[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Pages 9867-9869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04102]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft National Toxicology Program Monograph on Immunotoxicity
Associated With Exposure to Perfluorooctanoic Acid or Perfluorooctane
Sulfonate; Availability of Document; Request for Comments; Notice of
Meeting
SUMMARY: The notice announces a meeting to peer review the draft NTP
monograph on immunotoxicity associated with exposure to
perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS). The
Office of Health Assessment and Translation, Division of the National
Toxicology Program (DNTP), National Institute of Environmental Health
Sciences (NIEHS), prepared the draft NTP monograph. The peer review
meeting is open to the public. Registration is requested for both
public attendance and oral comment and required to access the webcast.
Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/36639.
DATES: Meeting: July 19, 2016, 9:00 a.m. to approximately 2:00 p.m.
Eastern Daylight Time (EDT).
Document Availability: The draft NTP monograph should be available
by June
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7, 2016, at http://ntp.niehs.nih.gov/go/36639.
Written Public Comment Submission: Deadline is July 5, 2016.
Registration for Oral Comments: Deadline is July 12, 2016.
Registration for Meeting and/or to View Webcast: Deadline is July
19, 2016. Registration to view the meeting via the webcast is required.
ADDRESSES: Meeting Location: Rodbell Auditorium, Rall Building, NIEHS,
111 T.W. Alexander Drive, Research Triangle Park, NC 27709.
Meeting Web page: The draft NTP monograph, preliminary agenda,
registration, and other meeting materials will be available at http://ntp.niehs.nih.gov/go/36639.
Webcast: The URL for viewing webcast will be provided to those who
register.
FOR FURTHER INFORMATION CONTACT: Dr. Yun Xie, NTP Designated Federal
Official, Office of Liaison, Policy, and Review, DNTP, NIEHS, P.O. Box
12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541-
3436, Fax: (301) 451-5455, Email: [email protected]. Hand Delivery/
Courier: 530 Davis Drive, Room 2161, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background on PFOA and PFOS: PFOA and PFOS are persistent chemicals
that are widely distributed in the environment, in part because of high
stability and little to no expected degradation in the environment.
PFOA and PFOS have been used extensively over the last 50 years in
commercial and industrial applications, including food packaging,
lubricants, water-resistant coatings, and fire-retarding foams. Through
voluntary agreements, the primary manufacturer of PFOS phased out
production in 2002, and PFOS is no longer manufactured in the United
States. Similar arrangements have been made for PFOA, and eight
companies that manufacture PFOA committed to eliminate emissions and
product content by 2015. Although emissions have been dramatically
reduced, the persistence and bioaccumulation of both PFOA and PFOS
result in detectable levels in the U.S. population and, therefore,
these chemicals are of potential human health relevance. Several recent
publications from 2012-2014 have linked PFOA and PFOS exposure to
functional immune changes in humans, which are consistent with evidence
of PFOA- and PFOS-related immunotoxicity in animal studies.
NTP has conducted a systematic review of the evidence for an
association between exposure to PFOA or PFOS and immunotoxicity or
immune-related health effects. The NTP evaluation concept for
immunotoxicity associated with exposure to PFOA or PFOS was presented
and discussed at the NTP Board of Scientific Counselors (BSC) meeting
on December 10, 2014 (79 FR 62640). The NTP evaluation concept, related
presentation, and BSC meeting minutes are available at http://ntp.niehs.nih.gov/go/9741. The protocol for conducting this systematic
review is available at http://ntp.niehs.nih.gov/go/749926.
Meeting and Registration: The meeting is open to the public with
time set aside for oral public comment. Please note that this will be
both an in-person and web-based meeting. The chair of the peer review
panel and NTP staff will be at the meeting location at NIEHS. The peer
review panel members will be attending the meeting via web-based video
conferencing. Public attendees are welcome to watch the meeting via
webcast or attend in person. Attendance at NIEHS is limited only by the
space available.
Registration to attend the meeting in-person or to view the webcast
is by July 19, 2016, at http://ntp.niehs.nih.gov/go/36639. Registration
is required to view the webcast; 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 http://www.niehs.nih.gov/about/visiting/index.cfm. Individuals with
disabilities who need accommodation to participate in this event should
contact Dr. Yun Xie at phone: (919) 541-3436 or email: [email protected].
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.
The preliminary agenda and draft NTP monograph should be posted on
the NTP Web site (http://ntp.niehs.nih.gov/go/36639) by June 7, 2016.
Additional information will be posted when available or may be
requested in hardcopy, see FOR FURTHER INFORMATION CONTACT. Following
the meeting, a report of the peer review will be prepared and made
available on the NTP Web site. Individuals are encouraged to access the
meeting Web page to stay abreast of the most current information
regarding the meeting.
Request for Comments: The NTP invites written and oral public
comments on the draft NTP monograph. The deadline for submission of
written comments is July 5, 2016, to enable review by the peer review
panel and NTP staff prior to the meeting. Registration to provide oral
comments is by July 12, 2016, at http://ntp.niehs.nih.gov/go/36639.
Public comments and any other correspondence on the draft NTP monograph
should be sent to the FOR FURTHER INFORMATION CONTACT. Persons
submitting written comments should include their name, affiliation,
mailing address, phone, email, and sponsoring organization (if any)
with the document. Written comments received in response to this notice
will be posted on the NTP Web site according to NTP's guidelines for
public comments (http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf), and the submitter will be
identified by name, affiliation, and/or sponsoring organization if
applicable.
Public comment at this meeting is welcome, with time set aside for
the presentation of oral comments on the draft NTP monograph. Guidance
for oral public comments is available at http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf. In addition to in-person
oral comments at NIEHS, public comments can be presented by
teleconference line. There will be 50 lines for this call; availability
is on a first-come, first-served basis. The lines will be open from
9:00 a.m. until approximately 2:00 p.m. EDT on July 19, 2016, although
oral comments will be received only during the formal public comment
periods indicated on the preliminary agenda. The access number for the
teleconference line will be provided to registrants by email prior to
the meeting. Each organization is allowed one time slot. At least 7
minutes will be allotted to each time slot, and if time permits, may be
extended to 10 minutes at the discretion of the chair.
Persons wishing to make an oral presentation are asked to register
online at http://ntp.niehs.nih.gov/go/36639 by July 12, 2016, and
indicate whether they will present comments in-person or via the
teleconference line. If possible, oral public commenters should send a
copy of their slides and/or statement or talking points at that time.
Written statements can supplement and may expand the oral presentation.
Registration for in-person oral comments will also be available at the
meeting, although time allowed for presentation by on-site registrants
may be less than that for registered speakers and will be determined by
the number of speakers who register on-site.
Background Information on OHAT: OHAT was established to serve as an
environmental health resource to the public and regulatory and health
agencies (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3094430). This
office conducts evaluations to assess the
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evidence that environmental chemicals, physical substances, or mixtures
(collectively referred to as ``substances'') cause adverse health
effects and provides opinions on whether these substances may be of
concern given what is known about current human exposure levels. OHAT
also organizes workshops or state-of-the-science evaluations to address
issues of importance in environmental health sciences. Information
about OHAT is found at http://ntp.niehs.nih.gov/go/ohat.
Background Information on NTP Peer Review Panels: NTP panels are
technical, scientific advisory bodies established on an ``as needed''
basis to provide independent scientific peer review and advise the 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. The NTP welcomes
nominations of scientific experts for upcoming panels. Scientists
interested in serving on an NTP panel should provide current curriculum
vitae to the FOR FURTHER INFORMATION CONTACT. The authority for NTP
panels is provided by 42 U.S.C. 217a; section 222 of the Public Health
Service (PHS) 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: February 22, 2016.
John R. Bucher,
Associate Director, NTP.
[FR Doc. 2016-04102 Filed 2-25-16; 8:45 am]
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