Clinical Laboratory Improvement Advisory Committee (CLIAC); Meeting, 48817-48818 [2018-21083]

Download as PDF 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 VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 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] BILLING CODE 6560–50–P 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: PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 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: E:\FR\FM\27SEN1.SGM 27SEN1 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 17:20 Sep 26, 2018 Jkt 244001 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. PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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: E:\FR\FM\27SEN1.SGM 27SEN1

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]
 BILLING CODE 4163-19-P


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