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FDA Domestic Outreach Meetings
FDA Domestic Outreach Meetings What You Need to Know to Ensure Compliance with the New Rules for Registration of Facilities and Prior Notice Number of Red&rations Location Date Radisson Hotel Denver Stapleton Plaza Denver, CO 80207 March 2,2004 Holiday Inn Fresno Airport Fresno, CA 93727 March 4,2004 89 Hilton El Paso Airport El Paso, TX 79925 March 9,2004 67 Marriott Salt Lake City Downtown Salt Lake City, UT 84101 March 11,2004 62 Kansas City Airport Marriott Kansas City, MO 64152 March 16,2004 94 Sheraton New Orleans New Orleans, LA 70130 March 18,2004 39 Embassy Suites Cary, NC 27513 March 23,2004 46 Embassy Suites Philadelphia Airport Philadelphia, PA 19153 March 24,2004 112 Holiday Inn, Mansfield Mansfield, MA 02048 April 1,2004 119 . 49 . Department of Health and Human Services Food and Drug Administration FDA Updates “What You Need To Know To Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Interim Fmal Rules” Tuesday, March 2,2004 - Denver, CO 7:OOAM- OpenRegistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............... ...........USDA GraduateSchool 9:OOAM- Welcome and Introductions.... ........ .... .......... ........ ...... ...... . . . . . . . . . . . .. . . .Dennis Baker Regional Food and Drug Director SouthwestRegion Office of Regulatory Affairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . , . .., . . . . . . . . . . . . . .. Leslye M, Fraser AssociateDirector for Regulations Office of Regulationsand Policy CFSAN 9:5OAM - Demonstrationof RegistrationIT system/Lessonslearned... . . . . . . . . . . . .Melinda E. Chen, IT Specialist Scientific Computer Support Branch CFSAN Questionsand Answers... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ., . . . . . . . ..CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of Imported Food Shipments/Lessonslearned... . . . . . . . . . . . . . . . . . . . . . . . ..Dennis Baker 11:25AM - Questionsand Answers.. _.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ORA Closing Remarks . . . . . ._.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .._. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...Dennis Baker DOMESTIC OUTREACH MEETINGS SPEAKERS AND PANEL INFORMATION Tuesday, March 2,2004 - Denver, CO FDA Dennis Baker Regional Food and Drug Director Southwest Region Office of Regulatory Affairs Leslye M. Fraser Associate Director for Regulations Office of Regulations and Policy Center for Food Safety and Applied Nutrition Mark Hackrnan Consumer Safety Officer Office of Surveillance Compliance Center for Veterinary Medicine Melinda E. Chen, IT Specialist Scientific Computer Support Branch Center for Food Safety and Applied Nutrition George Brush, IT Specialist Office of Information Technology Office of Regulatory Affairs FDA Domestic Outreach Meeting - Denver, CO LastName FirstName Organivrtion City State Apodaca Rachel Gallagher Transport Int’l Denver, CO Blizzard Scott W.J. Byrnes & Co. Denver, CO Carr Justin R. FDA Denver, CO Childers Dan Hauser CR0 Denver, CO Ehlenbeck Jessie Graebel Movers International, Inc Aurora, CO Evans O.D. FDA Dallas, TX Gallagher Patrick Gallagher Transport Int’l Denver, CO Hamman Richard Fountain Valley Foods, Inc. Aurora, CO Hammang Denise J. Biopharma Compliance Services, LLC Golden, CO Hartgrove Shultz G. Passport Foods Company Denver, CO Heflin Kelli Scott’s Liquid Gold Denver, CO Hinton David A. Similasan Corporation Highlands Ranch, CO klo Anthony Continental Airlines Chelsea Denver, CO James Carrie J. UTi, Untied States, inc Denver, CO Kelley Lou Graebel Movers International. Inc Aurora, CO Ketteler Kay Five Star Custom Foods fort Worth, TX Kimbel Jacob W. VistarNSA Denver, CO Klocker Patricia Colorado Dept. of Public Health & Environment Denver, CO Lakin Gary L. UTi, Untied States, Inc Denver, CO Lanotte Kevin Hellmann Worldwide Logistics Denver, CO Lashway Robert Shamrock Foods Company Commerce City, CO Loyacono Mark D. Fountain Valley Foods, Inc Aurora, CO Loyacono Rush Fountain Valley Foods, Inc. Aurora, CO McKee Rick OKAMI Foods Denver, CO McKenney Greg Acme Distribution Centers Inc. Aurora, CO Nafziger Adam Hammond’s Candies Denver, CO Olson Jim Feed Products, Inc Denver, CO Olson Jim Feed Products, Inc Denver, CO Parachini Susan CO Dept. of Public Health & Environment Denver, CO Monday, April ZS.2004 Page 1 of 2 LastName FirstName Organization C&&ate Pelsmaeker Alwin Eldorado Artesian Springs, Inc Eldorado Springs, CO Eldorado Arlesian Springs Louisville, CO Pelsmaeker CO Rae Cindy A. Passport Foods Company Denver, CO Reis John J. Coastline Seafood Company Englewood, CO ROl0S Edward C. Abbott Laboratories Abbott Park, IL Roth David S. Aspen Pet Products, Inc. Denver, CO Schiller Lpuise A. FedEx Trade Networks Denver, CO Schmitt Michael Aqua Serve Broomfield, CO Sewald David Ranch Way Feed Mills Ft. Collins, CO Shaver Chris John Ewing Company LaSalle, CO Sipple Kevin Eldorado Artesian Springs, Inc Eld. Springs, CO Smelser Jack Hammonds Candies Denver, CO Smith Elvtn R. FDA Denver, CO Smith Yuma 0. Graebel Movers International, Inc Aurora, CO Stutesmafl Terry Menlo Worldwide Trade Services Denver, CO Teitell Paul FDA Denver, CO Thomas Jay New Vistas Denver, CO Warren Vi&i A. Uti, Untied States, Inc Denver, CO Wells Lupe Graebel Movers International, Inc Aurora, CO Zimmerman Nikki Customs Broker Denver, CO Monday,April 26,2004 Page 2 of 2 Department of Health and Human Services Food and Drug Administration FDA Updates “What You Need To Know To Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Thursday, March 4,2004 - Fresno, CA 7:OOAM- OpenRegistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ..f........ ...... ...*..USDA GraduateSchool 9:OOAM- Welcome and Introductions................ .......... ............. ...... . . . . . . . . . . . . .. . . ..Mark Roh Deputy Regional Food and Drug Director Pacific Region Office of Regulatory Affairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities . . . . .._....................................................... L&ye M. Fraser Associate Director for Regulations Office of Regulationsand Policy CFSAN 9:5OAM - Demonstrationof RegistrationIT system/Lessonslearned.,. . . .‘.. . . . . . . .Diane Schmit, Project Manager Computer Technology Services,Inc. Questionsand Answers.. . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of Imported Food Shipments/Lessonslearned... . . . . . . . . . . . . . . . . . . . . . . . ...Mark Roh 11:25- Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ORA Closing Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...Mark Roh Thursday, March 4,2004 - Fresno, CA FDA Mark Roh Deputy Regional Food and Drug Director Pacific Region Office of Regulatory Affairs Leslye M. Fraser Associate Director for Regulations Office of Regulations and Policy Center for Food Safety and Applied Nutrition Mark Hackman Consumer Safety Officer Office of Surveillance Compliance Center for Veterinary Medicine Diane Schmit, Project Manager (Contractor) Computer Technology Services, Inc George Brush, IT Specialist Office of Information Technology Office of Regulatory Affairs FDA Domestic Outreach Meeting - Fresno, CA LastName FirstName Organization CityState Adolph Chris Adolph Inc. Fresno, CA Adolph Phil Titus Ent. Inc. Fresno, CA Aquino David Sun World International Inc Bakersfield, CA Assali Frank J. Assali Hulling & Shelling Hughson, CA Avellar Thomas A & P Growers Tulare, CA Barry Debbie F&A Dairy of California Newman, CA Bath Kenny S. Marquez Bros. lnt’l, Inc Hanford, CA Beshwate Greg R. Best Logistics Clovis, CA Bouin James Expro Manufacturing Corporation Los Angeles, CA Bunkley Thomas E & J Gallo Winery Fresno, CA Carlile Duane Foster Farms Livingston, CA Carter Jim Farmington Fresh Stockton, CA Ceja Rigoberto Golden Valley Dairy Products Tulare, CA Chavez Linda La Tapatia Tortilleria, Inc Fresno, CA Clutter Kevin California Grain & Feed Association Sacramento, CA Coff ie Lonnie Penny-Newman Grain Co Hanford, CA Cohan Willa Nick Sciabica &. Sons Modesto, CA Colbum Gary B. Western Milling LLC Goshen, CA Cole Caleb L. Rio Bravo Tomato Company LLC Buttonwillow, CA Coleman Tony E & J Gallo Winery Livingston Livingston, CA Collar Carol A. University of CA Cooperative Ext Hanford, CA Collins Doris A. Zoria Farms, Inc Madera, CA Cotiez Gabriel Golden State Feeds Reedley, CA Crisp Daryl L. Athens Baking Co. Fresno, CA De La Torre Juan Luis Marquez Bros. Int’l, Inc Hanford, CA Delgado Frank CA Dept of Food & Ag Fresno, CA Dores Frank Golden State Feeds Tulare, CA Dunn Sean Lion Raisins Selma, CA Falkenberg Rick White Oak Frozen Foods Newman, CA Femandes Jose Valley Gold Gustine, CA \ Mon&y, April 26.2004 Page 1 of 3 LastName FirstName Organization City State Flage Ben A. World Food Products Inc Ripon, CA Floyd Frank Sun-Maid Growers of California Kingsburg, CA Ford Ken The Wine Group, Inc Ripon, CA Fretto Terry Sun-Maid Growers of California Kingsburg, CA Garibay Jose J. E & J Gallo Winery Modesto, CA Gonsalves John Associated Feed & Supply Turlock, CA Goodrich Stanley G. A.L. Gilbert Co Oakdale, CA Grow Landry CA Grain & Feed Assn Sacramento, CA Hansen Chris Ca Dept of Food & Ag Fresno, CA Hansen John G. La Tapatia Tortilleria Fresno, CO Hazrati Kayhan N. Sun-Maid Growers of California Kingsburg, CA Heim Stanley Magic Ice Products Stockton, CA Herrick Robert L. HMS Veterinary Development, Inc Tulare, CA Hodge Tanya Ak-mak Bakeries Sanger, CA Hubble Bobbi Valley Gold Gustine, CA Licking Stephanie CA Citrus Producers Inc Lindsay, CA Loo Kai-Mei San Joaquin Valley Concentrates Fresno, CA Lopez Norma Amber Foods lnc Dinuba, CA Lubong Rogelio Foster FarmsCommodities Div Kingsburg, CA Maddux Dave Brandt Farms Reedley, CA Marshbum Gary Sun-Maid Growers of California Kingsburg, CA McDonald Janet FDA Alameda, CA Mendoza Carlos G. SBA Fresno, CA Mentelos Robert W. Penny-Newman Grain Co. Stockton, CA Miller Steven E & J Gallo Winery Livingston Livingston, CA Mills Larry D. Miller Milling Company Fresno, CA Morgan Gene Formulation Technology, Inc. Oakdale, CA Mulanax Matthew W. ATP Consultants Salinas, CA Mulvaney John initiative Foods Inc. Sanger, CA Munoz Lupe E&J Gallo Winery Fresno, CA Netto James Penny-Newman Grain Co Hanford, CA Nguyen Dominique G-UP Corporation San Jose, CA Monday, April 26,2004 Page 2 of 3 FirstName C’Farrell Brian Gfiara Sheri ADM Fresno, CA Papangellin George C. Gerawan Farming Sanger, CA Paradiso John E & J Gallo Winery Livingston Livingston, CA Paul Kimberly K. CA Citrus Producers, Inc. Lindsay, CA Pickering Larry SNaP Logistics, Inc. Fresno, CA Preis Edward Caruthers Raisin Packing Caruthers, CA Risinger Virginie Del Rey Juice Company Del Rey, CA Rivera Lorraine Akmak Bakeries Sanger, CA Roberts Lance D. Johanson Transportation Service Fresno, CA Robinson Dave K. The Brownie Baker Fresno, CA Rollin Paul Sweet Haven Dairy Riverdale, CA Ruddick-Shannon Shaun L and C Foods, Inc Exeter, CA Santiluan Hilda Hye Cuisine Inc Del Rey, CA Sciabica Daniel R. Nick Sciabica & Sons Modesto, CA Silva Ronald J. Westar Transport Selma, CA Simpson Phil Titus Ent. Inc. Fresno, CA Stein Steven J. Unified Western Grocers Commerce, CA Stewart William R. E&J Gallo Winery Fresno, CA stuyt Rick A. Stuyt Dairy Es&on, Taorrnina Bob Zoria Farms, lnc Madera, CA Thornton William C. Mid Valley Nut Company Hughson, CA Trujillo Larry Central California Warehouse Service Inc Visalia, CA Weist Michael A. Magic Ice Products Stockton, CA Wetherell Todd Best Logistics Inc. Stockton, CA Wilgenburg Bert Flint Dairy Hanford, CA Wofford Wayne Vie-Del Company Fresno, CA Monday, April 26,2004 Organization CityState LastName Selma, CA CA Page 3 of 3 Department of Health and Human Services Food and Drug Administration FDA Updates “What You Need To Know To Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Tuesday, March 9,2004 - El Paso, TX 7:OOAM - Open Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .... .. .... ............USDA Graduate School 9:OOAM - Welcome and Introductions ... ....... ... .. ..... ...... ...... ........... .. . . . . . _.. . . . ... . . ..O.D. Evans Deputy Regional Food and Drug Director SouthwestRegion Offke of Regulatory Affairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities.. . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. Mary J. Ayling Lead Inspections/Compliance Food Safety and Security Staff CFSAN 9:5OAM - Demonstration of Registration IT system/Lessonslearned.. . . . . . . . . . . . , .Elaine Johanson,Director Office of Information Technology Office of the Chief Information Officer FDA Questions and Answers.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..CFSAN. IT, CVM, ORA Break (15 minutes) 10:45&I - Overview and Update of Interim Final Rules for Prior Notice of Imported Food ShipmentsLessons learned.. . . . . . . . . . . . . +.. . . . . . . . . . ..O.D. Evans Howard Duchan Bureau of Customs and Border Protection Department of Homeland Security 11:25AM - Questionsand Answers.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . _. . . . ORA, CBP Closing Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..O.D. Evans Tuesday, March 9,2004 - El Paso, TX FDA O.D. Evans Deputy Regional Food and Drug Director Southwest Region Office of Regulatory Affairs Mary J. Ayling Lead Inspections/Compliance Food Safety and Security Staff Center for Food Safety and Applied Nutrition Kim Young Supervisory Consumer Safety Officer Office of Surveillance Compliance . Center for Veterinary Medicine Elaine Johanson, Director Office of Information Technology Office of the Chief Information Officer FDA Kelle Fry Division of Import Operations and Policy Office of Regulatory Offices CBP Howard Duchan Bureau of Customs and Border Protection Department of Homeland Security FDA Domestic Outreach Meeting - El Paso, TX LastName FirstName Organization CityState Abujawayed Mohamad Expeditors International Ei Paso, TX Adamson Barbara UPS Supply Chain Solutions Coppell, TX Alarcon Maria Franklin Logistics El Paso, TX Alcantar Joe Brown, Alcantar & Brown, lnc El Paso, TX F.C. Felhaber Customs Brokers El Paso, TX Baca Barron Anthony Oaniel Hastings Inc El Paso, TX Behrens Shannon Expediters International El Paso, TX Carillo Rosa A. Economy Cash & Carry LP El Paso, TX Carlson Todd Glazer’s Wholesale Drug co El Paso, TX Castro Manny Cardinal Health El Paso, TX Contreras Blancal El Paso Seafood Inc El Paso, TX Creek Jim New Mexico Broder Authority Santa Teresa, NM Cruz Eduardo FedEx Trade Networks El Paso, TX Delgado Lourdes Barcel, S.A de C.V. Mexico City, MX Dominguez Ramon Productos Real Inc Anthony, TX Flores Alfonso Bimbo Bakeries El Paso, TX Garracho Jesus Hoody’s Original Nut House Brands El Paso, TX Gill Daniel FDA El Paso, TX Gonzalez Angelica Grupo Bimbo Mexico, DF Gonzalez Jesus H. lntrade Consultants El Paso, TX Grady Jack FDA El Paso, TX Gutierrez Griselda Bimbo Bakeries USA Fort Worth, TX Hayward David FDA El Paso, TX Hurley Beverly AVS Services, Ltd El Paso, TX Jaramillo Claudia Cordova Brokerage, lnc El Paso, TX Knowles Rosa Samuel L. Sanchez El Paso, TX Kuper Jennifer Price’s Creameries El Paso, TX Lane Chris Lane’s Dairy LTO El Paso, TX Lemmons Kevin National Dairy Holdings Dallas, TX Lopez Jose Guerrero Customs Brokers Brownsville, TX Monday, April 26,2004 Page 1 of 3 LastName FirstName Organization CityState Lott Jerry FDA El Paso, TX Luna Manuel Brown, Alcantar & Brown, Inc El Paso, TX Madero Sergio A. Aduana Mexico El Paso, TX Martinez lsmael Novamex El Paso, TX Mendoza Estela Paso del Norte Food Bank El Paso, TX Mendoza Francisca FDA El Paso, TX Miller Kenneth V. BNSF RR Fort Worth, TX Miramontes Joe Franklin Logistics El Paso, TX Monielongo Ray Chamizal Trailer Rental, inc El Paso, TX Navarro Marco A. lntrade Customs Brokers Santa Teresa, NM Nunez Jose Luis Franklin Logistics El Paso, TX Olivas Bernard0 DHS Customs & Border Protection El Paso, TX Oropesa Albert0 Grupo Bimbo Mexico, DF Ortic Edger AA Custom Broker El Paso, TX Paclilla Noel DHS Customs & Border Protection El Paso, TX UPS Supply Chain Solutions El Paso, TX Palono Paredes Irma Union Ganadera Regional De Chihuahua Santa Teresa, NM Portillo Victor F.C. Felhaber & Coi., nc. Columbus, NM Puentes Robert BNSF Railroad El Paso, TX Quiroz Mari C. A.A. Customs Brokers, Inc El Paso, TX Ramirez Maria FC Felhaber & Co., Inc. Columbus, NM Ramos Luis Novamex El Paso, TX Raskiewicz Matthew G. VMS Richardson, TX Saldivar Adolf0 RM Customhouse Brokers lnc El Paso, TX Samaniego Emelda Glazer’s Wholesale Drug Co., Inc. Dallas. TX Sanchez Gerard0 Customs Broker Del Rio, TX Sanchez Manuel DHS Customs & Border Protection El Paso, TX Tellez Alejandra Portillo Customs Brokerage El Paso, TX Torres Brenda La Morena Distributor’s, Inc Eagle Pass, TX Trueba Fernando A.A. Customs Brokers, Inc El Paso, TX Monday, April 26,2004 ’ Page 2 of 3 c ,! LustName FirstName Organization CityState Valdez Steve Brown, Alcantar & Brown, Inc El Paso, TX Valedez Mario Sunwest Seafood Sales El Paso, TX Valenzuela Jack Isabella Foods, Inc. El Paso, TX Vazquez Bertha A. Economy Cash & Carry LP El Paso, TX Villanueva Chaga Brown, Alcantar & Brown, Inc El Paso, TX Wallace William W. Union Ganadera Regional De Chihuahu Santa Teresa, NM Webster Mila Glazer’s Wholesale Drug Co., Inc Dallas, TX Monday, April 26,2004 Page 3 of 3 Department of Health and Human Services Food and Drug Administration FDA Updates “What You Need To Know To Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Thursday, March 11,2004 - Salt Lake City, UT 7:OOAM- Open Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .......... ..... ..........USDA GraduateSchool 9:OOAM-Welcome and Introductions.... .. ..... .............. .................... . . . . . . . . . . . .. .. . . -O.D. Evans Deputy Regional Food and Drug Director SouthwestRegion Office of Regulatory Affairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . .. . Mary J. Ayling Lead Inspections/Compliance Food Safety and Security Staff CFSAN 95OAM - Demonstrationof Registration IT system/Lessonslearned... . . . . . . . . . . . .Pino Marinelli, Lead Analyst GlobalNet Services,Inc. Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CFSAN, CVM, IT, OIL4 Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of Imported Food Shipments/Lessonslearned... . . . . . . . . . . . . . . . . . . . . . . . . .O.D. Evans 11:25AM - Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ORA Closing Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..f.........................*.............. O.D. Evans Thursday, March X2004 - Salt Lake City, UT FDA O.D. Evans Deputy Regional Food and Drug Director Southwest Region Office of Regulatory Affairs Mary J. Ayling Lead Inspections/Compliance Food Safety and Security Staff Center for Food Safety and Applied Nutrition Kim Young Supervisory Consumer Safety Officer Office of Surveillance Compliance Center for Veterinary Medicine Pino Marinelli, Lead Analyst (Contractor) GlobalNet Services, Inc. Kelle Fry Division of Import Operations and Policy Office of Regulatory Offices FDA Domestic Outreach Meeting - Salt Luke City, UT LastName Fir&Name Organization CityState Adondakis George Nicholas & Company Salt Lake City, UT Agee Tammie Jerome Cheese Company Jerome, ID Archer Steven Twinlab Utah American Fork, UT Argyle Layne A. Tahitian Noni International Provo, UT Barker Chris Condies Foods Salt Lake City, UT Barnum Anthony White Wave Cedar City, UT Bates Peggy AMT Labs, Inc North Salt Lake City, UT Baum Mary Twinlab Utah American Fork, UT Burningham Brent Albion Advanced Nutrition Clearfield, UT Carher Dave Nelson-Ricks Creamery Co Salt Lake City, UT Colebrook Michael UCI Milk Plant Draper, UT Crafts Jason Gossner Foods, Inc Logan, UT Daniels Jeff Central Milling Co Logan, UT Demeo Derek Expeditors International Salt Lake City, UT Eyres Melody Kuehne 81Nagel Inc Salt Lake City, UT Ferguson A.J. Utah Farm Bureau Federation Sandy, UT florek David Quality Distributing of Utah Salt Lake City, UT Foster Clarence M. Admiral Beverage Corp Pleasant View, UT Fox Celeste DHL Danzas Air & Ocean Salt Lake City, UT Garza Holly High Desert Chb Inc Riverton, UT George Phil D. Asset Farr & Sons Salt Lake City, UT Gunclersen Ted Nichdas & Company Salt Lake City, UT Hall Blaine Intermountain Farmers Assn Hammons Lynda M. Nature’s Sunshine Products Spanish Fork, UT Hardcastle Val Nelson Ricks Salt Lake City, UT Hawkes Shera L. Tropical Resources, Inc Provo, UT Jarrett Debbie Menlo Worldwide Trade Service Salt Lake City, UT Jensen Paul Mrs. Cavanaugh’s Candies, Inc Bountiful, UT Jessen Jim Gossner Foods, Inc Logan, UT Johnson Stuart Hanjin Shipping Co., Ltd. Salt Lake City, UT Monday, April 26,2004 Page 7 of2 L&Name FirstName Organization CityState Jones Marion L. Jones Bee Company Salt Lake Cii, UT Kay DeWayne HBH Enterprises Springville, UT Knight Susan M. Exe1 Global Logisticw Salt Lake City, UT LaFieur Floyd Basic Convenience Food, Inc Ogden, UT Lindsey Kim P. MarketFare Foods Salt Lake City, UT Longaker John Condies Foods Salt Lake City, UT Majerus Warren Pharmore Ingredients River-ton, UT Moore Kenneth Basic Research Salt Lake City, UT Mowrey Brokk Bydex Management Salt Lake City, UT Niesen Andy Hanjin Shipping Co. Ltd. Salt Lake City, UT Noble Shannon D. UPS Supply Chain Solutions Salt Lake City, UT Oltihewski Jared H C Brill Co Inc Pleasant View, UT Parker Chad Condies Foods Salt Lake City, UT Perry Evan Wheatland Seed, Inc Collinston, UT Perry Lee C. Jerome Cheese Company Jerome, ID Pezely Ryan J. Renegade Oil, Inc Salt Lake City, UT Price Carolyn UCI Meat Plant Draper, UT Ramaswamy Natesan Western Quality Foods Cedar City, UT Sanabria Naomi UPS Supply Chain Solutions Salt Lake City, UT Sanchez Pamela Hanjin Shipping Salt Lake City, UT Seaman Heidi UTI, United States Salt Lake City, UT Sharma Pragati White Wave Cedar City, UT Shelton De Lois Weider Nutrition Inc. Salt Lake City, UT Shreeve Becky Utah Department of Agricufture & Food Salt Lake City, UT Sims Doug AMT Labs, lnc North Salt Lake City, UT Slagowski Thane Twinlab Utah American Fork, UT Stickney Jack L. Associated Food Stores, Inc Farr West, UT Strasburg Nikki Menlo Worldwide Trade Services Salt Lake City, UT Thompson Teresa FDA Salt Lake City, UT voss Tim Jerome Cheese Company Jerome, ID Walton Tara Hanjin ShippingCo. Ltd., Salt Lake City, UT Weston Fred Central Milling Co Logan, UT @%%-I 62 Monday, April 26,2004 / Page 2 of 2 Department of Health and Human Services Food and Drug Administration FDA Updates ‘What You Need To Know To Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Tuesday, March 16,2004 - Kansas City, MO 7:OOAM- Open Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ................. ......USDA GraduateSchool 9:OOAM- Welcome and Introductions.................... .... ........ ..... ........ . . . , . . . . . . . ..,. . ..DermisBaker Regional Food and Drug Director SouthwestRegion Of&e of Regulatory Affairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities.. . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. Melissa Scales RegulatoryCounsel Office of RegulationsandPolicy CFSAN 9:5OAM - Demonstrationof RegistrationIT system/Lessonslearned... . . . . . . , . . . . .Daniel Goldman, Vice President GlobalNet Services,Inc. Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*...... CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of Imported Food Shipments/Lessonslearned... . . . . . . . . . . . . . . . . . . . . . . . ..Dennis Baker Michael Craig Bureau of Customs and Border Protection Departmentof Homeland Security 11:25AM - Questionsand Answers.. . . . . . . . . . . . . . . . . . . . . . . . _. . . . . . . . . . . . . . . . . . . . . . .. . . . . ORA, CBP Closing Remarks . . . . . . . . _.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . .-DennisBaker Tuesday, March 16,2004 - Kansas City, MO FDA Dennis Baker Regional Food and Drug Director Southwest Region Office of Regulatory Affairs Melissa Scales Regulatory Counsel Office of Regulations and Policy Center for Food Safety and Applied Nutrition Mark Hackman Consumer Safety Officer Office of Surveillance Compliance Center for Veterinary Medicine George Brush, IT Specialist Office of Information Technology Office of Regulatory Affairs Daniel Goldman, Vice President (Contract) GlobalNet Services, Inc. CBP Michael Craig Bureau of Customs and Border Protection Department of Homeland Security FDA Domestic Outreach Meeting - Kansas City, MO LustName FirstName Orgai&don CityState Flynn Center for North American Studies College Station, TX Aghakhani Mark Ancient Formulas, Inc Wichita, KS Ahle Neil Hill’s Pet Nutrition Topeka, KS Alexander Carla O‘Neill & Whitaker, Inc Kansas City, MO Aragon Lou US Customs and Border Protection Kansas City, MO Baker John Pfizer Inc. Lincoln, NE Barricklow Wes Hill’s Pet Nutrition Topeka, KS Beard Holly Old World Spices Kansas City, MO Beever James W. Cereal Food Processors, Inc. Mission Wooks, KS Bell Dave Kuehne and Nagel Kansas City, MO Bogdon Eric Bogdon Candy Co. Inc Westwood, KS Bogdon Jon Bogdon Candy Co. Inc Westwood, KS Bangers Henry Kerry, Inc. Beloit, WI Brink Don Excel Corporation Wichita, KS Claxton Tony MO Department of Agriculture Kansas City, MO Collins Casey PDM Distribution Services Des Moines, IA tort Christina O’Neill & Whitaker, Inc Kansas City, MO Coughenour Jo Danisco USA Inc New Century, KS Croan Don Hallmark Cards Corp Kansas City, MO Cross Emetick Unified Government Public Health Dept Kansas City, KS Devine Diane Andira USA Inc Olathe, KS Dickenson Ron US Customs and Border Protection Kansas City, MO Dillon Charles AWG Kansas City, KS Farmer Mike Three Dog Bakery Kansas City, MO Fithian Dana Scarbrough International Ltd. Kasnas City, MO Geiger Rod Bartlett Milling Company Kansas City, MO Golden Chris Phoenix lntemationial Kansas City, MO Grabau Peggy McCormick Distilling Co Weston, MO Gross Shane Scarbrough International Ltd. Kansas City, MO Monday, April Z&2004 Page 1 of 4 FirstName Organization CityStute Guminger Catherine UPS Supply Chain Solutions Kansas City, MO Guttoimson Gerald Mrs. Clark’s Foods LC Ankeny, IA Haak Brad Rockwell Automation Omaha, NE Hale Reecie American Italian Pasta Co Excelsior Springs, MO Harris Sue Hill’s Pet Nutrition Topeka, KS Heintzelman Nancy USDA/FSA Kansas City, MO Hentges Heidi Expediters International of Washington Kansas City, MO Hudson Thomas Three Dog Bakery Kansas City, MO Hunt Eula McCormick Distilling Co Weston, MO Jones Jerry Marfsol international Kansas Cl, Jordon Marion Jordon Foods Co. Inc. Knob Noster, MO Keller Donald O’Neilf & Whitaker, Inc Kansas City, MO Klassen Tiffany Cass County Health Department Harrisonville, MO Knight 0. T. Gallagher Transport lntl Kansas City, MO Koscielski Brian Rockwell Automation Lenexa, KS Kraft Kirby Busch Agricultural Resource, Inc St. Louis, MO Kutfiek Lori Bunge North American Inc St. Louis, MO Layton Kerry US Customs and Border Protection Kansas City, MO Leatherhury Mary Ellen Alliance Customs Clearance, Inc Mission, KS Sea Harvest Seafood Company Kansas City, MO Lee ’ MO Lombardi Ann US Customs and Border Protection Kansas City, MO Lorimor Gary Henningsen Foods Inc Omaha, NE Madden Patrick Danisco USA Inc. New Century, KS Martin Ken USDA/FSA Kansas City, MO McMillin Raymond City Ice Co., Inc. Junction City, KS McMullen John N. Roberts Dairy Kansas City, MO Meinhardt Russell Old World Spices Kansas City, MO Mendlik Jim Hansen-Mueller Co Omaha, NE Merrick Brenda O’Neill & Whitaker, lnc Kansas City, MO Mitchell Robert Manildra Milling Corporation Shawnee Mission, KS Moore Tommy R. Held & Associates Inc North Kansas City, MO Monday. April 26,2004 Page 2 of 4 LustName FirstName Organization City State Moores James S. Moores English Fine Foods, LLC Liberty, MO Mundy Cynthia Ancient Formulas, Inc Wichita, KS Murray Sean Miller & Company, P.C. Kansas City, MO Paul Tywanna FDA Lenexa, KS Platania Peter S. Harry F. Long, Inc Kansas City, MO Polk Cindy O’Neill & W hitaker Kansas City, MO Ramsey Patricia Harry F. Long, Inc Kansas City, MO Rasmussen Oscar Ancient Formulas, Inc Wichita, KS Sample Randy ADM Alliance Nutrition Quincy, IL Satterstrom Bill Des Moines, IA Schrick Raymond Centennial Warehouse hrp Atchison Wholesale Grocery, Inc Siebers Stephen F. Mansol International Kansas City, MO Sims Mike Vitalab Kansas City, MO Smith Rob J. Alliance Customs Clearance Mission, KS Sobetski Mike Lifeline Foods, LLC St. Joseph, MO Suttee Gregg Hallmark Cards Corp Kansas City, MO Thayer Chris Hallmark Cards Corp Kansas City, MO Thuston K. Hallmark Cards Corp Kansas City, MO Turner Richard Missouri Dept. of Health & Independence, MO Utchell Michael Miller & Company, P.C. Kansas City, MO Vincent Brian Bimeda inc Riverside, MO Vogt Gale Mr. Dell Foods, Inc. Keamey, MO Walros-Drake Shirley A. Western Overseas Corporation Springfield, MO Wehrle Tom United Bakers Supply Kansas City, MO Welch Michael Hallmard Cards Corp Kansas City, MO White Gloria Vitalab Kansas City, MO Wilkins Rick Mr. Dell Foods, Inc. Keamey, MO Williams Karen USDAJFSA Kansas City, MO Williams Lisa McCormick Distilling Co Weston, MO Wiseman Gene MO Department of Agriculture Kansas City, MO Woita Garry L. Herman Nut Company Omaha, NE Yager Karlan Bimeda Inc Riverside, MO Monday, April 26,2004 ss Atchison, KS Page 3 of 4 LastName FirstName Organizati0n CityState Zender Bob Bogdon Candy Co. Inc Westwood, KS Ziha Brian W. Customs Express, Inc St. Louis, MO \ Monday,April 26,2004 Page 4 of 4 Department of Health and Human Services Food and Drug Administration FDA Updates “What You Need To Know To Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Thursday, March 18,2004 - New Orleans, LA 7:OOAM- Open Registration . . . . . . . . *. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..........................USDA GraduateSchool 9:OOAM-Welcome and Introductions., ... ..*...... .... ....... .. ...... ........ .... . . . . . . . . . . . . .. . . . .Malcolm Frazier Deputy Regional Food and Drug Director SoutheastRegion Office of Regulatory Affairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities ,.,.....................................................-..... L. Robert Lake, Director Office of Regulationsand Policy CFSAN 9:5OAM - Demonstrationof Registration IT system/Lessonslearned... . . . . . . . . . . . .Ray Russo, Director Office of BusinessEnterprise Solutions Office of Chief InformationOfficer F7DA Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*...... . . . . . . . . . . .CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of Imported Food Shipments/Lessonslearned.. . . . . . . . . . . . . . . . . . . . . . . . . ..Malcohn Frazier Howard Hodes Bureau of Customs and Border Protection Departmentof Homeland Security 11:25AM - Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*..............*.... ORA, CBP Closing Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...Malcolm Frazier Thursday, March l&2004 - New Orleans, LA FDA Malcolm Frazier Deputy Regional Food and Drug Director Southeast Region Office of Regulatory Affairs L. Robert Lake, Director Office of Regulations and Policy Center for Food Safety and Applied Nutrition Mark Hackman Consumer Safety Officer Office of Surveillance Compliance Center for Veterinary Medicine Michael Marley Division of Import Operations and Policy Office of Regulatory Affairs Ray Russo, Director Office of Business Enterprise Solutions Office of Chief Information Officer FDA CBP Howard Hodes Bureau of Customs and Border Protection Department of Homeland Security FDA Domestic Outreach Meeting - New Orleans, LA LastName FirstName Organiz@ion CityState Adamson Barbara L. UPS - scs Coppell, TX Alger Bill Port Cargo Service New Orleans, LA Linda MSU-CREC Biloxi, MS Bernstein Shelly The Irwin Brown Co New Orleans, LA Botts Daniel Florida Fruit & Vegetable Assn Orlando, FL Burdine Fredie The Irwin Brown Co Gulfport, MS Carrgil Charles John M. Brining Co. Inc Mobile, AL Cazaubon Gary W. State of Louisiana/ DHH Baton Rouge, LA Clark Jeffery Sun Seed Company Bowling Green, OH Daffemer Russell Fedex Trade Networks Memphis, TN Daleo A.J. Port Cargo New Orleans, LA Flanagan Deborah Barton Brands, Ltd Chicago, IL Frazier Sandra Robert W. Cisco Customs Broker lnc Kenner, LA Gailo Margarita FedEx Expess Corp Memphis, TN Gay Daniel Geo Wm Rueff New Orleans, LA Guilbeau David State of Louisiana/ DHH Baton Rouge, LA Hicks Tricia G. Alexander International Memphis, TN Higgins G. N. Higgins Int’l Services Inc New Orleans, LA Jama Larissa Sazerac Company Inc. New Orleans, LA Johnson Dana The Folger Coffee Company New Orleans, LA Jordan Ron MS Dept. of Marine Resources Biloxi. MS Koch Catherine Sazerac Company Inc. New Orleans, LA McNeil Colleen The Kearney Companies Metairie, LA Mejia Fernando J. Hondu Products Missouri City, TX Melan Claudia Geo Wm Rueff New Orleans, LA O’Neill Jean The Kearney Companies Metairie, LA Pawlik Faith FedEx Express Corp. Memphis, TN Perez Silvia M. M.G. Maher & Co, Inc New Orleans, LA Porter Scott A. Ecologic Environmental Houma, IA Posadas Ruth MS-DMR Biloxi, MS Raskiewicz Matthew VMS Richardson, TX Monday, April 26.2004 Page I of 2 LastName FirstName Organization City Skbte Ricker Todd Accenture New York, NY Royster Priscilla The Irwin Brown Co Gulfport, MS Terrell M. Colleen The Folgers Coffee Company New Orleans, LA Turner Jacqueline A. Alexander International Me&tine, LA Wactor Kim Alexander International LLC Metairie, LA Williams JoAnn Liner Services lnt’l Inc Diamondhead, MS Melzana Mallory Alexander International Logistics Memphis, TN Nikki Mallory Alexander International Little Rock, AR / Monday, April 26,2004 Page 2 of 2 Department of Health and Human Services Food and Drug Administration FDA Updates “What You Need To Know To Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Tuesday, March 23,2004 - Raleigh, NC 7:OOAM- Open Registration . . . *. . . *. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . f . . ....... ... ..I... ...........USDA GraduateSchool 9:OOAM- Welcome and Introductions...*......... ..._.............................. . . . . . . . . . . .. . . . .Gary Dykstra Regional Food and Drug Director SoutheastRegion Office of Regulatory Affairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.............. Louis J. Carson,Deputy Director Food Safety and Security Staff CFSAN 9:5OAM - Demonstrationof Registration IT system/Lessonslearned... . . . . , . . . . . . .Erwin Miller, IT Specialist Division of Information ResourceMgmt Computer Support Branch Questionsand Answers.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of Imported Food Shipments/Lessonslearned... . . . . , . . . . . . . . . . . . . . . . . . ..Gary Dykstra 11:25AM - Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..f. . . . . . . . . . ORA Closing Remarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . .Gary Dykstra Tuesday, March 23,2004 - Raleigh, NC FDA Gary Dykstra Regional Food and Drug Director Southeast Region Office of Regulatory Affairs Louis J. Carson, Deputy Director Food Safety and Security Staff Center for Food Safety and Applied Nutrition Kim Young Supervisory Consumer Safety Officer Office of Surveillance Compliance Center for Veterinary Medicine Erwin Miller, IT Specialist (Contractor) Division of Information Resource Mgmt Computer Support Branch Kelle Fry Division of Import Operations and Policy Office of Regulatory Offices 1 F D A D o m e s tic O u treachM e e tin g - Raleigh, N C LastName FirstName Organization CityState Brock Douglas M o u n t olive Pickle Company M o u n t O live, N C Chafin Cathy W a ters S h i p p i n g C o m p a n y W ilmington, N C Chrapliwy C. Vincent Miller B r e w i n g Co. Eden, NC Davis J o s e p h D. Davis S e a f o o d Inc. S n e a d s Ferry, N C Davis Vickie H. Davis S e a f o o d , Inc. S n e a d s Ferry, N C Dillingham Lynn PerformanceF o o d G r o u p Richmond, V A E d w a r d s Jr. T h o m a s L. C a r o l i n a Ice C o m p a n y Kinston, N C Figueroa A m i e L. E X E L G lobal Logistics, Inc. Morrisvflle, N C Fletcher James W a n c h e s e Fish C o m p a n y Wanchese, NC Ford Wendy G . UPS Supply Chain Solutions Greensboro,N C Franklin RandallA . Great Eastern Sun Asheville, N C Frazier G lenn A q u a P u r e Bottled W a ter Inc. Asheboro, NC Fubelli David DHL Danzas Morrisville, N C Gabriel Larry NCDA & CS Raleigh, N C Goison M. G r a d y O ld S a r a t o g a , Inc. Saratoga, NC Hauser W illiam E . Le Bleu Corp Advance, NC Helms D a v i d L. N o r t h a m p t o n P e a n u t Co. Severn, NC Henthorn Danielle M. T h e H i p a g e C o m p a n y Inc. Morrisville, N C Howard Duane C a r o l i n a Ice C o m p a n y Kinston, N C Howell Don NCDA Raleigh, N C . Huff Donna E. D a n c i n g D o e Dairy Pittsboro, N C Hutchinson Lona E. Unilever Bestfoods Asheboro, NC lbrahim Salam A. North C a r o l i n a A T & T S U Greensboro,N C lngraham Joyce Ocean Seafood W ilmington, N C Jacobs Ralph Amalfitano’s Italian B a k e r y N e w Castle, D E Johnston Keith R. O ld S a r a t o g a , Inc. Saratoga, NC King Joe C a r o l i n a Treet, Inc. W ilmington, N C Lewis Ken E. L e w i s S t o r a g e Co. Greensboro,N C Moore O o n n a S .‘ S tar F o o d Products Inc. Burlington, N C Moretz M a r k Ft. Carolina Foods Charlotte, N C Oakley Keith Montibello Food.+,L L C Graham, NC M o n d a y , April 2 6 , 2 0 0 4 P a g e 7 of 2 CityState LustName FirstName Organizdion Patrick Cheryl-Lynne Brown-Forman Corporation Louisville, KY Patterson John E. Milkco, Inc. Asheville, NC Peters Michael W. Garland C. Norris Co. Apex, NC Seay Alan Harris Teeter Inc. Matthews, NC Sessoms Roberts Tyson Foods, Inc. Sanford, NC Sigmon Kay S. NC Dairy & Food Protection Branch Denver, NC Smith Achan W. Le Bleu Corp Advance, NC Smith Robert Central Carolina Bottling co Alton, VA Swanson Kenneth Classic Food Service Durham, NC Szyperski Dawne C. John S. James Co. Wilmington, NC Tatman David R. Fresher Than Fresh inc. Gastonia, NC Taylor Todd Winn-Dixie Stores, Inc Clayton, NC Trout Charles T. Mother Murphy’s Laboratories, Inc. Greensboro, NC Van Dyk Deborah A. Schreiber Foods Inc Green Bay, WI Williams Thomas J. TJERRY, Inc. Raleigh, NC Monday, April 26,2004 Page 2 of 2 . Department of Health and Human Services Food and Drug Administration FDA Updates “What You Need To Know To Ensure Compliance With the New mlA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Thursday, March 24,2004 - Philadelphia, PA 7:OOAM- Open Registration . . . . . . . . . . . . . . . . . . ._.. . . . . ,. . . . . . . . . . . . . . ........... ...... ...... ... .USDA GraduateSchool 9:OOAM-Welcome and Introductions..,.................... ...................... . . . . . . . . . . . ... . . ..SusanSetterberg Regional Food and Drug Director Central Region Office of Regulatory Affairs 9: lOAM - Overview and Update of Interim Final Rules for Registration of Food Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... Louis J. Carson,Deputy Director Food Safety and Security Staff CFSAN 95OAM - Demonstrationof RegistrationIT system/Lessonslearned... . . . . . . . . . . . Larry Dusold, Chief Division of Information ResourceMgmt Scientific Computer Support & Webmaster CFSAN Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of Imported Food Shipments/Lessonslearned............................ SusanSetterberg 11:25AM - Questionsand Answers....................................................... ORA Closing Remarks ............................................................................. SusanSetterberg Thursday, March 24,2004 - Philadelphia, PA FDA Susan Setterberg Regional Food and Drug Director Central Region Office Regulatory Affairs Louis J. Carson, Deputy Director Food Safety and Security Staff Center for Food Safety and Applied Nutrition Kim Young Supervisory Consumer Safety Officer Office of Surveillance Compliance Center for Veterinary Medicine Michael Marley Division of Import Operations and Policy Office of Regulatory Affairs Larry Dusold, Chief Division of Information Resource Mgmt Scientific Computer Support & Webrnaster Center for Food Safety and Applied Nutrition FDA Domestic Outreach Meeting - Philadelphia, PA LustName FirstName Organization CityState Abegaz Eyassu Ajinomoto USA Inc Washington, DC Acuna Susan L. Schenker Inc. Sharon Hill, PA Ali Tahzi N. FedEx Canada Richmond, BC Ames Steven A. Pack & Process, Inc. Wilmington, DE Anderson Robert Independent Container Line LTD Eddystone, PA Angelina Michelle R. Expeditors lntl Folcroft, PA Austin Penny M. Tasty Baking Oxford, Inc. Oxford, PA Bahr Nora H. Rhodia Inc Cranbury, NJ Barbieri Roberta Barras Kelly M. Frankford Candy & Chocolate Company Philadelphia, PA Borja Miriam Western Fumigation Parsippany, NJ Brabon Barbara Kraft Foods Allentown, PA Brady Joseph Food and Drug Administration Philadelphia, PA Brauner Matt Brauner International Corp Jersey City, NJ Brodzinski Lorie Bristol-Myers Squibb Co. Hillside, NJ Brown Tim Horizon Stevedoring Inc Philadelphia, PA Brown-Reed Anitra D. US Food and Drug Administration Philadelphia, PA Budd Dave Metzler Systems Woodbury, NJ Burkhatt Kathy A. Joel, Inc. dba Simon Candy Co: Elizabethtown, PA Bursey Robert Ajinomoto USA, Inc Washington, DC Bushnell John DSM Food Specialties USA Eagleville, PA Bustard Benjamin C.B.C.C. Boothwyn, PA Caldwell Benjamin D. Somerset industries, Inc Spring House, PA Amanda W. Campbell Trade Group, Inc. York, PA Campbell Randy P. Campbell Trade Group, Inc. York, PA Capuito Kim Tasty Baking Oxford, Inc. Oxford, PA Clauss Fredrick Bayard-Prete Candy Co. Pennsauken, NJ Dougherty Richard C. FedEx Trade Networks Sharon Hill, PA Durr Sandra A. Frankford Candy & Chocolate Company Philadelphia, PA Monday, Apiii 26,2004 Stamford, CT Page 1 of4 T LastName FirstName Organization CityState Echols Marsha Counsel to National Assoc for the Specialty Food Trade Washington, DC Ellis Dennis Melitta USA Cherry Hill, NJ Elmer Julie Rutgers Food Innovations Center Bridgeton, NJ Falcone Marie Federal Drug Administration Philadelphia, PA Fichtel, Jr. John W. State of Louisiana-DHH Baton Rouge, LA Fitzpatrick Barbara Bausch &. Lomb Rochester, NY Flores Ray Melitta USA Cherry Hill, NJ Gerhart Ted BDP International Philadelphia, PA Gilpin Michael Nutramax Laboratories Edgewood, MD Glatfelter Timothy Mr. Bills Fresh Seafood Lancaster, PA Glavin Felecia Schenker inc. Sharon Hill, PA Godfrey AmY PA Liquor Control Board Harrisburg, PA Goldberg Richard Helen’s Pure Foods Cheltenham, PA Gomez Santiago Guttinger Renaud G. AMC USA, Inc New York, NY Hagenbuch Rena 6. Melitta USA Cherry Hill, NJ Halman Robert D. University of Maryland College Park, MD Hand Chris Wawa, Inc. Wawa, PA Hannig Valerie F. UPS Supply Chain Solutions Wilmington, DE Harper Jeanie S. Dawson’s Sea Food, inc. Wilmington, DE Himber Lisa B. Maritime Exchange for the Delaware River and Bay Philadelphia, PA House Kevin Export INC Bamagat Light, NJ Hyman Herbert International Food Distributors, Inc. Philadelphia, PA Jacobs Ralph A. Amalfitano’s Italian Bakery New Castle, DE Johnson Deane A. Sandler, Travis & Rosenberg Washington, DC Juzaitis John A. John- Jeffrey Corporation Bellmawr, NJ Kakkar Sanjiv Globa Reliance Inc Princeton, NJ Kardosh Kamal Unilever Best Foods Englewood Cliffs, NJ Keegan Michael J. Schenker Inc. Sharon Hill, PA Kerrigan Ralph J. Hanjin Shipping Company Ltd. Paramus, NJ BDP International Philadelphia, PA Knott Monday, April 26,2004 Pittsburgh, PA Page 2 of 4 FirstNane Organizati5n City S tate RebeccaA. B a y e r Chemicals Corporation Pittsburgh, P A Kropiewnicki J o h n J. Mafco W o r l d w i d e Corporation C a m d e n , NJ Lacotte Joseph G . S e a b r o o k Brothers a n d Sons S e a b r o o k , NJ land Mark Boiron-Bomeman Newtown Square, PA Lassen Thor Nordic V e n t u r e s G r e a t Falls, V A Mantello Joseph N B T Y , Inc. Holbrook, N Y McNeil Anita G . A M C U S A , Inc. N e w York, N Y Meintzer JoAnne J a d e International Inc. Philadelphia,P A Menzel S tuart K . P e p s i C o l a Bottling Company Charlotte, N C Merola Monty J. B r a v o Packing, Inc C a m e y ’s Point, NJ Molnar Allen Klett R o o n e y L i e b e r & Schorfing P .C. Newark, NJ Frankford C a n d y & Chocolate Company Philadelphia,P A LustName .G Moore t Mullan Shaun A l p h a International Essington, P A Noga Frank S . Campbell Soup Company C a m d e n , NJ Novak Jeffrey T. U n i q u e Industries, Inc. Philadelphia,P A Ouellette M a r k H. FedEx Express Mississauga, O N Palchak T h o m a s R. University C r e a m e r y University Park, P A Palm Gregory S u n s w e e t G r o w e r s , Inc. Y u b a City, C A Parrotti Diane B r o o k s Provisions, Inc. Philadelphia,P A Perry Jim Particle Size Technology, Inc. Q u a k e r - t o w n ,P A P e t e Jr. S c o ttc. Hilo Export B a r n e g a t Light, NJ Pinchok Mark Bayer Corporateand B u s i n e s s Services Pittsburgh, P A Rainey-Wright B o n n i e L. D B A Distribution Services Somerset, NJ Ready Elizabeth M. Campbell Soup Company C a m d e n , NJ Reininger Cathy D. Uptown Bakeries Bridgeport, NJ Reynolds Jim J o h n A . S teer C o Philadelphia,P A Rhoades Joseph S c h e n k e r Inc. S h a r o n Hill, P A Richardson Robert A s h e r ’s Chocolates Inc. Souderton,P A Rihs DeborahA. Aldon Food Corp Schwenksville, P A Riley Lynn USDA/APHIS Robbinsville, NJ Rodriguez P a u l D. A m e r i c a n River B r o k e r a g e Elizabeth, NJ ,I Set-vices M o n d a y , April 2 6 ‘2 0 0 4 P a g e 3 of 4 I LastName Fir&Name Organization CityState Roth Joanne Nestle W a ters North America Breinigsville,P A Scammahorn C a r o l i n e C. Bayer Corporateand B u s i n e s s Services Pittsburgh, P A Selkowitz Scott J. International F o o d Distributors, Inc. Philadelphia,P A Smith Alexa Colorcon W e s t Point, P A Solari Patrizio Mafco W o r l d w i d e Corporation C a m d e n , NJ R i c h a r d T. T h e P h i l a d e l p h i aC o c a Cola Company Philadelphia,P A S tanley Gw DFA Chester Heights, P A S tartare Joseph A. J a d e International Inc. Philadelphia,P A S tromback Susan USDA/APHIS Robbinsville, NJ Sudario Judy S . Joyce Logistics, Inc. Lester, P A Suprenant M a r k N. W a w a Inc. Wawa, PA Taglang Tim Melitta U S A C h e r r y Hill, NJ Walker Shirley P A L i q u o r Control B o a r d Philadelphia,P A Waltuck-Barnett Randi S. Fonterra ( U S A ) Inc. Lemoyne, PA Warchol Mary Ann C u m b e r l a n d Dairy R o s e n h a y n , NJ Weaver Kristen E . Nelson Weaver and Son Inc. Lititz, P A Whitson B r a d L. K B R V e n d i n g Services, Inc. Bridgeton, NJ W illiams Jeremy Diageo S tamford, C T Wojciehowski Nancy A . C a p t ’n C h u n c k y ’s C r a b C a k e Co., L L C Newtown Square, PA Wyman Andrea Melitta U S A C h e r r y Hill, NJ Zupito . Richard M o n t g o m e r y Int’l Inc Essington, P A M o n d a y , April 2 6 , 2 0 0 4 P a g e 4 of 4 Department of Health and Human Services Food and Drug Administration FDA Updates “What You Need To Know To Ensure Compliance With the New FDA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Thursday, April 1,2004 - Boston, MA 7:OOAM- Open Registration . . . . . . . . . . . . . . . . . . . . . . . a. . . . . . . . . . . . . . . . . . . .........................USDA GraduateSchool 9:OOAM-Welcome and Introductions...... ........,.... ...... ... ..,.,._.. ........ . . . . . . . . . . . 1..1. . .Diana Koiaitis Regional Food and Drug Director NortheastRegion Office of Regulatory Affairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ., . . . . . . . . . . . . . . . . . .. Louis J. Carson,Deputy Director Food Safety and Security Staff CFSAN 95OAM - Demonstrationof Registration IT system/Lessonslearned... . . . . . . . . . . . . Diane Schmit, Project Manager ComputerTechnology Services,Inc. Questionsand Answers.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ._.. . . . . . ..CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of Imported Food Shipments/Lessonslearned... . . . . . . . . . . . . . . . . . . . . . . . ..Diana Kolaitis JamesMcLaughlin Bureauof Customs and Border Protection Departmentof Homeland Security 11:25PM - Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ORA, CBP Closing Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*............................................ Diana Kolaitis Thursday, April 1,2004 - Boston, M A 4 FDA Diana Kolaitis Regional Food and Drug Director Northeast Region Office of Regulatory Affairs Louis J. Carson, Deputy Director Food Safety and Security Staff Center for Food Safety and Applied Nutrition Kim Young Supervisory Consumer Safety Officer Office of Surveillance Compliance Center for Veterinary Medicine Diane Schmit, Project Manager (Contractor) Computer Technology Services, Inc M ichael Marley Division of Import Operations and Policy Office of Regulatory Affairs CBP James McLaughlin Bureau of Customs and Border Protection Department of Homeland Security FDA Domestic Outreach Meeting - Boston, MA i LustName FirstName Organization CityState Aiello Steve Creo Inc. Methuen, MA Albatal Susan Hasbro, Inc. East Providence, RI Anderson Jon Safe Markets LLP Ouincy, MA Aslanis Patricia A. Aslanis Seafoods, Inc. Quincy, MA Aufiero Jim Ruby Wines Avon, MA Backus Mike Blount Seafood Corporation Warren, RI Barrows Sam Barrows Tea Company New Bedford, MA Beane Robin Shaws Supermarkets W. Bridgewater, MA Borges Maria Hasbro, Inc. East Providence. RI Brady John E. International Trade Consuitants,‘lnc. South Portland, ME Bunn Jill E. Arkophanna, LLC Bedford, MA Burgos John PureTech, Inc. Hyannis, MA Burke Brian United Citrus Products Corp Norwood, MA Carlson Frank Woodland Partners, LLC Walpole, MA Cicerone Robert Superior Bakery, Inc Cranston, RI Ciesinski William Kuehne & Nagel, Inc. Boston, MA Clifford Robert Delmonte Fresh Produce Canton, MA Collins Dave Barthco International Philadelphia, PA Connelly Paula Middleton & Shrull Burlington, MA Dawson Kevin MA Department of Education Malden, MA D’Ettorre Tom Grand Union Family Markets Clifton Park, NY Donovan Paul DOPP Diane CFE International Watertown, MA Douglas Robin Boston Warehouse Trading Cot-p Norwood, MA Doyle Casey Hasbro, Inc. East Providence, RI Fazio Michael Christmas Tree Shops South Yarmouth, MA Fernandes Francisco Atlantic Shipping Company, Inc. Fall River, MA Fokum Jude MA Port Authority East Boston, MA Forman Andrew Infinity Seafoods, Inc. Chartley, MA Monday, April 26,2004 Newton, MA Page 1 of 4 \t LustName FirstName Organization CityState Frizzell Kathleen New England Toffee Company Actor-r, MA Frongillo Betty Americold Logistics Gloucester, MA Gilbert Helen British Consulate-General Cambridge, MA Gofferdo Frank Hanjim Shipping Braintree, MA Goulet Michelle Commonwealth Wine 8. Spirit Mansfield, MA Haddix Frances Venus Wafers inc. Hingham, MA Haley Christine Woodland Partners, LLC Walpole, MA Hardy Vicky Lindt and Sprungli USA Stratham, NH Harmon Joanne M. cvs Woonsocket, RI Haydu Robert J. Bayer Pharmaceutical Corporation West Haven, CT Hedglin Kelly A. The Massachusetts Port Authority East Boston, MA Heinz Michael Christmas Tree Shops So. Yarmouth, MA Higashibaba Shinichi True World Foods, Inc Boston, MA Hinsvark Sampson Katzman David C. H. Powell Company Westwood, MA Kazama Pamela Shawls Supermarkets West Bridgewater, MA Kazianis Arthur Hasbro, Inc. Pawtucket, RI Kenneally Bob FedEx Trade Networks Chelsea, MA Kenny Joe J.F. Moran Co. Inc. Smithfield, RI Kim Michael Lindt and Sprungli USA Stratham, NH Koh Robin MIT Cambridge, MA Kost Claudia Brigham’s Inc Arlington, MA Krauchu Mike FDA Boston, MA Kulesza Ann Customs House Broker Boston, MA Kulesza Ann AMK Custom House Broker South Boston, MA Labrecque Linda C. Dynasty CHB Inc. East Boston, MA Landers Cole Langelier Lisa Ocean Spray Cranberries, Inc. Lakeville, MA LaRosa John US Customs and Border Protection South Boston, MA Lawless James W. C.H. Powell Co Westwood, MA Le Mingwei Eastwest Pharmaceuticals International Shrewsbury, MA Leadbetter Bob Alliance Shipping North Easton, MA i Monday, April 26,2004 Woodbum, OR Boston, MA Page 2 of 4 11 ’ LastName FirstName Organization CiQState Levesque Meredith Phoenix lntl Freight Services Boston, MA Little Bette New England Pottery Foxboro, MA Lonergan Mark Classic Wine Imports, Inc. Boston, MA Macchione Richard Boston Bay Brokers, Inc. Boston, MA Machado Robert 1.Q.F. Custom Packing, Inc. Fall River, MA Mahn Stephanie Boston Warehouse Trading Corp Norwood. MA Martel Paul Americold Logistics Boston, MA Martin Debbie Cm0 Americans, Inc. Billerica, MA McCarthy John F. Sullivan 8 Lynch, P.C. Boston, MA McCarthy John M. Aslanis Seafoods, Quincy, MA Mcllvene Nancy Liberty International Pawtucket:RI McKay James Jungbunzlauer, Inc Newton Centre, MA McLaughlin Paul FedEx Trade Networks Chelsea, MA Miller James M. Expeditors International of Washington DC Peabody, MA Monroe John Perishables by Ocean Air Revere, MA Murray John JF Moran Co Chelsea, MA Musser John Jonathan’s Organic East Freetown, MA Neary Anne Christmas Tree Shops So. Yarmouth, MA O’Neill Steve Seppic Inc Fairfietd, NJ O’Rourke Carol Liberty International Pawtucket, RI Ortiz Dominique Hasbro, Inc. East Providence, RI Osinaga Christopher Naga Food Prcducts 1% Providence, RI Osinaga Mary Naga Food Products Inc Providence, RI Pepper Leo GMRI Inc. Boston, MA Pessoa Andre Agroconsult Florianopolis, SC Petri Norman DSA/Foxboro Terminals, Inc. Foxboro, MA Piotrowski Joseph A. Menlo Worldwide Trade Services Inc. Chelsea, MA Priest Michael 8. Millbrook Distribution Services Inc. Leicester, MA Quasarano Linda Boston Bay Brokers, lnc Boston, MA Queenan Mark Hans Kissle Company Haverhill, MA Reid Bob GMRI Inc. Boston, MA Renaut Steven P. A & A Ltd Custom Brokers New Bedford, MA Monday, April 26,2004 Inc. Page 3 of 4 r LustiVaine FirstName Organimtion C&State Rose Connie Hasbro, Inc. East Providence, RI Rothstein Herb Global Trade System Atteboro, MA Rounseville Cathy Jonathan’s Organic East Freetown, MA Roy0 Gabriel Royo Import & Export LLC Southborough. MA Russell Rosemary Eastern Bank Boston, MA SWCO Sharon J.F. Moran Co, inc. Chelsea, MA Santos Cheryl CVS Pharmacy Woonsocket, Rf Santos Linda Hasbro, Inc. East Providence, RI Saulnier Dan 1 BC Plant 69 New Bedford, MA Saunders Charlene R. Aslanis Seafoods, Inc. Quincy, MA Schon Janine M. Marine Management Insurance Brokers, Inc. Stoneham, MA Silva Michael Panalpina Inc. Windsor Locks, CT Smith Christine FedEx Trade Networks Chelsea, MA Spwd Philip Global Trade Systems North Atteboro, MA Spinali William Stacy’s Pita Chip Company Randolph, MA Stadelhofer David True World Foods, Inc Boston, MA Sullivan Michael MassachusettsExport Center New Bedford, MA Teixeira Louis 1 BC Plant #69 New Bedford, MA Velasquez Jim Boston Food Imports Boston, MA Watkins Christine Fair Tide Shellfish, Ltd New Bedford, MA Weaver Steven Net Yield Sales Westport, MA West Thomas Jungbunzlauer, Inc Newton Centre, MA Young Russel I.Q.F. Custom Packing, Inc. Fall River, MA US Customs and Border Protection South Boston, MA Young Zaniboni Greta FedEx Trade Networks Chelsea, MA Zur Muhlen Dorothy USDOC Commercial Service Boston, MA Monday, April 26,2004 Page 4 of 4