Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 6211 

1Available on the Internet at http://www.fda.gov/ 

downloads/Drugs/GuidanceComplianceRegulatory

Information/Guidances/ucm072229.pdf. 

related to look-alike and sound-alike 

proprietary names, unclear label 

abbreviations, acronyms, dose 

designations, and error-prone label and 

packaging designs. Among these 

measures, FDA agreed to publish 

guidance on the contents of a complete 

submission package for a proposed 

proprietary name for a drug/biological 

product. FDA also agreed to 

performance goals for review of 

proprietary names submitted during the 

investigational new drug application 

(IND) phase or with a new drug 

application (NDA) or biologics license 

application (BLA); the goals stipulate 

that a complete submission is required 

to begin the review clock. (See section 

IX.A of the goals letter at http:// 

www.fda.gov/ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

ucm119243.htm). 

This proprietary names submission 

guidance is intended to promote 

prevention of medication errors by 

assisting industry in the submission of 

complete product information that will 

help FDA to evaluate the safety of 

proposed proprietary drug and 

biological product names, taking into 

account other factors that, in association 

with the name, can contribute to 

medication errors. In addition, FDA 

intends to use this information in the 

assessment of promotional aspects of 

proposed proprietary names. 

This proprietary names submission 

guidance applies to prescription drug 

products, including biologics, that are 

the subject of an IND, NDA, abbreviated 

new drug application (ANDA), or BLA; 

and nonprescription drug products that 

are the subject of an IND, NDA, or 

ANDA. 

The proprietary names submission 

guidance does not address other 

performance goals under PDUFA IV, 

including developing FDA internal 

policies and procedures to ensure that 

proprietary name review goals are met; 

developing guidance on best practices 

for naming, labeling, and packaging 

drugs and biologics to reduce 

medication errors; developing guidance 

on proprietary name evaluation best 

practices; and developing and 

implementing a pilot program for 

evaluating proposed proprietary names. 

These performance goals are or will be 

addressed elsewhere. 

In the Federal Register of November 

24, 2008 (73 FR 71009), FDA announced 

the availability of a draft guidance for 

industry entitled ‘‘Contents of a 

Complete Submission for the Evaluation 

of Proprietary Names’’ and invited 

comments. Many comments discussed 

topics that were beyond the scope of the 

proprietary names submission guidance, 

including other performance goals 

under PDUFA IV that are addressed in 

other public dockets. These comments 

concerned the contents of any industrysponsored reviews and data for 

submission to FDA under the pilot 

program described in the FDA concept 

paper entitled ‘‘PDUFA Pilot Project 

Proprietary Name Review’’ (concept 

paper) (73 FR 58604, October 7, 2008). 

FDA acknowledges that information in 

the proprietary names submission 

guidance could be useful to participants 

in the voluntary pilot program for 

proprietary name review. However, the 

proprietary names submission guidance 

does not describe the information 

needed by FDA to evaluate proposed 

proprietary names under the pilot 

program. Rather, the purpose is limited 

to informing industry about what 

information is needed by FDA to 

evaluate proposed proprietary names 

within PDUFA IV goal dates under the 

traditional review process. We welcome 

submission of comments about the tools 

and methods FDA uses for its analysis 

of proposed proprietary names under 

the pilot program to docket number 

FDA–2008–N–0281. 

After considering comments on the 

draft guidance, FDA has issued the 

proprietary names submission guidance. 

Changes made to the guidance were 

editorial and primarily clarifying in 

response to comments. The revisions 

included: (1) Clarifying that the purpose 

of this guidance is to provide industry 

with a complete listing of the 

information FDA needs to evaluate a 

proposed proprietary name under the 

traditional review process; (2) adding 

the respective PDUFA IV review 

performance timeframes for complete 

submissions of a proposed proprietary 

name submitted during the IND phase 

or with an NDA, BLA, or supplement; 

and (3) referencing the concept paper1

for a complete discussion of the tools 

and methods used for FDA’s safety 

evaluation that are mentioned in the 

proprietary names submission guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the contents of a 

complete submission for the evaluation 

of proprietary names. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 312 and FDA Form 1571 

have been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information in 21 CFR part 601 and 

FDA Form 356h have been approved 

under OMB control number 0910–0338. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: February 3, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–2660 Filed 2–5–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License: Purified Inactivated 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, HHS. 

ACTION: Notice. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

6212 Federal Register / Vol. 75, No. 25 / Monday, February 8, 2010 / Notices 

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 (HHS), is 

contemplating the grant of a an 

exclusive license to practice the 

following invention as embodied in the 

following patent applications: 

(1) E–120–2001/0, Whitehead et al., 

‘‘Development of Mutations Useful for 

Attenuating Dengue Viruses and 

Chimeric Dengue Viruses’’—European 

Patent Application Number 02739358.6, 

filed May 22, 2002; United States Patent 

Application Number 10/719,547, filed 

November 21, 2003, now U.S. Patent 

Number 7,226,602, issued June 5, 2007; 

Canadian Patent Application Number 

2448329, filed May 22, 2002; Australian 

Patent Application Number 

2002312011, filed May 22, 2002, now 

Australian Patent Number 2002312011, 

issued August 8, 2007; Brazilian Patent 

Application Number PI0209943.8, filed 

May 22, 2002; Indian Patent Application 

Number 2184/DELNP/2003, filed May 

22, 2002, now Indian Patent Number 

218306, issued March 31, 2007; Indian 

Patent Application Number 165/ 

DELNP/2008, filed May 22, 2002; 

United States Patent Application 

Number 11/446,050, filed June 2, 2006, 

now U.S. Patent Number 7,560,118, 

issued July 14, 2009; Australian Patent 

Application Number 2008203275, filed 

May 22, 2002; Indian Patent Application 

Number 204/DELNP/2005, filed May 22, 

2002; and United States Patent 

Application Number 12/396,376, filed 

March 2, 2009 

(2) E–089–2002/0,1, Whitehead et al., 

‘‘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’’—United States 

Patent Application Number 10/970,640, 

filed October 21, 2004, now United 

States Patent Number 7,517,531, issued 

April 14, 2009; Canadian Patent 

Application Number 2483653, filed 

April 25, 2003; European Patent 

Application Number 03724319.3, filed 

April 25, 2003; Japanese Patent 

Application Number 2004–50077, filed 

April 25, 2003; Indian Patent 

Application Number 3450/DELNP/2004, 

filed April 25, 2003, now Indian Patent 

Number 3450/DELNP, issued May 29, 

2006; Australian Patent Application 

2003231185, filed April 25, 2003, now 

Australian Patent Number 2003231185, 

issued January 10, 2008; United States 

Patent Application Number 12/398,043, 

filed March 4, 2009; and Brazilian 

Patent Application PI0309631–9, filed 

April 25, 2003 

(3) E–139–2006/0, Whitehead et al., 

‘‘Development of Dengue Vaccine 

Components’’—Australian Patent 

Application 2007285929, filed August 

15, 2007; Canadian Patent Application 

Number 2661296, filed August 15, 2007; 

Chinese Patent Application Number 

200780031489.4, filed August 15, 2007; 

European Patent Application Number 

07840969.5, filed August 15, 2007; 

Indian Patent Application Number 

1608/DELNP/2009, filed August 15, 

2007; United States Patent Application 

Number 12/376,756, filed February 6, 

2009; and Brazilian Patent Application 

TBA, filed August 15, 2007 to 

GlaxoSmithKline Biologicals, having a 

place of business in Rixensart, Belgium. 

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 March 

10, 2010 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; E-mail: 

ps193c@nih.gov; Telephone: (301) 435– 

4646; 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 thirty (30) 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 

purified inactivated vaccines against 

dengue infections in humans. 

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: January 28, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–2697 Filed 2–5–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–129, Revision of an 

Existing Information Collection; 

Comment Request 

ACTION: 60-Day Notice of Information 

Collection Under Review: Form I–129, 

Petition for Nonimmigrant Worker; 

OMB Control Number 1615–0009. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services has submitted the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection is 

published to obtain comments from the 

public and affected agencies. Comments 

are encouraged and will be accepted for 

60 days until April 9, 2010. 

Written comments and suggestions 

regarding items contained in this notice, 

and especially with regard to the 

estimated public burden and associated 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES