Preparation for the International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting, 17698-17699 [05-7020]
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17698
Federal Register / Vol. 70, No. 66 / Thursday, April 7, 2005 / Notices
at home for lack of an appropriate
caregiver are provided care in a facility
of 20 or fewer beds that offers, within
its walls, the full range of services
provided by hospice programs under
section 1861(dd) of the Social Security
Act (42 U.S.C. 1395x(dd)).
Under the demonstration project, the
hospice program shall comply with
otherwise applicable requirements,
except that it shall not be required to
offer services outside of the hospice
facility or to meet the requirements of
section 1861(dd)(2)(A)(iii) of the Social
Security Act (SSA) regarding the 20percent cap on inpatient care days.
The Secretary may require the hospice
demonstration to comply with
additional quality assurance standards
for provision of services. Upon
completion of the project, the Secretary
shall submit a report to the Congress on
the project including recommendations
regarding extensions to hospice
programs serving rural areas.
B. The Rural Hospice Demonstration
The demonstration will be offered to
up to three hospice programs and will
not exceed a period of 5 years. The
demonstration is designed to test
whether hospice services provided by a
demonstration hospice program to
Medicare beneficiaries who lack an
appropriate caregiver and who reside in
rural areas results in wider access,
improved hospice services, benefits to
the rural community, and a sustainable
pattern of care. Hospice provides
palliative care to individuals who have
a terminal illness with a prognosis of 6
months or less. The care is provided
typically in the individual’s home or
place of residence with family members
present. Individuals who lack family or
someone to serve as the primary
caregiver need proportionately more
support from hospice staff. Due to long
distances and difficult terrain, it can be
particularly difficult to provide the
Medicare hospice benefit efficiently in
rural areas. There may be situations
where the hospice benefit could be
provided to beneficiaries who would
not otherwise be able to receive these
services if the location of hospice care
is altered. This demonstration will
allow a hospice with up to 20 beds to
provide all levels of hospice services
within its walls to individuals who
reside in rural areas and lack an
appropriate caregiver, while not having
to provide services outside of the
hospice facility or comply with the 20percent cap on inpatient care days.
While the demonstration provider
will not have to meet the limit on
inpatient care days or provide care
outside of the facility, it will not alter
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18:22 Apr 06, 2005
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the level of care requirements for
general inpatient care. In order to
provide general inpatient care to
hospice patients, a hospice participating
in the demonstration must assure that
the need for general inpatient care is
met according to Medicare guidelines.
The demonstration will test whether
hospice services provided by a facility
that does not meet the limit on inpatient
care days or provide services outside of
the facility for hospice individuals
residing in rural areas who lack an
appropriate caregiver results in wider
access, improved hospice services,
benefits to the rural community, and a
sustainable pattern of care.
The demonstration is designed for a
demonstration hospice to provide the
full range of services within its facility
to Medicare beneficiaries who reside in
rural areas and lack an appropriate
caregiver. If a demonstration hospice
provides care to any patient who either
lives outside a rural area or has an
appropriate caregiver, then the hospice
must comply with all of Medicare
hospice requirements at 1861(dd) of the
SSA for these patients since they are not
considered part of the demonstration.
We plan to make up to three awards.
Interested parties can obtain complete
solicitation and supporting information
on the CMS Web site at: https://
www.cms.hhs.gov/researchers/demos/
rmbh/default.asp. Paper copies can be
obtained by writing to Cindy Massuda at
the address listed in the ADDRESSES
section of this notice.
II. Collection of Information
Requirements
Since CMS will receive less than 10
applications to this solicitation, the
information collection requested
reference in this solicitation are not
subject to the PRA as stipulated under
5 CFR 1320.3(c).
Authority: Section 409 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub. L.
108–173).
(Domestic Assistance No. 93.773 Medicare—
Hospital insurance Program; and No. 93.774,
Medicare-Supplementary Medical Insurance
Program)
Dated: March 10, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–6861 Filed 4–1–05; 4:42 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0119]
Preparation for the International
Conference on Harmonization
Meetings in Brussels, Belgium; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting to provide information
and receive comments on the
International Conference on
Harmonization (ICH) in advance of its
next next Steering Committee and
Expert Working Group meetings in
Brussels, Belgium, May 9 through 12,
2005. Scheduled for the ICH meetings is
an Efficacy Brainstorming Session
focusing on the review of the existing
efficacy guidelines and their need for
updating as well as potential new topics
for consideration. To promote a fuller
discussion of this topic the public
meeting will be expanded to include
public input on initiatives related to
current ICH efficacy guidelines and
consider needs for further information
both within and between existing
guidances. These initiatives include
electronic source data, clinical
development plan summaries, Health
Level 7 structured product labeling, and
other initiatives including information
exchange standards (e.g., Electronic
Common Technical Document (eCTD)
and terminology standards).
Date and Time: The meeting will be
held on April 20, 2005, from 9 a.m. to
5:30 p.m.
Location: The meeting will be held at
The DoubleTree Hotel and Executive
Meeting Center, 1750 Rockville Pike,
Rockville, MD. A block of rooms for
those wishing to attend the meeting
have been set aside at the government
rate. Please contact the hotel directly for
your reservation: DoubleTree Hotel and
Executive Meeting Center, 301–468–
1100, FAX: 301–468–0308.
Contact Person: Sema Hashemi, Office
of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–3050,
FAX: 301–480–0716, e-mail:
Sema.Hashemi@fda.hhs.gov.
Registration and Requests for Oral
Presentations: Send registration
information (including name, title, firm
name, address, telephone, and FAX
number), and written material and
E:\FR\FM\07APN1.SGM
07APN1
Federal Register / Vol. 70, No. 66 / Thursday, April 7, 2005 / Notices
requests to make oral presentations, to
the contact person by April 14, 2005.
Transcripts: Transcripts of the
meeting may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
12A–16, Rockville, MD 20857,
approximately 15 working days after the
meeting at a cost of 10 cents per page.
If you need special accommodations
due to a disability, please contact Sema
Hashemi at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The ICH
was established in 1990 as a joint
regulatory/industry project to improve,
through harmonization, the efficiency of
the process for developing and
registering new medicinal products in
Europe, Japan, and the United States
without compromising the regulatory
obligations of safety and effectiveness.
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for medical product
development among regulatory
agencies. ICH was organized to provide
an opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. ICH is concerned with
harmonization among the following
three regions: The European Union,
Japan, and the United States. The six
ICH sponsors are the European
Commission; the European Federation
of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labor, and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations. The ICH
Steering Committee includes
representatives from each of the ICH
sponsors and Health Canada, the
European Free Trade Area and the
World Health Organization. The ICH
process has achieved significant
harmonization of the technical
VerDate jul<14>2003
18:22 Apr 06, 2005
Jkt 205001
requirements for the approval of
pharmaceuticals for human use in the
three ICH regions.
The current ICH process and structure
can be found at the following Web site:
https://www.ich.org. (FDA has verified
the Web site address, but we are not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register.)
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 p.m. Time
allotted for oral presentations may be
limited to 10 minutes. Those desiring to
make oral presentations should notify
the contact person by April 14, 2005,
and submit a brief statement of the
general nature of the evidence or
arguments they which to present, the
names and addresses, phone number,
FAX, and e-mail of proposed
participants, and an indication of the
approximate time requested to make
their presentation.
The topics to be discussed are the
topics for discussion at the forthcoming
ICH Steering Committee Meeting and
ICH Expert Working Groups. One of the
topics for the upcoming ICH meeting is
an Efficacy Brainstorming Session
focusing on the review of the existing
efficacy guidelines and their need for
updating as well as potential new topics
for consideration. The complete set of
ICH Efficacy Guidelines may be found at
https://www.ich.org/ or https://
www.fda.gov/cder/guidance/index.htm.
To promote a fuller discussion of this
topic the public meeting will be
expanded to include public input on
initiatives related to current ICH
efficacy guidelines and consider needs
for further information both within and
between existing guidances. These
initiatives include electronic source
data, clinical development plan
summaries, Health Level 7 structured
product labeling, and other initiatives
including information exchange
standards (e.g., eCTD and terminology
standards).
The agenda for the public meeting
will be made available on April 15,
2005, via the internet at https://
www.fda.gov/cder/meeting/
ICH_Spring2005.htm.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7020 Filed 4–5–05; 11:53 am]
BILLING CODE 4160–01–S
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17699
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Methods for High-Efficiency Single
Genome Sequencing of HIV
Drs. John Coffin, Mary Kearney, Frank
Maldarelli and Sarah E. Palmer (NCI),
et al.
U.S. Provisional Application filed 25
Jan 2005 (DHHS Reference No. E–
022–2005/0–US–01).
Licensing Contact: Sally Hu; 301/435–
5606; hus@mail.nih.gov.
The invention is directed to a method
for efficiently obtaining single genome
sequences (SGS) of HIV from a
biological sample. The invention has the
following advantages over the current
commercial genotyping in use: (1) It
might improve the sensitivity of
diagnosis of drug resistant HIV in newly
infected HIV patients; (2) It might
provide a more affordable diagnostic
tool for early detection of drug
resistance since the invention is
adaptable to an automated approach for
the high-throughput processing of a
large number of patient sample; (3) It
might improve patient outcome since
SGS has the ability to identify low level
mutation and will permit a more
comprehensive evaluation of resistance
in patients and might potentially change
the clinical approach to treating
resistant virus. In summary, this
E:\FR\FM\07APN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 66 (Thursday, April 7, 2005)]
[Notices]
[Pages 17698-17699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7020]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0119]
Preparation for the International Conference on Harmonization
Meetings in Brussels, Belgium; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to provide information and receive comments on the
International Conference on Harmonization (ICH) in advance of its next
next Steering Committee and Expert Working Group meetings in Brussels,
Belgium, May 9 through 12, 2005. Scheduled for the ICH meetings is an
Efficacy Brainstorming Session focusing on the review of the existing
efficacy guidelines and their need for updating as well as potential
new topics for consideration. To promote a fuller discussion of this
topic the public meeting will be expanded to include public input on
initiatives related to current ICH efficacy guidelines and consider
needs for further information both within and between existing
guidances. These initiatives include electronic source data, clinical
development plan summaries, Health Level 7 structured product labeling,
and other initiatives including information exchange standards (e.g.,
Electronic Common Technical Document (eCTD) and terminology standards).
Date and Time: The meeting will be held on April 20, 2005, from 9
a.m. to 5:30 p.m.
Location: The meeting will be held at The DoubleTree Hotel and
Executive Meeting Center, 1750 Rockville Pike, Rockville, MD. A block
of rooms for those wishing to attend the meeting have been set aside at
the government rate. Please contact the hotel directly for your
reservation: DoubleTree Hotel and Executive Meeting Center, 301-468-
1100, FAX: 301-468-0308.
Contact Person: Sema Hashemi, Office of the Commissioner, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
FAX number), and written material and
[[Page 17699]]
requests to make oral presentations, to the contact person by April 14,
2005.
Transcripts: Transcripts of the meeting may be requested in writing
from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
If you need special accommodations due to a disability, please
contact Sema Hashemi at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint
regulatory/industry project to improve, through harmonization, the
efficiency of the process for developing and registering new medicinal
products in Europe, Japan, and the United States without compromising
the regulatory obligations of safety and effectiveness.
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for medical product development among regulatory agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. ICH is concerned with harmonization among the
following three regions: The European Union, Japan, and the United
States. The six ICH sponsors are the European Commission; the European
Federation of Pharmaceutical Industries Associations; the Japanese
Ministry of Health, Labor, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; the Centers for Drug Evaluation and Research
and Biologics Evaluation and Research, FDA; and the Pharmaceutical
Research and Manufacturers of America. The ICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation of Pharmaceutical Manufacturers Associations.
The ICH Steering Committee includes representatives from each of the
ICH sponsors and Health Canada, the European Free Trade Area and the
World Health Organization. The ICH process has achieved significant
harmonization of the technical requirements for the approval of
pharmaceuticals for human use in the three ICH regions.
The current ICH process and structure can be found at the following
Web site: https://www.ich.org. (FDA has verified the Web site address,
but we are not responsible for subsequent changes to the Web site after
this document publishes in the Federal Register.)
Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Oral
presentations from the public will be scheduled between approximately 1
p.m. and 2 p.m. Time allotted for oral presentations may be limited to
10 minutes. Those desiring to make oral presentations should notify the
contact person by April 14, 2005, and submit a brief statement of the
general nature of the evidence or arguments they which to present, the
names and addresses, phone number, FAX, and e-mail of proposed
participants, and an indication of the approximate time requested to
make their presentation.
The topics to be discussed are the topics for discussion at the
forthcoming ICH Steering Committee Meeting and ICH Expert Working
Groups. One of the topics for the upcoming ICH meeting is an Efficacy
Brainstorming Session focusing on the review of the existing efficacy
guidelines and their need for updating as well as potential new topics
for consideration. The complete set of ICH Efficacy Guidelines may be
found at https://www.ich.org/ or https://www.fda.gov/cder/guidance/
index.htm. To promote a fuller discussion of this topic the public
meeting will be expanded to include public input on initiatives related
to current ICH efficacy guidelines and consider needs for further
information both within and between existing guidances. These
initiatives include electronic source data, clinical development plan
summaries, Health Level 7 structured product labeling, and other
initiatives including information exchange standards (e.g., eCTD and
terminology standards).
The agenda for the public meeting will be made available on April
15, 2005, via the internet at https://www.fda.gov/cder/meeting/ICH_
Spring2005.htm.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7020 Filed 4-5-05; 11:53 am]
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