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	Food and Drug Administration Forms
FDA Form #	Date	Title	Format	Paper Copy or Contact Info.
356h	04/03	Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use		Pamela Pope 301-827-9540
356v	01/02	New Animal Drug Application [VET]		Sam Hansard, Ph.D. 301-827-0211
358v	03/89	NADA Folders (VET)	Not Yet Electronic	David Newkirk 301-827-6967
359v	06/90	INAD Folder (VET)	Not Yet Electronic	David Newkirk 301-827-6967
421	03/80	Sample Accountability Record (ORA)	Not Yet Electronic	PPF
431	05/84	Analyst Worksheet		PPF
431a	05/84	General Continuation Sheet		PPF
431d	10/74	Bacteriological Record		PPF
431e	03/80	Industrial Chemicals Worksheet	Not Yet Electronic	PPF
431f	11/89	Quantity of Contents		PPF
431g	08/85	Salmonella Record		William Campanaro 301-827-1036
431h	07/85	Shigella Record		PPF
431i	10/85	Canned Food Continuation Sheet		PPF
431j	08/85	Botulism Continuation Sheet		William Campanaro 301-827-1036
431k	08/85	Shellfish Bacteriological Record		William Campanaro 301-827-1036
431m	12/79	Elemental Analysis Worksheet		PPF
433	06/82	Tomato Inspection Report		Gerald Blackwell 301-827-5639
465	08/85	Sample Summary		PPF
701	01/89	Customs Form 3461 "Entry/Immediate Delivery"		Sammie Hadden 301-827-9632
766	12/97	Application for Authorization to Relabel or to Perform Other Action		Carl R. Nielsen 301-443-6553
1533	10/01	Results of Sediment Pad Grading		Gerald Blackwell 301-827-5639
1551	04/94	Report of Sample Analysis		PPF
1551b	01/93	Report of Sample Analysis (Aflatoxins)	Not Yet Electronic	PPF
1570	04/78	Summary of Bacteriological Results		William Campanaro 301-827-1036
1570a	04/78	Bacteriological Definitions		William Campanaro 301-827-1036
1571	01/03	Investigational New Drug Application {Instructions}		Mia Prather Mia.Prather@fda.hhs.gov
1572	01/03	Statement of Investigator {Instructions}		Mia Prather Mia.Prather@fda.hhs.gov
1609	03/86	Research Project Record		William Campanaro 301-827-1036
1609a	03/86	Research Progress Record		William Campanaro 301-827-1036
1814	02/03	Permit to Ship or Transport Milk and/or Cream into the United States Under the Federal Import Milk Act		Monica Metz 301-436-2041
1815	02/03	Certificate/ Transmittal for an Application		Monica Metz 301-436-2041
1932	09/03	Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report		Glen A. Peterson 301-827-0224
1932a	09/03	Veterinary Adverse Reaction, Lack of Effectiveness or Product Defect Report		Glen A. Peterson 301-827-0224
1993	02/03	Application for Permit to Ship or Transport Milk and/or Cream into US		Monica Metz 301-436-2041
1994	02/03	Report of Tuberculin Tests of Cattle		Ester Lazar 301-436-1485
1995	02/03	Report of Physical Examination of Cows		Monica Metz 301-436-2041
1996	02/03	Dairy Farm Sanitation Report		Monica Metz 301-436-2041
1997	02/03	Score Card for Sanitation Inspections of Milk Plants		Monica Metz 301-436-2041
2096	03/04	Regulation Certification for New Employee		Jenny Slaughter 301-827-5511
2097	1/03	Regulation Certification for Separating Employees		Jenny Slaughter 301-827-5511
2098	11/02	Regulation Certification for Special Government Employees		Jenny Slaughter 301-827-5511
2196	07/87	Laboratory Management Coding Sheet	Not Yet Electronic	PPF
2252	04/02	Transmittal of Annual Report for Drugs for Human Use		Mia Prather Mia.Prather@fda.hhs.gov
2253	07/02	Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use		Mike Wade 301-827-2828
2301	03/04	Transmittal of Periodic Reports and Promotional Material for New Animal Drugs		Glen A. Peterson 301-827-0224
2359	06/00	Milk Plant Inspection Report		Richard Eubanks 301-436-2174
2359a	03/97	Dairy Farm Inspection Report		Richard Eubanks 301-436-2174
2359b	06/00	Milk Plant Equipment Tests Report		Richard Eubanks 301-436-2174
2359c	03/92	Manufacturing Plant Inspection Report		PPF
2359d	03/04	Report of Certification		PPF
2359g	04/86	Condensed & Dry-Milk & Whey Plant Inspection Report		PPF
2359h	02/98	Interstate Milk Shipper Check-Rating Report		PPF
2359i	03/04	Interstate Milk Shipper Report		Richard Eubanks 301-436-2174
2359j	06/04	Milk Sanitation Rating Report		PPF
2359k	09/03	Status of Raw Milk for Pasteurization		Richard Eubanks 301-436-2174
2359l	06/04	Status of Milk Plants		Richard Eubanks 301-436-2174
2359l-1	05/04	Status of Condensed and Dry Milk Plants		Richard Eubanks 301-436-2174
2399	07/04	Dairy Plant Sampling - Raw & Pasteurized Milk		Richard Eubanks 301-436-2174
2399a	08/04	Milk Tank Truck, Hauler Report and Sampler Evaluation		Richard Eubanks 301-436-2174
2399b	07/04	Milk Tank Truck Inspection		Richard Eubanks 301-436-2174
2399c	10/88	Farm Bulk Tank Milk Sampling Inspection Record	Not Yet Electronic	Richard Eubanks 301-436-2174
2400	03/01	Cultural Procedures - General Requirements		Virgil Jones 708-728-4120
2400a	03/01	Milk Laboratory Evaluation Form: Standard Plate Count, Coliform, and Simplified Count Methods		Virgil Jones 708-728-4120
2400a-1	03/01	Milk Laboratory Evaluation Form: Spiral Plate Count Methods		Virgil Jones 708-728-4120
2400b	05/87	MLEF Detention of Inhibitory Substances in Milk	Not Yet Electronic	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
2400d	03/01	MLEF Direct Microscopic Somatic Cell Count		Virgil Jones 708-728-4120
2400h	03/01	Optical Somatic Cell Count		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-2	03/01	MLEF Electronic Somatic Cell Count Bentley Somacount 150/300/500		Virgil Jones 708-728-4120
2400h-3	03/01	MLEF Electronic Somatic Cell Count Fossmatic 5000		Virgil Jones 708-728-4120
2400i	03/01	Pasteurized Milk Containers		Virgil Jones 708-728-4120
2400j	03/01	Phosphatase Tests		Virgil Jones 708-728-4120
2400k	03/01	MLEF Flat Lid Methods		Virgil Jones 708-728-4120
2400l	03/01	MLEF Disintegration Method for Paper, etc.		Virgil Jones 708-728-4120
2400m	03/01	MLEF Dairy Waters		Virgil Jones 708-728-4120
2511	02/03	Registration of Cosmetic Product Establishment{Instructions}		VCRP 202-418-3414
2512	02/03	Cosmetic Product Ingredient Statement {Instructions}		VCRP 202-418-3414
2512a	02/03	Cosmetic Product Ingredient Statement {Instructions}		VCRP 202-418-3414
2514	01/03	Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation {Instructions}		VCRP 202-418-3414
2541	07/04	Food Canning Registration {Instructions}		LACF Coordinator 301-436-2411
2541a	10/03	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
2567	09/02	Transmittal of Labels and Circulars		Pamela Pope 301-827-9540
2579	07/02	Report of Assembly of a Diagnostic X-Ray System	Not Yet Electronic	PPF
2589	08/01	Inspection Summary - Bus Service Area Sanitation		PPF
2591	08/01	Inspection Summary - Equipment Evaluation		PPF
2626	07/04	New Drug Application/Biologic Licensing Application (Blue Folder) Archival	Not Yet Electronic	GPO
2626a	07/04	New Drug Application/Biologic Licensing Application (Red Folder) Chemistry	Not Yet Electronic	GPO
2626b	07/04	New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology	Not Yet Electronic	GPO
2626c	07/04	New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic	Not Yet Electronic	GPO
2626d	07/04	New Drug Application/Biologic Licensing Application (White Folder) Microbiology	Not Yet Electronic	GPO
2626e	07/04	New Drug Application/Biologic Licensing Application (Tan Folder) Clinical Data	Not Yet Electronic	GPO
2626f	07/04	New Drug Application/Biologic Licensing Application (Light Green Folder) Statistics	Not Yet Electronic	GPO
2626h	07/04	New Drug Application/Biologic Licensing Application (Maroon Folder) Field Submission Chemistry	Not Yet Electronic	GPO
2656	09/03	Registration of Drug Establishment/Labeler Code Assignment {Instructions} THIS FORM MUST BE SUBMITTED IN TRIPLICATE		OTCOM 301-827-4573
2657	08/04	Drug Product Listing {Instructions}		OTCOM 301-827-4573
2658	08/04	Registered Establishments Report of Private Label Distributors {Instructions}		OTCOM 301-827-4573
2675	07/84	Investigational New Drug Folder (Red)	Not Yet Electronic	GPO
2675a	07/84	Investigational New Drug Folder (Green)	Not Yet Electronic	GPO
2675b	07/84	Investigational New Drug Folder (Orange)	Not Yet Electronic	GPO
2679	08/01	Food Warehouse Inspection Report		Glen Johnson 301-827-2907
2681	02/02	Bakery Inspection Report		Glen Johnson 301-827-2907
2682	08/01	Beverage Plant Inspection Report		PPF
2684	03/87	State Contract Monthly Food Report		Glen Johnson 301-827-2907
2684a	04/02	State Contract Monthly Feed Establishment Report		Glen Johnson 301-827-2907
2767	12/03	Notice of Availability of Sample Electronic Product		Debbie Perrell 301-594-4654
2782	09/98	Field Test Record Continuation Sheet		Stephen Toigo 301-827-2906
2783	10/80	Mobile Radiographic Systems Field Test Record		PPF
2784	10/80	Above Table X-Ray Source Radiographic Systems {2784.1-Pg1, 2784.2-Pg2, 2784.3-Pg3}		PPF
2785	05/82	Dental Radiographic Systems Field Test Record		PPF
2786	05/82	Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record		Stephen Toigo 301-827-2906
2814	08/93	Field Equipment Request		William Campanaro 301-827-1036
2830	02/03	Blood Establishment Registration and Product Listing {Instructions}		Janet Ishimoto 301-827-3543
2877	12/03	Declaration of Products Subject to Radiation Control Standards		Chris Colburn 301-827-7669
2891	03/02	Initial Registration of Medical Device EstablishmentTHIS FORM MUST BE SUBMITTED IN TRIPLICATE		DSMA FAX 301-443-8818
2891a	03/02	Annual Registration of Medical Device Establishment	Not Yet Electronic	Bryan H. Benesch 301-594-4591 Ext. 151
2892	03/02	Medical Device Listing		DSMA FAX 301-443-8818
2914	10/01	Radioactive Drug Research Committee (RDRC) Report/Research Use of Drug Membership Summary		Ray Farkas & Richard Fekla 301-827-7482
2915	10/01	Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary		PPF
2966	10/88	Food GMP Inspection Report		PPF
3038	08/03	Interstate Shellfish Dealer's Certificate		Charlotte Epps 301-436-2154
3068	08/92	Peak Kilovoltage Determination Field Test Record		PPF
3069	10/80	Above Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record		PPF
3070	08/92	Mammography Systems Field Test Record		PPF
3071	10/80	General Information Field Test Record	Not Yet Electronic	PPF
3131	08/01	Contract Property Administration Completion Report		Mike McGrath 301-827-7105
3147	12/03	Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device		Debbie Perrell 301-594-4654
3260	02/83	C-Arm Fluoroscopic & Spot-Film Systems Field Test Record		PPF
3261	02/83	Vertical Mount Cassette Holder Radiographic Systems Field Test Record		PPF
3297	04/84	Head and Neck Radiographic Systems Field Test Record		PPF
3316	08/85	Folder, Drug Master File (Red)	Not Yet Electronic	GPO
3316a	08/85	Folder, Drug Master File (Blue)	Not Yet Electronic	GPO
3331	02/03	NDA Field Alert Report		Juliaette Johnson 301-827-8930
3356	08/04	Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products		tissuereg@cber.fda.gov
3397	12/03	User Fee Cover Sheet		Mike Jones 301-594-2041
3410	10/01	Confidential Financial Disclosure Report		Jenny Slaughter 301-827-5511
3417	04/00	Medical Device Reporting- Baseline Report- Part 1 {Instructions}		William Huff 301-594-3888
3419	06/03	Medical Device Reporting Annual User Facility Report {Instructions}		William Huff 301-594-3888
3422	03/04	Government Entity Declaration		Susan Bradt 301-594-3653
3427	01/03	Supplemental Data Sheet		Marjorie Shulman 301-594-1190
3429	01/03	General Device Classification Questionnaire		Marjorie Shulman 301-594-1190
3437	06/95	CDER Pediatric Use Supplement		CDR 301-827-4210
3448	12/03	Medicated Feed Mill License Application		Jo W. Gulley 301-827-0170
3452	04/03	Export Certificate to Foreign Governments		Gloria Dunnavan 301-827-1166
3454	02/03	Certification: Financial Interest and Arrangements of Clinical Investigators		Leah W. Ripper 301-827-5921
3455	02/03	Disclosure: Financial Interest and Arrangements of Clinical Investigators		Leah W. Ripper 301-827-5921
3458	12/03	Notice of Claimed Investigational Exemption (electronic) Instructions		Margaret Zabriski 301-827-4023
3463	07/00	EDI Gateway Training Partner Agreement	Not Yet Electronic	Bill Taylor 301-827-6504
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
3486	07/04	Biological Product Deviation Report {Instructions}		Sharon O'Callaghan 301-827-6220
3487	12/03	Notice of Final Disposition of Animals not Intended for Immediate Slaughter Instructions		Margaret Zabriski 301-827-4023
3488	12/03	Notice of Intent to Slaughter for Human Food Purposes Instructions		Margaret Zabriski 301-827-4023
3489	12/03	Request for a Meeting or Teleconference Instructions		Margaret Zabriski 301-827-4023
3500	09/03	MedWatch: FDA Medical Product Reporting Program {Instructions}		MEDWATCH 1-800-FDA-1088
3500A	09/03	MedWatch: FDA Medical Products Reporting Program - Mandatory {Instructions}		MEDWATCH 1-800-FDA-1088
3501	01/01	Domestic Seafood (HACCP) Report	Not Yet Electronic	Roshelle King 301-436-1416
3502	01/01	Importer Seafood HACCP Report	Not Yet Electronic	Roshelle King 301-436-1416
3503	03/01	Food Additive Petition Submission		Maribeth LaVecchi 202-418-3072
3504	03/01	Color Additive Petition Submission		Maribeth LaVecchi 202-418-3072
3511	01/01	FDA LACF Inspection Report		Brian Hendrickson 317-226-6500 Ext. 12
3511-2	01/02	FDA Acidified Food Inspection Report		Brian Hendrickson 317-226-6500 Ext. 12
3511-3	06/04	Aseptic Processing & Packaging Report		Brian Hendrickson 317-226-6500 Ext. 12
3511a	01/01	Processing in Steam in Still Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511b	01/01	Processing in Water in Still Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511c	11/03	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
3511e	01/01	Processing in Water 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
3511g	01/01	Processing in Cascading/Spray Water Retort		Brian Hendrickson 317-226-6500 Ext. 12
3511h	01/01	Processing in Steam-Air Retorts		Brian Hendrickson 317-226-6500 Ext. 12
3511i	01/01	Processing in Other Unique Retort Systems		Brian Hendrickson 317-226-6500 Ext. 12
3514	12/03	CDRH Submission Cover Sheet		Chris Colburn 301-827-7669
3536	12/03	Protocol for Non-Clinical Laboratory and Effectiveness StudiesInstructions		Margaret Zabriski 301-827-4023
3537	10/03	Food Facility Registration {Instructions}		Melissa Scales 301-436-1720
3537a	10/03	Cancellation of Food Facility Registration {Instructions}		Melissa Scales 301-436-1720
3538	12/03	Electronic Submission System Participant Password or Addition Instructions		Margaret Zabriski 301-827-4023
3539	07/04	Review/Approval of Free Attendance at Widely Attended Gatherings (WAG)		Jenny Slaughter 301-827-5511
3540	10/03	Prior Notice Submission Instructions		Anne T. Taylor 301-436-1888
3541	12/02	Premarket Notification [510(K)] Status Request and Response		Chris Colburn 301-827-7669
3542	07/03	Patent Information Submitted Upon and After Approval of An NDA or Supplement		Mary Ann Holovac 301-827-5846
3542a	07/03	Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement		Mary Ann Holovac 301-827-5846
3543	12/03	Certificate of a Pharmaceutical Product		Jocelyn V. Lewis 301-827-8983
3546	02/04	Animal Drug User Fee Cover Sheet		Martha Louviere 301-827-3912
3570	05/02	Model Small Business Food Labeling Exemption Notice		SBusiness 301-436-2375
3601	04/03	Medical Device User Fee Cover Sheet		David Wardrop Jr. 301-827-3512
3602	02/03	MDUFMA Small Business Qualification Certificate	Not Yet Electronic	James Norman 301-827-6829
3608	06/04	Medical Device Fellowship Program Student Application {Instructions}		Michelle Mattera 301-827-7969
3610	10/03	Contract Audit		Glen Johnson 301-827-2907
3611	09/03	Audit Report		Glen Johnson 301-827-2907
VAERS-1		Vaccine Adverse Event Reporting System		VAERS 800-822-7967

Edition: September 30, 2004

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