83 FR 55903 - National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 217 (November 8, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 217 (November 8, 2018)
| Page Range | 55903-55904 | |
| FR Document | 2018-24472 |
[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)] [Notices] [Pages 55903-55904] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24472] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments AGENCY: National Institutes of Health, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165. DATES: Meeting: Scheduled for December 11, 2018 at 8:30 a.m. to adjournment on December 12, 2018 at approximately 5:00 p.m. Eastern Standard Time (EST). Written Public Comment Submissions: Deadline is December 3, 2018. Registration for Oral Comments: Deadline is December 3, 2018. Registration to Attend Meeting In-person or to View Webcast: Deadline is December 12, 2018. Registration to view the meeting via the webcast is required. ADDRESSES: Meeting Location: Rodbell Auditorium, Rall Building, National Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Meeting web page: The preliminary agenda, registration, and other meeting materials are at http://ntp.niehs.nih.gov/go/165. Webcast: The URL for viewing the meeting webcast will be provided to registrants. FOR FURTHER INFORMATION CONTACT: Dr. Mary Wolfe, Designated Federal Official for the BSC, Office of Liaison, Policy and Review, Division of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. Phone: 984-287-3209, Fax: 301-451-5759, email: [email protected]. Hand Deliver/Courier address: 530 Davis Drive, Room K2130, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: The BSC will provide input to the NTP on programmatic activities and issues. The agenda on December 11 will recognize NTP's 40th anniversary with the theme ``Celebrate the Past, and Embrace the Future,'' and on December 12, several talks will focus on translation as a scientific framework. Please see the preliminary agenda for information about the specific presentations. The preliminary agenda, roster of BSC members, background materials, public comments, and any additional information, when available, will be posted on the BSC meeting website (http://ntp.niehs.nih.gov/go/165) or may be requested in hardcopy from the Designated Federal Official for the BSC. Following the meeting, summary minutes will be prepared and made available on the BSC meeting website. Meeting Attendance Registration: The meeting is open to the public with time set aside for oral public comment; in-person attendance at the NIEHS is limited by the space available (~100 attendees). Registration for in-person attendance is on a first-come, first-served basis, and registrants will be assigned a number in their confirmation email. 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-in person or view the webcast is by December 12, 2018 at http://ntp.niehs.nih.gov/go/165. Registration is required to view the webcast; 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 niehs.nih.gov/about/visiting/index.cfm. Individuals with disabilities who need accommodation to participate in this event should contact Ms. Robbin Guy at phone: (984) 287-3136 or email: [email protected]. TTY users should contact the Federal TTY Relay Service at 800-877-8339. Requests should be made at [[Page 55904]] least five business days in advance of the event. Written Public Comments: NTP invites written public comments. Guidelines for public comments are available at https://ntp.niehs.nih.gov/ntp/about_ntp/guidelines_public_comments_508.pdf. The deadline for submission of written comments is December 3, 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). Oral Public Comment Registration: The agenda allows for two public comment periods: The first comment period on the CLARITY-BPA Research Program: Integration Report Strategy (5 commenters, up to 5 minutes per speaker) and the second comment period on the peer review of the Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night (5 commenters, up to 5 minutes per speaker); oral comments may be presented in person at NIEHS or by teleconference line. Registration for oral comments is on or before December 3, 2018, at http://ntp.niehs.nih.gov/go/165. Registration is on a first-come, first-served basis, and registrants will be assigned a number in their confirmation email. Each organization is allowed one time slot per comment period. After the maximum number of speakers per comment period is exceeded, individuals registered to provide oral comment will be placed on a wait list and notified should an opening become available. Commenters will be notified after December 3, 2018, about the actual time allotted per speaker, and the teleconference number will be sent to those registered to give oral comments by teleconference line. If possible, oral public commenters should send a copy of their slides and/or statement or talking points to [email protected] by December 3, 2018. Meeting Materials: The preliminary meeting agenda is available on the meeting web page (http://ntp.niehs.nih.gov/go/165) 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. Background Information on the BSC: The BSC is a technical advisory body comprised of scientists from the public and private sectors that provides primary scientific oversight to the NTP. Specifically, the BSC advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and their overall scientific quality. Its members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral toxicology, neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. Members serve overlapping terms of up to four years. The BSC usually meets biannually. The authority for the BSC is provided by 42 U.S.C. 217a, section 222 of the Public Health Service Act (PHS), as amended. The BSC is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. app.), which sets forth standards for the formation and use of advisory committees. Dated: October 31, 2018. Brian R. Berridge, Associate Director, National Toxicology Program. [FR Doc. 2018-24472 Filed 11-7-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices 55903
provisions set forth in sections Bethesda, MD 20892–9606, 301–443–2742, materials are at http://ntp.niehs.nih.gov/
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., nick.gaiano@nih.gov. go/165.
as amended. The grant applications and This notice is being published less than 15 Webcast: The URL for viewing the
the discussions could disclose days prior to the meeting due to the timing meeting webcast will be provided to
confidential trade secrets or commercial limitations imposed by the review and
funding cycle.
registrants.
property such as patentable material,
and personal information concerning (Catalogue of Federal Domestic Assistance FOR FURTHER INFORMATION CONTACT: Dr.
Program No. 93.242, Mental Health Research Mary Wolfe, Designated Federal Official
individuals associated with the grant
Grants, National Institutes of Health, HHS) for the BSC, Office of Liaison, Policy
applications, the disclosure of which
would constitute a clearly unwarranted Dated: November 5, 2018. and Review, Division of NTP, NIEHS,
invasion of personal privacy. Melanie J. Pantoja, P.O. Box 12233, K2–03, Research
Program Analyst, Office of Federal Advisory Triangle Park, NC 27709. Phone: 984–
Name of Committee: National Institute of 287–3209, Fax: 301–451–5759, email:
Mental Health Special Emphasis Panel; Committee Policy.
Silvio O. Conte Centers for Basic [FR Doc. 2018–24480 Filed 11–7–18; 8:45 am] wolfe@niehs.nih.gov. Hand Deliver/
Neuroscience or Translational Mental Health BILLING CODE 4140–01–P
Courier address: 530 Davis Drive, Room
Research (P50). K2130, Morrisville, NC 27560.
Date: November 14, 2018. SUPPLEMENTARY INFORMATION: The BSC
Time: 8:00 a.m. to 5:00 p.m. DEPARTMENT OF HEALTH AND will provide input to the NTP on
Agenda: To review and evaluate grant HUMAN SERVICES programmatic activities and issues. The
applications.
Place: Bethesda North Marriott Hotel &
agenda on December 11 will recognize
National Institutes of Health NTP’s 40th anniversary with the theme
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852. ‘‘Celebrate the Past, and Embrace the
National Toxicology Program Board of
Contact Person: Rebecca Steiner Garcia, Future,’’ and on December 12, several
Scientific Counselors; Announcement
Ph.D., Scientific Review Officer, Division of talks will focus on translation as a
of Meeting; Request for Comments
Extramural Activities, National Institute of scientific framework. Please see the
Mental Health, NIH Neuroscience Center, AGENCY: National Institutes of Health, preliminary agenda for information
6001 Executive Blvd., Room 6149, MSC 9608, HHS. about the specific presentations. The
Bethesda, MD 20892–9608, 301–443–4525, preliminary agenda, roster of BSC
steinerr@mail.nih.gov.
ACTION: Notice.
members, background materials, public
This notice is being published less than 15 SUMMARY: This notice announces the comments, and any additional
days prior to the meeting due to the timing next meeting of the National Toxicology information, when available, will be
limitations imposed by the review and Program (NTP) Board of Scientific
funding cycle.
posted on the BSC meeting website
Counselors (BSC). The BSC, a federally (http://ntp.niehs.nih.gov/go/165) or may
Name of Committee: National Institute of chartered, external advisory group
Mental Health Special Emphasis Panel; First
be requested in hardcopy from the
in Human and Early Stage Clinical Trials of
composed of scientists from the public Designated Federal Official for the BSC.
Novel Investigational Drugs or Devices for and private sectors, will review and Following the meeting, summary
Psychiatric Disorders. provide advice on programmatic minutes will be prepared and made
Date: November 14, 2018. activities. The meeting is open to the available on the BSC meeting website.
Time: 1:00 p.m. to 3:00 p.m. public and registration is requested for Meeting Attendance Registration: The
Agenda: To review and evaluate grant both attendance and oral comment and meeting is open to the public with time
applications. required to access the webcast. set aside for oral public comment; in-
Place: National Institutes of Health Information about the meeting and
Neuroscience Center, 6001 Executive person attendance at the NIEHS is
registration are available at http:// limited by the space available (∼100
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
ntp.niehs.nih.gov/go/165. attendees). Registration for in-person
Contact Person: Vinod Charles, Ph.D., DATES: attendance is on a first-come, first-
Scientific Review Officer, Division of Meeting: Scheduled for December 11, served basis, and registrants will be
Extramural Activities, National Institute of 2018 at 8:30 a.m. to adjournment on assigned a number in their confirmation
Mental Health, NIH Neuroscience Center, December 12, 2018 at approximately email. After the first 100 registrants,
6001 Executive Blvd., Room 6151, MSC 9606, 5:00 p.m. Eastern Standard Time (EST). persons will be placed on a wait list and
Bethesda, MD 20892–9606, 301–443–1606, Written Public Comment notified should an opening become
charlesvi@mail.nih.gov.
Submissions: Deadline is December 3, available. Registration to attend the
This notice is being published less than 15 2018. meeting in-in person or view the
days prior to the meeting due to the timing
Registration for Oral Comments: webcast is by December 12, 2018 at
limitations imposed by the review and
funding cycle. Deadline is December 3, 2018. http://ntp.niehs.nih.gov/go/165.
Registration to Attend Meeting In- Registration is required to view the
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
person or to View Webcast: Deadline is webcast; the URL for the webcast will be
NRSA Institutional Research Grant Training December 12, 2018. provided in the email confirming
Review. Registration to view the meeting via registration. Visitor and security
Date: November 16, 2018. the webcast is required. information for those attending in-
Time: 8:00 a.m. to 5:00 p.m. ADDRESSES: person is available at niehs.nih.gov/
Agenda: To review and evaluate grant Meeting Location: Rodbell about/visiting/index.cfm. Individuals
daltland on DSKBBV9HB2PROD with NOTICES
applications Auditorium, Rall Building, National with disabilities who need
Place: Washington Plaza Hotel, 10 Thomas
Institute of Environmental Health accommodation to participate in this
Circle NW, Washington, DC 20005.
Contact Person: Nicholas Gaiano, Ph.D., Sciences (NIEHS), 111 T.W. Alexander event should contact Ms. Robbin Guy at
Review Branch Chief, Division of Extramural Drive, Research Triangle Park, NC phone: (984) 287–3136 or email: guyr2@
Activities, National Institute of Mental 27709. niehs.nih.gov. TTY users should contact
Health, NIH Neuroscience Center/Room Meeting web page: The preliminary the Federal TTY Relay Service at 800–
6150/MSC 9606, 6001 Executive Boulevard, agenda, registration, and other meeting 877–8339. Requests should be made at
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![55904 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
least five business days in advance of and private sectors that provides Property Office, National Institute of
the event. primary scientific oversight to the NTP. Allergy and Infectious Diseases, 5601
Written Public Comments: NTP Specifically, the BSC advises the NTP Fishers Lane, Rockville, MD, 20852; tel.
invites written public comments. on matters of scientific program content, 301–496–2644. A signed Confidential
Guidelines for public comments are both present and future, and conducts Disclosure Agreement will be required
available at https://ntp.niehs.nih.gov/ periodic review of the program for the to receive copies of unpublished patent
ntp/about_ntp/guidelines_public_ purpose of determining and advising on applications.
comments_508.pdf. the scientific merit of its activities and SUPPLEMENTARY INFORMATION:
The deadline for submission of their overall scientific quality. Its Technology description follows.
written comments is December 3, 2018. members are selected from recognized
Written public comments should be authorities knowledgeable in fields such Universal Influenza Virus Probes for
submitted through the meeting website. as toxicology, pharmacology, pathology, Enrichment of Influenza Viral
Persons submitting written comments biochemistry, epidemiology, risk Sequences
should include name, affiliation, assessment, carcinogenesis, Description of Technology:
mailing address, phone, email, and mutagenesis, molecular biology, This technology is a set of influenza
sponsoring organization (if any). Written behavioral toxicology, neurotoxicology, virus enrichment probes developed to
comments received in response to this immunotoxicology, reproductive increase the sensitivity of sequence-
notice will be posted on the NTP toxicology or teratology, and based, universal detection of all
website, and the submitter will be biostatistics. Members serve overlapping influenza viruses. This universal
identified by name, affiliation, and terms of up to four years. The BSC influenza enrichment probe set contains
sponsoring organization (if any). usually meets biannually. The authority a unique set of 46,953 biotin-labeled,
Oral Public Comment Registration: for the BSC is provided by 42 U.S.C. RNA probes, each 120 base-pairs long,
The agenda allows for two public 217a, section 222 of the Public Health that can be used to enrich for any
comment periods: The first comment Service Act (PHS), as amended. influenza sequences without prior
period on the CLARITY–BPA Research The BSC is governed by the knowledge of type or subtype. This
Program: Integration Report Strategy (5 provisions of the Federal Advisory probe set can capture and enrich
commenters, up to 5 minutes per Committee Act, as amended (5 U.S.C. influenza viral sequences selectively
speaker) and the second comment app.), which sets forth standards for the and effectively in a variety of samples,
period on the peer review of the Draft formation and use of advisory such as clinical samples with degraded
Report on Carcinogens Monograph on committees. nucleotides or samples containing very
Night Shift Work and Light at Night (5 low amounts of influenza virus, thus
commenters, up to 5 minutes per Dated: October 31, 2018.
Brian R. Berridge, making it a valuable tool for influenza
speaker); oral comments may be virus diagnoses and surveillance.
presented in person at NIEHS or by Associate Director, National Toxicology
Program.
This technology is available for
teleconference line. Registration for oral licensing for commercial development
comments is on or before December 3, [FR Doc. 2018–24472 Filed 11–7–18; 8:45 am]
in accordance with 35 U.S.C. 209 and 37
2018, at http://ntp.niehs.nih.gov/go/165. BILLING CODE 4140–01–P
CFR part 404, as well as for further
Registration is on a first-come, first- development and evaluation under a
served basis, and registrants will be research collaboration.
assigned a number in their confirmation DEPARTMENT OF HEALTH AND
Potential Commercial Applications:
email. Each organization is allowed one HUMAN SERVICES
• Influenza diagnostics; influenza
time slot per comment period. After the surveillance
maximum number of speakers per National Institutes of Health
Competitive Advantages:
comment period is exceeded, Government-Owned Inventions; • Highly sensitive detection of
individuals registered to provide oral Availability for Licensing influenza viruses
comment will be placed on a wait list • Detection of any influenza viruses
and notified should an opening become AGENCY: National Institutes of Health, in a variety of samples
available. Commenters will be notified HHS. Development Stage:
after December 3, 2018, about the actual ACTION: Notice. • In vitro Testing
time allotted per speaker, and the Inventors: Yongli Xiao, Ph.D.,
teleconference number will be sent to SUMMARY: The invention listed below is (NIAID), Jeffrey Taubenberger, Ph.D.,
those registered to give oral comments owned by an agency of the U.S. (NIAID), and Zong-Mei Sheng, Ph.D.
by teleconference line. Government and is available for (NIAID)
If possible, oral public commenters licensing to achieve expeditious Publications: Xiao Y, et al. Design and
should send a copy of their slides and/ commercialization of results of validation of a universal influenza virus
or statement or talking points to NTP- federally-funded research and enrichment probe set and its utility in
Meetings@icf.com by December 3, 2018. development. Foreign patent deep sequence analysis of primary
Meeting Materials: The preliminary applications are filed on selected cloacal swab surveillance samples of
meeting agenda is available on the inventions to extend market coverage wild birds. Virology, 2018, Nov;
meeting web page (http:// for companies and may also be available 524:182–191 [PMID 30212665]
ntp.niehs.nih.gov/go/165) and will be for licensing. Intellectual Property: HHS Reference
updated one week before the meeting. FOR FURTHER INFORMATION CONTACT: Dr. No. E–032–2018/0—US–01 Patent
daltland on DSKBBV9HB2PROD with NOTICES
Individuals are encouraged to access the Jenish Patel, Ph.D., 240–669–2894; Application No. 62/611,734 filed
meeting web page to stay abreast of the jenish.patel@nih.gov. Licensing December 29, 2017.
most current information regarding the information and copies of the U.S. Licensing Contact: Jenish Patel, Ph.D.,
meeting. patent application listed below may be 240–669–2894; jenish.patel@nih.gov
Background Information on the BSC: obtained by communicating with the Collaborative Research Opportunity:
The BSC is a technical advisory body indicated licensing contact at the The National Institute of Allergy and
comprised of scientists from the public Technology Transfer and Intellectual Infectious Diseases (NIAID) is also
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Document Created: 2018-11-08 06:22:59
Document Modified: 2018-11-08 06:22:59
| 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: Scheduled for December 11, 2018 at 8:30 a.m. to adjournment on December 12, 2018 at approximately 5:00 p.m. Eastern Standard Time (EST). | |
| Contact | Dr. Mary Wolfe, Designated Federal Official for the BSC, Office of Liaison, Policy and Review, Division of NTP, NIEHS, P.O. Box 12233, K2-03, Research Triangle Park, NC 27709. Phone: 984-287-3209, Fax: 301-451-5759, email: [email protected] | |
| FR Citation | 83 FR 55903 |
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