Strategic Plan of the Chronic Fatigue Syndrome Research Program, 17499-17500 [E9-8632]

Download as PDF 17499 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices 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 Number of respondents Types of data collection Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Focus Group .................................................................................................... ACASI (Computer) Survey—Mothers .............................................................. ACASI (Computer) Survey—Children .............................................................. 48 400 400 1 1 1 2 2 2 96 800 800 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 rwilkins on PROD1PC63 with PROPOSALS 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 VerDate Nov<24>2008 16:44 Apr 14, 2009 Jkt 217001 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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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. E:\FR\FM\15APN1.SGM 15APN1 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] 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 3410–16–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration [Docket No. FDA–2009–N–0178] 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. rwilkins on PROD1PC63 with PROPOSALS 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. VerDate Nov<24>2008 16:44 Apr 14, 2009 Jkt 217001 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. PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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 https://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 E:\FR\FM\15APN1.SGM 15APN1

Agencies

[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17499-17500]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8632]


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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_program-external_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 best-placed 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.


[[Page 17500]]


    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
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