Delegation of Authorities, 62149-62150 [2016-21504]
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Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
to provide advice to the Commissioner.
The Oncologic Drugs Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
as required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cancer and
makes appropriate recommendations to
the Commissioner of Food and Drugs.
The Committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of general
oncology, pediatric oncology,
hematologic oncology, immunology
oncology, biostatistics, and other related
professions. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
OncologicDrugsAdvisoryCommittee/
ucm107395.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: September 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21550 Filed 9–7–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on the
National Health Service Corps; Notice
of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
the National Health Service Corps
(NACNHSC).
Dates and Times: September 28, 2016
12:00 p.m.–3:30 p.m. EST.
Place: U.S. Department of Health and
Human Services, Health Resources and
Services Administration, 5600 Fishers
Lane, Rockville, Maryland 20857,
Conference Call Format.
Status: This advisory council meeting
will be open to the public.
Purpose: The NACNHSC makes
recommendations with respect to their
responsibilities under Subpart II, Part D
of Title III of the Public Health Service
Act, as amended (National Health
Service Corps and Health Professional
Shortage Area Designations), and shall
review and comment upon regulations
promulgated by the Secretary under
Subpart II.
Agenda: The NACNHSC has
concluded its discussion for Fiscal Year
2016 and will present its formal
recommendations for each priority area.
The Council will discuss policy
recommendations for the National
Health Service Corps scholarship and
loan repayment programs with respect
to clinician recruitment and retention in
underserved communities throughout
the service areas of the NHSC,
telehealth, Medication Assisted
Treatment (MAT) certification,
mentorship, and NHSC discipline
expansion, specifically for mental and
behavioral, and oral health providers.
The content of the agenda is subject
to change prior to the meeting. The
NACNHAC final agenda will be
available 3 days in advance of the
meeting at https://nhsc.hrsa.gov/
corpsexperience/aboutus/
nationaladvisorycouncil/
meetingsummaries/.
SUPPLEMENTARY INFORMATION: Further
information regarding the NACNHSC,
including the roster of members and
past meetings summaries, is available at
https://nhsc.hrsa.gov/corpsexperience/
aboutus/nationaladvisorycouncil/
index.html. Members of the public and
interested parties may request to
participate in the meeting by contacting
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62149
Monica-Tia Bullock via email at
MBullock@hrsa.gov.
• The conference call-in number is 1–
800–619–2521. Passcode: 9271697.
• The webinar link is https://
hrsa.connectsolutions.com/nacnhsc.
Public participants may submit
written statements in advance of the
scheduled meeting. If you would like to
provide oral public comment during the
meeting please register with Monica-Tia
Bullock at MBullock@hrsa.gov. Public
comment will be limited to 3 minutes
per speaker. Statements and comments
can be addressed to Monica-Tia Bullock
by emailing her at MBullock@hrsa.gov.
In addition, please be advised that
committee members are given copies of
all written statements submitted from
the public. Any further public
participation will be solely at the
discretion of the Chair, with approval of
the DFO. Registration through the
designated contact for the public
comment session is required.
Individuals who need reasonable
accommodations should contact
Monica-Tia Bullock at least 10 days
prior to the meeting.
FOR FURTHER INFORMATION CONTACT:
Anyone requesting information
regarding the NACNHSC should contact
CAPT Jeanean Willis-Marsh, Director,
Division of National Health Service
Corps, Bureau of Health Workforce,
Health Resources and Services
Administration, in one of three ways: (1)
Send a request to the following address:
CAPT Jeanean Willis-Marsh, Director,
Division of National Health Service
Corps, Bureau of Health Workforce,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 14N108, Rockville, Maryland
20857; (2) call (301) 443–4494; or (3)
send an email to jwillis@hrsa.gov.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–21581 Filed 9–7–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Delegation of Authorities
Notice is hereby given that I have
delegated to the Commissioner of Food
and Drugs (the Commissioner) the
authorities vested in the Secretary of the
Department of Health and Human
Services under sections 102(b)(2), (c);
103(b), (c), (d), (h); 104; 105(b); 106(b),
(c); 113(b); 114(d); 115; 201(c); 202(b);
204; 205(b)(2), (c); 206(b); 207(b); 304(b);
305; 306(b); 308; and 309 of the FDA
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Federal Register / Vol. 81, No. 174 / Thursday, September 8, 2016 / Notices
Food Safety Modernization Act (FSMA
or the Act), which relate to the functions
of the Food and Drug Administration.
This authority may be redelegated.
This authority will be exercised in
accordance with the Department of
Health and Human Services applicable
policies, procedures, guideline, and
regulations.
I hereby ratify and affirm any actions
taken the Commissioner, or the
Commissioner’s subordinates, that
involved the exercise of the authority
delegated herein prior to the effective
date of this delegation.
This delegation is effective upon date
of signature.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016–21504 Filed 9–7–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases Notice of Closed
Meeting
mstockstill on DSK3G9T082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Peer Review Meeting.
Date: October 5, 2016.
Time: 10:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
4H200A/B, 5601 Fishers Lane, Rockville, MD
20892 (Telephone Conference Call).
Contact Person: Maryam Feili-Hariri,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institutes of Health/
NIAID, 5601 Fishers Lane, Rockville, MD
20852, 240–669–5026, haririmf@
niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
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Dated: September 2, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–21616 Filed 9–7–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Cellular Signaling
and Regulatory Systems Study Section,
September 29, 2016, 08:00 a.m. to
September 29, 2017, 06:00 p.m.,
Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814
which was published in the Federal
Register on August 31, 2016, 81 FR PG
60010.
The end date is September 29, 2016
instead of September 29, 2017. The
meeting location remains the same. The
meeting is closed to the public.
Dated: September 1, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–21514 Filed 9–7–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Training
Grants.
Date: October 18, 2016.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2W200, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Jeannette L. Johnson,
Ph.D., National Institute on Aging, National
Institutes of Health, 7201 Wisconsin Avenue,
Suite 2W200, Bethesda, MD 20892, 301–402–
7705, JohnsonJ9@NIA.NIH.GOV.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: September 1, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–21516 Filed 9–7–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Announcement of Requirements and
Registration for ‘‘Antimicrobial
Resistance Rapid, Point-of-Need
Diagnostic Test’’ Challenge
Authority: 15 U.S.C. 3719.
Through the ‘‘Antimicrobial
Resistance Rapid, Point-of-Need
Diagnostic Test’’ Challenge (the
‘‘Challenge’’), the National Institutes of
Health (NIH) and the Biomedical
Advanced Research and Development
Authority (BARDA) of the Office of the
Assistant Secretary for Preparedness
and Response (ASPR) are searching for
novel and innovative in vitro diagnostic
tests that would rapidly inform clinical
treatment decisions and be of potential
significant clinical and public health
utility to combat the development and
spread of antibiotic resistant bacteria.
Tests of interest will provide novel,
innovative solutions for use in inpatient
and/or outpatient settings. The goal of
the challenge is to identify a diagnostic
test that when utilized would lead to
more rapid clinical decision making
such that antibiotic use and/or
outcomes of patients infected with
resistant pathogens are fundamentally
improved compared to current standard
of care, and/or reduce transmission of
resistant pathogens such that population
infection rates significantly decrease.
The Challenge competition seeks to
incentivize a broad range of scientists,
engineers, and innovators to develop
diagnostic tests that would enable
health care providers to make more
informed decisions on appropriate
antibiotic use and infection prevention.
This Challenge, structured in three
steps, will complement existing BARDA
and NIH research portfolios by reaching
SUMMARY:
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[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62149-62150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21504]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Delegation of Authorities
Notice is hereby given that I have delegated to the Commissioner of
Food and Drugs (the Commissioner) the authorities vested in the
Secretary of the Department of Health and Human Services under sections
102(b)(2), (c); 103(b), (c), (d), (h); 104; 105(b); 106(b), (c);
113(b); 114(d); 115; 201(c); 202(b); 204; 205(b)(2), (c); 206(b);
207(b); 304(b); 305; 306(b); 308; and 309 of the FDA
[[Page 62150]]
Food Safety Modernization Act (FSMA or the Act), which relate to the
functions of the Food and Drug Administration.
This authority may be redelegated. This authority will be exercised
in accordance with the Department of Health and Human Services
applicable policies, procedures, guideline, and regulations.
I hereby ratify and affirm any actions taken the Commissioner, or
the Commissioner's subordinates, that involved the exercise of the
authority delegated herein prior to the effective date of this
delegation.
This delegation is effective upon date of signature.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016-21504 Filed 9-7-16; 8:45 am]
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