Collection 1010– 

0048 in your subject line and mark your 

message for return receipt. Include your 

name and return address in your 

message text. 

SUPPLEMENTARY INFORMATION: 

Title: 30 CFR Part 251, Geological and 

Geophysical (G&G) Explorations of the 

Outer Continental Shelf. 

Form(s): MMS–327. 

OMB Control Number: 1010–0048. 

Abstract: The Outer Continental Shelf 

(OCS) Lands Act, as amended (43 U.S.C. 

1331 et seq. and 43 U.S.C. 1801 et seq.), 

authorizes the Secretary of the Interior 

(Secretary) to prescribe rules and 

regulations to administer leasing of the 

OCS. Such rules and regulations will 

apply to all operations conducted under 

a lease. Operations on the OCS must 

preserve, protect, and develop oil and 

natural gas resources in a manner that 

is consistent with the need to make such 

resources available to meet the Nation’s 

energy needs as rapidly as possible; to 

balance orderly energy resource 

development with protection of human, 

marine, and coastal environments; to 

ensure the public a fair and equitable 

return on the resources of the OCS; and 

to preserve and maintain free enterprise 

competition. 

The OCS Lands Act (43 U.S.C. 1340) 

also states that ‘‘any person authorized 

by the Secretary may conduct geological 

and geophysical explorations in the 

[O]uter Continental Shelf, which do not 

interfere with or endanger actual 

operations under any lease maintained 

or granted pursuant to this OCS Lands 

Act, and which are not unduly harmful 

to aquatic life in such area.’’ The section 

further requires that permits to conduct 

such activities may only be issued if it 

is determined that the applicant is 

qualified; the activities are not 

polluting, hazardous, or unsafe; they do 

not interfere with other users of the 

area; and do not disturb a site, structure, 

or object of historical or archaeological 

significance. Applicants for permits are 

required to submit form MMS–327 to 

provide the information necessary to 

evaluate their qualifications. 

The OCS Lands Act (43 U.S.C. 1352) 

further requires that certain costs be 

reimbursed to the parties submitting 

required G&G information and data. 

Under the OCS Lands Act, permittees 

are to be reimbursed for the costs of 

reproducing any G&G data required to 

be submitted. Permittees are to be 

reimbursed also for the reasonable cost 

of processing geophysical information 

required to be submitted when 

processing is in a form or manner 

required by the Director of MMS and is 

not used in the normal conduct of the 

business of the permittee. 

The Independent Offices 

Appropriations Act (31 U.S.C. 9701), the 

Omnibus Appropriations Bill (Pub. L. 

104–133, 110 Stat. 1321, April 26, 

1996), and the Office of Management 

and Budget (OMB) Circular A–25, 

authorize Federal agencies to recover 

the full cost of services that confer 

special benefits. Under the Department 

of the Interior’s (DOI) implementing 

policy, the Minerals Management 

Service (MMS) is required to charge the 

full cost for services that provide special 

benefits or privileges to an identifiable 

non-Federal recipient above and beyond 

those that accrue to the public at large. 

The G&G permits are subject to cost 

recovery, and MMS regulations specify 

the filing fee for the application. 

Regulations at 30 CFR part 251 

implement these statutory requirements. 

We use the information to ensure there 

is no environmental degradation, 

personal harm or unsafe operations and 

conditions, damage to historical or 

archaeological sites, or interference with 

other uses; to analyze and evaluate 

preliminary or planned drilling 

activities; to monitor progress and 

activities in the OCS; to acquire G&G 

data and information collected under a 

Federal permit offshore; and to 

determine eligibility for reimbursement 

from the government for certain costs. 

The information is necessary to 

determine if the applicants for permits 

or filers of notices meet the 

qualifications specified by the OCS 

Lands Act. The MMS uses information 

collected to understand the G&G 

characteristics of oil- and gas-bearing 

physiographic regions of the OCS. It 

aids the Secretary in obtaining a proper 

balance among the potentials for 

environmental damage, the discovery of 

oil and gas, and adverse impacts on 

affected coastal states. Information from 

permittees is necessary to determine the 

propriety and amount of 

reimbursement. 

We will protect information from 

respondents considered proprietary 

according to the Freedom of Information 

Act (5 U.S.C. 552) and its implementing 

regulations (43 CFR part 2), the Federal 

Oil and Gas Royalty Management Act of 

1982 (30 U.S.C. 1733), and under 

regulations at 30 CFR parts 250, 251, 

and 252. 

No items of a sensitive nature are 

collected. Responses are mandatory. 

Frequency: On occasion, annual; and 

as specified in permits. 


tjames on PRODPC61 with NOTICES