Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee (CLIAC), 76576-76577 [2020-26257]
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Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–CK–21–001, US Travelers Health
Research, Surveillance,
Communication, and Outreach
Network; RFA–CK–21–002, Emerging
Infections Network—Research for
Preventing, Detecting, and Managing
Travelers who Acquire Infectious
Diseases Abroad; and RFA–CK–21–003,
Monitoring Cause-specific School
Absenteeism for Estimating Communitywide Influenza and SARS-CoV–2
Transmission.
Date: February 10–11, 2021.
Time: 10:00 a.m.–5:00 p.m., EST.
Place: Teleconference, Centers for
Disease Control and Prevention, Room
1080, 8 Corporate Square Boulevard,
Atlanta, GA 30329.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road NE, Mailstop US8–1,
Atlanta, Georgia 30329–4027, (404) 718–
8833, GAnderson@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of 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.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–26258 Filed 11–27–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TKELLEY on DSKBCP9HB2PROD with NOTICES
Centers for Disease Control and
Prevention
Solicitation of Nominations for
Appointment to the Clinical Laboratory
Improvement Advisory Committee
(CLIAC)
ACTION:
Notice.
The Centers for Disease
Control and Prevention (CDC) is seeking
nominations for membership on the
CLIAC. The CLIAC consists of 20
experts including the Chair who
SUMMARY:
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20:03 Nov 27, 2020
Jkt 253001
represents a diverse membership across
laboratory specialties, professional roles
(laboratory management, technical
specialists, physicians, nurses) and
practice settings (academic, clinical,
public health), and includes a consumer
representative.
DATES: Nominations for membership on
the CLIAC must be received no later
than March 1, 2021. Packages received
after this time will not be considered for
the current membership cycle.
ADDRESSES: All nominations should be
mailed to Nancy Anderson, MMSc,
MT(ASCP), CLIAC Secretary, 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 V24–3,
Atlanta, Georgia 30329–4018; telephone
(404) 498–2741; or via email at CLIAC@
cdc.gov.
FOR FURTHER INFORMATION CONTACT:
Heather Stang, MS, Deputy Branch
Chief, Quality and Safety Systems
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 V24–3, Atlanta, Georgia
30329–4018; telephone (404) 498–2769;
HStang@cdc.gov.
SUPPLEMENTARY INFORMATION: The
Committee also includes three ex officio
members (or designees), including the
Director, CDC; the Administrator,
Centers for Medicare and Medicaid
Services (CMS); and the Commissioner,
Food and Drug Administration (FDA). A
nonvoting representative from the
Advanced Medical Technology
Association (AdvaMed) serves as the
industry liaison. The Designated Federal
Official (DFO) or their designee and the
Executive Secretary are present at all
meetings to ensure meetings are within
applicable statutory, regulatory, and
HHS General Administration manual
directives.
Nominations are being sought for
individuals who have the expertise and
qualifications necessary to contribute to
the accomplishments of the committee’s
objectives. Nominees will be selected
based on expertise in the fields of
microbiology (including bacteriology,
mycobacteriology, mycology,
parasitology, and virology), immunology
(including histocompatibility),
chemistry, hematology, pathology
(including histopathology and cytology),
or genetic testing (including
cytogenetics); from representatives in
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the fields of medical technology,
bioinformatics, public health, and
clinical practice; and from consumer
representatives. Federal employees will
not be considered for membership.
Members may be invited to serve for up
to four-year terms.
Selection of members is based on
candidates’ qualifications to contribute
to the accomplishment of CLIAC
objectives (https://www.cdc.gov/cliac/).
The U.S. Department of Health and
Human Services policy stipulates that
committee membership be balanced in
terms of points of view represented, and
the committee’s function. Appointments
shall be made without discrimination
on the basis of age, race, ethnicity,
gender, sexual orientation, gender
identity, HIV status, disability, and
cultural, religious, or socioeconomic
status. Nominees must be U.S. citizens,
and cannot be full-time employees of
the U.S. Government. Current
participation on federal workgroups or
prior experience serving on a federal
advisory committee does not disqualify
a candidate; however, HHS policy is to
avoid excessive individual service on
advisory committees and multiple
committee memberships. Committee
members are Special Government
Employees (SGEs), requiring the filing
of financial disclosure reports at the
beginning and annually during their
terms. CDC reviews potential candidates
for CLIAC membership each year and
provides a slate of nominees for
consideration to the Secretary of HHS
for final selection. HHS notifies selected
candidates of their appointment near
the start of the term in July, or as soon
as the HHS selection process is
completed. Note that the need for
different expertise varies from year to
year and a candidate who is not selected
in one year may be reconsidered in a
subsequent year. Candidates should
submit the following items:
■ Current curriculum vitae, including
complete contact information
(telephone numbers, mailing address,
email address)
■ At least one letter of
recommendation from person(s) not
employed by the U.S. Department of
Health and Human Services.
(Candidates may submit letter(s) from
current HHS employees if they wish,
but at least one letter must be submitted
by a person not employed by an HHS
agency (e.g., CDC, NIH, FDA, etc.).
Nominations may be submitted by the
candidate, or by the person/organization
recommending the candidate.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
E:\FR\FM\30NON1.SGM
30NON1
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices
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.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–26257 Filed 11–27–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifiers: CMS–304/–304a,
CMS–367a—d, and CMS–368/–R–144]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare and
Medicaid Services, Health and Human
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 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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 must be received by
January 29, 2021.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
TKELLEY on DSKBCP9HB2PROD with NOTICES
SUMMARY:
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20:03 Nov 27, 2020
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www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development
Attention: Document Identifier/OMB
Control Number llll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html
2. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–304/–304a Reconciliation of
State Invoice (ROSI) and Prior Quarter
Adjustment Statement (PQAS)
CMS–367a–d Medicaid Drug Rebate
Program Labeler Reporting Format
CMS–368/–R–144 Medicaid Drug
Rebate Program State Reporting Forms
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
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76577
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Reconciliation
of State Invoice (ROSI) and Prior
Quarter Adjustment Statement (PQAS);
Use: Form CMS–304 (ROSI) is used by
manufacturers to respond to the state’s
rebate invoice for current quarter
utilization. Form CMS–304a (PQAS) is
required only in those instances where
a change to the original rebate data
submittal is necessary. Effective July 1,
2021, the Medicaid Drug Rebate
Program (MDRP) is updating to a new
Medicaid Drug Programs (MDP) system
which will now accept a delimited text
file format, Comma Separated Values
(.CSV), in addition to the current Text
(.TXT) file format. We have also
increased several file format data field
sizes in order to accommodate the
higher priced drugs that are entering the
market. These changes in conjunction
with numerous edits to verbiage are
applicable to Forms CMS–304 and
–304a. Separately, we are also updating
corresponding collection of information
requests (OMB 0938–0578 and OMB
0938–0582) so that all the MDP file
formats, field sizes, and verbiage will
align across the MDRP. Form Number:
CMS–304 and –304a (OMB control
number: 0938–0676); Frequency:
Quarterly; Affected Public: Private
sector (Business or other for-profits);
Number of Respondents: 749; Total
Annual Responses: 5,841; Total Annual
Hours: 248,584. (For policy questions
regarding this collection contact Andrea
Wellington at 410–786–3490.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Rebate Program Labeler Reporting
Format; Use: Labelers transmit drug
product and pricing data to CMS within
30 days after the end of each calendar
month and quarter. CMS calculates the
unit rebate amount (URA) and the unit
rebate offset amount (UROA) for each
new drug application (NDC) and
distributes to all State Medicaid
agencies. States use the URA to invoice
the labeler for rebates and the UROA to
report onto CMS–64. The monthly data
is used to calculate Federal Upper Limit
(FUL) prices for applicable drugs and
for states that opt to use this data to
establish their pharmacy reimbursement
methodology. Effective July 1, 2021, the
MDRP is updating to a new Medicaid
Drug Programs (MDP) system which
will now accept a delimited text file
format, Comma Separated Values
(.CSV), in addition to the current Text
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]]>Agencies
[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76576-76577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26257]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Solicitation of Nominations for Appointment to the Clinical
Laboratory Improvement Advisory Committee (CLIAC)
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) is
seeking nominations for membership on the CLIAC. The CLIAC consists of
20 experts including the Chair who represents a diverse membership
across laboratory specialties, professional roles (laboratory
management, technical specialists, physicians, nurses) and practice
settings (academic, clinical, public health), and includes a consumer
representative.
DATES: Nominations for membership on the CLIAC must be received no
later than March 1, 2021. Packages received after this time will not be
considered for the current membership cycle.
ADDRESSES: All nominations should be mailed to Nancy Anderson, MMSc,
MT(ASCP), CLIAC Secretary, 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 V24-3, Atlanta, Georgia 30329-4018; telephone (404) 498-2741;
or via email at [email protected].
FOR FURTHER INFORMATION CONTACT: Heather Stang, MS, Deputy Branch
Chief, Quality and Safety Systems 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 V24-3, Atlanta,
Georgia 30329-4018; telephone (404) 498-2769; [email protected].
SUPPLEMENTARY INFORMATION: The Committee also includes three ex officio
members (or designees), including the Director, CDC; the Administrator,
Centers for Medicare and Medicaid Services (CMS); and the Commissioner,
Food and Drug Administration (FDA). A nonvoting representative from the
Advanced Medical Technology Association (AdvaMed) serves as the
industry liaison. The Designated Federal Official (DFO) or their
designee and the Executive Secretary are present at all meetings to
ensure meetings are within applicable statutory, regulatory, and HHS
General Administration manual directives.
Nominations are being sought for individuals who have the expertise
and qualifications necessary to contribute to the accomplishments of
the committee's objectives. Nominees will be selected based on
expertise in the fields of microbiology (including bacteriology,
mycobacteriology, mycology, parasitology, and virology), immunology
(including histocompatibility), chemistry, hematology, pathology
(including histopathology and cytology), or genetic testing (including
cytogenetics); from representatives in the fields of medical
technology, bioinformatics, public health, and clinical practice; and
from consumer representatives. Federal employees will not be considered
for membership. Members may be invited to serve for up to four-year
terms.
Selection of members is based on candidates' qualifications to
contribute to the accomplishment of CLIAC objectives (https://www.cdc.gov/cliac/).
The U.S. Department of Health and Human Services policy stipulates
that committee membership be balanced in terms of points of view
represented, and the committee's function. Appointments shall be made
without discrimination on the basis of age, race, ethnicity, gender,
sexual orientation, gender identity, HIV status, disability, and
cultural, religious, or socioeconomic status. Nominees must be U.S.
citizens, and cannot be full-time employees of the U.S. Government.
Current participation on federal workgroups or prior experience serving
on a federal advisory committee does not disqualify a candidate;
however, HHS policy is to avoid excessive individual service on
advisory committees and multiple committee memberships. Committee
members are Special Government Employees (SGEs), requiring the filing
of financial disclosure reports at the beginning and annually during
their terms. CDC reviews potential candidates for CLIAC membership each
year and provides a slate of nominees for consideration to the
Secretary of HHS for final selection. HHS notifies selected candidates
of their appointment near the start of the term in July, or as soon as
the HHS selection process is completed. Note that the need for
different expertise varies from year to year and a candidate who is not
selected in one year may be reconsidered in a subsequent year.
Candidates should submit the following items:
[squf] Current curriculum vitae, including complete contact
information (telephone numbers, mailing address, email address)
[squf] At least one letter of recommendation from person(s) not
employed by the U.S. Department of Health and Human Services.
(Candidates may submit letter(s) from current HHS employees if they
wish, but at least one letter must be submitted by a person not
employed by an HHS agency (e.g., CDC, NIH, FDA, etc.).
Nominations may be submitted by the candidate, or by the person/
organization recommending the candidate.
The Director, Strategic Business Initiatives Unit, Office of the
Chief Operating Officer, Centers for Disease Control and Prevention,
has been
[[Page 76577]]
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.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2020-26257 Filed 11-27-20; 8:45 am]
BILLING CODE 4163-18-P
