81 FR 62513 - Nominations to the National Toxicology Program for the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 175 (September 9, 2016)

Page Range		62513-62514
FR Document		2016-21698

The National Toxicology Program (NTP) requests information on four nominations. Four substances are being considered for possible review for future editions of the Report on Carcinogens (RoC). Three of these four substances are also being considered for evaluation of non- cancer health outcomes by the Office of Health Assessment and Translation (OHAT).

Federal Register, Volume 81 Issue 175 (Friday, September 9, 2016)

[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62513-62514]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21698]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Nominations to the National Toxicology Program for the Report on 
Carcinogens and Office of Health Assessment and Translation; Request 
for Information

SUMMARY: The National Toxicology Program (NTP) requests information on 
four nominations. Four substances are being considered for possible 
review for future editions of the Report on Carcinogens (RoC). Three of 
these four substances are also being considered for evaluation of non-
cancer health outcomes by the Office of Health Assessment and 
Translation (OHAT).

DATES: Receipt of information: Deadline is October 11, 2016.

ADDRESSES: Information on substances for possible review should be 
submitted electronically at http://ntp.niehs.nih.gov/go/778417.

FOR FURTHER INFORMATION CONTACT: 
    RoC Nominations: Dr. Ruth Lunn, Director, Office of RoC; telephone 
(919) 316-4637; [email protected]. OHAT Nominations: Dr. Windy Boyd, 
OHAT, telephone (919) 541-9810; [email protected]. Address for Dr. 
Lunn and Dr. Boyd: Division of NTP, National

[[Page 62514]]

Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, 
P.O. Box 12233, Research Triangle Park, NC 27709.

SUPPLEMENTARY INFORMATION: 
    Request for Information: NTP requests information on four 
substances that have been nominated for possible review for future 
editions of the RoC (see http://ntp.niehs.nih.gov/go/rocnom); three of 
these four substances are also under consideration for evaluation of 
non-cancer health outcomes (see http://ntp.niehs.nih.gov/go/763346). 
The four nominations are:
     Consumption of red meat: cancer and non-cancer health 
hazard evaluations.
     Consumption of processed meat: cancer and non-cancer 
health hazard evaluations.
     Consumption of meat cooked at high temperatures: cancer 
and non-cancer health hazard evaluations.
     Antimony trioxide: cancer hazard evaluation.
    Cancer hazard evaluation of a substance for the RoC may seek to 
list a new substance in the report, reclassify the listing status of a 
substance already listed, or remove a listed substance.
    Specifically, NTP requests information on: (1) Current production, 
use patterns, and human exposure estimates for antimony trioxide; (2) 
data on dietary intake estimates of red meat, processed meat, or meat 
cooked at high temperatures; and for all four nominations (3) recently 
published, ongoing, or planned studies related to evaluating adverse 
health outcomes (e.g., cancer, development, reproductive, or 
immunological disorders); (4) scientific issues important for 
prioritizing and assessing adverse health outcomes; and (5) names of 
scientists with expertise or knowledge on any of these substances--
please indicate the substance and include any bibliographic citations 
when available. NTP will use this information in determining which 
substances to propose for formal health hazard evaluations.
    Information on substances for possible review should be submitted 
electronically at http://ntp.niehs.nih.gov/go/778417 or emailed to Dr. 
Lunn or Dr. Boyd (see FOR FURTHER INFORMATION CONTACT). Contact 
information for comments should include the submitter's name, 
affiliation, sponsoring organization (if any), telephone, and email. 
Written information received in response to this notice will be posted 
on the NTP Web site, and the submitter identified by name, affiliation, 
and/or sponsoring organization. Guidelines for public comments are at 
http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf.
    Responses to this request for information are voluntary. This 
request for information is for planning purposes only and is not a 
solicitation for applications or an obligation on the part of the 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 information submitted or for its use. No 
proprietary, classified, confidential, or sensitive information should 
be included in your response.
    Background Information on ORoC: On behalf of NTP, ORoC prepares the 
RoC following an established, four-part process (http://ntp.niehs.nih.gov/go/rocprocess). The RoC is a congressionally 
mandated, science-based, public health report that identifies agents, 
substances, mixtures, or exposures (collectively called ``substances'') 
in our environment that pose a cancer hazard for people in the United 
States. Published biennially, each edition of the RoC is cumulative and 
consists of substances newly reviewed in addition to those listed in 
previous editions. Newly reviewed substances with their recommended 
listing are reviewed and approved by the Secretary of Health and Human 
Services. The 13th RoC, the latest edition, was published on October 2, 
2014 (available at http://ntp.niehs.nih.gov/go/roc13). The 14th RoC is 
under development.
    Background Information on OHAT: On behalf of NTP, OHAT conducts 
literature-based evaluations to assess the evidence whether 
environmental chemicals, physical substances, or mixtures (collectively 
called ``substances'') cause adverse non-cancer health outcomes. As 
part of these evaluations, NTP may also provide opinions on whether 
these substances might be of concern for causing adverse effects on 
human health given what is known about toxicity and current human 
exposure levels. Information about OHAT can be found at http://ntp.niehs.nih.gov/go/ohat.

    Dated: September 6, 2016.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2016-21698 Filed 9-8-16; 8:45 am]
BILLING CODE 4140-01-P

62514 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices

Institute of Environmental Health organization. Guidelines for public DEPARTMENT OF HEALTH AND
Sciences, 111 T.W. Alexander Drive, comments are at http:// HUMAN SERVICES
P.O. Box 12233, Research Triangle Park, ntp.niehs.nih.gov/ntp/about_ntp/
NC 27709. guidelines_public_comments_508.pdf. National Institutes of Health
SUPPLEMENTARY INFORMATION: Responses to this request for Government-Owned Inventions;
Request for Information: NTP requests information are voluntary. This request Availability for Licensing
information on four substances that for information is for planning purposes
have been nominated for possible only and is not a solicitation for AGENCY: National Institutes of Health,
review for future editions of the RoC applications or an obligation on the part HHS.
(see http://ntp.niehs.nih.gov/go/ of the U.S. Government to provide ACTION: Notice.
rocnom); three of these four substances
support for any ideas identified in SUMMARY: The inventions listed below
are also under consideration for
response to it. Please note that the U.S. are owned by an agency of the U.S.
evaluation of non-cancer health
outcomes (see http://ntp.niehs.nih.gov/ Government will not pay for the Government and are available for
go/763346). The four nominations are: preparation of any information licensing in the U.S. in accordance with
• Consumption of red meat: cancer submitted or for its use. No proprietary, 35 U.S.C. 209 and 37 CFR part 404 to
and non-cancer health hazard classified, confidential, or sensitive achieve expeditious commercialization
evaluations. information should be included in your of results of federally-funded research
• Consumption of processed meat: response. and development.
cancer and non-cancer health hazard Background Information on ORoC: On FOR FURTHER INFORMATION CONTACT:
evaluations. behalf of NTP, ORoC prepares the RoC Licensing information may be obtained
• Consumption of meat cooked at following an established, four-part by emailing the indicated licensing
high temperatures: cancer and non- process (http://ntp.niehs.nih.gov/go/ contact at the National Heart, Lung, and
cancer health hazard evaluations. rocprocess). The RoC is a Blood, Office of Technology Transfer
• Antimony trioxide: cancer hazard congressionally mandated, science- and Development Office of Technology
evaluation. based, public health report that Transfer, 31 Center Drive, Room 4A29,
Cancer hazard evaluation of a identifies agents, substances, mixtures, MSC2479, Bethesda, MD 20892–2479;
substance for the RoC may seek to list or exposures (collectively called telephone: 301–402–5579. A signed
a new substance in the report, reclassify ‘‘substances’’) in our environment that Confidential Disclosure Agreement may
the listing status of a substance already be required to receive any unpublished
pose a cancer hazard for people in the
listed, or remove a listed substance. information.
United States. Published biennially,
Specifically, NTP requests SUPPLEMENTARY INFORMATION:
information on: (1) Current production, each edition of the RoC is cumulative
and consists of substances newly Technology description follows.
use patterns, and human exposure
estimates for antimony trioxide; (2) data reviewed in addition to those listed in Reagent for Mapping Genome-Wide
on dietary intake estimates of red meat, previous editions. Newly reviewed Enhancer-Promoter Interactions
processed meat, or meat cooked at high substances with their recommended This invention is a research reagent
temperatures; and for all four listing are reviewed and approved by named the ‘‘bivalent Tn5 complex’’
nominations (3) recently published, the Secretary of Health and Human used in transposition-mediated analysis
ongoing, or planned studies related to Services. The 13th RoC, the latest of chromatin looping (TrAC-looping) to
evaluating adverse health outcomes edition, was published on October 2, determine genome-wide enhancer-
(e.g., cancer, development, 2014 (available at http:// promoter interactions during studies of
reproductive, or immunological ntp.niehs.nih.gov/go/roc13). The 14th 4D nucleomes in normal development
disorders); (4) scientific issues RoC is under development. and disease conditions. Enhancer-
important for prioritizing and assessing Background Information on OHAT: promoter interactions are key in
adverse health outcomes; and (5) names On behalf of NTP, OHAT conducts temporospatial control of gene
of scientists with expertise or literature-based evaluations to assess the expression during normal development
knowledge on any of these substances— evidence whether environmental and pathological conditions. Currently
please indicate the substance and available methods of analyzing genome-
chemicals, physical substances, or
include any bibliographic citations wide enhancer-promoter interactions
mixtures (collectively called
when available. NTP will use this are insufficient in achieving necessary
information in determining which ‘‘substances’’) cause adverse non-cancer
resolution, give rise to false positive
substances to propose for formal health health outcomes. As part of these
artifacts due to in vitro ligation steps, or
hazard evaluations. evaluations, NTP may also provide
too expensive due to the necessity of
Information on substances for opinions on whether these substances sequencing over a billion reads. The
possible review should be submitted might be of concern for causing adverse instant reagent and associated TrAC-
electronically at http:// effects on human health given what is looping technique effectively reduce
ntp.niehs.nih.gov/go/778417 or emailed known about toxicity and current false positive detection and achieve a 10
to Dr. Lunn or Dr. Boyd (see FOR human exposure levels. Information to 100-times higher resolution at lower
FURTHER INFORMATION CONTACT). Contact about OHAT can be found at http://
asabaliauskas on DSK3SPTVN1PROD with NOTICES

cost for mapping genome-wide
information for comments should ntp.niehs.nih.gov/go/ohat. interactions between enhancers and
include the submitter’s name, Dated: September 6, 2016. promotes essential for the control of
affiliation, sponsoring organization (if gene expression in normal development
John R. Bucher,
any), telephone, and email. Written and pathological conditions.
information received in response to this Associate Director, National Toxicology
notice will be posted on the NTP Web Program. References
site, and the submitter identified by [FR Doc. 2016–21698 Filed 9–8–16; 8:45 am] —Lieberman-Aiden E et al., Science
name, affiliation, and/or sponsoring BILLING CODE 4140–01–P 2009 Oct 9;326(5950):289–93.

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Document Created: 2018-02-09 13:15:10
Document Modified: 2018-02-09 13:15:10

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		Receipt of information: Deadline is October 11, 2016.
Contact		RoC Nominations: Dr. Ruth Lunn, Director, Office of RoC; telephone (919) 316-4637; [email protected] OHAT Nominations: Dr. Windy Boyd,
FR Citation		81 FR 62513

81 FR 62513 - Nominations to the National Toxicology Program for the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 81, Issue 175 (September 9, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health