Global Regulatory .com -US FDA regulatory forms for pharmaceuticals, medical devices, biotechnology, food, cosmetics

FDA Form #	Date	Title	Format	Paper Copy or Contact Info.
3069	10/80	Above Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record		CFPDC
2784	10/80	Above Table X-Ray Source Radiographic {2784.1-Pg1, 2784.2-Pg2, 2784.3-Pg3} Systems		CFPDC
431	05/84	Analyst Worksheet		CFPDC
2891a	03/02	Annual Registration of Medical Device Establishment{Instructions}	Not Yet Electronic	Bryan H. Benesch 301-594-4699 EXT 122
2656e	12/98	Annual Update of Drug EstablishmentNO LONGER USED	Not Yet Electronic	OTCOM 301-827-4573
766	12/97	Application for Authorization to Relabel or to Perform Other Action		CFPDC
3147	12/00	Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show		Debbie Clingan 301-594-4654
1993	02/03	Application for Permit to Ship or Transport Milk and/or Cream into US		Ester Lazar 301-436-1485
356h	04/03	Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use		CFPDC
1570a	04/78	Bacteriological Definitions	Not Yet Electronic	CFPDC
431d	10/74	Bacteriological Record		CFPDC
2682	10/88	Beverage Plant Inspection Report		CFPDC
3486	03/01	Biological Product Deviation Report{Instructions}		Sharon O'Callaghan 301-827-6220
2830	02/03	Blood Establishment Registration and Product Listing{Instructions}		Janet Ishimoto 301-827-3543
431j	08/85	Botulism Continuation Sheet		CFPDC
431i	10/85	Canned Food Continuation Sheet		CFPDC
3260	02/83	C-Arm Fluoroscopic & Spot-Film Systems Field Test Record		CFPDC
3437	06/95	CDER Pediatric Use Supplement		CDR 301-827-4210
3514	12/01	CDRH Submission Cover Sheet		Chris Colburn 301-827-7669
1815	02/03	Certificate/ Transmittal for an Application		CFPDC
3454	02/03	Certification: Financial Interest and Arrangements of Clinical Investigators		Leah W. Ripper 301-827-5921
3504	03/01	Color Additive Petition Submission		Maribeth LaVecchi 202-418-3072
2359g	04/86	Condensed & Dry-Milk & Whey Plant Inspection Report	Not Yet Electronic	CFPDC
3131	08/01	Contract Property Administration Completion Report		Mike McGrath 301-827-7105
2512a	02/03	Cosmetic Product Ingredient Statement{Instructions}		VCRP 202-418-3414
2512	02/03	Cosmetic Product Ingredient Statement {Instructions}		VCRP 202-418-3414
2400	03/01	Cultural Procedures - General Requirements		Virgil Jones 708-728-4120
2359a	06/02	Dairy Farm Inspection Report		CFPDC
1996	10/99	Dairy Farm Sanitation Report		Ester Lazar 301-436-1485
1996	02/03/99	Dairy Farm Sanitation Report		Ester Lazar 301-436-1485
2399	06/02	Dairy Plant Sampling - Raw & Pasteurized Milk	Not Yet Electronic	Norris Robertson 301-436-1560
2877	12/00	Declaration of Products Subject to Radiation Control Standards		Debbie Clingan 301-594-4654
2785	05/82	Dental Radiographic Systems Field Test Record		CFPDC
3455	02/03	Disclosure: Financial Interest and Arrangements of Clinical Investigators		Leah W. Ripper 301-827-5921
3501	01/01	Domestic Seafood (HACCP) Report	Not Yet Electronic	Rochelle King 301-436-1416
2657	07/01	Drug Product Listing{Instructions}		OTCOM 301-827-4573
3463	07/00	EDI Gateway Training Partner Agreement	Not Yet Electronic	Bill Taylor 301-827-6504
3538	11/02	Electronic Submission System Participant Password or Addition		Elizabeth Parbuoni 301-827-03845
431m	12/79	Elemental Analysis Worksheet		CFPDC
3356	10/02	Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products		tissuereg@cber.fda.gov
3452	04/97	Export Certificate to Foreign Governments		Gloria Dunnavan 301-827-1166
3511-2	01/02	FDA Acidified Food Inspection Report		Brian Hendrickson 317-226-6500 Ext. 12
3511	01/01	FDA LACF Inspection Report		Brian Hendrickson 317-226-6500 Ext. 12
2814	08/93	Field Equipment Request		William Campanaro 301-827-1035
2782	09/98	Field Test Record Continuation Sheet		Stephen Toigo 301-827-2906
3316a	08/85	Folder, Drug Master File (Blue)	Not Yet Electronic	GPO
3316	08/85	Folder, Drug Master File (Red)	Not Yet Electronic	GPO
3503	03/01	Food Additive Petition Submission		Maribeth LaVecchi 202-418-3072
2541	09/02	Food Canning Registration{Instructions}		LACF Coordinator 301-436-2411
2966	10/88	Food GMP Inspection Report		CFPDC
2541a	09/02	Food Process Filing For All Methods Except Low-Acid Aseptic{Instructions}		LACF Coordinator 301-436-2411
2541c	04/02	Food Process Filing For Low-Acid Aseptic Systems{Instructions}		LACF Coordinator 301-436-2411
2679	09/88	Food Warehouse Inspection Report		CFPDC
431a	05/84	General Continuation Sheet		CFPDC
3429	01/03	General Device Classification Questionnaire		Marjorie Shulman 301-594-1190
3071	10/80	General Information Field Test Record	Not Yet Electronic	CFPDC
3422	09/02	Government Entity Declaration		Susan Appleby 301-594-3653
3297	04/84	Head and Neck Radiographic Systems Field Test Record		CFPDC
3502	01/01	Importer Seafood HACCP Report	Not Yet Electronic	Rochelle King 301-436-1416
359v	06/90	INAD Folder (VET)	Not Yet Electronic	David Newkirk 301-827-6967
431e	03/80	Industrial Chemicals Worksheet	Not Yet Electronic	CFPDC
2891	03/02	Initial Registration of Medical Device Establishment{Instructions}THIS FORM MUST BE SUBMITTED IN TRIPLICATE		DSMA FAX 301-443-8818
2589	08/01	Inspection Summary - Bus Service Area Sanitation		CFPDC
2591	08/01	Inspection Summary - Equipment Evaluation		CFPDC
2359h	02/98	Interstate Milk Shipper Check-Rating Report		CFPDC
2359i	03/97	Interstate Milk Shipper Report		CFPDC
3038	08/03	Interstate Shellfish Dealer's Certificate		Charlotte Epps 202-205-8155
1571	01/03	Investigational New Drug Application{Instructions}		CFPDC
2675a	07/84	Investigational New Drug Folder (Green)	Not Yet Electronic	GPO
2675b	07/84	Investigational New Drug Folder (Orange)	Not Yet Electronic	GPO
2675	07/84	Investigational New Drug Folder (Red)	Not Yet Electronic	GPO
2196	07/87	company Management Coding Sheet	Not Yet Electronic	CFPDC
3070	08/92	Mammography Systems Field Test Record		CFPDC
2359c	03/92	Manufacturing Plant Inspection Report		CFPDC
3602	02/03	MDUFMA Small Busines Qualification Certificate	Not Yet Electronic	James Norman 301-827-6829
2892	03/02	Medical Device Listing{Instructions}	Not Yet Electronic	DSMA FAX 301-443-8818
3419	04/00	Medical Device Reporting Annual User Facility Report{Instructions}		William Huff 301-594-3888
3417	04/00	Medical Device Reporting- Baseline Report- Part 1{Instrucitons}		William Huff 301-594-3888
3601	04/03	Medical Device User Fee Cover Sheet		David Wardrop Jr. 301-827-3512
3448	03/97	Medicated Feed Mill License Application		Patsy Gardner 301-827-0187
3500	11/02	MedWatch: FDA Medical Product Reporting Program{Instructions}		CFPDC
3500A	11/02	MedWatch: FDA Medical Products Reporting Program - Mandatory{Instructions}		CFPDC
2400a-1	03/01	Milk company Evaluation Form: Spiral Plate Count Methods		Virgil Jones 708-728-4120
2400a	03/01	Milk company Evaluation Form: Standard Plate Count, Coliform, and Simplified Count Methods		Virgil Jones 708-728-4120
2359b	06/00	Milk Plant Equipment Tests Report		CFPDC
2359	06/00	Milk Plant Inspection Report		CFPDC
2399a	06/02	Milk Tank Truck, Hauler Report and Sampler Evaluation	Not Yet Electronic	Norris Robertson 301-436-1560
2399b	06/02	Milk Tank Truck Inspection	Not Yet Electronic	Norris Robertson 301-436-1560
2400m	03/01	MLEF Dairy Waters		Virgil Jones 708-728-4120
2400b-1	03/01	MLEF Detection of Inhibitory Substances in Milk Bacillus Stearothermophilus		Virgil Jones 708-728-4120
2400b-3	03/01	MLEF Detection of Inhibitory Substances in Milk Delvotest 5 Pack		Virgil Jones 708-728-4120
2400b	05/87	MLEF Detention of Inhibitory Substances in Milk	Not Yet Electronic	Virgil Jones 708-728-4120
2400d	03/01	MLEF Direct Microscopic Somatic Cell Count		Virgil Jones 708-728-4120
2400l	03/01	MLEF Disintegration Method for Paper, etc.		Virgil Jones 708-728-4120
2400h-2	03/01	MLEF Electronic Somatic Cell Count Bentley Somacount 150/300/500		Virgil Jones 708-728-4120
2400 h-1	03/01	MLEF Electronic Somatic Cell Count Foss 250/300/360/400		Virgil Jones 708-728-4120
2400h-3	03/01	MLEF Electronic Somatic Cell Count Fossmatic 5000		Virgil Jones 708-728-4120
2400k	03/01	MLEF Flat Lid Methods		Virgil Jones 708-728-4120
2400e	05/87	MLEF Membrane Filter - DNA Somatic Cell Count	Not Yet Electronic	Virgil Jones 708-728-4120
2783	10/80	Mobile Radiographic Systems Field Test Record		CFPDC
358v	03/89	NADA Folders (VET)	Not Yet Electronic	David Newkirk 301-827-6967
3331	02/03	NDA Field Alert Report		Rodger Gregorio 301-827-8921
356v	01/02	New Animal Drug Application [VET]		Sam Hansard, Ph.D. 301-827-0211
2626	07/84	New Drug Application Folder (Blue) Archival	Not Yet Electronic	GPO
2626f	02/87	New Drug Application Folder (Light Green) Statistics	Not Yet Electronic	GPO
2626h	08/92	New Drug Application Folder (Maroon) Field Submission Chemistry	Not Yet Electronic	GPO
2626c	05/86	New Drug Application Folder (Orange) Pharmacokinetic	Not Yet Electronic	GPO
2626a	05/86	New Drug Application Folder (Red) Chemistry	Not Yet Electronic	GPO
2626e	05/86	New Drug Application Folder(Tan) Clinical Data	Not Yet Electronic	GPO
2626d	02/87	New Drug Application Folder (White) Microbiology	Not Yet Electronic	GPO
2626b	05/86	New Drug Application Folder (Yellow) Pharmacology	Not Yet Electronic	GPO
NLEAF	03/00	NLEA Exemption		ONPLDS 202-205-4561
2767	01/01	Notice of Availability of Sample Electronic Product		Debbie Clingan 301-594-4654
3458	09/02	Notice of Claimed Investigational Exemption (electronic) Instructions		Elizabeth Parbuoni 301-827-3845
3458p	11/02	Notice of Claimed Investigational Exemption (paper)Instructions		Elizabeth Parbuoni 301-827-3845
2514	01/03	Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation{Instructions}		VCRP 202-418-3414
3487	07/01	Notice of Final Disposition of Animals not Intended for Immediate Slaughter Instructions		Elizabeth Parbuoni 301-827-3845
3488	07/01	Notice of Intent to Slaughter for Human Food PurposesInstructions		Elizabeth Parbuoni 301-827-3845
3479	06/02	Notification for a Food Contact Substance Formulation		Mitchell Cheeseman 202-418-3083
3480	06/02	Notification For New Use Of A Food Contact Substance		Mitchell Cheeseman 202-205-3083
2400i	03/01	Pasteurized Milk Containers		Virgil Jones 708-728-4120
3542	07/03	Patent Information Submitted Upon and After Approval of An NDA or Supplement		Jarilyn Dupont 301-827-5906
3542a	07/03	Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement		Jarilyn Dupont 301-827-5906
3068	08/92	Peak Kilovoltage Determination Field Test Record		CFPDC
1814	02/03	Permit to Ship or Transport Milk and/or Cream into the United States Under the Federal Import Milk Act		Ester Lazar 301-436-148
2400j	03/01	Phosphatase Tests		Virgil Jones 708-728-4120
3541	12/02	Premarket Notification [510(K)] Status Request and Response		Chris Colburn 301-827-7669
3511g	01/01	Processing in Cascading/Spray Water Retort		Brian Hendrickson 317-226-6500 Ext. 12
3511i	01/01	Processing in Other Uniques Retort Systems		Brian Hendrickson 317-226-6500 Ext. 12
3511h	01/01	Processing in Steam-Air Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511c	01/01	Processing in Steam in Continuous Agitating Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511d	01/01	Processing in Steam in Discontinuous Agitating Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511f	01/01	Processing in Steam in Hydrostatic Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511a	01/01	Processing in Steam in Still Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511e	01/01	Processing in Water in Discontinuous Agitating Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511b	01/01	Processing in Water in Still Retorts		Brian Hendrickson 317-226-6500 Ext. 12
431f	11/89	Quantity of Contents		CFPDC
2915	10/01	Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary		Ray Farkas 301-443-3560
2914	10/01	Radioactive Drug Research Committee (RDRC) Report/Research Use of Drug Membership Summary		Ray Farkas 301-443-3560
2658	08/01	Registered Establishments Report of Private Label Distributors{Instructions}		OTCOM 301-827-4573
2511	02/03	Registration of Cosmetic Product Establishment{Instructions}		VCRP 202-418-3414
2656	09/03	Registration of Drug Establishment/Labeler Code Assignment {Instructions} THIS FORM MUST BE SUBMITTED IN TRIPLICATE		OTCOM 301-827-4573
2579	12/00	Report of Assembly of a Diagnostic X-Ray System	Not Yet Electronic	CFPDC
2359d	04/92	Report of Certification		CFPDC
2359j	03/97	Report of Milk Sanitation Rating Report of Enforcement Methods		CFPDC
1995	02/03	Report of Physical Examination of Cows		Ester Lazar 301-436-1485
1551b	01/93	Report of Sample Analysis (Aflatoxins)	Not Yet Electronic	CFPDC
1551	04/94	Report of Sample Analysis		CFPDC
1994	02/03	Report of Tuberculin Tests of Cattle		Ester Lazar 301-436-1485
3489	12/01	Request for a Meeting or Teleconference Instructions		Elizabeth Parbuoni 301-827-3845
3489	12/01	Request for a Meeting or Teleconference Instructions		Elizabeth Parbuoni 301-827-3845
1609a	03/86	Research Progress Record		William Campanaro 301-827-1036
1609	03/86	Research Project Record		William Campanaro 301-827-1036
1533	10/01	Results of Sediment Pad Grading		CFPDC
431g	08/85	Salmonella Record	Not Yet Electronic	CFPDC
421	03/80	Sample Accountability Record (ORA)	Not Yet Electronic	CFPDC
465	08/85	Sample Summary		CFPDC
1997	02/03	Score Card for Sanitation Inspections of Milk Plants		Ester Lazar 301-436-1485
431k	08/85	Shellfish Bacteriological Record		CFPDC
431h	07/85	Shigella Record	Not Yet Electronic	CFPDC
1572	01/03	Statement of Investigator{Instructions}		CFPDC
2359l	03/97	Status of Condensed and Dry Milk Plants		CFPDC
2359k	03/97	Status of Raw Milk for Pasteurization		CFPDC
1570	04/78	Summary of Bacteriological Results	Not Yet Electronic	CFPDC
3427	01/03	Supplemental Data Sheet		Marjorie Shulman 301-594-1190
433	06/82	Tomato Inspection Report		CFPDC
2253	10/01	Transmittal of Advertisements and Promotional Labeling for Drugs and biotechnology for Human Use		CFPDC
2252	04/02	Transmittal of Annual Report for Drugs for Human Use		CFPDC
2567	09/02	Transmittal of Labels and Circulars		Astrid Szeto 301-827-6210
2301	07/03	Transmittal of Periodic Reports and Promotional Material for New Animal Drugs		Glen A. Peterson 301-827-0224
2786	05/82	Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record		Stephen Toigo 301-827-2906
3397	01/03	User Fee Cover Sheet		Mike Jones 301-594-2041
VAERS-1		Vaccine Adverse Event Reporting System		CFPDC
3261	02/83	Vertical Mount Cassette Holder Radiographic Systems Field Test Record		CFPDC
1932	06/03	Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report		Glen A. Peterson 301-827-0224
1932a	06/03	Veterinary Adverse Reaction, Lack of Effectiveness or Product Defect Report		Glen A. Peterson 301-827-0224

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