National Advisory Committee on Rural Health and Human Services; Notice of Meeting, 45468-45469 [E8-17850]
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45468
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices
King, Sr., Center for Drug
Evaluation and Research (HFD–
003), Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 4150,
Silver Spring, MD 20993–0002,301–
796–1242; or
Christopher Joneckis, Center for
Biologics Evaluation and Research
(HFM–1),Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852–1448,
301–827–0373.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
dwashington3 on PRODPC61 with NOTICES
I. Background
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 drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products 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, Labour,
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 (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
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observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
In June 2008, the ICH Steering
Committee agreed that a draft guidance
entitled ‘‘Q4B Evaluation and
Recommendation of Pharmacopoeial
Texts for Use in the ICH Regions; Annex
4C: Microbiological Examination of
Non-Sterile Products: Acceptance
Criteria for Pharmaceutical Preparations
and Substances for Pharmaceutical Use
General Chapter’’ should be made
available for public comment. The draft
guidance is the product of the Q4B
Expert Working Group of the ICH.
Comments about this draft will be
considered by FDA and the Q4B Expert
Working Group.
The draft guidance provides the
specific evaluation results from the ICH
Q4B process for the Microbiological
Examination of Non-Sterile Products:
Acceptance Criteria for Pharmaceutical
Preparations and Substances for
Pharmaceutical Use General Chapter
harmonization proposal originating
from the three-party PDG. This draft
guidance is in the form of an annex to
the core ICH Q4B guidance. Once
finalized, the annex will provide
guidance to assist industry and
regulators in the implementation of the
specific topic evaluated by the ICH Q4B
process.
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 this topic. 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. 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 docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
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management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/cder/guidance/index.htm,
or https://www.fda.gov/cber/
guidelines.htm.
Dated: July 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17865 Filed 8–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
that the following committee will
convene its fifty-ninth meeting.
Name: National Advisory Committee on
Rural Health and Human Services.
Dates and Times: September 24, 2008, 9
a.m.–4:30 p.m.; September 25, 2008, 8:45
a.m.–5:30 p.m.; September 26, 2008, 8:15
a.m.–10 a.m.
Place: Madden’s on Gull Lake, 11266 Pine
Beach Peninsula, Brainerd, MN 56401,
Phone: 800–642–5363.
Status: The meeting will be open to the
public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides advice and
recommendations to the Secretary with
respect to the delivery, research,
development and administration of health
and human services in rural areas.
Agenda: Wednesday morning, at 9 a.m.,
the meeting will be called to order by the
Chairperson of the Committee, the Honorable
David Beasley. The first presentation will be
an overview of rural Minnesota. The
Committee will hear presentations on the
three chosen Subcommittee topics. The first
panel will focus on Workforce and
Community Development. Jay Fonkert, with
the Minnesota Office of Rural Health and
Primary Care, and Valerie DeFor, Director of
the Healthcare Education Industry
Partnership, are confirmed speakers. The
second panel of speakers will lead a
discussion on Serving At-Risk Children with
a representative from the Minnesota Early
Childhood Comprehensive System. The final
panel for the day is on the Medical Home
Model, with Scott Leitz, Assistant
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Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices
Commissioner of the Minnesota Department
of Health, as a confirmed speaker. After the
panel discussions, the Committee Chair will
give an overview of the site visits. The
Wednesday meeting will close at 4:30 p.m.
Tuesday morning, at 8:45 a.m., the
Committee will break into Subcommittees
and depart to the site visits. The Workforce
and Community Development Subcommittee
will learn about the Bridges to Excellence
Program and a cross-training program for
paramedics in Crosby, Minnesota. The
Serving At-Risk Children Subcommittee will
learn about child welfare, family support and
prevention initiatives in rural Minnesota.
The Medical Home Subcommittee will visit
a medical home model at Lakewood Health
System in Staples, Minnesota. Transportation
to the site visits will not be provided to the
public. At 4 p.m. the Subcommittees will
arrive back at Madden’s on Gull Lake for
Subcommittee meetings. The Committee as a
whole will reconvene at 4:45 p.m. There will
be a review of the site visits and action items
will be developed for the Committee
members and staff. The meeting will be
adjourned at 5:30 p.m.
The final session will be convened on
Friday morning, at 8:15 a.m. Those available
from the Committee will meet to discuss
topic ideas for the next report. The Friday
meeting will adjourn at 10 a.m.
For Further Information Contact: Anyone
requiring information regarding the
Committee should contact Jennifer Chang,
MPH, Executive Secretary, National Advisory
Committee on Rural Health and Human
Services, Health Resources and Services
Administration, Parklawn Building, Room
9A–55, 5600 Fishers Lane, Rockville, MD
20857, Telephone (301) 443–0835, Fax (301)
443–2803.
Persons interested in attending any portion
of the meeting should contact Michele PrayGibson, Office of Rural Health Policy
(ORHP), Telephone: (301) 443–0835. The
Committee meeting agenda will be posted on
ORHP(s Web site: https://
www.ruralhealth.hrsa.gov.
Dated: July 29, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–17850 Filed 8–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
dwashington3 on PRODPC61 with NOTICES
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Advisory Environmental
Health Sciences Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
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Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Environmental Health Sciences Council.
Date: September 9–10, 2008.
Open: September 9, 2008, 8:30 a.m. to 1
p.m.
Agenda: Discussion of program policies
and issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709.
Closed: September 9, 2008, 1 p.m. to 5 p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709.
Closed: September 10, 2008, 8:30 a.m. to 12
p.m.
Agenda: To review and evaluate
programmatic and personnel issues.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T.W. Alexander Drive, Research Triangle
Park, NC 27709.
Contact Person: Dennis R. Lang, PhD.,
Acting Director, Division of Extramural
Research and Training, Nat. Inst. of
Environmental Health Sciences, National
Institutes of Health, P.O. Box 12233/EC–
3431, 79 Alexander Drive, Research Triangle
Park, NC 27709, (919) 541–7729,
lang4@niehs.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.niehs.nih.gov/dert/c-agenda.htm, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
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45469
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: July 28, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–17728 Filed 8–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel:
MIDARP.
Date: August 19, 2008.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852.
(Telephone Conference Call).
Contact Person: Nadine Rogers, PhD.,
Scientific Review Administrator, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Boulevard, Bethesda,
MD 20892–8401, 301–402–2105,
rogersn2@nida.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health HHS)
Dated: July 29, 2008.
Jennifer Spaeth
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–17819 Filed 8–4–08; 8:45 am]
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[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45468-45469]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17850]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Committee on Rural Health and Human Services;
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given that the
following committee will convene its fifty-ninth meeting.
Name: National Advisory Committee on Rural Health and Human
Services.
Dates and Times: September 24, 2008, 9 a.m.-4:30 p.m.; September
25, 2008, 8:45 a.m.-5:30 p.m.; September 26, 2008, 8:15 a.m.-10 a.m.
Place: Madden's on Gull Lake, 11266 Pine Beach Peninsula,
Brainerd, MN 56401, Phone: 800-642-5363.
Status: The meeting will be open to the public.
Purpose: The National Advisory Committee on Rural Health and
Human Services provides advice and recommendations to the Secretary
with respect to the delivery, research, development and
administration of health and human services in rural areas.
Agenda: Wednesday morning, at 9 a.m., the meeting will be called
to order by the Chairperson of the Committee, the Honorable David
Beasley. The first presentation will be an overview of rural
Minnesota. The Committee will hear presentations on the three chosen
Subcommittee topics. The first panel will focus on Workforce and
Community Development. Jay Fonkert, with the Minnesota Office of
Rural Health and Primary Care, and Valerie DeFor, Director of the
Healthcare Education Industry Partnership, are confirmed speakers.
The second panel of speakers will lead a discussion on Serving At-
Risk Children with a representative from the Minnesota Early
Childhood Comprehensive System. The final panel for the day is on
the Medical Home Model, with Scott Leitz, Assistant
[[Page 45469]]
Commissioner of the Minnesota Department of Health, as a confirmed
speaker. After the panel discussions, the Committee Chair will give
an overview of the site visits. The Wednesday meeting will close at
4:30 p.m.
Tuesday morning, at 8:45 a.m., the Committee will break into
Subcommittees and depart to the site visits. The Workforce and
Community Development Subcommittee will learn about the Bridges to
Excellence Program and a cross-training program for paramedics in
Crosby, Minnesota. The Serving At-Risk Children Subcommittee will
learn about child welfare, family support and prevention initiatives
in rural Minnesota. The Medical Home Subcommittee will visit a
medical home model at Lakewood Health System in Staples, Minnesota.
Transportation to the site visits will not be provided to the
public. At 4 p.m. the Subcommittees will arrive back at Madden's on
Gull Lake for Subcommittee meetings. The Committee as a whole will
reconvene at 4:45 p.m. There will be a review of the site visits and
action items will be developed for the Committee members and staff.
The meeting will be adjourned at 5:30 p.m.
The final session will be convened on Friday morning, at 8:15
a.m. Those available from the Committee will meet to discuss topic
ideas for the next report. The Friday meeting will adjourn at 10
a.m.
For Further Information Contact: Anyone requiring information
regarding the Committee should contact Jennifer Chang, MPH,
Executive Secretary, National Advisory Committee on Rural Health and
Human Services, Health Resources and Services Administration,
Parklawn Building, Room 9A-55, 5600 Fishers Lane, Rockville, MD
20857, Telephone (301) 443-0835, Fax (301) 443-2803.
Persons interested in attending any portion of the meeting
should contact Michele Pray-Gibson, Office of Rural Health Policy
(ORHP), Telephone: (301) 443-0835. The Committee meeting agenda will
be posted on ORHP(s Web site: https://www.ruralhealth.hrsa.gov.
Dated: July 29, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E8-17850 Filed 8-4-08; 8:45 am]
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