83 FR 44280 - 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 169 (August 30, 2018)

Page Range		44280-44281
FR Document		2018-18778

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. This meeting is by webcast only and is open to the public. Registration is requested for oral comment and is required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.

Federal Register, Volume 83 Issue 169 (Thursday, August 30, 2018)

[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Notices]
[Pages 44280-44281]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18778]


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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. This meeting is by webcast only and is open to 
the public. Registration is requested for oral comment and is required 
to access the webcast. Information about the meeting and registration 
are available at http://ntp.niehs.nih.gov/go/165.

DATES: 
    Meeting: October 9, 2018; 1:00--4:00 p.m. (EDT).
    Written Public Comment Submissions: Deadline is October 1, 2018.
    Oral Comments: Deadline is October 1, 2018.
    Registration to view the webcast: Deadline October 9, 2018.
    Registration to view the meeting via the webcast is required.

ADDRESSES: 
    Meeting Webpage: The preliminary agenda, registration, and other 
meeting materials are at http://ntp.niehs.nih.gov/go/165.
    Webcast: The meeting will be webcast; the URL will be provided to 
those who register for viewing.

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.

[[Page 44281]]


SUPPLEMENTARY INFORMATION: The BSC will provide input to the NTP on 
programmatic activities and issues. Preliminary agenda topics include 
discussions on strategic realignment of NTP and updates on peer 
reviews. 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 and Registration: The meeting is open to the public with 
time scheduled for oral public comments. Registration to view the 
webcast is by October 9, 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. 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.
    Written Public Comments: NTP invites written and oral public 
comments on the agenda topics. 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 October 1, 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 Comments: Registration for oral comments is on or 
before October 1, 2018, at http://ntp.niehs.nih.gov/go/165. Oral 
comments will be received only during the formal public comment periods 
indicated on the preliminary agenda. Oral comments may be by 
teleconference line. The access number for the teleconference line will 
be provided to registrants by email prior to the meeting. Each 
organization is allowed one time slot, and five minutes will be 
allotted to each time slot.
    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: August 20, 2018
Brian R. Berridge,
Associate Director, National Toxicology Program.
[FR Doc. 2018-18778 Filed 8-29-18; 8:45 am]
BILLING CODE 4140-01-P

44280 Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices

hour × 48 hours (i.e., two fully VI. What are the consequences of not of Biomedical Imaging and Bioengineering,
supported FTEs × ((2 travel days × 8 paying this fee? National Institutes of Health, 6707
hours) + (1 day onsite × 8 hours))) = Democracy Blvd., Suite 957, Bethesda, MD
The consequences of not paying these 20892, 301–496–4773, zhour@mail@nih.gov.
$13,536. The estimated average cost of fees are outlined in 21 CFR 1.725. If
the work FDA performs in total for Dated: August 23, 2018.
FDA does not receive an application fee
reviewing an initial application for with an application for recognition, the David D. Clary,
direct accreditation of a certification application will be considered Program Analyst, Office of Federal Advisory
body based on these figures would be incomplete and FDA will not review the Committee Policy.
$24,675 + $13,536 = $38,211. Therefore, application. If a recognized [FR Doc. 2018–18769 Filed 8–29–18; 8:45 am]
the application fee for certification accreditation body fails to submit its BILLING CODE 4140–01–P
bodies applying for direct accreditation annual user fee within 30 days of the
from FDA in FY 2019 will be $38,211. due date, we will suspend its
recognition. If the recognized DEPARTMENT OF HEALTH AND
IV. Estimated Fees for Accreditation HUMAN SERVICES
accreditation body fails to submit its
Bodies and Certification Bodies in
annual user fee within 90 days of the National Institutes of Health
Other Fee Categories for FY 2019
due date, we will revoke its recognition.
Section 1.705(a) also establishes If an accredited certification body fails National Toxicology Program Board of
application fees for recognized to pay its annual fee within 30 days of Scientific Counselors; Announcement
accreditation bodies submitting renewal the due date, we will suspend its of Meeting; Request for Comments
applications and certification bodies accreditation. If the accredited
certification body fails to pay its annual AGENCY: National Institutes of Health,
applying for renewal of direct HHS.
accreditation. Section 1.705(b) also fee within 90 days of the due date, we
will withdraw its accreditation. ACTION: Notice.
establishes annual fees for certification
bodies directly accredited by FDA. Dated: August 24, 2018. SUMMARY: This notice announces the
Although we will not be collecting Leslie Kux, next meeting of the National Toxicology
these other fees in FY 2019, for Associate Commissioner for Policy. Program (NTP) Board of Scientific
transparency and planning purposes, we [FR Doc. 2018–18802 Filed 8–29–18; 8:45 am] Counselors (BSC). The BSC, a federally
have provided an estimate of what these BILLING CODE 4164–01–P chartered, external advisory group
fees would be for FY 2019 based on the composed of scientists from the public
fully supported FTE hourly rates for FY and private sectors, will review and
2019 and estimates of the number of DEPARTMENT OF HEALTH AND provide advice on programmatic
hours it would take FDA to perform HUMAN SERVICES activities. This meeting is by webcast
relevant activities as outlined in the only and is open to the public.
National Institutes of Health Registration is requested for oral
Final Regulatory Impact Analysis for the
Third-Party Certification Regulation. comment and is required to access the
National Institute of Biomedical webcast. Information about the meeting
Table 4 provides an overview of the Imaging and Bioengineering; Notice of
estimated fees for other fee categories. and registration are available at http://
Closed Meeting ntp.niehs.nih.gov/go/165.
TABLE 4—ESTIMATED FEE RATES FOR Pursuant to section 10(d) of the DATES:
Meeting: October 9, 2018; 1:00—4:00
OTHER FEE CATEGORIES UNDER Federal Advisory Committee Act, as p.m. (EDT).
amended, notice is hereby given of a
THE FSMA THIRD-PARTY CERTIFI- Written Public Comment
meeting.
CATION PROGRAM The meetings will be closed to the Submissions: Deadline is October 1,
public in accordance with the 2018.
Estimated provisions set forth in sections Oral Comments: Deadline is October
fee rates 1, 2018.
Fee category for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
FY 2019 as amended. The grant applications and Registration to view the webcast:
the discussions could disclose Deadline October 9, 2018.
Renewal application fee for rec- confidential trade secrets or commercial Registration to view the meeting via
ognized accreditation body ... $21,350 property such as patentable material, the webcast is required.
Renewal application fee for di- and personal information concerning ADDRESSES:
rectly accredited certification individuals associated with the grant Meeting Webpage: The preliminary
body ...................................... 28,999 applications, the disclosure of which agenda, registration, and other meeting
Annual fee for certification body would constitute a clearly unwarranted materials are at http://ntp.niehs.nih.gov/
directly accredited by FDA .... 21,056 go/165.
invasion of personal privacy.
Webcast: The meeting will be
V. How must the fee be paid? Name of Committee: National Institute of webcast; the URL will be provided to
Biomedical Imaging and Bioengineering
Special Emphasis Panel, NIBIB Team-based
those who register for viewing.
Accreditation bodies seeking initial FOR FURTHER INFORMATION CONTACT: Dr.
R25 Review (2019/01).
recognition must submit the application Date: September 24, 2018. Mary Wolfe, Designated Federal Official
fee with the application. Time: 10:00 a.m. to 5:00 p.m. for the BSC, Office of Liaison, Policy
amozie on DSK3GDR082PROD with NOTICES1

For recognized accreditation bodies Agenda: To review and evaluate grant and Review, Division of NTP, NIEHS,
and accredited certification bodies, an applications. P.O. Box 12233, K2–03, Research
invoice will be sent annually. Payment Place: National Institutes of Health, Triangle Park, NC 27709. Phone: 984–
National Institute of Biomedical Imaging and
must be made within 30 days of the Bioengineering, 6707 Democracy Blvd., Suite 287–3209, Fax: 301–451–5759, Email:
invoice date. Detailed payment 920, Bethesda, MD 20892 (Virtual Meeting). wolfe@niehs.nih.gov. Hand Deliver/
information will be included with the Contact Person: Ruixia Zhou, Ph.D., Courier address: 530 Davis Drive, Room
invoice when it is issued. Scientific Review Officer, National Institute K2130, Morrisville, NC 27560.

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Federal Register / Vol. 83, No. 169 / Thursday, August 30, 2018 / Notices 44281

SUPPLEMENTARY INFORMATION: The BSC ntp.niehs.nih.gov/go/165) and will be for companies and may also be available
will provide input to the NTP on updated one week before the meeting. for licensing.
programmatic activities and issues. Individuals are encouraged to access the FOR FURTHER INFORMATION CONTACT:
Preliminary agenda topics include meeting web page to stay abreast of the Yogikala Prabhu, Ph.D., 301–761–7789;
discussions on strategic realignment of most current information regarding the prabhuyo@niaid.nih.gov. Licensing
NTP and updates on peer reviews. meeting. information and copies of the patent
Please see the preliminary agenda for Background Information on the BSC: applications listed below may be
information about the specific The BSC is a technical advisory body obtained by communicating with the
presentations. The preliminary agenda, comprised of scientists from the public indicated licensing contact at the
roster of BSC members, background and private sectors that provides Technology Transfer and Intellectual
materials, public comments, and any primary scientific oversight to the NTP. Property Office, National Institute of
additional information, when available, Specifically, the BSC advises the NTP Allergy and Infectious Diseases, 5601
will be posted on the BSC meeting on matters of scientific program content, Fishers Lane, Rockville, MD 20852; tel.
website (http://ntp.niehs.nih.gov/go/ both present and future, and conducts 301–496–2644. A signed Confidential
165) or may be requested in hardcopy periodic review of the program for the Disclosure Agreement will be required
from the Designated Federal Official for purpose of determining and advising on to receive copies of unpublished patent
the BSC. Following the meeting, the scientific merit of its activities and applications.
summary minutes will be prepared and their overall scientific quality. Its SUPPLEMENTARY INFORMATION:
made available on the BSC meeting members are selected from recognized Technology description follows.
website. authorities knowledgeable in fields such
Meeting and Registration: The Methods of Diagnosing and Treating
as toxicology, pharmacology, pathology, CHAPLE, a Newly Identified Orphan
meeting is open to the public with time biochemistry, epidemiology, risk
scheduled for oral public comments. Disease Description of Technology
assessment, carcinogenesis,
Registration to view the webcast is by mutagenesis, molecular biology, This technology is directed towards a
October 9, 2018, at http:// behavioral toxicology, neurotoxicology, potential treatment for a new disease,
ntp.niehs.nih.gov/go/165. Registration is immunotoxicology, reproductive CHAPLE (Complement Hyperactivation,
required to view the webcast; the URL Angiopathic thrombosis, and Protein-
toxicology or teratology, and
for the webcast will be provided in the Losing Enteropathy), identified by
biostatistics. Members serve overlapping
email confirming registration. TTY users NIAID researchers. CHAPLE is
terms of up to four years. The BSC
should contact the Federal TTY Relay associated with GI symptoms and
usually meets biannually. The authority
Service at 800–877–8339. Requests vascular thrombosis and is caused by
for the BSC is provided by 42 U.S.C.
should be made at least five business loss-of-function variants in the gene
217a, section 222 of the Public Health
days in advance of the event. encoding the complement regulatory
Written Public Comments: NTP Service Act (PHS), as amended.
protein CD55. The disease is caused by
invites written and oral public The BSC is governed by the
enhanced activation of the complement
comments on the agenda topics. provisions of the Federal Advisory
pathway and complement-mediated
Guidelines for public comments are Committee Act, as amended (5 U.S.C.
induction of intestinal lymphangiectasia
available at https://ntp.niehs.nih.gov/ app.), which sets forth standards for the
and protein-losing enteropathy. There is
ntp/about_ntp/guidelines_public_ formation and use of advisory
no current therapy for the newly
comments_508.pdf. The deadline for committees.
described heritable genetic disorder and
submission of written comments is Dated: August 20, 2018 the symptoms are poorly controlled.
October 1, 2018. Written public Brian R. Berridge, CHAPLE is similar to other complement
comments should be submitted through Associate Director, National Toxicology activating diseases that can be fatal,
the meeting website. Persons submitting Program. particularly for patients who develop
written comments should include name, [FR Doc. 2018–18778 Filed 8–29–18; 8:45 am] severe thrombosis. Recent off-label use
affiliation, mailing address, phone, of a complement inhibiting drug,
BILLING CODE 4140–01–P
email, and sponsoring organization (if eculizumab (CD55 inhibitor) was shown
any). Written comments received in to provide a dramatic benefit in patients
response to this notice will be posted on DEPARTMENT OF HEALTH AND with CHAPLE disease with an
the NTP website, and the submitter will HUMAN SERVICES immediate correction of gastrointestinal
be identified by name, affiliation, and protein loss. Thus, identification of
sponsoring organization (if any). National Institutes of Health CD55 deficiency in CHAPLE patients,
Oral Public Comments: Registration
and the possibility to use complement
for oral comments is on or before Government-Owned Inventions;
inhibitory drugs provide opportunities
October 1, 2018, at http:// Availability for Licensing
for treatment.
ntp.niehs.nih.gov/go/165. Oral This technology is available for
comments will be received only during AGENCY: National Institutes of Health,
HHS. licensing for commercial development
the formal public comment periods in accordance with 35 U.S.C. 209 and 37
indicated on the preliminary agenda. ACTION: Notice. CFR part 404, as well as for further
Oral comments may be by development and evaluation under a
teleconference line. The access number SUMMARY: The invention listed below is
research collaboration.
for the teleconference line will be owned by an agency of the U.S.
amozie on DSK3GDR082PROD with NOTICES1

provided to registrants by email prior to Government and is available for Potential Commercial Applications
the meeting. Each organization is licensing to achieve expeditious • Diagnostic.
allowed one time slot, and five minutes commercialization of results of • Therapeutic.
will be allotted to each time slot. federally-funded research and
Meeting Materials: The preliminary development. Foreign patent Competitive Advantages
meeting agenda is available on the applications are filed on selected • There is no therapy currently
meeting web page (http:// inventions to extend market coverage approved for CHAPLE disease, and

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Document Created: 2018-08-30 01:21:16
Document Modified: 2018-08-30 01:21:16

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: October 9, 2018; 1:00--4:00 p.m. (EDT).
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 44280

83 FR 44280 - National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 169 (August 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health