4934 Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 

assessment of histological and 

serological endpoints. 

I. Participation in the Public Workshop 

There is no fee to attend the public 

workshop, but attendees must register in 

advance. Space is limited and 

registration will be on a first-come, firstserved basis. Persons interested in 

attending this workshop must register 

online at http://www.great3.org before 

March 1, 2015. For those without 

Internet access, please contact Kelly 

Richards (see FOR FURTHER INFORMATION

CONTACT) to register. Onsite registration 

will not be available. 

If you need special accommodations 

due to a disability, please contact Kelly 

Richards (see FOR FURTHER INFORMATION

CONTACT) at least 7 days in advance. 

II. Transcripts 

Transcripts of the workshop will be 

available for review at the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and on the Internet at http://

www.regulations.gov approximately 30 

days after the workshop. A transcript 

will also be available in either hard 

copy or on CD–ROM after submission of 

a Freedom of Information request. Send 

written requests to the Division of 

Freedom of Information (ELEM–1029), 

Food and Drug Administration, 12420 

Parklawn Dr., Element Bldg., Rockville, 

MD 20857. Fax requests to 301–827– 

9267. 

Dated: January 22, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01625 Filed 1–28–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request Generic Clearance 

for the Collection of Qualitative 

Feedback on Agency Service Delivery 

(NIH) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on November 21, 

2014, volume #79, page 69500 and 

allowed 60 days for public comment. No 

public comments were received. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

The NIH may not conduct or sponsor, 

and the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: 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. Mikia P. Currie, Program 

Analyst, Office of Policy for Extramural 

Research Administration, 6705 

Rockledge Drive, Suite 350, Bethesda, 

Maryland 20892, or call a non-toll-free 

number 301–435–0941 or Email your 

request, including your address to 

curriem@mail.nih.gov. Formal requests 

for additional plans and instruments 

must be requested in writing. 

Proposed Collection: Generic 

Clearance for the Collection of 

Qualitative Feedback on Agency Service 

Delivery (NIH), 0925–0648, Expiration 

Date 1/31/2015, EXTENSION, National 

Institutes of Health (NIH), Office of the 

Director (OD). 

Need and Use of Information 

Collection: There are no changes being 

requested for this submission. The 

information collection activity will 

garner qualitative customer and 

stakeholder feedback in an efficient, 

timely manner, in accordance with the 

Administration’s commitment to 

improving service delivery. This generic 

will provide information about the NIH 

Institutes and Centers customer or 

stakeholder perceptions, experiences 

and expectations, provide an early 

warning of issues with service, or focus 

attention on areas where 

communication, training, or changes in 

operations might improve delivery of 

products or services. It will also allow 

feedback to contribute directly to the 

improvement of program management. 

Feedback collected under this generic 

clearance will provide useful 

information but it will not yield data 

that can be generalized to the overall 

population. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated burden hours are 49,358. 

Estimated Annualized Burden Hours 

ESTIMATED ANNUAL REPORTING BURDEN

Type of collection Number of 

espondents 

Annual 

frequency per 

esponse 

Hours per 

response 

Total annual 

burden hours 

Customer Satisfaction Surveys ....................................................................... 1,000 1 30/60 500 

In-Depth Interviews (IDIs) or Small Discussion Groups .................................. 1,000 1 90/60 1,500 

Focus Groups .................................................................................................. 1,000 1 90/60 1,500 

Usability and Pilot Testing ............................................................................... 150,000 1 5/60 12,525

Conference/Training—Pre and Post Surveys ................................................. 100,000 2 10/60 33,333 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices 4935 

Dated: January 22, 2015. 

Lawrence A. Tabak, 

Principal Deputy Director, National Institutes 

of Health. 

[FR Doc. 2015–01685 Filed 1–28–15; 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. 

Miniature System for Manipulating 

Small Animals in High-Throughput 

Screening Small Molecules 

Description of Technology: The 

invention pertains to a miniaturized 

plating and feeding system based on a 

96-well microplate base and is intended 

to reduce manipulation of organisms as 

well as amounts of test drug/anesthetic, 

thereby mitigating waste. The kit 

comprises a feeder plate, transfer 

adaptor and receiver plate. The feeder 

plate is defined by, for example, a 

plastic 96-well plate with rounded 

wells. The rounded bottoms can 

dispense to or permit access to the test 

organism of liquid food or drug through 

about 7 holes of approximately 350 

microns in diameter. A top portion of 

the well provides test organisms (e.g., 

drosophila, daphnia) with sufficient 

space to enjoy normal life-cycles 

without confinement stress. The feeder 

plate includes means for interfacing 

with complementary components of the 

transfer and receiver plates through 

receiving holes and complementary 

dowels or pins. A transfer adapter 

allows the interconnection of the feeder 

plate to the receiver plate. The transfer 

plate can be configured to be square or 

rounded for the transfer of organisms 

from the feeder plate to the receiver 

plate. 

Potential Commercial Applications 

• Drug Development 

• Toxicity Studies 

• Drug Design 

Competitive Advantages 

• Small animals 

• High Throughput 

• Space efficiency 

• Resource economy 

Development Stage 

• Early stage 

• Prototype 

Inventors: Maria De Los Angeles Jaime 

and Brian Oliver (NIDDK). 

Intellectual Property: HHS Reference 

No. E–034–2015/0—US Provisional 

Application No. 62/080,181 filed 

November 14, 2015. 

Licensing Contact: Michael 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@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 

High-Throughput Small Animal 

Manipulation for Drug Design. For 

collaboration opportunities, please 

contact Marguerite J. Miller at 

millermarg@niddk.nih.gov. 

LRKK2 Inhibitors: Novel Treatment for 

Intestinal Bowel Disorders 

Description of Technology: Use of 

Leucine Rich Repeat Kinase 2 (LRRK2) 

inhibitors for the treatment of Intestinal 

Bowel Disorders (IBD) is disclosed. IBD 

is a broad term that describes conditions 

with chronic or recurring immune 

response and inflammation of the 

gastrointestinal tract. Crohn’s disease 

and ulcerative colitis, two common 

forms of idiopathic IBD, are chronic, 

relapsing inflammatory disorders of the 

gastrointestinal tract. 

LRRK2 is a kinase encoded by a gene 

that contains a non-coding 

polymorphism (SNP). LRRK2 has been 

associated with and is a risk factor for 

inflammatory bowel disease. NIH 

inventors have shown that human cells 

expressing this SNP have increased 

levels of LRRK2 and, correspondingly, 

mice with increased levels of LRRK2 

exhibit more severe Dextran Sulfate 

colitis. In various studies of the role of 

LRRK2 in cell signaling, NIH inventors 

have shown that increased levels of 

LRRK2 lead to increased proinflammatory cytokine secretion. Also, 

an inhibitor of LRRK2 is shown to 

abrogate the pro-inflammatory activity 

of LRRK2 both in vitro and in vivo. 

Potential Commercial Applications: 

Treatment for or prevention of Intestinal 

Bowel Disorders. 

Competitive Advantages 

• A LRRK2 inhibitor would be a 

unique form of anti-inflammatory 

therapy that will complement or 

compete with an array of cytokines in 

primary treatment for lBD. 

• A LRRK2 inhibitor would provide a 

much needed alternate mode of therapy. 

Development Stage 

• Early-stage 

• In vitro data available 

• In vivo data available (animal) 

Inventors: Warren Strober, Ivan J. 

Fuss, Tetsuya Takagawa, Atsushi Kitani 

(all of NIAID). 

Intellectual Property: HHS Reference 

No. E–070–2014/0—US Provisional 

Application No. 61/993,637 filed May 

15, 2014. 

Licensing Contact: Suryanarayana 

Vepa, Ph.D., J.D.; 301–435–5020; 

vepas@mail.nih.gov. 

Dated: January 22, 2015. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2015–01610 Filed 1–28–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings 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 material, 

and personal information concerning 

mstockstill on DSK4VPTVN1PROD with NOTICES