Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41081 

ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

IRB Registration 0990–0279 ........................................................................... 5,650 2 1 11,300 

350 2 1.5 525 

Total .......................................................................................................... ........................ ........................ ........................ 11,825 

Terry Clark, 

Asst. Information Collection Clearance 

Officer. 

[FR Doc. 2018–17748 Filed 8–16–18; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

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. 

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) 

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. 

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®

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; 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 http://

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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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. 

SUMMARY: 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 

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, 

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 


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