Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 54795-54796 [2015-22920]
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Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Notices
meeting participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
All comments should be identified with
the docket number found in brackets in
the heading of this document.
FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/Drugs/
NewsEvents/ucm459342.htm.
FOR FURTHER INFORMATION CONTACT:
Christine Le, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3196, Silver Spring,
MD 20993, 301–796–2398, email:
Christine.Le@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
In general, HCs are highly effective in
preventing pregnancy when used
correctly. However, concomitant use of
other drugs may affect the safety and/or
efficacy of HCs due to drug interactions
affecting either blood levels (PK) and/or
physiologic effects (PD) of HC
components (e.g., estrogen and
progestins). Understanding drug
interaction potential of HCs and other
drugs is important when investigating
HC-related issues, and in the design and
conduct of clinical trials. Evolving
knowledge on drug interaction
mechanisms has led to new insights and
increased interest in the clinical
investigation of drug interactions with
HCs.
Historically, most drug interaction
studies conducted during drug
development with HCs have not had a
clearly stated rationale for the choice of
HCs being studied. Questions remain as
to whether the study results of specific
contraceptive steroids can be
extrapolated to other progestins or
estrogens or other dose strengths. The
choice of HC is important because
different progestins may have different
metabolic and/or transporter pathways
and safety profiles. Without a
mechanistic understanding of the
underlying drug-drug interaction (DDI)
mechanism, it is difficult to interpret
and extrapolate study results from one
HC to another.
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II. Discussion Topics for the Meeting
and for Public Comments
The public meeting on November 9,
2015, will include a discussion of the
following topics on which FDA is also
seeking public comment:
• Public health concerns associated
with use of HCs and interacting drugs
that might affect efficacy and safety.
• PK and PD considerations in
designing drug interaction studies with
HCs during drug development. Key
elements in designing a study include a
mechanistic understanding of potential
DDI mechanisms, the choice of
contraceptive products and their dose,
study population/duration, and proper
selection of a PK alone or PK–PD-based
drug interaction study approach.
• Drug interaction study result
interpretation and its potential impact
on guidance of HC use in women of
childbearing potential who are enrolled
in clinical trials for other therapeutic
agents during drug development.
• The current approach of translating
the results from drug interaction studies
into labeling recommendations and
opportunities to improve the
communication to healthcare providers.
• Research opportunities and tools for
investigating the safe use of HCs in the
presence of other drugs.
The input received may be used to
refine FDA’s thinking on the drug
interaction study design with HCs and
labeling communication of drug
interaction risks with HCs.
III. Meeting Attendance and
Participation
If you wish to attend these meetings,
register online at https://
www.surveymonkey.com/r/HCDDIMeeting. Please register by October
9, 2015. Those who are unable to attend
the meetings in person can register to
view a live Web cast of the meetings.
You will be asked to indicate in your
registration whether you plan to attend
in person or via the Web cast. Your
registration should also contain your
complete contact information, including
name, title, affiliation, address, email
address, and phone number.
Seating will be limited, so early
registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, FDA
may limit the number of participants
from each organization based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the meetings will be based on space
availability. If you need special
accommodations because of disability,
please contact Christine Le (see FOR
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54795
FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
FDA will hold an open public
comment period during the November
9, 2015, public meeting to give the
public an opportunity to comment.
Registration for open public comment
will occur at the registration desk on the
day of the meeting on a first-come, firstserved basis.
IV. Comments
Regardless of whether you attend this
meeting, you can submit electronic or
written comments, including responses
to the public docket (see ADDRESS
above), by December 15, 2015. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
V. Transcripts
Transcripts for the November 9, 2015,
meeting will be posted, when available,
at https://www.fda.gov/Drugs/
NewsEvents/ucm459342.htm.
Dated: September 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22949 Filed 9–10–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting of the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (the
Advisory Council) is scheduled for
September 29, 2015, from 9:00 a.m. to
5:00 p.m. ET. The meeting will be open
to the public; a public comment session
will be held during the meeting. Preregistration is required for members of
the public who wish to attend the
meeting and who wish to participate in
the public comment session. Individuals
who wish to attend the meeting and/or
send in their public comment via email
should email CARB@hhs.gov.
Registration information is available on
the Web site https://www.hhs.gov/ash/
SUMMARY:
E:\FR\FM\11SEN1.SGM
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54796
Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Notices
carb/ and must be completed by
September 21, 2015; all in-person
attendees must pre-register by this date.
Additional information about registering
for the meeting and providing public
comment can be obtained at https://
www.hhs.gov/ash/carb/.
DATES: The meeting is scheduled to be
held on September 29, 2015, from 9:00
a.m. to 5:00 p.m. ET. Pre-registration for
attending the meeting in person is
required to be completed no later than
September 21, 2015; public attendance
at the meeting is limited to the available
space.
ADDRESSES: U.S. Department of Health
and Human Services, Hubert H.
Humphrey Building, Great Hall, 200
Independence Avenue SW.,
Washington, DC 20201.
The meeting also can be accessed
through a live webcast the day of the
meeting. For more information, visit
https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT:
Bruce Gellin, Designated Federal
Official, Presidential Advisory Council
on Combating Antibiotic-Resistant
Bacteria, Office of the Assistant
Secretary for Health, U.S. Department of
Health and Human Services, Room
715H, Hubert H. Humphrey Building,
200 Independence Avenue SW.,
Washington, DC 20201. Phone: (202)
260–6638; email: CARB@hhs.gov.
SUPPLEMENTARY INFORMATION:
Under Executive Order 13676, dated
September 18, 2014, authority was given
to the Secretary of Health and Human
Services to establish the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (Advisory
Council), in consultation with the
Secretaries of Defense and Agriculture.
Activities of the Advisory Council are
governed by the provisions of Public
Law 92–463, as amended (5 U.S.C.
App.), which sets forth standards for the
formation and use of federal advisory
committees.
The Advisory Council will provide
advice, information, and
recommendations to the Secretary of
HHS regarding programs and policies
intended to support and evaluate the
implementation of Executive Order
13676, including the National Strategy
for Combating Antibiotic-Resistant
Bacteria and the National Action Plan
for Combating Antibiotic-Resistant
Bacteria. The Advisory Council shall
function solely for advisory purposes.
In carrying out its mission, the
Advisory Council will provide advice,
information, and recommendations to
the Secretary regarding programs and
policies intended to preserve the
effectiveness of antibiotics by
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15:14 Sep 10, 2015
Jkt 235001
optimizing their use; advance research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthen surveillance of antibioticresistant bacterial infections; prevent
the transmission of antibiotic-resistant
bacterial infections; advance the
development of rapid point-of-care and
agricultural diagnostics; further research
on new treatments for bacterial
infections; develop alternatives to
antibiotics for agricultural purposes;
maximize the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal
healthcare providers; and improve
international coordination of efforts to
combat antibiotic resistance.
The September public meeting will be
the inaugural meeting for the Advisory
Council. The Advisory Council
members will be sworn in and
presented with an overview of different
topics surrounding antibiotic resistance,
including an overview of the National
Strategy for Combating AntibioticResistant Bacteria and Action Plan for
Combating Antibiotic-Resistant Bacteria.
The meeting agenda will be posted on
the Advisory Council Web site at https://
www.hhs.gov/ash/carb/ when it has
been finalized.
Public attendance at the meeting is
limited to the available space.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the National Vaccine Program
Office at the address/telephone number
listed above at least one week prior to
the meeting. For those unable to attend
in person, a live webcast will be
available. More information on
registration and accessing the webcast
can be found at https://www.hhs.gov/
ash/carb/.
Members of the public will have the
opportunity to provide comments prior
to the Advisory Council meeting by
emailing CARB@hhs.gov. Public
comments should be sent in by
midnight September 28, 2015, and
should be limited to no more than one
page. All public comments will be read
during the public comment period
designated on the agenda; limited to two
minutes per comment.
Dated: August 19, 2015.
Bruce Gellin,
Deputy Assistant Secretary for Health,
Designated Federal Official, Presidential
Advisory Council on Combating AntibioticResistant Bacteria.
[FR Doc. 2015–22920 Filed 9–10–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review Notice of
Closed Meetings
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 meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; Molecular
Targets for Cancer Intervention.
Date: October 5–6, 2015.
Time: 7:30 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin St. Francis, 335 Powell
Street, San Francisco, CA 94102.
Contact Person: Careen K. Tang-Toth,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, (301) 435–
3504, tothct@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Nursing and Related Clinical Sciences Study
Section.
Date: October 8–9, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Dupont Hotel, 1500 New
Hampshire Avenue NW., Washington, DC
20036.
Contact Person: Martha L. Hare, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3154,
MSC 7770, Bethesda, MD 20892, (301) 451–
8504, harem@mail.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Macromolecular Structure
and Function B Study Section.
Date: October 15–16, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Pier 2620 Hotel at Fisherman’s
Wharf, 2620 Jones St, San Francisco, CA
94133.
Contact Person: C-L Albert Wang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4146,
MSC 7806, Bethesda, MD 20892, 301–435–
1016, wangca@csr.nih.gov.
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[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)]
[Notices]
[Pages 54795-54796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22920]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services (HHS) is hereby giving notice
that a meeting of the Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria (the Advisory Council) is scheduled for
September 29, 2015, from 9:00 a.m. to 5:00 p.m. ET. The meeting will be
open to the public; a public comment session will be held during the
meeting. Pre-registration is required for members of the public who
wish to attend the meeting and who wish to participate in the public
comment session. Individuals who wish to attend the meeting and/or send
in their public comment via email should email CARB@hhs.gov.
Registration information is available on the Web site https://
www.hhs.gov/ash/
[[Page 54796]]
carb/ and must be completed by September 21, 2015; all in-person
attendees must pre-register by this date. Additional information about
registering for the meeting and providing public comment can be
obtained at https://www.hhs.gov/ash/carb/.
DATES: The meeting is scheduled to be held on September 29, 2015, from
9:00 a.m. to 5:00 p.m. ET. Pre-registration for attending the meeting
in person is required to be completed no later than September 21, 2015;
public attendance at the meeting is limited to the available space.
ADDRESSES: U.S. Department of Health and Human Services, Hubert H.
Humphrey Building, Great Hall, 200 Independence Avenue SW., Washington,
DC 20201.
The meeting also can be accessed through a live webcast the day of
the meeting. For more information, visit https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT: Bruce Gellin, Designated Federal
Official, Presidential Advisory Council on Combating Antibiotic-
Resistant Bacteria, Office of the Assistant Secretary for Health, U.S.
Department of Health and Human Services, Room 715H, Hubert H. Humphrey
Building, 200 Independence Avenue SW., Washington, DC 20201. Phone:
(202) 260-6638; email: CARB@hhs.gov.
SUPPLEMENTARY INFORMATION:
Under Executive Order 13676, dated September 18, 2014, authority
was given to the Secretary of Health and Human Services to establish
the Presidential Advisory Council on Combating Antibiotic-Resistant
Bacteria (Advisory Council), in consultation with the Secretaries of
Defense and Agriculture. Activities of the Advisory Council are
governed by the provisions of Public Law 92-463, as amended (5 U.S.C.
App.), which sets forth standards for the formation and use of federal
advisory committees.
The Advisory Council will provide advice, information, and
recommendations to the Secretary of HHS regarding programs and policies
intended to support and evaluate the implementation of Executive Order
13676, including the National Strategy for Combating Antibiotic-
Resistant Bacteria and the National Action Plan for Combating
Antibiotic-Resistant Bacteria. The Advisory Council shall function
solely for advisory purposes.
In carrying out its mission, the Advisory Council will provide
advice, information, and recommendations to the Secretary regarding
programs and policies intended to preserve the effectiveness of
antibiotics by optimizing their use; advance research to develop
improved methods for combating antibiotic resistance and conducting
antibiotic stewardship; strengthen surveillance of antibiotic-resistant
bacterial infections; prevent the transmission of antibiotic-resistant
bacterial infections; advance the development of rapid point-of-care
and agricultural diagnostics; further research on new treatments for
bacterial infections; develop alternatives to antibiotics for
agricultural purposes; maximize the dissemination of up-to-date
information on the appropriate and proper use of antibiotics to the
general public and human and animal healthcare providers; and improve
international coordination of efforts to combat antibiotic resistance.
The September public meeting will be the inaugural meeting for the
Advisory Council. The Advisory Council members will be sworn in and
presented with an overview of different topics surrounding antibiotic
resistance, including an overview of the National Strategy for
Combating Antibiotic-Resistant Bacteria and Action Plan for Combating
Antibiotic-Resistant Bacteria. The meeting agenda will be posted on the
Advisory Council Web site at https://www.hhs.gov/ash/carb/ when it has
been finalized.
Public attendance at the meeting is limited to the available space.
Individuals who plan to attend and need special assistance, such as
sign language interpretation or other reasonable accommodations, should
notify the National Vaccine Program Office at the address/telephone
number listed above at least one week prior to the meeting. For those
unable to attend in person, a live webcast will be available. More
information on registration and accessing the webcast can be found at
https://www.hhs.gov/ash/carb/.
Members of the public will have the opportunity to provide comments
prior to the Advisory Council meeting by emailing CARB@hhs.gov. Public
comments should be sent in by midnight September 28, 2015, and should
be limited to no more than one page. All public comments will be read
during the public comment period designated on the agenda; limited to
two minutes per comment.
Dated: August 19, 2015.
Bruce Gellin,
Deputy Assistant Secretary for Health, Designated Federal Official,
Presidential Advisory Council on Combating Antibiotic-Resistant
Bacteria.
[FR Doc. 2015-22920 Filed 9-10-15; 8:45 am]
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