Notices. Notice of meeting

2,542 words·~12 min read·/register/2007/04/04/07-1633·

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BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-06BD] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Joan Karr, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* *Comments are invited on:*

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Economic Analysis of the National Breast and Cervical Cancer Early Detection Program—New National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC administers the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) that provides critical breast and cervical cancer screening services to underserved women in the United States, the District of Columbia, 4 U.S. territories, and 13 American Indian/Alaska Native organizations. The program provides breast and cervical cancer screening for eligible women who participate in the program as well as diagnostic procedures for women who have abnormal findings. For the past decade, the NBCCEDP has provided over 5 million breast and cervical cancer screening and diagnostic exams to almost 2.1 million low-income women. Women diagnosed with cancer through the program are eligible for Medicaid coverage through the Breast and Cervical Cancer Prevention and Treatment Act passed by Congress in 2000. The NBCCEDP is the largest organized cancer screening program in the United States but to date there has been no systematic analysis of the economic costs incurred by the program. CDC is proposing to collect one year (period covering 07/01/2005-06/30/2006) of cost data from all the 68 NBCCEDP grantees to assess the cost and cost-effectiveness of the program. The information required to perform an activity-based cost analysis includes: staff and consultant salaries, screening costs, contracts and material costs, provider payments, in-kind contributions, administrative costs, allocation of funds and staff time devoted to specific program activities. CDC has developed and tested a draft questionnaire with 9 NBCCEDP grantees to assess the ability of the grantees to provide the cost data elements requested, identify the cost information required, and to complete the questionnaire within the allocated timeframe. The grantees were able to complete the questionnaire with the instructions provided. The activity-based cost data provided by the 68 grantees will be used to evaluate the programs to ensure the most appropriate use of limited program resources. Performing an assessment of the resources expended on NBCCEDP will provide valuable information to the CDC and it partners for improving program efficiency within the various components of the NBCCEDP including screening, case management, outreach, and overall management. The detailed cost data will allow CDC to assess the costs of the various program components, identify factors that impact average cost, perform cost-effectiveness analysis and develop a resource allocation tool. The collection and analysis of the cost data will allow CDC to utilize a more systematic process to allocate program resources based on grantees' past performance, level of efficiency, and future needs. Since information on screening and diagnosis volumes (the effectiveness measures) are already collected as part of the Minimum Data Elements (MDEs), the additional burden on grantees to provide the requested cost data will be modest. If future cost data collection efforts are undertaken, the response burden would be further reduced because the infrastructure established to capture the data is already in place. There are no costs to respondents except their time to participate in the survey. Estimated Annualized Burden Hours Type of respondent Form name Number of respondents Number responses per respondent Average burden per response (in hours) Total burden hours Program Director Cost Assessment Tool 68 1 4 272 Business Manager 68 1 4 272 Data Manager 68 1 14 952 Total 1,496 Dated: March 28, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-6275 Filed 4-3-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-06AY] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(CDC)developed the National Arthritis Action Plan in 1998 as a comprehensive approach to reducing the burden of arthritis in the United States. As part of its efforts to implement the National Arthritis Action Plan, CDC developed and tested a health communications campaign promoting physical activity among Caucasian and African-American adults with arthritis. In 2003-2004, CDC developed a similar campaign for Spanish-speaking people with arthritis. Hispanic populations have a slightly lower prevalence rate of self-reported, doctor-diagnosed arthritis, but Hispanics with arthritis report greater work limitations, and higher rates of severe pain than do Caucasian populations with arthritis. The Spanish-language campaign, Good Morning Arthritis, Today you will not defeat us, is designed to reach Spanish speaking adults with arthritis who are aged 45-64, who have high school education or less, and whose annual income is less than $35,000. The key message elements of the Spanish language health communications campaign are similar to its English counterpart, as are the campaign objectives and materials. The campaign objectives are to increase target audience members'

(1)Beliefs about physical activity as an arthritis management strategy (there are “things they can do” to make arthritis better, and physical activity is an important part of arthritis management);

(2)Knowledge of the benefits of physical activity and appropriate physical activity for people with arthritis;

(3)Confidence in their ability to be physically active, and

(4)Trial of physical activity behaviors. Based on formative research, campaign materials refer to exercise instead of physical activity. Campaign materials include; print ads, 30- and 60-second radio ads and public service announcements, and desktop displays with brochures for pharmacies, doctors' offices, and community centers. In the Fall of 2005, the Spanish language campaign was pilot tested by 5 state health departments that receive funding from CDC for their arthritis programs. CDC will eventually disseminate these materials to all 36 CDC-funded states. The 5 preliminary pilot tests focused on reach and exposure; a more thorough evaluation is necessary to assess impact of the campaign. This information will be used to guide the public health practice of the 36 state arthritis programs and their partners. CDC will conduct an evaluation of the impact of the Spanish language health communications campaign on the exercise/physical activity-related attitudes, beliefs, and behaviors among the target audience of Spanish-speaking people with arthritis. There are no costs to the respondents other than their time. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Screening Survey 12,000 1 2/60 400 Telephone Survey 2,500 1 15/60 625 Total 1,025 Dated: March 28, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-6276 Filed 4-3-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Technical Support for Birth Defects and Developmental Disabilities Prevention Education Efforts, Contract Solicitation Number

(CSN)2006-N-08835 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting of the aforementioned SEP: *Time and Date:* 12 p.m.-3 p.m., April 30, 2007 (Closed). *Place:* Teleconference, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., Atlanta, GA 30333. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of applications received in response to CSN 2006-N-08835, “Technical Support for Birth Defects and Developmental Disabilities Prevention Education Efforts.” *For Further Information Contact:* Christine Morrison, Ph.D., Scientific Review Administrator, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop D72, Atlanta, GA 30333, Telephone 404.639.3098. 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 Agency for Toxic Substances and Disease Registry. Dated: March 28, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6270 Filed 4-3-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Preparation for International Conference on Harmonisation Meetings in Brussels, Belgium; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. SUMMARY: The Food and Drug Administration

(FDA)is announcing a public meeting entitled “Preparation for ICH Meetings in Brussels, Belgium” to provide information and receive comments on the International Conference on Harmonisation

(ICH)as well as the upcoming meetings in Brussels, Belgium. 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 Brussels, Belgium May 5-10, 2007, at which discussion of the topics underway and the future of ICH will continue. *Date and Time* : The meeting will be held on Friday April 6, 2007, from 3:30 p.m. to 5 p.m. *Location* : The meeting will be held at 5600 Fishers Lane, third floor, Conference Room G, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 3:20 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room G. *Contact Person* : Michelle Limoli, Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0908, e-mail: *michelle.limoli@fda.hhs.gov* , 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 presentations, to the contact person by April 5, 2007. If you need special accommodations due to a disability, please contact Michelle Limoli as soon as possible. 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 Associations; the Japanese Ministry of Health, Labor and Welfare; the Japanese Pharmaceutical Manufacturers 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. The ICH steering committee includes representatives from each of the ICH sponsors and Health Canada, the European Free Trade Area, and the World Health Organization. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the three ICH regions. The current ICH process and structure can be found at the following Web site: *http://www.ich.org* . Interested persons may present data, information, or views orally or in writing, on issues pending at the public meeting. Oral presentations from the public will be scheduled between approximately 4:30 p.m. and 5 p.m. Time allotted for oral presentations may be limited to 10 minutes. Those desiring to make oral presentations should notify the contact person by April 5, 2007, and submit a brief statement of the general nature of the evidence or arguments they which to present, the names and addresses, phone number, fax, and e-mail of proposed participants, and an indication of the approximate time requested to make their presentation. The agenda for the public meeting will be made available via the Internet at *http://www.fda.gov/cder/meeting/ICH_20060508.htm* . *Transcripts* : Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. Dated: March 28, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-1633 Filed 3-29-07; 3:56 pm]

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Pub. L. 92-463

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Pub. L.Pub. L. 92-463

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