Preparation for International Conference on Harmonisation Meetings in Brussels, Belgium; Public Meeting, 16370-16371 [07-1633]
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16370
Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Notices
pharmacies, doctors’ offices, and
community centers.
In the Fall of 2005, the Spanish
language campaign was pilot tested by
5 state health departments that receive
funding from CDC for their arthritis
programs. CDC will eventually
disseminate these materials to all 36
CDC will conduct an evaluation of the
impact of the Spanish language health
communications campaign on the
exercise/physical activity-related
attitudes, beliefs, and behaviors among
the target audience of Spanish-speaking
people with arthritis. There are no costs
to the respondents other than their time.
CDC-funded states. The 5 preliminary
pilot tests focused on reach and
exposure; a more thorough evaluation is
necessary to assess impact of the
campaign. This information will be used
to guide the public health practice of the
36 state arthritis programs and their
partners.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Screening Survey ............................................................................................
Telephone Survey ............................................................................................
12,000
2,500
1
1
2/60
15/60
400
625
Total ..........................................................................................................
........................
........................
........................
1,025
Dated: March 28, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–6276 Filed 4–3–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
jlentini on PROD1PC65 with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Technical
Support for Birth Defects and
Developmental Disabilities Prevention
Education Efforts, Contract Solicitation
Number (CSN) 2006–N–08835
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned SEP:
Time and Date: 12 p.m.–3 p.m., April
30, 2007 (Closed).
Place: Teleconference, Centers for
Disease Control and Prevention, 1600
Clifton Road, NE., Atlanta, GA 30333.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section
552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters to be Discussed: The meeting
will include the review, discussion, and
evaluation of applications received in
response to CSN 2006–N–08835,
‘‘Technical Support for Birth Defects
and Developmental Disabilities
Prevention Education Efforts.’’
VerDate Aug<31>2005
17:57 Apr 03, 2007
Jkt 211001
For Further Information Contact:
Christine Morrison, Ph.D., Scientific
Review Administrator, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., Mailstop D72, Atlanta,
GA 30333, Telephone 404.639.3098.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: March 28, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–6270 Filed 4–3–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Preparation for International
Conference on Harmonisation
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 entitled ‘‘Preparation for
ICH Meetings in Brussels, Belgium’’ to
provide information and receive
comments on the International
Conference on Harmonisation (ICH) as
well as the upcoming meetings in
Brussels, Belgium. The topics to be
discussed are the topics for discussion
at the forthcoming ICH steering
PO 00000
Frm 00046
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committee meeting. The purpose of the
meeting is to solicit public input prior
to the next steering committee and
expert working groups meetings in
Brussels, Belgium May 5–10, 2007, at
which discussion of the topics
underway and the future of ICH will
continue.
Date and Time: The meeting will be
held on Friday April 6, 2007, from 3:30
p.m. to 5 p.m.
Location: The meeting will be held at
5600 Fishers Lane, third floor,
Conference Room G, Rockville, MD
20857. For security reasons, all
attendees are asked to arrive no later
than 3:20 p.m., as you will be escorted
from the front entrance of 5600 Fishers
Lane to Conference Room G.
Contact Person: Michelle Limoli,
Office of the Commissioner (HFG–1),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–0908, e-mail:
michelle.limoli@fda.hhs.gov, FAX: 301–
827–0003.
Registration and Requests for Oral
Presentations: Send registration
information (including name, title, firm
name, address, telephone, and fax
number), written material, and requests
to make oral presentations, to the
contact person by April 5, 2007.
If you need special accommodations
due to a disability, please contact
Michelle Limoli as soon as possible.
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
E:\FR\FM\04APN1.SGM
04APN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Notices
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 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.
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 4:30 p.m. and 5 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 5, 2007, 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 email of proposed participants, and an
indication of the approximate time
requested to make their presentation.
The agenda for the public meeting
will be made available via the Internet
at https://www.fda.gov/cder/meeting/
ICH_20060508.htm.
VerDate Aug<31>2005
17:57 Apr 03, 2007
Jkt 211001
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.
6–30, Rockville, MD 20857,
approximately 15 working days after the
meeting at a cost of 10 cents per page.
Dated: March 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–1633 Filed 3–29–07; 3:56 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
List of Recipients of Indian Health
Scholarships Under the Indian Health
Scholarship Program
The regulations governing Indian
Health Care Improvement Act Programs
(Pub. L. 94–437) provide at 42 CFR
136.334 that the Indian Health Service
shall publish annually in the Federal
Register a list of recipients of Indian
Health Scholarships, including the
name of each recipient, school and
Tribal affiliation, if applicable. These
scholarships were awarded under the
authority of Sections 103 and 104 of the
Indian Health Care Improvement Act, 25
U.S.C. 1613–1613a, as amended by the
Indian Health Care Amendments of
1988, Pub. L. 100–713.
The following is a list of Indian
Health Scholarship Recipients funded
under Sections 103 and 104 for Fiscal
Year 2006:
Adams, Staci Brook, Northern
Oklahoma College, Ponca Tribe of
Indians of Oklahoma.
Ahenakew, Carol Marie, Walla Walla
College, Blackfeet Tribe of the
Blackfeet Indian Reservation of
Montana.
Albers, Travis Alan, University of Mary,
Turtle Mountain Band of Chippewa
Indians of North Dakota.
Allen, Bryan Zachary, Southwestern
Oklahoma State University, Choctaw
Nation of Oklahoma.
Arredondo, Michael Howard, University
of Minnesota/Duluth, Eastern
Shawnee Tribe of Oklahoma.
Augare-Deal, Rael, University of Kansas,
Blackfeet Tribe of the Blackfeet Indian
Reservation of Montana.
Azure, Donna Rae, Turtle Mountain
Community College, Turtle Mountain
Band of Chippewa Indians of North
Dakota.
Azure, Krysten Ross, University of
North Dakota, Sisseton-Wahpeton
PO 00000
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Fmt 4703
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Sioux Tribe of the Lake Traverse
Reservation, South Dakota.
Babbitt, Jaime Lynn, Indiana University,
Navajo Nation, Arizona, New
Mexico& Utah.
Baker, Allison Marie, University of
North Dakota, Three Affiliated Tribes
of the Fort Berthold Reservation,
North Dakota.
Baker, Laiel Inez, University of North
Dakota, Three Affiliated Tribes of the
Fort Berthold Reservation, North
Dakota.
Baker, Valerie, University of New
Mexico, Navajo Nation, Arizona, New
Mexico & Utah.
Bales-Poirot, Deidre Leann, University
of Missouri/Columbia, Eastern
Shawnee Tribe of Oklahoma.
Banteah, Melinda Erika, University of
New Mexico/Albuquerque, Zuni Tribe
of the Zuni Reservation, New Mexico.
Barnett, Stephanie Deann, University of
Pittsburgh, Cherokee Nation,
Oklahoma.
Barrett, Courtney Paige, University of
Oklahoma, Seminole Nation of
Oklahoma.
Bayer, Amelia Dianne, University of
New Mexico, Choctaw Nation of
Oklahoma.
Beals, Bryan James, University of North
Dakota, Muscogee (Creek) Nation,
Oklahoma.
Beardslee, Amber Rochelle, The
University of Puget Sound, Central
Council of Tlingit & Haida Indian
Tribes.
Beaver, Aaron Don, University of
Oklahoma, Choctaw Nation of
Oklahoma.
Beaver, Allen Don, University of
Oklahoma, Choctaw Nation of
Oklahoma.
Bebeau, Shari Kaye, University of
Minnesota, Minnesota Chippewa
Tribe, Minnesota.
Becenti, Elton, New Mexico State
University, Navajo Nation, Arizona,
New Mexico & Utah.
Becker, Tischa Lee, University of New
Mexico, Cherokee Nation, Oklahoma.
Begay, Melanie, University of New
Mexico, Navajo Nation, Arizona, New
Mexico & Utah.
Begay, Monica Calley, University of
New Mexico/Albuquerque, Navajo
Nation, Arizona, New Mexico & Utah.
Begay, Velda Ann, Arizona State
University, Navajo Nation, Arizona,
New Mexico & Utah.
Begaye, Adrienne Marie, University of
Arizona, Navajo Nation, Arizona, New
Mexico & Utah.
Begaye, Amelia June, University of New
Mexico, Navajo Nation, Arizona, New
Mexico & Utah.
Begaye, Julianna, University of New
Mexico, Navajo Nation, Arizona, New
Mexico & Utah.
E:\FR\FM\04APN1.SGM
04APN1
Agencies
[Federal Register Volume 72, Number 64 (Wednesday, April 4, 2007)]
[Notices]
[Pages 16370-16371]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1633]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Preparation for International Conference on Harmonisation
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 entitled ``Preparation for ICH Meetings in Brussels, Belgium''
to provide information and receive comments on the International
Conference on Harmonisation (ICH) as well as the upcoming meetings in
Brussels, Belgium. The topics to be discussed are the topics for
discussion at the forthcoming ICH steering committee meeting. The
purpose of the meeting is to solicit public input prior to the next
steering committee and expert working groups meetings in Brussels,
Belgium May 5-10, 2007, at which discussion of the topics underway and
the future of ICH will continue.
Date and Time: The meeting will be held on Friday April 6, 2007,
from 3:30 p.m. to 5 p.m.
Location: The meeting will be held at 5600 Fishers Lane, third
floor, Conference Room G, Rockville, MD 20857. For security reasons,
all attendees are asked to arrive no later than 3:20 p.m., as you will
be escorted from the front entrance of 5600 Fishers Lane to Conference
Room G.
Contact Person: Michelle Limoli, Office of the Commissioner (HFG-
1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-0908, e-mail: michelle.limoli@fda.hhs.gov, FAX: 301-827-
0003.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), written material, and requests to make oral presentations,
to the contact person by April 5, 2007.
If you need special accommodations due to a disability, please
contact Michelle Limoli as soon as possible.
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
[[Page 16371]]
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 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.
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
4:30 p.m. and 5 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 5, 2007, 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 agenda for the public meeting will be made available via the
Internet at https://www.fda.gov/cder/meeting/ICH_20060508.htm.
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. 6-30, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
Dated: March 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1633 Filed 3-29-07; 3:56 pm]
BILLING CODE 4160-01-S