Clinical Laboratory Improvement Advisory Committee (CLIAC); Meeting, 48817-48818 [2018-21083]
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daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
with the revised federal criteria. The SIR
does not require the use of a particular
application form. Section 239.3 of the
SIR, however, requires that all state
applications contain the following five
components:
(1) A transmittal letter requesting
permit program approval.
(2) A narrative description of the state
permit program, including a
demonstration that the state’s standards
for non-municipal, non-hazardous waste
disposal units that receive CESQG
hazardous waste are technically
comparable to the Part 257, Subpart B
criteria and/or that its MSWLF
standards are technically comparable to
the Part 258 criteria.
(3) A legal certification demonstrating
that the state has the authority to carry
out the program.
(4) Copies of state laws, regulations,
and guidance that the state believes
demonstrate program adequacy.
(5) Copies of relevant state-tribal
agreements if the state has negotiated
with a tribe for the implementation of a
permit program for non-municipal, nonhazardous waste disposal units that
receive CESQG hazardous waste and/or
MSWLFs on tribal lands.
The EPA Administrator has delegated
the authority to make determinations of
adequacy, as contained in the statute, to
the EPA Regional Administrator. The
appropriate EPA Regional Office,
therefore, will use the information
provided by each state to determine
whether the state’s permit program
satisfies the statutory test reflected in
the requirements of 40 CFR part 239. In
all cases, the information will be
analyzed to determine the adequacy of
the state’s permit program for ensuring
compliance with the federal revised
criteria.
Form Numbers: None.
Respondents/affected entities: State,
Local, or Tribal Governments.
Respondent’s obligation to respond:
Mandatory under Section 4005(c) of
RCRA.
Estimated number of respondents: 12.
Frequency of response: On occasion.
Total estimated burden: 968 hours
(per year). Burden is defined at 5 CFR
1320.03(b).
Total estimated cost: $57,872 (per
year), which includes $57,872 for
annual labor and $0 for annualized
capital or operation & maintenance
costs.
Changes in the Estimates: There is no
change in the total estimated burden
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currently identified in the OMB
Inventory of Approved ICR Burdens.
Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018–20635 Filed 9–26–18; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9984–26—Region 9]
Clean Air Act Operating Permit
Program; Petition for Objection to
State Operating Permit for the Phillips
66 San Francisco Refinery
Environmental Protection
Agency (EPA).
ACTION: Notice of final Order on Petition
for objection to Clean Air Act title V
operating permit.
AGENCY:
The Environmental Protection
Agency (EPA) Administrator signed an
Order dated August 8, 2018, denying a
Petition dated March 19, 2018, from
Communities for a Better Environment,
San Francisco Baykeeper, Center for
Biological Diversity, Friends of the
Earth, Stand.earth, and Sierra Club. The
Petition requested that the EPA object to
a Clean Air Act (CAA) title V operating
permit issued by the Bay Area Air
Quality Management District (BAAQMD
or the District) to Facility No. A0016,
the Phillips 66 San Francisco Refinery
(Phillips 66 or the facility), located in
Contra Costa County, California.
ADDRESSES: The EPA requests that you
contact the individual listed in the FOR
FURTHER INFORMATION CONTACT section to
view copies of the final Order, the
Petition, and other supporting
information. You may review copies of
the final Order, the Petition, and other
supporting information at the EPA
Region IX Office, 75 Hawthorne Street,
San Francisco, California 94105. You
may view the hard copies Monday
through Friday, from 9 a.m. to 3 p.m.,
excluding federal holidays. If you wish
to examine these documents, you
should make an appointment at least 24
hours before the visiting day.
Additionally, the final Order and
Petition are available electronically at:
https://www.epa.gov/title-v-operatingpermits/title-v-petition-database.
FOR FURTHER INFORMATION CONTACT:
Shaheerah Kelly, EPA Region IX, (415)
947–4156, kelly.shaheerah@epa.gov.
SUPPLEMENTARY INFORMATION: The CAA
affords the EPA a 45-day period to
review and object to, as appropriate,
operating permits proposed by state
permitting authorities under title V of
the CAA. Section 505(b)(2) of the CAA
SUMMARY:
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48817
authorizes any person to petition the
EPA Administrator to object to a title V
operating permit within 60 days after
the expiration of the EPA’s 45-day
review period if the EPA has not
objected on its own initiative. Petitions
must be based only on objections to the
permit that were raised with reasonable
specificity during the public comment
period provided by the state, unless the
petitioner demonstrates that it was
impracticable to raise such objections
during the comment period or unless
the grounds for such objections arose
after this period.
The EPA received the Petition from
Communities for a Better Environment,
San Francisco Baykeeper, Center for
Biological Diversity, Friends of the
Earth, Stand.earth, and Sierra Club
dated March 19, 2018, requesting that
the EPA object to the issuance of
operating permit for Facility No. A0016,
issued by the BAAQMD to Phillips 66
in Contra Costa County, California. The
Petition raised various claims centered
around the allegation that the District
improperly and unlawfully issued a title
V permit renewal because it included an
approval of permitted capacity increases
for two hydrocracking emission units
without providing adequate notice to
the public and without a legal or factual
basis for the approval.
On August 8, 2018, the EPA
Administrator issued an Order denying
the Petition. The Order explains the
basis for the EPA’s decision.
Sections 307(b) and 505(b)(2) of the
CAA provide that a petitioner may
request judicial review of those portions
of an order that deny issues in a
petition. Any petition for review shall
be filed in the United States Court of
Appeals for the appropriate circuit no
later than November 26, 2018.
Dated: September 6, 2018.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2018–21085 Filed 9–26–18; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee (CLIAC); Meeting
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
SUMMARY:
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daltland on DSKBBV9HB2PROD with NOTICES
48818
Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
CDC announces the following meeting
for the Clinical Laboratory Improvement
Advisory Committee (CLIAC). This
meeting is open to the public, limited
only by the space available. The meeting
room accommodates approximately 100
people. The public is also welcome to
view the meeting by webcast. Check the
CLIAC website on the day of the
meeting for the webcast link https://
cdclabtraining.adobeconnect.com/
cliac/.
DATES: The meeting will be held on
November 7, 2018, 8:30 a.m. to 5:30
p.m., EST and November 8, 2018, 8:30
a.m. to 1:00 p.m., EST.
ADDRESSES: CDC, 2500 Century Parkway
NE, Rooms 1200/1201, Atlanta, Georgia
30345 and https://cdclabtraining.adobe
connect.com/
cliac/.
FOR FURTHER INFORMATION CONTACT:
Nancy Anderson, MMSc, MT(ASCP),
Senior Advisor for Clinical Laboratories,
Division of Laboratory Systems, Center
for Surveillance, Epidemiology and
Laboratory Services, Office of Public
Health Scientific Services, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mailstop F–11,
Atlanta, Georgia 30329–4027, telephone
(404) 498–2741; NAnderson@cdc.gov.
SUPPLEMENTARY INFORMATION: All people
attending the CLIAC meeting in-person
are required to register for the meeting
online at least five business days in
advance for U.S. citizens and at least 15
business days in advance for
international registrants. Register at:
https://wwwn.cdc.gov/cliac/. Register by
scrolling down and clicking the
‘‘Register for this Meeting’’ button and
completing all forms according to the
instructions given. Please complete all
the required fields before submitting
your registration and submit no later
than October 30, 2018 for U.S.
registrants and October 20, 2018 for
international registrants.
It is the policy of CLIAC to accept
written public comments and provide a
brief period for oral public comments on
agenda items. Public comment periods
for each agenda item are scheduled
immediately prior to the Committee
discussion period for that item. In
general, each individual or group
requesting to make oral comments will
be limited to a total time of five minutes
(unless otherwise indicated). To assure
adequate time is scheduled for public
comments, speakers should notify the
contact person below at least five
business days prior to the meeting date.
For individuals or groups unable to
attend the meeting, CLIAC accepts
written comments until the date of the
meeting (unless otherwise stated).
VerDate Sep<11>2014
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However, it is requested that comments
be submitted at least five business days
prior to the meeting date so that the
comments may be made available to the
Committee for their consideration and
public distribution. Written comments,
one hard copy with original signature,
should be provided to the contact
person at the mailing or email address
below, and will be included in the
meeting’s Summary Report.
The CLIAC meeting materials will be
made available to the Committee and
the public in electronic format (PDF) on
the internet instead of by printed copy.
Check the CLIAC website on the day of
the meeting for materials: https://
wwwn.cdc.gov/cliac/.
Purpose: This Committee is charged
with providing scientific and technical
advice and guidance to the Secretary of
Health and Human Services (HHS); the
Assistant Secretary for Health; the
Director, Centers for Disease Control
and Prevention; the Commissioner,
Food and Drug Administration (FDA);
and the Administrator, Centers for
Medicare and Medicaid Services (CMS).
The advice and guidance pertain to
general issues related to improvement in
clinical laboratory quality and
laboratory medicine practice and
specific questions related to possible
revision of the Clinical Laboratory
Improvement Amendment (CLIA)
standards. Examples include providing
guidance on studies designed to
improve safety, effectiveness, efficiency,
timeliness, equity, and patientcenteredness of laboratory services;
revisions to the standards under which
clinical laboratories are regulated; the
impact of proposed revisions to the
standards on medical and laboratory
practice; and the modification of the
standards and provision of nonregulatory guidelines to accommodate
technological advances, such as new
test methods, the electronic
transmission of laboratory information,
and mechanisms to improve the
integration of public health and clinical
laboratory practices.
Matters To Be Considered: The agenda
will include agency updates from CDC,
CMS, and FDA. Presentations and
discussions will focus on an update
from the CDC’s Office of Infectious
Diseases Board of Scientific Counselors
meeting; updates on laboratory
interoperability; updates on antibiotic
resistance activities; the Clinical
Laboratory Improvement Amendments
personnel requirements; the role of the
laboratory in the opioid crisis; and the
role of the laboratory in improving
diagnoses. Agenda items are subject to
change as priorities dictate.
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The Chief Operating Officer, Centers
for Disease Control and Prevention, has
been delegated the authority to sign
Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–21083 Filed 9–26–18; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10599]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by October 29, 2018.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
SUMMARY:
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Agencies
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48817-48818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21083]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Clinical Laboratory Improvement Advisory Committee (CLIAC);
Meeting
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, the
[[Page 48818]]
CDC announces the following meeting for the Clinical Laboratory
Improvement Advisory Committee (CLIAC). This meeting is open to the
public, limited only by the space available. The meeting room
accommodates approximately 100 people. The public is also welcome to
view the meeting by webcast. Check the CLIAC website on the day of the
meeting for the webcast link https://cdclabtraining.adobeconnect.com/cliac/ cliac/.
DATES: The meeting will be held on November 7, 2018, 8:30 a.m. to 5:30
p.m., EST and November 8, 2018, 8:30 a.m. to 1:00 p.m., EST.
ADDRESSES: CDC, 2500 Century Parkway NE, Rooms 1200/1201, Atlanta,
Georgia 30345 and https://cdclabtraining.adobeconnect.com/cliac/ cliac/.
FOR FURTHER INFORMATION CONTACT: Nancy Anderson, MMSc, MT(ASCP), Senior
Advisor for Clinical Laboratories, Division of Laboratory Systems,
Center for Surveillance, Epidemiology and Laboratory Services, Office
of Public Health Scientific Services, Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mailstop F-11, Atlanta, Georgia
30329-4027, telephone (404) 498-2741; [email protected].
SUPPLEMENTARY INFORMATION: All people attending the CLIAC meeting in-
person are required to register for the meeting online at least five
business days in advance for U.S. citizens and at least 15 business
days in advance for international registrants. Register at: https://wwwn.cdc.gov/cliac/. Register by scrolling down and clicking the
``Register for this Meeting'' button and completing all forms according
to the instructions given. Please complete all the required fields
before submitting your registration and submit no later than October
30, 2018 for U.S. registrants and October 20, 2018 for international
registrants.
It is the policy of CLIAC to accept written public comments and
provide a brief period for oral public comments on agenda items. Public
comment periods for each agenda item are scheduled immediately prior to
the Committee discussion period for that item. In general, each
individual or group requesting to make oral comments will be limited to
a total time of five minutes (unless otherwise indicated). To assure
adequate time is scheduled for public comments, speakers should notify
the contact person below at least five business days prior to the
meeting date. For individuals or groups unable to attend the meeting,
CLIAC accepts written comments until the date of the meeting (unless
otherwise stated). However, it is requested that comments be submitted
at least five business days prior to the meeting date so that the
comments may be made available to the Committee for their consideration
and public distribution. Written comments, one hard copy with original
signature, should be provided to the contact person at the mailing or
email address below, and will be included in the meeting's Summary
Report.
The CLIAC meeting materials will be made available to the Committee
and the public in electronic format (PDF) on the internet instead of by
printed copy. Check the CLIAC website on the day of the meeting for
materials: https://wwwn.cdc.gov/cliac/.
Purpose: This Committee is charged with providing scientific and
technical advice and guidance to the Secretary of Health and Human
Services (HHS); the Assistant Secretary for Health; the Director,
Centers for Disease Control and Prevention; the Commissioner, Food and
Drug Administration (FDA); and the Administrator, Centers for Medicare
and Medicaid Services (CMS). The advice and guidance pertain to general
issues related to improvement in clinical laboratory quality and
laboratory medicine practice and specific questions related to possible
revision of the Clinical Laboratory Improvement Amendment (CLIA)
standards. Examples include providing guidance on studies designed to
improve safety, effectiveness, efficiency, timeliness, equity, and
patient-centeredness of laboratory services; revisions to the standards
under which clinical laboratories are regulated; the impact of proposed
revisions to the standards on medical and laboratory practice; and the
modification of the standards and provision of non-regulatory
guidelines to accommodate technological advances, such as new test
methods, the electronic transmission of laboratory information, and
mechanisms to improve the integration of public health and clinical
laboratory practices.
Matters To Be Considered: The agenda will include agency updates
from CDC, CMS, and FDA. Presentations and discussions will focus on an
update from the CDC's Office of Infectious Diseases Board of Scientific
Counselors meeting; updates on laboratory interoperability; updates on
antibiotic resistance activities; the Clinical Laboratory Improvement
Amendments personnel requirements; the role of the laboratory in the
opioid crisis; and the role of the laboratory in improving diagnoses.
Agenda items are subject to change as priorities dictate.
The Chief Operating Officer, Centers for Disease Control and
Prevention, has been delegated the authority to sign Federal Register
notices pertaining to announcements of meetings and other committee
management activities, for both the Centers for Disease Control and
Prevention and the Agency for Toxic Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2018-21083 Filed 9-26-18; 8:45 am]
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