Educational Workshops on Current Good Manufacturing Practices; Public Workshops, 51825-51826 [05-17248]

Download as PDF 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] BILLING CODE 4163–18–P VerDate Aug<18>2005 16:33 Aug 30, 2005 Jkt 205001 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 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 51825 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] BILLING CODE 4163–18–P 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, E:\FR\FM\31AUN1.SGM 31AUN1 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: http://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? BILLING CODE 4160–01–S TABLE 1.—WORKSHOP LOCATION AND SCHEDULES VerDate Aug<18>2005 II. Background Information Jkt 205001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 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 E:\FR\FM\31AUN1.SGM 31AUN1

Agencies

[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]


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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,

[[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 http://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