Submission for OMB Review; 30-Day Comment Request Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH), 4934-4935 [2015-01685]
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Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
assessment of histological and
serological endpoints.
I. Participation in the Public Workshop
National Institutes of Health
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 https://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.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submission for OMB Review; 30-Day
Comment Request Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
(NIH)
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 https://
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
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
SUMMARY:
Estimated Annualized Burden Hours
ESTIMATED ANNUAL REPORTING BURDEN
Number of
espondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Type of collection
Customer Satisfaction Surveys .......................................................................
In-Depth Interviews (IDIs) or Small Discussion Groups ..................................
Focus Groups ..................................................................................................
Usability and Pilot Testing ...............................................................................
Conference/Training—Pre and Post Surveys .................................................
VerDate Sep<11>2014
18:16 Jan 28, 2015
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Annual
frequency per
esponse
1,000
1,000
1,000
150,000
100,000
E:\FR\FM\29JAN1.SGM
1
1
1
1
2
29JAN1
Hours per
response
30/60
90/60
90/60
5/60
10/60
Total annual
burden hours
500
1,500
1,500
12,525
33,333
Federal Register / Vol. 80, No. 19 / Thursday, January 29, 2015 / Notices
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:
Potential Commercial Applications
• Drug Development
• Toxicity Studies
• Drug Design
National Institutes of Health,
HHS.
ACTION:
Notice.
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.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
18:16 Jan 28, 2015
Jkt 235001
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.
• 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.
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
PO 00000
Frm 00083
Fmt 4703
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
Competitive Advantages
•
•
•
•
4935
Sfmt 4703
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
E:\FR\FM\29JAN1.SGM
29JAN1
Agencies
[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4934-4935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01685]
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Annual
Type of collection Number of frequency per Hours per Total annual
respondents response response burden hours
----------------------------------------------------------------------------------------------------------------
Customer Satisfaction Surveys................... 1,000 1 30/60 500
In-Depth Interviews (IDIs) or Small Discussion 1,000 1 90/60 1,500
Groups.........................................
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
----------------------------------------------------------------------------------------------------------------
[[Page 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