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Code · REGISTER · 2006-05-10 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice of public workshop

1,448 words·~7 min read·/register/2006/05/10/06-4366·

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BILLING CODE 4150-04-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-06-0423X] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)371-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project The National Electronic Disease Surveillance System (NEDSS)—New—National Center for Public Health Informatics (NCPHI), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is responsible for the collection and dissemination of nationally notifiable diseases information and for monitoring and reporting the impact of epidemic influenza on mortality, Public Health Services Act (42 U.S.C. 241). Since April 1984, CDC Epidemiology Program Office
(EPO)has been working with the Council of State and Territorial Epidemiologists
(CSTE)to demonstrate the efficiency and effectiveness of computer transmission of surveillance data between CDC and the state health departments. By 1989, all 50 states were using this computerized disease surveillance system, which was then renamed the National Electronic Telecommunications System for Surveillance (NETSS) to reflect its national scope (OMB numbers 0920-0447 and 0920-0007). Beginning in 1999, CDC, Epidemiology Program Office
(EPO)worked with CSTE, state and local public health system staff, and other CDC disease prevention and control program staff to identify information categories and information technology standards to support integrated disease surveillance. That effort is now focused on development and completion of the National Electronic Disease Surveillance System (NEDSS), coordinated by CDC's National Center for Public Health Informatics, Division of Integrated Surveillance Systems and Services (DISSS). States will continue to use portions of NETSS to transmit data to CDC. One of the reasons for providing NETSS to NEDSS data mapping is to identify what data elements in NETSS correspond to data elements in NEDSS. Those elements mapped from NETSS to NEDSS were collected in OMB number 0920-0007. NEDSS will electronically integrate and link together a wide variety of surveillance activities and will facilitate more accurate and timely reporting of disease information to CDC and state and local health departments. Consistent with recommendations supported by our state and local surveillance partners and described in the 1995 report, *Integrating Public Health Information and Surveillance Systems* , NEDSS will include data standards, an internet based communications infrastructure built on industry standards, and policy-level agreements on data access, sharing, burden reduction, and protection of confidentiality. To support NEDSS, CDC is developing an information system, the NEDSS Base System, which will use NEDSS technical and information standards ( *http://www.cdc.gov/nedss/BaseSystem/NEDSSBaseSysDescription.pdf* ). Currently 11 states participate in NEDSS. It is expected that 4 additional states will be added by the end of the first year after OMB approval. Thereafter, it is estimated that 5 states will be added in years 2 and 3, depending on funding. CDC is requesting a three-year OMB clearance of collecting the NEDSS data that is not currently covered by existing clearances. There are no costs to respondents other than their time. The average total annualized burden for the Weekly Morbidity Reports and the Annual Summary Report is 660 hours. Annualized Weekly Morbidity Report Respondent Burden Type of respondent Number of respondents Number of responses per respondents Average burden per response (in hours) States 20 52 30/60 Annualized Annual Summary Report Respondent Burden Type of respondent Number of respondents Number of responses per respondents Average burden per response (in hours) States 20 1 7 Dated: April 28, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-7077 Filed 5-9-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food Safety and Defense Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas and the Mid-Continental Association of Food and Drug Officials, is announcing a public workshop entitled “Food Safety and Defense Workshop.” This public workshop is intended to provide information about current Good Manufacturing Practice regulations for foods, Hazard Analysis Critical Control Point (HACCP), food defense awareness, and other related subjects to the regulated industry, particularly small businesses and startups. *Date and Time:* This public workshop will be held on June 6 and 7, 2006, from 8 a.m. to 5 p.m. *Location:* The public workshop will be held at the Continuing Education Center in Fayetteville, AR, located downtown (2 East Center St.). *Accommodations:* There are many lodging choices in the area, but the Radisson Hotel in Fayetteville (479-442-5555) is immediately adjacent to the Continuing Education Center. *Contact:* Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575-4221, FAX: 479-575-2165, or e-mail: *seideman@uark.edu* . You may also contact David Arvelo, Food and Drug Administration, 4040 N Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, or e-mail: *david.arvelo@fda.hhs.gov* . *Registration:* Registration by May 28, 2006, is encouraged. The University of Arkansas has a $150 registration fee to cover the cost of facilities, materials, speakers, and breaks. Please submit your registration as soon as possible. Those accepted into the course will receive confirmation. Registration at the site is not guaranteed, but may be possible on a space-available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $200, payable to “The University of Arkansas.” If you need special accommodations due to a disability, please contact Steven C. Seideman (see *Contact* ) at least 7 days in advance. *Registration Form Instructions:* To register, please complete the form available online at *http://www.mcafdo.org/* or the registration form in this document and submit along with a check or money order for $150 payable to the “The University of Arkansas.” Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704. **Food Safety and Defense Workshop Registration Form** Name: Affiliation: Mailing Address: City/State/Zip Code: Phone: Fax: E-mail: Special Accommodations Required: *Transcripts:* Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested at cost through 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 public workshop at a cost of 10 cents per page. SUPPLEMENTARY INFORMATION: This public workshop is being held in response to the large volume of food safety and defense inquiries from small food manufacturers and startups originating from the area covered by the FDA Dallas District Office. The SWR SBR presents these workshops to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is consistent with the purposes of the Small Business Representative Program, which are in part to respond to industry inquiries, develop educational materials, and sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA's requirements and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as outreach activities by Government agencies to small businesses. The goal of this public workshop is to present information that will enable manufacturers and regulated industry to better understand food safety and defense requirements and guidance, especially in light of growing concerns about food safety, food allergen cross-contact, and food defense. Information presented will be based on agency position as articulated through regulation, compliance policy guides, and information previously made available to the public. The following topics will be discussed at the workshop:
(1)Code of Federal Regulations, Title 21, Part 110, *Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food* ,
(2)pathogens of public health concern,
(3)food allergen cross-contact,
(4)an overview of HACCP, and
(5)food defense awareness; as well as other related topics. FDA expects that participation in this public workshop will provide regulated industry with greater understanding of the regulatory and policy perspectives on food safety and defense and will increase voluntary compliance. Dated: May 4, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06-4366 Filed 5-5-06; 3:27 pm]
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Notices
Notice of public workshop
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