Medicare Program; Renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), 76471-76472 [2010-30761]
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76471
Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices
substantial impact on prevention
program development and monitoring at
the local, State, and national levels.
CDC estimates that NHBS will
involve, per year in each of the 25
MSAs, eligibility screening of 50 to 200
persons and eligibility screening plus
the behavioral assessment with 500
eligible respondents, resulting in a total
of 37,500 eligible survey respondents
and 7,500 ineligible screened persons
during a 3-year period. Data collection
will rotate such that interviews will be
conducted among one group per year:
MSM in year 1, IDU in year 2, and HET
in year 3. The type of data collected for
each group will vary slightly due to
different sampling methods and risk
characteristics of the group.
Participation of respondents is
voluntary and there is no cost to the
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Respondent
Number of
respondents
Form
Year 1:
Men Approached at Eligible
Venue.
Eligible Men ...............................
Year 2:
Injecting Drug Users Referred
by Peer Recruiters.
Eligible Injecting Drug Users .....
Year 3:
Heterosexual Men and Women
Referred by Peer Recruiters.
Eligible Heterosexual Men and
Women.
Total ....................................
1
5/60
1,458
Behavioral Assessment ....................
12,500
1
60/60
12,500
Screener ...........................................
13,750
1
5/60
1,146
Behavioral Assessment ....................
12,500
1
85/60
17,708
Screener ...........................................
13,750
1
5/60
1,146
Behavioral Assessment ....................
12,500
1
70/60
14,583
...........................................................
45,000
1
........................
48,541
[FR Doc. 2010–30763 Filed 12–7–10; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4163–18–P
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3234–N]
Medicare Program; Renewal of the
Medicare Evidence Development &
Coverage Advisory Committee
(MEDCAC)
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
renewal of the Medicare Evidence
Development & Coverage Advisory
Committee (MEDCAC).
ADDRESSES: Copies of the Charter: To
obtain a copy of the Secretary’s Charter
for the MEDCAC submit a request to:
See FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT:
Maria Ellis, Executive Secretary for
MEDCAC, Centers for Medicare &
Medicaid Services, Office of Clinical
Standards and Quality, Coverage and
Analysis Group, C1–09–06, 7500
SUMMARY:
jlentini on DSKJ8SOYB1PROD with NOTICES
Total burden
(in hours)
17,500
Security Boulevard, Baltimore, MD
21244 or contact Ms. Ellis by phone
(410–786–0309) or via e-mail at
Maria.Ellis@cms.hhs.gov.
18:23 Dec 07, 2010
Average
burden per
response
(hours)
Screener ...........................................
Dated: December 2, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
VerDate Mar<15>2010
Number of
responses per
respondent
Jkt 223001
On December 14, 1998, we published
a notice in the Federal Register (63 FR
68780) announcing the establishment of
the Medicare Coverage Advisory
Committee (MCAC). The Secretary
signed the initial charter for the MCAC
on November 24, 1998. The MCAC was
originally established to provide
independent guidance and expert
advice to CMS on specific clinical
topics. In 2007 the Charter was renewed
and the name MCAC was modified to
Medicare Evidence Development and
Coverage Advisory Committee
(MEDCAC) to more accurately reflect
the Committee’s role. The MEDCAC is
advisory, with the final decision on all
issues resting with CMS. Under the
current charter, the MEDCAC advises
the Secretary of the Department of
Health and Human Services (DHHS) and
the Administrator of the CMS, on the
quality of evidence on clinical topics
under review by CMS.
The MEDCAC consists of a pool of
100 appointed members. Members are
selected from authorities in clinical
medicine of all specialties,
administrative medicine, public health,
biologic and physical sciences, health
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
care data and information management
and analysis, patient advocacy, the
economics of health care, medical ethics
and other related professions such as
epidemiology and biostatistics, and
methodology of trial design. There are
94 at-large standing voting members. Six
of the members are patient advocates
and six are nonvoting members
representing the industry interest.
II. Provisions of this Notice
This notice announces the signing of
the MEDCAC charter renewal by the
Secretary on November 23, 2010. The
new charter makes the following
changes:
• There are 4–8 meetings per year.
• A period of service for the Chair
and Vice-Chair of no more than 4 years.
The MEDCAC functions on a
committee basis. The MEDCAC—(1)
Hears public testimony; (2) reviews
medical literature, technology
assessments and other relevant evidence
and advises CMS on the strength and
weaknesses of that evidence; (3) advises
CMS of any evidence gaps that may
exist and recommends the types of
evidence that should be developed to
fill those evidentiary gaps. The
Committee may be asked to develop
recommendations about specific clinical
issues under review and to review and
comment upon proposed or existing
Medicare coverage policies. The
Committee may also be asked to
comment on pertinent aspects of
E:\FR\FM\08DEN1.SGM
08DEN1
76472
Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices
proposals being considered and other
policies. The Committee works from an
agenda provided by the designated
Federal official that lists specific issues.
Authority: 5 U.S.C. App. 2, section 10(a)(1)
and (a)(2).
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program).
Dated: November 16, 2010.
Barry M. Straube,
CMS Chief Medical Officer, Director, Office
of Clinical Standards and Quality, Centers
for Medicare & Medicaid Services.
[FR Doc. 2010–30761 Filed 12–7–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
Food and Drug Administration
[Docket No. FDA–2010–N–0602]
Biologics Price Competition and
Innovation Act of 2009; Meetings on
User Fee Program for Biosimilar and
Interchangeable Biological Product
Applications; Request for Notification
of Stakeholder Intention To Participate
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA) is issuing this
notice to request that public
stakeholders, including patient and
consumer advocacy groups, health care
professionals, and scientific and
academic experts, notify FDA of their
intent to participate in consultation
meetings relating to the development of
a user fee program for biosimilar and
interchangeable biological product
applications submitted under the Public
Health Service Act (PHS Act). FDA is
holding these consultation meetings to
satisfy the requirement in the Patient
Protection and Affordable Care Act that
FDA consult with such public
stakeholders regarding the development
of recommendations to present to
Congress with respect to the goals, and
plans for meeting the goals, for the
process for the review of biosimilar and
interchangeable biological product
applications for fiscal years (FYs) 2013
through 2017. To ensure continuity and
to support the development of
recommendations for establishing a user
fee program for biosimilars and
interchangeable products, the Agency
requests stakeholder representation
throughout this consultation process.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:23 Dec 07, 2010
Jkt 223001
Submit notification of intention
to participate by January 10, 2011.
Stakeholder discussions with FDA will
occur during negotiations with the
regulated industry.
ADDRESSES: Submit notification of
intention to participate in stakeholder
meetings by e-mail to Biosimilars
UserFeeProgram@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Sunanda Bahl, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, rm. 1168,
Silver Spring, MD 20993–0002, 301–
796–3584, FAX: 301–847–8443, e-mail:
sunanda.bahl@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
On March 23, 2010, President Obama
signed into law the Patient Protection
and Affordable Care Act (Affordable
Care Act) (Pub. L. 111–148). The
Affordable Care Act contains a subtitle
called the Biologics Price Competition
and Innovation Act of 2009 (BPCI Act)
that amends the PHS Act and other
statutes to create an abbreviated
approval pathway for biological
products shown to be highly similar
(biosimilar) to, or interchangeable with,
an FDA-licensed reference biological
product. (See sections 7001 through
7003 of the BPCI Act.) Section 351(k) of
the PHS Act (42 U.S.C. 262(k)), added
by the BPCI Act, allows a company to
submit an application for licensure of a
biosimilar or interchangeable biological
product.
The BPCI Act amends section 735 of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 379g) to
include 351(k) applications for
biosimilar or interchangeable biological
products in the definition of ‘‘human
drug application’’ for the purposes of the
prescription drug user fee provisions.
(See section 7002(f)(3)(A) of the BPCI
Act.) The authority conferred by the
FD&C Act’s prescription drug user fee
provisions expires in September 2012.
The BPCI Act directs FDA to develop
recommendations for a user fee program
for biosimilar and biological product
applications for FYs 2013 through 2017.
(See section 7002(f)(1) of the BPCI Act.)
II. FDA Consultation With Stakeholders
FDA is required to develop
recommendations to present to Congress
by January 15, 2012, that address the
goals, and plans for meeting the goals,
for the process for the review of
biosimilar and interchangeable
biological product applications for FYs
2013 through 2017. (See section
7002(f)(1) of the BPCI Act.) In
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
developing such recommendations,
FDA must consult with a range of
groups, including scientific and
academic experts; health care
professionals; representatives of patient
and consumer advocacy groups; and
regulated industry. (See section
7002(f)(1) of the BPCI Act.) FDA
initiated this consultation process on
November 2 and 3, 2010, by holding a
public hearing at which stakeholders
and other members of the public were
given an opportunity to present their
views on issues associated with the
implementation of the BPCI Act. To
facilitate identification of regulated
industry, in the Federal Register notice
that announced the November 2010
public hearing, FDA requested that
comments identify companies that
would be affected by a user fee program
for biosimilar or interchangeable
biological products, as well as industry
associations representing such
companies. (See 75 FR 61497, October
5, 2010.)
FDA is issuing this Federal Register
notice to request that other stakeholders,
including patient and consumer
advocacy groups, health care
professionals, and scientific and
academic experts, notify FDA of their
intent to participate in consultation
meetings related to the development of
recommendations for a user fee program
for biosimilar and interchangeable
biological product applications. FDA
believes that consistent stakeholder
representation at these consultation
meetings will be important to ensure
progress in the discussions. If you wish
to participate in this process, please
designate one or more representatives
from your organization who will
commit to attending these meetings and
preparing for the discussions as needed.
Stakeholders who identify themselves
through this notice will be included in
future stakeholder discussions as FDA
negotiates with regulated industry.
These discussions will satisfy the
requirement for consultation with
public stakeholders in section 7002(f)(1)
of the BPCI Act.
III. Additional Information on the BPCI
Act
There are several sources of
information on FDA’s Web site that may
serve as useful resources for
stakeholders intending to participate in
consultation meetings:
• The Federal Register notice that
announced the November 2 and 3, 2010,
public hearing and requested public
comments is available at https://
edocket.access.gpo.gov/2010/pdf/2010–
24853.pdf.
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Notices]
[Pages 76471-76472]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30761]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3234-N]
Medicare Program; Renewal of the Medicare Evidence Development &
Coverage Advisory Committee (MEDCAC)
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the renewal of the Medicare Evidence
Development & Coverage Advisory Committee (MEDCAC).
ADDRESSES: Copies of the Charter: To obtain a copy of the Secretary's
Charter for the MEDCAC submit a request to: See FOR FURTHER INFORMATION
CONTACT.
FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for
MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical
Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500
Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone
(410-786-0309) or via e-mail at Maria.Ellis@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On December 14, 1998, we published a notice in the Federal Register
(63 FR 68780) announcing the establishment of the Medicare Coverage
Advisory Committee (MCAC). The Secretary signed the initial charter for
the MCAC on November 24, 1998. The MCAC was originally established to
provide independent guidance and expert advice to CMS on specific
clinical topics. In 2007 the Charter was renewed and the name MCAC was
modified to Medicare Evidence Development and Coverage Advisory
Committee (MEDCAC) to more accurately reflect the Committee's role. The
MEDCAC is advisory, with the final decision on all issues resting with
CMS. Under the current charter, the MEDCAC advises the Secretary of the
Department of Health and Human Services (DHHS) and the Administrator of
the CMS, on the quality of evidence on clinical topics under review by
CMS.
The MEDCAC consists of a pool of 100 appointed members. Members are
selected from authorities in clinical medicine of all specialties,
administrative medicine, public health, biologic and physical sciences,
health care data and information management and analysis, patient
advocacy, the economics of health care, medical ethics and other
related professions such as epidemiology and biostatistics, and
methodology of trial design. There are 94 at-large standing voting
members. Six of the members are patient advocates and six are nonvoting
members representing the industry interest.
II. Provisions of this Notice
This notice announces the signing of the MEDCAC charter renewal by
the Secretary on November 23, 2010. The new charter makes the following
changes:
There are 4-8 meetings per year.
A period of service for the Chair and Vice-Chair of no
more than 4 years.
The MEDCAC functions on a committee basis. The MEDCAC--(1) Hears
public testimony; (2) reviews medical literature, technology
assessments and other relevant evidence and advises CMS on the strength
and weaknesses of that evidence; (3) advises CMS of any evidence gaps
that may exist and recommends the types of evidence that should be
developed to fill those evidentiary gaps. The Committee may be asked to
develop recommendations about specific clinical issues under review and
to review and comment upon proposed or existing Medicare coverage
policies. The Committee may also be asked to comment on pertinent
aspects of
[[Page 76472]]
proposals being considered and other policies. The Committee works from
an agenda provided by the designated Federal official that lists
specific issues.
Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2).
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program).
Dated: November 16, 2010.
Barry M. Straube,
CMS Chief Medical Officer, Director, Office of Clinical Standards and
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-30761 Filed 12-7-10; 8:45 am]
BILLING CODE 4120-01-P
