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 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices 51827 

agency of the Federal Government, or 

for a facility or program operated by (or 

through contract with) the Federal 

Government, in positions involved with 

the provision to children under the age 

of 18 or child care services, to contain 

a question asking whether the 

individual has ever been arrested for or 

charged with a crime involving a child. 

Affected Public: Individuals and 

households. 

Type of Respondents: Individuals. 

The table below provides the 

estimated burden hours for this 

information collection: 

ESTIMATED BURDEN HOURS

42 CFR Part 36 

Estimated 

number of 

respondents 

Responses 

per 

respondent 

Average burden hour per 

response * 

Total annual 

burden hours 

Addendum to OF 306 Declaration for Federal Employment ........................... 2,000 1 0.25 (15 mins) 500 

* For ease of understanding, burden hours are also provided in actual minutes. 

There are no Capital Costs, Operating 

Costs and/or Maintenance Costs to 

report. 

Request For Comments: Your written 

comments and/or suggestions are 

invited on one or more of the following 

points: (a) Whether the information 

collection activity is necessary to carry 

out an agency function; (b) whether the 

agency processes the information 

collected in a useful and timely fashion; 

(c) the accuracy of public burden 

estimate (the estimated amount of time 

needed for individual respondents to 

provide the requested information); (d) 

whether the methodology and 

assumptions used to determine the 

estimate are logical; (e) ways to enhance 

the quality, utility, and clarity of the 

information being collected; and (f) 

ways to minimize the public burden 

through the use of automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Send Comments and Requests For 

Further Information: Send your written 

comments and requests for more 

information on the proposed collection 

or requests to obtain a copy of the data 

collection instrument(s) and 

instructions to: Mrs. Chris Rouleau, IHS 

Reports Clearance Officer, 801 

Thompson Avenue, Rockville, MD 

20852, call non-toll free (301) 443–5938, 

send via facsimile to (301) 443–2316, or 

send your E-mail requests, comments, 

and return address to: 

crouleau@hqe.ihs.gov. 

Comment Due Date: Your comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Dated: August 24, 2005. 

Robert G. McSwain, 

Deputy Director, Indian Health Service. 

[FR Doc. 05–17320 Filed 8–30–05; 8:45 am] 

BILLING CODE 4165–16–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Survey of NIGMS 

Minority Opportunities in Research 

(MORE) Division Institutional Program 

Directors 

Summary: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute of General Medical Sciences 

(NIGMS), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request for review and approval of the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on February 22, 2005, pages 

8594–8595 and allowed 60 days for 

public comment. No public comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. The National 

Institutes of Health may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 

Proposed Collection: Title: Survey of 

NIGMS Minority Opportunities in 

Research (MORE) Division Institutional 

Program Directors. Type of Information 

Collection Request: NEW. Need and Use 

of Information Collection: NIGMS 

provides research and research training 

support in the basic biomedical sciences 

through a variety of programs and grant 

mechanisms. Several of these programs 

are targeted toward support of 

underrepresented minority students at 

various educational levels and research 

faculty at minority-serving institutions. 

Although significant resources are 

dedicated to funding these programs, 

there is a lack of quantitative 

information on program outcomes. This 

proposed one-time survey is part of a 

larger study that will provide NIGMS 

with the high-quality data needed to 

evaluate the educational outcomes and 

research activity of students and faculty 

who are supported by NIGMS training 

and research support programs. Data on 

student enrollment and highest degree 

received will be collected from 

institutional program directors in the 

following programs: Minority Access to 

Research Careers Undergraduate 

Student Training in Academic Research 

(U*STAR), Minority Biomedical 

Research Support Initiative for Minority 

Student Development (IMSD), and 

Minority Biomedical Research Support 

Research Initiative for Scientific 

Enhancement (RISE). Other data will be 

collected from existing sources, 

including grant records and Medline 

databases. Taken together, the data will 

be used as a baseline for future 

assessments, as well to further develop 

current programs and in the creation of 

proposals for new initiatives in minority 

recruitment and training. These results 

will be reported to the National 

Advisory General Medical Sciences 

Council (NAGMSC) and shared with the 

community of NIGMS grantees. 

Frequency of Response: Once. Affected 

Public: Individuals or households; Notfor-profits. Type of Respondents: 

Training grant program directors. 

The annual reporting burden is as 

follows: