81 FR 33540 - Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 81, Issue 102 (May 26, 2016)
Federal Register Volume 81, Issue 102 (May 26, 2016)
| Page Range | 33540-33541 | |
| FR Document | 2016-12472 |
[Federal Register Volume 81, Number 102 (Thursday, May 26, 2016)] [Notices] [Pages 33540-33541] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12472] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria AGENCY: Office of the Secretary, Office of the Assistant Secretary for Health, 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 is scheduled to be held of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). 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 send an email to [email protected]. Registration information is available on the Web site http://www.hhs.gov/ash/carb/ and must be completed by June 18, 2016; 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/ on the Meetings page. DATES: The meeting is scheduled to be held on June 21, 2016, from 10:00 a.m. to 5:00 p.m. ET, and June 22, 2016, from 9:00 a.m. to 4:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the Web site for the Advisory Council at http://www.hhs.gov/ash/carb/ when this information becomes available. Pre-registration for attending the meeting in person is required to be completed no later than June 18, 2016; 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 on the day of the meeting. For more information, visit http://www.hhs.gov/ash/carb/. FOR FURTHER INFORMATION CONTACT: Bruce Gellin, Designated Federal Officer, 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]. SUPPLEMENTARY INFORMATION: Under Executive Order 13676, dated September 18, 2014, authority was given to the Secretary of HHS to establish the 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. On June 21, the public meeting will be dedicated to presentations from federal and non-federal stakeholders surrounding topic areas related to incentives for the development of vaccines, diagnostics, and therapeutics. On June 22, the meeting will focus on the topic of the environment and antibiotic-resistance, in addition to a presentation regarding the new guidance from the Food and Drug Administration for Industry #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209.'' The meeting agenda will be posted on the Advisory Council Web site at http://www.hhs.gov/ash/carb/ when it has been finalized. All agenda items are tentative and subject to change. 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 Designated Federal Officer 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 [email protected]. Public [[Page 33541]] comments should be sent in by midnight June 15, 2016, and should be limited to no more than one page. All public comments received prior to June 15, 2016, will be provided to Advisory Council members; comments are limited to two minutes per speaker. Dated: May 18, 2016. Bruce Gellin, Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Deputy Assistant Secretary for Health. [FR Doc. 2016-12472 Filed 5-25-16; 8:45 am] BILLING CODE 4150-44-P
![33540 Federal Register / Vol. 81, No. 102 / Thursday, May 26, 2016 / Notices
finalizes the draft guidance dated Registration information is available on In carrying out its mission, the
October 2009. the Web site http://www.hhs.gov/ash/ Advisory Council will provide advice,
FDA encourages firms that market carb/ and must be completed by June information, and recommendations to
sugar cane-derived sweeteners or 18, 2016; all in-person attendees must the Secretary regarding programs and
products that contain a sugar cane- pre-register by this date. Additional policies intended to preserve the
derived sweetener to review the final information about registering for the effectiveness of antibiotics by
guidance and consider whether the meeting and providing public comment optimizing their use; advance research
name under which the sweetener is can be obtained at http://www.hhs.gov/ to develop improved methods for
declared in food labeling accurately ash/carb/ on the Meetings page. combating antibiotic resistance and
describes its basic nature and DATES: The meeting is scheduled to be conducting antibiotic stewardship;
characterizing properties, as required by held on June 21, 2016, from 10:00 a.m. strengthen surveillance of antibiotic-
the common or usual name regulation to 5:00 p.m. ET, and June 22, 2016, from resistant bacterial infections; prevent
(21 CFR 102.5). As explained in the 9:00 a.m. to 4:00 p.m. ET (times are the transmission of antibiotic-resistant
final guidance, our view is that products tentative and subject to change). The bacterial infections; advance the
currently labeled as containing confirmed times and agenda items for development of rapid point-of-care and
‘‘evaporated cane juice’’ should be the meeting will be posted on the Web agricultural diagnostics; further research
relabeled to use the name ‘‘sugar,’’ site for the Advisory Council at http:// on new treatments for bacterial
optionally accompanied by a truthful, www.hhs.gov/ash/carb/ when this infections; develop alternatives to
non-misleading descriptor to information becomes available. Pre- antibiotics for agricultural purposes;
distinguish the ingredient from other registration for attending the meeting in maximize the dissemination of up-to-
cane-based sweeteners. FDA would not person is required to be completed no date information on the appropriate and
object to the use of stickers to make this later than June 18, 2016; public proper use of antibiotics to the general
change until the next regularly attendance at the meeting is limited to public and human and animal
scheduled label printing. the available space. healthcare providers; and improve
ADDRESSES: U.S. Department of Health international coordination of efforts to
II. Electronic Access combat antibiotic resistance.
and Human Services, Hubert H.
Persons with access to the Internet On June 21, the public meeting will
Humphrey Building, Great Hall, 200
may obtain the guidance at either http:// be dedicated to presentations from
Independence Avenue SW.,
www.fda.gov/FoodGuidances or http:// federal and non-federal stakeholders
Washington, DC 20201.
www.regulations.gov. Use the FDA Web The meeting also can be accessed surrounding topic areas related to
sites listed previously to find the most through a live webcast on the day of the incentives for the development of
current version of the guidance. meeting. For more information, visit vaccines, diagnostics, and therapeutics.
Dated: May 20, 2016. http://www.hhs.gov/ash/carb/. On June 22, the meeting will focus on
the topic of the environment and
Leslie Kux, FOR FURTHER INFORMATION CONTACT:
antibiotic-resistance, in addition to a
Associate Commissioner for Policy. Bruce Gellin, Designated Federal presentation regarding the new
[FR Doc. 2016–12402 Filed 5–25–16; 8:45 am] Officer, Presidential Advisory Council guidance from the Food and Drug
BILLING CODE 4164–01–P on Combating Antibiotic-Resistant Administration for Industry #213, ‘‘New
Bacteria, Office of the Assistant Animal Drugs and New Animal Drug
Secretary for Health, U.S. Department of Combination Products Administered in
DEPARTMENT OF HEALTH AND Health and Human Services, Room or on Medicated Feed or Drinking Water
HUMAN SERVICES 715H, Hubert H. Humphrey Building, of Food-Producing Animals:
200 Independence Avenue SW., Recommendations for Drug Sponsors for
Meeting of the Presidential Advisory Washington, DC 20201. Phone: (202)
Council on Combating Antibiotic- Voluntarily Aligning Product Use
260–6638; email: CARB@hhs.gov. Conditions With Guidance for Industry
Resistant Bacteria SUPPLEMENTARY INFORMATION: Under #209.’’ The meeting agenda will be
AGENCY: Office of the Secretary, Office Executive Order 13676, dated posted on the Advisory Council Web
of the Assistant Secretary for Health, September 18, 2014, authority was given site at http://www.hhs.gov/ash/carb/
Department of Health and Human to the Secretary of HHS to establish the when it has been finalized. All agenda
Services. Advisory Council, in consultation with items are tentative and subject to
ACTION: Notice. the Secretaries of Defense and change.
Agriculture. Activities of the Advisory Public attendance at the meeting is
SUMMARY: As stipulated by the Federal Council are governed by the provisions limited to the available space.
Advisory Committee Act, the of Public Law 92–463, as amended (5 Individuals who plan to attend and
Department of Health and Human U.S.C. App.), which sets forth standards need special assistance, such as sign
Services (HHS) is hereby giving notice for the formation and use of federal language interpretation or other
that a meeting is scheduled to be held advisory committees. reasonable accommodations, should
of the Presidential Advisory Council on The Advisory Council will provide notify the Designated Federal Officer at
Combating Antibiotic-Resistant Bacteria advice, information, and the address/telephone number listed
(Advisory Council). The meeting will be recommendations to the Secretary of above at least one week prior to the
open to the public; a public comment HHS regarding programs and policies meeting. For those unable to attend in
session will be held during the meeting. intended to support and evaluate the person, a live webcast will be available.
sradovich on DSK3TPTVN1PROD with NOTICES
Pre-registration is required for members implementation of Executive Order More information on registration and
of the public who wish to attend the 13676, including the National Strategy accessing the webcast can be found at
meeting and who wish to participate in for Combating Antibiotic-Resistant http://www.hhs.gov/ash/carb/.
the public comment session. Individuals Bacteria and the National Action Plan Members of the public will have the
who wish to attend the meeting and/or for Combating Antibiotic-Resistant opportunity to provide comments prior
send in their public comment via email Bacteria. The Advisory Council shall to the Advisory Council meeting by
should send an email to CARB@hhs.gov. function solely for advisory purposes. emailing CARB@hhs.gov. Public
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![Federal Register / Vol. 81, No. 102 / Thursday, May 26, 2016 / Notices 33541
comments should be sent in by advice to the Deputy Assistant Secretary Homeland Security will be submitting
midnight June 15, 2016, and should be for Minority Health in improving the the following information collection
limited to no more than one page. All health of each racial and ethnic request to the Office of Management and
public comments received prior to June minority group and on the development Budget (OMB) for review and approval
15, 2016, will be provided to Advisory of goals and specific program activities in accordance with the Paperwork
Council members; comments are limited of the Office of Minority Health. Reduction Act: NAFTA Regulations and
to two minutes per speaker. Topics to be discussed during this Certificate of Origin (Forms 434, 446,
Dated: May 18, 2016. meeting will include strategies to and 447). CBP is proposing that this
Bruce Gellin,
improve the health of racial and ethnic information collection be extended with
minority populations through the a change to the burden hours. There is
Designated Federal Officer, Presidential
Advisory Council on Combating Antibiotic-
development of health policies and no change to the information collected.
Resistant Bacteria, Deputy Assistant Secretary programs that will help eliminate health This document is published to obtain
for Health. disparities, as well as other related comments from the public and affected
[FR Doc. 2016–12472 Filed 5–25–16; 8:45 am] issues. agencies.
BILLING CODE 4150–44–P
Public attendance at this meeting is DATES: Written comments should be
limited to space available. Individuals received on or before July 25, 2016 to be
who plan to attend and need special assured of consideration.
DEPARTMENT OF HEALTH AND assistance, such as sign language
ADDRESSES: Written comments may be
HUMAN SERVICES interpretation or other reasonable
mailed to U.S. Customs and Border
accommodations, should notify the
Protection, Attn: Tracey Denning,
Meeting of the Advisory Committee on designated contact person at least
Regulations and Rulings, Office of
Minority Health fourteen (14) business days prior to the
Trade, 90 K Street NE., 10th Floor,
meeting. Members of the public will
AGENCY: Office of the Secretary, Office Washington, DC 20229–1177.
have an opportunity to provide
of Minority Health, Department of comments at the meeting. Public FOR FURTHER INFORMATION CONTACT:
Health and Human Services. comments will be limited to three Requests for additional information
ACTION: Notice of meeting. minutes per speaker. Individuals who should be directed to Tracey Denning,
would like to submit written statements U.S. Customs and Border Protection,
SUMMARY: As stipulated by the Federal Regulations and Rulings, Office of
Advisory Committee Act, the should mail or fax their comments to
the Office of Minority Health at least Trade, 90 K Street NE., 10th Floor,
Department of Health and Human Washington, DC 20229–1177, at 202–
Services (DHHS) is hereby giving notice seven (7) business days prior to the
meeting. Any members of the public 325–0265.
that the Advisory Committee on
Minority Health (ACMH) will hold a who wish to have printed material SUPPLEMENTARY INFORMATION: CBP
meeting. This meeting will be open to distributed to ACMH committee invites the general public and other
the public. Preregistration is required members should submit their materials Federal agencies to comment on
for both public attendance and to the Designated Federal Officer, proposed and/or continuing information
comment. Any individual who wishes ACMH, Tower Building, 1101 Wootton collections pursuant to the Paperwork
to attend the meeting and/or participate Parkway, Suite 600, Rockville, Reduction Act of 1995 (Pub. L. 104–13).
in the public comment session should Maryland 20852, prior to close of The comments should address: (a)
email OMH-ACMH@hhs.gov by June 17, business on Monday, June 13, 2016. whether the collection of information is
2016. Dated: May 5, 2016. necessary for the proper performance of
Information about the meeting is Minh Wendt, the functions of the agency, including
available from the designated contact whether the information shall have
Designated Federal Officer, ACMH, Office of
and will be posted on the Web site for Minority Health, U.S. Department of Health practical utility; (b) the accuracy of the
the Office of Minority Health (OMH), and Human Services. agency’s estimates of the burden of the
www.minorityhealth.hhs.gov. [FR Doc. 2016–12473 Filed 5–25–16; 8:45 am]
collection of information; (c) ways to
Information about ACMH activities can enhance the quality, utility, and clarity
BILLING CODE 4150–29–P
be found on the OMH Web site under of the information to be collected; (d)
the heading About OMH. ways to minimize the burden including
the use of automated collection
DATES: The meeting will be held on DEPARTMENT OF HOMELAND techniques or the use of other forms of
Monday, June 20, 2016, from 9:00 a.m. SECURITY information technology; and (e) the
to 5:00 p.m. and on Tuesday, June 21,
U.S. Customs and Border Protection annual cost burden to respondents or
2016, from 9:00 a.m. to 1:00 p.m. ET.
record keepers from the collection of
ADDRESSES: The meeting will be held at [1651–0098] information (total capital/startup costs
the Doubletree by Hilton Hotel and operations and maintenance costs).
Bethesda, 8120 Wisconsin Avenue, Agency Information Collection The comments that are submitted will
Bethesda, MD 20814. Activities: NAFTA Regulations and be summarized and included in the CBP
FOR FURTHER INFORMATION CONTACT: Dr. Certificate of Origin request for OMB approval. All
Minh Wendt, Designated Federal AGENCY: U.S. Customs and Border comments will become a matter of
Officer, ACMH; Tower Building, 1101 Protection, Department of Homeland public record. In this document, CBP is
sradovich on DSK3TPTVN1PROD with NOTICES
Wootton Parkway, Suite 600, Rockville, Security. soliciting comments concerning the
Maryland 20852. Phone: 240–453–8222, following information collection:
Fax: 240–453–8223; OMH-ACMH@ ACTION: 60-Day Notice and request for
comments; extension of an existing Title: NAFTA Regulations and
hhs.gov. Certificate of Origin.
collection of information.
SUPPLEMENTARY INFORMATION: In OMB Number: 1651–0098.
accordance with Public Law 105–392, SUMMARY: U.S. Customs and Border Form Number: CBP Forms 434, 446,
the ACMH was established to provide Protection (CBP) of the Department of and 447.
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Document Created: 2016-05-26 01:13:39
Document Modified: 2016-05-26 01:13:39
| 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 June 21, 2016, from 10:00 a.m. to 5:00 p.m. ET, and June 22, 2016, from 9:00 a.m. to 4:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for the meeting will be posted on the Web site for the Advisory Council at http://www.hhs.gov/ash/carb/ when this information becomes available. Pre-registration for attending the meeting in person is required to be completed no later than June 18, 2016; public attendance at the meeting is limited to the available space. | |
| Contact | Bruce Gellin, Designated Federal Officer, 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 | 81 FR 33540 |
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