Meeting: Clinical Laboratory Improvement Advisory Committee, 63792-63793 [2015-26758]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES 63792 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices includes: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; Report by the Dose Reconstruction Review Methods Work Group; SEC Petitions Update; Site Profile reviews for: Dow Chemical Co. (Madison, Illinois), and General Steel Industries (Granite City, Illinois); SEC petitions for: Battelle Laboratories, King Avenue (1956–1970; Columbus, Ohio), Lawrence Livermore National Laboratory (1974–1995; Livermore, California), Blockson Chemical Co. (1960–1991; Joliet, Illinois), Rocky Flats Plant (1984–1989; Golden, Colorado), Idaho National Laboratory (1949–1970; Scoville, Idaho), and Kansas City Plant (1949–1993; Kansas City, Missouri); and Board Work Sessions. The agenda is subject to change as priorities dictate. 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Contact Person For More Information: Theodore Katz, Designated Federal Officer, NIOSH, CDC, 1600 Clifton Road NE., MS E–20, Atlanta, Georgia 30333, telephone: (513) 533–6800, toll free: 1– 800–CDC–INFO, email: dcas@cdc.gov. The Director, Management Analysis and Services Office, 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. Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2015–26757 Filed 10–20–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Meeting: Clinical Laboratory Improvement Advisory Committee In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following committee meeting. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Times and Dates 8:30 a.m.–5 p.m.., November 18, 2015. 8:30 a.m.–12 p.m., November 19, 2015. Place: CDC, 2500 Century Center Boulevard, Rooms 1200/1201, Atlanta, Georgia 30345. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. This meeting will also be webcast, please see information below. 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 and the electronic transmission of laboratory information. Matters for Discussion: The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will include laboratory information exchange (interoperability); noninvasive prenatal testing; CLIA waiver guidance; the Institute of Medicine (IOM) report ‘‘Improving Diagnosis in Health Care;’’ and FDA guidance for laboratory developed tests. Agenda items are subject to change as priorities dictate. Webcast: The meeting will also be webcast. Persons interested in viewing the webcast can access information at: https:// cdclabtraining.adobeconnect.com/ novcliac/. Online Registration Required: All people attending the CLIAC meeting inperson are required to register for the meeting online at least 5 business days in advance for U.S. citizens and at least 10 business days in advance for E:\FR\FM\21OCN1.SGM 21OCN1 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices tkelley on DSK3SPTVN1PROD with NOTICES international registrants. Register at: https://wwwn.cdc.gov/cliac/Meetings/ MeetingDetails.aspx#. 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 November 13, 2015 for U.S. registrants and November 8, 2015 for international registrants. Providing Oral or Written Comments: It is the policy of CLIAC to accept written public comments and provide a brief period for oral public comments on agenda items whenever possible. Oral Comments: In general, each individual or group requesting to make oral comments will be limited to a total time of five minutes (unless otherwise indicated). Speakers must also submit their comments in writing for inclusion in the meeting’s Summary Report. To assure adequate time is scheduled for public comments, speakers should notify the contact person below at least one week prior to the meeting date. Written Comments: 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 one week prior to the meeting date so that the comments may be made available to the Committee for their consideration and public distribution. Written comments, to include the original signature of the submitter, should be provided to the contact person at the mailing or email address below, and will be included in the meeting’s Summary Report. Availability of Meeting Materials: To support the green initiatives of the federal government, 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 Web site on the day of the meeting for materials: https://wwwn.cdc.gov/cliac/ cliac_meeting_all_documents.aspx. Laboratory Services, Office of Public Health Scientific Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop F–11, Atlanta, Georgia 30329–4018; telephone (404) 498–2741; or via email at NAnderson@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for CDC and the Agency for Toxic Substances and Disease Registry. Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2015–26758 Filed 10–20–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0536] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. Note: If using a mobile device to access the materials, please verify that the device’s browser is able to download the files from the CDC’s Web site before the meeting. Alternatively, the files can be downloaded to a computer and then emailed to the portable device. An internet connection, power source, and limited hard copies may be available at the meeting location, but cannot be guaranteed. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3601, entitled ‘‘Medical Device User Fee Cover Sheet,’’ which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications. DATES: Submit either electronic or written comments on the collection of information by December 21, 2015. ADDRESSES: You may submit comments as follows: Contact Person for Additional Information: Nancy Anderson, Chief, Laboratory Practice Standards Branch, Division of Laboratory Systems, Center for Surveillance, Epidemiology and Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the VerDate Sep<11>2014 22:39 Oct 20, 2015 Jkt 238001 SUMMARY: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 63793 instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions’’. Instructions: All submissions received must include the Docket No. FDA– 2012–N–0536 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions’’, publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including E:\FR\FM\21OCN1.SGM 21OCN1

Agencies

[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63792-63793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26758]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Meeting: Clinical Laboratory Improvement Advisory Committee

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC) announces the following committee meeting.

Times and Dates

    8:30 a.m.-5 p.m.., November 18, 2015.
    8:30 a.m.-12 p.m., November 19, 2015.
    Place: CDC, 2500 Century Center Boulevard, Rooms 1200/1201, 
Atlanta, Georgia 30345.
    Status: Open to the public, limited only by the space available. 
The meeting room accommodates approximately 100 people. This meeting 
will also be webcast, please see information below.
    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 and the electronic transmission of laboratory information.
    Matters for Discussion: The agenda will include agency updates from 
CDC, CMS, and FDA. Presentations and discussions will include 
laboratory information exchange (interoperability); noninvasive 
prenatal testing; CLIA waiver guidance; the Institute of Medicine (IOM) 
report ``Improving Diagnosis in Health Care;'' and FDA guidance for 
laboratory developed tests.
    Agenda items are subject to change as priorities dictate.
    Webcast: The meeting will also be webcast. Persons interested in 
viewing the webcast can access information at: https://cdclabtraining.adobeconnect.com/novcliac/.
    Online Registration Required: All people attending the CLIAC 
meeting in-person are required to register for the meeting online at 
least 5 business days in advance for U.S. citizens and at least 10 
business days in advance for

[[Page 63793]]

international registrants. Register at: https://wwwn.cdc.gov/cliac/Meetings/MeetingDetails.aspx#. 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 
November 13, 2015 for U.S. registrants and November 8, 2015 for 
international registrants.
    Providing Oral or Written Comments: It is the policy of CLIAC to 
accept written public comments and provide a brief period for oral 
public comments on agenda items whenever possible.
    Oral Comments: In general, each individual or group requesting to 
make oral comments will be limited to a total time of five minutes 
(unless otherwise indicated). Speakers must also submit their comments 
in writing for inclusion in the meeting's Summary Report. To assure 
adequate time is scheduled for public comments, speakers should notify 
the contact person below at least one week prior to the meeting date.
    Written Comments: 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 one week prior to the meeting date so that the 
comments may be made available to the Committee for their consideration 
and public distribution. Written comments, to include the original 
signature of the submitter, should be provided to the contact person at 
the mailing or email address below, and will be included in the 
meeting's Summary Report.
    Availability of Meeting Materials: To support the green initiatives 
of the federal government, 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 Web site on 
the day of the meeting for materials: https://wwwn.cdc.gov/cliac/cliac_meeting_all_documents.aspx.

    Note: If using a mobile device to access the materials, please 
verify that the device's browser is able to download the files from 
the CDC's Web site before the meeting. Alternatively, the files can 
be downloaded to a computer and then emailed to the portable device. 
An internet connection, power source, and limited hard copies may be 
available at the meeting location, but cannot be guaranteed.

    Contact Person for Additional Information: Nancy Anderson, Chief, 
Laboratory Practice Standards Branch, 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 
30329-4018; telephone (404) 498-2741; or via email at 
NAnderson@cdc.gov.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register Notices pertaining to 
announcements of meetings and other committee management activities, 
for CDC and the Agency for Toxic Substances and Disease Registry.

Catherine Ramadei,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 2015-26758 Filed 10-20-15; 8:45 am]
BILLING CODE 4163-18-P
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