Request for Information To Solicit Feedback on the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative, 41081-41082 [2018-17759]
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41081
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total burden
hours
IRB Registration 0990–0279 ...........................................................................
5,650
350
2
2
1
1.5
11,300
525
Total ..........................................................................................................
........................
........................
........................
11,825
Contact Person: Elizabeth A. Webber,
Ph.D., Scientific Review Officer, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3208, MSC 9529, Bethesda, MD 20892–
9529, (301) 496–1917, webbere@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Terry Clark,
Asst. Information Collection Clearance
Officer.
[FR Doc. 2018–17748 Filed 8–16–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Neurological Sciences
Training Initial Review Group; NST–1
Subcommittee.
Date: September 17–18, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Kinzie Hotel, 20 West Kinzie Street,
Chicago, IL 60654.
Contact Person: William C. Benzing, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., SUITE 3204,
MSC 9529, Bethesda, MD 20892–9529, (301)
496–0660, benzingw@mail.nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Ruth L. Kirschstein National
Research Service Award (NRSA) Institutional
Research Training Grant (T32) Program.
Date: November 14–15, 2018.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Crystal City, 2399 Jefferson
Davis Hwy., Arlington, VA 22202.
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Dated: August 13, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–17780 Filed 8–16–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information To Solicit
Feedback on the Brain Research
Through Advancing Innovative
Neurotechnologies (BRAIN) Initiative
AGENCY:
National Institutes for Health,
HHS.
ACTION:
Notice.
The purpose of this Request
for Information (RFI) is to solicit input
on how best to accomplish the
ambitious vision for the Brain Research
through Advancing Innovative
Neurotechnologies (BRAIN) Initiative®
set forth in BRAIN 2025: A Scientific
Vision. NIH is soliciting input from all
interested stakeholders, including
members of the scientific community,
trainees, academic institutions, the
private sector, health professionals,
professional societies, advocacy groups,
and patient communities, as well as
other interested members of the public.
DATES: The Request for Information is
open for public comment. To assure
consideration, your responded must be
received by November 15, 2018, 11:59
p.m.
ADDRESSES: Responses to this RFI must
be submitted electronically using the
web-based form at https://
www.braininitiative.nih.gov/rfi.aspx.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Please direct all inquiries to Samantha
White, Ph.D., National Institute of
Neurological Disorders and Stroke, 301–
496–1675; BRAINFeedback@nih.gov
with ‘‘BRAIN RFI’’ in the subject line.
SUPPLEMENTARY INFORMATION:
Background
The BRAIN Initiative aims to develop
new tools and technologies to
understand and manipulate networks of
cells in the brain. BRAIN 2025: A
Scientific Vision serves as the strategic
plan for the BRAIN Initiative at NIH and
outlines an overarching vision, seven
high level scientific priorities, and many
specific goals. Designed to be achieved
over at least a decade, the first five years
of BRAIN 2025 emphasizes
development of tools and technology,
and the next five years shifts emphasis
to using these tools to make
fundamental discoveries about how
brain circuits work and what goes
wrong in disease.
The BRAIN Initiative is well
underway (see https://
www.braininitiative.nih.gov), and we are
now approaching the midpoint. At this
time, NIH is seeking feedback on the
BRAIN Initiative’s progress and on
opportunities moving forward given the
current state of the science. NIH has
established a new BRAIN Initiative
Advisory Committee of the NIH Director
(ACD) Working Group that will provide
scientific guidance to the ACD on how
best to continue to accelerate the
ambitious vision for the BRAIN
Initiative.
The ACD–WG will use the responses
to this RFI, along with information
gathered through a series of public
workshops, to help inform their
discussions of the BRAIN Initiative’s
progress and potential updates to the
plan moving forward.
Information Requested
Anyone wishing to submit a response
is asked to include:
• Ideas for new tools and
technologies that have the potential to
transform brain circuit research.
• Suggestions for fundamental
questions about brain circuit function in
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17AUN1
41082
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices
humans or animal models that could be
addressed with new technologies.
• Considerations for data sharing
infrastructure and policies.
• Areas and topics for research on the
ethical implications of BRAIN Initiativesupported emerging neurotechnologies
and advancements and their
applications.
• Approaches for disseminating new
tools and technologies as well as
training the broader neuroscience
research community.
• Any other topic relevant to the
strategic plan of the BRAIN Initiative.
Responses to this RFI are voluntary.
Any personal identifiers will be
removed when responses are compiled.
Individual feedback will not be
provided to any responder. Proprietary,
classified, confidential, or sensitive
information should not be included in
your response. This Request for
Information (RFI) is for planning
purposes only and is not a solicitation
for applications or an obligation on the
part of the United States (U.S.)
Government to provide support for any
ideas identified in response to it. Please
note that the U.S. Government will not
pay for the preparation of any comment
submitted or for its use of that comment.
Dated: August 10, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018–17759 Filed 8–16–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health (NIH)
Office of Science Policy (OSP)
Recombinant or Synthetic Nucleic Acid
Research: Proposed Changes to the
NIH Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institutes of
Health (NIH) seeks public comment on
its proposal to amend the NIH
Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines) to
streamline oversight for human gene
transfer clinical research protocols and
reduce duplicative reporting
requirements already captured within
the existing regulatory framework.
Specifically, NIH proposes amendments
to: Delete the NIH protocol registration
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SUMMARY:
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submission and reporting requirements
under Appendix M of the NIH
Guidelines, and modify the roles and
responsibilities of entities that involve
human gene transfer or the Recombinant
DNA Advisory Committee (RAC).
DATES: To ensure consideration,
comments must be submitted in writing
by October 16, 2018.
ADDRESSES: Comments may be
submitted electronically by visiting:
https://osp.od.nih.gov/comment-formnih-guidelines/. Comments may also be
sent via fax to 301–496–9839, or by mail
to the Office of Science Policy, National
Institutes of Health, 6705 Rockledge
Drive, Suite 750, Bethesda, Maryland
20892–7985. All written comments
received in response to this notice will
be available for public inspection at NIH
Office of Science Policy (OSP), 6705
Rockledge Drive, Suite 750, Bethesda,
MD 20892–7985, weekdays between the
hours of 8:30 a.m. and 5 p.m. and may
be posted without change, including
any personal information, to the NIH
OSP website.
FOR FURTHER INFORMATION CONTACT: If
you have questions, or require
additional background information
about these proposed changes, please
contact the NIH by email at
SciencePolicy@od.nih.gov, or telephone
at 301–496–9838. You may also contact
Jessica Tucker, Ph.D., Director of the
Division of Biosafety, Biosecurity, and
Emerging Biotechnology Policy, Office
of Science Policy, NIH, at 301–451–4431
or Jessica.Tucker@nih.gov.
SUPPLEMENTARY INFORMATION: NIH is
proposing a series of actions to the NIH
Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines) to
streamline oversight of human gene
transfer research (HGT), and to focus the
NIH Guidelines more specifically on
biosafety issues associated with research
involving recombinant or synthetic
nucleic acid molecules. The field of
HGT has recently experienced a series
of advances that have resulted in the
translation of research into clinical
practice, including U.S. Food and Drug
Administration (FDA) approvals for
licensed products. Additionally,
oversight mechanisms for ensuring HGT
proceeds safely have sufficiently
evolved to keep pace with new
discoveries in this field.
At this time, there is duplication in
submitting protocols, annual reports,
amendments, and serious adverse
events for HGT clinical protocols to
both NIH and FDA that does not exist
for other areas of clinical research.
Historically, this duplication was
conceived as harmonized reporting,
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enabling FDA to provide regulatory
oversight while NIH provided a forum
for open dialogue and transparency.
However, since these complementary
functions were first envisioned, we have
now seen several converging systems
emerge that provide some of these
functions. For instance,
ClinicalTrials.gov has been instituted,
which provides a transparent and
searchable database for clinical trials. In
addition, the protection of human
research subjects was improved through
changes that updated provisions of the
Common Rule. In 2018, FDA released a
suite of draft guidance documents
pertaining to gene therapy that includes
new guidance on manufacturing issues,
long-term follow-up, and pathways for
clinical development in certain areas,
including hemophilia, ophthalmologic
indications, and rare diseases.
While the science and oversight
system have evolved, HGT protocols
continue to receive special oversight
that is not afforded to other areas of
clinical research. This observation was
also noted in a 2014 Institute of
Medicine of the National Academies
report, Oversight and Review of Clinical
Gene Transfer Protocols: Assessing the
Role of the Recombinant DNA Advisory
Committee, in which it was
recommended that NIH begin to limit
RAC review to only exceptional HGT
protocols that meet certain criteria and
that would significantly benefit from
RAC review. As very few protocols have
been assessed by NIH to merit review
under this new system, NIH asserts it is
an opportune time to make changes to
the NIH Guidelines to make oversight of
HGT commensurate with oversight
afforded to other areas of clinical
research given the robust infrastructure
in place to oversee this type of research.
Briefly to summarize, NIH proposes
amending the NIH Guidelines to:
1. Eliminate RAC review and
reporting requirements to NIH for HGT
protocols.
2. Modify roles and responsibilities of
investigators, institutions, IBCs, the
RAC, and NIH to be consistent with
these goals including:
a. Modifying roles of IBCs in
reviewing HGT to be consistent with
review of other covered research, and
b. Eliminating references to the RAC,
including its roles in HGT and biosafety.
NIH suggests that the series of
changes proposed in this Notice is a
rational next step in the process of
considering appropriate oversight of
HGT. Consistent with these proposed
changes to the NIH Guidelines, Section
I–A, the Purpose of the NIH Guidelines,
is proposed to be amended to clarify
that the focus of the policy is biosafety
E:\FR\FM\17AUN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41081-41082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17759]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information To Solicit Feedback on the Brain Research
Through Advancing Innovative Neurotechnologies (BRAIN) Initiative
AGENCY: National Institutes for Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The purpose of this Request for Information (RFI) is to
solicit input on how best to accomplish the ambitious vision for the
Brain Research through Advancing Innovative Neurotechnologies (BRAIN)
Initiative[supreg] set forth in BRAIN 2025: A Scientific Vision. NIH is
soliciting input from all interested stakeholders, including members of
the scientific community, trainees, academic institutions, the private
sector, health professionals, professional societies, advocacy groups,
and patient communities, as well as other interested members of the
public.
DATES: The Request for Information is open for public comment. To
assure consideration, your responded must be received by November 15,
2018, 11:59 p.m.
ADDRESSES: Responses to this RFI must be submitted electronically using
the web-based form at https://www.braininitiative.nih.gov/rfi.aspx.
FOR FURTHER INFORMATION CONTACT: Please direct all inquiries to
Samantha White, Ph.D., National Institute of Neurological Disorders and
Stroke, 301-496-1675; [email protected] with ``BRAIN RFI'' in the
subject line.
SUPPLEMENTARY INFORMATION:
Background
The BRAIN Initiative aims to develop new tools and technologies to
understand and manipulate networks of cells in the brain. BRAIN 2025: A
Scientific Vision serves as the strategic plan for the BRAIN Initiative
at NIH and outlines an overarching vision, seven high level scientific
priorities, and many specific goals. Designed to be achieved over at
least a decade, the first five years of BRAIN 2025 emphasizes
development of tools and technology, and the next five years shifts
emphasis to using these tools to make fundamental discoveries about how
brain circuits work and what goes wrong in disease.
The BRAIN Initiative is well underway (see https://www.braininitiative.nih.gov), and we are now approaching the midpoint.
At this time, NIH is seeking feedback on the BRAIN Initiative's
progress and on opportunities moving forward given the current state of
the science. NIH has established a new BRAIN Initiative Advisory
Committee of the NIH Director (ACD) Working Group that will provide
scientific guidance to the ACD on how best to continue to accelerate
the ambitious vision for the BRAIN Initiative.
The ACD-WG will use the responses to this RFI, along with
information gathered through a series of public workshops, to help
inform their discussions of the BRAIN Initiative's progress and
potential updates to the plan moving forward.
Information Requested
Anyone wishing to submit a response is asked to include:
Ideas for new tools and technologies that have the
potential to transform brain circuit research.
Suggestions for fundamental questions about brain circuit
function in
[[Page 41082]]
humans or animal models that could be addressed with new technologies.
Considerations for data sharing infrastructure and
policies.
Areas and topics for research on the ethical implications
of BRAIN Initiative-supported emerging neurotechnologies and
advancements and their applications.
Approaches for disseminating new tools and technologies as
well as training the broader neuroscience research community.
Any other topic relevant to the strategic plan of the
BRAIN Initiative.
Responses to this RFI are voluntary. Any personal identifiers will be
removed when responses are compiled. Individual feedback will not be
provided to any responder. Proprietary, classified, confidential, or
sensitive information should not be included in your response. This
Request for Information (RFI) is for planning purposes only and is not
a solicitation for applications or an obligation on the part of the
United States (U.S.) Government to provide support for any ideas
identified in response to it. Please note that the U.S. Government will
not pay for the preparation of any comment submitted or for its use of
that comment.
Dated: August 10, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-17759 Filed 8-16-18; 8:45 am]
BILLING CODE 4140-01-P
