55798 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Murray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6360, 

Silver Spring, MD 20993–0002, 301– 

796–1500. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Chronic Hepatitis C Virus Infection: 

Developing Direct-Acting Antiviral 

Agents for Treatment.’’ This draft 

guidance addresses nonclinical 

development, early phases of clinical 

development, phase 3 protocol designs, 

and endpoints for the treatment of CHC, 

including in patients who are treatment 

naı ̈ve or experienced, patients without 

cirrhosis, patients with compensated 

and decompensated cirrhosis, and 

patients co-infected with HCV and HIV. 

Important issues addressed in this 

guidance include: Drug development 

methods to reduce the emergence of 

drug resistance, types of trial designs to 

assess optimal dose and treatment 

duration, combination therapy with 

multiple investigational drugs, 

recommendations on development of 

drugs to meet unmet medical needs, and 

use of treatment INDs or other smaller 

safety protocols to provide early access 

of multiple DAAs for patients at risk of 

imminent progression of liver disease. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on developing DAAs for treatment of 

CHC virus infection. 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. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

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 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, and the collections 

of information referred to in the 

guidance ‘‘Establishment and Operation 

of Clinical Trial Data Monitoring 

Committees’’ have been approved under 

OMB control number 0910–0581. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

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 or http:// 

www.regulations.gov. 

Dated: September 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22806 Filed 9–13–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0455] 

North American Bioproducts 

Corporation; Filing of Food Additive 

Petition (Animal Use); Penicillin G 

Procaine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that North American Bioproducts Corp. 

has filed a petition proposing that the 

food additive regulations be amended to 

provide for the safe use of penicillin G 

procaine as an antimicrobial processing 

aid in fuel-ethanol fermentations with 

respect to its consequent presence in byproduct distiller grains used as an 

animal feed or feed ingredient. 

DATES: Submit either electronic or 

written comments on the petitioner’s 

environmental assessment by October 

14, 2010. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Isabel W. Pocurull, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6853, 

email: isabel.pocurull@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(section 409(b)(5) (21 U.S.C. 348(b)(5))), 

notice is given that a food additive 

petition (FAP 2268) has been filed by 

North American Bioproducts Corp., 

Corporate Support Center, 1815 Satellite 

Blvd., Bldg. 200, Duluth, GA 30097. The 

petition proposes to amend the food 

additive regulations in part 573 Food 

Additives Permitted in Feed and 

Drinking Water of Animals (21 CFR part 

573) to provide for the safe use of 

penicillin G procaine as an 

antimicrobial processing aid in fuelethanol fermentations with respect to its 

consequent presence in by-product 

distiller grains used as an animal feed 

or feed ingredient. 

The potential environmental impact 

of this action is being reviewed. To 

encourage public participation 

consistent with regulations issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see ADDRESSES) for public review and 

comment. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments regarding this document. It is 

only necessary to submit one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the agency finds 

that an environmental impact statement 

is not required and this petition results 

in a regulation, the notice of availability 

of the agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 55799 

Dated: September 8, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–22811 Filed 9–13–10; 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, 

Public Health Service, 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. 

Assay for Arf GTP-Binding Proteins 

Description of Invention: The 

worldwide laboratory research reagents 

market is expected to surpass $13 

billion in 2010, and the field of 

biotechnology appears key to 

maintaining the market’s growth. 

Antibodies are becoming increasingly 

significant, especially for targeting the 

diseased cells and cell compounds. 

Researchers at the National Cancer 

Institute (NCI), NIH, have developed an 

antibody-based assay that measures 

levels of Arf GTP-binding proteins, 

some of which have been linked to the 

invasive behavior of cancer cells. The 

assay is robust, can be performed both 

on cell lysates and fixed cells, and can 

distinguish among specific endogenous 

Arf-GTP isoforms. 

Applications: 

• Research on Arf function in 

physiology and cancer. 

• Research on cancer invasion. 

• Research on membrane traffic and 

actin reorganization. 

Advantages: 

• Ability to distinguish between the 

specific isoforms (i.e., Arf1, Arf3, Arf4, 

Arf5, and Arf6). 

• Antibodies bind preferentially to 

the GTP-bound form of Arf. 

Inventor: Paul A. Randazzo (NCI). 

Relevant Publications: 

1. Spang A et al. Arf GAPs: 

gatekeepers of vesicle generation. FEBS 

Lett. 2010 Jun 18;584(12):2646–2651. 

[PubMed: 20394747]. 

2. Campa F and Randazzo PA. Arf 

GTPase-activating proteins and their 

potential role in cell migration and 

invasion. Cell Adh Migr. 2008 Oct; 

2(4):258–262. [PubMed: 19262159]. 

Patent Status: HHS Reference No. E– 

198–2010/0—Research Material. Patent 

protection is not being pursued for this 

technology. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Patrick P. McCue, 

PhD, (301) 435–5560; 

mccuepat@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

Laboratory of Cellular and Molecular 

Biology, 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. 

Sequences Encoding Two Novel Human 

Polyomaviruses 

Description of Invention: Researchers 

at the National Cancer Institute, NIH, 

have discovered two species of a 

previously unknown polyomavirus 

genus. 

Polyomaviruses are a diverse group of 

DNA-based viruses that infect humans 

and various animals. At least one 

human polyomavirus, the Merkel cell 

polyomavirus (MCV), plays a causal role 

in the development of an unusual form 

of skin cancer called Merkel cell 

carcinoma. The coat proteins of 

polyomaviruses can spontaneously 

assemble into virus-like particles (VLPs) 

similar to those that have been used in 

the recent vaccines against human 

papillomaviruses (HPVs). 

Applications: 

• Development of clinical diagnostic 

assays to detect linkages between the 

new polyomaviruses and human 

cancers. 

• Development of a VLP-based 

prophylactic vaccine similar to the HPV 

vaccine. 

Advantages: DNA sequences have 

broad applications in the studies of 

polyomavirus infection mechanisms 

and carcinogenesis. Notably, they are: 

• Identification and purification of 

the normal and mutated polyomaviral 

proteins. 

• Studies of antisense 

oligonucleotides in polyomavirus 

biology. 

• Development of polyclonal and 

monoclonal antibodies against 

polyomaviruses. 

Development Status: Pre-clinical. 

Inventors: Christopher B. Buck and 

Diana V. Pastrana (NCI). 

Relevant Publication: Schowalter RM 

et al. Merkel cell polyomavirus and two 

previously unknown polyomaviruses 

are chronically shed from human skin. 

Cell Host Microbe Jun 25;7(6):509–515. 

[PubMed: 20542254]. 

Patent Status: U.S. Provisional 

Application No. 61/318,080 filed 26 Mar 

2010 (HHS Reference No. E–051–2010/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Patrick P. McCue, 

PhD; 301–435–5560; 

mccuepat@mail.nih.gov. 

Fenoterol and Fenoterol Analogues for 

Treatment of Glioma, Glioblastoma, 

and Astrocytoma 

Description of Invention: To date 

there is no effective treatment for the 

brain tumors or brain cancers 

indentified as gliomas, glioblastomas, or 

astrocytomas. 

This technology relates to the 

discovery that fenoterol and related 

analogues block astrocytoma and 

glioblastoma cell division at low doses. 

In a xenograft model utilizing the 

1321N1 astrocytoma tumor implanted in 

the flank of SKID mice, the (R,R)-4- 

methoxyfenoterol analogue significantly 

decreased tumor growth relative to a 

control group receiving vehicle and 

studies utilizing [3H]-(R,R)-4- 

methoxyfenoterol have shown that the 

compound readily passes the bloodbrain barrier. The anti-tumor effect is 

associated with the ability of fenoterol 

and related analogues to induce 

production of cyclic adenosine 

monophosphate (cAMP), which is 

normally decreased in glioblastomas 

and astrocytomas. Induced cAMP 

production inhibits brain tumor growth 

in vivo. Fenoterol and related analogues 

are beta-2 adrenergic receptor (b2 AR) 

agonists and the anti-tumor effect is 

associated with the expression of this 

receptor. Since there is a heterogeneous 

expression of b2 AR in human brain 

tumors, patients who will respond to 

fenoterol therapy can be predetermined 

leading to individualized treatment. In 

addition to use in the initial treatment 

of brain tumors, the systemic and CNS 

bioavailability of the drug after oral 


jlentini on DSKJ8SOYB1PROD with NOTICES