Meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages, 53641-53642 [2018-23185]
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Federal Register / Vol. 83, No. 206 / Wednesday, October 24, 2018 / Notices
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toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human biologic product LARTRUVO
(olaratumab). LARTRUVO is a plateletderived growth factor receptor alpha
blocking antibody 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. This indication
is approved under accelerated approval.
Continued approval for this indication
may be contingent upon verification and
description of clinical benefit in the
confirmatory trial. Subsequent to this
approval, the USPTO received a patent
term restoration application for
LARTRUVO (U.S. Patent No. 8,128,929)
from Imclone LLC, and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
November 6, 2017, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
LARTRUVO represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
LARTRUVO is 3,766 days. Of this time,
3,527 days occurred during the testing
phase of the regulatory review period,
while 239 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: June 30, 2006. The
applicant claims July 1, 2006, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 30, 2006,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
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17:43 Oct 23, 2018
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U.S.C. 262): February 24, 2016. The
applicant claims December 10, 2015, as
the date the biologics license
application (BLA) for LARTRUVO (BLA
761038) was initially submitted.
However, FDA records indicate that
BLA 761038 was submitted on February
24, 2016.
3. The date the application was
approved: October 19, 2016. FDA has
verified the applicant’s claim that BLA
761038 was approved on October 19,
2016.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,003 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including, but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: October 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23219 Filed 10–23–18; 8:45 am]
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53641
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Meeting of the Advisory Committee on
Interdisciplinary, Community-Based
Linkages
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Advisory Committee on
Interdisciplinary, Community-Based
Linkages (ACICBL) has scheduled a
public meeting. Information about the
ACICBL is located on the ACICBL
website at https://www.hrsa.gov/
advisory-committees/interdisciplinarycommunity-linkages/. This
notice is being published less than 15
days prior to the meeting date due to
unexpected administrative delays.
DATES: October 30, 2018 from 11:00
a.m.–5:00 p.m. ET.
ADDRESSES: This meeting will be held
through teleconference and webinar.
The conference call-in number is 1–
888–455–0640; passcode: HRSA
COUNCIL. The webinar link is https://
hrsa.connectsolutions.com/acicbl.
FOR FURTHER INFORMATION CONTACT: Joan
Weiss, Ph.D., RN, CRNP, FAAN, Senior
Advisor and Designated Federal Official
(DFO), Division of Medicine and
Dentistry, HRSA, 5600 Fishers Lane,
Room 15N39, Rockville, Maryland
20857; 301–443–0430; or jweiss@
hrsa.gov.
SUMMARY:
ACICBL
provides advice and recommendations
to the Secretary of HHS (Secretary) and
submits an annual report to the
Secretary and Congress on a broad range
of issues relating to grant programs
authorized by Sections 750–760, Title
VII, Part D of the Public Health Service
Act (PHS Act).
During the October 30 meeting,
ACICBL members will discuss possible
topics to work on for fiscal year 2019.
Under Section 757 of the PHS Act,
ACICBL submits annual reports to the
Secretary, the Committee on Health,
Education, Labor, and Pensions of the
Senate, and the Committee on Energy
and Commerce of the House of
Representatives. Not later than 14 days
prior to the convening of the meeting,
ACICBL shall prepare and make
available an agenda of the matters to be
considered by ACICBL at the meeting.
The agenda will be posted on the
ACICBL website at https://
www.hrsa.gov/advisory-committees/
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 83, No. 206 / Wednesday, October 24, 2018 / Notices
interdisciplinary-community-linkages/
index.html. Agenda items are subject to
change as priorities dictate. Refer to the
ACICBL website for any updated
information concerning the meeting.
Members of the public will have the
opportunity to provide comments. Oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to make oral
comments or provide written comments
to ACICBL should be sent to Joan Weiss,
DFO, using the contact information
above at least 3 business days prior to
the meeting.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–23185 Filed 10–23–18; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2018–0963]
Area Maritime Security Advisory
Committee (AMSC), Eastern Great
Lakes Northwestern Pennsylvania
Regional Sub-Committee Vacancy
Coast Guard, DHS.
Notice of Solicitation for
Membership.
AGENCY:
ACTION:
This notice requests
individuals interested in serving on the
AMSC, Eastern Great Lakes regional
sub-committee Northwestern
Pennsylvania Region submit their
applications for membership to the
Captain of the Port, Buffalo. The
Committee assists the Captain of the
Port as the Federal Maritime Security
Coordinator (FMSC), Buffalo, in
developing, reviewing, and updating the
Area Maritime Security Plan (AMSP) for
their area of responsibility.
DATES: Requests for membership should
reach the U.S. Coast Guard Captain of
the Port, Buffalo, by November 23, 2018.
ADDRESSES: Applications for
membership should be submitted to the
Captain of the Port at the following
address: Captain of the Port, Buffalo,
Attention: LCDR Marvin Kimmel, 1
Fuhrmann Boulevard, Buffalo, NY
14203–3189.
FOR FURTHER INFORMATION CONTACT: For
questions about submitting an
application, or about the AMSC in
general, contact Mr. Joseph Fetscher,
Northwestern Pennsylvania Region SubCommittee Executive Coordinator, at
216–937–0126.
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SUPPLEMENTARY INFORMATION:
Authority
Section 102 of the Maritime
Transportation Security Act (MTSA) of
2002 (Pub. L. 107–295) added section
70112 to Title 46 of the U.S. Code, and
authorized the Secretary of the
Department in which the Coast Guard is
operating to establish Area Maritime
Security Advisory Committees for any
port area of the United States. (See 33
U.S.C. 1226; 46 U.S.C.; 33 CFR 1.05–1,
6.01; Department of Homeland Security
Delegation No. 0170.1.) The MTSA
includes a provision exempting these
AMSCs from the Federal Advisory
Committee Act (FACA), Public Law 92–
436, 86 Stat. 470 (5 U.S.C. App.2). The
AMSCs shall assist the Federal Maritime
Security Coordinator in the
development, review, update, and
exercising of the Area Maritime Security
Plan for their area of responsibility.
Such matters may include, but are not
limited to: Identifying critical port
infrastructure and operations;
Identifying risks (threats,
vulnerabilities, and consequences);
Determining mitigation strategies and
implementation methods; Developing
strategies to facilitate the recovery of the
Maritime Transportation System after a
Transportation Security Incident;
Developing and describing the process
to continually evaluate overall port
security by considering consequences
and vulnerabilities, how they may
change over time, and what additional
mitigation strategies can be applied; and
Providing advice to, and assisting the
Federal Maritime Security Coordinator
in developing and maintaining the Area
Maritime Security Plan.
AMSC Membership
Members of the AMSC should have at
least five years of experience related to
maritime or port security operations.
The Northwestern Pennsylvania Region
Sub-Committee of the Eastern Great
Lakes AMSC has 23 members. We are
seeking to fill one (1) vacancy with this
solicitation, an Executive Board member
to serve as Vice-Chairperson of the SubCommittee and concurrently as a
member of the Eastern Great Lakes
AMSC when so convened by the FMSC.
Applicants may be required to pass an
appropriate security background check
prior to appointment to the committee.
Applicants must register with and
remain active as a Coast Guard
Homeport user if appointed. Member’s
term of office will be for five years;
however, a member is eligible to serve
additional terms of office. Members will
not receive any salary or other
compensation for their service on an
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AMSC. In accordance with 33 CFR 103,
members may be selected from Federal,
Territorial, or Tribal governments; State
government and political subdivisions
of the State; local public safety, crisis
management, and emergency response
agencies; law enforcement and security
organizations; maritime industry,
including labor; other port stakeholders
having a special competence in
maritime security; and port stakeholders
affected by security practices and
policies.
The Department of Homeland
Security does not discriminate in
selection of committee members on the
basis of race, color, religion, sex,
national origin, political affiliation,
sexual orientation, gender identity,
marital status, disability, and genetic
information, age, membership in an
employee organization, or any other
non-merit factor. The Department of
Homeland Security strives to achieve a
widely diverse candidate pool for all of
its recruitment actions.
Request for Applications
Those seeking membership are not
required to submit formal applications
to the local Captain of the Port,
however, because we do have an
obligation to ensure that a specific
number of members have the
prerequisite maritime security
experience, we encourage the
submission of resumes highlighting
experience in the maritime and security
industries.
Dated: October 18, 2018.
J.S. DuFresne,
Captain, U.S. Coast Guard, Captain of the
Port/Federal Maritime Security Coordinator,
Buffalo.
[FR Doc. 2018–23243 Filed 10–23–18; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2018–0790]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0006
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting an
SUMMARY:
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[Federal Register Volume 83, Number 206 (Wednesday, October 24, 2018)]
[Notices]
[Pages 53641-53642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23185]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Service Administration
Meeting of the Advisory Committee on Interdisciplinary,
Community-Based Linkages
AGENCY: Health Resources and Service Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Advisory Committee on Interdisciplinary, Community-Based
Linkages (ACICBL) has scheduled a public meeting. Information about the
ACICBL is located on the ACICBL website at https://www.hrsa.gov/advisory-committees/interdisciplinary-community-linkages/.
This notice is being published less than 15 days prior to the meeting
date due to unexpected administrative delays.
DATES: October 30, 2018 from 11:00 a.m.-5:00 p.m. ET.
ADDRESSES: This meeting will be held through teleconference and
webinar. The conference call-in number is 1-888-455-0640; passcode:
HRSA COUNCIL. The webinar link is https://hrsa.connectsolutions.com/acicbl.
FOR FURTHER INFORMATION CONTACT: Joan Weiss, Ph.D., RN, CRNP, FAAN,
Senior Advisor and Designated Federal Official (DFO), Division of
Medicine and Dentistry, HRSA, 5600 Fishers Lane, Room 15N39, Rockville,
Maryland 20857; 301-443-0430; or [email protected].
SUPPLEMENTARY INFORMATION: ACICBL provides advice and recommendations
to the Secretary of HHS (Secretary) and submits an annual report to the
Secretary and Congress on a broad range of issues relating to grant
programs authorized by Sections 750-760, Title VII, Part D of the
Public Health Service Act (PHS Act).
During the October 30 meeting, ACICBL members will discuss possible
topics to work on for fiscal year 2019. Under Section 757 of the PHS
Act, ACICBL submits annual reports to the Secretary, the Committee on
Health, Education, Labor, and Pensions of the Senate, and the Committee
on Energy and Commerce of the House of Representatives. Not later than
14 days prior to the convening of the meeting, ACICBL shall prepare and
make available an agenda of the matters to be considered by ACICBL at
the meeting. The agenda will be posted on the ACICBL website at https:/
/www.hrsa.gov/advisory-committees/
[[Page 53642]]
interdisciplinary-community-linkages/. Agenda items are
subject to change as priorities dictate. Refer to the ACICBL website
for any updated information concerning the meeting. Members of the
public will have the opportunity to provide comments. Oral comments
will be honored in the order they are requested and may be limited as
time allows. Requests to make oral comments or provide written comments
to ACICBL should be sent to Joan Weiss, DFO, using the contact
information above at least 3 business days prior to the meeting.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-23185 Filed 10-23-18; 8:45 am]
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