Solicitation of Nominations for Appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 22550-22551 [2017-09778]
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Federal Register / Vol. 82, No. 93 / Tuesday, May 16, 2017 / Notices
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competence of testing and calibration
laboratories) or ISO 15189:2012—
Medical laboratories—Requirements for
quality and competence plus FDA
ASCA program specific requirements?
FDA would still retain the authority to
recognize, deny, amend, or revoke
recognition of testing laboratories and
maintain the official list of recognized
testing laboratories.
4. Where no appropriate accreditation
bodies step forward to serve the needs
for the specific areas within the ASCA
program, FDA is considering a model
under which it will serve as the
accreditation body. What are the
benefits, weaknesses, incentives/
disincentives associated with this
approach, and how do you compare this
approach to the private sector approach?
5. Describe your familiarity with
accreditation to ISO/IEC 17025 (General
requirements for testing and calibration
laboratories) or ISO 15189:2012—
Medical laboratories—Requirements for
quality and competence? If accredited,
what is the scope of accreditation?
6. Do you utilize another management
system other than ISO/IEC 17025 or ISO
15189:2012—Medical laboratories—
Requirements for quality and
competence? If so, what management
system has been implemented?
7. Are there specific FDA recognized
consensus standards available at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm or
testing capabilities related to the
medical devices sector that you
perform?
8. For more complex standards, such
as those that have normative references
or include references to management
systems (e.g., Risk Management, Quality
Management, Cybersecurity, Infection
Control), are there specific assessment
techniques that should be included?
9. Would you consider participating
in the ASCA Pilot Program? If so, what
scope of testing would you consider?
10. Generally, are there any other
comments that you would like to
provide regarding the development of
the ASCA pilot program? Do you have
recommendations for other alternatives
to consider?
Dated: May 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–09850 Filed 5–15–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Appointment to the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The U.S. Department of
Health and Human Services (HHS) is
soliciting nominations of individuals
who are interested in being considered
for appointment to the Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria (Advisory
Council) as a non-voting liaison
representative member from an
organization and/or interest group.
Nominations from qualified individuals
who wish to be considered for
appointment to this member category of
the Advisory Council are currently
being accepted.
DATES: Nominations must be received
no later than 5:00 p.m. ET on June 30,
2017.
ADDRESSES: Information on how to
submit a nomination is on the Advisory
Council Web site, https://www.hhs.gov/
ash/carb/.
FOR FURTHER INFORMATION CONTACT:
MacKenzie Robertson, Committee
Management 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) 690–5566; email: CARB@
hhs.gov. The Advisory Council charter
may be accessed online at https://
www.hhs.gov/ash/carb/. The charter
includes detailed information about the
Advisory Council’s purpose, function,
and structure.
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
SUMMARY:
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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 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 Advisory Council is authorized to
consist of not more than 30 members,
including the voting and non-voting
members and the Chair and Vice Chair.
The current composition of the
Advisory Council consists of 15 voting
members, including the Chair and Vice
Chair, five non-voting liaison
representative members, and 10 nonvoting ex-officio members. The nonvoting liaison representatives are
selected from organizations and/or
interest groups that have involvement in
the development, testing, licensing,
production, procurement, distribution,
and/or use of antibiotics and/or
antibiotic research. Organizations are
invited to participate as non-voting
liaison representatives as it is deemed
necessary by the Secretary or designee
to accomplish the established mission of
the Advisory Council.
This announcement is to solicit
nominations to fill positions that are
scheduled to be vacated during the 2017
calendar year in the non-voting liaison
representative member category. Nonvoting liaison representative members
are appointed to serve two-year terms.
Individuals from the following sectors
are being sought to serve a non-voting
liaison representatives: (1) Professional
organizations representing infectious
disease, epidemiology, infection control,
physicians, nurses, pharmacists,
microbiologists, and veterinarians; (2)
public health organizations representing
laboratories, health officials,
epidemiologists (state/territorial,
county, or local); (3) organizations
advocating for patients and consumers;
(4) organizations representing state
departments of agriculture; (5) hospitals;
(6) foundations with an interest in
antibiotic resistance and promoting
antibiotic stewardship; (7)
pharmaceutical industry—animal and
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Federal Register / Vol. 82, No. 93 / Tuesday, May 16, 2017 / Notices
human health; (8) food producers—
livestock, poultry, and seafood; (9) in
vitro diagnostics; (10) food retailers; (11)
food processors; (12) animal feed
producers; and (13) farm bio-security.
Individuals who are appointed to
serve as non-voting liaison
representative members may be allowed
to receive per diem and reimbursement
for any applicable expenses for travel
that is performed to attend meetings of
the Advisory Council in accordance
with federal travel regulations. The
Advisory Council meets, at a minimum,
two times per fiscal year depending on
the availability of funds. Meetings are
open to the public, except as
determined otherwise by the Secretary
or other official to whom the authority
has been delegated in accordance with
guidelines under the Government in the
Sunshine Act, 5 U.S.C. 552b(c).
Nominations, including selfnominations, of individuals who
represent organizations that have the
specified expertise and knowledge
sought will be considered for
appointment as non-voting liaison
representative members of the Advisory
Council. Every effort will be made to
ensure that the Advisory Council is a
diverse group of individuals with
representation from various geographic
locations, racial and ethnic minorities,
all genders, and persons living with
disabilities. Detailed information on
what is required in a nomination
package and how to submit one is on
the Advisory Council Web site, https://
www.hhs.gov/ash/carb/.
Dated: April 25, 2017.
Jewel Mullen,
Acting Director, National Vaccine Program
Office.
[FR Doc. 2017–09778 Filed 5–15–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Minority Health
Office of Minority Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Advisory Committee on
Minority Health (ACMH) will hold a
meeting conducted as a telephone
conference call. This call will be open
to the public. Preregistration is required
for both public participation and
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SUMMARY:
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16:42 May 15, 2017
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comment. Any individual who wishes
to participate in the call should email
OMH-ACMH@hhs.gov by May 30, 2017.
Instructions regarding participating in
the call and how to provide verbal
public comments will be given at the
time of preregistration.
Information about the meeting is
available from the designated contact
and will be posted on the Web site for
the Office of Minority Health (OMH),
www.minorityhealth.hhs.gov.
Information about ACMH activities can
be found on the OMH Web site under
the heading About OMH.
DATES: The conference call will be held
on June 1, 2017, 12:30 p.m.–2:30 p.m.
ET.
Instructions regarding
participating in the call will be given at
the time of preregistration.
FOR FURTHER INFORMATION CONTACT: Dr.
Minh Wendt, Designated Federal
Officer, Advisory Committee on
Minority Health, Office of Minority
Health, Department of Health and
Human Services, Tower Building, 1101
Wootton Parkway, Suite 600, Rockville,
Maryland 20852. Phone: 240–453–8222;
fax: 240–453–8223; email OMH-ACMH@
hhs.gov.
SUPPLEMENTARY INFORMATION: In
accordance with Public Law 105–392,
the ACMH was established to provide
advice to the Deputy Assistant Secretary
for Minority Health on improving the
health of each racial and ethnic
minority group and on the development
of goals and specific program activities
of the OMH.
The topics to be discussed during the
teleconference include creating a work
plan for developing recommendations
related to opioid usage and health
disparities. The recommendations will
be given to the Deputy Assistant
Secretary for Minority Health.
This call will be limited to 125
participants. The OMH will make every
effort to accommodate persons with
special needs. Individuals who have
special needs for which special
accommodations may be required
should contact Professional and
Scientific Associates at (703) 234–1700
and reference this meeting. Requests for
special accommodations should be
made at least ten (10) business days
prior to the meeting.
Members of the public will have an
opportunity to provide comments at the
meeting. Public comments will be
limited to two minutes per speaker
during the time allotted. Individuals
who would like to submit written
statements should email, mail, or fax
their comments to the designated
ADDRESSES:
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22551
contact at least seven (7) business days
prior to the meeting.
Any members of the public who wish
to have electronic or printed material
distributed to ACMH members should
email OMH-ACMH@hhs.gov or mail
their materials to the Designated Federal
Officer, ACMH, Tower Building, 1101
Wootton Parkway, Suite 600, Rockville,
Maryland 20852, prior to close of
business on May 25, 2017.
Dated: May 11, 2017.
Minh Wendt,
Designated Federal Officer, Advisory
Committee on Minority Health.
[FR Doc. 2017–09862 Filed 5–15–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Solicitation of Public Comments on the
Draft Federal Pain Research Strategy
National Institute of Neurological
Disorders and Stroke, Interagency Pain
Research Coordinating Committee
Solicitation for Public Comments on the
Draft Federal Pain Research Strategy
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of a meeting hosted by the
National Institutes of Health to present
the Draft Federal Pain Research Strategy
and to solicit public comments on this
document. The meeting will be open to
the public and videocast.
Dates: June 1, 2017.
Time: 12:45 p.m. to 3:30 p.m.
*Eastern Time*.
Agenda: Invited speakers will present
and discuss research recommendations
developed for the Draft Federal Pain
Research Strategy. Attendees will have
the opportunity to pose questions on
site or on-line. Information to submit
comments in advance and during the
meeting will be posted on May 25th,
2017, at https://iprcc.nih.gov/.
Summary: The Federal Pain Research
Strategy is an effort of the Interagency
Pain Research Coordinating Committee
(IPRCC) and the NINDS Office of Pain
Policy to oversee development of a longterm strategic plan for pain research. A
diverse and balanced group of scientific
experts, patient advocates, and federal
representatives identified and
prioritized research recommendations
as a basis for a long-term strategic plan
to coordinate and advance the federal
research agenda. The key areas of
prevention of acute and chronic pain,
acute pain and acute pain management,
the transition from acute to chronic
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]]>Agencies
[Federal Register Volume 82, Number 93 (Tuesday, May 16, 2017)]
[Notices]
[Pages 22550-22551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09778]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Solicitation of Nominations for Appointment to 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: The U.S. Department of Health and Human Services (HHS) is
soliciting nominations of individuals who are interested in being
considered for appointment to the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria (Advisory Council) as a non-
voting liaison representative member from an organization and/or
interest group. Nominations from qualified individuals who wish to be
considered for appointment to this member category of the Advisory
Council are currently being accepted.
DATES: Nominations must be received no later than 5:00 p.m. ET on June
30, 2017.
ADDRESSES: Information on how to submit a nomination is on the Advisory
Council Web site, https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT: MacKenzie Robertson, Committee
Management 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) 690-5566; email: CARB@hhs.gov. The Advisory Council
charter may be accessed online at https://www.hhs.gov/ash/carb/. The
charter includes detailed information about the Advisory Council's
purpose, function, and structure.
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 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 Advisory Council is authorized to consist of not more than 30
members, including the voting and non-voting members and the Chair and
Vice Chair. The current composition of the Advisory Council consists of
15 voting members, including the Chair and Vice Chair, five non-voting
liaison representative members, and 10 non-voting ex-officio members.
The non-voting liaison representatives are selected from organizations
and/or interest groups that have involvement in the development,
testing, licensing, production, procurement, distribution, and/or use
of antibiotics and/or antibiotic research. Organizations are invited to
participate as non-voting liaison representatives as it is deemed
necessary by the Secretary or designee to accomplish the established
mission of the Advisory Council.
This announcement is to solicit nominations to fill positions that
are scheduled to be vacated during the 2017 calendar year in the non-
voting liaison representative member category. Non-voting liaison
representative members are appointed to serve two-year terms.
Individuals from the following sectors are being sought to serve a non-
voting liaison representatives: (1) Professional organizations
representing infectious disease, epidemiology, infection control,
physicians, nurses, pharmacists, microbiologists, and veterinarians;
(2) public health organizations representing laboratories, health
officials, epidemiologists (state/territorial, county, or local); (3)
organizations advocating for patients and consumers; (4) organizations
representing state departments of agriculture; (5) hospitals; (6)
foundations with an interest in antibiotic resistance and promoting
antibiotic stewardship; (7) pharmaceutical industry--animal and
[[Page 22551]]
human health; (8) food producers--livestock, poultry, and seafood; (9)
in vitro diagnostics; (10) food retailers; (11) food processors; (12)
animal feed producers; and (13) farm bio-security.
Individuals who are appointed to serve as non-voting liaison
representative members may be allowed to receive per diem and
reimbursement for any applicable expenses for travel that is performed
to attend meetings of the Advisory Council in accordance with federal
travel regulations. The Advisory Council meets, at a minimum, two times
per fiscal year depending on the availability of funds. Meetings are
open to the public, except as determined otherwise by the Secretary or
other official to whom the authority has been delegated in accordance
with guidelines under the Government in the Sunshine Act, 5 U.S.C.
552b(c).
Nominations, including self-nominations, of individuals who
represent organizations that have the specified expertise and knowledge
sought will be considered for appointment as non-voting liaison
representative members of the Advisory Council. Every effort will be
made to ensure that the Advisory Council is a diverse group of
individuals with representation from various geographic locations,
racial and ethnic minorities, all genders, and persons living with
disabilities. Detailed information on what is required in a nomination
package and how to submit one is on the Advisory Council Web site,
https://www.hhs.gov/ash/carb/.
Dated: April 25, 2017.
Jewel Mullen,
Acting Director, National Vaccine Program Office.
[FR Doc. 2017-09778 Filed 5-15-17; 8:45 am]
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