63162 Federal Register / Vol. 69, No. 209 / Friday, October 29, 2004 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Dengue Tetravalent Vaccine 

Containing a Common 30 Nucleotide 

Deletion in The 3′–UTR of Dengue 

Types 1,2,3, And 4

AGENCY: National Institutes of Health, 

Public Health Service, DHHS.

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 a an 

exclusive license to practice the 

following invention as embodied in the 

following patent applications: (1) E–

120–2001, Whitehead et al., 

‘‘Development of Mutations Useful for 

Attenuating Dengue Viruses and 

Chimeric Dengue Viruses’’, U.S. 

Provisional Patent Application 60/

293,049, filed May 22, 2001, PCT/US02/

16308, filed May 22, 2002, U.S. Patent 

Application 10/719,547, filed November 

21, 2003, European Patent Application 

02739358.6, filed May 22, 2002, 

Canadian Patent Application 2448329, 

filed May 22, 2002, Indian Patent 

Application 2814DELNP2003, filed May 

22, 2002, Australian Patent Application 

2002312011, filed May 22, 2002, and 

Brazilian Patent Application 

PI0209943.8, filed May 22, 2002, and (2) 

E–089–2002, ‘‘Dengue Tetravalent 

Vaccine Containing a Common 30 

Nucleotide Deletion in The 3′–UTR of 

Dengue Types 1,2,3, And 4, or Antigenic 

Chimeric Dengue Viruses 1,2,3, And 4’’, 

U.S. Provisional Applications 60/

377,860, filed May 3, 2002, 60/436,500, 

filed December 23, 2002, PCT/US03/

13279, filed April 25, 2003, to Fundaco 

Butantan, having a place of business in 

Sao Paulo, Brazil. The patent rights in 

this invention have been assigned to the 

United States of America.

DATES: Only written comments and/or 

application for a license which are 

received by the NIH Office of 

Technology Transfer on or before 

December 28, 2004, will be considered.

ADDRESSES: Requests for a copy of the 

patent application, inquiries, comments 

and other materials relating to the 

contemplated license should be directed 

to: Peter Soukas, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Boulevard, Suite 325, 

Rockville, MD 20852–3804; Email: 

ps193c@nih.gov; Telephone: (301) 496–

7056, ext. 268; Facsimile: (301) 402–

0220.

SUPPLEMENTARY INFORMATION: The global 

prevalence of dengue has grown 

dramatically in recent decades. The 

disease is now endemic in more than 

100 countries in Africa, North and 

South America, the Eastern 

Mediterranean, Southeast Asia and the 

Western Pacific. Southeast Asia and the 

Western Pacific are most seriously 

affected. Before 1970 only nine 

countries had experienced Dengue 

Hemorrhagic Fever (DHF) epidemics, a 

number that had increased more than 

four-fold by 1995. WHO currently 

estimates there may be 50 million cases 

of dengue infection worldwide every 

year. 

The methods and compositions of this 

invention provide a means for 

prevention of dengue infection and 

dengue hemorrhagic fever (DHF) by 

immunization with attenuated, 

immunogenic viral vaccines against 

dengue. The vaccine is further described 

in Blaney JE et al., ‘‘Mutations which 

enhance the replication of dengue virus 

type 4 and an antigenic chimeric dengue 

virus type 2/4 vaccine candidate in Vero 

cells,’’ Vaccine 2003 Oct 1;21(27–

30):4317–27 and Whitehead SS et al., 

‘‘A live, attenuated dengue virus type 1 

vaccine candidate with a 30-nucleotide 

deletion in the 3′ untranslated region is 

highly attenuated and immunogenic in 

monkeys,’’ J. Virol. 2003 Jan;77(2):1653–

7. 

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, 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. 

The field of use may be limited to live 

attenuated vaccines against dengue 

infections in humans. The Licensed 

Territory may be limited to Brazil. 

Properly filed competing applications 

for a license filed in response to this 

notice will be treated as objections to 

the contemplated 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: October 22, 2004. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–24167 Filed 10–28–04; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Public Health Service; Notice of Listing 

of Members of the Substance Abuse 

and Mental Health Services 

Administration’s Senior Executive 

Service Performance Review Board 

(PRB) 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) announces the persons who 

will serve on the Substance Abuse and 

Mental Health Services 

Administration’s Performance Review 

Board. This action is being taken in 

accordance with Title 5, U.S.C., Section 

4314(c)(4), which requires that members 

of performance review boards be 

appointed in a manner to ensure 

consistency, stability, and objectivity in 

performance appraisals, and requires 

that notice of the appointment of an 

individual to serve as a member be 

published in the Federal Register. 

The following persons will serve on 

the SAMHSA Performance Review 

Board, which oversees the evaluation of 

performance appraisals of SAMHSA’s 

Senior Executive Service (SES) 

members: James L. Stone, Chairperson; 

Daryl W. Kade; Douglas Morgan; 

Kathryn Power. 

For further information about the 

SAMHSA Performance Review Board, 

contact the Division of Management 

Systems, Substance Abuse and Mental 

Health Services Administration, 1 

Choke Cherry Road, Room 3–1017, 

Rockville, Maryland 20857, telephone 

(240) 276–1124 (not a toll-free number).

Dated: October 4, 2004. 

Charles G. Curie, 

Administrator, SAMHSA.

[FR Doc. 04–24155 Filed 10–28–04; 8:45 am] 

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