Medicare Program; Town Hall Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 30, 2008, 11120-11121 [E8-3829]
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Federal Register / Vol. 73, No. 41 / Friday, February 29, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
Application and Update Form is used
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NPIs and furnish updates to the
information they supplied on their
initial applications. The form is also
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providers and provide additional
guidance on how to accurately complete
the form. The form captures additional
data elements that will assist with
unique identification. It also includes
more detailed instructions. Form
Number: CMS–10114 (OMB #0938–
0931); Frequency: Reporting—On
occasion, one-time; Affected Public:
Business or other for-profit, Not-forprofit institutions, and Federal
government; Number of Respondents:
325,608; Total Annual Responses:
325,608; Total Annual Hours: 108,560.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
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1326.
In commenting on the proposed
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number. To be assured consideration,
comments and recommendations must
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1. Electronically. You may submit
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Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
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address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number llllll, Room
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Baltimore, Maryland 21244–1850.
Dated: February 21, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–3839 Filed 2–28–08; 8:45 am]
BILLING CODE 4120–01–P
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Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3196–N]
Medicare Program; Town Hall Meeting
of the Medicare Evidence Development
and Coverage Advisory Committee—
April 30, 2008
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: This notice announces a
public meeting of the Medicare
Evidence Development & Coverage
Advisory Committee (MedCAC)
(‘‘Committee’’). We are soliciting
comments from the scientific
community and the public on
prioritizing research topics of
importance to the Medicare population.
This meeting is a follow up to the CMS
Evidentiary Priorities MedCAC meeting,
which was held on October 22, 2007 to
establish a list of evidentiary priorities
for research to improve the health of
Medicare beneficiaries.
The Committee generally provides
advice and recommendations about
whether scientific evidence is adequate
to determine whether certain medical
items and services are reasonable and
necessary under the Medicare statute.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)).
DATES: Meeting Date: The public
meeting will be held on Wednesday,
April 30, 2008 from 7:30 a.m. until 4:30
p.m., e.s.t.
Deadline for Written Comments:
Written comments must be received at
the address specified in the ADDRESSES
section of this notice by April 2, 2008,
5 p.m., e.s.t. Once submitted, comments
are final. The meeting will not include
PowerPoint presentations.
Deadline for Meeting Registration:
Individuals may register by phone or email by contacting the contact listed in
the FOR FURTHER INFORMATION CONTACT
section of this notice by close of
business on Monday April 21, 2008.
Deadline for Submitting Request for
Special Accommodations: Persons
attending the meeting who are hearing
or visually impaired, or have a
condition that requires special
assistance or accommodations, are
asked to contact the Executive Secretary
as specified in the FOR FURTHER
INFORMATION CONTACT section of this
notice no later than April 23, 2008.
ADDRESSES: Meeting Location: The
meeting will be held in the main
PO 00000
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auditorium of the Centers for Medicare
and Medicaid Services, 7500 Security
Blvd., Baltimore, MD 21244.
Submission of Presentations and
Comments: Written comments and those
that will be presented verbally at the
meeting must be submitted by e-mail to
MedCACpresentations@cms.hhs.gov or
by regular mail to the contact listed in
the FOR FURTHER INFORMATION CONTACT
section of this notice.
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 via phone
(410–786–0309) or 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) to describe the Medicare
Coverage Advisory Committee (MCAC),
now known as the MedCAC, which
provides advice and recommendations
to CMS about clinical issues.
The purpose of the MedCAC meeting
is to discuss the priorities for research
topics that are important for the
Medicare program and the Medicare
population and to make
recommendations to CMS. This public
discussion may also provide useful
information for researchers in the
scientific community who are interested
in developing research projects
concerning Medicare beneficiaries. This
meeting is a follow up to the CMS
Evidentiary Priorities MedCAC meeting
which was held on October 22, 2007.
The purpose of the October 22, 2007
meeting was to establish a list of
evidentiary priorities for research to
improve the health of Medicare
beneficiaries. Details on the October 22,
2007 meeting and the CMS Evidentiary
Priorities can be found at https://
www.cms.hhs.gov/mcd/
viewmcac.asp?where=index&mid=41.
The Committee generally provides
advice and recommendations about
whether scientific evidence is adequate
to determine whether certain medical
items and services are reasonable and
necessary and thus eligible for coverage
under the Medicare statute.
II. Meeting Format
This meeting is open to the public.
The Committee will hear oral
presentations from the public for
approximately 30 minutes. The
Committee may limit the number and
E:\FR\FM\29FEN1.SGM
29FEN1
Federal Register / Vol. 73, No. 41 / Friday, February 29, 2008 / Notices
duration of oral presentations to the
time available. Your comments should
consider the list of topics that we have
proposed to the Committee and should
focus on issues specific to those topics.
The list of research topics to be
discussed at the meeting will be
available on the following Web site
prior to the meeting: https://
www.cms.hhs.gov/mcd/
index_list.asp?list_type=mcac. We
require that you declare at the meeting
whether you have any financial
involvement with manufacturers of any
items or services being discussed (or
with their competitors).
The Committee will deliberate openly
on the topics under consideration.
Interested persons may observe the
deliberations, but the Committee will
not hear further comments during this
time except at the request of the
chairperson. The Committee will also
allow a 15-minute unscheduled open
public session for any attendee to
address issues specific to the topics
under consideration. At the conclusion
of the day, the members will vote and
the Committee will make its
recommendation(s) to CMS.
III. Registration Instructions
The Coverage and Analysis Group is
coordinating meeting registration. While
there is no registration fee, individuals
must register to attend. You may register
by contacting the person listed in the
FOR FURTHER INFORMATION CONTACT
rwilkins on PROD1PC63 with NOTICES
section of this notice by the deadline
listed in the DATES section of this notice.
Please provide your full name (as it
appears on your state issued driver’s
license), address, organization,
telephone, fax number(s), and e-mail
address.
You will receive a registration
confirmation with instructions for your
arrival at the CMS complex. You will be
notified if the seating capacity has been
reached.
This meeting is located on Federal
property; therefore, for security reasons,
any individuals wishing to attend this
meeting must register by the date as
specified in the DATES section of this
notice.
IV. Security, Building, and Parking
Guidelines
This meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. In
planning your arrival time, we
recommend that you arrive reasonably
early to allow additional time to clear
security. Security measures include the
following:
• Presentation of government-issued
photographic identification to the
VerDate Aug<31>2005
19:22 Feb 28, 2008
Jkt 214001
Federal Protective Service or Guard
Service personnel.
• Interior and exterior inspection of
vehicles (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Passing through a metal detector
and inspection of items brought into the
building. We note that all items brought
to CMS, whether personal or for the
purpose of presentation or to support a
presentation, are subject to inspection.
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
presentation or to support a
presentation.
Note: Individuals who are not registered in
advance will not be permitted to enter the
building and will be unable to attend the
meeting. The public may not enter the
building earlier than 30 to 45 minutes prior
to the convening of the meeting.
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building.
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program).
Dated: February 14, 2008.
Barry M. Straube,
Chief Medical Officer and Director, Office
of Clinical Standards and Quality, Centers
for Medicare and Medicaid Services.
[FR Doc. E8–3829 Filed 2–28–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No FDA–2008–P–0125] (formerly
Docket No. 2007P–0172)
Determination That MINOCIN
(Minocycline Hydrochloride) Capsules
Equivalent to 75 Milligrams Base Was
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that MINOCIN
(minocycline hydrochloride) Capsules
equivalent to (EQ) 75 milligrams (mg)
base was not withdrawn from sale for
reasons of safety or effectiveness. This
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11121
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for minocycline
hydrochloride capsules if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Carol E. Drew, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Regulations also provide that the agency
must make a determination as to
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness before an ANDA that refers
to that listed drug may be approved
(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).
FDA may not approve an ANDA that
does not refer to a listed drug.
On May 1, 2007, Kendle International,
on behalf of Aurobindo
Pharmaceuticals, Ltd., submitted a
citizen petition (Docket No. 2007P–
0172/CP1) to FDA under 21 CFR 10.30.
The petition requests that the agency
determine whether MINOCIN
E:\FR\FM\29FEN1.SGM
29FEN1
]]>Agencies
[Federal Register Volume 73, Number 41 (Friday, February 29, 2008)]
[Notices]
[Pages 11120-11121]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3829]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3196-N]
Medicare Program; Town Hall Meeting of the Medicare Evidence
Development and Coverage Advisory Committee--April 30, 2008
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces a public meeting of the Medicare
Evidence Development & Coverage Advisory Committee (MedCAC)
(``Committee''). We are soliciting comments from the scientific
community and the public on prioritizing research topics of importance
to the Medicare population. This meeting is a follow up to the CMS
Evidentiary Priorities MedCAC meeting, which was held on October 22,
2007 to establish a list of evidentiary priorities for research to
improve the health of Medicare beneficiaries.
The Committee generally provides advice and recommendations about
whether scientific evidence is adequate to determine whether certain
medical items and services are reasonable and necessary under the
Medicare statute.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. App. 2, section 10(a)).
DATES: Meeting Date: The public meeting will be held on Wednesday,
April 30, 2008 from 7:30 a.m. until 4:30 p.m., e.s.t.
Deadline for Written Comments: Written comments must be received at
the address specified in the ADDRESSES section of this notice by April
2, 2008, 5 p.m., e.s.t. Once submitted, comments are final. The meeting
will not include PowerPoint presentations.
Deadline for Meeting Registration: Individuals may register by
phone or e-mail by contacting the contact listed in the FOR FURTHER
INFORMATION CONTACT section of this notice by close of business on
Monday April 21, 2008.
Deadline for Submitting Request for Special Accommodations: Persons
attending the meeting who are hearing or visually impaired, or have a
condition that requires special assistance or accommodations, are asked
to contact the Executive Secretary as specified in the FOR FURTHER
INFORMATION CONTACT section of this notice no later than April 23,
2008.
ADDRESSES: Meeting Location: The meeting will be held in the main
auditorium of the Centers for Medicare and Medicaid Services, 7500
Security Blvd., Baltimore, MD 21244.
Submission of Presentations and Comments: Written comments and
those that will be presented verbally at the meeting must be submitted
by e-mail to MedCACpresentations@cms.hhs.gov or by regular mail to the
contact listed in the FOR FURTHER INFORMATION CONTACT section of this
notice.
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 via phone
(410-786-0309) or 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) to describe the Medicare Coverage Advisory Committee
(MCAC), now known as the MedCAC, which provides advice and
recommendations to CMS about clinical issues.
The purpose of the MedCAC meeting is to discuss the priorities for
research topics that are important for the Medicare program and the
Medicare population and to make recommendations to CMS. This public
discussion may also provide useful information for researchers in the
scientific community who are interested in developing research projects
concerning Medicare beneficiaries. This meeting is a follow up to the
CMS Evidentiary Priorities MedCAC meeting which was held on October 22,
2007. The purpose of the October 22, 2007 meeting was to establish a
list of evidentiary priorities for research to improve the health of
Medicare beneficiaries. Details on the October 22, 2007 meeting and the
CMS Evidentiary Priorities can be found at https://www.cms.hhs.gov/mcd/
viewmcac.asp?where=index&mid=41.
The Committee generally provides advice and recommendations about
whether scientific evidence is adequate to determine whether certain
medical items and services are reasonable and necessary and thus
eligible for coverage under the Medicare statute.
II. Meeting Format
This meeting is open to the public. The Committee will hear oral
presentations from the public for approximately 30 minutes. The
Committee may limit the number and
[[Page 11121]]
duration of oral presentations to the time available. Your comments
should consider the list of topics that we have proposed to the
Committee and should focus on issues specific to those topics. The list
of research topics to be discussed at the meeting will be available on
the following Web site prior to the meeting: https://www.cms.hhs.gov/
mcd/index_list.asp?list_type=mcac. We require that you declare at the
meeting whether you have any financial involvement with manufacturers
of any items or services being discussed (or with their competitors).
The Committee will deliberate openly on the topics under
consideration. Interested persons may observe the deliberations, but
the Committee will not hear further comments during this time except at
the request of the chairperson. The Committee will also allow a 15-
minute unscheduled open public session for any attendee to address
issues specific to the topics under consideration. At the conclusion of
the day, the members will vote and the Committee will make its
recommendation(s) to CMS.
III. Registration Instructions
The Coverage and Analysis Group is coordinating meeting
registration. While there is no registration fee, individuals must
register to attend. You may register by contacting the person listed in
the FOR FURTHER INFORMATION CONTACT section of this notice by the
deadline listed in the DATES section of this notice. Please provide
your full name (as it appears on your state issued driver's license),
address, organization, telephone, fax number(s), and e-mail address.
You will receive a registration confirmation with instructions for
your arrival at the CMS complex. You will be notified if the seating
capacity has been reached.
This meeting is located on Federal property; therefore, for
security reasons, any individuals wishing to attend this meeting must
register by the date as specified in the DATES section of this notice.
IV. Security, Building, and Parking Guidelines
This meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. In planning your
arrival time, we recommend that you arrive reasonably early to allow
additional time to clear security. Security measures include the
following:
Presentation of government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel.
Interior and exterior inspection of vehicles (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to CMS,
whether personal or for the purpose of presentation or to support a
presentation, are subject to inspection. 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 presentation or to support a presentation.
Note: Individuals who are not registered in advance will not be
permitted to enter the building and will be unable to attend the
meeting. The public may not enter the building earlier than 30 to 45
minutes prior to the convening of the meeting.
All visitors must be escorted in areas other than the lower and
first floor levels in the Central Building.
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program).
Dated: February 14, 2008.
Barry M. Straube,
Chief Medical Officer and Director, Office of Clinical Standards and
Quality, Centers for Medicare and Medicaid Services.
[FR Doc. E8-3829 Filed 2-28-08; 8:45 am]
BILLING CODE 4120-01-P
