Agency Information Collection Activities: Proposed Collection; Comment Request, 57927-57928 [2016-20239]
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Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices
expertise outside the federal
government. Additional information
about ICCVAM can be found at https://
ntp.niehs.nih.gov/go/iccvam.
NICEATM administers ICCVAM,
provides scientific and operational
support for ICCVAM-related activities,
and conducts and publishes analyses
and evaluations of data from new,
revised, and alternative testing
approaches. NICEATM and ICCVAM
work collaboratively to evaluate new
and improved testing approaches
applicable to the needs of U.S. federal
agencies. NICEATM and ICCVAM
welcome the public nomination of new,
revised, and alternative testing
approaches for validation studies and
technical evaluations. Additional
information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/
niceatm.
Dated: August 16, 2016.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2016–20159 Filed 8–23–16; 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 invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing and/or co-development 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 and/or co-development.
ADDRESSES: Invention Development and
Marketing Unit, Technology Transfer
Center, National Cancer Institute, 9609
Medical Center Drive, Mail Stop 9702,
Rockville, MD 20850–9702.
FOR FURTHER INFORMATION CONTACT:
Information on licensing and codevelopment research collaborations,
and copies of the U.S. patent
applications listed below may be
obtained by contacting: Attn. Invention
Development and Marketing Unit,
Technology Transfer Center, National
Cancer Institute, 9609 Medical Center
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SUMMARY:
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Drive, Mail Stop 9702, Rockville, MD
20850–9702, Tel. 240–276–5515 or
email ncitechtransfer@mail.nih.gov. A
signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
Title of invention: Methods of
Analyzing Virus-Derived Therapeutics.
Description of Technology:
Researchers at the National Cancer
Institute’s Biopharmaceutical
Development Program recently
developed massively parallel
sequencing methods for virus-derived
therapeutics such as viral vaccines and
oncolytic immunotherapies. The
methods allow for the determination of
micro-heterogeneity and quantitation of
low frequency sequence variants, which
have the possibility of supplanting
monkey neurovirulence safety testing
(MNVT), mutant analysis by PCR, and
restriction enzyme cleavage (MAPREC)
methods that are currently used to
screen RNA virus-derived therapeutics.
Potential Commercial Applications:
• Improved methods for detecting
mutations in GMP-manufactured virusderived therapeutics, including viruses,
viral template plasmids, or vaccines;
• The method allows for at least two
different virus-derived therapeutics to
be assayed simultaneously.
Value Proposition:
• Provides a cost- and time-effective
means of assaying a virus-derived
therapeutic, such as oncolytic viruses,
for viral sequence variants, for
regulatory approval;
• RNA virus preparation steps
increase the amount of viral RNA
obtained;
• Demonstrated superiority of
massively parallel sequencing (‘‘MPS’’)
over mutant analysis by PCR and
restriction enzyme cleavage
(‘‘MAPREC’’) analysis.
Development Stage: Clinical Phase I.
Inventor(s): Trevor Broadt (NCI),
Michael D. Harwich (American
International Biotechnology, LLC),
William T. Budd (American
International Biotechnology, LLC),
Gregory A. Myers (American
International Biotechnology, LLC).
Intellectual Property:
HHS Ref. No. E–240–2015/0–U.S.–01,
corresponding to U.S. Provisional
Patent App. No. 62/199,663, filed July
31, 201562/173,777, entitled
‘‘Methods of Analysis of RNA VirusDerived Therapeutics’’
HHS Ref. No. E–240–2015/0–PCT–02,
corresponding to International Patent
App. No. PCT/US2016/044788, filed
July 29, 2016, entitled ‘‘Methods of
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57927
Analyzing Virus-Derived
Therapeutics’’
Related Technologies: HHS Reference
#E–267–2014/0 entitled ‘‘Processes for
Production and Purification of Nucleic
Acid Containing Compositions’’.
Contact Information: Requests for
copies of the patent application or
inquiries about licensing, research
collaborations, and co-development
opportunities should be sent to John D.
Hewes, Ph.D., email: john.hewes@
nih.gov.
Dated: August 16, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology
Transfer Center, National Cancer Institute.
[FR Doc. 2016–20162 Filed 8–23–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
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Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices
Proposed Project: Voluntary Customer
Satisfaction Surveys To Implement
Executive Order 12862 in the Substance
Abuse and Mental Health Services
Administration (SAMHSA)—(OMB No.
0930–0197)—Extension
Executive Order 12862 directs
agencies that ‘‘provide significant
services directly to the public’’ to
‘‘survey customers to determine the
kind and quality of services they want
and their level of satisfaction with
existing services.’’ SAMHSA provides
significant services directly to the
public, including treatment providers
satisfaction surveys expected to be
implemented under this approval will
provide data for measurement of
program effectiveness under the
Government Performance and Results
Act (GPRA). Information from these
customer surveys will be used to plan
and redirect resources and efforts to
improve or maintain a high quality of
service to health care providers and
members of the public. Focus groups
may be used to develop the survey
questionnaire in some instances.
The estimated annual hour burden is
as follows:
and State substance abuse and mental
health agencies, through a range of
mechanisms, including publications,
training, meetings, technical assistance
and Web sites. Many of these services
are focused on information
dissemination activities. The purpose of
this submission is to extend the existing
generic approval for such surveys.
The primary use for information
gathered is to identify strengths and
weaknesses in current service
provisions by SAMHSA and to make
improvements that are practical and
feasible. Several of the customer
Number of
respondents
Type of data collection
Responses/
respondent
Hours/
response
Total hours
Focus groups ...................................................................................................
Self-administered, mail, telephone and e-mail surveys ...................................
250
89,750
1
1
2.50
.250
625
22,438
Total ..........................................................................................................
90,000
........................
........................
23,063
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
5600 Fishers Lane, Room 15E57–B,
Rockville, Maryland 20857, OR email a
copy to summer.king@samhsa.hhs.gov.
Written comments should be received
by October 24, 2016.
Summer King,
Statistician.
from the addition of a new application
for brokers, importers, sureties,
attorneys and other parties to establish
an ACE Portal account to file protests.
There are no proposed changes to the
existing ACE Portal application for
imported merchandise. This document
is published to obtain comments from
the public and affected agencies.
Written comments should be
received on or before September 23,
2016 to be assured of consideration.
DATES:
[FR Doc. 2016–20239 Filed 8–23–16; 8:45 am]
BILLING CODE 4162–20–P
Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to oira_submission@
omb.eop.gov or faxed to (202) 395–5806.
ADDRESSES:
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0105]
Agency Information Collection
Activities: Application To Use the
Automated Commercial Environment
(ACE)
AGENCY:
FOR FURTHER INFORMATION CONTACT:
U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: Application to Use the
Automated Commercial Environment
(ACE). CBP is proposing that this
information collection be extended with
a change to the burden hours resulting
Requests for additional information
should be directed to Paperwork
Reduction Act Officer, U.S. Customs
and Border Protection, Regulations and
Rulings, Office of Trade, 90 K Street
NE., 10th Floor, Washington, DC 20229–
1177, or via email (CBP_PRA@
cbp.dhs.gov). Please note contact
information provided here is solely for
questions regarding this notice.
Individuals seeking information about
other CBP programs please contact the
CBP National Customer Service Center
at 877–227–5511, (TTY) 1–800–877–
8339, or CBP Web site at https://
www.cbp.gov/. For additional help:
https://help.cbp.gov/app/home/search/
1.
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30-Day notice and request for
comments; Extension and revision of an
existing collection of information.
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SUMMARY:
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This
proposed information collection was
previously published in the Federal
Register (81 FR 38727) on June 14, 2016,
allowing for a 60-day comment period.
This notice allows for an additional 30
days for public comments. This process
is conducted in accordance with 5 CFR
1320.10. CBP invites the general public
and other Federal agencies to comment
on proposed and/or continuing
information collections pursuant to the
Paperwork Reduction Act of 1995
(Public Law 104–13; 44 U.S.C. 3507).
The comments should address: (a)
Whether the collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden, including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
annual costs to respondents or record
keepers from the collection of
information (total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for OMB approval. All
comments will become a matter of
public record. In this document, CBP is
soliciting comments concerning the
following information collection:
Title: Application to Use the
Automated Commercial Environment
(ACE).
OMB Number: 1651–0105.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57927-57928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
[[Page 57928]]
Proposed Project: Voluntary Customer Satisfaction Surveys To Implement
Executive Order 12862 in the Substance Abuse and Mental Health Services
Administration (SAMHSA)--(OMB No. 0930-0197)--Extension
Executive Order 12862 directs agencies that ``provide significant
services directly to the public'' to ``survey customers to determine
the kind and quality of services they want and their level of
satisfaction with existing services.'' SAMHSA provides significant
services directly to the public, including treatment providers and
State substance abuse and mental health agencies, through a range of
mechanisms, including publications, training, meetings, technical
assistance and Web sites. Many of these services are focused on
information dissemination activities. The purpose of this submission is
to extend the existing generic approval for such surveys.
The primary use for information gathered is to identify strengths
and weaknesses in current service provisions by SAMHSA and to make
improvements that are practical and feasible. Several of the customer
satisfaction surveys expected to be implemented under this approval
will provide data for measurement of program effectiveness under the
Government Performance and Results Act (GPRA). Information from these
customer surveys will be used to plan and redirect resources and
efforts to improve or maintain a high quality of service to health care
providers and members of the public. Focus groups may be used to
develop the survey questionnaire in some instances.
The estimated annual hour burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses/ Hours/
Type of data collection respondents respondent response Total hours
----------------------------------------------------------------------------------------------------------------
Focus groups.................................... 250 1 2.50 625
Self-administered, mail, telephone and e-mail 89,750 1 .250 22,438
surveys........................................
---------------------------------------------------------------
Total....................................... 90,000 .............. .............. 23,063
----------------------------------------------------------------------------------------------------------------
Send comments to Summer King, SAMHSA Reports Clearance Officer,
5600 Fishers Lane, Room 15E57-B, Rockville, Maryland 20857, OR email a
copy to summer.king@samhsa.hhs.gov. Written comments should be received
by October 24, 2016.
Summer King,
Statistician.
[FR Doc. 2016-20239 Filed 8-23-16; 8:45 am]
BILLING CODE 4162-20-P
