46606 Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 

Dated: September 1, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–21786 Filed 9–9–09; 8:45 am] 

BILLING CODE 4140–01–P 

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. 

Rapid Diagnostic Applications of Phage 

Description of Technology: The NIH 

has available for licensing two 

techniques for rapid detection of a 

particular bacteria strain. Similar 

detection using currently available 

technologies take 1–2 days; this 

technology reduces the time to less than 

one hour. These technologies utilize 

phage, which has no pathogenic effect 

on higher plants and animals and are 

part of approved food-preparation 

formulations, indicating their known 

safety profile and an existing regulatory 

pathway. The first technique involves a 

phage that incorporates a reporter gene 

(e.g., luciferase) that will be expressed 

only when the phage successfully 

infects a bacterium. This technique is 

particularly useful where only bacteriakilling (‘‘lytic’’) phages are known 

because the method also deactivates the 

lytic genes, enabling infection and 

subsequent detection. The second 

technique involves an engineered phage 

that will bind with quantum dots upon 

infection of bacteria; if a sample is 

treated first with this phage and then 

with quantum dots, the sample will 

only respond if the bacteria are present. 

Both techniques can be used to diagnose 

a clinical sample (tissue, blood, etc.) or 

an environmental isolate. 

Applications 

• Bacterial detection and diagnostics, 

including clinical or environment 

samples. 

• Food safety and biodefense. 

Advantages 

• Detection methods are novel, rapid, 

and potentially applicable in many 

contexts (e.g., clinic, food preparation, 

bioterror response). 

• Phage is easy and inexpensive to 

cultivate. 

• Phage is on sale in the US for foodpreparation formulations and thus has a 

known regulatory pathway. 

Development Status: A range of 

phages have been synthesized, many of 

which have been tested proof-ofprinciple using major standardized 

testing systems. 

Inventors: Dr. Carl Merrill (NIMH), Dr. 

Sankar Adhya (NCI), et al. 

Publications 

1. R Edgar et al. High-sensitivity 

bacterial detection using biotin-tagged 

phage and quantum-dot nanocomplexes. 

Proc Natl Acad Sci. USA 2006 Mar 

28;103(13):4841–4845. 

2. C Merril et al. The prospect for 

bacteriophage therapy in Western 

medicine. Nat Rev Drug Discov. 2003 

Jun;2(6):489–497. 

Patent Status 

HHS Reference No. E–169–2004—U.S. 

Patent Application No. 11/547,587 filed 

05 Oct 2006. 

HHS Reference No. E–281–2005—U.S. 

Patent Application No. 11/884,604 filed 

17 Aug 2007. 

HHS Reference No. E–318–2000— 

Research Materials (patent protection is 

not being pursued for this technology): 

‘‘Method for Determining Sensitivity to 

a Bacteriophage.’’ 

Licensing Status: Technologies are 

available for licensing, either 

individually or as a package. 

Licensing Contact: Bruce Goldstein, 

J.D., M.S.; 301–435–5470; 

goldsteb@mail.nih.gov. 

Collaborative Research Opportunity: 

The NCI Laboratory of 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. 

Therapeutic Antibacterial Applications 

of Phage 

Description of Technology: The NIH, 

in collaboration with others, has 

developed three groups of inventions 

related to the use of bacteriophages in 

therapeutic situations. The first group is 

a method of adapting phages to survive 

in the body substantially longer than 

wild-type phages, using serial passaging 

and/or genetic engineering. The second 

group involves phages designed to bind 

the toxins and cytokines that killed 

bacteria release into the bloodstream, 

reducing the pathogenic properties of 

the bacteria. The third group is a 

method of engineering a phage to have 

multiple binding sites, such that a single 

phage can target multiple types of 

bacteria. 

Application: Therapeutic applications 

of phage to treat bacterial infection. 

Advantages 

• Improved efficacy through longer 

circulation. 

• Additional antibacterial functions. 

• Can be used independently or as an 

adjuvant to another antibacterial 

therapy. 

Development Status: A range of 

phages have been synthesized and 

tested in vivo. A Phase 1 study of a 

phage targeting vancomycin-resistant 

Enterococcus faecium was completed by 

Exponential Biotherapies, Inc., with no 

adverse effects reported. 

Inventors: Dr. Carl Merrill (NIMH), Dr. 

Sankar Adhya (NCI), et al. 

Publications 

1. C Merril et al. The prospect for 

bacteriophage therapy in Western 

medicine. Nat Rev Drug Discov. 2003 

Jun;2(6):489–497. 

2. B Biswas et al. Bacteriophage 

therapy rescues mice bacteremic from a 

clinical isolate of vancomycin-resistant 

Enterococcus faecium. Infect Immun. 

2002 Jan;70(1):204–210. 

3. C Merrill et al. Long-circulating 

bacteriophage as antibacterial agents. 

Proc Natl Acad Sci. USA 1996 Apr 

16;93(8):3188–3192. 

Patent Status 

HHS Reference No. E–110–1993—U.S. 

Patent No. 5,688,601 issued 19 Jun 

1997; U.S. Patent No. 7,332,307 issued 

19 Feb 2008. 

HHS Reference No. E–257–2000—U.S. 

Patent No. 7,163,818 issued 16 Jan 2007. 

HHS Reference No. E–178–1996— 

Research Materials (patent protection is 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 174 / Thursday, September 10, 2009 / Notices 46607 

not being pursued for this technology): 

‘‘Deletion of Lysogeny Genes and Toxin 

Genes from Bacteriophage Used in the 

Epidemiologic Control of Bacterial 

Illness.’’ 

HHS Reference No. E–179–1996— 

Research Materials (patent protection is 

not being pursued for this technology): 

‘‘Therapeutics Use of Phage Expressing 

Toxin-Binding and/or Cytokine-Binding 

Proteins and Elimination of Genes 

Associate with Lysogeny.’’ 

HHS Reference No. E–196–1997— 

Research Materials (patent protection is 

not being pursued for this technology): 

‘‘Antibacterial Therapy with 

Bacteriophage Genotypically Modified 

to Delay Inactivation by the Host 

Defense System.’’ 

HHS Reference Nos. E–089–1998 and 

E–257–2003—Research Materials (patent 

protection is not being pursued for this 

technology): ‘‘Two Enterocin-Producing 

Strains of Bacteria and Their Enterocins, 

Both of Which Are Lethal to 

Vancomycin-Resistant Enterococcus 

faecium.’’ 

HHS Reference No. E–012–1999— 

Research Materials (patent protection is 

not being pursued for this technology): 

‘‘Long Circulating Phage Vectors.’’ 

Licensing Status: Technologies are 

available for licensing, either 

individually or as a package. 

Licensing Contact: Bruce Goldstein, 

J.D., M.S.; 301–435–5470; 

goldsteb@mail.nih.gov. 

Collaborative Research Opportunity: 

The NCI Laboratory of 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. 

Dated: September 1, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–21787 Filed 9–9–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0392] 

Medical Devices: Neurological 

Devices; Electroconvulsive Therapy 

Device; Establishing a Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

opening of a public docket to receive 

information and comments regarding 

the current classification process related 

to electroconvulsive therapy devices 

(ECT). The current classification process 

for this device pertains to the ‘‘Order for 

Certain Class III Devices; Submission of 

Safety and Effectiveness,’’ published in 

the Federal Register of April 9, 2009 (74 

FR 16214). Under the Order, FDA 

required manufacturers of certain Class 

III devices, including ECT, to submit a 

summary of, and citation to, any 

information known or otherwise 

available to them respecting such 

devices, including adverse safety or 

effectiveness information which has not 

been submitted under the Federal Food, 

Drug, and Cosmetic Act (the act). For 

each device subject to the Order, FDA 

is reviewing the submitted information 

to determine whether FDA should 

maintain the device as class III and 

require the submission of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP), or whether FDA should 

reclassify the device into class II or class 

I. FDA is now inviting interested 

persons to submit comments that relate 

to the safety and effectiveness of ECT. 

DATES: Submit written or electronic 

comments and information by January 

8, 2010. 

ADDRESSES: Submit written comments 

and information to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments and 

information to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Victor Krauthamer, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., W066–1106, Silver Spring, MD 

20993, 301–796–2474. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of April 9, 

2009 (74 FR 16214), FDA published an 

‘‘Order for Certain Class III Devices; 

Submission of Safety and Effectiveness 

Information’’ (‘‘515(i) Order’’). Under 

this Order, as mandated by section 

515(i) of the act (21 U.S.C. 360e(i)), FDA 

required manufacturers of certain class 

III devices that were in commercial 

distribution before May 28, 1976, and 

devices found to be substantially 

equivalent to them that were marketed 

on or after that date, including ECT, to 

submit to FDA by August 7, 2009, a 

summary of, and citation to, any 

information known, or otherwise 

available to them respecting those 

devices including, adverse safety or 

effectiveness data that had not been 

submitted under section 519 of the act 

(21 U.S.C. 360i). In addition, 

manufacturers were encouraged by FDA 

to submit a summary of the information 

previously sent to FDA under section 

519 of the act. Currently, the agency is 

in the process of reviewing the 

information that has been submitted by 

the manufacturers subject to the 515(i) 

Order. 

Based upon the review of this 

submitted information, FDA is 

considering whether to issue a proposed 

rule requiring the device to remain in 

class III, followed by the issuance of a 

regulation requiring submission of a 

PMA or PDP, or to revise the 

classification of the devices into class II, 

requiring the designation of special 

controls, or into class I, requiring only 

general controls. In determining 

whether to revise the classification of a 

device, or to require a device to remain 

in class III, FDA will apply the criteria 

set forth in section 513(a) of the act. If 

FDA decides to reclassify the device, 

FDA must determine that general 

controls alone (class I) or general 

controls plus special controls (class II) 

would provide reasonable assurance of 

the safety and effectiveness of the 

device. FDA’s proposed classification of 

ECT devices will be subject to notice 

and comment rulemaking to allow for 

additional public comment. 

FDA has received a significant 

number of inquiries from members of 

the public and the health care 

community in response to this order to 

ECT manufacturers. In recognition of 

this significant public interest, FDA is 

opening this docket to permit 

individuals other than manufacturers to 

submit information related to the safety 

and effectiveness of ECT. If individuals 

wish to report an adverse event 

associated with the use of an ECT 

device, please use the MedWatch 

Online Voluntary Reporting Form 

available at https:// 

www.accessdata.fda.gov/scripts/ 

medwatch/medwatch-online.htm. FDA 

will review information submitted 

through the MedWatch program prior to 

making any changes to the classification 

of ECT devices. 

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 


erowe on DSK5CLS3C1PROD with NOTICES