17196 Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Joseph T. Hughes, 

Jr., Director, Worker Education and 

Training Branch, Division of Extramural 

Research and Training, NIEHS, P.O. Box 

12233, Research Triangle Park, NC 

27709 or call non-toll-free number (919) 

541–0217 or E-mail your request, 

including your address to 

wetp@niehs.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Dated: April 2, 2009. 

Marc S. Hollander, 

NIEHS Associate Director for Management. 

[FR Doc. E9–8472 Filed 4–13–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–P–0250] (formerly 

Docket No. 2007P–0341) 

Determination That ZOMETA 

(Zoledronic Acid for Injection), 

Equivalent to 4 Milligrams Base Per 

Vial, Lyophilized Powder for Injection, 

Was Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that ZOMETA (zoledronic acid for 

injection), equivalent to (EQ) 4 

milligrams (mg) base/vial, lyophilized 

powder for injection, was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for zoledronic 

acid lyophilized powder for injection, 4- 

mg base/vial. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Boocker, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6244, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

sponsors must, with certain exceptions, 

show that the drug for which they are 

seeking approval contains the same 

active ingredient in the same strength 

and dosage form as the ‘‘listed drug,’’ 

which is a version of the drug that was 

previously approved. Sponsors of 

ANDAs do not have to repeat the 

extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are withdrawn from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under 21 CFR 314.161(a)(1), the 

agency must determine whether a listed 

drug was withdrawn from sale for 

reasons of safety or effectiveness before 

an ANDA that refers to that listed drug 

may be approved. FDA may not approve 

an ANDA that does not refer to a listed 

drug. 

ZOMETA (zoledronic acid for 

injection), EQ 4-mg base/vial, 

lyophilized powder for injection, is the 

subject of approved NDA 21–223 held 

by Novartis Pharmaceuticals Corp. 

(Novartis). Zoledronic acid, lyophilized 

powder for injection, EQ 4-mg base/vial, 

is indicated for treatment of 

hypercalcemia of malignancy. It also is 

indicated for the treatment of patients 

with multiple myeloma and patients 

with documented bone metastases from 

solid tumors, in conjunction with 

standard antineoplastic therapy. 

Novartis ceased manufacturing 

ZOMETA (zoledronic acid for injection), 

EQ 4 mg-base/vial, lyophilized powder 

for injection, in May 2003. On 

September 13, 2007, Kendle 

International, on behalf of Sun 

Pharmaceutical Industries Ltd., 

submitted a citizen petition (Docket No. 

2007P–0341/CP1), under 21 CFR 10.30, 

requesting that the agency determine 

whether zoledronic acid lyophilized 

powder for injection, EQ 4-mg base/vial, 

was withdrawn from sale for reasons of 

safety or effectiveness. 

The agency has determined that 

ZOMETA (zoledronic acid for injection), 

EQ 4-mg base/vial, lyophilized powder 

for injection, was not withdrawn from 

sale for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that zoledronic acid 

lyophilized powder for injection, 4-mg 

base/vial, was withdrawn from sale as a 

result of safety or effectiveness 

concerns. FDA’s independent 

evaluation of relevant information has 

uncovered no information that would 

indicate this product was withdrawn for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing agency records, FDA 

determines that for the reasons outlined 

previously, ZOMETA (zoledronic acid 

for injection), EQ 4-mg base/vial, 

lyophilized powder for injection, was 

not withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

agency will continue to list ZOMETA 

(zoledronic acid for injection), 4-mg 

base/vial, lyophilized powder for 

injection, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. 

ANDAs that refer to ZOMETA 

(zoledronic acid for injection), EQ 4-mg 

base/vial, lyophilized powder for 

injection, may be approved by the 

agency as long as they meet all relevant 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that the labeling of this drug 

product should be revised to meet 

current standards, the agency will 

advise ANDA applicants to submit such 

labeling. 

Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 17197 

Dated: March 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8524 Filed 4–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

Federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Insect Salivary Proteins as Potent 

Adjuvants for Enhancing Immune 

Responses 

Description of Technology: This 

invention relates to the discovery that 

specific sand fly salivary proteins have 

marked effects on the outcome of 

Leishmania infection. These proteins 

have the ability to stimulate strong Th1 

and Th2 responses. The Th1 responses 

with one protein, PpSP15, result in 

immune protection while the Th2 

responses to another protein, PpSP44, 

exacerbate infection. The protective 

protein enhanced a specific immune 

response to the infection, suggesting 

that it acts as an adjuvant to alter the 

environment and presentation of the 

parasite antigens. 

These immunogenic salivary proteins, 

capable of driving Th1 or Th2 

responses, can be used as adjuvants in 

vaccine development for a broad 

spectrum of diseases that require 

different immune responses. They may 

therefore be used to enhance immune 

responses to pathogens other than 

Leishmania parasites. They are also very 

potent in their effect, and small doses 

are sufficient to elicit a strong immune 

response. This potency can reduce the 

need to use chemical adjuvants, which 

often require large mounts of material 

and can have deleterious side effects. 

Applications: 

• Vaccine for Leishmania parasite 

and other pathogenic infections. 

• Potent adjuvant for a broad 

spectrum of diseases. 

Advantages: Efficient, potent, and less 

toxic than many chemical adjuvants. 

Development Status: Early Stage. 

Market: 

• 88 countries with an estimated 2 

million people affected each year. 

• Estimated 350 million at risk 

worldwide. 

Inventors: Jesus G. Valenzuela et al. 

(NIAID). 

Publication: F Oliveira, PG Lawyer, S 

Kamhawi, JG Valenzuela. Immunity to 

distinct sand fly salivary proteins 

primes the anti-Leishmania immune 

response towards protection or 

exacerbation of disease. PLoS Negl Trop 

Dis. 2008 Apr 16;2(4):e226. 

Patent Status: U.S. Provisional 

Application No. 61/089,884 filed 08 

Aug 2008 (HHS Reference No. E–303– 

2008/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jeffrey A. James 

PhD; 301–435–5474; 

jeffreyja@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIAID, Office of Technology 

Development is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize the Insect Salivary 

Proteins as potent immune response 

adjuvants. Please contact Charles 

Rainwater at crainwater@niaid.nih.gov 

or 301/496–2644 for more information. 

Anti-Cancer Oligodeoxynucleotides 

Description of Technology: A majority 

of human cancers originate from 

epithelial tissue. A common cancer of 

epithelial cell origin is non-melanoma 

skin cancer (NMSC), including basal 

cell carcinoma (BCC) and squamous cell 

carcinoma (SCC), with more than seven 

hundred thousand (700,000) new cases 

diagnosed each year in the United States 

alone. BCC is rarely life-threatening 

because it is slow growing and is mostly 

localized. Unlike BCC, SCC metastasizes 

at a rate of two (2) to six (6) percent over 

several years after the initial diagnosis. 

A highly malignant form invades and 

destroys tissue, and then metastasizes, 

initially to a regional lymph node before 

more distant organs such as the lungs or 

brain are affected. SCC is commonly 

encountered in a number of epithelial 

tissues, including the oral cavity, 

esophagus, larynx, bronchi, intestines, 

colon, genital tract, and skin. 

This application relates to 

suppressive CpG oligodeoxynucleotides 

(ODNs). This application claims 

suppressive ODN compositions and 

their use to prevent or delay the 

formation of a tumor, reducing the risk 

of developing a tumor, treating a tumor, 

preventing conversion of a benign to a 

malignant lesion, or preventing 

metastasis. Topical application of the 

ODNs of this invention in preclinical 

studies resulted in significantly fewer 

animals developing papillomas and 

fewer papillomas/animal. The invention 

also relates to use of suppressive ODNs 

to prevent/delay cancer when 

administered systemically as well as 

locally. 

Application: Development of anticancer vaccines, therapeutics and 

diagnostics. 

Development Status: ODNs have been 

synthesized and preclinical studies have 

been performed. 

Inventors: Dennis M. Klinman and 

Hidekazu Ikeuchi (NCI) 

Patent Status: U.S. Provisional 

Application No. 61/119,998 filed 04 Dec 

2008 (HHS Reference No. E–296–2008/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301–435–4646; 

soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, 

Laboratory of Experimental 

Immunology, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact John D. Hewes, PhD at 301–435– 

3121 or hewesj@mail.nih.gov for more 

information. 

Neutralization of Hepatitis C Virus 

(HCV) 

Description of Technology: Available 

for licensing and commercial 

development are compositions and 

methods for preventing and/or treating 

infection caused by hepatitis C virus 

(HCV). The invention is based on 

mapping studies conducted by the 

inventors of two epitopes within HCV 

E2: epitope I and epitope II. It has been 

discovered that epitope I is involved in 

virus neutralization but that epitope II 

mediates antibody interference,