Draft Report on Carcinogens Monograph on Helicobacter pylori: Chronic Infection; Availability of Document; Request for Comments, 22088-22089 [2018-10075]

Download as PDF 22088 Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Minority Health Office of Minority Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by June 18, 2018. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH. DATES: The conference call will be held on June 19, 2018, 1:00 p.m.–3:00 p.m. ET. SUMMARY: Instructions regarding participating in the call will be given at the time of preregistration. FOR FURTHER INFORMATION CONTACT: Dr. Minh Wendt, Designated Federal Officer, Advisory Committee on Minority Health, Office of Minority Health, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Suite 600, Rockville, Maryland 20852. Phone: 240–453–8222; fax: 240–453–8223; email OMH-ACMH@ hhs.gov. SUPPLEMENTARY INFORMATION: In accordance with Public Law 105–392, the ACMH was established to provide advice to the Deputy Assistant Secretary for Minority Health on improving the health of each racial and ethnic minority group and on the development of goals and specific program activities of the OMH. The topics to be discussed during the teleconference include finalizing recommendations regarding creating a culturally sensitive system of care related to opioid misuse, discussing recommendations on the topic of serious mental illness, and discussing sradovich on DSK3GMQ082PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 19:21 May 10, 2018 Jkt 244001 the agenda for the next meeting. The recommendations will be given to the Deputy Assistant Secretary for Minority Health. This call will be limited to 125 participants. The OMH will make every effort to accommodate persons with special needs. Individuals who have special needs for which special accommodations may be required should contact Professional and Scientific Associates at (703) 234–1700 and reference this meeting. Requests for special accommodations should be made at least ten (10) business days prior to the meeting. Members of the public will have an opportunity to provide comments at the meeting. Public comments will be limited to two minutes per speaker during the time allotted. Individuals who would like to submit written statements should email, mail, or fax their comments to the designated contact at least seven (7) business days prior to the meeting. Any members of the public who wish to have electronic or printed material distributed to ACMH members should email OMH-ACMH@hhs.gov or mail their materials to the Designated Federal Officer, ACMH, Tower Building, 1101 Wootton Parkway, Suite 600, Rockville, Maryland 20852, prior to close of business on June 14, 2018. Dated: May 4, 2018. Minh Wendt, Designated Federal Officer, Advisory Committee on Minority Health. [FR Doc. 2018–10125 Filed 5–10–18; 8:45 am] BILLING CODE 4150–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Name of Committee: NIGMS Initial Review Group; Training and Workforce Development Subcommittee—B Review of T32 Applications. Date: June 25–26, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at Chevy Chase, 4300 Military Road NW, Washington, DC 20015. Contact Person: Lisa A. Newman, SCD, Scientific Review Officer, Office of Scientific Review, National Institutes of General Medical Sciences, 45 Center Drive, RM 3AN18A, Bethesda, MD 20814, (301) 435– 0965, newmanla2@mail.nih.gov. Name of Committee: NIGMS Initial Review Group; Training and Workforce Development Subcommittee—A Review of T32 Applications. Date: July 16–17, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at Chevy Chase, 4300 Military Road NW, Washington, DC 20015. Contact Person: John J. Laffan, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, Natcher Building, Room 3AN18J, Bethesda, MD 20892, 301–594–2773, laffanjo@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: May 8, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–10078 Filed 5–10–18; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P National Institute of General Medical Sciences; 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. PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 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. The National Toxicology Program (NTP) announces the availability of the Draft Report on Carcinogens (RoC) Monograph on Helicobacter pylori: Chronic Infection SUMMARY: E:\FR\FM\11MYN1.SGM 11MYN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices 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: NTP-Meetings@icf.com. SUPPLEMENTARY INFORMATION: Background: The RoC is a congressionally mandated, sciencebased, 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 VerDate Sep<11>2014 19:21 May 10, 2018 Jkt 244001 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: NTP-Meetings@icf.com. 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 https://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 https://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 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 22089 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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: National Institute of Mental Health Special Emphasis Panel; BRAIN Initiative: Tools to Facilitate HighThroughput Microconnectivity Analysis. Date: June 5, 2018. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting). Contact Person: Vinod Charles, Ph.D., Scientific Review Officer Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room 6151, MSC 9606, Bethesda, MD 20892–9606, 301–443–1606, charlesvi@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Confirmatory Efficacy Clinical Trials of NonPharmacological Interventions for Mental Disorders. Date: June 7, 2018. Time: 12:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Marcy Ellen Burstein, Ph.D., Scientific Review Officer Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room 6143, MSC 9606, Bethesda, MD 20892–9606, 301–443–9699, bursteinme@mail.nih.gov. Name of Committee: National Institute of Mental Health Special Emphasis Panel; Early Phase Developmental Pharma/Device Clinical Trials. Date: June 12, 2018. Time: 11:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health Neuroscience Center, 6001 Executive E:\FR\FM\11MYN1.SGM 11MYN1

Agencies

[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 https://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 https://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
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