Medicare Program; Medicare Provider Feedback Group Town Hall Meeting-September 22, 2008, 49683-49684 [E8-19564]
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Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: August 7, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–18971 Filed 8–21–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1405–N]
Medicare Program; Medicare Provider
Feedback Group Town Hall Meeting—
September 22, 2008
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
jlentini on PROD1PC65 with NOTICES
SUMMARY: This notice announces the
annual Medicare Provider Feedback
Group (MPFG) Town Hall meeting. This
meeting is open to all Medicare fee-forservice (FFS) providers and suppliers
that participate in the Medicare
program, including physicians,
hospitals, home health agencies, thirdparty billers, and interested parties, to
present their individual views and
opinions on selected FFS Medicare
topics. In addition, we will be soliciting
input on how we can improve
communications to better serve the
Medicare providers and suppliers.
DATES: Meeting Date: The Town Hall
meeting announced in this notice will
be held on Monday, September 22, 2008
from 2 p.m. to 4 p.m. EDT.
ADDRESSES: Meeting Location: The
Town Hall meeting will be held in the
main auditorium of the central building
of the Centers for Medicare and
Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244. The
meeting will also be available by
teleconference.
FOR FURTHER INFORMATION CONTACT:
Colette Shatto, (410) 786–6932. You
may also send inquiries about this
meeting via e-mail to
MFG@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Since 2005, CMS has held four
Medicare Provider Feedback Group
(MPFG) Town Hall meetings. The
purpose of these meetings is to capture
individual provider and supplier
feedback on relevant Fee-For-Service
VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
(FFS) Medicare policy and operational
issues. These meetings allow us to
further advance our efforts to strengthen
the Medicare program and enhance our
relationship with providers and
suppliers. The meetings also provide a
venue to allow us to continue a process
of communication with individual
providers and suppliers through the
following year.
II. Meeting Format and Agenda
The meeting will begin with an
overview of the goals and objectives of
the MPFG efforts to gather feedback
from individual Medicare providers and
suppliers. This meeting will be held onsite at CMS and by teleconference. The
meeting agenda and discussion
materials will be available to download
by September 19, 2008. These materials
can be located at https://
www.cms.hhs.gov/center/provider.asp.
The feedback provided during this
meeting will assist us as we evaluate
FFS Medicare policy, operational issues,
and CMS’ provider and supplier
communication activities. Topics to be
discussed include, but are not limited
to, 5010 (possible next version of
HIPAA standards for claims and other
transactions), Medicare Administrative
Contract Transitions, and Recovery
Auditing.
There will be a question and answer
session that offers meeting participants
an opportunity to provide feedback on
how CMS services physicians, providers
and suppliers, as well as make
suggestions on how this process can be
improved. Time for participants to ask
questions or provide feedback will be
limited according to the number of
registered participants; however, written
submissions will be accepted.
Individuals who wish to provide written
feedback should e-mail that feedback to
Colette Shatto at MFG@cms.hhs.gov.
Written feedback will be accepted
through September 30, 2008.
Consideration will be given to
feedback received on the topics
discussed at the meeting, but written
responses will not be provided. The
meeting is open to the public, but onsite attendance is limited to space
available. Registered participants from
the meeting will be included in the
MPFG and may be contacted throughout
the year for follow-up meetings to solicit
additional opinions or clarify any issues
that may arise from the September 22,
2008 meeting.
III. Registration Instructions
The Division of Provider Relations
and Evaluations, Provider
Communications Group, Center for
Medicare Management is coordinating
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
49683
the meeting registration. While there is
no registration fee, individuals,
providers, and suppliers must register to
participate both on-site and by
teleconference. Individuals must
complete the on-line registration located
at https://registration.intercall.com/go/
cms2.
The on-line registration system will
capture contact information and
practice characteristics (for example,
names, e-mail addresses, and provider,
and supplier types). Registration will be
open beginning August 29, 2008 and
will close on September 17, 2008.
Registration after 5 p.m. EDT on
September 17, 2008 will not be
accepted.
The on-line registration system will
generate a confirmation page to indicate
the completion of your registration.
Participants should print this page as
his or her registration receipt.
Teleconference instructions will be
issued as part of the confirmation page
once participants have registered
through the on-line registration
instrument. If seating capacity has been
reached for on-site participants,
notification will be sent that the meeting
has reached capacity; however, those
wishing to participate may still do so by
teleconference.
IV. Security, Building, and Parking
Guidelines
Because this meeting will be located
on Federal property, for security
reasons, any persons wishing to attend
this meeting must register by 5 p.m.
EDT on September 17, 2008. Individuals
who have not registered by the
registration deadline will not be allowed
to enter the building to attend the
meeting or attend the meeting by
teleconference. Seating capacity is
limited to the first 250 registrants.
The on-site check-in for visitors will
be held from 12:30 p.m. to 1:30 p.m.
EDT. Participants should allow
sufficient time to go through the
security checkpoints. It is suggested that
participants arrive at 7500 Security
Boulevard no later than 1:30 p.m. EDT
in order to arrive promptly at the
meeting by 2 p.m.
Security measures will include
inspection of vehicles, inside and out, at
the entrance to the grounds. In addition,
all persons entering the building must
pass through a metal detector. All items
brought to the building, whether
personal or for the purpose of
demonstration or to support a
presentation, are subject to inspection.
In order to gain access to the building,
participants will be required to show a
government-issued photo identification
(for example, driver’s license, or
E:\FR\FM\22AUN1.SGM
22AUN1
49684
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
passport), and must be listed on an
approved security list before persons are
permitted entrance. Persons not
registered in advance will not be
permitted into the CMS building and
will not be permitted to attend the
meeting.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for the purpose
of presentation.
Individuals requiring sign language
interpretation or other special
accommodation must contact the
Designated Federal Officer specified in
the FOR FURTHER INFORMATION CONTACT
section of this notice by September 17,
2008.
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Dated: August 19, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–19564 Filed 8–21–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0419]
Draft Guidance for Industry on Acute
Bacterial Exacerbations of Chronic
Bronchitis in Patients With Chronic
Obstructive Pulmonary Disease:
Developing Antimicrobial Drugs for
Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Acute Bacterial
Exacerbations of Chronic Bronchitis in
Patients With Chronic Obstructive
Pulmonary Disease: Developing
Antimicrobial Drugs for Treatment.’’
The purpose of this draft guidance is to
assist clinical trial sponsors and
investigators in the development of
antimicrobial drugs for the treatment of
acute bacterial exacerbations of chronic
bronchitis in patients with chronic
obstructive pulmonary disease (ABECB–
COPD). The agency’s thinking in this
area has evolved in recent years, and
this draft guidance, when finalized, will
inform sponsors of the changes in our
recommendations. In addition, it will
VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
fulfill a statutory requirement enacted in
the Food and Drug Administration
Amendments Act of 2007 (FDAAA) to
publish such a guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by November 20, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Steven Gitterman, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6134,
Silver Spring, MD 20993–0002, 301–
796–1600.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Acute Bacterial Exacerbations of
Chronic Bronchitis in Patients With
Chronic Obstructive Pulmonary Disease:
Developing Antimicrobial Drugs for
Treatment.’’ The purpose of this draft
guidance is to assist clinical trial
sponsors and investigators in the
development of antimicrobial drugs for
the treatment of ABECB–COPD. This
guidance revises the draft guidance
regarding ABECB published in 1998.
Section 911 of FDAAA (Public Law
110–85) adds section 511 to the Federal
Food, Drug, and Cosmetic Act that
directs the Secretary of Health and
Human Services to ‘‘issue guidance for
the conduct of clinical trials with
respect to antibiotic drugs, including
antimicrobials to treat * * * acute
bacterial exacerbation of chronic
bronchitis.’’
The design of ABECB clinical trials
was discussed at a meeting of the AntiInfective Drugs Advisory Committee on
February 19, 2002, and an IDSA/
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
PhRMA/FDA workshop on November
19 and 20, 2002. In addition, other
advisory committee meetings have
focused on the development of specific
drugs for this indication. As a result of
these public discussions, as well as
review of applications at FDA, the
agency’s thinking in this area has
evolved in recent years, and this draft
guidance informs sponsors of the
changes in our recommendations.
Specifically, this draft guidance
recommends that ABECB–COPD clinical
trials be designed as superiority rather
than noninferiority trials, and discusses
some possible study designs that might
be employed in an ABECB–COPD trial
designed to show superiority. This draft
guidance discusses patient-reported
outcome instruments for assessing
clinical response, and the use of time to
resolution of symptoms as a possible
approach to assessing the primary
endpoint in clinical studies.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on developing drugs for the treatment of
ABECB–COPD. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; the
collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001; and
the collections of information referred to
in the guidance ‘‘Establishment and
Operation of Clinical Trial Data
Monitoring Committees’’ have been
approved under OMB control number
0910–0581.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 73, Number 164 (Friday, August 22, 2008)]
[Notices]
[Pages 49683-49684]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19564]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1405-N]
Medicare Program; Medicare Provider Feedback Group Town Hall
Meeting--September 22, 2008
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the annual Medicare Provider Feedback
Group (MPFG) Town Hall meeting. This meeting is open to all Medicare
fee-for-service (FFS) providers and suppliers that participate in the
Medicare program, including physicians, hospitals, home health
agencies, third-party billers, and interested parties, to present their
individual views and opinions on selected FFS Medicare topics. In
addition, we will be soliciting input on how we can improve
communications to better serve the Medicare providers and suppliers.
DATES: Meeting Date: The Town Hall meeting announced in this notice
will be held on Monday, September 22, 2008 from 2 p.m. to 4 p.m. EDT.
ADDRESSES: Meeting Location: The Town Hall meeting will be held in the
main auditorium of the central building of the Centers for Medicare and
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244. The
meeting will also be available by teleconference.
FOR FURTHER INFORMATION CONTACT: Colette Shatto, (410) 786-6932. You
may also send inquiries about this meeting via e-mail to
MFG@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Since 2005, CMS has held four Medicare Provider Feedback Group
(MPFG) Town Hall meetings. The purpose of these meetings is to capture
individual provider and supplier feedback on relevant Fee-For-Service
(FFS) Medicare policy and operational issues. These meetings allow us
to further advance our efforts to strengthen the Medicare program and
enhance our relationship with providers and suppliers. The meetings
also provide a venue to allow us to continue a process of communication
with individual providers and suppliers through the following year.
II. Meeting Format and Agenda
The meeting will begin with an overview of the goals and objectives
of the MPFG efforts to gather feedback from individual Medicare
providers and suppliers. This meeting will be held on-site at CMS and
by teleconference. The meeting agenda and discussion materials will be
available to download by September 19, 2008. These materials can be
located at https://www.cms.hhs.gov/center/provider.asp.
The feedback provided during this meeting will assist us as we
evaluate FFS Medicare policy, operational issues, and CMS' provider and
supplier communication activities. Topics to be discussed include, but
are not limited to, 5010 (possible next version of HIPAA standards for
claims and other transactions), Medicare Administrative Contract
Transitions, and Recovery Auditing.
There will be a question and answer session that offers meeting
participants an opportunity to provide feedback on how CMS services
physicians, providers and suppliers, as well as make suggestions on how
this process can be improved. Time for participants to ask questions or
provide feedback will be limited according to the number of registered
participants; however, written submissions will be accepted.
Individuals who wish to provide written feedback should e-mail that
feedback to Colette Shatto at MFG@cms.hhs.gov. Written feedback will be
accepted through September 30, 2008.
Consideration will be given to feedback received on the topics
discussed at the meeting, but written responses will not be provided.
The meeting is open to the public, but on-site attendance is limited to
space available. Registered participants from the meeting will be
included in the MPFG and may be contacted throughout the year for
follow-up meetings to solicit additional opinions or clarify any issues
that may arise from the September 22, 2008 meeting.
III. Registration Instructions
The Division of Provider Relations and Evaluations, Provider
Communications Group, Center for Medicare Management is coordinating
the meeting registration. While there is no registration fee,
individuals, providers, and suppliers must register to participate both
on-site and by teleconference. Individuals must complete the on-line
registration located at https://registration.intercall.com/go/cms2.
The on-line registration system will capture contact information
and practice characteristics (for example, names, e-mail addresses, and
provider, and supplier types). Registration will be open beginning
August 29, 2008 and will close on September 17, 2008. Registration
after 5 p.m. EDT on September 17, 2008 will not be accepted.
The on-line registration system will generate a confirmation page
to indicate the completion of your registration. Participants should
print this page as his or her registration receipt. Teleconference
instructions will be issued as part of the confirmation page once
participants have registered through the on-line registration
instrument. If seating capacity has been reached for on-site
participants, notification will be sent that the meeting has reached
capacity; however, those wishing to participate may still do so by
teleconference.
IV. Security, Building, and Parking Guidelines
Because this meeting will be located on Federal property, for
security reasons, any persons wishing to attend this meeting must
register by 5 p.m. EDT on September 17, 2008. Individuals who have not
registered by the registration deadline will not be allowed to enter
the building to attend the meeting or attend the meeting by
teleconference. Seating capacity is limited to the first 250
registrants.
The on-site check-in for visitors will be held from 12:30 p.m. to
1:30 p.m. EDT. Participants should allow sufficient time to go through
the security checkpoints. It is suggested that participants arrive at
7500 Security Boulevard no later than 1:30 p.m. EDT in order to arrive
promptly at the meeting by 2 p.m.
Security measures will include inspection of vehicles, inside and
out, at the entrance to the grounds. In addition, all persons entering
the building must pass through a metal detector. All items brought to
the building, whether personal or for the purpose of demonstration or
to support a presentation, are subject to inspection. In order to gain
access to the building, participants will be required to show a
government-issued photo identification (for example, driver's license,
or
[[Page 49684]]
passport), and must be listed on an approved security list before
persons are permitted entrance. Persons not registered in advance will
not be permitted into the CMS building and will not be permitted to
attend the meeting.
We cannot assume responsibility for coordinating the receipt,
transfer, transport, storage, set-up, safety, or timely arrival of any
personal belongings or items used for the purpose of presentation.
Individuals requiring sign language interpretation or other special
accommodation must contact the Designated Federal Officer specified in
the FOR FURTHER INFORMATION CONTACT section of this notice by September
17, 2008.
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: August 19, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-19564 Filed 8-21-08; 8:45 am]
BILLING CODE 4120-01-P
