Solicitation of Nominations for Appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 11312-11313 [2019-05751]
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11312
Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
§ 118.10(a)(2) is kept roughly once
annually per layer house basis. We
estimate that 4,731 layer houses
maintain 1 record each and that it takes
approximately 0.5 hour per
recordkeeping. Thus, the total annual
burden for chick and pullet
procurement recordkeeping is
calculated to be 2,366 hours (4,731
records × 0.5 hour).
We estimate that rodent and other
pest control records under
§ 118.10(a)(3)(ii) and biosecurity records
under § 118.10(a)(3)(i) are kept weekly
on a per layer house basis. We assume
that 4,731 layer houses maintain a
weekly record under each provision.
Thus, we estimate 9,462 recordkeepers
maintain 52 records each for a total of
492,024 records. We estimate a
recordkeeping burden of 0.5 hours per
record for a total of 246,012 burden
hours (492,024 records × 0.5 hour).
New prevention plan design required
by § 118.10(a)(1) is only undertaken by
new farms and records are kept on a per
farm basis. We estimate that there are
350 new farm registrations annually,
and we assume that this reflects 350
new farms requiring prevention plan
design. This is an increase from our
previous estimate based on new
registrations received. We estimate that
it takes 20 hours to complete this work.
Thus, the total annual burden for
prevention plan design is calculated to
be 7,000 hours (350 records × 20 hours).
Cleaning and disinfection
recordkeeping under § 118.10(a)(3)(iii)
needs to be performed every time a
house tests positive. We estimate that
331 layer houses test positive requiring
1 record each and that it takes
approximately 0.5 hour per
recordkeeping. Thus, the total annual
burden for cleaning and disinfection
recordkeeping in the event of a positive
test result is calculated to be 166 hours
(331 records × 0.5 hour).
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Description and 21 CFR section
2 FDA
Registrations or Updates, § 118.11 .........
Cancellations, § 118.11 ............................
Total ..................................................
Number of
respondents
Form
Number of
responses per
respondent
Average burden
per response
Total annual
responses
Total hours
3733
FDA 3733
350
30
1
1
350
30
2.3
1
805
30
........................
........................
........................
........................
........................
835
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
term ‘‘Form FDA 3733’’ refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration Module, which is available at https://www.access.fda.gov per § 118.11(b)(1).
jbell on DSK30RV082PROD with NOTICES
2 The
This estimate is based on the average
number of new shell egg producer
registrations and cancellations received
in the past 3 years under § 118.11. We
estimate that we will receive an average
of 350 registrations or updates per year
over the next 3 years and that it takes
the average farm 2.3 hours to register,
taking into account that some
respondents completing the registration
may not have readily available internet
access. Thus, the total annual burden for
new shell egg producer registrations or
updates is calculated to be 805 hours
(350 respondents × 2.3 hours).
We estimate that we will receive 30
cancellations per year over the next 3
years and that cancelling a registration,
on average, requires a burden of 1 hour,
taking into account that some
respondents may not have readily
available internet access. Thus, the total
annual burden for cancelling shell egg
producer registrations is calculated to be
30 hours (30 cancellations × 1 hour).
We have increased our burden
estimate for the information collection
based on an increase in annual new
farm registrations.
Dated: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–05757 Filed 3–25–19; 8:45 am]
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17:54 Mar 25, 2019
Jkt 247001
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.
AGENCY:
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 voting member or 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 either
member category of the Advisory
Council are currently being accepted.
Nominations must be received
no later than 5:00 p.m. ET on May 10,
2019.
DATES:
Information on how to
submit a nomination is on the Advisory
Council website, https://www.hhs.gov/
ash/carb/.
ADDRESSES:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Jomana Musmar, 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
L133, Switzer Building, 330 C. St. 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.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26MRN1.SGM
26MRN1
jbell on DSK30RV082PROD with NOTICES
Federal Register / Vol. 84, No. 58 / Tuesday, March 26, 2019 / Notices
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.
This announcement is to solicit
nominations to fill eight positions in the
voting member category that are
scheduled to be vacated during the 2019
calendar year, and the terms of five
positions in the liaison representative
category that are scheduled to be
vacated during the 2020 calendar year.
Voting members are appointed to serve
three or four-year terms, and liaison
representative members are appointed
to serve a two-year term.
The eight public voting members
sought for this solicitation will be
selected from individuals who are
engaged in: Research on, or
implementation of, interventions
regarding efforts to preserve the
effectiveness of antibiotics by
optimizing their use; advancing research
to develop improved methods for
combating antibiotic resistance and
conducting antibiotic stewardship;
strengthening surveillance of antibioticresistant bacterial infections; preventing
the transmission of antibiotic-resistant
bacterial infections; advancing the
development of rapid point-of-care and
agricultural diagnostics; furthering
research on new treatments for bacterial
infections; developing alternatives to
antibiotics for agricultural purposes;
maximizing the dissemination of up-todate information on the appropriate and
proper use of antibiotics to the general
public and human and animal health
care providers; and improving
international coordination of efforts to
combat antibiotic resistance.
The public voting members will
represent balanced points of view from
human biomedical, public health, and
VerDate Sep<11>2014
17:54 Mar 25, 2019
Jkt 247001
agricultural fields to include
surveillance of antibiotic-resistant
infections, prevention and/or
interruption of the spread of antibioticresistant threats, or development of
rapid diagnostics and novel treatments.
The public voting members may be
physicians, veterinarians,
epidemiologists, microbiologists, or
other health care professionals (e.g.,
nurses, pharmacists, others); individuals
who have expertise and experience as
consumer or patient advocates
concerned with antibiotic resistance, or
in the fields of agriculture and
pharmaceuticals; and they also may be
from state or local health agencies or
public health organizations. The voting
public members will be appointed by
the Secretary, in consultation with the
Secretaries of Defense and Agriculture.
All public voting members will be
classified as special government
employees (SGEs).
Individuals who are appointed to
serve as voting 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
as authorized by 5 U.S.C. 5703, for
persons employed intermittently in the
Government service. 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).
The non-voting liaison representative
members 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. Non-voting liaison
representative members are appointed
to serve two-year terms. Individuals
from the following sectors are being
sought to serve as non-voting liaison
representatives:
• Professional organizations or
associations representing providers or
professionals for human and/or animal
health involved in infection control and
prevention; this can include physicians,
nurses, pharmacists, microbiologists,
veterinarians.
• Public health, environmental
health, and/or animal health
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
11313
organizations or associations (state/
territorial, county, or local) representing
laboratories, health officials,
epidemiologists, agricultural state
departments, or environmental
associations.
• Other organizations representing
patients and consumer advocates,
hospitals, pharmaceutical industry, food
producers and retailers, or other
commodity groups.
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 membership of federal advisory
committees is fairly balanced in terms of
points of view represented. Detailed
information on what is required in a
nomination package and how to submit
one is on the Advisory Council website,
https://www.hhs.gov/ash/carb/.
Dated: March 12, 2019.
Jomana F. Musmar,
Designated Federal Officer, Presidential
Advisory Council on Combating AntibioticResistant Bacteria, Committee Manager.
[FR Doc. 2019–05751 Filed 3–25–19; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood and Tissue Safety and
Availability; Amendment
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice; amendment.
AGENCY:
SUMMARY: A notice was published in the
Federal Register on Monday, March 11,
2019 (Vol. 84, No. 47, pages 8731–8732),
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[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11312-11313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05751]
-----------------------------------------------------------------------
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 voting
member or 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 either member
category of the Advisory Council are currently being accepted.
DATES: Nominations must be received no later than 5:00 p.m. ET on May
10, 2019.
ADDRESSES: Information on how to submit a nomination is on the Advisory
Council website, https://www.hhs.gov/ash/carb/.
FOR FURTHER INFORMATION CONTACT: Jomana Musmar, 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 L133, Switzer Building,
330 C. St. 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
[[Page 11313]]
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.
This announcement is to solicit nominations to fill eight positions
in the voting member category that are scheduled to be vacated during
the 2019 calendar year, and the terms of five positions in the liaison
representative category that are scheduled to be vacated during the
2020 calendar year. Voting members are appointed to serve three or
four-year terms, and liaison representative members are appointed to
serve a two-year term.
The eight public voting members sought for this solicitation will
be selected from individuals who are engaged in: Research on, or
implementation of, interventions regarding efforts to preserve the
effectiveness of antibiotics by optimizing their use; advancing
research to develop improved methods for combating antibiotic
resistance and conducting antibiotic stewardship; strengthening
surveillance of antibiotic-resistant bacterial infections; preventing
the transmission of antibiotic-resistant bacterial infections;
advancing the development of rapid point-of-care and agricultural
diagnostics; furthering research on new treatments for bacterial
infections; developing alternatives to antibiotics for agricultural
purposes; maximizing the dissemination of up-to-date information on the
appropriate and proper use of antibiotics to the general public and
human and animal health care providers; and improving international
coordination of efforts to combat antibiotic resistance.
The public voting members will represent balanced points of view
from human biomedical, public health, and agricultural fields to
include surveillance of antibiotic-resistant infections, prevention
and/or interruption of the spread of antibiotic-resistant threats, or
development of rapid diagnostics and novel treatments. The public
voting members may be physicians, veterinarians, epidemiologists,
microbiologists, or other health care professionals (e.g., nurses,
pharmacists, others); individuals who have expertise and experience as
consumer or patient advocates concerned with antibiotic resistance, or
in the fields of agriculture and pharmaceuticals; and they also may be
from state or local health agencies or public health organizations. The
voting public members will be appointed by the Secretary, in
consultation with the Secretaries of Defense and Agriculture. All
public voting members will be classified as special government
employees (SGEs).
Individuals who are appointed to serve as voting 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 as authorized by 5 U.S.C. 5703, for persons employed
intermittently in the Government service. 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).
The non-voting liaison representative members 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. Non-voting liaison
representative members are appointed to serve two-year terms.
Individuals from the following sectors are being sought to serve as
non-voting liaison representatives:
Professional organizations or associations representing
providers or professionals for human and/or animal health involved in
infection control and prevention; this can include physicians, nurses,
pharmacists, microbiologists, veterinarians.
Public health, environmental health, and/or animal health
organizations or associations (state/territorial, county, or local)
representing laboratories, health officials, epidemiologists,
agricultural state departments, or environmental associations.
Other organizations representing patients and consumer
advocates, hospitals, pharmaceutical industry, food producers and
retailers, or other commodity groups.
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 membership of federal
advisory committees is fairly balanced in terms of points of view
represented. Detailed information on what is required in a nomination
package and how to submit one is on the Advisory Council website,
https://www.hhs.gov/ash/carb/.
Dated: March 12, 2019.
Jomana F. Musmar,
Designated Federal Officer, Presidential Advisory Council on Combating
Antibiotic-Resistant Bacteria, Committee Manager.
[FR Doc. 2019-05751 Filed 3-25-19; 8:45 am]
BILLING CODE 4150-28-P
