83 FR 7488 - Draft NTP Research Report on the CLARITY-BPA Core Study; Availability of Document; Request for Comments; Notice of Peer-Review Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 35 (February 21, 2018)

The National Toxicology Program (NTP) announces a meeting to peer review the Draft NTP Research Report on the CLARITY-BPA Core Study. This report presents the results of the core, guideline- compliant, chronic, extended-dose-range study of bisphenol A (BPA) in rats conducted as part of the CLARITY-BPA Research Program. The U.S. Food and Drug Administration's National Center for Toxicological Research (NCTR) conducted the study under the auspices of the National Toxicology Program and prepared the draft report in collaboration with the National Institute of Environmental Health Sciences (NIEHS). The peer-review meeting will be held at NIEHS in Research Triangle Park, NC and is open to the public. Registration is requested for attendance at the meeting either in-person or by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/rrprp.

[Federal Register Volume 83, Number 35 (Wednesday, February 21, 2018)]
[Notices]
[Pages 7488-7490]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft NTP Research Report on the CLARITY-BPA Core Study; 
Availability of Document; Request for Comments; Notice of Peer-Review 
Meeting

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Toxicology Program (NTP) announces a meeting to 
peer review the Draft NTP Research Report on the CLARITY-BPA Core 
Study. This report presents the results of the core, guideline-
compliant, chronic, extended-dose-range study of bisphenol A (BPA) in 
rats conducted as part of the CLARITY-BPA Research Program. The U.S. 
Food and Drug Administration's National Center for Toxicological 
Research (NCTR) conducted the study under the auspices of the National 
Toxicology Program and prepared the draft report in collaboration with 
the National Institute of Environmental Health Sciences (NIEHS). The 
peer-review meeting will be held at NIEHS in Research Triangle Park, NC 
and is open to the public. Registration is requested for attendance at 
the meeting either in-person or by webcast and to present oral 
comments. Information about the meeting and registration is available 
at https://ntp.niehs.nih.gov/go/rrprp.

DATES: 
    Meeting: Tentatively scheduled for April 26, 2018, 8:30 a.m. to 
adjournment at approximately 5:00 p.m. Eastern Daylight Time (EDT). The 
meeting may end earlier or later than 5:00 p.m. EDT. The preliminary 
agenda of topics is available at https://ntp.niehs.nih.gov/go/rrprp and 
will be updated one week before the meeting.
    Document Availability: The draft NTP Research Report should be 
available by February 23, 2018, at https://ntp.niehs.nih.gov/go/rrprp.
    Written Public Comment Submissions: Deadline is April 12, 2018.

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    Registration for Oral Comments: Deadline is April 12, 2018.
    Registration to Attend Meeting In-person or to View Webcast: 
Deadline is April 26, 2018.

ADDRESSES: 
    Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111 
T.W. Alexander Drive, Research Triangle Park, NC 27709.
    Meeting web page: The draft NTP Research Report, preliminary 
agenda, registration, and other meeting materials will be available at 
https://ntp.niehs.nih.gov/go/rrprp.
    Webcast: The URL for viewing the peer-review meeting webcast will 
be provided to registrants.

FOR FURTHER INFORMATION CONTACT: Canden Byrd, ICF, 2635 Meridian 
Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: 
(919) 293-1645, Email: [email protected].

SUPPLEMENTARY INFORMATION: 
    Background: Bisphenol A (BPA) is a chemical produced in large 
quantities for use primarily in the production of polycarbonate 
plastics and epoxy resins. BPA also is used in the production of 
certain flame retardants and as a color developer in some thermal 
paper. BPA has been detected in air, soil, water, landfill leachate, 
and the human body. The primary source of human exposure to BPA is 
thought to be through the diet. More than 800 studies were published on 
the health effects of BPA between the mid-1990s and the mid-2000s. 
Although BPA is a well-studied chemical, few existing, chronic toxicity 
studies have included exposure during the perinatal period. There is 
also inconsistency among BPA toxicological studies with regard to 
findings and their interpretation for human health. Given the 
uncertainty regarding the potential health effects from BPA exposure, 
NTP, NIEHS, and U.S. Food and Drug Administration (FDA) established the 
consortium-based research program, called Consortium Linking Academic 
and Regulatory Insights on Toxicity of BPA (CLARITY-BPA).
    The aim of the CLARITY-BPA program was to attempt to bridge 
guideline-compliant research conducted at the FDA with hypothesis-based 
research investigations conducted by academia on the toxicity of BPA. A 
detailed description of the CLARITY-BPA program has been published 
(https://www.ncbi.nlm.nih.gov/pubmed/26232693). The CLARITY-BPA 
research program has two components: (1) A ``core,'' guideline-
compliant, chronic study conducted at NCTR according to FDA Good 
Laboratory Practice (GLP) regulations (2-year perinatal only or chronic 
BPA exposure, including perinatal), and (2) CLARITY-BPA grantee studies 
of various health endpoints, conducted by NIEHS-funded researchers at 
academic institutions using animals born to the same exposed pregnant 
rats as the core GLP study.
    The draft NTP Research Report presents the results of the core GLP 
chronic study. The interpretation of biological and toxicological 
responses described in the draft NTP Research Report is based only on 
the results of the core GLP study. Integration of these data with other 
data from the grantee-studies conducted as part of the CLARITY-BPA 
research program or extrapolation of the results to other species, 
including characterization of hazards and risks to humans, is outside 
of the scope of the draft NTP Research Report.
    Meeting Attendance Registration: The meeting is open to the public 
with time set aside for oral public comment; in-person attendance at 
NIEHS is limited by the space available (~100 attendees). Registration 
for in-person attendance is on a first-come, first-served 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 April 26, 2018, at https://ntp.niehs.nih.gov/go/rrprp. 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 Canden Byrd by phone: 
(919) 293-1660 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.
    Public Comment Registration: NTP invites written and oral public 
comments on the draft NTP Research Report. Guidelines for public 
comments are at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    The deadline for submission of written comments is April 12, 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 or 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 (12 
commenters, up to 5 minutes per speaker). Registration to provide oral 
comments is on or before April 12, 2018, at https://ntp.niehs.nih.gov/go/rrprp. 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. After the maximum number of speakers is exceeded, 
individuals registered to provide oral comment will be placed on a wait 
list (6 slots on wait list) and notified should an opening become 
available. Commenters will be notified after April 12, 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 Canden Byrd by email: [email protected] by April 12, 2018.
    Meeting Materials: The draft NTP Research Report and preliminary 
agenda will be available on the NTP website at https://ntp.niehs.nih.gov/go/rrprp. The draft NTP Research Report should be 
available by February 23, 2018. Additional information will be posted 
when available or may be requested in hardcopy; contact Canden Byrd by 
phone: (919) 293-1660 or email: [email protected]. The preliminary 
meeting agenda is 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 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 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

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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 Canden Byrd by email: [email protected]. 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: February 7, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-03472 Filed 2-20-18; 8:45 am]
 BILLING CODE 4140-01-P