Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 60761 

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. 

Inhibitors of 6-hydroxymethyl-7,8- 

dihydropterin Pyrophosphokinase as 

Novel Antibiotics 

Description of Invention: The 

invention offered for licensing describes 

and claims novel inhibitors of 6- 

hydroxymethyl-7,8-dihydropterin 

pyrophosphokinase (HPPK), a key 

enzyme in the folate biosynthetic 

pathway which is essential for 

microorganisms but absent in mammals. 

These novel inhibitors are based on 

linked purine pterin compounds. They 

can disrupt the folate biosynthesis of 

bacteria and thus can find utility as 

potential antimicrobials. Antibiotics 

based on these lead molecules can be 

specifically designed and synthesized to 

serve as broad-spectrum or narrowspectrum antibiotics. None of the 

currently established antibiotics target 

HPPK. 

Applications: 

• Antimicrobial agents. 

• Use in anti-bioterrorism. 

Advantages: 

• Potential as broad-spectrum or 

narrow-spectrum antibiotics. 

• The antibiotics of present invention 

target a new biological pathway that has 

not been targeted by existing antibiotics, 

and thus circumvent issues related to 

drug resistance. 

Inventors: Genbin Shi, Gary Shaw, 

Xinhua Ji (NCI). 

Patent Status: U.S. Provisional 

Application No. 61/356,213 filed 18 Jun 

2010 (HHS Reference No. E–170–2010/ 

0–US–01). 

Relevant Publications: 

1. Blaszczyk J, Shi G, Li Y, Yan H, Ji 

X. Reaction trajectory of 

pyrophosphoryl transfer catalyzed by 6- 

hydroxymethyl-7,8-dihydropterin 

pyrophosphokinase. Structure 2004 

Mar;12(3):467–475. [PubMed: 

15016362]. 

2. Blaszczyk J, Shi G, Yan H, Ji X. 

Catalytic center assembly of HPPK as 

revealed by the crystal structure of a 

ternary complex at 1.25A ̊ resolution. 

Structure 2000 Oct 15; 8(10):1049–1058. 

[PubMed: 11080626]. 

3. Wood HCS. 1975. Specific 

inhibition of dihydrofolate 

biosynthesis—a new approach to 

chemotherapy. Chemistry and Biology 

of Pteridines, W. Pfleiderer, ed. (BerlinNew York: Walter de Gruyter). 

Licensing Status: Available for 

licensing. 

Licensing Contacts: 

• Uri Reichman, Ph.D., MBA; 301– 

435–4616; UR7a@nih.gov. 

• John Stansberry, Ph.D.; 301–435– 

5236; js852e@nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, 

Biomolecular Structure Section, is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize the 

inhibitors of HPPK as novel antibiotics. 

Please contact John Hewes, PhD at 301– 

435–3121 or hewesj@mail.nih.gov for 

more information. 

Compositions and Methods for the 

Treatment of Cancer 

Description of Invention: Cancer is the 

second leading cause of human death 

next to coronary disease in the United 

States. Worldwide, millions of people 

die from cancer every year. In the 

United States alone, as reported by the 

American Cancer Society, cancer causes 

the death of well over a half-million 

people annually, with over 1.2 million 

new cases diagnosed per year. While 

deaths from heart disease have been 

declining significantly, those resulting 

from cancer generally are on the rise. 

Cancer is soon predicted to become the 

leading cause of death in the United 

States. 

This application claims methods for 

inducing an immune response to a 

tumor. These methods include 

administering a therapeutically effective 

amount of apoptotic tumor cells 

conjugated to a K-type CpG 

oligodeoxynucleotide (ODN) to a 

subject. Methods for treating a tumor in 

a subject are also claimed in this 

application. These methods include 

administering a therapeutically effective 

amount of apoptotic tumor cells 

conjugated to a K-type CpG 

oligodeoxynucleotide (ODN) to a 

subject. More specifically, the tumor 

cells may be autologous, and the tumor 

may be a lymphoma, cervical cancer, 

prostate cancer, breast cancer, colon 

cancer, or a lung cancer. 

Applications: 

• Vaccines for the prevention of 

cancer and other indications 

• Use of CpG oligonucleotides for 

prophylaxis and/or therapy 

Advantages: 

• Novel vaccine candidates 

• Increased immunogenicity 

Development Status: Preclinical 

studies have been conducted by the 

inventors. 

Inventors: Dennis M. Klinman and 

Hidekazu Shirota (NCI). 

Patent Status: U.S. Provisional 

Application No. 61/309,802 filed 02 Mar 

2010 (HHS Reference No. E–266–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Peter A. Soukas; 

301–435–4646; soukasp@mail.nih.gov. 

Collaborative Research Opportunity: 

The Center for Cancer Research, 

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 Hewes, Ph.D. at 301–435– 

3121 or hewesj@mail.nih.gov for more 

information. 

Dated: September 27, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–24679 Filed 9–30–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0270] 

Medical Device User Fee and 

Modernization Act; Notice to Public of 

Web site Location of Fiscal Year 2011 

Proposed Guidance Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


emcdonald on DSK2BSOYB1PROD with NOTICES
60762 Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

Web site location where it will post a 

list of guidance documents the Center 

for Devices and Radiological Health 

(CDRH) is considering for development. 

In addition, FDA has established a 

docket where stakeholders may provide 

comments and/or draft language for 

those topics as well as suggestions for 

new or different guidances. 

DATES: Submit either written or 

electronic comments at any time. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Pirt, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. WO66, rm. 4438, Silver 

Spring, MD 20993, 301–796–5739. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations over the 

reauthorization of the Medical Device 

User Fee and Modernization Act 

(MDUFMA), FDA agreed, in return for 

additional funding from industry, to 

meet a variety of quantitative and 

qualitative goals intended to help get 

safe and effective medical devices to 

market more quickly. These 

commitments include annually posting 

a list of guidance documents that CDRH 

is considering for development and 

providing stakeholders an opportunity 

to provide comments and/or draft 

language for those topics, or suggestions 

for new or different guidances. This 

notice announces the Web site location 

of the list of guidances on which CDRH 

is intending to work over the next Fiscal 

Year (FY). We note that the agency is 

not required to issue every guidance on 

the list, nor is it precluded from issuing 

guidance documents that are not on the 

list. The list includes topics that 

currently have no guidance associated 

with them, topics where updated 

guidance may be helpful, and topics for 

which CDRH has already issued level 1 

drafts that may be finalized following 

review of public comments. We will 

consider stakeholder comments as we 

prioritize our guidance efforts. 

FDA and CDRH priorities are subject 

to change at any time. Topics on this 

and past guidance priority lists may be 

removed or modified based on current 

priorities. We also note that CDRH’s 

experience over the years has shown 

that there are many reasons CDRH staff 

does not complete the entire annual 

agenda of guidances it undertakes. Staff 

are frequently diverted from guidance 

development to other activities, 

including review of premarket 

submissions or postmarket problems. In 

addition, the Center is required each 

year to issue a number of guidances that 

it cannot anticipate at the time the 

annual list is generated. These may 

involve newly identified public health 

issues as well as special control 

guidance documents for de novo 

classifications of devices. It will be 

helpful, therefore, to receive comments 

that indicate the relative priority of 

different guidance topics to interested 

stakeholders. 

Through feedback from stakeholders, 

including draft language for guidance 

documents, CDRH expects to be able to 

better prioritize and more efficiently 

draft guidances that will be useful to 

industry and other stakeholders. This 

will be the fourth annual list CDRH has 

posted. FDA intends to update the list 

each year. 

FDA invites interested persons to 

submit comments on any or all of the 

guidance documents on the list. FDA 

has established a docket where 

comments about the FY 2011 list, draft 

language for guidance documents on 

those topics, and suggestions for new or 

different guidances may be submitted 

(see ADDRESSES). FDA believes this 

docket is an important tool for receiving 

information from interested parties and 

for sharing this information with the 

public. Similar information about 

planned guidance development is 

included in the annual agency-wide 

notice issued by FDA under its good 

guidance practices (21 CFR 10.115(f)(5)). 

This CDRH list, however, will be 

focused exclusively on device-related 

guidances and will be made available on 

FDA’s Web site prior to the beginning of 

each FY from 2008 to 2012. 

To access the list of the guidance 

documents CDRH is considering for 

development in FY 2011, visit the FDA 

Web site http://www.fda.gov/Medical

Devices/DeviceRegulationandGuidance/ 

Overview/MedicalDeviceUserFee

andModernizationActMDUFMA/ 

ucm109196.htm. 

II. Request for 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. 

Dated: September 28, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–24669 Filed 9–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors (BSC), 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry (NCEH/ATSDR) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), CDC and NCEH/ 

ATSDR announces the following 

committee meeting: 

TIMES AND DATES: 

8:30 a.m.–4:15 p.m., October 21, 2010. 

8:30 a.m.–12 p.m., October 22, 2010. 

PLACE: CDC, 4770 Buford Highway, 

Atlanta, Georgia 30341. 

STATUS: Open to the public, limited only 

by the space available. The meeting 

room accommodates approximately 75 

people. 

PURPOSE: The Secretary, Department of 

Health and Human Services (HHS) and 

by delegation, the Director, CDC and 

Administrator, NCEH/ATSDR, are 

authorized under Section 301 (42 U.S.C. 

241) and Section 311 (42 U.S.C. 243) of 

the Public Health Service Act, as 

amended, to: (1) Conduct, encourage, 

cooperate with, and assist other 

appropriate public authorities, scientific 

institutions, and scientists in the 

conduct of research, investigations, 

experiments, demonstrations, and 

studies relating to the causes, diagnosis, 

treatment, control, and prevention of 

physical and mental diseases and other 

impairments; (2) assist States and their 

political subdivisions in the prevention 

of infectious diseases and other 

preventable conditions and in the 

promotion of health and well being; and 

(3) train State and local personnel in 

health work. The BSC, NCEH/ATSDR 

provides advice and guidance to the 

Secretary, HHS; the Director, CDC and 

Administrator, ATSDR; and the 

Director, NCEH/ATSDR, regarding 

program goals, objectives, strategies, and 

priorities in fulfillment of the agency’s 


emcdonald on DSK2BSOYB1PROD with NOTICES