80_FR_63995 80 FR 63792 - Meeting: Clinical Laboratory Improvement Advisory Committee

80 FR 63792 - Meeting: Clinical Laboratory Improvement Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 203 (October 21, 2015)

Page Range63792-63793
FR Document2015-26758

Federal Register, Volume 80 Issue 203 (Wednesday, October 21, 2015) 
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63792-63793]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26758]


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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: http://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: http://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: http://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 
[email protected].
    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

63792 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices includes: NIOSH Program Update; the authorized representative of the Times and Dates Department of Labor Program Update; deceased third party; (b) if it is unclear 8:30 a.m.–5 p.m.., November 18, 2015. Department of Energy Program Update; whether the third party is living or 8:30 a.m.–12 p.m., November 19, Report by the Dose Reconstruction deceased; or (c) the information is 2015. Review Methods Work Group; SEC unrelated or irrelevant to the purpose of Place: CDC, 2500 Century Center Petitions Update; Site Profile reviews the disclosure. Boulevard, Rooms 1200/1201, Atlanta, for: Dow Chemical Co. (Madison, The Board will take reasonable steps Georgia 30345. Illinois), and General Steel Industries to ensure that individuals making Status: Open to the public, limited (Granite City, Illinois); SEC petitions for: public comment are aware of the fact only by the space available. The meeting Battelle Laboratories, King Avenue that their comments (including their room accommodates approximately 100 (1956–1970; Columbus, Ohio), name, if provided) will appear in a people. This meeting will also be Lawrence Livermore National transcript of the meeting posted on a webcast, please see information below. Laboratory (1974–1995; Livermore, public Web site. Such reasonable steps Purpose: This Committee is charged California), Blockson Chemical Co. include: (a) A statement read at the start with providing scientific and technical (1960–1991; Joliet, Illinois), Rocky Flats advice and guidance to the Secretary of of each public comment period stating Plant (1984–1989; Golden, Colorado), Health and Human Services (HHS); the that transcripts will be posted and Idaho National Laboratory (1949–1970; Assistant Secretary for Health; the names of speakers will not be redacted; Scoville, Idaho), and Kansas City Plant Director, Centers for Disease Control (b) A printed copy of the statement (1949–1993; Kansas City, Missouri); and mentioned in (a) above will be and Prevention; the Commissioner, Board Work Sessions. displayed on the table where Food and Drug Administration (FDA); The agenda is subject to change as priorities dictate. individuals sign up to make public and the Administrator, Centers for In the event an individual cannot comments; (c) A statement such as Medicare and Medicaid Services (CMS). attend, written comments may be outlined in (a) above will also appear The advice and guidance pertain to submitted to the contact person well in with the agenda for a Board Meeting general issues related to improvement in advance of the meeting. Any written when it is posted on the NIOSH Web clinical laboratory quality and comments received will be provided at site; (d) A statement such as in (a) above laboratory medicine practice and the meeting in accordance with the will appear in the Federal Register specific questions related to possible redaction policy provided below. Notice that announces Board and revision of the Clinical Laboratory Policy on Redaction of Board Meeting Subcommittee meetings. Improvement Amendment (CLIA) Transcripts (Public Comment): (1) If a Contact Person For More Information: standards. Examples include providing person making a comment gives his or Theodore Katz, Designated Federal guidance on studies designed to her personal information, no attempt Officer, NIOSH, CDC, 1600 Clifton Road improve safety, effectiveness, efficiency, will be made to redact the name; NE., MS E–20, Atlanta, Georgia 30333, timeliness, equity, and patient- however, NIOSH will redact other telephone: (513) 533–6800, toll free: 1– centeredness of laboratory services; personally identifiable information, 800–CDC–INFO, email: dcas@cdc.gov. revisions to the standards under which such as contact information, social clinical laboratories are regulated; the The Director, Management Analysis impact of proposed revisions to the security numbers, case numbers, etc., of and Services Office, has been delegated standards on medical and laboratory the commenter. (2) If an individual in making a the authority to sign Federal Register practice; and the modification of the statement reveals personal information Notices pertaining to announcements of standards and provision of non- (e.g., medical or employment meetings and other committee regulatory guidelines to accommodate information) about themselves that management activities, for both the technological advances, such as new information will not usually be Centers for Disease Control and test methods and the electronic redacted. The NIOSH Freedom of Prevention and the Agency for Toxic transmission of laboratory information. Information Act (FOIA) coordinator Substances and Disease Registry. Matters for Discussion: The agenda will, however, review such revelations Catherine Ramadei, will include agency updates from CDC, in accordance with the Federal Acting Director, Management Analysis and CMS, and FDA. Presentations and Advisory Committee Act and if deemed Services Office, Centers for Disease Control discussions will include laboratory appropriate, will redact such and Prevention. information exchange (interoperability); information. [FR Doc. 2015–26757 Filed 10–20–15; 8:45 am] noninvasive prenatal testing; CLIA (3) If a commenter reveals personal waiver guidance; the Institute of BILLING CODE 4163–18–P information concerning a living third Medicine (IOM) report ‘‘Improving party, that information will be reviewed Diagnosis in Health Care;’’ and FDA by the NIOSH FOIA coordinator, and DEPARTMENT OF HEALTH AND guidance for laboratory developed tests. upon determination, if deemed HUMAN SERVICES Agenda items are subject to change as appropriated, such information will be priorities dictate. redacted, unless the disclosure is made Centers for Disease Control and Webcast: The meeting will also be by the third party’s authorized Prevention webcast. Persons interested in viewing representative under the Energy the webcast can access information at: Employees Occupational Illness Meeting: Clinical Laboratory http:// Compensation Program Act (EEOICPA) Improvement Advisory Committee cdclabtraining.adobeconnect.com/ tkelley on DSK3SPTVN1PROD with NOTICES program. novcliac/. (4) In general, information concerning In accordance with section 10(a)(2) of Online Registration Required: All a deceased third party may be disclosed; the Federal Advisory Committee Act people attending the CLIAC meeting in- however, such information will be (Pub. L. 92–463), the Centers for Disease person are required to register for the redacted if (a) the disclosure is made by Control and Prevention (CDC) meeting online at least 5 business days an individual other than the survivor announces the following committee in advance for U.S. citizens and at least claimant, a parent, spouse, or child, or meeting. 10 business days in advance for VerDate Sep<11>2014 22:39 Oct 20, 2015 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\21OCN1.SGM 21OCN1

Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices 63793 international registrants. Register at: Laboratory Services, Office of Public instructions for submitting comments. http://wwwn.cdc.gov/cliac/Meetings/ Health Scientific Services, Centers for Comments submitted electronically, MeetingDetails.aspx#. Register by Disease Control and Prevention, 1600 including attachments, to http:// scrolling down and clicking the Clifton Road NE., Mailstop F–11, www.regulations.gov will be posted to ‘‘Register for this Meeting’’ button and Atlanta, Georgia 30329–4018; telephone the docket unchanged. Because your completing all forms according to the (404) 498–2741; or via email at comment will be made public, you are instructions given. Please complete all NAnderson@cdc.gov. solely responsible for ensuring that your the required fields before submitting The Director, Management Analysis comment does not include any your registration and submit no later and Services Office, has been delegated confidential information that you or a than November 13, 2015 for U.S. the authority to sign Federal Register third party may not wish to be posted, registrants and November 8, 2015 for Notices pertaining to announcements of such as medical information, your or international registrants. meetings and other committee anyone else’s Social Security number, or Providing Oral or Written Comments: management activities, for CDC and the confidential business information, such It is the policy of CLIAC to accept Agency for Toxic Substances and as a manufacturing process. Please note written public comments and provide a Disease Registry. that if you include your name, contact brief period for oral public comments on Catherine Ramadei, information, or other information that agenda items whenever possible. identifies you in the body of your Acting Director, Management Analysis and Oral Comments: In general, each Services Office, Centers for Disease Control comments, that information will be individual or group requesting to make and Prevention. posted on http://www.regulations.gov. oral comments will be limited to a total • If you want to submit a comment [FR Doc. 2015–26758 Filed 10–20–15; 8:45 am] time of five minutes (unless otherwise with confidential information that you BILLING CODE 4163–18–P indicated). Speakers must also submit do not wish to be made available to the their comments in writing for inclusion public, submit the comment as a in the meeting’s Summary Report. To DEPARTMENT OF HEALTH AND written/paper submission and in the assure adequate time is scheduled for HUMAN SERVICES manner detailed (see ‘‘Written/Paper public comments, speakers should Submissions’’ and ‘‘Instructions’’). notify the contact person below at least Food and Drug Administration Written/Paper Submissions one week prior to the meeting date. [Docket No. FDA–2012–N–0536] Submit written/paper submissions as Written Comments: For individuals or groups unable to attend the meeting, follows: Agency Information Collection • Mail/Hand delivery/Courier (for CLIAC accepts written comments until Activities; Proposed Collection; the date of the meeting (unless written/paper submissions): Division of Comment Request; Medical Device Dockets Management (HFA–305), Food otherwise stated). However, it is User Fee Cover Sheet, Form FDA 3601 requested that comments be submitted and Drug Administration, 5630 Fishers at least one week prior to the meeting AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. date so that the comments may be made HHS. • For written/paper comments available to the Committee for their ACTION: Notice. submitted to the Division of Dockets consideration and public distribution. Management, FDA will post your Written comments, to include the SUMMARY: The Food and Drug comment, as well as any attachments, original signature of the submitter, Administration (FDA) is announcing an except for information submitted, should be provided to the contact opportunity for public comment on the marked and identified, as confidential, person at the mailing or email address proposed collection of certain if submitted as detailed in information by the Agency. Under the ‘‘Instructions’’. below, and will be included in the Paperwork Reduction Act of 1995 (the Instructions: All submissions received meeting’s Summary Report. Availability of Meeting Materials: To PRA), Federal Agencies are required to must include the Docket No. FDA– support the green initiatives of the publish notice in the Federal Register 2012–N–0536 for ‘‘Agency Information federal government, the CLIAC meeting concerning each proposed collection of Collection Activities; Proposed materials will be made available to the information, including each proposed Collection; Comment Request; Medical Committee and the public in electronic extension of an existing collection of Device User Fee Cover Sheet, Form FDA format (PDF) on the internet instead of information, and to allow 60 days for 3601.’’ Received comments will be by printed copy. Check the CLIAC Web public comment in response to the placed in the docket and, except for site on the day of the meeting for notice. This notice solicits comments on those submitted as ‘‘Confidential materials: http://wwwn.cdc.gov/cliac/ Form FDA 3601, entitled ‘‘Medical Submissions’’, publicly viewable at cliac_meeting_all_documents.aspx. Device User Fee Cover Sheet,’’ which http://www.regulations.gov or at the must be submitted along with certain Division of Dockets Management Note: If using a mobile device to access the medical device product applications, between 9 a.m. and 4 p.m., Monday materials, please verify that the device’s supplements, and fee payment of those browser is able to download the files from through Friday. the CDC’s Web site before the meeting. applications. • Confidential Submissions—To Alternatively, the files can be downloaded to DATES: Submit either electronic or submit a comment with confidential a computer and then emailed to the portable written comments on the collection of information that you do not wish to be device. An internet connection, power information by December 21, 2015. made publicly available, submit your source, and limited hard copies may be ADDRESSES: You may submit comments comments only as a written/paper tkelley on DSK3SPTVN1PROD with NOTICES available at the meeting location, but cannot submission. You should submit two be guaranteed. as follows: copies total. One copy will include the Contact Person for Additional Electronic Submissions information you claim to be confidential Information: Nancy Anderson, Chief, Submit electronic comments in the with a heading or cover note that states Laboratory Practice Standards Branch, following way: ‘‘THIS DOCUMENT CONTAINS Division of Laboratory Systems, Center • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION’’. The for Surveillance, Epidemiology and www.regulations.gov. Follow the Agency will review this copy, including VerDate Sep<11>2014 22:39 Oct 20, 2015 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\21OCN1.SGM 21OCN1


Document Created: 2018-02-27 08:53:52
Document Modified: 2018-02-27 08:53:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation80 FR 63792 
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