80 FR 54795 - Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 80, Issue 176 (September 11, 2015)
Federal Register Volume 80, Issue 176 (September 11, 2015)
| Page Range | 54795-54796 | |
| FR Document | 2015-22920 |
[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)] [Notices] [Pages 54795-54796] From the Federal Register Online [www.thefederalregister.org] [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 http:// 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 http://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 http://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 http://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 http://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] BILLING CODE 4150-44-P
![Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Notices 54795
meeting participants (non-FDA II. Discussion Topics for the Meeting FURTHER INFORMATION CONTACT) at least 7
employees) is through Building 1, where and for Public Comments days before the meeting.
routine security check procedures will FDA will hold an open public
The public meeting on November 9,
be performed. For more information on comment period during the November
2015, will include a discussion of the
parking and security procedures, please 9, 2015, public meeting to give the
following topics on which FDA is also
refer to http://www.fda.gov/AboutFDA/ public an opportunity to comment.
seeking public comment:
WorkingatFDA/BuildingsandFacilities/ • Public health concerns associated Registration for open public comment
WhiteOakCampusInformation/ with use of HCs and interacting drugs will occur at the registration desk on the
ucm241740.htm. that might affect efficacy and safety. day of the meeting on a first-come, first-
Submit electronic comments to • PK and PD considerations in served basis.
http://www.regulations.gov. Submit designing drug interaction studies with IV. Comments
written comments to the Division of HCs during drug development. Key
Dockets Management (HFA–305), Food Regardless of whether you attend this
elements in designing a study include a meeting, you can submit electronic or
and Drug Administration, 5630 Fishers mechanistic understanding of potential
Lane, Rm. 1061, Rockville, MD 20852. written comments, including responses
DDI mechanisms, the choice of to the public docket (see ADDRESS
All comments should be identified with contraceptive products and their dose,
the docket number found in brackets in above), by December 15, 2015. Received
study population/duration, and proper comments may be seen in the Division
the heading of this document. selection of a PK alone or PK–PD-based
FDA will post the agenda of Dockets Management between 9 a.m.
drug interaction study approach. and 4 p.m., Monday through Friday, and
approximately 5 days before the meeting • Drug interaction study result
at: http://www.fda.gov/Drugs/ will be posted to the docket at http://
interpretation and its potential impact www.regulations.gov.
NewsEvents/ucm459342.htm. on guidance of HC use in women of
FOR FURTHER INFORMATION CONTACT: childbearing potential who are enrolled V. Transcripts
Christine Le, Center for Drug Evaluation in clinical trials for other therapeutic Transcripts for the November 9, 2015,
and Research, Food and Drug agents during drug development. meeting will be posted, when available,
Administration, 10903 New Hampshire • The current approach of translating at http://www.fda.gov/Drugs/
Ave., Bldg. 51, Rm. 3196, Silver Spring, the results from drug interaction studies NewsEvents/ucm459342.htm.
MD 20993, 301–796–2398, email: into labeling recommendations and
Christine.Le@fda.hhs.gov. Dated: September 4, 2015.
opportunities to improve the
SUPPLEMENTARY INFORMATION: communication to healthcare providers. Leslie Kux,
• Research opportunities and tools for Associate Commissioner for Policy.
I. Background [FR Doc. 2015–22949 Filed 9–10–15; 8:45 am]
investigating the safe use of HCs in the
In general, HCs are highly effective in presence of other drugs. BILLING CODE 4164–01–P
preventing pregnancy when used The input received may be used to
correctly. However, concomitant use of refine FDA’s thinking on the drug
other drugs may affect the safety and/or interaction study design with HCs and DEPARTMENT OF HEALTH AND
efficacy of HCs due to drug interactions labeling communication of drug HUMAN SERVICES
affecting either blood levels (PK) and/or interaction risks with HCs.
physiologic effects (PD) of HC Meeting of the Presidential Advisory
components (e.g., estrogen and III. Meeting Attendance and Council on Combating Antibiotic-
progestins). Understanding drug Participation Resistant Bacteria
interaction potential of HCs and other If you wish to attend these meetings, AGENCY: Office of the Assistant
drugs is important when investigating register online at https:// Secretary for Health, Office of the
HC-related issues, and in the design and www.surveymonkey.com/r/HC- Secretary, Department of Health and
conduct of clinical trials. Evolving DDIMeeting. Please register by October Human Services.
knowledge on drug interaction 9, 2015. Those who are unable to attend ACTION: Notice.
mechanisms has led to new insights and the meetings in person can register to
increased interest in the clinical view a live Web cast of the meetings. SUMMARY: As stipulated by the Federal
investigation of drug interactions with You will be asked to indicate in your Advisory Committee Act, the
HCs. registration whether you plan to attend Department of Health and Human
Historically, most drug interaction in person or via the Web cast. Your Services (HHS) is hereby giving notice
studies conducted during drug registration should also contain your that a meeting of the Presidential
development with HCs have not had a complete contact information, including Advisory Council on Combating
clearly stated rationale for the choice of name, title, affiliation, address, email Antibiotic-Resistant Bacteria (the
HCs being studied. Questions remain as address, and phone number. Advisory Council) is scheduled for
to whether the study results of specific Seating will be limited, so early September 29, 2015, from 9:00 a.m. to
contraceptive steroids can be registration is recommended. 5:00 p.m. ET. The meeting will be open
extrapolated to other progestins or Registration is free and will be on a first- to the public; a public comment session
estrogens or other dose strengths. The come, first-served basis. However, FDA will be held during the meeting. Pre-
choice of HC is important because may limit the number of participants registration is required for members of
different progestins may have different from each organization based on space the public who wish to attend the
rmajette on DSK7SPTVN1PROD with NOTICES
metabolic and/or transporter pathways limitations. Registrants will receive meeting and who wish to participate in
and safety profiles. Without a confirmation once they have been the public comment session. Individuals
mechanistic understanding of the accepted. Onsite registration on the day who wish to attend the meeting and/or
underlying drug-drug interaction (DDI) of the meetings will be based on space send in their public comment via email
mechanism, it is difficult to interpret availability. If you need special should email CARB@hhs.gov.
and extrapolate study results from one accommodations because of disability, Registration information is available on
HC to another. please contact Christine Le (see FOR the Web site http://www.hhs.gov/ash/
VerDate Sep<11>2014 15:14 Sep 10, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1](https://thefederalregister.org/doc/80_FR_54971/page/1.svg)
![54796 Federal Register / Vol. 80, No. 176 / Friday, September 11, 2015 / Notices
carb/ and must be completed by optimizing their use; advance research DEPARTMENT OF HEALTH AND
September 21, 2015; all in-person to develop improved methods for HUMAN SERVICES
attendees must pre-register by this date. combating antibiotic resistance and
Additional information about registering conducting antibiotic stewardship; National Institutes of Health
for the meeting and providing public strengthen surveillance of antibiotic-
comment can be obtained at http:// resistant bacterial infections; prevent Center for Scientific Review Notice of
www.hhs.gov/ash/carb/. the transmission of antibiotic-resistant Closed Meetings
DATES: The meeting is scheduled to be bacterial infections; advance the Pursuant to section 10(d) of the
held on September 29, 2015, from 9:00 development of rapid point-of-care and Federal Advisory Committee Act, as
a.m. to 5:00 p.m. ET. Pre-registration for agricultural diagnostics; further research amended (5 U.S.C. App.), notice is
attending the meeting in person is on new treatments for bacterial hereby given of the following meetings.
required to be completed no later than infections; develop alternatives to The meetings will be closed to the
September 21, 2015; public attendance antibiotics for agricultural purposes; public in accordance with the
at the meeting is limited to the available maximize the dissemination of up-to- provisions set forth in sections
space. date information on the appropriate and 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
ADDRESSES: U.S. Department of Health proper use of antibiotics to the general as amended. The grant applications and
and Human Services, Hubert H. public and human and animal the discussions could disclose
Humphrey Building, Great Hall, 200 healthcare providers; and improve confidential trade secrets or commercial
Independence Avenue SW., international coordination of efforts to property such as patentable material,
Washington, DC 20201. combat antibiotic resistance. and personal information concerning
The meeting also can be accessed The September public meeting will be individuals associated with the grant
through a live webcast the day of the the inaugural meeting for the Advisory applications, the disclosure of which
meeting. For more information, visit Council. The Advisory Council would constitute a clearly unwarranted
http://www.hhs.gov/ash/carb/. members will be sworn in and invasion of personal privacy.
FOR FURTHER INFORMATION CONTACT: presented with an overview of different
Name of Committee: Center for Scientific
Bruce Gellin, Designated Federal topics surrounding antibiotic resistance, Review Special Emphasis Panel; Molecular
Official, Presidential Advisory Council including an overview of the National Targets for Cancer Intervention.
on Combating Antibiotic-Resistant Strategy for Combating Antibiotic- Date: October 5–6, 2015.
Bacteria, Office of the Assistant Resistant Bacteria and Action Plan for Time: 7:30 a.m. to 6:30 p.m.
Combating Antibiotic-Resistant Bacteria. Agenda: To review and evaluate grant
Secretary for Health, U.S. Department of applications.
Health and Human Services, Room The meeting agenda will be posted on
the Advisory Council Web site at http:// Place: The Westin St. Francis, 335 Powell
715H, Hubert H. Humphrey Building, Street, San Francisco, CA 94102.
200 Independence Avenue SW., www.hhs.gov/ash/carb/ when it has Contact Person: Careen K. Tang-Toth,
Washington, DC 20201. Phone: (202) been finalized. Ph.D., Scientific Review Officer, Center for
260–6638; email: CARB@hhs.gov. Public attendance at the meeting is Scientific Review, National Institutes of
limited to the available space. Health, 6701 Rockledge Drive, Room 6214,
SUPPLEMENTARY INFORMATION:
Individuals who plan to attend and MSC 7804, Bethesda, MD 20892, (301) 435–
Under Executive Order 13676, dated 3504, tothct@csr.nih.gov.
need special assistance, such as sign
September 18, 2014, authority was given
language interpretation or other Name of Committee: Healthcare Delivery
to the Secretary of Health and Human and Methodologies Integrated Review Group;
reasonable accommodations, should
Services to establish the Presidential Nursing and Related Clinical Sciences Study
notify the National Vaccine Program
Advisory Council on Combating Section.
Office at the address/telephone number
Antibiotic-Resistant Bacteria (Advisory Date: October 8–9, 2015.
listed above at least one week prior to Time: 8:00 a.m. to 5:00 p.m.
Council), in consultation with the
the meeting. For those unable to attend Agenda: To review and evaluate grant
Secretaries of Defense and Agriculture.
in person, a live webcast will be applications.
Activities of the Advisory Council are
available. More information on Place: The Dupont Hotel, 1500 New
governed by the provisions of Public Hampshire Avenue NW., Washington, DC
registration and accessing the webcast
Law 92–463, as amended (5 U.S.C. 20036.
can be found at http://www.hhs.gov/
App.), which sets forth standards for the Contact Person: Martha L. Hare, Ph.D.,
ash/carb/.
formation and use of federal advisory Scientific Review Officer, Center for
Members of the public will have the Scientific Review, National Institutes of
committees.
opportunity to provide comments prior Health, 6701 Rockledge Drive, Room 3154,
The Advisory Council will provide
to the Advisory Council meeting by MSC 7770, Bethesda, MD 20892, (301) 451–
advice, information, and
emailing CARB@hhs.gov. Public 8504, harem@mail.nih.gov.
recommendations to the Secretary of
comments should be sent in by Name of Committee: Biological Chemistry
HHS regarding programs and policies
midnight September 28, 2015, and and Macromolecular Biophysics Integrated
intended to support and evaluate the
should be limited to no more than one Review Group; Macromolecular Structure
implementation of Executive Order and Function B Study Section.
page. All public comments will be read
13676, including the National Strategy Date: October 15–16, 2015.
during the public comment period
for Combating Antibiotic-Resistant Time: 8:00 a.m. to 5:00 p.m.
designated on the agenda; limited to two
Bacteria and the National Action Plan Agenda: To review and evaluate grant
minutes per comment. applications.
for Combating Antibiotic-Resistant
Bacteria. The Advisory Council shall Dated: August 19, 2015. Place: Pier 2620 Hotel at Fisherman’s
rmajette on DSK7SPTVN1PROD with NOTICES
function solely for advisory purposes. Bruce Gellin, Wharf, 2620 Jones St, San Francisco, CA
In carrying out its mission, the 94133.
Deputy Assistant Secretary for Health,
Contact Person: C-L Albert Wang, Ph.D.,
Advisory Council will provide advice, Designated Federal Official, Presidential
Scientific Review Officer, Center for
information, and recommendations to Advisory Council on Combating Antibiotic-
Scientific Review, National Institutes of
the Secretary regarding programs and Resistant Bacteria.
Health, 6701 Rockledge Drive, Room 4146,
policies intended to preserve the [FR Doc. 2015–22920 Filed 9–10–15; 8:45 am] MSC 7806, Bethesda, MD 20892, 301–435–
effectiveness of antibiotics by BILLING CODE 4150–44–P 1016, wangca@csr.nih.gov.
VerDate Sep<11>2014 15:14 Sep 10, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\11SEN1.SGM 11SEN1](https://thefederalregister.org/doc/80_FR_54971/page/2.svg)
Document Created: 2015-12-15 10:00:30
Document Modified: 2015-12-15 10:00:30
| 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 | 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. | |
| 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: [email protected] | |
| FR Citation | 80 FR 54795 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR