Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 61877 

sites after this document publishes in 

the Federal Register.) 

Requests for Oral Presentations: This 

public workshop includes a public 

comment session. During online 

registration you may indicate if you 

wish to speak during the public 

comment session and which topics you 

wish to address. FDA has included 

general topics in this document. FDA 

will do its best to accommodate requests 

to make public comments. Following 

the close of registration, FDA will 

determine the amount of time allotted to 

each speaker and will select and notify 

participants by November 10, 2014. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public workshop. 

Comments: FDA is holding this public 

workshop to obtain input on insulin 

bolus calculators. In order to permit the 

widest possible opportunity to obtain 

public comment, FDA is soliciting 

either electronic or written comments 

regarding the public workshop topics 

that pertain to insulin bolus calculators. 

The deadline for submitting comments 

related to this public workshop is 

December 11, 2014. 

Regardless of attendance at the public 

workshop, interested persons may 

submit either electronic comments 

regarding this document to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Please identify comments with the 

docket number found in brackets in the 

heading of this document. In addition, 

when responding to specific questions 

as outlined in section II of this 

document, please identify the question 

number you are addressing. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see Comments). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. A link to the 

transcripts will also be available on the 

Internet at http://www.fda.gov/

MedicalDevices/NewsEvents/

WorkshopsConferences/default.htm 

(select this public workshop from the 

posted events list), approximately 45 

days after the workshop. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is seeking to foster greater 

stakeholder collaboration in the area of 

diabetes device interoperability. To that 

end, the Agency requests input from the 

clinical community, academia, 

government, industry, and other 

stakeholders regarding usability 

considerations for appropriate 

information consumption (e.g., 

notifications, indicators, data, and 

displays) based on user skill and 

knowledge. The Agency also requests 

input regarding the technical 

considerations for calculator design and 

use. 

The first topic of discussion is the 

interoperability between diabetes 

devices. The Agency recognizes that the 

diabetes community possesses an 

interest in patients having greater 

flexibility to pair device components, 

e.g., continuous glucose meters with 

insulin pumps from different 

manufacturers. Pairing would allow 

those devices to communicate with each 

other and enable patients to interact 

with a single interface platform. 

Achieving this goal would improve data 

tracking and access, thereby facilitating 

more productive patient interactions 

with their healthcare providers. In order 

to realize the objective of effective 

diabetes device interoperability, 

developers and manufacturers should 

discuss technical, safety, and regulatory 

challenges that lay before this goal. A 

forum that elicits opinions from 

physicians and patients regarding their 

desires and needs will help inform 

those discussions. FDA is committed to 

fostering a collaborative environment to 

promote these interactions. 

The second topic of discussion is 

insulin bolus calculators. These devices 

are intended to calculate insulin boluses 

for patients who manage their diabetes 

with insulin-intensive therapy. FDA 

currently regulates insulin bolus 

calculators as class II devices, often 

clearing them in combination with 

insulin pumps or blood glucose meters. 

Devices that calculate insulin boluses 

are increasingly available on the market, 

including those devices that use novel 

dosing algorithms and new user 

interface formats. Although these 

devices can benefit patient care, they 

could also jeopardize patient safety 

without proper regulation guarding 

against the serious health consequences 

of miscalculating insulin dosages. The 

Agency will host a public dialogue 

about insulin bolus calculators to help 

realize the aim of ensuring continued 

access to safe and effective 

technological innovations, regardless of 

interface format. 

The public workshop will include 

two sessions, one for each of the topics 

noted previously. Each session will 

include presentations from physicians, 

FDA, and other experts in the field. A 

panel discussion will follow the session 

addressing insulin bolus calculators, 

and the panel will address questions 

from the audience. In addition, Agency 

representatives will update the diabetes 

community on relevant FDA news. 

II. Topics for Discussion at the Public 

Workshop 

Among other topics, the workshop 

will include discussion of the following 

questions. 

1. How can patients and providers be 

confident that the insulin bolus values 

obtained from the calculators are 

accurate and appropriate for their use? 

2. What information do patients and 

providers need about how a particular 

calculator works so that they may 

appropriately use the calculator for 

diabetes management? 

3. How can FDA foster both 

innovation and safety of insulin dose 

calculators intended for use by 

healthcare practitioners? 

4. How can FDA foster both 

innovation and safety of insulin dose 

calculators intended for use by patients? 

Dated: October 8, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24451 Filed 10–14–14; 8:45 am] 

BILLING CODE 4164–01–P 

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. 209 and 37 CFR Part 404 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. 


tkelley on DSK3SPTVN1PROD with NOTICES
61878 Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 

FOR FURTHER INFORMATION CONTACT: 

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. 

SUPPLEMENTARY INFORMATION: 

Technology descriptions follow. 

The Use of Chimeric Antigen Receptor 

To Control HIV Infection 

Description of Technology: Chimeric 

Antigen Receptors (CARs) are 

engineered proteins expressed by 

transduction on autologous CD8 T cells; 

after adoptive transfer, they promote 

targeted killing of specific cell types. 

CARs are showing great promise for 

treating cancer. The present invention 

(CD4–CRD CAR) is a novel bifunctional 

targeting motif for an anti-HIV CAR, 

consisting of a region of human CD4 

linked to a carbohydrate recognition 

domain (CRD) from one of several 

human C-type lectins known to interact 

with high-mannose glycans on HIV 

gp120. Compared to a ‘‘standard’’ CD4 

CAR, the CD4–CRD CAR displays two 

major enhancements: (1) Increased 

potency for suppression of HIV–1 

infection by selective killing of 

productively infected cells, and (2) 

complete absence of CD4-mediated 

entry receptor activity that would 

otherwise render the transduced CD8 T 

cells susceptible to HIV infection. 

Compared to antibody-based anti-HIV 

CARs, the CD4–CRD CAR of the present 

invention is predicted to have two major 

advantages: (1) Lower escape potential, 

due to the universality of HIV CD4- 

dependence and high-mannose glycan 

display on gp120, and (2) reduced 

immunogenicity, since the all-human 

CD4–CRD CAR sequences are devoid of 

variable regions that would likely elicit 

anti-idiotypic antibody responses 

against scFv-based targeting motifs. 

Potential Commercial Applications: 

• Therapy for HIV infection 

• Research on antiretroviral infection 

Competitive Advantages: Enhanced 

potency for HIV inhibition and does not 

render transduced CD8T cells 

susceptible to HIV infection. 

Development Stage: 

• In vitro data available 

• In vivo data available (animal) 

Inventors: Mustafa H. Ghanem, Bama 

Dey, Edward Berger (all of NIAID) 

Publications: 

1. Scholler J, et al. Decade-long safety 

and function of retroviral-modified 

chimeric antigen receptor T cells. Sci 

Transl Med. 2012 May 2;4(132):132ra53. 

[PMID 22553251] 

2. Du T, et al. Bifunctional CD4–DC– 

SIGN fusion proteins demonstrate 

enhanced avidity to gp120 and inhibit 

HIV–1 infection and dissemination. 

Antimicrob Agents Chemother. 2012 

Sep;56(9):4640–9. [PMID 22687513] 

3. Lamers CH, et al. Immune 

responses to transgene and retroviral 

vector in patients treated with ex vivoengineered T cells. Blood. 2011 Jan 

6;117(1):72–82. [PMID 20889925] 

Intellectual Property: HHS Reference 

No. E–212–2014/0—US Provisional 

Application No. 62/040,398 filed 21 

August 2014 

Licensing Contact: John Stansberry, 

Ph.D.; 301–435–5236; stansbej@

mail.nih.gov 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize this technology. For 

collaboration opportunities, please 

contact Chris Kornak at chris.kornak@

nih.gov. 

Photo-Controlled Removal of Targets In 

Vitro and In Vivo 

Description of Technology: The 

invention relates to a novel technology 

for separation, isolation and removal of 

target molecules or cells from a complex 

mixture. The technology can be used for 

both in vitro and in vivo applications. 

It comprises a conjugate of a 

biomolecule with specific binding 

activity (e.g. antibody, hapten, protein, 

nucleic acid) and the fluorescence dye 

IR700. When the conjugate is allowed to 

contact with a sample, it binds to the 

target molecule in the sample to form a 

biological complex. Upon exposure to 

near infrared light (NIR) of 

approximately 700 nm the biological 

complex becomes hydrophobic due to 

cleavage of a part of the fluorescent dye. 

Such hydrophobic complex can 

aggregate and readily be separated and 

removed from the biological mixture. 

The technology can be used in a broad 

range of applications, such as 

environmental or food (removal of 

contaminants from samples), or in vivo 

removal of toxins, pathogens or drugs 

from a subject, where the latter may 

provide a photo-controlled way to 

control the pharmacokinetics of a drug 

in vivo. The technology can also be 

applied in the therapeutic field, for 

example in cancer therapy, by killing 

and removal of tumor cells in a subject 

with the aid of wearable NIR device. In 

such treatment, the aggregated target 

cells may be removed from the subject 

via the liver and/or spleen. 

Potential Commercial Applications: 

• Environmental or food (removal of 

contaminants from samples) 

• In vivo removal of toxins, 

pathogens or drugs from a subject 

• Cancer therapy 

Competitive Advantages: Simple and 

versatile way to separate and remove 

molecules or cells from a complex 

mixture. 

Development Stage: Early-stage 

Inventors: Hisataka Kobayashi, et al. 

(NCI) 

Intellectual Property: HHS Reference 

No. E–209–2014/0—US Provisional 

Application No. 62/034,990 filed 08 

August 2014 

Licensing Contact: Uri Reichman, 

Ph.D., MBA; 301–435–4616; ur7a@

nih.gov 

Collaborative Research Opportunity: 

The National Cancer Institute is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate or 

commercialize this technology. For 

collaboration opportunities, please 

contact John D. Hewes, Ph.D. at hewesj@

mail.nih.gov. 

Human Monoclonal Antibodies Against 

5T4 as Therapeutic Agents 

Description of Technology: 5T4 is an 

antigen expressed in a number of 

carcinomas. Its expression is limited in 

normal tissue, but is prevalent in 

malignant tumors throughout their 

development. This confined expression 

makes it an attractive target for cancer 

immunotherapy. 5T4 is often found in 

colorectal, ovarian, and gastric tumors 

and thus has been used as a prognostic 

aid for these cancers. In addition, its 

role in antibody-directed 

immunotherapy for delivering response 

modifiers to tumors has been studied 

using murine monoclonal antibodies 

(mAbs) and the cancer vaccine TroVax 

(currently in clinical trials for multiple 

solid tumors) targets 5T4. 

The present invention describes the 

identification and characterization of 

two fully human mAbs (m1001 and 

m1002) that bind to 5T4. Since the 

mAbs are fully human, they could have 

less immunogenicity and better safety 

profiles than the existing mouse and 

humanized antibodies. These mAbs 

have the potential to be cancer 

therapeutics as naked mAbs, Chimerica 

Antigen Receptors (CARs) and/or 

Antibody-Drug Conjugates (ADCs). 

Potential Commercial Applications: A 

mAb, CAR, or ADC therapeutic for the 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 199 / Wednesday, October 15, 2014 / Notices 61879 

treatment of various human cancers 

expressing 5T4. 

Competitive Advantages: 

• The fully human antibodies may 

have better drugability, especially less 

immunogenicity and better safety. 

• This antibodies could be used as 

naked mAbs, CARs and/or as ADCs. 

• The confined expression of 5T4 

makes it an attractive target for cancer 

immunotherapy. 

• 5T4 mAbs could be used to treat 

several solid tumor cancers. 

Development Stage: In vitro data 

available 

Inventors: Dimiter Dimitrov, Tianlei 

Ying, Yang Feng (all of NCI) 

Intellectual Property: HHS Reference 

No. E–158–2014/0—U.S. Provisional 

Application No. 62/034,995 filed 08 

August 2014 

Licensing Contact: Whitney Hastings; 

301–451–7337; hastingw@mail.nih.gov 

Quantitative Multiplex Methods for 

Rapid Detection and Identification of 

Viral Nucleic Acids 

Description of Technology: The 

subject technologies are quantitative 

multiplex loop mediated isothermal 

amplification assays that can detect and 

distinguish different viral pathogens, 

including HIV, Hepatitis B Virus (HBV), 

Hepatitis C Virus (HCV), Hepatitis E 

Virus (HEV), Dengue Virus (DENV), 

Chikungunya virus (CHIKV) and West 

Nile Virus (WNV). The assay has the 

advantage of distinguishing between 

different genotypes of HCV. It has the 

potential to detect other pathogens. A 

quantitative multiplex variation of the 

assay can detect and identify all seven 

viruses using one reaction mixture. The 

detection-reaction is performed on a 

simple heat-source and viral 

quantitation can be measured using a 

simple fluorospectrophotometer. The 

entire detection process using these 

assays can be accomplished within 30 to 

60 minutes in a doctor’s office, 

laboratory setting, or in the field. 

Detection limits of as little as 1–10 

International Units (viral copies) are 

possible with the use of fluorogenic 

oligonucleotides. The assays 

demonstrate very high specificity when 

tested with human clinical samples. 

Potential Commercial Applications: 

Detection assays for viral pathogens 

such as HIV, HBV, HCV, HEV, Dengue 

Virus, Chikungunya, and West Nile 

Virus. 

Competitive Advantages: 

• Assays can be completed within 30 

to 60 minutes and in a doctor’s office, 

laboratory setting, or in the field. 

• Assays can be performed without 

expensive instrumentation or 

specialized technical operators. 

• Assays are highly specific and can 

distinguish between different viruses 

and between different genotypes of 

viruses. 

Development Stage: 

• Early-stage 

• In vitro data available 

• In vivo data available (human) 

Inventors: Dougbeh-Chris Nyan 

(FDA), Deborah R. Taylor (FDA), Maria 

Rios (FDA), Kevin L. Swinson (Morgan 

State University), Laura E. Ulitzky 

(FDA) 

Publication: Nyan DC, et al. Rapid 

Detection of Hepatitis B Virus in Blood 

Plasma by a Specific and Sensitive 

Loop-Mediated Isothermal 

Amplification Assay. Clin Infect Dis. 

2014 July 1;59(1):16–23. [PMID 

24704724] 

Intellectual Property: HHS Reference 

No. E–135–2014/0—US Provisional 

Patent Application No. 61/979,446 filed 

14 April 2014 

Licensing Contact: Kevin W. Chang, 

Ph.D.; 301–435–5018; changke@

mail.nih.gov 

Collaborative Research Opportunity: 

The Food and Drug Administration, 

Center for Biologics Evaluation and 

Research, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize blood screening test and/ 

or diagnostic test for infectious diseases. 

For collaboration opportunities, please 

contact Nisha Narayan at 

Nisha.Narayan@fda.hhs.gov or 240– 

402–9770. 

Dated: October 8, 2014. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2014–24403 Filed 10–14–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, 

October 27, 2014, 07:30 a.m. to October 

28, 2014, 06:00 p.m., Doubletree Guest 

Suites Santa Monica, 1707 Fourth 

Street, Santa Monica, CA, 90401 which 

was published in the Federal Register 

on October 06, 2014, 79 FR 60175. 

The meeting will start on October 27, 

2014. The meeting time and location 

remains the same. 

The meeting is closed to the public. 

Dated: October 7, 2014. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–24380 Filed 10–14–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of meetings of the Board of 

Regents of the National Library of 

Medicine. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Regents of 

the National Library of Medicine; Extramural 

Programs Subcommittee. 

Date: February 10, 2015. 

Closed: 7:45 a.m. to 8:45 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Library of Medicine, 

Building 38, Billings Conference Room, 8600 

Rockville Pike, Bethesda, MD 20892. 

Contact Person: Donald A.B. Lindberg, MD, 

Director, National Library of Medicine, 8600 

Rockville Pike, Bethesda, MD 20892, 301– 

496–6221, lindberg@mail.nih.gov. 

Name of Committee: Board of Regents of 

the National Library of Medicine; 

Subcommittee on Outreach and Public 

Information. 

Date: February 10, 2015. 

Open: 7:45 a.m. to 8:45 a.m. 

Agenda: To review and discuss outreach 

activities. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Conference Room B, 

8600 Rockville Pike, Bethesda, MD 20892. 


tkelley on DSK3SPTVN1PROD with NOTICES