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omestic Outreach Meetin
omestic Outreach Meetin What You Need to Know to Ensure Compliance with the New Rules for Registration of Facilities and Prior Notice Location Date Radisson Hotel Denver Stapleton Plaza Denver, CO 80207 March 2,2004 49 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 Cat-y, 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 Number . of Reqistrations Department of Health and Human Services Food and Drug Admix&ration 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 &ZOO4 - Denver, CO 7:OOAM- OpenRegistration. . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . ............... .......... .USDA GraduateSchool 9:OOAM- Welcomeand Introductions............. ............................ ..... . . . . . . , . . . . .. . . .Dennis Baker RegionalFood and Drug Director SouthwestRegion Office of RegulatoryAffairs 9: 1OAM - Overview and Updateof Interim Final Rules for Registration of Food Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Leslye M. Fraser AssdciateDirector for Regulations Office of Regulationsand Policy CFSAN 9:5OAM - Demonstrationof RegistrationIT system/Lessonslearned...... . . . . .Melinda E. Chen,IT Specialist Scientific ComputerSupport Branch CFSAN Questionsand Answers............................................................ . . . . ..CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Updateof Interim Final Rules for Prior Notice of ImportedFood Shipments/Lessonslearned........................... .DennisBaker 11:25AM - Questionsand Answers...................................................... ORA Closing Remarks........................................................................... ..Dennis Baker _” _ .” DOMESTIC OUTREACH MEETINGS SPEAKXRS 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 Hackman 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 L&Name FirstName Organization 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 0.0. 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 m Anthony Continental Airlines Chelsea Denver, CO James Carrie J. UTi, Untied States, Inc Denver, CO Keiley Lou Graebel Movers International, Inc Aurora, CO Ketteier Kay Five Star Custom Foods Fort Worth, TX Kimbel Jacob W. VistarfVSA Denver, CO Klocker Patricia Colorado Dept. of Public Health i3 Environment Denver, CO Lakin Gary L. LJTi, 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 OKAMl 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 26,2004 Page 1 of 2 LastName FirstName Pelsmaeker Pelsmaeker Organization City State Eldorado Artesian Springs, Inc Eldorado Springs, CO Eldorado Arlesian Springs Louisville, CO CO Rae Cindy A. Passport Foods Company Denver, CO Reis John J. Coastline Seafood Company Englewood, CO Roles Edward C. Abbott Laboratories Abbott Park, IL Roth David S. Aspen Pet Products, Inc. Denver, CO Schiller Louise 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 Elvin Ft. FDA Denver, CO Smith Yuma 0. Graebel Movers International, Inc Aurora, CO Stutesman Terry Menlo Worldwide Trade Services Denver. CO Teitell Paul FDA Denver, CO Thomas Jay New Vistas Denver, CO Warren Vicki 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 W ith the New FDA Bioterrorism Act Registration and Prior Notice Interim F inal Rules” Thursday, March 4,2004 - Fresno, CA 7:OOAM- OpenRegistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ~.. . . . . .... ... ....,..............USDA GraduateSchool 9:OOAM- W e lcomeand Introductions........ .......... .............. .......... ... . . . . . . . . . . . ..1. . . .Mark Roh DeputyRegionalFoodandDrug Director Pacific Region O ffice of RegulatoryAffairs 9: 1OAM- Overview andUpdateof Interim F inal Rulesfor Registration of FoodFacilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... LeslyeM . Fraser AssociateDirector for Regulations O ffice of RegulationsandPolicy CFSAN 9:SOAM- Demonstrationof RegistrationIT system/Lessons learned... . . . . . . . . . . . *DianeSchmit, Project Manager ComputerTechnologyServices,Inc. Questionsand Answers... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ~.. . . . . . . . . . . . . . . . . . . . . . _.. . . . ..CFSAN, CVM, IT, ORA Break (15 m inutes) 10:45AM- Overview andUpdateof Interim F inal Rulesfor Prior Notice of ImportedFoodShipments/Lessons learned.., . . . . . . . . . . . . . , . . . . . . . . . ...Mark Roh 11:25- Questionsand Answers. . . . . .._.................................................... ClosingRemarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .._._.......................... ORA 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 l . F D A D o m e s ticO u treachM e e tin g - Fresno, C A LastName FirstName Organization CityState Adolph Chris A d o l p h Inc. Fresno, C A Adolph Phil Titus Ent. Inc. Fresno, C A Aquino David S u n W o r l d InternationalInc Bakersfield. C A Assali F r a n k J. Assali Hulling & Shelling Hughson,CA Avellar Thomas A & P Growers Tulare, C A Barry Debbie F & A Dairy of California Newman, CA Bath KennyS. M a r q u e z Bros. Int’l, Inc Hanford, C A Beshwate G r e g Ft. Best Logistics Clovis, C A Bouin James Expro Manufacturing Corporation Los Angeles, CA Bunkley Thomas E & J G a l l o W inery Fresno, C A Carlile Duane Foster F a r m s Livingston, C A Carter Jim F a r m i n g t o nF r e s h S tockton, C A Ceja Rigobetto G o l d e n Valley Dairy Products Tulare, C A Chavez Linda L a Tapatia Tortilleria, Inc Fresno, C A Clutter Kevin California G r a i n & F e e d Association Sacramento,CA Coffie Lonnie P e n n y - N e w m a nG r a i n C o Hanford, C A Cohan W illa Nick Sciabica & S o n s Modesto, C A Colbum Gary B. W e s t e r n Milling L L C Goshen,CA Cole C a l e b L. Rio B r a v o T o m a t o CompanyLLC Buttonwillow,C A Coleman Tony E & J G a l l o W inery Livingston Livingston, C A Collar Carol A . University of C A C o o p e r a t i v eExt Hanford, C A Collins Doris A . Zoria Farms, Inc Madera,CA Coitez Gabriel G o l d e n S tate F e e d s Reedley, C A Crisp Daryl L. A thens B a k i n g Co. Fresno, C A De La Torre J u a n Luis M a r q u e z Bros. Int’l, Inc Hanford, C A Delgado Frank C A D e p t of F o o d & A g Fresno. C A Dores Frank G o l d e n S tate F e e d s Tulare, C A Dunn Sean L i o n Raisins Selma, CA Falkenberg Rick White Oak Frozen Foods Newman, CA Fernandes Jose Valley G o l d Gustine, C A M o n d a y , April 2 6 . 2 0 0 4 P a g e 1 of 3 LastName FirstName Organimtion CityState 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 8 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 Hubbte 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 Inc 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 Lupe E&J Gallo Winery Fresno, CA Netto James Penny-Newman Grain Co Hanford, CA Nguyen Dominique G-UP Corporation San Jose, CA Munoz Monday,April 26.2004 . Page 2 of 3 LastName FirstName C’Farrell Brian Cfiara Sheri ADM Fresno, CA Papangellin George C. Gsrawan 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 Escalon, CA Taorm ina Bob Zoria Farms, Inc Madera, CA Thornton William C. Mid Valley Nut Company Hughson, CA Trujillo Larry Central California Warehouse Service Inc Visafia, CA Weist Michael A. Magic ke 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 Selma, 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- OpenRegistration. . . . . . . . . . . _. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ .. ................USDA GraduateSchool 9:OOAM- Welcomeand Introductions..... ........ ...... ........................ .. . . . . . . . . . . . . .. . . ..O.D. Evans Deputy RegionalFood and Drug Director SouthwestRegion Office of RegulatoryAffairs 9: lOAM - Overview and Updateof Interim Final Rules for Registration of Food Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. Mary J. Ayling Lead Inspections/Compliance Food Safetyand Security Staff CFSAN 95OAM - Demonstrationof RegistrationIT systemLessonslearned... . . . . . . . ., . . .Elaine Johanson,Director Office of information Technology Office of theChief InformationOfficer FDA Questionsand Answers... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +. . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . ..CFSAN, IT, CVM, ORA Break (15 minutes) 10:45AM - Overview and Update of Interim Final Rules for Prior Notice of ImportedFood ShipmentsLessonslearned... . . . . . . . . . . . , . . . . . ,. . . . . ..O.D. Evans Howard Duchan Bureauof Customsand Border Protection Departmentof HomelandSecurity 11:25&I - 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 El Paso, TX Adamson Barbara UPS Supply Chain Solutions Coppell, TX Alarcon Maria Franklin Logistics El Paso, TX Alcantar Joe Brown, Alcantar & Brown, Inc El Paso, TX Baca Javier F.C. Felhaber Customs Brokers El Paso, TX Barron Anthony Daniel Hastings Inc El Paso, TX Behrens Shannon Expeditom 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 Et 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 Aores Affonso Bimbo Bakeries El Paso, TX Garracho Jesus Hoody’s Original Nut House Brands Ei Paso, TX Gill Daniel FDA El Paso, TX Gonzalez Axigelii 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, Inc El Paso, TX Knowles Rosa Samuel L. Sanchez El Paso, TX Kuper Jennifer Price’s Creameries El Paso, TX Lane Chris Lane‘s Dairy LTD El Paso, TX Lemrnons Kevin National Dairy Holdings Dallas, TX Lopez Jose Guerrero Customs Brokers Brownsville, TX Monday, April 26,2004 Page 1 of 3 LastName FirstName Urgani@5n 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 Montelongo 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 OHS Customs & Border Protection El Paso, TX Oropesa Albert0 Grupo Bimbo Mexico, OF Ortic Edger AA Custom Broker El Paso, TX Padilla Noel OHS Customs & Border Protection El Paso, TX Palono Jacorm UPS Supply Chain Solutions El Paso, TX 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 Inc El Paso, TX Samaniego Emelda Glazer’s Wholesale Drug Co., Inc. Dallas, TX Sanchez Gerard0 Customs Broker Del Rio, TX Sanchez Manuel OHS 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 ” “. .._.,.“.,,” ,” LastName 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, lnc El Paso, TX William W. Union Ganadera Regional De Chihuahu Santa Teresa, NM Mila Glazer’s Wholesale Drug Co., Inc Dallas, TX Webster Count: 1 c I- ,,“_,, ““, 67 Monday, April 26,2004 ,_ ” ,. ., x,”,” ”“. ” I Page 3 of 3 ,“.,l”,“-” “I 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- OpenRegistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....*..*...................USDA GraduateSchool 9:OOAM- Weicomeand Introductions..... ... .., ........ ...... ..................._. . . . . . . . . . . ... . . . .O.D. Evans Deputy RegionalFood and Drug Director SouthwestRegion Office of RegulatoryAffairs 9: 1OAM- Overview andUpdateof Interim Final Rules for Registration of Food Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*........................... Mary J. Ayling Lead Inspections/Compliance Food Safety and Security Staff CFSAN 9:SOAM- Demonstrationof RegistrationIT system/Lessonslearned... . . . . . . . . . . . .Pino Marinelli, Lead Analyst GlobalNet Services,Inc. Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .CFSAN, CVM, IT, ORA Break (15 minutes) 10:4X&I - Overview andUpdateof Interim Final Rules for Prior Notice of ImportedFood Shipments/Lessons learned... . . . . . . . . . . . . . . . . . . . . . . . ..O.D. Evans 11:25AM - Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ORA Closing Remarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .O.D. Evans Thursday, March l&2004 - 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 FirstName Organization City State 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 Cattter Dave Nelson-Ricks Creamery Co Salt Lake City, UT Colebrook Michael UCI Milk Plant Draper, UT Crafts Jason Gossner Foods, tnc Logan, UT Daniels Jeff Central Milling Co Logan, UT Demeo Derek Expeditors International Salt Lake City, UT Eyres Melody Kuehne & Nagel 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. Asael Farr & Sons Salt Lake City, UT Gundersen Ted Nicholas & 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 1 of2 LastName FirstName Organization CityState Jones Marion L. Jones Bee Company Salt Lake City, UT Kay DeWayne HBH Enterprises Springville, UT Knight Susan M. Exe1Global Logisticw Salt Lake City, UT LaFleur Floyd Basic Convenience Food, lnc Ogden, UT Lindsey Kim P. MarketFare Foods Salt Lake City, UT Longaker John Condies Foods Salt Lake City, UT Majerus Warren Pharmore Ingredients Riverton, 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 Olschewski 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 Agriculture & Food Salt Lake City, UT Sims Doug AMT Labs, Inc North Salt Lake City, UT Slagowski Thane Twinlab Utah American Fork, UT Stickney Jack L. Associated Food Stores, Inc Fan 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 Tara Hanjin ShippingCo. Ltd., Salt Lake City, UT Fred Central Milling Co Logan, UT Walton Weston 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- OpenRegistration. . . . , . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . ........... ..............USDA GraduateSchool 9:OOAM- Welcomeand Introductions....... ......................... ............. . . . . . . . . . . . ... . . . .Dennis Baker RegionalFood and Drug Director SouthwestRegion Of&e of RegulatoryAffairs 9: 1OAM- Overview and Updateof Interim Final Rules for Registration of Food Facilities. . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . .. Melissa Scales RegulatoryCounsel Office of Regulationsand Policy CFSAN 9:5OAM - Demonstrationof RegistrationIT system/Lessonslearned. . . . . . . . . . . . . . .Daniel Goldman,Vice President GlobalNetServices,Inc. Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..I. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..CFSAN. CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Updateof Interim Final Rules for Prior Notice of ImportedFood Shipments/Lessons learned.. . . . . . . _.. . . . . . . . . . . . . . . . ..DermisBaker Michael Craig Bureauof Customsand Border Protection Departmentof HomelandSecurity 11:25AM - Questionsand Answers... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . . . . ORA, CBP Closing Remarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . _. . . . . . . . . . . . .. . . . . . . . . .-DennisBaker Tuesday, March l&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 Organization CityState AdcoCk 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 & Whkaker, lnc 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. lnc Westwood, KS Bongers Henry Kerry, Inc. Beloit, WI Brink Don Excel Corporation Wichii, Claxtorl Tony MO DepaFbnent of Agriculture Kansas City, MO Collins Casey PDM Distribution Services Des Moines, IA cot-l Christina O’Neill & Whitaker, Inc Kansas City, MO Coughenour Jo Danisco USA Inc New Century, KS Croan Don Hallmark Cards Carp Kansas City, MO Cross Emerick Unified Government Public Health Dept Kansas City, KS s 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 Cii, 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 26,2004 KS Page I of 4 LastName FirstName Organi@on Ci&!hte Guminger Catherine UPS Supply Chain Solutions Kansas City, MO Guttormson Gerald Mrs. Clark’s Foods LC Ankeny, IA Haak Brad Rockwell Automation Omaha, NE Hale Reecie Amencan Italian Pasta Co Excelsior Springs, MO Harris Sue Hill’s Pet Nutrition Topeka, KS Heintzelman Nancy USDAfFSA Kansas City, MO Hentges Heidi Expeditors International of Washington Kansas City, MO Hudson Thomas Three Dog Bakery Kansas City, MO Hunt Eula McCormick Distilling Co Weston, MO Jones Jerry Marisol International Kansas City, MO Jordon Marion Jordon Foods Co. Inc. Knob Noster, MO Keller Donald O’Neill & Whitaker, Inc Kansas City, MO Klassen Tiiany Cass County Health Department Harrisonville, MO Knight D. T. Gallagher Transport lntf Kansas City, MO Koscielski Brian Rockwell Automation Lenexa, KS Kraft Kirby Busch Agricultural Resource, Inc St. Louis, MO Kutliek Lori Bunge North American lnc St. Louis, MO Layton Kw US Customs and Border Protection Kansas City, MO Leatherbury Mary Ellen Alliance Customs Clearance, Inc Mission, KS Lee Rachel Sea Harvest Seafood Company Kansas City, 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 USDAIFSA Kansas City, MO McMillin Raymond City Ice Co., Inc. Junction City, KS McMullen John N. Roberts Dairy Kansas City, MO Meinharclt Russell Old World Spices Kansas Cii, MO Mendlik Jim Hansen-Mueller Co Omaha, NE Merrick Brenda O’Neill & Whitaker, Inc Kansas City, MO Mitchell Robert Manildra Milling Corporation Shawnee Mission, KS Moore Tommy R. Held & Associates lnc North Kansas City, MO Monday, April 26,2004 Page 2 of 4 LastName FirstName Organization CityState Moores James S. Moores English Fine Foods, LLC Liberty, MO Mundy Cynthia Ancient Formulas, Inc Wichita, KS MUWay 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 & Whitaker 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 Schtick Raymond Centennial Warehouse CQrp Atchison Wholesale Grocery, Inc Siebers Stephen F. Marisol 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. Deil 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 Viialab Kansas City, MO Wilkins Rick Mr. Dell Foods, Inc. Keamey, MO Williams Karen USDA/FSA Kansas City, MO Williams Lisa McCormick Distilling Co Weston, MO Wiseman Gene MO Department of Agriculture Kansas City, MO Garry L. Herman Nut Company Omaha, NE Karlan Bimeda Inc Riverside, MO Woita Yager Monday, April 26,2004 . ss . Atchison, KS Page 3 of 4 LastName FirstName Organization CityState Zender Bob Bogdon Candy Co. Inc Westwood, KS Ziha Brian W. Customs Express, Inc St. Louis, MO 1Count: i 94 t 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 FQA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Thursday, March 18,2004 - New Orleans, LA 7:OOAM- OpenRegistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ....._................... USDA GraduateSchool 9:OOAM- Welcome and Introductions....... .......................... ....... ..... . . . . . . . . . . . _.... ..Malcolm Frazier Deputy RegionalFood and Drug Director SoutheastRegion 0ffb.x of RegulatoryAffairs 9: 1OAM- Overview and Updateof Interim Final Rules for Registration of Food Facilities.. . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... L. RobertLake, Director Office of Regulationsand Policy CFSAN 95OAM - Demonstrationof RegistrationIT system/Lessonslearned... . . . . .Ray Russo,Director Office of BusinessEnterpriseSolutions Office of Chief Information Officer FDA Questionsand Answers... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Updateof Interim Final Rules for Prior Notice of ImportedFood Shipments/Lessonslearned... . . . . . . . . . . . . . . . . . ,.Malcolm Frazier Howard Hodes Bureauof Customsand Border Protection Departmentof HomelandSecurity 11:25AM - Questionsand Answers...................................................... ORA, CBP Closing Remarks........................................................................... ..MalcoIm Frazier Thursday, March l&2004 - New Orleans, LA FDA Malcolm Frazier Deputy Regional Food and Drug Director SoutheastRegion 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 LastNume FirstName Organization citystate Adamson Barbara L. UPS - scs Coppell, TX Alger Bill Port Cargo Service New Orleans, LA Andrews 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 Inc Kenner, LA Gallo 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, L4 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 7 of2 LastName FirstName Organizsztion C%yState Ricker Todd Accenture New York, NY Royster Priscilla The Irwin Brown Co Gulfport, MS Terre0 M. Colleen The Folgers Coffee Company New Orleans, LA Turner Jacqueline A. Alexander International Metairie, LA Wactor Kim Alexander International LLC Metairie, LA Williams JoAnn Liner Services Int’l Inc Diamondhead, MS Wilson Melzana Mallory Alexander International Logistics Memphis, TN Wilson Nikki Mallory Alexander International Little Rock, AR Count: [ 39 Monday,April 26,2004 1 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 FlDA Bioterrorism Act Registration and Prior Notice Interim Final Rules” Tuesday, March 23,2004 - Raleigh, NC 7:OOAM- OpenRegistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........................USDA GraduateSchool 9:OOAM-Welcome and Introductions.... ........-.. ..... .... ...........f..... ..... . . . . . , . . . . ... . . . .Gary Dykstra RegionalFood and Drug Director SoutheastRegion Office of RegulatoryAffairs 9: 1OAM - Overview and Update of Interim Final Rules for Registration of Food Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. Louis J. Carson,DeputyDirector Food SafetyandSecurityStaff CFSAN 9:5OAM - Demonstrationof RegistrationIT system/Lessonslearned... . . . . . . . . . . . .Erwin Miller, IT Specialist Division of InformationResourceMgmt ComputerSupportBranch Questionsand Answers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*...................................* CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Updateof Interim Final Rules for Prior Notice of ImportedFood Shipments/Lessonslearned... . . , . . . . . . . . . . . . . . . . . . . . . .Gary Dykstra 11:25AM - Questionsand Answers... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ORA Closing Remarks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .._.........................I... Gary Dykstra _. __ ” _ -, “, , _ ” “” _, ” ” ” _, -_ __ _“,” .,,,,,,, _x ,_“,_,-xx,” I,lr”, .--, T u e s d a yM , a rch 2 3 ,2 0 0 4- R a le ig h N , C FDA G a ry Dykstra R e g ionalF o o d a n d D r u g D irector S o u th e a sRt e g ion O ffice o f R e g u latoryA ffa irs L o u is J. C a r s o n ,D e p u tyD irector F o o d S a fe tya n d SecurityS ta ff C e n terfor F o o d S a fe tya n d A p p lie d N u tritio n K im Y o u n g SupervisoryC o n s u m e rS a fe tyO fficer O ffice o f SurveillanceC o m p lia n c e C e n terfor V e terinaryM e d icine E rwin M iller, IT S p e c ialist( C o n tractor) D ivision o f In fo r m a tio n R e s o u r c eM g m t C o m p u terS u p p o r tB ranch K e lle Fry D ivision o f Im p o r t O p e r a tio n sa n d P o licy O ffice o f R e g u latoryO ffices _ ,,,-- _l__,_^*,” ,,,, “,“~ 1.,,, 1”“““” _-,r .““S.. _I 1.1 .““.x-..-“I-.I-----“.- FDA Domestic Outreach Meeting - Raleigh, NC La&Name FirstName Organization CityState Brock Douglas Mount Olive Pickle Company Mount Olive, NC Chafin Cathy Waters Shipping Company Wilmington, NC Chrapliw-y C. Vincent Miller Brewing Co. Eden, NC Davis Joseph D. Davis Seafood Inc. Sneads Ferry, NC Davis Vickie H. Davis Seafood, Inc. Sneads Ferry, NC Dillingham Lynn Performance Food Group Richmond, VA Edwards Jr. Thomas L. Carolina Ice Company Kinston, NC Figueroa Amie L. EXEL Global Logistics, Inc. Morrisville, NC Fletcher James Wanchese Fish Company Wanchese, NC Ford Wendy G. UPS Supply Chain Solutions Greensboro, NC Franklin Randall A. Great Eastern Sun Asheville, NC Frazier Glenn Aqua Pure Bottled Water Inc. Asheboro, NC Fubelli David DHL Danzas Morrfsville, NC Gabriel Larry NCDA & CS Raleigh, NC Golson M. Grady Old Saratoga, Inc. Saratoga, NC Hauser William E. Le Bleu Corp Advance, NC Helms David L. Northampton Peanut Co. Sevem, NC Henthorn Danielle M. The Hipage Company Inc. Morrisville, NC Howard Duane Carolina Ice Company Kinston, NC Howell Don NCDA Raleigh, NC , Huff Donna E. Dancing Doe Dairy Pittsboro, NC Hutchinson Lona E. Unilever Bestfoods Asheboro, NC lbrahim Salam A. North Carofina AT&T S U Greensboro, NC lngraham Joyce Ocean Seafood Wilmington, NC Jacobs Ralph Amalfitano’s Italian Bakery New Castle, DE Johnston Keith Ft. Old Saratoga, Inc. Saratoga, NC King Joe Carolina Treet, Inc. Wilmington, NC Lewis Ken E. Lewis Storage Co. Greensboro, NC Moore Donna S.’ Star Food Products Inc. Burlington, NC Moretz Mark R. Carolina Foods Charlotte, NC Oakley Keith Montibello Foods, LLC Graham, NC Monday, April 26,2004 Page 1 of 2 LastName FirstName Organivltion 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 RObfiSt 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 GtySlate 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 24,2004 - Philadelphia, PA 7:OOAM- OpenRegistration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........ .. ....... .........USDA GraduateSchool 9:OOAM- Welcome and Introductions............. ... ................. ............ . . . . . . . . . . . . .. . . . .SusanSetterberg RegionalFood and Drug Director CentralRegion Office of RegulatoryAffairs 9: IOAM - Overview and Updateof Interim Final Rules for Registration of Food Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. Louis J. Carson,Deputy Director Food Safety and Security Staff CFSAN 9:5OAM - Demonstrationof RegistrationIT system/Lessonslearned.. . . . . . . . . . . . . Larry Dusold, Chief Division of Information ResourceMgmt Scientific ComputerSupport& Webmaster CFSAN Questionsand Answers... . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Updateof Interim Final Rules for Prior Notice of ImportedFood Shipments/Lessons learned. . . . . . . . . . . . . . . . . . . . . . . . . . ..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 Offrce Regulatory Affairs Louis I. 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 ResourceMgmt Scientific Computer Support & Webmaster Center for Food Safety and Applied Nutrition FDA Domestic Outreach Meeting - Philadelphia, PA Fir&Name 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 Intl Folcroft, PA Austin Penny M. Tasty Baking Oxford, Inc. Oxford, PA Bahr Nora H. Rhodia Inc Cranbuty, NJ Barbieri ROberta Oiageo Stamford, CT 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 Cii, 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 Burkhart 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 Campbell 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, April 26,2004 Page 1 of 4 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 Flares Ray Melitta USA Cherry Hill, NJ Gerhart Ted BDP International Philadelphia, PA Gilpin Michael Nutramax Laboratories Edgewood, MD Glatfelter Timothy Mr. Bill’s 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 B. 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 Ray BDP International Philadelphia, PA Monday,April 26.2004 Pittsburgh, PA Page 2 of 4 LastName FirstName Organization CityState Kralik Rebecca A. Bayer Chemicals Corporation Pittsburgh, PA Kropiewnicki John J. Mafco Worldwide Corporation Camden, NJ Lacotte Joseph G. Seabrook Brothers and Sons Seabrook, NJ Land Mark Boiron-Borneman Newtown Square, PA Lassen Thor Nordic Ventures Great Falls, VA Mantello Joseph NBTY, Inc. Holbrook, NY McNeil Anita G. AMC USA, Inc. New York, NY Meintzer JoAnne Jade International Inc. Philadelphia, PA Menzel Stuart K. Pepsi Cola Bottling Company Charlotte, NC fvlerola Monty J. Bmvo Packing, Inc Carney’s Point, NJ Molnar Allen Klett Rooney Lieber & Schoriing P.C. Newark, NJ Frankford Candy & Chocolate Company Philadelphia, PA Moore Mullan Shaun Alpha International Essington, PA Noga Frank S. Campbell Soup Company Camden, NJ Novak Jeffrey T. Unique Industries, Inc. Philadelphia, PA Ouellette Mark H. FedEx Express Mississauga, ON Palchak Thomas R. University Creamery University Park, PA Palm Gregory Sunsweet Growers, Inc. Yuba City, CA Parrotti Diane Brooks Provisions, Inc. Philadelphia, PA Perry Jim Particle Size Technology, Inc. Quaker-town, PA Pete Jr. Scottc. Hilo Export Barnegat Light, NJ Bayer Corporate and Business Services Pittsburgh, PA Pinchok Rainey-Wright Bonnie L. DBA Distribution Services Somerset, NJ Ready Elizabeth M. Campbell Soup Company Camden, NJ Reininger Cathy D. Uptown Bakeries Bridgeport, NJ Reynolds Jim John A. Steer Co Philadelphia, PA Rhoades Joseph Schenker Inc. Sharon Hill, PA Richardson Robert Asher’s Chocolates Inc. Souderton, PA Rihs Deborah A. Aldon Food Corp Schwenksville, PA Riley Lynn USDA/APHIS Robbinsville, NJ Rodriguez Paul 0. American River Brokerage Elizabeth, NJ Monday, April 26,2004 I Page 3 of 4 LastName FirstName Organization City State Roth Joanne Nestle Waters North America Breinigsville, PA Scammahorn Caroline C. Bayer Corporate and Business Services Pittsburgh, PA Selkowitz Scott J. International Food Distributors, Inc. Philadelphia, PA Smith Alexa Colorcon West Point, PA Solari Patrizio Mafco Worldwide Corporation Camden, NJ Somershoe Richard T. The Philadelphia CocaCola Company Philadelphia, PA Stanley Gary DFA Chester Heights, PA Startare Joseph A. Jade International Inc. Philadelphia, PA Stromback Susan USDA/APHIS Robbinsville, NJ Sudario Judy S. Joyce Logistics, Inc. Lester, PA Suprenant Mark N. Wawa Inc. Wawa, PA Taglang Tim Melitta USA Cherry Hill, NJ Walker Shirley PA Liquor Control Board Philadelphia, PA Waltuck-Barnett Randi S. Fonterra (USA) Inc. Lemoyne, PA Warchol Mary Ann Cumberland Dairy Rosenhayn, NJ Weaver Kristen E. Nelson Weaver and Son Inc. Lititz, PA Whitson Brad L. K & R Vending Services, Inc. Bridgeton, NJ Williams Jeremy Diageo Stamford, CT Wojciehowski Nancy A. Caprn Chuncky’s Crab Cake Co., LLC Newtown Square, PA Wyman Andrea Melitta USA Cherry Hill, NJ Zupito . Richard Montgomery Int’l lnc Essington, PA Jcouf?t: 1 112 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, April I,2004 - Boston, MA 7:OOAM- OpenRegistration. . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . ............ ..............USDA GraduateSchool 9:OOAM- Welcome and Introductions.... .. ....................................... . . . . . . . . . . . ... . . ..Diana Kolaitis RegionalFood and Drug Director NortheastRegion Office of RegulatoryAffairs 9: 1OAM- Overview and Updateof Interim Final Rules for Registration of Food Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. Louis J. Carson,Deputy Director Food Safetyand Security Staff CFSAN 9:SOAM- Demonstrationof RegistrationIT system/Lessonslearned... . . . . . . . . . . . . Diane Schmit, Project Manager ComputerTechnologyServices,Inc. Questionsand Answers.. . . . . . . . . . ..,... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..CFSAN, CVM, IT, ORA Break (15 minutes) 10:45AM - Overview and Updateof Interim Final Rules for Prior Notice of ImportedFood Shipments/Lessonslearned.., . . . . . . . . . . . . . . . . . . . . . . , ..Diana Kolaitis JamesMcLaughlin Bureauof Customsand Border Protection Departmentof HomelandSecurity 11:25PM- Questionsand Answers.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . _.. . . . . . . . . . . . . _.. ORA, CBP Closing Remarks. . . . . . . . . . . . . , . . . . . . , . . . . . . . . . . . . . . _. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..DianaKolaitis Thursday, April 1,2004 - Boston, MA 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 S&nit, Project Manager (Contractor) Computer Technology Services, Inc Michael Marley Division of Import Operations and Policy Offrce of Regulatory Affairs JamesMcLaughlin Bureau of Customs and Border Protection Department of Homeland Security FDA Domestic Outreach Meeting - Boston, MA i LastName Fir&Name Organization CityState Aiello Steve Creo Inc. Methuen, MA Atbatal Susan Hasbro, Inc. East Providence, RI Anderson Jon Safe Markets LLP Quincy, 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 Barges Maria Hasbro, Inc. East Providence, RI Brady John E. International Trade Consultants,‘lnc. South Portland, ME Bunn Jill E. Arkopharma, LLC Bedford, MA Burgos John PureTech, Inc. Hyannis, MA Burke Brian Norwood, MA Carlson Frank United Citrus Products COP 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 Corp 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. Chartiey, MA Monday, April 26,2004 Newton, MA Page 1 of 4 LastName FiktName Organization CityState Frizzell Kathleen New England Toffee Company Acton, MA Frongillo Betty Americold Logistics Gloucester, MA Gilbert Helen British Consulate-General Cambridge, MA Gofferdo Frank Hanjim Shipping Braintree, MA Goulet Michelle Commonwealth Wine & Spirit Mansfield, MA Haddix Frances Venus Wafers Inc. Hingham, MA Haley Christine Woodland Partners, LLC Walpole, MA Hardy Vicky Lindt and Sprungfi 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, lnc Boston, MA Hinsvatk Sampson Katzman David C. H. Powell Company Westwood, MA Kazama Pamela Shaw’s 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 Shrewsbury, MA International Leadbetter Bob Alliance Shipping Monday, April 26,2004 Woodburn, OR Boston, MA North Easton, MA Page 2 of 4 LastName FirstName Organization City State 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 I.Q.F. Custom Packing, Inc. Fall River, MA Mahn Stephanie Boston Warehouse Trading Corp Norwood, MA Martel Paul Americold Logistics Boston, MA Martin Debbie Creo Americans, Inc. Billerica, MA McCarthy John F. Sullivan & Lynch, P.C. Boston, MA McCarthy John M. Aslanis Seafoods, Inc. 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 Q’Neiil Steve Seppic Inc Fairfield, NJ O’Rourke Carol Liberty International Pawtucket, RI Ortiz Dominique Hasbro, Inc. East Providence, RI Osinaga Christopher Naga Food Products Inc Providence, RI Osinaga Maly Naga Food Products Inc Providence, RI Pepper Leo GMRI Inc. Boston, MA Pessoa Andre Agroconsult Florianopolis, SC Petri Norman DSAfFoxboro Terminals, inc. Foxbom, MA Piotrowski Joseph A. Menlo Worldwide Trade Services Inc. Chelsea, MA Michael B. Millbrook Distribution Services Inc. Leicester, MA Quasarano Linda Boston Bay Brokers, Inc 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 Page 3 of 4 L&Name FirstName Organiz@ion CityState ROSf3 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 UC Southborough, MA Russell Rosemary Eastern Bank Boston, MA Sacco Sharon J.F. Moran Co, Inc. Chelsea, MA santos Cheryl CVS Pharmacy Woonsocket, RI Santos Linda Hasbro, Inc. East Providence, RI Saulnier Dan 1 BC Plant 69 New Bedford, MA Saunders Charlene Ft. Aslanis Seafoods, Inc. Quincy, MA Schon Janine M. Marine Management Insurance Brokers, Inc. Stoneham, MA Silva Michael Panalpina Inc. Windsor Locks, CT Smith Christine Fe&x Trade Networks Chelsea, MA Sfwd Philip Global Trade Systems North Atteboro, MA Spinali William Stacy’s Pi Stadelhofer David True World Foods, Inc Boston, MA Sullivan Michael Massachusetts Export Center New Bedford, MA Teixeira Louis 1 BC Plant X69 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, lnc Newton Centre, MA Young Russel I.Q.F. Custom Packing, Inc. Fall River, MA Young Steve US Customs and Border Protection South Boston, MA Zaniboni Greta FedEx Trade Networks Chelsea, MA Zur Muhlen Dorothy USDOC Commercial Boston, MA /Count- 1 Chip Company Randolph, MA 119 Monday, April 26,2004 Page 4 of 4