National Preparedness for Response Exercise Program, 45231-45232 [E8-17755]

Download as PDF Federal Register / Vol. 73, No. 150 / Monday, August 4, 2008 / Notices 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 National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: 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. 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, pwalker on PROD1PC71 with NOTICES DATES: VerDate Aug<31>2005 16:50 Aug 01, 2008 Jkt 214001 45231 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. DEPARTMENT OF HOMELAND SECURITY 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. National Preparedness for Response Exercise Program SUPPLEMENTARY INFORMATION: 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Coast Guard [Docket No. USCG–2008–0521] Coast Guard, DHS. Notice; request for public comment. AGENCY: ACTION: 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. 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: https:// 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 DATES: E:\FR\FM\04AUN1.SGM 04AUN1 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 https://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. pwalker on PROD1PC71 with NOTICES 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 https://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. VerDate Aug<31>2005 16:50 Aug 01, 2008 Jkt 214001 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 the Internet at https://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 https://www.regulations.gov and at https://homeport.uscg.mil/ exercises under Port Level Exercises. Any revisions to the schedule will appear on the https://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 Transportation Security Administration, DHS. ACTION: 30-day Notice. AGENCY: 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 E:\FR\FM\04AUN1.SGM 04AUN1

Agencies

[Federal Register Volume 73, Number 150 (Monday, August 4, 2008)]
[Notices]
[Pages 45231-45232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17755]


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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: https://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

[[Page 45232]]

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 https://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 8\1/2\ 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 https://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 https://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 https://www.regulations.gov 
and at https://homeport.uscg.mil/exercises under Port Level Exercises. 
Any revisions to the schedule will appear on the https://
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

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