70194 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Immediately in Effect Guidance 

Document: Product Labeling for 

Laparoscopic Power Morcellators’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1400052 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information 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 807, subpart E have been 

approved under OMB control number 

0910–0120; and the collections of 

information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485. 

In addition, FDA concludes that the 

labeling statements in the guidance do 

not constitute a ‘‘collection of 

information’’ under the Paperwork 

Reduction Act. Rather, the labeling 

statements are ‘‘public disclosure of 

information originally supplied by the 

Federal government to the recipient for 

the purpose of disclosure to the public.’’ 

(5 CFR 1320.3(c)(2)). 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

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, and 

will be posted to the docket at http://

www.regulations.gov. 

VI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site addresses in this reference 

section, but FDA is not responsible for 

any subsequent changes to the Web sites 

after this document publishes in the 

Federal Register.) 

1. FDA Center for Devices and Radiological 

Health, Safety Communications Page, 

‘‘Laparoscopic Uterine Power 

Morcellation in Hysterectomy and 

Myomectomy,’’ (http://www.fda.gov/

medicaldevices/safety/alertsandnotices/

ucm393576.htm). 

2. Public meeting in 2014, Obstetrics and 

Gynecology Devices Panel of the Medical 

Devices Advisory Committee, Federal 

Register notice, available at http://

www.gpo.gov/fdsys/pkg/FR-2014-06-09/

pdf/2014-13290.pdf. 

Dated: November 19, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27857 Filed 11–24–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; The Genetic Testing Registry 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

Office of the Director (OD), National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) 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) 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) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to 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. 

To Submit Comments and for Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing, or request 

more information on the proposed 

project, contact: Ms. Sarah Carr, Acting 

Director, Office of Clinical Research and 

Bioethics Policy, Office of Science 

Policy, NIH, 6705 Rockledge Dr., Suite 

750, Bethesda, MD 20892, or call nontoll-free number (301) 496–9838, or 

Email your request, including your 

address to: OCRBP–OSP@od.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Comment 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. 

Proposed Collection: The Genetic 

Testing Registry, 0925–0651, Expiration 

Date 02/28/2015—EXTENSION, Office 

of the Director (OD), National Institutes 

of Health (NIH). 

Need and Use of Information 

Collection: Clinical laboratory tests are 

available for more than 5,000 genetic 

conditions. The Genetic Testing Registry 

(GTR) provides a centralized, online 

location for test developers, 

manufacturers, and researchers to 

voluntarily submit detailed information 

about the availability and scientific 

basis of their genetic tests. The GTR is 

of value to clinicians by providing 

information about the accuracy, 

validity, and usefulness of genetic tests. 

The GTR also highlights evidence gaps 

where additional research is needed. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

5,536. 


wreier-aviles on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices 70195 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name 

Estimated 

annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

Laboratory Personnel Using Bulk Submission ..... Minimal Fields .............. 190 29 18/60 1,653 

Optional Fields ............. 159 29 14/60 1,076 

Laboratory Personnel Not Using Bulk Submission.Minimal Fields .............. 116 29 30/60 1,682 

Optional Fields ............. 97 29 24/60 1,125 

Dated: November 17, 2014. 

Lawrence A. Tabak, 

Principal Deputy Director, National Institutes 

of Health. 

[FR Doc. 2014–27898 Filed 11–24–14; 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, 

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. 

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. 

T-cell Chimeric Receptors of TSLPR for 

Diagnosis and Immunotherapy of 

Cancer 

Description of Technology: T-cellbased immunotherapies allow a 

patient’s immune system to concentrate 

its efforts and destroy cancer cells. In 

the present technology, the researchers 

at the National Cancer Institute have 

developed chimeric antigen receptors 

(or CARs), which encode an antigen 

binding domain specific for thymic 

stromal lymphopoietin receptor 

(TSLPR) and a T-cell signaling domain. 

TSLPR is over-expressed on the surface 

of approximately 10% of adult and 

pediatric B-cell precursor acute 

lymphoblastic leukemias (BCP–ALL). 

Available for licensing is the abovereference CAR technology as well as 

methods for diagnosing and treating 

cancer using these CARs. 

Potential Commercial Applications: 

• Immunotherapy against cancer, 

especially leukemia 

• Immunotoxins 

Competitive Advantages: CAR 

receptors are specific for TSLPR. 

Development Stage: 

• In vitro data available 

• In vivo data available (animal) 

• Prototype 

Inventors: Terry Fry and Haiying Qin 

(NCI). 

Publication: Qin H, et al. Pre-clinical 

development of a novel chimerical 

antigen receptor targeting high-risk 

pediatric ALL over-expressing Tslpr. 

Blood 2013 Nov 15;122(21):2665. 

Intellectual Property: 

• HHS Reference No. E–008–2014/0— 

US Provisional Application No. 61/ 

912,948 filed 06 Dec 2013 

• HHS Reference No. E–008–2014/1— 

US Provisional Application No. 61/ 

991,697 filed 12 May 2014 

• HHS Reference No. E–008–2014/2— 

PCT Application No. PCT/US2014/ 

063096 filed 30 Oct 2014 

Licensing Contact: Patrick McCue, 

Ph.D.; 301–435–5560; mccuepat@

mail.nih.gov 

Novel Bridged Bicyclic Thiazepinone 

Compounds 

Description of Technology: The 

invention is directed to small molecules 

containing a novel, bridged, bicyclic 

thiazepinone pharmacophore. Invention 

compounds inhibit the Nav1.7 sodium 

channel. Additionally, invention 

compounds bind the human 

norepinephrine transporter (NET), with 

selectivity over the serotonin transporter 

(SERT) and dopamine transporter 

(DAT). 

Invention compounds could be used 

to treat neuropathic pain associated 

with diabetes and fibromyalgia, 

Attention Deficit Hyperactivity Disorder 

(ADHD), urinary incontinence, 

depression, anxiety, and other mood 

disorders. 

Invention compounds can be 

conjugated with fluorescent or 

radioactive tags, and used to probe the 

structure and activity of the Nav1.7 

sodium channel and NET. 

Potential Commercial Applications: 

• Therapeutic 

• Chemical probe 

Competitive Advantages: 

• Small molecule compounds made 

using facile synthesis scheme 

• Inhibition of Nav1.7 sodium channel 

• NET inhibition with selectivity over 

other transporters 

Development Stage: 

• Early-stage 

• In vitro data available 

Inventors: Hans F. Luecke (NIDDK), 

Michael T. Scerba (NIDDK), Dongwook 

Kang (Daegu Catholic University). 

Intellectual Property: HHS Reference 

No. E–224–2012/0— 

• US Application No. 61/876,262 filed 

09 Sept 2013 

• PCT Application No. PCT/US2014/

054660 filed 09 Sept 2014 

Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074; 

nguyenantczakla@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Diabetes and 

Digestive and Kidney Diseases is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate or commercialize use 

of bridged bicyclic thiazepinones. For 

collaboration opportunities, please 

contact Marguerite J. Miller, M.B.A. at 

marguerite.miller@nih.gov or 301–496– 

9003. 


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