Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting, 43587-43588 [2020-15524]
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Federal Register / Vol. 85, No. 138 / Friday, July 17, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1618]
Eli Lilly and Co.; Announcement of the
Revocation of the Biologics License
for LARTRUVO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the revocation of the
biologics license application (BLA) for
LARTRUVO (olaratumab) injection. Eli
Lilly and Co. requested withdrawal
(revocation) of the biologics license
application and has waived its
opportunity for a hearing.
DATES: The BLA is revoked as of
February 25, 2020.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
SUPPLEMENTARY INFORMATION: On
October 19, 2016, FDA approved the
BLA for LARTRUVO (olaratumab)
injection held by Eli Lilly and Co. (Eli
Lilly), Lilly Corporate Center,
Indianapolis, IN 46285, indicated, in
combination with doxorubicin, for the
treatment of adult patients with soft
tissue sarcoma with a histologic subtype
for which an anthracycline-containing
regimen is appropriate and which is not
amenable to curative treatment with
radiotherapy or surgery, under the
Agency’s accelerated approval
regulations at 21 CFR part 601, subpart
E. On January 18, 2019, Eli Lilly
reported in a press release that the
confirmatory study required as a
condition of LARTRUO’s accelerated
approval, entitled ‘‘Randomized,
Double-Blind, Placebo-Controlled,
Phase 3 Trial of Doxorubicin Plus
Olaratumab Versus Doxorubicin Plus
Placebo in Patients With Advanced or
Metastatic Soft Tissue Sarcoma’’
(ANNOUNCE trial), ‘‘did not meet the
primary endpoints of overall survival in
the full study population or in the
leiomyosarcoma subpopulation.’’ On
September 27, 2019, Eli Lilly requested
withdrawal (revocation), in writing, of
the BLA for LARTRUVO (olaratumab)
injection (BLA 761038) under § 601.5(a)
(21 CFR 601.5(a)) because the
ANNOUNCE trial failed to demonstrate
improvement in overall survival for
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olaratumab in combination with
doxorubicin compared to doxorubicin
alone. In that letter, Eli Lilly waived its
opportunity for a hearing. On February
25, 2020, the Agency issued a letter to
Eli Lilly revoking the approval to
manufacture and market LARTRUVO
(olaratumab) injection (BLA 761038).
Therefore, under § 601.5(a), the
Agency revoked the BLA for
LARTRUVO (olaratumab) injection
(BLA 761038), applicable as of February
25, 2020.
Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15516 Filed 7–16–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1647]
Science Advisory Board to the
National Center for Toxicological
Research Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Science Advisory Board (SAB) to the
National Center for Toxicological
Research (NCTR). The general function
of the committee is to provide advice
and recommendations to the Agency on
research being conducted at the NCTR.
At least one portion of the meeting will
be closed to the public.
DATES: The meeting will be held on
August 18, 2020, from 8 a.m. to 5:55
p.m. (CST), and on August 19, 2020,
from 8 a.m. to 11:30 a.m. (CST).
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. The meeting will be
webcast both days and will be available
at the following link: https://
collaboration.fda.gov/nctr1000/.
FOR FURTHER INFORMATION CONTACT:
Donna Mendrick, National Center for
Toxicological Research, Food and Drug
SUMMARY:
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43587
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 2208, Silver Spring,
MD 20993–0002, 301–796–8892, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On August 18, 2020, the SAB
Chair will welcome the participants,
and the NCTR Director will provide a
Center-wide update on scientific
initiatives and accomplishments during
the past year. The SAB will be
presented with an overview of the SAB
Subcommittee Site Visit Report and a
response to this review. The Center for
Biologics Evaluation and Research,
Center for Drug Evaluation and
Research, Center for Devices and
Radiological Health, Center for Food
Safety and Applied Nutrition, Center for
Tobacco Products, and Office of
Regulatory Affairs will each briefly
discuss their specific research strategic
needs and potential areas of
collaboration.
On August 19, 2020, there will be
updates from the NCTR Research
Divisions and a public comment
session. Following an open discussion
of all the information presented, the
open session of the meeting will close
so the SAB members can discuss
personnel issues at the NCTR at the end
of the day.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On August 18, 2020, from
8 a.m. to 5:55 p.m., and on August 19,
2020, from 8 a.m. to 11:30 a.m. (CST),
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43588
Federal Register / Vol. 85, No. 138 / Friday, July 17, 2020 / Notices
the meeting is open to the public.
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
August 11, 2020. Oral presentations
from the public will be scheduled
between approximately 1 p.m. and 2
p.m. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 3, 2020. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 4, 2020.
Closed Committee Deliberations: On
August 18, 2020, from 11:30 a.m. to 12
p.m. (CST), the meeting will be closed
to permit discussion where disclosure
would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). This portion of the meeting
will be closed to permit discussion of
information concerning individuals
associated with the research programs at
the NCTR.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Donna
Mendrick at least 14 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15524 Filed 7–16–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Renewal for the Advisory
Commission on Childhood Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, HHS
is hereby giving notice that the Advisory
Commission on Childhood Vaccines
(ACCV) charter has been renewed. The
effective date of the renewed charter is
July 20, 2020.
FOR FURTHER INFORMATION CONTACT:
Tamara Overby, Designated Federal
Officer, Healthcare Systems Bureau,
HRSA, 5600 Fishers Lane, 08N186A,
Rockville, Maryland 20857; 301–443–
3766; or toverby@hrsa.gov.
SUPPLEMENTARY INFORMATION: The ACCV
was established by section 2119 of the
Public Health Service Act (the Act) (42
U.S.C. 300aa–19), as enacted by Public
Law (Pub. L.) 99–660, and as
subsequently amended, and advises the
Secretary of Health and Human Services
(the Secretary) on issues related to the
implementation of the National Vaccine
Injury Compensation Program (VICP).
Other activities of the ACCV include:
Recommending changes in the Vaccine
Injury Table at its own initiative or as
the result of the filing of a petition;
advising the Secretary in implementing
section 2127 of the Act regarding the
need for childhood vaccination
products that result in fewer or no
significant adverse reactions; surveying
federal, state, and local programs and
activities related to gathering
information on injuries associated with
the administration of childhood
vaccines, including the adverse reaction
reporting requirements of section
2125(b) of the Act; advising the
Secretary on the methods of obtaining,
compiling, publishing, and using
credible data related to the frequency
and severity of adverse reactions
associated with childhood vaccines;
consulting on the development or
revision of Vaccine Information
Statements; and recommending to the
Director of the National Vaccine
Program research related to vaccine
injuries which should be conducted to
carry out the VICP.
The renewed charter for the ACCV
was approved on July 20, 2020, which
will also stand as the filing date.
Renewal of the ACCV charter gives
SUMMARY:
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authorization for the commission to
operate until July 20, 2022.
A copy of the ACCV charter is
available on the ACCV’s website at
https://www.hrsa.gov/advisorycommittees/vaccines/. A
copy of the charter also can be obtained
by accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
website address for the FACA database
is https://www.facadatabase.gov/.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–15494 Filed 7–16–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice of a virtual meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will be
holding the 68th full Council meeting
utilizing virtual technology. PACHA
members will be discussing novel
coronavirus (COVID–19) and HIV, and
Ready, Set, PrEP enrollment. The
meeting will be open to the public; a
public comment session will be held
during the meeting. Pre-registration is
required to provide public comment.
DATES: The meeting will be held on
Thursday, August 6, from
approximately 3:00 p.m. to 5:00 p.m.
(ET). This meeting will be conducted
utilizing virtual technology.
ADDRESSES: Instructions regarding
attending this meeting virtually will be
posted one week prior to the meeting at:
https://www.hiv.gov/federal-response/
pacha/about-pacha.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, MPA, Public Health
Analyst, Presidential Advisory Council
on HIV/AIDS, 330 C Street SW, Room
L609A, Washington, DC 20024; (202)
795–7622 or PACHA@hhs.gov.
Additional information can be obtained
by accessing the Council’s page on the
HIV.gov site at www.hiv.gov/pacha.
SUPPLEMENTARY INFORMATION:
Individuals who wish to participate in
the meeting and/or provide public
SUMMARY:
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Agencies
[Federal Register Volume 85, Number 138 (Friday, July 17, 2020)]
[Notices]
[Pages 43587-43588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15524]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1647]
Science Advisory Board to the National Center for Toxicological
Research Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Science Advisory
Board (SAB) to the National Center for Toxicological Research (NCTR).
The general function of the committee is to provide advice and
recommendations to the Agency on research being conducted at the NCTR.
At least one portion of the meeting will be closed to the public.
DATES: The meeting will be held on August 18, 2020, from 8 a.m. to 5:55
p.m. (CST), and on August 19, 2020, from 8 a.m. to 11:30 a.m. (CST).
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. The meeting will be webcast both
days and will be available at the following link: https://collaboration.fda.gov/nctr1000/.
FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for
Toxicological Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-
796-8892, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area). A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On August 18, 2020, the SAB Chair will welcome the
participants, and the NCTR Director will provide a Center-wide update
on scientific initiatives and accomplishments during the past year. The
SAB will be presented with an overview of the SAB Subcommittee Site
Visit Report and a response to this review. The Center for Biologics
Evaluation and Research, Center for Drug Evaluation and Research,
Center for Devices and Radiological Health, Center for Food Safety and
Applied Nutrition, Center for Tobacco Products, and Office of
Regulatory Affairs will each briefly discuss their specific research
strategic needs and potential areas of collaboration.
On August 19, 2020, there will be updates from the NCTR Research
Divisions and a public comment session. Following an open discussion of
all the information presented, the open session of the meeting will
close so the SAB members can discuss personnel issues at the NCTR at
the end of the day.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: On August 18, 2020, from 8 a.m. to 5:55 p.m., and on
August 19, 2020, from 8 a.m. to 11:30 a.m. (CST),
[[Page 43588]]
the meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person on
or before August 11, 2020. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before August 3, 2020. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by August 4, 2020.
Closed Committee Deliberations: On August 18, 2020, from 11:30 a.m.
to 12 p.m. (CST), the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be
closed to permit discussion of information concerning individuals
associated with the research programs at the NCTR.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Donna Mendrick at least 14 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15524 Filed 7-16-20; 8:45 am]
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