Proposed Collection; 60-Day Comment Request; Evaluation of the NIH Academic Research Enhancement Award (NIH OD), 38921-38922 [2014-16072]
Download as PDF
<![CDATA[
38921
Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be provided within 30
days of publication of this document
(see DATES) by logging into the FDA
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
FDA will forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process).
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages nominations
for appropriately qualified candidates
from these groups. Specifically, in this
document, nominations for nonvoting
representatives of industry interests are
encouraged from the cell, tissue, and
gene transfer products manufacturing
industry.
This notice is issued under the
Federal Advisory Committee Act
(5 U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: July 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–16038 Filed 7–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Evaluation of the NIH
Academic Research Enhancement
Award (NIH OD)
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
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 to address 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: Michelle M.
Timmerman, Ph.D., Director, AREA
Program, Office of the Director, National
Institutes of Health, 6705 Rockledge
Drive, Bethesda, Maryland 20892; or
call non-toll-free number 301–402–
0672; or email your request, including
your address to michelle.timmerman@
mail.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: Evaluation of the
NIH Academic Research Enhancement
Award, 0925-New, Office of the Director
(OD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The Academic Research
Enhancement Award (AREA) Program is
a grant mechanism spanning most of the
Institutes and Centers (ICs) of the
National Institutes of Health (NIH). The
AREA program was established by
Congress in 1985 to provide support to
scientists at public and private colleges
and universities that receive relatively
small amounts of NIH funding. The
purpose of the program is to support
meritorious research, expose
undergraduate and graduate students to
research, and strengthen the research
environment of the institutions
receiving the grants. In the past three
years alone, the federal government has
awarded approximately 78 million
dollars annually in AREA grants. The
evaluation will allow the NIH and
Congress to assess the extent to which
the AREA program is meeting its goals
and make recommendations so that this
significant investment of public funds
may be used as effectively as possible.
The evaluation will utilize the NIH’s
archived data on grants, institutions,
Principal Investigators (PIs), and
students funded with AREA monies.
The evaluation will collect new data
about (1) the quantity and quality of
student participation in AREA projects,
(2) records of PIs’ subsequent funding
histories, (3) applicants’ experiences
with the application process, (4) PIs’
experiences implementing AREA
Program objectives, and (5) the impact
of AREA Program research participation
on student career paths and outcomes.
The results of the evaluation will
indicate the extent to which the AREA
Program is meeting its goals of
supporting meritorious research,
strengthening the research environment
at institutions of higher education that
are not research intensive, and
recruiting and training subsequent
generations of the United States’
biomedical scientist workforce.
Intended audiences include the United
States Congress, staff at NIH ICs that
make AREA awards, and staff of the
NIHOD.
OMB approval is requested for one
year. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
629.
sroberts on DSK5SPTVN1PROD with NOTICES
ESTIMATES OF ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Principal Investigator Survey ...........................................................................
Awardee Semi-Structured Interview ................................................................
Student Survey ................................................................................................
VerDate Mar<15>2010
20:08 Jul 08, 2014
Jkt 232001
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
480
50
301
E:\FR\FM\09JYN1.SGM
1
1
1
09JYN1
Average
burden per
response
(in hours)
45/60
45/60
30/60
Total annual
burden hours
360
38
151
38922
Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices
ESTIMATES OF ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondents
Applicant Survey ..............................................................................................
Dated: July 2, 2014.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2014–16072 Filed 7–8–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up
Exclusive Evaluation Option License
Agreement: AAV Mediated
Aquaporin-1 Gene Transfer To Treat
¨
Sjogren’s Syndrome
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health
(NIH), Department of Health and Human
Services (HHS), is contemplating the
grant of a Start-Up Exclusive Evaluation
Option License Agreement to Milo, LLC,
a company having its headquarters in
Cleveland, Ohio, to practice the
inventions embodied in U.S. Provisional
Patent Application No. 61/695,753, filed
20 April 2011 (HHS Ref. No. E–139–
2011/1–US–01]), and PCT Patent
Application No. PCT/US13/57632, filed
30 August 2013 (HHS Ref. No. E–139–
2011/1–PCT–02), entitled ‘‘AAV
Mediated Aquaporin-1 Gene Transfer to
¨
Treat Sjogren’s Syndrome.’’ The patent
rights in these inventions have been
assigned to or exclusively licensed to
the Government of the United States of
America. The territory of the
prospective license may be worldwide
and the field of use may be limited to:
‘‘the use of the Licensed Patent Rights,
limited to AAV mediated aquaporin-1,
¨
for the treatment of Sjogren’s syndrome
in humans.’’
Upon the expiration or termination of
the Start-Up Exclusive Evaluation
Option License Agreement, Milo will
have the exclusive right to execute a
Start-up Exclusive Patent License
Agreement which will supersede and
replace the Start-up Exclusive
Evaluation Option License Agreement,
with no greater field of use and territory
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:08 Jul 08, 2014
Jkt 232001
240
than granted in the Start-Up Exclusive
Evaluation Option License Agreement.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before July
24, 2014 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments
and other materials relating to the
contemplated Start-Up Exclusive
Evaluation Option License Agreement
should be directed to: Vince Contreras,
Ph.D., Licensing and Patenting Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4711; Facsimile: (301) 402–0220; Email:
vince.contreras@nih.gov. A signed
confidentiality nondisclosure agreement
will be required to receive copies of any
patent applications that have not been
published or issued by the United States
Patent and Trademark Office or the
World Intellectual Property
Organization.
The
subject technology includes methods of
¨
treating Sjogren’s syndrome by using
recombinant adeno associated virus
(rAAV) serotypes as vectors to deliver a
gene that expresses AQP1. Aquaporin-1
is a pore protein that selectively
channels water molecules across the cell
membrane. Using animal models that
mimic the dry mouth symptoms
¨
(xerostomia) of Sjogren’s, it was
discovered that there was restoration of
fluid movement upon expression of
AQP1. This potentially represents a
long-term treatment for restoring
¨
exocrine gland function in Sjogren’s
patients where salivary gland activity is
significantly reduced.
The prospective Start-Up Exclusive
Evaluation Option License Agreement
will be royalty bearing and will comply
with the terms and conditions of 35
U.S.C. 209 and 37 CFR part 404. The
prospective Start-Up Exclusive
Evaluation Option License Agreement
and a subsequent Start-Up Exclusive
Patent License Agreement may be
granted unless the NIH receives, within
fifteen (15) days from the date of this
published notice, written evidence and
argument that establishes that the grant
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
1
Total annual
burden hours
20/60
80
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.
Complete applications for a license in
the prospective field of use that are filed
in response to this Notice will be treated
as objections to the grant of the
contemplated Start-Up Exclusive
Evaluation Option License Agreement.
Comments and objections submitted in
response to this Notice will not be made
available for public inspection, and, to
the extent permitted by law, will not be
released under the Freedom of
Information Act, 5 U.S.C. 552.
Dated: July 7, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–16030 Filed 7–8–14; 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.
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
SUMMARY:
E:\FR\FM\09JYN1.SGM
09JYN1
]]>Agencies
[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38921-38922]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16072]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Evaluation of the
NIH Academic Research Enhancement Award (NIH OD)
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 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 to address 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: Michelle
M. Timmerman, Ph.D., Director, AREA Program, Office of the Director,
National Institutes of Health, 6705 Rockledge Drive, Bethesda, Maryland
20892; or call non-toll-free number 301-402-0672; or email your
request, including your address to michelle.timmerman@mail.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: Evaluation of the NIH Academic Research
Enhancement Award, 0925-New, Office of the Director (OD), National
Institutes of Health (NIH).
Need and Use of Information Collection: The Academic Research
Enhancement Award (AREA) Program is a grant mechanism spanning most of
the Institutes and Centers (ICs) of the National Institutes of Health
(NIH). The AREA program was established by Congress in 1985 to provide
support to scientists at public and private colleges and universities
that receive relatively small amounts of NIH funding. The purpose of
the program is to support meritorious research, expose undergraduate
and graduate students to research, and strengthen the research
environment of the institutions receiving the grants. In the past three
years alone, the federal government has awarded approximately 78
million dollars annually in AREA grants. The evaluation will allow the
NIH and Congress to assess the extent to which the AREA program is
meeting its goals and make recommendations so that this significant
investment of public funds may be used as effectively as possible.
The evaluation will utilize the NIH's archived data on grants,
institutions, Principal Investigators (PIs), and students funded with
AREA monies. The evaluation will collect new data about (1) the
quantity and quality of student participation in AREA projects, (2)
records of PIs' subsequent funding histories, (3) applicants'
experiences with the application process, (4) PIs' experiences
implementing AREA Program objectives, and (5) the impact of AREA
Program research participation on student career paths and outcomes.
The results of the evaluation will indicate the extent to which the
AREA Program is meeting its goals of supporting meritorious research,
strengthening the research environment at institutions of higher
education that are not research intensive, and recruiting and training
subsequent generations of the United States' biomedical scientist
workforce. Intended audiences include the United States Congress, staff
at NIH ICs that make AREA awards, and staff of the NIHOD.
OMB approval is requested for one year. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 629.
Estimates of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total annual
Type of respondents respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Principal Investigator Survey................... 480 1 45/60 360
Awardee Semi-Structured Interview............... 50 1 45/60 38
Student Survey.................................. 301 1 30/60 151
[[Page 38922]]
Applicant Survey................................ 240 1 20/60 80
----------------------------------------------------------------------------------------------------------------
Dated: July 2, 2014.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2014-16072 Filed 7-8-14; 8:45 am]
BILLING CODE 4140-01-P
