Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices 17499 

Data suggest that parent-adolescent 

communication about sex is an 

important determinant of adolescent 

sexual risk behavior. 

The purpose of the proposed study is 

to identify effective strategies African 

American and Latino parents use to 

communicate with their children about 

sex. Families will be enrolled at a local 

community Boys and Girls Club that has 

ongoing activities for youth and their 

parents. In phase 1 (sample=48), African 

American and Hispanic mothers will 

complete a 90 minute focus group. In 

phase 2 (sample=800), mothers and 

their children (ages 12–15) will 

complete a 100 minute selfadministered survey on a lap-top 

computer using Audio-computer 

Assisted Interviewing (ACASI). 

Findings will be used to provide 

recommendations for behavioral 

interventions and educational materials 

for parent-adolescent sexual health 

communications for minority families. 

The survey will take approximately 100 

minutes to complete. The total response 

burden for the two-year period is 

estimated to be 1406 hours (703 

annualized burden hours). There is no 

cost to respondents except for their 

time. 

ESTIMATE OF ANNUALIZED BURDEN TABLE

Types of data collection Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Focus Group .................................................................................................... 48 1 2 96 

ACASI (Computer) Survey—Mothers .............................................................. 400 1 2 800 

ACASI (Computer) Survey—Children .............................................................. 400 1 2 800 

Total burden hours ................................................................................... ........................ ........................ ........................ 1696 

Dated: April 8, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–8540 Filed 4–14–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Strategic Plan of the Chronic Fatigue 

Syndrome Research Program 

The Centers for Disease Control and 

Prevention (CDC) of the U.S. 

Department of Health and Human 

Services (HHS) announces an open 

meeting concerning chronic fatigue 

syndrome. 

Name: Strategic Plan of CDC’s 

Chronic Fatigue Syndrome (CFS) 

Research Program. 

Times and Date: 1 p.m.–5 p.m., April 

27, 2009. 

Place: Centers for Disease Control and 

Prevention, Global Communications 

Center, Building 19, Auditorium B2, 

1600 Clifton Road NE., Atlanta, Georgia 

30333. 

Status: Open to the public, limited 

only by the space available. 

Purpose: The purpose of the public 

meeting is to solicit input from 

interested parties on issues that CDC 

will consider as it develops a five-year 

strategic plan for its chronic fatigue 

syndrome research program. Input is 

sought only on the CFS strategic 

research plan, not on CDC’s overall CFS 

program. As CDC is one of many 

institutions conducting research on 

chronic fatigue syndrome, the strategic 

plan will only address research that is 

within CDC’s purview. 

Topics Include: The objective of the 

five-year strategic plan is to conduct 

public health research leading to the 

control and prevention of medically 

unexplained chronically fatiguing 

illnesses, in particular CFS. The agenda 

will focus on the goals and objectives of 

CDC’s chronic fatigue syndrome 

research program in five major 

categories: 

1. Studies of Defined populations. 

2. Provider-based Patient Registries. 

3. In-hospital Clinical Studies. 

4. Laboratory Studies. 

5. Provider and Public Educational 

Intervention Research. 

The agenda does not include 

development of consensus positions, 

guidelines, or discussions or 

endorsements of specific commercial 

products. Agenda items are subject to 

change as priorities dictate. Members of 

the public wishing to make an oral 

statement during the meeting should 

limit their remarks to 5 minutes and 

should address the research agenda. 

Written comments and suggestions from 

the public on the research agenda are 

encouraged and may be submitted to the 

e-mail address listed below by April 22, 

2009. While CDC will carefully consider 

the individual comments and opinions 

it receives, it will retain discretion in its 

decision-making process. A draft 

strategic plan will also be presented to 

the Chronic Fatigue Syndrome Advisory 

Committee meeting held May 27–28, 

2009. 

Background: CDC recently solicited 

and considered recommendations from 

an external review panel that evaluated 

the research and professional education 

components of the CFS research 

program. The panel’s report 

summarizing the findings of the peer 

review has been published on the CDC 

CFS Web site at www.cdc.gov/cfs/pdf/ 

cdc_cfs_research_programexternal_review.pdf. In brief, the panel 

noted that: (1) The CDC team currently 

leads the world in both the breadth and 

depth of their research into CFS; (2) the 

efforts of CDC have highlighted the 

public health importance of CFS; (3) all 

current research projects address 

important issues; (4) CDC is uniquely 

positioned to conduct a broadly based 

research program derived from the 

population, a large-scale educational 

outreach program, particularly to 

healthcare professionals, and to provide 

expert Web-based resources for patients, 

their families and non-healthcare 

professionals; and (5) CDC is the bestplaced institution to lead the 

establishment of research and 

educational networks, both nationally 

and internationally. 

The report included several valuable 

recommendations which CDC has begun 

to implement, starting with the 

development of a strategic plan to drive 

the program’s research, prevention, and 

control activities for the next five years. 

This meeting will provide input to that 

strategic plan. 

Persons anticipating attending the 

meeting are requested to send written 

notification by April 22, 2009, including 

name, organization (if applicable), 

address, phone, fax, and e-mail 

addresses to the contact below. 

FOR FURTHER INFORMATION CONTACT: 

CFSResearchPlan@cdc.gov. 


rwilkins on PROD1PC63 with PROPOSALS
17500 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices 

Dated: April 8, 2009. 

Carlton Duncan, 

Deputy Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–8632 Filed 4–14–09; 8:45 am] 

BILLING CODE 3410–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Annual Meeting 

The Vessel Sanitation Program, 

National Center for Environmental 

Health, Centers for Disease Control and 

Prevention (CDC), announces the 

following meeting: 

Name: Vessel Sanitation Program: 

Annual Program Status Update and 

Experience to Date with Program 

Operations. 

Time and Date: 9 a.m. to 4 p.m., June 

12, 2009. 

Location: Auditorium, Port Everglades 

Administration Building, 1850 Eller 

Drive, Fort Lauderdale, Florida 33316. 

Status: The meeting is open to the 

public, but space is limited. The 

meeting room can accommodate 

approximately 100 persons. Annual 

attendees normally include cruise ship 

industry officials, private sanitation 

consultants, and other interested 

parties. 

Meeting Objectives 

CDC staff will update attendees on the 

current status of program topics, 

including but not limited to the 

following: 

• 2008 Program Review. 

• Proposed revisions to the Vessel 

Sanitation Program Operations Manual 

2005. 

• Proposed revisions to the Vessel 

Sanitation Program Construction 

Guidelines 2005. 

• Updates on cruise ship outbreaks. 

An official record of this meeting will 

remain open for 15 days (through June 

27, 2009) so that additional materials or 

comments may be submitted and made 

part of the record. 

Advanced registration is encouraged. 

You may contact Stephanie Lawrence to 

register in advance or to receive 

additional information about the 

meeting. Ms. Lawrence can be reached 

by phone (770–488–3141), fax (770– 

488–4127), or e-mail 

(slawrence@cdc.gov). Please provide 

your name, title, company name, 

mailing address, telephone number, fax 

number, and e-mail address when 

contacting Ms. Lawrence. 

Dated: April 8, 2009. 

Carlton Duncan, 

Deputy Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–8631 Filed 4–14–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0178] 

Preparation for International 

Conference on Harmonisation 

Meetings in Yokohama, Japan; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH meetings in Yokohama, Japan’’ to 

provide information and receive 

comments on the International 

Conference on Harmonisation (ICH) as 

well as the upcoming meetings in 

Yokohama, Japan. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Groups meetings in 

Yokohama, Japan, scheduled for June 6 

through 11, 2009, at which discussion of 

the topics underway and the future of 

ICH will continue, as well as provide 

comprehensive updates of the various 

ICH topics. 

Date and Time: The meeting will be 

held on May 6, 2009, from 2:30 p.m. to 

5 p.m. 

Location: The meeting will be held in 

the Washington Room at the Hilton 

Washington DC/Rockville Hotel & 

Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

For security reasons, all attendees are 

asked to arrive no later than 2:15 p.m. 

Contact Person: All participants must 

register with Tammie Jo Bell, Office of 

the Commissioner (HFG–1), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, e-mail: 

Tammie.Bell2@fda.hhs.gov, or FAX: 

301–827–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material and requests 

to make oral presentation, to the contact 

person by April 29, 2009. 

If you need special accommodations 

due to a disability, please contact 

Tammie Jo Bell (see Contact Person) at 

least 7 days in advance. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://www.fda.gov/ 

ohrms/dockets/ac/acmenu.htm. It may 

be viewed at the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The ICH 

was established in 1990 as a joint 

regulatory/industry project to improve, 

through harmonization, the efficiency of 

the process for developing and 

registering new medicinal products in 

Europe, Japan and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

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 medical product 

development among regulatory 

agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization 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 

Association; the Japanese Ministry of 

Health, Labor and Welfare; the Japanese 

Pharmaceutical Manufactures 

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 


rwilkins on PROD1PC63 with PROPOSALS