Educational Workshops on Current Good Manufacturing Practices; Public Workshops, 51825-51826 [05-17248]
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Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices
(Pub. L. 92–463), the Centers for Disease
Control and Prevention, NCEH/ATSDR
announces the following subcommittee
meeting:
Name: Community and Tribal
Subcommittee (CTS).
Time and Date: 3 p.m.–4:30 p.m.,
September 8, 2005.
Place: The teleconference will originate at
the National Center for Environmental
Health/Agency for Toxic Substances and
Disease Registry in Atlanta, Georgia. Please
see Supplementary Information for details on
accessing the teleconference.
Status: Open to the public, teleconference
access limited only by availability of
telephone ports.
Purpose: Under the charge of the Board of
Scientific Counselors, NCEH/ATSDR the
Community and Tribal Subcommittee will
provide the BSC, NCEH/ATSDR with a forum
for community and tribal first-hand
perspectives on the interactions and impacts
of the NCEH/ATSDR’s national and regional
policies, practices and programs.
Matters To Be Discussed: The
teleconference agenda will include an update
on the Report on the Program Peer Review
Subcommittee, a discussion on the NCEH/
ATSDR portfolio of programs; and an open
discussion for other important issues.
Items are subject to change as priorities
dictate.
Supplementary Information: This
conference call is scheduled to begin at 3
p.m. eastern standard time. To participate in
the teleconference, please dial (877) 315–
6535 and enter conference code 383520.
For Further Information Contact: Sandra
Malcom, Committee Management Specialist,
Office of Science, NCEH/ATSDR, M/S E–28,
1600 Clifton Road, NE., Atlanta, Georgia
30333, telephone (404) 498–0003.
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 National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
Dated: August 25, 2005.
B. Kathy Skipper,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 05–17295 Filed 8–30–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Agency for Toxic Substances and
Disease Registry (ATSDR) Public
Meeting of the Citizens Advisory
Committee on Public Health Service
(PHS) Activities and Research at
Department of Energy (DOE) Sites:
Oak Ridge Reservation Health Effects
Subcommittee
Name: Public meeting of the Citizens
Advisory Committee on PHS Activities and
Research at DOE Sites: Oak Ridge
Reservation Health Effects Subcommittee
(ORRHES).
Time and Date: 12 p.m.—8 p.m.,
September 22, 2005.
Place: Oak Ridge Mall, Alpine Room, 333
East Main Street, Oak Ridge, Tennessee
37830.
Status: Open to the public, limited only by
the space available. The meeting room
accommodates approximately 50 people.
Background: A Memorandum of
Understanding (MOU) was signed in October
1990 and renewed in September 2000
between ATSDR and DOE. The MOU
delineates the responsibilities and
procedures for ATSDR’s public health
activities at DOE sites required under
sections 104, 105, 107, and 120 of the
Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA or
‘‘Superfund’’). These activities include health
consultations and public health assessments
at DOE sites listed on, or proposed for, the
Superfund National Priorities List and at
sites that are the subject of petitions from the
public; and other health-related activities
such as epidemiologic studies, health
surveillance, exposure and disease registries,
health education, substance-specific applied
research, emergency response, and
preparation of toxicological profiles. In
addition, under an MOU signed in December
1990 with DOE and replaced by an MOU
signed in 2000, the Department of Health and
Human Services (DHHS) has been given the
responsibility and resources for conducting
analytic epidemiologic investigations of
residents of communities in the vicinity of
DOE facilities, workers at DOE facilities, and
other persons potentially exposed to
radiation or to potential hazards from nonnuclear energy production and use. DHHS
has delegated program responsibility to CDC.
Community involvement is a critical part of
ATSDR’s and CDC’s energy-related research
and activities, and input from members of the
ORRHES is part of these efforts.
Purpose: The purpose of this meeting is to
address issues that are unique to community
involvement with the ORRHES, and agency
updates.
Matters To Be Discussed: Agenda items
will include a brief discussion on the Beir VII
report; a presentation on the draft public
health assessment: Current and Future
Chemical Exposure Evaluation (1990–2003);
an update on ATSDR’s project management
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plan and the schedule of public health
assessments to be released in FY2005–2006;
updates and recommendations from the
Exposure Evaluation, Community Concerns
and Communications, and the Health
Outcome Data Workgroups; and agency
updates.
Agenda items are subject to change as
priorities dictate.
For Further Information Contact: Marilyn
Horton, Designated Federal Official and
Health Communication Specialist, Division
of Health Assessment and Consultation,
ATSDR, 1600 Clifton Road, NE., M/S E–32,
Atlanta, Georgia 30333, telephone 1–888–42–
ATSDR (28737), fax (404) 498–1744.
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 ATDSR.
Dated: August 25, 2005.
B. Kathy Skipper,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 05–17296 Filed 8–30–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Educational Workshops on Current
Good Manufacturing Practices; Public
Workshops
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshops.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
series of educational workshops on
current good manufacturing practice
(CGMP). The workshops, which will be
held in collaboration with Peking
University (Beijing, China) and the
International Society for Pharmaceutical
Engineering (ISPE), are intended to
educate participants on current methods
for compliance with good
manufacturing practices (GMP). The
workshops are being offered to help
ensure effective CGMP programs and to
further the common goals of FDA and
providers of quality pharmaceutical
products.
DATES: See table 1 in the SUPPLEMENTARY
INFORMATION section of this document.
ADDRESSES: See table 1 in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT: Erik
N. Henrikson, Center for Drug
Evaluation and Research (HFD–320),
Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852,
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51826
Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices
301–827–9035, FAX: 301–827–8907,
henriksone@cder.fda.gov or Qiang
Zheng, Peking University, Beijing,
China, 86–10–6275–6489, FAX: 86–10–
6275–1207, zhengqiang@pku.edu.cn.
SUPPLEMENTARY INFORMATION:
https://www.fda.gov/cder/meeting/
CTP2005.htm.
I. General Information
FDA is cosponsoring these 3-day
workshops to provide information and
training opportunities for industry as
well as CGMP compliance officials.
A. Who Should Attend?
This announcement is directed
towards professionals involved in the
manufacture, control, and regulation of
pharmaceutical products who will
benefit from these workshops, including
process/production engineers,
manufacturing personnel, quality
assurance/quality control and regulatory
affairs professionals, consultants,
regulatory investigators and CGMP
compliance officials. Other entities or
individuals may also be interested in
attending.
B. Where and When Will These
Workshops Be Held?
The location and times for the two
workshops are listed in table 1 of this
document.
B. What Will Be Covered?
The workshops will provide
information on specific topics designed
to educate and guide participants on
methodologies and implementation of
CGMP as applied to quality drug
manufacturing. Presentations by both
FDA and industry will provide a
regulatory and practical perspective on
the current relevant critical topics.
Dated: August 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17248 Filed 8–30–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Workshop Address
Dates and Local
Times
Ying Jie Convention
Center, Peking University, Beijing,
China
Ying Jie Convention
Center, Peking University, Beijing,
China
December 5 through
7, 2005, from 9
a.m. to 5 p.m. each
day.
April 24 through 26,
2006, from 9 a.m.
to 5 p.m. each day.
Request for Public Comment: 60-Day
Proposed Information Collection:
Indian Health Service (IHS)
Background Investigations of
Individuals in Position Involving
Regular Contact With or Control Over
Indian Children OPM–306.
Indian Health Service, HHS.
The Department of Health and
Human Services, as part of its
continuing efforts to reduce paperwork
and respondent burden, conducts a preclearance consultation program to
provide the general public and Federal
agencies with an opportunity to
comment on proposed and/or
continuing collections of information in
accordance with the Paperwork
Reduction Act of 1995 (PRA95) (44
U.S.C. 3506(c)(2)(A)). This program
helps to ensure that requested data can
be provided in the desired format,
reporting burden (time and financial
resources) is minimized, collection
instruments are clearly understood, and
the impact of collection requirements on
respondents can be properly assessed.
Currently, the IHS is providing a 60-day
advance opportunity for public
comment on a proposed extension of
current information collection activity
to be submitted to the office of
Management and Budget for review.
AGENCY:
C. How Can I Participate?
You can participate in person.
Anyone interested in the GMP
workshops can register through the
contact person in the FOR FURTHER
INFORMATION CONTACT section of this
document.
SUMMARY:
D. Is There a Registration Fee for These
Workshops?
Yes, a registration fee of $440 is
required for this workshop. This
registration fee includes workshop
reference materials and meals.
Government employees qualify for a
discounted rate of $120.
E. How Can I Get Additional
Information?
The notice of participation form,
information about the workshops, and
other related documents are available
from the contact person in the FOR
FURTHER INFORMATION CONTACT section of
this document or from the Internet at
16:33 Aug 30, 2005
A. Why Is FDA Cosponsoring These
Workshops?
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TABLE 1.—WORKSHOP LOCATION AND
SCHEDULES
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II. Background Information
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Proposed Collection
Title: 0917–0028, ‘‘IHS Background
Investigations of Individuals in
Positions Involving Regular Contact
With or Control Over Indian Children’’
OPM–306.
Type of Information Collection
Request: Extension, without revision, of
currently approved information
collection, 0917–0028. ‘‘IHS
Background Investigations of
Individuals in Position Involving
Regular Contact With or Control Over
Indian Children’’ OPM–306.
Form Number: OF–306.
Forms: Declaration for Federal
Employment.
Need and Use of Information
Collection: This is a request for approval
of collection information required by
section 408 of the Indian Child
Protection and Family Violence
Prevention Act, Public Law 101–630,
104 Stat. 4544, 25 U.S.C. 3201–3211.
The IHS is required to compile a list of
all authorized positions within the IHS
where the duties and responsibilities
involve regular contact with, or control
over, Indian children; and to conduct an
investigation of the character of each
individual who is employed, or is being
considered for employment in a
position having regular contact with, or
control over, Indian children. Section
3207(b) of the Indian Child Protection
and Family Violence Prevention Act
was amended by section 814 of S. 3031,
the Native American Laws Technical
Corrections Act of 2000, which requires
that the regulations prescribing the
minimum standards of character ensure
that none of the individuals appointed
to positions involving regular contact
with, or control over Indian children
have been found guilty of, or entered a
plea of nolo contendere or guilty to any
felonious offense, or any of two or more
misdemeanor offenses under Federal,
State, or tribal law involving crimes of
violence; sexual assault, molestation,
exploitation, contact or prostitution;
crimes against persons; or offenses
committed against children. In addition,
42 U.S.C. 13041 requires each agency of
the Federal Government, and every
facility operated by the Federal
Government (or operated under contract
with the Federal Government), that
hires (or contracts for hire) individuals
involved with children under the age of
18 or child care services to assure that
all existing and newly-hired employees
undergo a criminal history background
check. The background is to be initiated
through the personnel program of the
applicable Federal agency. This section
requires employment applications for
individuals who are seeking work for an
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[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Notices]
[Pages 51825-51826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17248]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Educational Workshops on Current Good Manufacturing Practices;
Public Workshops
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshops.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a series
of educational workshops on current good manufacturing practice (CGMP).
The workshops, which will be held in collaboration with Peking
University (Beijing, China) and the International Society for
Pharmaceutical Engineering (ISPE), are intended to educate participants
on current methods for compliance with good manufacturing practices
(GMP). The workshops are being offered to help ensure effective CGMP
programs and to further the common goals of FDA and providers of
quality pharmaceutical products.
DATES: See table 1 in the SUPPLEMENTARY INFORMATION section of this
document.
ADDRESSES: See table 1 in the SUPPLEMENTARY INFORMATION section of this
document.
FOR FURTHER INFORMATION CONTACT: Erik N. Henrikson, Center for Drug
Evaluation and Research (HFD-320), Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852,
[[Page 51826]]
301-827-9035, FAX: 301-827-8907, henriksone@cder.fda.gov or Qiang
Zheng, Peking University, Beijing, China, 86-10-6275-6489, FAX: 86-10-
6275-1207, zhengqiang@pku.edu.cn.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Who Should Attend?
This announcement is directed towards professionals involved in the
manufacture, control, and regulation of pharmaceutical products who
will benefit from these workshops, including process/production
engineers, manufacturing personnel, quality assurance/quality control
and regulatory affairs professionals, consultants, regulatory
investigators and CGMP compliance officials. Other entities or
individuals may also be interested in attending.
B. Where and When Will These Workshops Be Held?
The location and times for the two workshops are listed in table 1
of this document.
Table 1.--Workshop Location and Schedules
------------------------------------------------------------------------
Workshop Address Dates and Local Times
------------------------------------------------------------------------
Ying Jie Convention Center, Peking December 5 through 7, 2005, from 9
University, Beijing, China a.m. to 5 p.m. each day.
Ying Jie Convention Center, Peking April 24 through 26, 2006, from 9
University, Beijing, China a.m. to 5 p.m. each day.
------------------------------------------------------------------------
C. How Can I Participate?
You can participate in person. Anyone interested in the GMP
workshops can register through the contact person in the FOR FURTHER
INFORMATION CONTACT section of this document.
D. Is There a Registration Fee for These Workshops?
Yes, a registration fee of $440 is required for this workshop. This
registration fee includes workshop reference materials and meals.
Government employees qualify for a discounted rate of $120.
E. How Can I Get Additional Information?
The notice of participation form, information about the workshops,
and other related documents are available from the contact person in
the FOR FURTHER INFORMATION CONTACT section of this document or from
the Internet at https://www.fda.gov/cder/meeting/CTP2005.htm.
II. Background Information
A. Why Is FDA Cosponsoring These Workshops?
FDA is cosponsoring these 3-day workshops to provide information
and training opportunities for industry as well as CGMP compliance
officials.
B. What Will Be Covered?
The workshops will provide information on specific topics designed
to educate and guide participants on methodologies and implementation
of CGMP as applied to quality drug manufacturing. Presentations by both
FDA and industry will provide a regulatory and practical perspective on
the current relevant critical topics.
Dated: August 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17248 Filed 8-30-05; 8:45 am]
BILLING CODE 4160-01-S
