[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22088-22089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10075]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Report on Carcinogens Monograph on Helicobacter pylori: 
Chronic Infection; Availability of Document; Request for Comments

AGENCY: National Institutes of Health, HHS

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Toxicology Program (NTP) announces the 
availability of the Draft Report on Carcinogens (RoC) Monograph on 
Helicobacter pylori: Chronic Infection

[[Page 22089]]

for public comment. The Office of the Report on Carcinogens (ORoC), 
Division of the National Toxicology Program (DNTP), National Institute 
of Environmental Health Sciences (NIEHS) prepared the monograph.

DATES: 
    Document Availability: The draft monograph should be available by 
May 11, 2018, at https://ntp.niehs.nih.gov/go/845046.
    Written Public Comments Submission: Deadline is June 1, 2018.

ADDRESSES: Written public comments should be submitted electronically 
at https://ntp.niehs.nih.gov/go/845046.

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

SUPPLEMENTARY INFORMATION: 
    Background: 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. NTP prepares the 
RoC on behalf of the Secretary of Health and Human Services.
    NTP follows a four-part process using established listing criteria 
to evaluate substances for possible listing in the RoC and prepare the 
report (https://ntp.niehs.nih.gov/go/rocprocess). For each substance 
selected for review, a draft RoC monograph is prepared that presents 
(1) information on human exposure to the substance; (2) an assessment 
of the evidence from cancer studies in humans and experimental animals, 
mechanisms of carcinogenicity, and other data relevant for evaluating 
the substance's potential carcinogenicity; and (3) NTP's preliminary 
RoC listing recommendation. This information is presented in the 
substance profile in the Helicobacter pylori (H. pylori) monograph. The 
monograph also includes a summary of strategies to prevent H. pylori-
associated cancers.
    H. pylori was selected for review following solicitation of public 
comment, review by the NTP Board of Scientific Counselors on April 11, 
2016, and approval by the NTP Director (https://ntp.niehs.nih.gov/go/9741). Information on the NTP review of H. pylori is available at 
https://ntp.niehs.nih.gov/go/791433. H. pylori is a gram-negative, 
multi-flagellated bacterium that colonizes the luminal mucosal surface 
of the body (corpus) and lower portion (antrum) of the stomach; if 
untreated, the infection usually lasts for the individual's lifetime. 
Chronic infection can cause gastritis and peptic ulcers. The bacterium 
is spread by person-to-person contact, especially among family members. 
Risk factors for H. pylori infection include age, race or ethnicity 
(minority), socioeconomic status (low family income and lower education 
level), and crowded housing.
    Request for Comments: NTP invites written public comments on the 
draft monograph. The deadline for submission of written comments is 
June 1, 2018. Written public comments should be submitted 
electronically at https://ntp.niehs.nih.gov/go/845046. Any other 
correspondence should be sent to NTP Meetings Staff by email: [email protected]. Persons submitting written comments should include 
their name, affiliation (if applicable), phone, email, and sponsoring 
organization (if any) with the document. Written comments received in 
response to this notice will be posted on the NTP website (https://ntp.niehs.nih.gov/go/845046), with the submitter identified by name, 
affiliation, and/or sponsoring organization. Following the public 
comment period, the draft monograph will undergo external peer review 
by letter. Comments that address scientific or technical issues will be 
shared with external scientists for their consideration during the peer 
review. Guidelines for public comments are at http://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_publiccomments_508.pdf.
    Background Information on RoC: Each edition of the RoC is 
cumulative and consists of substances newly reviewed in addition to 
those listed in previous editions. The Secretary of Health and Human 
Services approves new listings. 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, informational 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 (available at http://ntp.niehs.nih.gov/go/roc).

    Dated: May 2, 2018.
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-10075 Filed 5-10-18; 8:45 am]
 BILLING CODE 4140-01-P