83 FR 53641 - Meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 206 (October 24, 2018)

Page Range		53641-53642
FR Document		2018-23185

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/index.html. This notice is being published less than 15 days prior to the meeting date due to unexpected administrative delays.

Federal Register, Volume 83 Issue 206 (Wednesday, October 24, 2018)

[Federal Register Volume 83, Number 206 (Wednesday, October 24, 2018)]
[Notices]
[Pages 53641-53642]
From the Federal Register Online  [www.thefederalregister.org]
[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/index.html. 
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/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]
 BILLING CODE 4165-15-P

Federal Register / Vol. 83, No. 206 / Wednesday, October 24, 2018 / Notices 53641

toward the actual amount of extension U.S.C. 262): February 24, 2016. The DEPARTMENT OF HEALTH AND
that the Director of USPTO may award applicant claims December 10, 2015, as HUMAN SERVICES
(for example, half the testing phase must the date the biologics license
be subtracted as well as any time that application (BLA) for LARTRUVO (BLA Health Resources and Service
may have occurred before the patent 761038) was initially submitted. Administration
was issued), FDA’s determination of the However, FDA records indicate that
length of a regulatory review period for Meeting of the Advisory Committee on
BLA 761038 was submitted on February
a human biological product will include Interdisciplinary, Community-Based
24, 2016. Linkages
all the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B). 3. The date the application was
approved: October 19, 2016. FDA has AGENCY: Health Resources and Service
FDA has approved for marketing the
verified the applicant’s claim that BLA Administration (HRSA), Department of
human biologic product LARTRUVO
761038 was approved on October 19, Health and Human Services (HHS).
(olaratumab). LARTRUVO is a platelet-
derived growth factor receptor alpha 2016. ACTION: Notice.
blocking antibody indicated, in This determination of the regulatory SUMMARY: The Advisory Committee on
combination with doxorubicin, for the review period establishes the maximum Interdisciplinary, Community-Based
treatment of adult patients with soft potential length of a patent extension. Linkages (ACICBL) has scheduled a
tissue sarcoma with a histologic subtype However, the USPTO applies several public meeting. Information about the
for which an anthracycline-containing ACICBL is located on the ACICBL
statutory limitations in its calculations
regimen is appropriate and which is not
of the actual period for patent extension. website at https://www.hrsa.gov/
amenable to curative treatment with
In its application for patent extension, advisory-committees/interdisciplinary-
radiotherapy or surgery. This indication
this applicant seeks 1,003 days of patent community-linkages/index.html. This
is approved under accelerated approval.
term extension. notice is being published less than 15
Continued approval for this indication
days prior to the meeting date due to
may be contingent upon verification and III. Petitions unexpected administrative delays.
description of clinical benefit in the
confirmatory trial. Subsequent to this Anyone with knowledge that any of DATES: October 30, 2018 from 11:00
approval, the USPTO received a patent the dates as published are incorrect may a.m.–5:00 p.m. ET.
term restoration application for submit either electronic or written ADDRESSES: This meeting will be held
LARTRUVO (U.S. Patent No. 8,128,929) comments and, under 21 CFR 60.24, ask through teleconference and webinar.
from Imclone LLC, and the USPTO for a redetermination (see DATES). The conference call-in number is 1–
requested FDA’s assistance in Furthermore, as specified in § 60.30 (21 888–455–0640; passcode: HRSA
determining this patent’s eligibility for CFR 60.30), any interested person may COUNCIL. The webinar link is https://
patent term restoration. In a letter dated petition FDA for a determination hrsa.connectsolutions.com/acicbl.
November 6, 2017, FDA advised the regarding whether the applicant for FOR FURTHER INFORMATION CONTACT: Joan
USPTO that this human biological Weiss, Ph.D., RN, CRNP, FAAN, Senior
extension acted with due diligence
product had undergone a regulatory Advisor and Designated Federal Official
during the regulatory review period. To
review period and that the approval of (DFO), Division of Medicine and
LARTRUVO represented the first meet its burden, the petition must
comply with all the requirements of Dentistry, HRSA, 5600 Fishers Lane,
permitted commercial marketing or use Room 15N39, Rockville, Maryland
of the product. Thereafter, the USPTO § 60.30, including, but not limited to:
20857; 301–443–0430; or jweiss@
requested that FDA determine the Must be timely (see DATES), must be
hrsa.gov.
product’s regulatory review period. filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA SUPPLEMENTARY INFORMATION: ACICBL
II. Determination of Regulatory Review investigation, and must certify that a provides advice and recommendations
Period true and complete copy of the petition to the Secretary of HHS (Secretary) and
FDA has determined that the has been served upon the patent submits an annual report to the
applicable regulatory review period for applicant. (See H. Rept. 857, part 1, 98th Secretary and Congress on a broad range
LARTRUVO is 3,766 days. Of this time, Cong., 2d sess., pp. 41–42, 1984.) of issues relating to grant programs
3,527 days occurred during the testing Petitions should be in the format authorized by Sections 750–760, Title
phase of the regulatory review period, specified in 21 CFR 10.30. VII, Part D of the Public Health Service
while 239 days occurred during the Act (PHS Act).
approval phase. These periods of time Submit petitions electronically to During the October 30 meeting,
were derived from the following dates: https://www.regulations.gov at Docket ACICBL members will discuss possible
1. The date an exemption under No. FDA–2013–S–0610. Submit written topics to work on for fiscal year 2019.
section 505(i) of the Federal Food, Drug, petitions (two copies are required) to the Under Section 757 of the PHS Act,
and Cosmetic Act (21 U.S.C. 355(i)) Dockets Management Staff (HFA–305), ACICBL submits annual reports to the
became effective: June 30, 2006. The Food and Drug Administration, 5630 Secretary, the Committee on Health,
applicant claims July 1, 2006, as the Fishers Lane, Rm. 1061, Rockville, MD Education, Labor, and Pensions of the
date the investigational new drug 20852. Senate, and the Committee on Energy
application (IND) became effective. Dated: October 19, 2018.
and Commerce of the House of
However, FDA records indicate that the Representatives. Not later than 14 days
amozie on DSK3GDR082PROD with NOTICES1

Leslie Kux,
IND effective date was June 30, 2006, prior to the convening of the meeting,
which was 30 days after FDA receipt of Associate Commissioner for Policy. ACICBL shall prepare and make
the IND. [FR Doc. 2018–23219 Filed 10–23–18; 8:45 am] available an agenda of the matters to be
2. The date the application was BILLING CODE 4164–01–P considered by ACICBL at the meeting.
initially submitted with respect to the The agenda will be posted on the
human biological product under section ACICBL website at https://
351 of the Public Health Service Act (42 www.hrsa.gov/advisory-committees/

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53642 Federal Register / Vol. 83, No. 206 / Wednesday, October 24, 2018 / Notices

interdisciplinary-community-linkages/ SUPPLEMENTARY INFORMATION: AMSC. In accordance with 33 CFR 103,
index.html. Agenda items are subject to members may be selected from Federal,
Authority
change as priorities dictate. Refer to the Territorial, or Tribal governments; State
ACICBL website for any updated Section 102 of the Maritime government and political subdivisions
information concerning the meeting. Transportation Security Act (MTSA) of of the State; local public safety, crisis
Members of the public will have the 2002 (Pub. L. 107–295) added section management, and emergency response
opportunity to provide comments. Oral 70112 to Title 46 of the U.S. Code, and agencies; law enforcement and security
comments will be honored in the order authorized the Secretary of the organizations; maritime industry,
they are requested and may be limited Department in which the Coast Guard is including labor; other port stakeholders
as time allows. Requests to make oral operating to establish Area Maritime having a special competence in
comments or provide written comments Security Advisory Committees for any maritime security; and port stakeholders
to ACICBL should be sent to Joan Weiss, port area of the United States. (See 33 affected by security practices and
DFO, using the contact information U.S.C. 1226; 46 U.S.C.; 33 CFR 1.05–1, policies.
above at least 3 business days prior to 6.01; Department of Homeland Security The Department of Homeland
the meeting. Delegation No. 0170.1.) The MTSA Security does not discriminate in
includes a provision exempting these selection of committee members on the
Amy P. McNulty, AMSCs from the Federal Advisory basis of race, color, religion, sex,
Acting Director, Division of the Executive Committee Act (FACA), Public Law 92– national origin, political affiliation,
Secretariat. 436, 86 Stat. 470 (5 U.S.C. App.2). The sexual orientation, gender identity,
[FR Doc. 2018–23185 Filed 10–23–18; 8:45 am] AMSCs shall assist the Federal Maritime marital status, disability, and genetic
BILLING CODE 4165–15–P Security Coordinator in the information, age, membership in an
development, review, update, and employee organization, or any other
exercising of the Area Maritime Security non-merit factor. The Department of
DEPARTMENT OF HOMELAND Plan for their area of responsibility. Homeland Security strives to achieve a
SECURITY Such matters may include, but are not widely diverse candidate pool for all of
limited to: Identifying critical port its recruitment actions.
Coast Guard infrastructure and operations;
Identifying risks (threats, Request for Applications
[Docket No. USCG–2018–0963] vulnerabilities, and consequences); Those seeking membership are not
Determining mitigation strategies and required to submit formal applications
Area Maritime Security Advisory
implementation methods; Developing to the local Captain of the Port,
Committee (AMSC), Eastern Great
strategies to facilitate the recovery of the however, because we do have an
Lakes Northwestern Pennsylvania Maritime Transportation System after a
Regional Sub-Committee Vacancy obligation to ensure that a specific
Transportation Security Incident; number of members have the
AGENCY:Coast Guard, DHS. Developing and describing the process prerequisite maritime security
Notice of Solicitation for
ACTION:
to continually evaluate overall port experience, we encourage the
Membership. security by considering consequences submission of resumes highlighting
and vulnerabilities, how they may experience in the maritime and security
SUMMARY: This notice requests change over time, and what additional industries.
individuals interested in serving on the mitigation strategies can be applied; and
Dated: October 18, 2018.
AMSC, Eastern Great Lakes regional Providing advice to, and assisting the
J.S. DuFresne,
sub-committee Northwestern Federal Maritime Security Coordinator
in developing and maintaining the Area Captain, U.S. Coast Guard, Captain of the
Pennsylvania Region submit their Port/Federal Maritime Security Coordinator,
applications for membership to the Maritime Security Plan.
Buffalo.
Captain of the Port, Buffalo. The AMSC Membership [FR Doc. 2018–23243 Filed 10–23–18; 8:45 am]
Committee assists the Captain of the
Port as the Federal Maritime Security Members of the AMSC should have at BILLING CODE 9110–04–P

Coordinator (FMSC), Buffalo, in least five years of experience related to
developing, reviewing, and updating the maritime or port security operations.
The Northwestern Pennsylvania Region DEPARTMENT OF HOMELAND
Area Maritime Security Plan (AMSP) for SECURITY
their area of responsibility. Sub-Committee of the Eastern Great
Lakes AMSC has 23 members. We are Coast Guard
DATES: Requests for membership should
seeking to fill one (1) vacancy with this
reach the U.S. Coast Guard Captain of [Docket No. USCG–2018–0790]
solicitation, an Executive Board member
the Port, Buffalo, by November 23, 2018.
to serve as Vice-Chairperson of the Sub-
ADDRESSES: Applications for Committee and concurrently as a Information Collection Request to
membership should be submitted to the member of the Eastern Great Lakes Office of Management and Budget;
Captain of the Port at the following AMSC when so convened by the FMSC. OMB Control Number: 1625–0006
address: Captain of the Port, Buffalo, Applicants may be required to pass an AGENCY:Coast Guard, DHS.
Attention: LCDR Marvin Kimmel, 1 appropriate security background check
Fuhrmann Boulevard, Buffalo, NY Sixty-day notice requesting
ACTION:
prior to appointment to the committee. comments.
14203–3189. Applicants must register with and
amozie on DSK3GDR082PROD with NOTICES1

FOR FURTHER INFORMATION CONTACT: For remain active as a Coast Guard SUMMARY: In compliance with the
questions about submitting an Homeport user if appointed. Member’s Paperwork Reduction Act of 1995, the
application, or about the AMSC in term of office will be for five years; U.S. Coast Guard intends to submit an
general, contact Mr. Joseph Fetscher, however, a member is eligible to serve Information Collection Request (ICR) to
Northwestern Pennsylvania Region Sub- additional terms of office. Members will the Office of Management and Budget
Committee Executive Coordinator, at not receive any salary or other (OMB), Office of Information and
216–937–0126. compensation for their service on an Regulatory Affairs (OIRA), requesting an

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Document Created: 2018-10-24 00:23:22
Document Modified: 2018-10-24 00:23:22

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		October 30, 2018 from 11:00 a.m.-5:00 p.m. ET.
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]
FR Citation		83 FR 53641

83 FR 53641 - Meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 83, Issue 206 (October 24, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration