44862 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices 

license or passport. All visitors should 

be prepared to have their personal 

belongings inspected and to go through 

metal detection inspection. 

When driving to NIH, plan some extra 

time to get through the security 

checkpoints at the visitor entrances to 

campus. Be aware that visitor parking 

lots on the NIH campus can fill up 

quickly. The NIH campus is also 

accessible via the metro Red Line, 

Medical Center Station. The Natcher 

Conference Center is a 5-minute walk 

from the Medical Center Metro Station. 

Additional NIH campus visitor 

information is available at: http:// 

www.nih.gov/about/visitor/index.htm. 

Information about the IACC and a 

registration link for this meeting are 

available on the Web site: http:// 

www.iacc.hhs.gov. 

Dated: August 24, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–20872 Filed 8–28–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Request for Nominations to the 

SAMHSA National Advisory Council 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) is accepting nominations 

through October 7, 2009, to fill 

vacancies for its five advisory 

committees (the SAMHSA National 

Advisory Council, the Center for 

Substance abuse Prevention, Center for 

Substance Abuse Treatment and Center 

for Mental Health Services National 

Advisory Councils and the Advisory 

Committee for Women’s Services). 

Under section 502 of the Public Health 

Service Act, the National Advisory 

Councils (NAC) provide advice to the 

Secretary of the U.S. Department of 

Health and Human Services (HHS), 

SAMHSA Administrator, and/or Center 

Directors on a broad range of polices 

and services related to substance use 

and mental health. 

Legislation requires that each NAC be 

composed of 12 members: nine 

members must be leading 

representatives of the health disciplines 

(including public health, behavioral 

health, and social sciences) relevant to 

the mission of SAMHSA and its Centers 

and three members must be from the 

general public and include leaders in 

the fields of public policy, public 

relations, law, health policy, economics, 

or management. 

Under section 501 of the Public 

Health Service Act, the Advisory 

Committee for Women’s Services 

(ACWS) is statutorily mandated to 

advise the SAMHSA Administrator and 

the Associate Administrator for 

Women’s Services on appropriate 

activities to be undertaken by SAMHSA 

and its Centers with respect to women’s 

substance abuse and mental health 

services. The SAMHSA Administrator 

will appoint the 10 members of this 

Committee. The members must be from 

among physicians, practitioners, 

treatment providers, and other health 

professionals, whose clinical practice, 

specialization, or professional expertise 

includes a significant focus on women’s 

substance abuse and mental health 

conditions. 

The current lists of members for the 

advisory committees are available on 

the SAMHSA Web site at https:// 

nac.samhsa.gov/index.aspx. 

Members are appointed for a term of 

up to four years. Individuals are 

nominated, selected, and appointed to a 

NAC or the ACWS to contribute to the 

advisory committee’s objectives based 

on their qualifications. The Federal 

Advisory Committee Act (FACA) and 

HHS policy require that committee 

membership be fairly balanced in terms 

of points of view represented and the 

committee’s functions to be performed. 

Consideration is given to a broad 

representation of geographic areas, 

gender, race/ethnicity, and disability. 

The advisory committees will meet not 

less than two times per year and on an 

as needed basis. 

Any interested person or organization 

may nominate qualified individuals for 

membership. Self-nominations are also 

welcome. Nominations must include a 

resume and short biography describing 

the educational and professional 

qualifications of the nominee and the 

nominee’s current occupation, position, 

address and daytime telephone number. 

Individuals may be recommended for 

membership on more than one advisory 

committee, but will be appointed to 

only one advisory body. Nominations 

can be sent by U.S. Mail or 

electronically to Ms. Toian Vaughn, 

Designated Federal Official, at the 

address below. 

Contact: Toian Vaughn, M.S.W., 

Designated Federal Official, SAMHSA 

National Advisory Council and 

SAMHSA Committee Management 

Officer, 1 Choke Cherry Road, Room 8– 

1089, Rockville, Maryland 20857. 

Telephone: (240) 276–2307; Fax: (240) 

276–2220 and E-mail: 

toian.vaughn@samhsa.hhs.gov. 

Toian Vaughn, 

Committee Management Officer, Substance 

Abuse and Mental Health Services 

Administration. 

[FR Doc. E9–20884 Filed 8–28–09; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Development of AntiAngiogenesis Cancer Therapeutics 

Targeting Adrenomedullin or 

Proadrenomedullin N-Terminal 20 

Peptide (PAMP) 

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)(i), 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 inventions 

embodied in U.S. Patent Application 

No. 60/002,514, filed on August 18, 

1995, entitled ‘‘Functional Role of 

Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human 

Pathology and Physiology’’ (HHS 

Reference No. E–206–1995/0–US–01); 

U.S. Patent Application No. 60/002,936, 

filed on August 30, 1995, entitled 

‘‘Functional Role of Adrenomedullin 

(AM) and the Gene-Related Product 

(PAMP) in Human Pathology and 

Physiology’’ (HHS Reference No. E– 

206–1995/1–US–01); U.S. Patent 

Application No. 60/013,172, filed on 

March 12, 1996, entitled ‘‘Functional 

Role of Adrenomedullin (AM) and the 

Gene-Related Product (PAMP) in 

Human Pathology and Physiology’’ 

(HHS Reference No. E–206–1995/2–US– 

01); PCT Application No. PCT/US96/ 

13286, filed on August 16, 1996, 

entitled ‘‘Functional Role of 

Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human 

Pathology and Physiology’’ (HHS 

Reference No. E–206–1995/3–PCT–01); 

Australian Patent No. 710662, issued on 

October 5, 2000, entitled ‘‘Functional 

Role of Adrenomedullin (AM) and the 

Gene-Related Product (PAMP) in 

Human Pathology and Physiology’’ 

(HHS Reference No. E–206–1995/3–AU– 

02); Canadian Patent Application No. 

2229741, filed on August 16, 1996, 

entitled ‘‘Functional Role of 


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Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices 44863 

Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human 

Pathology and Physiology’’ (HHS 

Reference No. E–206–1995/3–CA–03); 

U.S. Patent No. 6,320,022, issued on 

November 20, 2001, entitled 

‘‘Adrenomedullin Peptides’’ (HHS 

Reference No. E–206–1995/3–US–04); 

European Patent No. 0845036, issued on 

June 2, 1999, entitled ‘‘Functional Role 

of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human 

Pathology and Physiology’’ (HHS 

Reference No. E–206–1995/3–EP–07), 

and validated in France, Germany, and 

the United Kingdom; Japanese Patent 

Application No. 509499/97, filed on 

August 16, 1996, entitled ‘‘Functional 

Role of Adrenomedullin (AM) and the 

Gene-Related Product (PAMP) in 

Human Pathology and Physiology’’ 

(HHS Reference No. E–206–1995/3–JP– 

09); U.S. Patent No. 7,101,548, issued on 

September 5, 2006, entitled ‘‘Functional 

Role of Adrenomedullin (AM) and the 

Gene-Related Product (PAMP) in 

Human Pathology and Physiology’’ 

(HHS Reference No. E–206–1995/3–US– 

10); U.S. Patent Application No. 11/ 

517,599, filed on September 5, 2006, 

entitled ‘‘Functional Role of 

Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human 

Pathology and Physiology’’ (HHS 

Reference No. E–206–1995/3–US–11); 

Japanese Patent No. 4077861, issued on 

February 8, 2008, entitled ‘‘Functional 

Role of Adrenomedullin (AM) and the 

Gene-Related Product (PAMP) in 

Human Pathology and Physiology’’ 

(HHS Reference No. E–206–1995/3–JP– 

12); U.S. Patent Application No. 60/ 

153,397, filed on September 10, 1999, 

entitled ‘‘Determination of AM–Binding 

Proteins and the Association of 

Adrenomedullin (AM) Therewith’’ 

(HHS Reference No. E–256–1999/0–US– 

01); PCT Application No. PCT/US00/ 

24722, filed on September 8, 2000, 

entitled ‘‘Determination of AM–Binding 

Proteins and the Association of 

Adrenomedullin (AM) Therewith’’ 

(HHS Reference No. E–256–1999/0– 

PCT–02); Australian Patent No. 774725, 

issued on May 25, 2004, entitled 

‘‘Determination of AM–Binding Proteins 

and the Association of Adrenomedullin 

(AM) Therewith’’ (HHS Reference No. 

E–256–1999/0–AU–03); Canadian 

Patent Application No. 2383419, filed 

on September 8, 2000, entitled 

‘‘Determination of AM–Binding Proteins 

and the Association of Adrenomedullin 

(AM) Therewith’’ (HHS Reference No. 

E–256–1999/0–CA–04); European Patent 

No. 1214600, issued on December 21, 

2005, entitled ‘‘Determination of AM– 

Binding Proteins and the Association of 

Adrenomedullin (AM) Therewith’’ 

(HHS Reference No. E–256–1999/0–EP– 

05), and validated in France, Germany, 

the United Kingdom, Italy, Spain, and 

Portugal; U.S. Patent Application No. 

10/070,853, filed on March 8, 2002, 

entitled ‘‘Determination of AM–Binding 

Proteins and the Association of 

Adrenomedullin (AM) Therewith’’ 

(HHS Reference No. E–256–1999/0–US– 

06); U.S. Patent Application No. 11/ 

530,411, filed on September 8, 2006, 

entitled ‘‘Determination of AM–Binding 

Proteins and the Association of 

Adrenomedullin (AM) Therewith’’ 

(HHS Reference No. E–256–1999/0–US– 

13); U.S. Patent Application No. 12/ 

236,418, filed on September 23, 2008, 

entitled ‘‘Determination of AM–Binding 

Proteins and the Association of 

Adrenomedullin (AM) Therewith’’ 

(HHS Reference No. E–256–1999/0–US– 

14); U.S. Patent Application No. 60/ 

425,018, filed on November 7, 2002, 

entitled ‘‘A New Target for Angiogenesis 

and Anti-Angiogenesis Therapy’’ (HHS 

Reference No. E–294–2002/0–US–01); 

PCT Application No. PCT/US03/35633, 

filed on November 7, 2003, entitled ‘‘A 

New Target for Angiogenesis and AntiAngiogenesis Therapy’’ (HHS Reference 

No. E–294–2002/0–PCT–02); U.S. Patent 

No. 7,462,593, issued on December 9, 

2008, entitled ‘‘Compositions and 

Methods for Promoting Angiogenesis’’ 

(HHS Reference No. E–294–2002/0–US– 

03); European Patent Application No. 

03786608.4, filed on November 7, 2003, 

entitled ‘‘A New Target for Angiogenesis 

and Anti-Angiogenesis Therapy’’ (HHS 

Reference No. E–294–2002/0–EP–04); 

Australian Patent Application No. 

2003295422, filed on April 18, 2005, 

entitled ‘‘A New Target for Angiogenesis 

and Anti-Angiogenesis Therapy’’ (HHS 

Reference No. E–294–2002/0–AU–05); 

Canadian Patent Application No. 

2504953, filed on November 7, 2003, 

entitled ‘‘A New Target for Angiogenesis 

and Anti-Angiogenesis Therapy’’ (HHS 

Reference No. E–294–2002/0–CA–06); 

Japanese Patent Application No. 2004– 

551922, filed on May 9, 2005, entitled 

‘‘A New Target for Angiogenesis and 

Anti-Angiogenesis Therapy’’ (HHS 

Reference No. E–294–2002/0–JP–07); 

U.S. Patent Application No. 12/240,656, 

filed on September 29, 2008, entitled 

‘‘Target for Anti-Angiogenesis Therapy’’ 

(HHS Reference No. E–294–2002/0–US– 

08); U.S. Patent Application No. 60/ 

500,650, filed on September 8, 2003, 

entitled ‘‘Non-Peptide Agonists and 

Antagonists of Adrenomedullin (AM) 

And Gastrin Releasing Peptide’’ (HHS 

Reference No. E–246–2003/0–US–01); 

PCT Application No. PCT/US04/29293, 

filed on September 8, 2004, entitled 

‘‘Non-Peptide Agonists and Antagonists 

of Adrenomedullin (AM) And Gastrin 

Releasing Peptide’’ (HHS Reference No. 

E–246–2003/1–PCT–01); European 

Patent Application No. 04783513.7, 

filed on September 8, 2004, entitled 

‘‘Non-Peptide Agonists and Antagonists 

of Adrenomedullin (AM) And Gastrin 

Releasing Peptide’’ (HHS Reference No. 

E–246–2003/1–EP–03); Canadian Patent 

Application No. 2539467, filed on 

September 8, 2004, entitled ‘‘NonPeptide Agonists and Antagonists of 

Adrenomedullin (AM) And Gastrin 

Releasing Peptide’’ (HHS Reference No. 

E–246–2003/1–CA–04); Australian 

Patent Application No. 2004273057, 

filed on September 8, 2004, entitled 

‘‘Non-Peptide Agonists and Antagonists 

of Adrenomedullin (AM) And Gastrin 

Releasing Peptide’’ (HHS Reference No. 

E–246–2003/1–AU–05); and U.S. Patent 

Application No. 10/571,012, filed on 

March 8, 2006, entitled ‘‘Non-Peptide 

Agonists and Antagonists of 

Adrenomedullin (AM) And Gastrin 

Releasing Peptide’’ (HHS Reference No. 

E–246–2003/1–US–06) to Arana 

Therapeutics (VIC) Pty. Ltd., having a 

place of business at Level 5, Building 4, 

399 Royal Parade, Parkville, Victoria 

3052, Australia, a wholly-owned 

subsidiary of Arana Therapeutics 

Limited, having a place of business at 

Level 2, 37 Epping Road, Macquarie 

Park, NSW 2113, Australia, a whollyowned subsidiary of Cephalon, Inc., 

having a place of business at 41 Moores 

Road, Frazer, PA 19355, USA. 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 ‘‘use of 

peptide and affinity binding reagents 

(including but not limited to antibodies) 

that neutralize the action of PAMP or 

adrenomedullin to treat cancer’’. 

DATES: Only written comments and/or 

application for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

October 30, 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: These 

technologies relate to adrenomedullin 

and proadrenomedullin N-terminal 20 


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44864 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Notices 

peptide (PAMP), two potent angiogenic 

factors that are products of the same 

gene. Therapies that reduce (antagonize) 

the action of these factors have the 

potential to treat conditions where 

angiogenesis plays a pathological role, 

such as cancer and macular 

degeneration. Conversely, increasing 

(agonizing) the action of these factors 

may be useful for conditions where 

enhanced angiogenesis is desired, such 

as wound healing and cardiovascular 

disease. Adrenomedullin and PAMP 

have also been shown to play a role in 

other diseases, such as 

neurodegenerative disorders, diabetes, 

and allergic and inflammatory disease. 

More specifically, these technologies 

include peptides, antibodies and small 

molecules that agonize or antagonize the 

activity of adrenomedullin and PAMP. 

They also include methods for 

inhibiting or inducing angiogenesis, 

methods for inhibiting tumor growth, 

methods for treating cancer, and 

methods of treating a number of other 

conditions, such as wounds, 

neurological disease, allergic or 

inflammatory disease, diabetes, and 

cardiovascular disease. 

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: August 24, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–20881 Filed 8–28–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2009–0396] 

Collection of Information Under 

Review by Office of Management and 

Budget: OMB Control Number: 1625– 

0008. 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, this 

request for comments announces that 

the U.S. Coast Guard is forwarding an 

Information Collection Request (ICR), 

abstracted below, to the Office of 

Information and Regulatory Affairs 

(OIRA), Office of Management and 

Budget (OMB) requesting an extension 

of its approval for the following 

collection of information: 1625–0008, 

Regattas and Marine Parades. Our ICR 

describes the information we seek to 

collect from the public. Review and 

comments by OIRA ensure we only 

impose paperwork burdens 

commensurate with our performance of 

duties. 

DATES: Please submit comments on or 

before September 30, 2009. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2009–0396] to the 

Docket Management Facility (DMF) at 

the U.S. Department of Transportation 

(DOT) or to OIRA. To avoid duplication, 

please submit your comments by only 

one of the following means: 

(1) Electronic submission: (a) To Coast 

Guard docket at http:// 

www.regulation.gov. (b) To OIRA by email via: oira_submission@omb.eop.gov. 

(2) Mail or Hand delivery: (a) DMF 

(M–30), DOT, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590– 

0001. Hand deliver between the hours of 

9 a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The 

telephone number is 202–366–9329. (b) 

To OIRA, 725 17th Street, NW., 

Washington, DC 20503, attention Desk 

Officer for the Coast Guard. 

(3) Fax: (a) To DMF, 202–493–2251. 

(b) To OIRA at 202–395–6566. To 

ensure your comments are received in 

time, mark the fax, attention Desk 

Officer for the Coast Guard. 

The DMF maintains the public docket 

for this Notice. Comments and material 

received from the public, as well as 

documents mentioned in this Notice as 

being available in the docket, will 

become part of the docket and will be 

available for inspection or copying at 

room W12–140 on the West Building 

Ground Floor, 1200 New Jersey Avenue, 

SE., Washington, DC, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find the docket on the Internet at 

http://www.regulations.gov. 

A copy of the ICR is available through 

the docket on the Internet at http:// 

www.regulations.gov. Additionally, 

copies are available from: Commandant 

(CG–611), ATTN Paperwork Reduction 

Act Manager, U.S. Coast Guard, 2100 

2nd St., SW., Stop 7101, Washington, 

DC 20593–7101. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Arthur Requina, Office of Information 

Management, telephone 202–475–3523 

or fax 202–475–3929, for questions on 

these documents. Contact Ms. Renee V. 

Wright, Program Manager, Docket 

Operations, 202–366–9826, for 

questions on the docket. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard invites comments on whether 

this ICR should be granted based on it 

being necessary for the proper 

performance of Departmental functions. 

In particular, the Coast Guard would 

appreciate comments addressing: (1) 

The practical utility of the collections; 

(2) the accuracy of the estimated burden 

of the collections; (3) ways to enhance 

the quality, utility, and clarity of 

information subject to the collections; 

and (4) ways to minimize the burden of 

collections on respondents, including 

the use of automated collection 

techniques or other forms of information 

technology. 

Comments to Coast Guard or OIRA 

must contain the OMB Control Number 

of the ICR. They must also contain the 

docket number of this request, [USCG 

2009–0396]. For your comments to 

OIRA to be considered, it is best if they 

are received on or before the September 

30, 2009. 

Public participation and request for 

comments: We encourage you to 

respond to this request by submitting 

comments and related materials. We 

will post all comments received, 

without change, to http:// 

www.regulations.gov. They will include 

any personal information you provide. 

We have an agreement with DOT to use 

their DMF. Please see the ‘‘Privacy Act’’ 

paragraph below. 

Submitting comments: If you submit a 

comment, please include the docket 

number [USCG–2009–0396], indicate 

the specific section of the document to 

which each comment applies, providing 

a reason for each comment. We 

recommend you include your name, 


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