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16370 Federal Register / Vol. 72, No.

64 / Wednesday, April 4, 2007 / Notices

pharmacies, doctors’ offices, and CDC-funded states. The 5 preliminary CDC will conduct an evaluation of the
community centers. pilot tests focused on reach and impact of the Spanish language health
In the Fall of 2005, the Spanish exposure; a more thorough evaluation is communications campaign on the
language campaign was pilot tested by necessary to assess impact of the exercise/physical activity-related
5 state health departments that receive campaign. This information will be used attitudes, beliefs, and behaviors among
funding from CDC for their arthritis to guide the public health practice of the the target audience of Spanish-speaking
programs. CDC will eventually 36 state arthritis programs and their people with arthritis. There are no costs
disseminate these materials to all 36 partners. to the respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS


Average
Number of
Number of burden per Total burden
Respondents responses per
respondents response (in hours)
respondent (in hours)

Screening Survey ............................................................................................ 12,000 1 2/60 400


Telephone Survey ............................................................................................ 2,500 1 15/60 625

Total .......................................................................................................... ........................ ........................ ........................ 1,025

Dated: March 28, 2007. For Further Information Contact: committee meeting. The purpose of the
Joan F. Karr, Christine Morrison, Ph.D., Scientific meeting is to solicit public input prior
Acting Reports Clearance Officer, Centers for Review Administrator, Centers for to the next steering committee and
Disease Control and Prevention. Disease Control and Prevention, 1600 expert working groups meetings in
[FR Doc. E7–6276 Filed 4–3–07; 8:45 am] Clifton Road NE., Mailstop D72, Atlanta, Brussels, Belgium May 5–10, 2007, at
BILLING CODE 4163–18–P GA 30333, Telephone 404.639.3098. which discussion of the topics
The Director, Management Analysis and underway and the future of ICH will
Services Office, has been delegated the continue.
DEPARTMENT OF HEALTH AND authority to sign Federal Register Date and Time: The meeting will be
HUMAN SERVICES notices pertaining to announcements of held on Friday April 6, 2007, from 3:30
meetings and other committee p.m. to 5 p.m.
Centers for Disease Control and management activities, for both CDC Location: The meeting will be held at
Prevention and the Agency for Toxic Substances 5600 Fishers Lane, third floor,
and Disease Registry. Conference Room G, Rockville, MD
Disease, Disability, and Injury 20857. For security reasons, all
Prevention and Control Special Dated: March 28, 2007.
attendees are asked to arrive no later
Emphasis Panel (SEP): Technical Elaine L. Baker, than 3:20 p.m., as you will be escorted
Support for Birth Defects and Acting Director, Management Analysis and from the front entrance of 5600 Fishers
Developmental Disabilities Prevention Services Office, Centers for Disease Control Lane to Conference Room G.
Education Efforts, Contract Solicitation and Prevention. Contact Person: Michelle Limoli,
Number (CSN) 2006–N–08835 [FR Doc. E7–6270 Filed 4–3–07; 8:45 am] Office of the Commissioner (HFG–1),
BILLING CODE 4163–18–P Food and Drug Administration, 5600
In accordance with Section 10(a)(2) of Fishers Lane, Rockville, MD 20857,
the Federal Advisory Committee Act 301–827–0908, e-mail:
(Pub. L. 92–463), the Centers for Disease DEPARTMENT OF HEALTH AND michelle.limoli@fda.hhs.gov, FAX: 301–
Control and Prevention (CDC) HUMAN SERVICES 827–0003.
announces the following meeting of the Registration and Requests for Oral
aforementioned SEP: Food and Drug Administration Presentations: Send registration
Time and Date: 12 p.m.–3 p.m., April information (including name, title, firm
30, 2007 (Closed). Preparation for International
name, address, telephone, and fax
Place: Teleconference, Centers for Conference on Harmonisation
number), written material, and requests
Disease Control and Prevention, 1600 Meetings in Brussels, Belgium; Public
to make oral presentations, to the
Clifton Road, NE., Atlanta, GA 30333. Meeting
contact person by April 5, 2007.
Status: The meeting will be closed to AGENCY: Food and Drug Administration, If you need special accommodations
the public in accordance with HHS. due to a disability, please contact
provisions set forth in Section ACTION: Notice of meeting. Michelle Limoli as soon as possible.
552b(c)(4) and (6), Title 5 U.S.C., and SUPPLEMENTARY INFORMATION: The ICH
the Determination of the Director, SUMMARY: The Food and Drug was established in 1990 as a joint
Management Analysis and Services Administration (FDA) is announcing a regulatory/industry project to improve,
Office, CDC, pursuant to Public Law 92– public meeting entitled ‘‘Preparation for through harmonization, the efficiency of
463. ICH Meetings in Brussels, Belgium’’ to the process for developing and
Matters to be Discussed: The meeting provide information and receive registering new medicinal products in
will include the review, discussion, and comments on the International Europe, Japan, and the United States
jlentini on PROD1PC65 with NOTICES

evaluation of applications received in Conference on Harmonisation (ICH) as without compromising the regulatory
response to CSN 2006–N–08835, well as the upcoming meetings in obligations of safety and effectiveness.
‘‘Technical Support for Birth Defects Brussels, Belgium. The topics to be In recent years, many important
and Developmental Disabilities discussed are the topics for discussion initiatives have been undertaken by
Prevention Education Efforts.’’ at the forthcoming ICH steering regulatory authorities and industry

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Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Notices 16371

associations to promote international Transcripts: Transcripts of the Sioux Tribe of the Lake Traverse
harmonization of regulatory meeting may be requested in writing Reservation, South Dakota.
requirements. FDA has participated in from the Freedom of Information Office Babbitt, Jaime Lynn, Indiana University,
many meetings designed to enhance (HFI–35), Food and Drug Navajo Nation, Arizona, New
harmonization and is committed to Administration, 5600 Fishers Lane, rm. Mexico& Utah.
seeking scientifically-based harmonized 6–30, Rockville, MD 20857, Baker, Allison Marie, University of
technical procedures for pharmaceutical approximately 15 working days after the North Dakota, Three Affiliated Tribes
development. One of the goals of meeting at a cost of 10 cents per page. of the Fort Berthold Reservation,
harmonization is to identify and then North Dakota.
Dated: March 28, 2007.
reduce differences in technical Baker, Laiel Inez, University of North
Jeffrey Shuren, Dakota, Three Affiliated Tribes of the
requirements for medical product
development among regulatory Assistant Commissioner for Policy. Fort Berthold Reservation, North
agencies. ICH was organized to provide [FR Doc. 07–1633 Filed 3–29–07; 3:56 pm] Dakota.
an opportunity for harmonization BILLING CODE 4160–01–S Baker, Valerie, University of New
initiatives to be developed with input Mexico, Navajo Nation, Arizona, New
from both regulatory and industry Mexico & Utah.
representatives. ICH is concerned with DEPARTMENT OF HEALTH AND Bales-Poirot, Deidre Leann, University
harmonization among three regions: The HUMAN SERVICES of Missouri/Columbia, Eastern
European Union, Japan, and the United Shawnee Tribe of Oklahoma.
Indian Health Service Banteah, Melinda Erika, University of
States. The six ICH sponsors are the
European Commission; the European New Mexico/Albuquerque, Zuni Tribe
List of Recipients of Indian Health of the Zuni Reservation, New Mexico.
Federation of Pharmaceutical Industries Scholarships Under the Indian Health
Associations; the Japanese Ministry of Barnett, Stephanie Deann, University of
Scholarship Program Pittsburgh, Cherokee Nation,
Health, Labor and Welfare; the Japanese
Pharmaceutical Manufacturers The regulations governing Indian Oklahoma.
Association; the Centers for Drug Barrett, Courtney Paige, University of
Health Care Improvement Act Programs
Evaluation and Research and Biologics Oklahoma, Seminole Nation of
(Pub. L. 94–437) provide at 42 CFR
Evaluation and Research, FDA; and the Oklahoma.
136.334 that the Indian Health Service
Bayer, Amelia Dianne, University of
Pharmaceutical Research and shall publish annually in the Federal
New Mexico, Choctaw Nation of
Manufacturers of America. The ICH Register a list of recipients of Indian
Oklahoma.
Secretariat, which coordinates the Health Scholarships, including the Beals, Bryan James, University of North
preparation of documentation, is name of each recipient, school and Dakota, Muscogee (Creek) Nation,
provided by the International Tribal affiliation, if applicable. These Oklahoma.
Federation of Pharmaceutical scholarships were awarded under the Beardslee, Amber Rochelle, The
Manufacturers Associations. The ICH authority of Sections 103 and 104 of the University of Puget Sound, Central
steering committee includes Indian Health Care Improvement Act, 25 Council of Tlingit & Haida Indian
representatives from each of the ICH U.S.C. 1613–1613a, as amended by the Tribes.
sponsors and Health Canada, the Indian Health Care Amendments of Beaver, Aaron Don, University of
European Free Trade Area, and the 1988, Pub. L. 100–713. Oklahoma, Choctaw Nation of
World Health Organization. The ICH The following is a list of Indian Oklahoma.
process has achieved significant Health Scholarship Recipients funded Beaver, Allen Don, University of
harmonization of the technical under Sections 103 and 104 for Fiscal Oklahoma, Choctaw Nation of
requirements for the approval of Year 2006: Oklahoma.
pharmaceuticals for human use in the Adams, Staci Brook, Northern Bebeau, Shari Kaye, University of
three ICH regions. Oklahoma College, Ponca Tribe of Minnesota, Minnesota Chippewa
The current ICH process and structure Indians of Oklahoma. Tribe, Minnesota.
can be found at the following Web site: Becenti, Elton, New Mexico State
Ahenakew, Carol Marie, Walla Walla
http://www.ich.org. University, Navajo Nation, Arizona,
College, Blackfeet Tribe of the
Interested persons may present data, New Mexico & Utah.
information, or views orally or in Blackfeet Indian Reservation of
Montana. Becker, Tischa Lee, University of New
writing, on issues pending at the public Mexico, Cherokee Nation, Oklahoma.
meeting. Oral presentations from the Albers, Travis Alan, University of Mary,
Turtle Mountain Band of Chippewa Begay, Melanie, University of New
public will be scheduled between Mexico, Navajo Nation, Arizona, New
approximately 4:30 p.m. and 5 p.m. Indians of North Dakota.
Allen, Bryan Zachary, Southwestern Mexico & Utah.
Time allotted for oral presentations may Begay, Monica Calley, University of
be limited to 10 minutes. Those desiring Oklahoma State University, Choctaw
New Mexico/Albuquerque, Navajo
to make oral presentations should notify Nation of Oklahoma.
Nation, Arizona, New Mexico & Utah.
the contact person by April 5, 2007, and Arredondo, Michael Howard, University Begay, Velda Ann, Arizona State
submit a brief statement of the general of Minnesota/Duluth, Eastern University, Navajo Nation, Arizona,
nature of the evidence or arguments Shawnee Tribe of Oklahoma. New Mexico & Utah.
they which to present, the names and Augare-Deal, Rael, University of Kansas, Begaye, Adrienne Marie, University of
addresses, phone number, fax, and e- Blackfeet Tribe of the Blackfeet Indian Arizona, Navajo Nation, Arizona, New
mail of proposed participants, and an Reservation of Montana. Mexico & Utah.
indication of the approximate time Azure, Donna Rae, Turtle Mountain Begaye, Amelia June, University of New
jlentini on PROD1PC65 with NOTICES

requested to make their presentation. Community College, Turtle Mountain Mexico, Navajo Nation, Arizona, New
The agenda for the public meeting Band of Chippewa Indians of North Mexico & Utah.
will be made available via the Internet Dakota. Begaye, Julianna, University of New
at http://www.fda.gov/cder/meeting/ Azure, Krysten Ross, University of Mexico, Navajo Nation, Arizona, New
ICH_20060508.htm. North Dakota, Sisseton-Wahpeton Mexico & Utah.

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