Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 51825 

(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 

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 

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, 

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: 

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 University, Beijing, 

China 

December 5 through 

7, 2005, from 9 

a.m. to 5 p.m. each 

day. 

Ying Jie Convention 

Center, Peking University, Beijing, 

China 

April 24 through 26, 

2006, from 9 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

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. 

AGENCY: Indian Health Service, HHS. 

SUMMARY: 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. 

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