Federal Register / Vol. 73, No. 150 / Monday, August 4, 2008 / Notices 45231 

Licensing Contact 

Surekha Vathyam, Ph.D.; 301–435–

4076; vathyams@mail.nih.gov. 

Dated: July 28, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–17812 Filed 8–1–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: The Development of Human 

Therapeutics for the Treatment of 

Depression 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: This 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 U.S. Patent Application 

11/137,114 entitled ‘‘Scopolamine For 

The Treatment Of Depression And 

Anxiety’’ [HHS Ref. E–175–2004/0–US–

01], PCT Application PCT/US2006/ 

019335 [HHS Ref. E–175–2004/0–PCT–

02] and all continuing applications and 

foreign counterparts (Europe, Australia 

and Canada), to Transcept 

Pharmaceuticals, Inc., which has offices 

in Pt. Richmond, CA. The patent rights 

in these inventions have been assigned 

to and/or exclusively licensed to the 

Government of the United States of 

America. 

The prospective exclusive license 

territory may be worldwide, and the 

field of use may be limited to: 

A worldwide exclusive license for the use 

of scopolamine for treatment of depression, 

including major depressive disorders (MDD), 

wherein the administration of scopolamine is 

intravenous, through the buccal membrane, 

intranasal, intramuscular or through a skin 

patch. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

October 3, 2008, 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: David A. Lambertson, 

Ph.D., Technology Licensing Specialist, 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, MD 

20852–3804; Telephone: (301) 435–

4632; Facsimile: (301) 402–0220; E-mail: 

lambertsond@od.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

invention concerns the use of 

scopolamine for the treatment of 

depression, including major depressive 

disorders (MDD). Although scopolamine 

has been employed in the treatment of 

nausea and motion sickness, the 

suitability of scopolamine for treating 

MDD was unrecognized prior to this 

invention. Current MDD treatments can 

be ineffective in large percentage of 

patients and typically do not take effect 

until 4 weeks after administration. In 

contrast, treatment with scopolamine 

has a wide-ranging and rapid effect, 

suggesting it can be effective either as a 

stand alone treatment or as a treatment 

for patients who are unresponsive to 

currently available drugs. 

A Cooperative Research and 

Development Agreement (CRADA) is 

simultaneously being negotiated to 

accompany the exclusive license 

agreement. The CRADA will involve the 

further development of the licensed 

technology between the National 

Institute of Mental Health and 

Transcept. 

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 sixty (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 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. 

Applicants may also contact the 

National Institute of Mental Health 

regarding the CRADA opportunity. 

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: July 29, 2008. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E8–17817 Filed 8–1–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2008–0521] 

National Preparedness for Response 

Exercise Program 

AGENCY: Coast Guard, DHS. 

ACTION: Notice; request for public 

comment. 

SUMMARY: The Coast Guard, the Pipeline 

and Hazardous Materials Safety 

Administration, the Environmental 

Protection Agency, and the Minerals 

Management Service, in concert with 

representatives from various State 

governments, industry, environmental 

interest groups, and the general public, 

developed the National Preparedness for 

Response Exercise Program (PREP) 

Guidelines to reflect the consensus 

agreement of the entire oil spill 

response community. This notice 

announces the PREP 5-year exercise 

cycle, 2009 through 2013, and requests 

comments from the public, and requests 

volunteers from industry to participate 

in the scheduled PREP Area exercises. 

The new schedule adjustment from 3 

years to 5 years was created to align 

with the Department of Homeland 

Security’s National Exercise 5-year 

Schedule. 

DATES: Comments and related material 

must reach the Docket Management 

Facility on or before October 3, 2008. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number USCG–2008–0521 to the Docket 

Management Facility at the U.S. 

Department of Transportation. To avoid 

duplication, please use only one of the 

following methods: 

(1) Online: http:// 

www.regulations.gov. 

(2) Mail: Docket Management Facility 

(M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590–

0001. 

(3) Hand delivery: Same as mail 

address above, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The telephone number 

is 202–366–9329. 

(4) Fax: 202–493–2251. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, or 

need general information regarding the 

PREP or the 5-year exercise schedule, 

contact Lieutenant Shawn Essert, Office 

of Contingency Exercises (CG–535), U.S. 

Coast Guard, telephone 202–372–2149, 

or e-mail shawn.g.essert@uscg.mil. If 


pwalker on PROD1PC71 with NOTICES
45232 Federal Register / Vol. 73, No. 150 / Monday, August 4, 2008 / Notices 

you have questions on viewing or 

submitting material to the docket, call 

Ms. Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366–

9826. 

SUPPLEMENTARY INFORMATION

Public Participation and Request for 

Comments 

We encourage you to respond to this 

notice by submitting comments and 

related materials. All comments 

received will be posted, without change, 

to http://www.regulations.gov and will 

include any personal information you 

provide. We have an agreement with the 

Department of Transportation to use 

their Docket Management Facility. 

Submitting Comments 

If you submit a comment, please 

include the docket number for this 

notice (USCG–2008–0521), indicate the 

specific section of this document to 

which each comment applies, and give 

the reason for each comment. We 

recommend that you include your name 

and a mailing address, an e-mail 

address, or a phone number in the body 

of your document so that we can contact 

you if we have questions regarding your 

submission. You may submit your 

comments and material by electronic 

means, mail, fax, or delivery to the 

Docket Management Facility at the 

address under ADDRESSES; but please 

submit your comments and material by 

only one means. If you submit them by 

mail or delivery, submit them in an 

unbound format, no larger than 81⁄2 by 

11 inches, suitable for copying and 

electronic filing. If you submit them by 

mail and would like to know that they 

reached the Facility, please enclose a 

stamped, self-addressed postcard or 

envelope. We will consider all 

comments and material received during 

the comment period. We may change 

this 5-year exercise schedule, as well as 

other elements of the PREP, in light of 

your comments. 

Viewing Comments and Documents 

To view comments, as well as 

documents mentioned in this preamble 

as being available in the docket, go to 

http://www.regulations.gov at any time. 

Enter the docket number for this notice 

(USCG–2008–0521) in the Search box, 

and click ‘‘Go>>.’’ If you do not have 

access to the Internet, you may view the 

docket online by visiting the Docket 

Management Facility in Room W12–140 

on the ground floor of the Department 

of Transportation West Building, 1200 

New Jersey Avenue, SE., Washington, 

DC 20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. 

Privacy Act 

Anyone can search the electronic 

form of all comments received into any 

of our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review a Privacy 

Act, system of records notice regarding 

our public dockets in the January 17, 

2008 issue of the Federal Register (73 

FR 3316). 

Background and Purpose 

In 1994, the United States Coast 

Guard (USCG), the Research and Special 

Programs Administration (RSPA) of the 

Department of Transportation, the U.S. 

Environmental Protection Agency 

(EPA), and the Minerals Management 

Service (MMS) of the Department of the 

Interior, coordinated the development of 

the National Preparedness for Response 

Exercise Program (PREP) Guidelines to 

ensure compliance with the Oil 

Pollution Act of 1990 (OPA 90) 

pollution response exercise 

requirements (33 U.S.C. 1321(j)). The 

guiding principles of PREP distinguish 

between internal and external exercises. 

Internal exercises are conducted within 

the planholder’s organization. External 

exercises extend beyond the 

planholder’s organization to involve 

other members of the response 

community. External exercises are 

separated into two categories: Area 

exercises, and Government-initiated, 

unannounced exercises. External 

exercises are designed to evaluate the 

entire pollution response mechanism in 

a given geographic Area to ensure 

adequate response preparedness. 

Area exercises involve the entire 

response community including Federal, 

State, local, tribal, and non-government 

organizations, and industry participants; 

therefore, these Area exercises require 

more extensive planning than other oil 

spill response exercises. The PREP 

Guidelines describe all of these 

exercises in more detail. 

A National Schedule Coordination 

Committee (NSCC) was established for 

scheduling Area exercises. The NSCC is 

comprised of personnel representing the 

four Federal regulating agencies—the 

USCG, EPA, MMS, and the Pipeline and 

Hazardous Materials Safety 

Administration’s (PHMSA) Office of 

Pipeline Safety (OPS). Since 1994, the 

NSCC published a triennial schedule of 

Area exercises. Starting in 2008, NSCC 

will publish a schedule of Area 

exercises every 5 years. 

Source for PREP Documents 

The PREP Area exercise schedule and 

exercise design manuals are available on 

the Internet at http://homeport.uscg.mil/ 

exercises. To obtain a hard copy of the 

exercise design manual, contact Ms. 

Melanie Barber at PHMSA, Office of 

Pipeline Safety at 202–366–4560. 

PREP Schedule 

This notice announces the next 5-year 

schedule of the Area exercises. The 

PREP schedule for calendar years 2009 

through 2013 for Government-led and 

Industry-led Area exercises is available 

on the Internet in the docket for this 

notice at http://www.regulations.gov 

and at http://homeport.uscg.mil/ 

exercises under Port Level Exercises. 

Any revisions to the schedule will 

appear on the http://homeport.uscg.mil 

Web site. We have include a table listing 

the dates and Federal Register cites of 

past PREP exercise notices in our online 

docket for those who wish to compare 

this 2009–2013 schedule with past 

schedules. 

If a company wants to volunteer for 

an Area exercise, a company 

representative may call either the Coast 

Guard or EPA on-scene coordinator for 

times and locations. If you have 

concerns or recommended 

improvements to the Government-led 

PREP exercises, please submit those 

using the procedures described under 

the ADDRESSES section of this notice. 

Dated: July 24, 2008. 

Joseph R. Castillo, 

Rear Admiral, U.S. Coast Guard, Director of 

Response Policy. 

[FR Doc. E8–17755 Filed 8–1–08; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

New Agency Information Collection 

Activity Under OMB Review: Critical 

Facility Information of the Top 100 

Most Critical Pipelines 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: 30-day Notice. 

SUMMARY: This notice announces that 

the Transportation Security 

Administration (TSA) has forwarded the 

new Information Collection Request 

(ICR) abstracted below to the Office of 

Management and Budget (OMB) for 

review and approval under the 

Paperwork Reduction Act. The ICR 

describes the nature of the information 

collection and its expected burden. TSA 

published a Federal Register notice, 

with a 60-day comment period soliciting 

comments, of the following collection of 


pwalker on PROD1PC71 with NOTICES