Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee, 56193-56194 [2019-22947]
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Federal Register / Vol. 84, No. 203 / Monday, October 21, 2019 / Notices
13(e)(1)). In addition, the contractor
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[FR Doc. 2019–22853 Filed 10–18–19; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3392–N]
Medicare Program; Request for
Nominations for Members for the
Medicare Evidence Development &
Coverage Advisory Committee
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
request for nominations for membership
on the Medicare Evidence Development
& Coverage Advisory Committee
(MEDCAC). Among other duties, the
MEDCAC provides advice and guidance
to the Secretary of the Department of
Health and Human Services (the
Secretary) and the Administrator of the
Centers for Medicare & Medicaid
Services (CMS) concerning the
adequacy of scientific evidence
available to CMS in making coverage
determinations under the Medicare
program.
The MEDCACs fundamental purpose
is to support the principles of an
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:52 Oct 18, 2019
Jkt 250001
evidence-based determination process
for Medicare’s coverage policies.
MEDCAC panels provide advice to CMS
on the strength of the evidence available
for specific medical treatments and
technologies through a public,
participatory, and accountable process.
DATES: Nominations must be received
by Monday, November 18, 2019.
ADDRESSES: You may mail nominations
for membership to the following
address: Centers for Medicare &
Medicaid Services, Center for Clinical
Standards and Quality, Attention: Leah
Cromwell, 7500 Security Boulevard,
Mail Stop: S3–02–01, Baltimore, MD
21244 or send via email to
MEDCACnomination@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Leah Cromwell, MEDCAC Coordinator,
Centers for Medicare & Medicaid
Services, Center for Clinical Standards
and Quality, Coverage and Analysis
Group, S3–02–01, 7500 Security
Boulevard, Baltimore, MD 21244 or
contact Ms. Cromwell by phone (410)
786–2243 or via email at
Leah.Cromwell@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Secretary signed the initial
charter for the Medicare Coverage
Advisory Committee (MCAC) on
November 24, 1998. A notice in the
Federal Register (63 FR 68780)
announcing establishment of the MCAC
was published on December 14, 1998.
The MCAC name was updated to more
accurately reflect the purpose of the
committee and on January 26, 2007, the
Secretary published a notice in the
Federal Register (72 FR 3853),
announcing that the Committee’s name
changed to the Medicare Evidence
Development & Coverage Advisory
Committee (MEDCAC). The current
Secretary’s Charter for the MEDCAC is
available on the CMS website at: https://
www.cms.hhs.gov/FACA/Downloads/
medcaccharter.pdf, or you may obtain a
copy of the charter by submitting a
request to the contact listed in the FOR
FURTHER INFORMATION section of this
notice.
The MEDCAC is governed by
provisions of the Federal Advisory
Committee Act, Public Law 92–463, as
amended (5 U.S.C. App. 2), which sets
forth standards for the formulation and
use of advisory committees, and is
authorized by section 222 of the Public
Health Service Act as amended (42
U.S.C. 217A).
We are requesting nominations for
candidates to serve on the MEDCAC.
Nominees are selected based upon their
individual qualifications and not solely
PO 00000
Frm 00034
Fmt 4703
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56193
as representatives of professional
associations or societies. We wish to
ensure adequate representation of the
interests of both women and men,
members of all ethnic groups, and
physically challenged individuals.
Therefore, we encourage nominations of
qualified candidates who can represent
these interests.
The MEDCAC consists of a pool of
100 appointed members including: 90
at-large standing members (10 of whom
are patient advocates), and 10
representatives of industry interests.
Members generally are recognized
authorities in clinical medicine
including subspecialties, administrative
medicine, public health, biological and
physical sciences, epidemiology and
biostatistics, clinical trial design, health
care data management and analysis,
patient advocacy, health care
economics, medical ethics or other
relevant professions.
The MEDCAC works from an agenda
provided by the Designated Federal
Official. The MEDCAC reviews and
evaluates medical literature and
technology assessments, and hears
public testimony on the evidence
available to address the impact of
medical items and services on health
outcomes of Medicare beneficiaries. The
MEDCAC may also advise the Centers
for Medicare & Medicaid Services (CMS)
as part of Medicare’s ‘‘coverage with
evidence development’’ initiative.
II. Provisions of the Notice
As of June 2020, there will be 25
membership terms expiring. Of the 25
memberships expiring, 2 are industry
representatives, 5 are patient advocates
and the remaining 18 membership
openings are for the at-large standing
MEDCAC membership.
All nominations must be
accompanied by curricula vitae.
Nomination packages should be sent to
Leah Cromwell at the address listed in
the ADDRESSES section of this notice.
Nominees are selected based upon their
individual qualifications. Nominees for
membership must have expertise and
experience in one or more of the
following fields:
• Clinical medicine including
subspecialties
• Administrative medicine
• Public health
• Biological and physical sciences
• Epidemiology and biostatistics
• Clinical trial design
• Health care data management and
analysis
• Patient advocacy
• Health care economics
• Medical ethics
• Other relevant professions
E:\FR\FM\21OCN1.SGM
21OCN1
56194
Federal Register / Vol. 84, No. 203 / Monday, October 21, 2019 / Notices
We are looking particularly for
experts in a number of fields. These
include cancer screening, genetic
testing, clinical epidemiology,
psychopharmacology, screening and
diagnostic testing analysis, and vascular
surgery. We also need experts in
biostatistics in clinical settings,
dementia treatment, minority health,
observational research design, stroke
epidemiology, and women’s health.
The nomination letter must include a
statement that the nominee is willing to
serve as a member of the MEDCAC and
appears to have no conflict of interest
that would preclude membership. We
are requesting that all curricula vitae
include the following:
• Date of birth
• Place of birth
• Social security number
• Title and current position
• Professional affiliation
• Home and business address
• Telephone and fax numbers
• Email address
• List of areas of expertise
In the nomination letter, we are
requesting that nominees specify
whether they are applying for a patient
advocate position, for an at-large
standing position, or as an industry
representative. Potential candidates will
be asked to provide detailed information
concerning such matters as financial
holdings, consultancies, and research
grants or contracts in order to permit
evaluation of possible sources of
financial conflict of interest. Department
policy prohibits multiple committee
memberships. A federal advisory
committee member may not serve on
more than one committee within an
agency at the same time.
Members are invited to serve for
overlapping 2-year terms. A member
may continue to serve after the
expiration of the member’s term until a
successor is named. Any interested
person may nominate one or more
qualified persons. Self-nominations are
also accepted. Individuals interested in
the representative positions must
include a letter of support from the
organization or interest group they
would represent.
khammond on DSKJM1Z7X2PROD with NOTICES
III. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
VerDate Sep<11>2014
16:52 Oct 18, 2019
Jkt 250001
Dated: October 3, 2019.
Kate Goodrich,
Director, Center for Clinical Standards and
Quality, Chief Medical Officer, Centers for
Medicare & Medicaid Services.
[FR Doc. 2019–22947 Filed 10–18–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–3989]
Drug Master Files; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Drug
Master Files.’’ Once finalized, this
guidance will provide FDA’s current
thinking on drug master files (DMFs),
which are submissions to FDA that may
be used to provide confidential, detailed
information about facilities, processes,
or articles used in the manufacturing,
processing, packaging, and storing of
human drug products. DMFs are
submitted solely at the discretion of
their holders and are not required by
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guidance, when finalized, will revise
the guidance for industry ‘‘Drug Master
Files: Guidelines’’ that published in
September 1989.
DATES: Submit either electronic or
written comments on the draft guidance
by December 20, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2019–D–3989 for ‘‘Drug Master Files.’’
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
Dockets Management Staff 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
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
E:\FR\FM\21OCN1.SGM
21OCN1
]]>Agencies
[Federal Register Volume 84, Number 203 (Monday, October 21, 2019)]
[Notices]
[Pages 56193-56194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22947]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3392-N]
Medicare Program; Request for Nominations for Members for the
Medicare Evidence Development & Coverage Advisory Committee
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the request for nominations for
membership on the Medicare Evidence Development & Coverage Advisory
Committee (MEDCAC). Among other duties, the MEDCAC provides advice and
guidance to the Secretary of the Department of Health and Human
Services (the Secretary) and the Administrator of the Centers for
Medicare & Medicaid Services (CMS) concerning the adequacy of
scientific evidence available to CMS in making coverage determinations
under the Medicare program.
The MEDCACs fundamental purpose is to support the principles of an
evidence-based determination process for Medicare's coverage policies.
MEDCAC panels provide advice to CMS on the strength of the evidence
available for specific medical treatments and technologies through a
public, participatory, and accountable process.
DATES: Nominations must be received by Monday, November 18, 2019.
ADDRESSES: You may mail nominations for membership to the following
address: Centers for Medicare & Medicaid Services, Center for Clinical
Standards and Quality, Attention: Leah Cromwell, 7500 Security
Boulevard, Mail Stop: S3-02-01, Baltimore, MD 21244 or send via email
to [email protected].
FOR FURTHER INFORMATION CONTACT: Leah Cromwell, MEDCAC Coordinator,
Centers for Medicare & Medicaid Services, Center for Clinical Standards
and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security
Boulevard, Baltimore, MD 21244 or contact Ms. Cromwell by phone (410)
786-2243 or via email at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Secretary signed the initial charter for the Medicare Coverage
Advisory Committee (MCAC) on November 24, 1998. A notice in the Federal
Register (63 FR 68780) announcing establishment of the MCAC was
published on December 14, 1998. The MCAC name was updated to more
accurately reflect the purpose of the committee and on January 26,
2007, the Secretary published a notice in the Federal Register (72 FR
3853), announcing that the Committee's name changed to the Medicare
Evidence Development & Coverage Advisory Committee (MEDCAC). The
current Secretary's Charter for the MEDCAC is available on the CMS
website at: https://www.cms.hhs.gov/FACA/Downloads/medcaccharter.pdf, or
you may obtain a copy of the charter by submitting a request to the
contact listed in the FOR FURTHER INFORMATION section of this notice.
The MEDCAC is governed by provisions of the Federal Advisory
Committee Act, Public Law 92-463, as amended (5 U.S.C. App. 2), which
sets forth standards for the formulation and use of advisory
committees, and is authorized by section 222 of the Public Health
Service Act as amended (42 U.S.C. 217A).
We are requesting nominations for candidates to serve on the
MEDCAC. Nominees are selected based upon their individual
qualifications and not solely as representatives of professional
associations or societies. We wish to ensure adequate representation of
the interests of both women and men, members of all ethnic groups, and
physically challenged individuals. Therefore, we encourage nominations
of qualified candidates who can represent these interests.
The MEDCAC consists of a pool of 100 appointed members including:
90 at-large standing members (10 of whom are patient advocates), and 10
representatives of industry interests. Members generally are recognized
authorities in clinical medicine including subspecialties,
administrative medicine, public health, biological and physical
sciences, epidemiology and biostatistics, clinical trial design, health
care data management and analysis, patient advocacy, health care
economics, medical ethics or other relevant professions.
The MEDCAC works from an agenda provided by the Designated Federal
Official. The MEDCAC reviews and evaluates medical literature and
technology assessments, and hears public testimony on the evidence
available to address the impact of medical items and services on health
outcomes of Medicare beneficiaries. The MEDCAC may also advise the
Centers for Medicare & Medicaid Services (CMS) as part of Medicare's
``coverage with evidence development'' initiative.
II. Provisions of the Notice
As of June 2020, there will be 25 membership terms expiring. Of the
25 memberships expiring, 2 are industry representatives, 5 are patient
advocates and the remaining 18 membership openings are for the at-large
standing MEDCAC membership.
All nominations must be accompanied by curricula vitae. Nomination
packages should be sent to Leah Cromwell at the address listed in the
ADDRESSES section of this notice. Nominees are selected based upon
their individual qualifications. Nominees for membership must have
expertise and experience in one or more of the following fields:
Clinical medicine including subspecialties
Administrative medicine
Public health
Biological and physical sciences
Epidemiology and biostatistics
Clinical trial design
Health care data management and analysis
Patient advocacy
Health care economics
Medical ethics
Other relevant professions
[[Page 56194]]
We are looking particularly for experts in a number of fields.
These include cancer screening, genetic testing, clinical epidemiology,
psychopharmacology, screening and diagnostic testing analysis, and
vascular surgery. We also need experts in biostatistics in clinical
settings, dementia treatment, minority health, observational research
design, stroke epidemiology, and women's health.
The nomination letter must include a statement that the nominee is
willing to serve as a member of the MEDCAC and appears to have no
conflict of interest that would preclude membership. We are requesting
that all curricula vitae include the following:
Date of birth
Place of birth
Social security number
Title and current position
Professional affiliation
Home and business address
Telephone and fax numbers
Email address
List of areas of expertise
In the nomination letter, we are requesting that nominees specify
whether they are applying for a patient advocate position, for an at-
large standing position, or as an industry representative. Potential
candidates will be asked to provide detailed information concerning
such matters as financial holdings, consultancies, and research grants
or contracts in order to permit evaluation of possible sources of
financial conflict of interest. Department policy prohibits multiple
committee memberships. A federal advisory committee member may not
serve on more than one committee within an agency at the same time.
Members are invited to serve for overlapping 2-year terms. A member
may continue to serve after the expiration of the member's term until a
successor is named. Any interested person may nominate one or more
qualified persons. Self-nominations are also accepted. Individuals
interested in the representative positions must include a letter of
support from the organization or interest group they would represent.
III. Collection of Information
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
Dated: October 3, 2019.
Kate Goodrich,
Director, Center for Clinical Standards and Quality, Chief Medical
Officer, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-22947 Filed 10-18-19; 8:45 am]
BILLING CODE 4120-01-P
