Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41093 

additional contact information is also 

available here and on the OSP website 

(www.osp.od.nih.gov). The NIH Director may 

rescind the certification of a host-vector 

system (see Section IV–C–1–b–(2)–(g), Minor 

Actions). If certification is rescinded, NIH 

will instruct investigators to transfer cloned 

DNA into a different system or use the clones 

at a higher level of physical containment 

level, unless NIH determines that the already 

constructed clones incorporate adequate 

biological containment. Certification of a 

host-vector system does not extend to 

modifications of either the host or vector 

component of that system. Such modified 

systems shall be independently certified by 

the NIH Director. If modifications are minor, 

it may only be necessary for the investigator 

to submit data showing that the 

modifications have either improved or not 

impaired the major phenotypic traits on 

which the containment of the system 

depends. Substantial modifications to a 

certified host-vector system requires 

submission of complete testing data. 

Appendix I–II–B. Data To Be Submitted 

for Certification 

Appendix I–II–B–1. Host-Vector 1 

Systems Other than Escherichia coli 

K–12 

The following types of data shall be 

submitted, modified as appropriate for the 

particular system under consideration: (i) A 

description of the organism and vector; the 

strain’s natural habitat and growth 

requirements; its physiological properties, 

particularly those related to its reproduction, 

survival, and the mechanisms by which it 

exchanges genetic information; the range of 

organisms with which this organism 

normally exchanges genetic information and 

the type of information is exchanged; and 

any relevant information about its 

pathogenicity or toxicity; (ii) a description of 

the history of the particular strains and 

vectors to be used, including data on any 

mutations which render this organism less 

able to survive or transmit genetic 

information; and (iii) a general description of 

the range of experiments contemplated with 

emphasis on the need for developing such an 

Host-Vector 1 system. 

Appendix I–II–B–2. Host-Vector 2 

Systems 

Investigators planning to request HostVector 2 systems certification may obtain 

instructions from NIH OSP concerning data 

to be submitted (see Appendices I–III–N and 

O, Footnotes and References of Appendix I). 

In general, the following types of data are 

required: (i) Description of construction steps 

with indication of source, properties, and 

manner of introduction of genetic traits; (ii) 

quantitative data on the stability of genetic 

traits that contribute to the containment of 

the system; (iii) data on the survival of the 

host-vector system under non-permissive 

laboratory conditions designed to represent 

the relevant natural environment; (iv) data on 

transmissibility of the vector and/or a cloned 

DNA fragment under both permissive and 

non-permissive conditions; (v) data on all 

other properties of the system which affect 

containment and utility, including 

information on yields of phage or plasmid 

molecules, ease of DNA isolation, and ease of 

transfection or transformation; and (vi) in 

some cases, the investigator may be asked to 

submit data on survival and vector 

transmissibility from experiments in which 

the host-vector is fed to laboratory animals or 

one or more human subjects. Such in vivo 

data may be required to confirm the validity 

of predicting in vivo survival on the basis of 

in vitro experiments. Data shall be submitted 

to the Office of Science Policy, National 

Institutes of Health, preferably by email to: 

NIHGuidelines@od.nih.gov; additional 

contact information is also available here and 

on the OSP website (www.osp.od.nih.gov). 

Investigators are encouraged to publish their 

data on the construction, properties, and 

testing of proposed Host Vector 2 systems 

prior to consideration of the system by NIH. 

Specific instructions concerning the 

submission of data for proposed Escherichia 

coli K–12 Host-Vector 2 system (EK2) 

involving either plasmids or bacteriophage in 

Escherichia coli K–12, are available from the 

Office of Science Policy, National Institutes 

of Health, preferably by submitting a request 

for this information to: NIHGuidelines@

od.nih.gov; additional contact information is 

also available here and on the OSP website 

(www.osp.od.nih.gov). 

Appendix L, GENE THERAPY 

POLICY CONFERENCES (GTPCS), is 

proposed to be deleted in its entirety. 

Appendix M, Points to Consider in 

the Design and Submission of Protocols 

for the Transfer of Recombinant or 

Synthetic Nucleic Acid Molecules into 

One or More Human Research 

Participants (Points to Consider), is 

proposed to be deleted in its entirety. 

Dated: August 7, 2018. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2018–17760 Filed 8–16–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; PAR–17– 

144: Limited Competition: National Primate 

Research Centers (P51). 

Date: September 11–14, 2018. 

Time: 8:00 a.m. to 12:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Vintage Portland, 422 SW 

Broadway, Portland, OR 97205. 

Contact Person: Brian H. Scott, Ph.D., 

Scientific Review Officer, National Institutes 

of Health, Center for Scientific Review, 6701 

Rockledge Drive, Bethesda, MD 20892, 301– 

827–7490, brianscott@mail.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group; Pathophysiological Basis of Mental 

Disorders and Addictions Study Section. 

Date: September 13–14, 2018. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Orlando at SeaWorld, 

6677 Sea Harbor Drive, Orlando, FL 32821. 

Contact Person: Boris P. Sokolov, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217A, 

MSC 7846, Bethesda, MD 20892, 301–408– 

9115, bsokolov@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: August 13, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–17785 Filed 8–16–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Draft Report on Carcinogens 

Monograph on Night Shift Work and 

Light at Night; Availability of 

Document; Request for Comments; 

Notice of Peer-Review Meeting 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Toxicology 

Program (NTP) announces a meeting to 

peer review the Draft Report on 

Carcinogens Monograph on Night Shift 

Work and Light at Night. NTP has 

conducted a literature-based assessment 

to determine whether night shift work 

(e.g., working at least three hours 

between 12 a.m. and 6 a.m.) and light 

at night are cancer hazards and should 


amozie on DSK3GDR082PROD with NOTICES1
41094 Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 

be listed the Report on Carcinogens. The 

peer-review meeting will be held at the 

National Institute of Environmental 

Health Sciences (NIEHS) in Research 

Triangle Park, NC and is open to the 

public. Registration is requested for 

attendance at the meeting either inperson or by webcast and to present oral 

comments. Information about the 

meeting and registration is available at 

https://ntp.niehs.nih.gov/go/36051. 

DATES:

Meeting: Scheduled for October 5, 

2018, 8:30 a.m. to adjournment at 

approximately 5:00 p.m. Eastern 

Daylight Time (EDT). The preliminary 

agenda is available at https://

ntp.niehs.nih.gov/go/36051 and will be 

updated one week before the meeting. 

Document Availability: The draft RoC 

monograph should be available by 

August 24, 2018, at https://

ntp.niehs.nih.gov/go/36051. 

Written Public Comment 

Submissions: Deadline is September 21, 

2018. 

Registration for Oral Comments: 

Deadline is September 21, 2018. 

Registration To Attend Meeting InPerson or To View Webcast: Deadline is 

October 5, 2018. 

ADDRESSES:

Meeting Location: Rodbell 

Auditorium, Rall Building, NIEHS, 111 

T.W. Alexander Drive, Research 

Triangle Park, NC 27709. 

Meeting Web Page: The draft RoC 

monograph, preliminary agenda, 

registration, and other meeting materials 

will be available at https://

ntp.niehs.nih.gov/go/36051. 

Webcast: The URL for viewing the 

peer-review meeting webcast will be 

provided to registrants. 

FOR FURTHER INFORMATION CONTACT: Kate 

Helmick, ICF, 2635 Meridian Parkway, 

Suite 200, Durham, NC, USA 27713. 

Phone: (919) 293–1673, Fax: (919) 293– 

1645, Email: NTP-Meetings@icf.com. 

SUPPLEMENTARY INFORMATION: 

Background: The invention of electric 

light transformed society, from one in 

which people’s activities and sleep 

patterns were limited by the natural 

light: Dark cycle to a culture in which 

people now work, sleep, eat, and receive 

goods or services throughout the 24- 

hour day. Through lifestyle choices, 

home location, and work schedule, 

people are exposed to different patterns 

and types of light, including electric 

light at night (LAN), which may lead to 

cancer and other adverse health effects. 

These health effects may arise from 

misalignment of daily physiological and 

behavioral cycles (i.e., circadian 

rhythms) with external stimuli or with 

each other (i.e., circadian disruption). 

Circadian rhythms can include 

processes and behaviors like sleep-wake 

cycles, eating, and body temperature, 

among others. 

NTP has conducted a literature-based 

assessment and applied the Report on 

Carcinogens (RoC) listing criteria to this 

assessment to determine whether night 

shift work (e.g., working at least three 

hours between midnight and 6 a.m.) and 

light at night are cancer hazards. As 

circadian disruption is thought to be a 

key intermediate step, NTP has also 

reviewed the literature on this topic. 

The monograph assesses the evidence 

from cancer studies in humans and 

experimental animals and mechanistic 

data and provides NTP’s preliminary 

recommendation regarding whether 

night shift work and or light at night 

should be listed in the Report on 

Carcinogens, and if so, how the two 

exposure scenarios should be defined. 

The listing categories include known or 

reasonably anticipated to be a human 

carcinogen. 

Meeting Attendance Registration: The 

meeting is open to the public with time 

set aside for oral public comment; inperson attendance at the NIEHS is 

limited by the space available (∼100 

attendees). Registration for in-person 

attendance is on a first-come, firstserved basis. After the first 100 

registrants, persons will be placed on a 

wait list and notified should an opening 

become available. Registration to attend 

the meeting in-person or view the 

webcast is by October 5, 2018, at https:// 

ntp.niehs.nih.gov/go/36051. The URL 

for the webcast will be provided in the 

email confirming registration. Visitor 

and security information for those 

attending in person is available at 

https://www.niehs.nih.gov/about/ 

visiting/index.cfm. Individuals with 

disabilities who need accommodation to 

view the webcast should contact Kate 

Helmick by phone: (919) 293–1673 or 

email: NTP-Meetings@icf.com. TTY 

users should contact the Federal TTY 

Relay Service at (800) 877–8339. 

Requests should be made at least five 

business days in advance of the event. 

Public Comment Registration: NTP 

invites written and oral public 

comments on the draft RoC monograph 

that address scientific/technical issues. 

Guidelines for public comments are 

available at https://ntp.niehs.nih.gov/ 

ntp/about_ntp/guidelines_public_

comments_508.pdf. 

The deadline for submission of 

written comments is September 21, 

2018. Written public comments should 

be submitted through the meeting 

website. Persons submitting written 

comments should include name, 

affiliation, mailing address, phone, 

email, and sponsoring organization (if 

any). Written comments received in 

response to this notice will be posted on 

the NTP website and the submitter will 

be identified by name, affiliation, and 

sponsoring organization (if any). 

Comments that address scientific/ 

technical issues will be forwarded to the 

peer-review panel and NTP staff prior to 

the meeting. 

The agenda allows for one oral public 

comment period (up to 12 commenters, 

up to 5 min per speaker). Registration to 

provide oral comments is September 21, 

2018, at https://ntp.niehs.nih.gov/go/ 

36051. Registration is on a first-come, 

first-served basis. Each organization is 

allowed one time slot. Oral comments 

may be presented in person at NIEHS or 

by teleconference line. The access 

number for the teleconference line will 

be provided to registrants by email prior 

to the meeting. Commenters will be 

notified after September 21, 2018, the 

deadline to register for oral public 

comments, about the actual time 

allotted per speaker. 

If possible, oral public commenters 

should send a copy of their slides and/ 

or statement or talking points to Kate 

Helmick by email: NTP-Meetings@

icf.com by September 21, 2018. 

Meeting Materials: The draft RoC 

monograph and preliminary agenda will 

be available on the NTP website at 

https://ntp.niehs.nih.gov/go/36051. The 

draft RoC monograph should be 

available by August 24, 2018. 

Additional information will be posted 

when available or may be requested in 

hardcopy, contact Kate Helmick by 

phone: (919) 293–1673 or email: NTPMeetings@icf.com. The preliminary 

meeting agenda will be available on the 

meeting web page and will be updated 

one week before the meeting. 

Individuals are encouraged to access the 

meeting web page to stay abreast of the 

most current information regarding the 

meeting. 

Following the meeting, a report of the 

peer review will be prepared and made 

available on the NTP website. 

Background Information on the RoC: 

Published biennially, each edition of the 

RoC is cumulative and consists of 

substances newly reviewed in addition 

to those listed in previous editions. For 

each listed substance, the RoC contains 

a substance profile, which provides 

information on cancer studies that 

support the listing—including those in 

humans and animals and studies on 

possible mechanisms of action, 

information about potential sources of 

exposure to humans, and current 

Federal regulations to limit exposures. 

The 14th RoC, the latest edition, was 

published on November 3, 2016 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Notices 41095 

1ANSI/CAN/UL 12402–5, Standard for Personal 

Flotation Devices—Part 5: Buoyancy Aids (Level 

50)—Safety Requirements (UL 12402–5), and ANSI/ 

CAN/UL 12402–9, Standard for Personal Flotation 

Devices—Part 9: Test Methods (UL12402–9). 

(available at https://ntp.niehs.nih.gov/ 

go/roc14). 

Background Information on NTP PeerReview Panels: NTP panels are 

technical, scientific advisory bodies 

established on an ‘‘as needed’’ basis to 

provide independent scientific peer 

review and advise NTP on agents of 

public health concern, new/revised 

toxicological test methods, or other 

issues. These panels help ensure 

transparent, unbiased, and scientifically 

rigorous input to the program for its use 

in making credible decisions about 

human hazard, setting research and 

testing priorities, and providing 

information to regulatory agencies about 

alternative methods for toxicity 

screening. NTP welcomes nominations 

of scientific experts for upcoming 

panels. Scientists interested in serving 

on an NTP panel should provide their 

current curriculum vitae to Kate 

Helmick by email: NTP-Meetings@

icf.com. The authority for NTP panels is 

provided by 42 U.S.C. 217a; section 222 

of the Public Health Service Act, as 

amended. The panel is governed by the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), which 

sets forth standards for the formation 

and use of advisory committees. 

Dated: August 8, 2018. 

Brian R. Berridge, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2018–17782 Filed 8–16–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2018–0565] 

Lifejacket Approval Harmonization 

AGENCY: Coast Guard, DHS. 

ACTION: Notice and request for 

comments. 

SUMMARY: The Coast Guard announces 

that it is harmonizing personal flotation 

device (PFD) standards between the 

United States and Canada by accepting 

a new standard for approval of PFDs. 

Specific elements of the new standard 

are contained in a policy letter and 

deregulatory savings analysis, on which 

we are requesting public comment, and 

are intended to promote the Coast 

Guard’s maritime safety and 

stewardship missions. 

DATES: Comments must be submitted to 

the online docket via http:// 

www.regulations.gov, or reach the 

Docket Management Facility, on or 

before October 16, 2018. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2018–0565 using the Federal 

eRulemaking Portal at http://

www.regulations.gov. See the ‘‘Public 

Participation and Comments’’ portion of 

the SUPPLEMENTARY INFORMATION section 

for further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: For 

information about this document call or 

email Jacqueline Yurkovich, Coast 

Guard; telephone 202–372–1389, email 

Jacqueline.M.Yurkovich@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Comments 

We encourage you to submit 

comments on the lifejacket approval 

harmonization policy letter entitled, 

ADOPTION OF ANSI/CAN/UL 12402–5 

AND –9, and the deregulatory savings 

analysis entitled, ‘‘Approval for 

Personal Floatation Devices/Adoption of 

ANSI/CAN/UL 12402–5 and 9,’’ which 

are available in the docket. The policy 

letter is also available on the USCG 

website, https://www.dco.uscg.mil/CGENG, listed as CG–ENG Policy 02–18. 

We will consider all submissions and 

may adjust our final action based on 

your comments. If you submit a 

comment, please include the docket 

number for this notice, indicate the 

specific section of the document to 

which each comment applies, and 

provide a reason for each suggestion or 

recommendation. 

We encourage you to submit 

comments through the Federal 

eRulemaking Portal at http://

www.regulations.gov. If your material 

cannot be submitted using http://

www.regulations.gov, contact the person 

in the FOR FURTHER INFORMATION

CONTACT section of this document for 

alternate instructions. Documents 

mentioned in this notice, and all public 

comments, are in our online docket at 

http://www.regulations.gov and can be 

viewed by following that website’s 

instructions. Additionally, if you go to 

the online docket and sign up for email 

alerts, you will be notified when 

comments or other documents are 

posted. 

We accept anonymous comments. All 

comments received will be posted 

without change to http://

www.regulations.gov and will include 

any personal information you have 

provided. For more about privacy and 

the docket, you may review a Privacy 

Act notice regarding the Federal Docket 

Management System in the March 24, 

2005, issue of the Federal Register (70 

FR 15086). 

Discussion 

The United States Coast Guard 

(USCG) has statutory authority under 

Title 46, U.S. Code, Sections 3306(a) 

and (b), 4102(a) and (b), 4302(a), and 

4502(a) and (c)(2)(B) to prescribe 

regulations for the design, construction, 

performance, testing, carriage, use, and 

inspection of lifesaving equipment on 

commercial and recreational vessels. 

Since 2008, the USCG has been working 

closely with Transport Canada (TC) and 

a diverse group of U.S. and Canadian 

stakeholders to harmonize PFD 

standards with the current international 

standard (ISO 12402) to create a single 

North American standard for PFD 

approval. A single North American 

standard will allow manufacturers the 

opportunity to produce more innovative 

equipment that meets the approval 

requirements of both the United States 

and Canada. 

In 2015, Underwriters Laboratories 

Inc. published bi-national standards 1 to 

set forth performance requirements and 

manufacturing standards for PFDs that 

are being used when vessels are close to 

shore, or where a rescue may be 

imminent. UL 12402–5 sets forth the 

performance requirements for PFDs and, 

within UL 12402–5, there are two levels 

of performance: Level 50 and Level 70. 

A Level 70 PFD provides an equivalent 

level of safety to a Type III PFD 

currently approved under 46 CFR 

160.064, 160.076, or 160.077–15, and 

certified to UL 1123 (Marine Buoyant 

Devices). A Level 50 PFD provides a 

reduced level of performance, and is not 

included in this policy. UL 12402–9 sets 

forth the test methods for determining 

compliance with UL 12402–5. 

In April 2017, the USCG and TC 

signed a Memorandum of 

Understanding (MOU) outlining 

intended cooperation for approval of 

personal lifesaving appliances that 

comply with mutually acceptable 

standards, are tested by mutually 

accepted conformity assessment bodies 

or independent test laboratories, and are 

covered by a mutually acceptable 

follow-up program. In January 2018, TC 

published a policy stating it will accept 

UL 12402–5 as a substitute for its PFD 

standards in support of the MOU. The 

policy letter on which we are requesting 

comment builds on the efforts described 

above by establishing that the USCG 

will accept Level 70 PFDs complying 


amozie on DSK3GDR082PROD with NOTICES1