Proposed Collection; 60-Day Comment Request; Evaluation of National Institutes of Health International Bilateral Programs (FIC, NCI, NIAAA, NIAID, NICHD, NIDA, NINDS, NIMH, OAR), 14256-14257 [2014-05514]
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Federal Register / Vol. 79, No. 49 / Thursday, March 13, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA imported products
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total
hours
Non-Tobacco ........................................................................
Tobacco ...............................................................................
3,406
330
1,089
68
3,709,134
22,440
2 0.14
2 0.14
519,279
3,142
Total ..............................................................................
........................
........................
........................
........................
522,421
1 There
2 (8
are no capital costs or operating and maintenance costs associated with this collection of information.
minutes).
The hourly burden for this
information collection is based on
FDA’s averaging of data obtained during
a survey of nine representative filers
nationwide and FDA’s experience. For
purposes of comparison of hourly
burden, the filers also were requested to
provide the same information with
regard to filing entries manually. FDA
felt that the average time for completing
either electronic or manual entries was
very similar.
Based on data collected by FDA’s
survey of nine filers and its experience,
the total annual burden to the import
community to submit information
electronically for 3,731,574 average
annual responses was 522,421 hours.
The previously OMB-approved hours
per response (0.14 hours) are expected
to remain the same.
This burden includes the time FDA
estimates it will take respondents to
compile and provide documents to FDA
for those entries where FDA cannot
make an admissibility decision based on
the electronic data alone. Based on the
survey of nine filers and FDA’s past
experience, FDA estimates that there
will be no additional costs to provide
import data electronically to FDA, as
filers already have equipment and
software in place to enable them to
provide data to USCS via the automated
system. Therefore, no additional
software or hardware need be developed
or purchased to enable filers to file the
FDA data elements at the same time
they file entries electronically with
USCS.
Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
TKELLEY on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2014–05516 Filed 3–12–14; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Evaluation of National
Institutes of Health International
Bilateral Programs (FIC, NCI, NIAAA,
NIAID, NICHD, NIDA, NINDS, NIMH,
OAR)
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 Cancer Institute (NCI),
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: Julie Schneider,
Program Director, Center for Global
Health, National Cancer Institute, 9609
Medical Center Dr., RM 3W564,
Rockville, MD 20850 or call non-tollfree number 240–276–5795 or Email
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
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your request, including your address to:
schneidj@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
DATES: 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
National Institutes of Health
International Bilateral Programs (FIC,
NCI, NIAAA, NIAID, NICHD, NIDA,
NIMH, NINDS, OAR), 0925–NEW,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: This submission is a request
for OMB to approve the Evaluation of
National Institutes of Health (NIH)
International Bilateral Programs for
three years. The bilateral awards are
made through the Funding Opportunity
Announcement mechanism and
administrative supplements, meaning
they are funded by set-aside funds that
are separate from the general pool of
research program grant funds used to
support investigator initiated research at
NIH. The bilateral programs to be
evaluated are the U.S.-China Program
for Biomedical Research Cooperation,
U.S.—India Bilateral Collaborative
Research Partnerships on the Prevention
of HIV/AIDS and Co-morbidities, U.S.Russia Bilateral Collaborative Research
Partnerships on the Prevention and
Treatment of HIV/AIDS and Comorbidities, and U.S.-South Africa
Program for Collaborative Biomedical
Research. These programs are funded
and administered by various
combinations of the following institutes:
Fogarty International Center (FIC), the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National Cancer
Institute (NCI), National Institute on
Alcohol Abuse and Alcoholism
(NIAAA), National Institute for Allergy
and Infectious Diseases (NIAID),
National Institute on Drug Abuse
(NIDA), National Institute of Mental
Health (NIMH), National Institute of
Neurological Disorders and Stroke
E:\FR\FM\13MRN1.SGM
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14257
Federal Register / Vol. 79, No. 49 / Thursday, March 13, 2014 / Notices
(NINDS), and the Office of AIDS
Research (OAR). While these programs
differ, their underlying concept is the
same; they require U.S. scientists to
collaborate with scientists from other
countries in order to conduct
scientifically meritorious investigations
of mutual interest to both countries. The
award, when possible. This information
is needed to evaluate the effectiveness
of these programs across NIH.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
128.
proposed evaluation requests
information about (1) accomplishments
of the awards, (2) unique findings or
opportunities due to the international
collaborations, and (3) successes and
challenges of these collaborations. The
information will be collected one year
into the award and at the end of the
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Principal Investigators Administrative Supplements ........................................
Principal Investigators Other Mechanisms ......................................................
Dated: March 7, 2014.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–05514 Filed 3–12–14; 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.
SUMMARY:
TKELLEY on DSK3SPTVN1PROD with 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.
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24
52
Rabies Vaccine for the Oral
Immunization of Domesticated
Animals, Wildlife and Feral Animals
Description of Technology: This
invention, developed by the CDC and
collaborators, entails a live, attenuated
recombinant rabies virus vaccine that
can elicit an effective anti-rabies
immune response in animal recipients.
Inoculation with a live, attenuated,
rabies virus allows for the optimized
production of immunity in the absence
of pathogenicity. Oral administration of
rabies vaccines is often a preferred route
of vaccine delivery because it is most
effective in wildlife. Unfortunately,
availability of an oral vaccine for
canines has been a significant hurdle to
date.
This vaccine technology could be
used for immunization of stray dogs by
an oral route. In developing nations,
more than 90% of human exposure
events and 99% of human deaths due to
rabies are caused by rabid dogs. Using
this vaccine with a broadly
implemented oral vaccination strategy
provides a promising opportunity for
reducing transmission of rabies between
stray dogs and, thereby, increasing
protection for people.
Potential Commercial Applications:
• Wildlife and humane shelter rabies
prevention and control programs
• Improved rabies vaccines for pets and
livestock
• Humane, targeted approach to
elimination of rabies reservoirs in
feral animal populations
Competitive Advantages:
• Safe and effective
• Oral immunization is the most
practical and efficient method of
rabies vaccination of wildlife and
feral animals
• Vaccine has demonstrated protection
in vivo
• Recombinant, non-neuroinvasive
virus expressing a neuroinvasive
PO 00000
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Number of
responses per
respondent
1
2
Average
burden per
response
(in hours)
Total
annual
burden
hours
1
1
24
104
glycoprotein and/or pro-apoptotis
gene safely induces a robust and
desirable immunological response
Development Stage:
• In vitro data available
• In vivo data available (animal)
Inventors: Charles E. Rupprecht
(CDC), et al.
Intellectual Property: HHS Reference
No. E–470–2013/0—U.S. Patent No.
7,074,413 issued 11 Jul 2006.
Licensing Contact: Whitney Blair, J.D.,
M.P.H.; 301–435–4937; whitney.blair@
nih.gov.
Cable-Line Safety System: Electro/
Hydraulic Emergency Stop Device for a
Winch, Drum or Capstan
Description of Technology: This CDCdeveloped invention entails a system of
electrical and hydraulic circuits used to
stop a rotating winch in an emergency.
Amongst other locations, one stop
switch can be positioned on a capstan
winch horn. This location makes it
available to a victim entangled in rope
being retrieved on a gypsy drum. As
designed, the stop circuit could be used
with an electrically, hydraulically or
pneumatically operated winch. A
variant of this safety system has been
successfully tested on a purse seining
fishing vessel in Alaskan waters.
Potential Commercial Applications:
• Retrofitting existing winches for
additional safety and adherence to
possible future regulations
• Specifically designed and tested for
the marine/fishing industries
• Applications in mining, construction,
forestry, and/or off-road automotive
industries
• Workers’ well-being concern groups
• Insurers of fishing vessels; also
mining, construction and forestry
operations
• Manufacturers of cable reel trailers
and wire-drawing machinery
Competitive Advantages:
E:\FR\FM\13MRN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Notices]
[Pages 14256-14257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05514]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Evaluation of
National Institutes of Health International Bilateral Programs (FIC,
NCI, NIAAA, NIAID, NICHD, NIDA, NINDS, NIMH, OAR)
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 Cancer Institute
(NCI), 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: Julie
Schneider, Program Director, Center for Global Health, National Cancer
Institute, 9609 Medical Center Dr., RM 3W564, Rockville, MD 20850 or
call non-toll-free number 240-276-5795 or Email your request, including
your address to: schneidj@mail.nih.gov. Formal requests for additional
plans and instruments must be requested in writing.
DATES: 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 National Institutes of Health
International Bilateral Programs (FIC, NCI, NIAAA, NIAID, NICHD, NIDA,
NIMH, NINDS, OAR), 0925-NEW, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: This submission is a
request for OMB to approve the Evaluation of National Institutes of
Health (NIH) International Bilateral Programs for three years. The
bilateral awards are made through the Funding Opportunity Announcement
mechanism and administrative supplements, meaning they are funded by
set-aside funds that are separate from the general pool of research
program grant funds used to support investigator initiated research at
NIH. The bilateral programs to be evaluated are the U.S.-China Program
for Biomedical Research Cooperation, U.S.--India Bilateral
Collaborative Research Partnerships on the Prevention of HIV/AIDS and
Co-morbidities, U.S.-Russia Bilateral Collaborative Research
Partnerships on the Prevention and Treatment of HIV/AIDS and Co-
morbidities, and U.S.-South Africa Program for Collaborative Biomedical
Research. These programs are funded and administered by various
combinations of the following institutes: Fogarty International Center
(FIC), the Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD), National Cancer Institute (NCI),
National Institute on Alcohol Abuse and Alcoholism (NIAAA), National
Institute for Allergy and Infectious Diseases (NIAID), National
Institute on Drug Abuse (NIDA), National Institute of Mental Health
(NIMH), National Institute of Neurological Disorders and Stroke
[[Page 14257]]
(NINDS), and the Office of AIDS Research (OAR). While these programs
differ, their underlying concept is the same; they require U.S.
scientists to collaborate with scientists from other countries in order
to conduct scientifically meritorious investigations of mutual interest
to both countries. The proposed evaluation requests information about
(1) accomplishments of the awards, (2) unique findings or opportunities
due to the international collaborations, and (3) successes and
challenges of these collaborations. The information will be collected
one year into the award and at the end of the award, when possible.
This information is needed to evaluate the effectiveness of these
programs across NIH.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 128.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Principal Investigators Administrative 24 1 1 24
Supplements....................................
Principal Investigators Other Mechanisms........ 52 2 1 104
----------------------------------------------------------------------------------------------------------------
Dated: March 7, 2014.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-05514 Filed 3-12-14; 8:45 am]
BILLING CODE 4140-01-P
