Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, National Institute of Mental Health, 17558-17559 [2018-08243]
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
to the Secretary of HHS and the U.S.
Congress on policy issues related to the
activities under section 851 of Title VIII
of the Public Health Service Act
(PHSA). The Secretary of HHS, and by
delegation the Administrator of HRSA,
is charged under Title VIII of the PHSA
as amended, with responsibility for a
wide range of activities in support of
nursing education and practice which
include: enhancement of the
composition of the nursing workforce;
improvement of the distribution and
utilization of nurses to meet the health
needs of the nation; expansion of the
knowledge, skills, and capabilities of
nurses to enhance the quality of nursing
practice; development and
dissemination of improved models of
organization; financing and delivery of
nursing services; and promotion of
interdisciplinary approaches to the
delivery of health services particularly
in the context of public health and
primary care.
During the May 16, 2018, meeting,
NACNEP members will be oriented to
the work of the Council and identify a
topic for 2018. The NACNEP final
agenda will be available on the
NACNEP website three (3) days prior to
the meeting at https://www.hrsa.gov/
advisory-committees/nursing/
index.html. Please note that agenda
items are subject to change as priorities
dictate.
Members of the public will have the
opportunity to provide comments,
which are part of the official Committee
record. Oral comments will be honored
in the order they are requested and may
be limited as time allows. Requests to
make oral comments or provide written
comments to the NACNEP should be
sent to CDR Antoine Smith, DFO, using
the contact information above, at least
three (3) business days prior to the
meeting.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–08263 Filed 4–19–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Advisory Committee on
Children and Disasters Public
Teleconference
Office of the Secretary,
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
SUMMARY:
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Department of Health and Human
Services is hereby giving notice that the
National Advisory Committee on
Children and Disasters (NACCD) will
hold a public teleconference on May 1,
2018.
The NACCD Teleconference is
May 1, 2018, from 3:00 p.m. to 4:00 p.m.
Eastern Standard Time EST.
Dated: April 9, 2018.
Robert P. Kadlec,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2018–08278 Filed 4–19–18; 8:45 am]
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DATES:
We encourage members of
the public to attend the teleconference.
To register, send an email to naccd@
hhs.gov with ‘‘NACCD Registration’’ in
the subject line. Submit your comments
to naccd@hhs.gov or on the NACCD
Contact Form located at https://
www.phe.gov/Preparedness/legal/
boards/naccd/Pages/contact.aspx. For
additional information, visit the NACCD
website located at https://www.phe.gov/
naccd.
ADDRESSES:
Pursuant
to the Federal Advisory Committee Act
of 1972 (5 U.S.C., Appendix, as
amended), and section 2811A of the
Public Health Service Act (42 U.S.C.
300hh–10a), as added by section 103 of
the Pandemic and All Hazards
Preparedness Reauthorization Act of
2013 (Pub. L. 113–5), the HHS
Secretary, in consultation with the
Secretary of the U.S. Department of
Homeland Security, established the
NACCD. The purpose of the NACCD is
to provide advice and consultation to
the HHS Secretary with respect to the
medical and public health needs of
children in relation to disasters.
Background: The NACCD Public
Teleconference on May 1, 2018, is
dedicated to the presentation,
deliberation, and vote on the NACCD
Funding Strategies Report.
Availability of Materials: We will post
all teleconference materials and any
modifications to the agenda prior to
May 1, 2018, on the NACCD website,
located at https://www.phe.gov/naccd.
Procedures for Providing Public Input:
Members of the public may attend the
teleconference via a toll-free call-in
phone number, which is available on
the NACCD website at https://
www.phe.gov/naccd.
We encourage members of the public
to provide written comments that are
relevant to the NACCD Teleconference
prior to May 1, 2018. Send written
comments by email to naccd@hhs.gov
with ‘‘NACCD Public Comment’’ in the
subject line. The NACCD Chair will
respond during the meeting to
comments received by April 30, 2018,
during the teleconference.
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; NIH NeuroBioBank Tissue
Access Request Form, National
Institute of Mental Health
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institute of Mental Health
(NIMH) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
SUMMARY:
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
DATES:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Melba Rojas, NIMH Project
Clearance Liaison, Science Policy and
Evaluation Branch, Office of Science
Policy, Planning and Communications,
NIMH, Neuroscience Center, 6001
Executive Boulevard, MSC 9667,
Bethesda, Maryland 20892, call 301–
443–4335, or email your request,
including your mailing address, to
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: 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
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 83, No. 77 / Friday, April 20, 2018 / Notices
the NIH NeuroBioBank must continue
completing the NIH NeuroBioBank
Tissue Access Request Form. The
primary use of the information collected
by this instrument is to document, track,
monitor, and evaluate the appropriate
use of the NIH NeuroBioBank resources,
as well as to notify stakeholders of
updates, corrections or changes to the
system.
OMB approval is requested for 3
years. There are no costs to respondents’
other than their time. The total
estimated annualized burden hours are
56.
07/31/2018, EXTENSION, National
Institute of Mental Health, National
Institutes of Health (NIH).
Need and Use of Information
Collection: This request serves as notice
that the National Institute of Mental
Health plans to continue supporting the
research community studying
neurological, developmental, and
psychiatric disorders by coordinating
access to human post-mortem brain
tissue and related biospecimens stored
by our federation of networked brain
and tissue repositories known as the
NIH NeuroBioBank. To facilitate this
process, researchers wishing to obtain
brain tissue and biospecimens stored by
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 minimizes
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.
Proposed Collection Title: NIH
NeuroBioBank Tissue Access Request
Form, 0925–0723, Expiration date
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Instrument type
Type of respondents
NIH NeuroBioBank Tissue Access Request Form
Researchers .................
225
1
15/60
56
Total ...............................................................
.......................................
225
225
........................
56
Dated: April 12, 2018.
Melba O. Rojas,
Project Clearance Liaison, National Institute
of Mental Health, National Institutes of
Health.
SUPPLEMENTARY INFORMATION:
Technology description follows.
[FR Doc. 2018–08243 Filed 4–19–18; 8:45 am]
Description of Technology
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An effective universal influenza
vaccine would eliminate the uncertain
and costly process of seasonal influenza
vaccine development each year.
Researchers at the National Institute of
Allergy and Infectious Diseases (NIAID)
are developing immunogens which
elicit neutralizing antibodies to the
highly conserved stem region of the
influenza viral protein hemagglutinin.
By targeting this highly conserved
region, which is nearly identical in
various strains of influenza virus, these
immunogens could train the immune
system to defend against a wide variety
of influenza strains including pandemic
strains derived from animal reservoirs.
This vaccine candidate employs a
protein nanoparticle platform to display
portions of the highly conserved stem
region of the group 1 hemagglutinin
(HA) viral surface protein in its native,
trimeric conformation. Animal studies
have shown that the HA stem region
trimers displayed on a nanoparticle are
more immunogenic compared to HA
stem region trimers alone.
Immunization of mice and ferrets with
an H1N1 nanoparticle HA stem
immunogen conferred protection from a
lethal dose of H5N1 virus.
NIAID is continuing development of
these vaccine candidates through
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.
SUMMARY:
Dr.
Amy Petrik, 240–627–3721;
amy.petrik@nih.gov. Licensing
information and copies of the U.S.
patent application listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD, 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
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FOR FURTHER INFORMATION CONTACT:
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Stabilized Influenza Hemagglutinin
Stem Region Trimers and Uses Thereof
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animal studies and moving toward
clinical evaluation.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications
• Universal influenza vaccine
Competitive Advantages
• Nucleic acid or recombinant proteinbased vaccine
• Increased ease of production relative
to current seasonal influenza vaccines
Development Stage
• Preclinical, animal data available
Inventors: John R. Mascola, Jeffrey C.
Boyington, Hadi M. Yassine, Peter D.
Kwong, Barney S. Graham, Masaru
Kanekiyo (all from NIAID).
Publications: Yassine, H.M., et al.
(2015) Hemagglutinin-stem
nanoparticles generate heterosubtypic
influenza protection. Nature Medicine
21: 1065–1070. [PMID: 26301691]
Intellectual Property: HHS Reference
Number E–066–2014 includes U.S.
Patent Application No. 15/13,265 filed
November 22, 2016 (Pending); Canada
Patent Application No. 2,950,085 filed
May 27, 2015 (Pending); China Patent
Application No. 201580041202.3 filed
January 24, 2017 (Pending); Europe
Patent Application No. 15727824.3 filed
December 23, 2016 (Pending); India
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]]>Agencies
[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Notices]
[Pages 17558-17559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08243]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank
Tissue Access Request Form, National Institute of Mental Health
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institute of Mental Health (NIMH)
will publish periodic summaries of proposed projects to be submitted to
the Office of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 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: Melba Rojas,
NIMH Project Clearance Liaison, Science Policy and Evaluation Branch,
Office of Science Policy, Planning and Communications, NIMH,
Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Bethesda,
Maryland 20892, call 301-443-4335, or email your request, including
your mailing address, to [email protected]. Formal
requests for additional plans and instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: 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
[[Page 17559]]
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 minimizes 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.
Proposed Collection Title: NIH NeuroBioBank Tissue Access Request
Form, 0925-0723, Expiration date 07/31/2018, EXTENSION, National
Institute of Mental Health, National Institutes of Health (NIH).
Need and Use of Information Collection: This request serves as
notice that the National Institute of Mental Health plans to continue
supporting the research community studying neurological, developmental,
and psychiatric disorders by coordinating access to human post-mortem
brain tissue and related biospecimens stored by our federation of
networked brain and tissue repositories known as the NIH NeuroBioBank.
To facilitate this process, researchers wishing to obtain brain tissue
and biospecimens stored by the NIH NeuroBioBank must continue
completing the NIH NeuroBioBank Tissue Access Request Form. The primary
use of the information collected by this instrument is to document,
track, monitor, and evaluate the appropriate use of the NIH
NeuroBioBank resources, as well as to notify stakeholders of updates,
corrections or changes to the system.
OMB approval is requested for 3 years. There are no costs to
respondents' other than their time. The total estimated annualized
burden hours are 56.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument type Type of Number of responses per per response Total annual
respondents respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
NIH NeuroBioBank Tissue Access Researchers..... 225 1 15/60 56
Request Form.
---------------------------------------------------------------
Total..................... ................ 225 225 .............. 56
----------------------------------------------------------------------------------------------------------------
Dated: April 12, 2018.
Melba O. Rojas,
Project Clearance Liaison, National Institute of Mental Health,
National Institutes of Health.
[FR Doc. 2018-08243 Filed 4-19-18; 8:45 am]
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