Announcement of the CDC-Wide Research Agenda Development Public Participation Meetings
The Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (CDC) is developing a CDC-Wide Research Agenda, and invites the public to provide input. Four Research Agenda Development Public Participation Meetings will be held across the country (March 8, 2005, Arlington, VA; March 18, 2005, Atlanta, GA; March 24, 2005, Seattle, WA; and March 31, 2005, Columbus, OH). Background: On January 10, 2005, the Centers for Disease Control and Prevention launched an effort to develop its first ever, agency- wide public health research agenda. The new agenda will address and support CDC's health protection goals (http://www.cdc.gov/futures/ Goals01-6-05.pdf). The agenda will also provide overall guidance for CDC's intramural and extramural research as well as serve as an effective planning and communication tool for CDC's public health research. Request for Comments: The public is invited to participate in the development of the CDC-Wide Research Agenda. The CDC will host four Research Agenda Development Public Participation Meetings. These events will give researchers, representatives of CDC key partner organizations and the public the opportunity to voice their opinions regarding the future direction of CDC's public health research. The four meetings will be held: March 8, 2005, 8:30 a.m.-5 p.m., Hilton Crystal City Hotel at Ronald Reagan National Airport, 2399 Jefferson Davis Highway, Arlington, VA 22202; telephone 703-418-6800. Registration begins February 25, 2005. March 18, 2005, 8:30 a.m.-5 p.m., National Center for Primary Care at Morehouse School of Medicine, 720 Westview Dr., SW., Atlanta, GA 30310; telephone 404-756-5740. Registration begins March 4, 2005. March 24, 2005, 8:30 a.m.-5 p.m., Crowne Plaza Seattle, 1113 Sixth Avenue, Seattle, WA 98101; telephone 206-464-1980. Registration begins March 11, 2005. March 31, 2005, 8:30 a.m.-5 p.m., Hyatt Regency, 350 North High Street, Columbus, OH, 43215; telephone 614-463-1234. Registration begins March 18, 2005. Attendance by the public will be limited to the space available. Please communicate with the individuals listed below to request special accommodations for persons with disabilities. All those wishing to attend any of the meetings must register. See specific meeting above for date of registration. To register, please visit http://www.maximumtechnology.com/cdcreg.htm. Additional information will be available as of February 21st via the Office of Public Health Research Web site, http://www.cdc.gov/od/ophr/, or may be obtained by communicating with the contact whose name and telephone number is listed below. Contacts: Ms. Mollie Ergle, Meeting Coordinator, Office of Public Health Research, Centers for Disease Control and Prevention, Mail Stop E-72 1600 Clifton Rd. NE., Atlanta, GA 30333, E-mail: firstname.lastname@example.org. Phone: 404-498-0132; Fax: 404-498-0011. 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 ATSDR.
Submission for OMB Review; Comment Request; Hazardous Waste Worker Training
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 8, 2004, pages 71061-71062, 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: Hazardous Waste Worker Training42 CFR Part 65. Type of Information Collection Request: Revision of OMB No. 0925-0348, expiration date February 28, 2005. Need and Use of Information Collection: This request for OMB review and approval of the information collection is required by regulation 42 CFR part 65(a)(6). The National Institute of Environmental Health Sciences (NIEHS) has been given major responsibility for initiating a worker safety and health training program under Section 126 of the Superfund Amendments and Reauthorization Act of 1986 (SARA) for hazardous waste workers and emergency responders. A network of non-profit organizations that are committed to protecting working and their communities by delivering high-quality, peer-reviewed safety and health curricula to target populations of hazardous waste workers and emergency responders has been developed. In seventeen years (FY 1987-2004), the NIEHS Worker Training program has successfully supported 20 primary grantees that have trained more than 1.3 million workers across the country and presented over 69,000 classroom and hands-on training courses, which have accounted for nearly 18 million contact hours of actual training. Generally, the grant will initially be for one year, and subsequent continuation awards are also for one year at a time. Grantees must submit a separate application to have the support continued for each subsequent year. Grantees are to provide information in accordance with S65.4 (a), (b), (c) and 65.6 (b) on the nature, duration, and purpose of the training, selection criteria for trainees' qualifications and competency of the project director and staff, cooperative agreements in the case of joint applications, the adequacy of training plans and resources, including budget and curriculum, and response to meeting training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulations (29 CFR 1910.120). As a cooperative agreement, there are additional requirements for the progress report section of the application. Grantees are to provide their information in hard copy as well as enter information into the WETP Grantee Data Management System. The information collected is used by the Director through officers, employees, experts, and consultants to evaluate applications based on technical merit to determine whether to make awards. Frequency of Response: Biannual. Affected Public: Non-profit organizations. Type of Respondents: Grantees. The annual reporting burden is as follows: Estimated Number of Respondents: 18; Estimated Number of Responses per Respondent: 2; Average Burden Hours Per Response: 10; and Estimated Total Annual Burden Hours Requested: 360. The annualized cost to respondents is estimated at: $10,764. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Joseph T. Hughes, Jr., Director, Worker Education and Training Program, Division of Extramural Research and Training, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541-0217 or E-mail your request, including your address to email@example.com. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Draft Guidance on the Open Public Hearing; Food and Drug Administration Advisory Committee Meetings; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``The Open Public Hearing; FDA Advisory Committee Meetings.'' This draft guidance is for members of the public who choose to participate in the open public hearing (OPH) session of an FDA advisory committee meeting. The draft guidance is intended to answer more fully questions about how the public may participate at an OPH session, and it includes topics such as meeting logistics and administrative requirements.
Draft Guidance for Industry on Internal Radioactive Contamination-Development of Decorporation Agents; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Internal Radioactive ContaminationDevelopment of Decorporation Agents.'' This draft document provides guidance to industry on the development of decorporation agents for the treatment of internal radioactive contamination when evidence is needed to demonstrate the effectiveness of the agents, but human efficacy studies are unethical or infeasible. In such instances, the Animal Efficacy Rule may be invoked to approve new medical products not previously marketed or new indications for previously marketed products. Specifically, this draft guidance addresses chemistry, manufacturing and controls (CMC) information; animal efficacy, safety pharmacology, and toxicology studies; clinical pharmacology, biopharmaceutics, and human safety studies; and postapproval commitments.