83 FR 63662 - Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; 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 237 (December 11, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 237 (December 11, 2018)
| Page Range | 63662-63664 | |
| FR Document | 2018-26745 |
[Federal Register Volume 83, Number 237 (Tuesday, December 11, 2018)] [Notices] [Pages 63662-63664] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26745] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft NTP Monograph on the Systematic Review of Evidence of Long- Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review Meeting AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The National Toxicology Program (NTP) announces availability of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin for public comment prior to peer review. In partnership with the National [[Page 63663]] Institutes of Health (NIH) Countermeasures Against Chemical Threats (CounterACT) Program, the Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), conducted a systematic review to evaluate the evidence of long-term neurological damage in humans after acute, sub-lethal exposure to sarin. The date for the peer review is not yet set; however, it is anticipated to occur in early 2019. The peer-review meeting will be held by webcast only and open to the public; registration will be required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051. DATES: Meeting: When set, the peer-review meeting date will be announced on the meeting web page at https://ntp.niehs.nih.gov/go/36051 along with deadlines for registration to present oral public comments and to view the webcast. The anticipated timeframe is early 2019. NTP will also announce the meeting date in an email Listserv notice. Persons can subscribe to news updates at https://tools.niehs.nih.gov/webforms/index.cfm/main/formViewer/form_id/361. Document Availability: The draft NTP monograph should be available by December 5, 2018, at https://ntp.niehs.nih.gov/go/36051. Written Public Comment Submissions: Deadline is January 17, 2019. Registration for Oral Comments: Please monitor the meeting web page at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the oral public comment registration deadline. Registration to View Webcast: Please monitor the meeting web page at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the webcast registration deadline. ADDRESSES: Meeting Location: Webcast. Meeting web page: The draft NTP monograph, preliminary agenda, registration, and other meeting materials will be available at https://ntp.niehs.nih.gov/go/36051. Webcast: The URL for viewing the peer-review meeting webcast will be provided to registrants. FOR FURTHER INFORMATION CONTACT: Ms. 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: OHAT serves as an environmental health resource to the public and to regulatory and health agencies. This office conducts evaluations to assess the 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. Sarin is a highly toxic organophosphorus nerve agent that was developed for chemical warfare during World War II and continues to be used as a weapon. The draft NTP monograph presents the results of the systematic review to evaluate the evidence for long-term neurological effects in humans following acute, sub-lethal exposure to sarin with consideration of human, experimental animal, and mechanistic date. Long-term neurological effects of acute exposure to sarin are not well characterized. Previous reviews of potential health effects of sarin have generally not assessed individual study quality or considered multiple evidence streams (human, animal, and mechanistic data). In addition, the interpretation of effects of sarin in some previous reviews was compounded by concurrent exposure to multiple chemicals, such as assessments of health effects in military personnel during the Gulf War or other conflicts. Meeting Attendance Registration: The meeting is open to the public with time set aside for oral public comment. Registration is required to view the webcast; the URL for the webcast will be provided in the email confirming registration. Please monitor the meeting web page at https://ntp.niehs.nih.gov/go/36051 for updates pertaining to the webcast registration deadline. 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 monograph that address scientific or technical issues. 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 January 17, 2019. 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 will allow for one oral public comment period (up to 12 commenters, up to 5 minutes per speaker). The deadline for registration to provide oral comments will be announced at https://ntp.niehs.nih.gov/go/36051 after the meeting date is set. Registration will be on a first-come, first-served basis. Each organization will be allowed one time slot. Oral comments will be presented by teleconference line. The access number for the teleconference line will be provided to registrants by email prior to the meeting. Commenters will be notified approximately one week before the peer-review meeting about the actual time allotted per speaker. If possible, oral public commenters will be asked to send a copy of their slides and/or statement or talking points to Canden Byrd by email: [email protected] by the registration deadline. Meeting Materials: The draft NTP monograph and preliminary agenda will be available on the NTP website at https://ntp.niehs.nih.gov/go/36051. The draft NTP monograph should be available by December 5, 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]. 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 [[Page 63664]] information to regulatory agencies about 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: November 28, 2018. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2018-26745 Filed 12-10-18; 8:45 am] BILLING CODE 4140-01-P
![63662 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices
accessing the ACBTSA website at http:// for attending Committee meetings and The Department also encourages
www.hhs.gov/bloodsafety. to carry out other Committee-related geographic diversity in the composition
SUPPLEMENTARY INFORMATION: The business. Individuals who are appointed of the committee. Appointment to this
ACBTSA provides advice to the to serve as representative members for a Committee shall be made without
Secretary through the Assistant particular interest group or industry are discrimination on the basis of age, race,
Secretary for Health. The Committee not authorized to receive a stipend for ethnicity, gender, sexual orientation,
advises on a range of policy issues to the performance of these duties. disability, and cultural, religious, or
include: (1) Broad public health, ethical This announcement is to solicit socioeconomic status.
and legal issues related to transfusion nominations of qualified candidates to The Standards of Ethical Conduct for
and transplantation safety, (2) risk five public member positions on the Employees of the Executive Branch are
communications related to blood ACBTSA. applicable to individuals who are
transfusion and tissue transplantation, Nominations appointed as public members of Federal
and (3) the identification of public advisory committees. Individuals
In accordance with the charter, appointed to serve as public members of
health issues that affect the availability persons nominated for appointment as
of blood, blood products, and tissues. Federal advisory committees are
members of the ACBTSA should be classified as special government
The Committee consists of 23 voting among authorities knowledgeable in
members; 14 public members, including employees (SGEs). SGEs are government
blood banking, tissue banking, employees for purposes of the conflict
the Chair, and nine (9) individuals transfusion medicine, organ or tissue
designated to serve as official of interest laws. Therefore, individuals
transplantation, plasma therapies, appointed to serve as public members of
representative members. The public transfusion and transplantation safety,
members are selected from State and the ACBTSA are subject to an ethics
bioethics, socioeconomics, health review. The ethics review is conducted
local organizations, patient advocacy policy/law, and/or related disciplines.
groups, provider organizations, to determine if the individual has any
Nominations should be typewritten. The interests and/or activities in the private
academic researchers, ethicists, following information should be
physicians, surgeons, scientists, risk sector that may conflict with
included in the package of material performance of their official duties as a
communication experts, consumer submitted for each individual being
advocates, and from among member of the Committee. Individuals
nominated for consideration of
communities of persons who are appointed to serve as public members of
appointment: (a) The name, return
frequent recipients of blood or blood the committee will be required to
address, daytime telephone number and
products or who have received tissues disclose information regarding financial
affiliation(s) of the individual being
or organs. The nine individuals who are holdings, consultancies, and research
nominated, the basis for the individual’s
appointed as official representatives are grants and/or contracts.
nomination, the category for which the
selected to serve the interests of the individual is being nominated, and a Dated: October 19, 2018.
blood, blood products, tissue and organ statement bearing an original signature James J. Berger,
professional organizations or business of the nominated individual that, if Senior Advisor for Blood and Tissue Policy,
sectors. The representative members are appointed, he or she is willing to serve Designated Federal Officer, Advisory
selected from the following groups: The as a member of the Committee; (b) the Committee on Blood and Tissue Safety and
AABB (formerly the American name, return address, and daytime Availability.
Association of Blood Banks); American telephone number at which the [FR Doc. 2018–26756 Filed 12–10–18; 8:45 am]
Association of Tissue Banks; Eye Bank nominator may be contacted. BILLING CODE 4150–41–P
Association of America; Association of Organizational nominators must
Organ Procurement Organizations; and identify a principal contact person in
one of either the American Red Cross or addition to the contact; and (c) a copy DEPARTMENT OF HEALTH AND
America’s Blood Centers. The of a current curriculum vitae or resume HUMAN SERVICES
Committee composition can include for the nominated individual.
additional representation from either Individuals can nominate themselves National Institutes of Health
the plasma protein fraction community for consideration of appointment to the
or a trade organization; a manufacturer Draft NTP Monograph on the
Committee. All nominations must
of blood, plasma, or other tissue/organ Systematic Review of Evidence of
include the required information.
test kits; a manufacturer of blood, Long-Term Neurological Effects
Incomplete nominations will not be
plasma or other tissue/organ equipment; Following Acute Exposure to the
processed for consideration. The letter
a major hospital organization; or a major Organophosphorus Nerve Agent Sarin;
from the nominator and certification of
hospital accreditation organization. Availability of Document; Request for
the nominated individual must bear
Where more than one company Comments; Notice of Peer-Review
original signatures; reproduced copies
produces a specified product or process, Meeting
of these signatures are not acceptable.
representatives from those companies The Department is legally required to AGENCY: National Institutes of Health,
shall rotate on the same schedule as ensure that the membership of HHS HHS.
public members. Federal advisory committees is fairly ACTION: Notice.
All ACBTSA members are authorized balanced in terms of points of view
to receive the prescribed per diem represented and the functions to be SUMMARY: The National Toxicology
allowance and reimbursement for travel performed by the advisory committee. Program (NTP) announces availability of
amozie on DSK3GDR082PROD with NOTICES1
expenses that are incurred to attend Every effort is made to ensure that the the Draft NTP Monograph on the
meetings and conduct Committee- views of women, all ethnic and racial Systematic Review of Evidence of Long-
related business, in accordance with groups, and people with disabilities are Term Neurological Effects Following
Standard Government Travel represented on HHS Federal Advisory Acute Exposure to the
Regulations. Individuals who are committees and, therefore, the Organophosphorus Nerve Agent Sarin
appointed to serve as public members Department encourages nominations of for public comment prior to peer
are authorized also to receive a stipend qualified candidates from these groups. review. In partnership with the National
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![63664 Federal Register / Vol. 83, No. 237 / Tuesday, December 11, 2018 / Notices
information to regulatory agencies about within 30-days of the date of this (OMB) a request for review and
alternative methods for toxicity publication. approval of the information collection
screening. NTP welcomes nominations listed below.
ADDRESSES: Written comments and/or
of scientific experts for upcoming Proposed Collection: National Cancer
suggestions regarding the item(s)
panels. Scientists interested in serving Institute Future Fellows Resume
contained in this notice, especially
on an NTP panel should provide their Databank, 0925–XXXX, Exp., Date XX/
regarding the estimated public burden
current curriculum vitae to Canden XXXX, EXISTING COLLECTION IN USE
and associated response time, should be
Byrd by email: NTP-Meetings@icf.com. WITHOUT OMB NUMBER, National
directed to the: Office of Management
The authority for NTP panels is
and Budget, Office of Regulatory Affairs, Cancer Institute (NCI), National
provided by 42 U.S.C. 217a; section 222
OIRA_submission@omb.eop.gov or by Institutes of Health (NIH).
of the Public Health Service Act, as
amended. The panel is governed by the fax to 202–395–6974, Attention: Desk Need and Use of Information
Federal Advisory Committee Act, as Officer for NIH. Collection: The National Cancer
amended (5 U.S.C. Appendix 2), which FOR FURTHER INFORMATION CONTACT: Institute, Center for Cancer Training
sets forth standards for the formation To request more information on the mission is to catalyze the development
and use of advisory committees. proposed project or to obtain a copy of of the 21st century workforce capable of
Dated: November 28, 2018.
the data collection plans and advancing cancer research through a
instruments, contact: Angela Jones, scientifically integrated approach. This
Brian R. Berridge,
Program Coordinator, Center for Cancer is accomplished by, (1) coordinating
Associate Director, National Toxicology
Training, National Cancer Institute, and providing research training and
Program.
9609 Medical Center Drive, Room 2W– career development activities for fellows
[FR Doc. 2018–26745 Filed 12–10–18; 8:45 am]
236, Bethesda, Maryland, 20892 or call and trainees in NCI’s laboratories,
BILLING CODE 4140–01–P
non-toll-free number (240) 276–5659 or clinics, and other research groups, (2)
Email your request, including your developing, coordinating, and
DEPARTMENT OF HEALTH AND address to: jonesangel@mail.nih.gov. implementing opportunities in support
HUMAN SERVICES SUPPLEMENTARY INFORMATION: This of cancer research training, career
proposed information collection was development, and education at
National Institutes of Health previously published in the Federal institutions nationwide, and (3)
Register on August 13, 2018, page 40071 identifying workforce needs in cancer
Submission for OMB Review; 30-Day (83 FR 40071) and allowed 60 days for research and adapting NCI’s training
Comment Request National Cancer public comment. No public comments and career development programs and
Institute (NCI) Future Fellows Resume were received. The purpose of this funding opportunities to address these
Databank notice is to allow an additional 30 days needs. The proposed information
for public comment. The National collection involves a website to collect
AGENCY: National Institutes of Health,
Cancer Institute (NCI), National and maintain resumes of interested
HHS.
Institutes of Health, may not conduct or candidates to be considered for
ACTION: Notice. postdoctoral fellowships and
sponsor, and the respondent is not
SUMMARY: In compliance with the required to respond to, an information internships in science. After posting
Paperwork Reduction Act of 1995, the collection that has been extended, their resume in the database, NCI
National Institutes of Health (NIH) has revised, or implemented on or after Scientists can view and select
submitted to the Office of Management October 1, 1995, unless it displays a candidates for current fellowship and
and Budget (OMB) a request for review currently valid OMB control number. internship opportunities offered at NCI.
and approval of the information In compliance with Section OMB approval is requested for 3
collection listed below. 3507(a)(1)(D) of the Paperwork years. There are no costs to respondents
DATES: Comments regarding this Reduction Act of 1995, the National other than their time. The total
information collection are best assured Institutes of Health (NIH) has submitted estimated annualized burden are 200
of having their full effect if received to the Office of Management and Budget hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average time
Number of Total annual
Category of respondent responses per per response
respondents burden hours
respondent (in hours)
Individual .......................................................................................................... 200 2 30/60 200
Totals ........................................................................................................ 200 400 ........................ 200
Patricia M. Busche, DEPARTMENT OF HEALTH AND amended, notice is hereby given of the
Project Clearance Liaison, National Cancer HUMAN SERVICES following meeting.
Institute, National Institutes of Health. The meeting will be closed to the
amozie on DSK3GDR082PROD with NOTICES1
[FR Doc. 2018–26765 Filed 12–10–18; 8:45 am] National Institutes of Health public in accordance with the
BILLING CODE 4140–01–P provisions set forth in sections
National Institute of Mental Health; 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Notice of Closed Meeting as amended. The grant applications and
the discussions could disclose
Pursuant to section 10(d) of the confidential trade secrets or commercial
Federal Advisory Committee Act, as property such as patentable material,
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Document Created: 2018-12-11 01:07:21
Document Modified: 2018-12-11 01:07:21
| 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 | |
| Action | Notice. | |
| Dates | Meeting: When set, the peer-review meeting date will be announced on the meeting web page at https://ntp.niehs.nih.gov/go/36051 along with deadlines for registration to present oral public comments and to view the webcast. The anticipated timeframe is early 2019. | |
| Contact | Ms. Canden Byrd, ICF, 2635 Meridian Parkway, Suite 200, Durham, NC, USA 27713. Phone: (919) 293-1660, Fax: (919) 293-1645, Email: [email protected] | |
| FR Citation | 83 FR 63662 |
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