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If you wish to add a form, please contact Elizabeth Sands at 301-827-1480.
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| FDA Form # | Date | Title | Format | Paper Copy or Contact Info. |
|---|---|---|---|---|
| 356h | 10/05 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | |
CBER MATT 301-827-2000 |
| 356v | 12/04 | New Animal Drug Application [VET] | |
Katherine Weld 301-827-0216 |
| 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 | 07/03 | Sample Accountability Record (ORA) | |
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 | |
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 | |
Norman Fogg 301-827-5645 |
| 465 | 08/85 | Sample Summary | |
PPF |
| 766 | 12/04 | Application for Authorization to Re label or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts | |
Carl R. Nielsen 301-443-6553 |
| 1533 | 10/01 | Results of Sediment Pad Grading |
|
Norman Fogg 301-827-5645 |
| 1551 | 02/06 | Report of Sample Analysis | |
PPF |
| 1551b | 01/93 | Report of Sample Analysis (Aflatoxins) | |
PPF |
| 1570 | 04/78 | Summary of Bacteriological Results | |
William
Campanaro 301-827-1036 |
| 1570a | 04/78 | Bacteriological Definitions | |
William
Campanaro 301-827-1036 |
| 1571 | 04/06 | Investigational New Drug Application {Instructions} |
|
Mia Prather Mia.Prather@fda.hhs.gov |
| 1572 | 05/06 | Statement of Investigator {Instructions-CBER} {Instructions-CDER} | |
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 |
| 1815 | 02/06 | Certificate/ Transmittal for an
Application |
|
Esther Lazar 301-436-1485 |
| 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 | 02/06 | Application for Permit to Ship or Transport Milk and/or Cream into US | |
Ester
Lazar 301-436-1485 |
| 1994 | 02/06 | Report of Tuberculin Tests of Cattle | |
Esther Lazar 301-436-1485 |
| 1995 | 02/06 | Report of Physical Examination of Cows | |
Esther Lazar 301-436-1485 |
| 1996 | 02/06 | Dairy Farm Sanitation Report | |
Esther Lazar 301-436-1485 |
| 1997 | 02/06 | Score Card for Sanitation Inspections of Milk Plants | |
Esther Lazar 301-436-1485 |
| 2096 | 03/04 | Regulation Certification for New Employee | |
Vincent Tolino 301-827-5514 |
| 2097 | 01/03 | Regulation Certification for Separating Employees | |
Vincent Tolino 301-827-5514 |
| 2098 | 11/02 | Regulation Certification for Special Government Employees | |
Vincent Tolino 301-827-5514 |
| 2196 | 07/87 | Laboratory Management Coding Sheet | |
PPF |
| 2252 | 06/05 | Transmittal of Annual Report for Drugs and Biologics for Human Use | |
Mia Prather Mia.Prather@fda.hhs.gov |
| 2253 | 10/07 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | |
DDMAC 301-796-1200 |
| 2301 | 03/07 | Transmittal of Periodic Reports and Promotional Material for New Animal Drugs | |
Pamela Esposito 240-276-9067 |
| 2359 | 10/06 | Milk Plant Inspection Report | |
Robert Hennes 301-436-2175 |
| 2359a | 10/06 | Dairy Farm Inspection Report | |
PPF |
| 2359b | 10/06 | Milk Plant Equipment Tests Report | |
Robert Hennes 301-436-2175 |
| 2359c | 10/06 | Manufacturing Plant Inspection Report (Single-Service Milk Containers and Closures) | |
PPF |
| 2359d | 10/06 | Report of Certification | |
PPF |
| 2359g | 04/86 | Condensed & Dry-Milk & Whey Plant Inspection Report | |
PPF |
| 2359h | 10/06 | Interstate Milk Shipper Check-Rating Report | |
PPF |
| 2359i | 10/06 | Interstate Milk Shipper Report | |
PPF |
| 2359j | 10/06 | Milk Sanitation Rating Report | |
PPF |
| 2359k | 10/06 | Status of Raw Milk for Pasteurization | |
Robert Hennes 301-436-2175 |
| 2359l | 10/06 | Status of Milk Plants | |
Robert Hennes 301-436-2175 |
| 2359l-1 | 05/04 | Status of Condensed and Dry Milk Plants | |
Richard Eubanks 301-436-2174 |
| 2359m | 10/06 | Milk Plant, Receiving Station or Transfer Station NCIMS HACPP System Audit Report | |
Robert Hennes 301-436-2175 |
| 2359n | 10/06 | NCIMS HACPP System Regulatory Agency Review Report (To be included with all NCIMS HACCP Listings and FDA Audits) | |
Robert Hennes 301-436-2175 |
| 2359o | 10/06 | Permission for Publication Interstate Milk Shipper's Listing | |
Robert Hennes 301-436-2175 |
| 2399 | 10/06 | Dairy Plant Sampling - Raw & Pasteurized Milk | |
Robert Hennes 301-436-2175 |
| 2399a | 10/06 | Bulk Milk Hauler/Sampler Evaluation Report | |
Robert Hennes 301-436-2175 |
| 2399b | 10/06 | Milk Tank Truck Inspection Report | |
Robert Hennes 301-436-2175 |
| 2399c | 10/06 | Farm Bulk Tank Milk Sampling Inspection Record | |
Robert Hennes 301-436-2175 |
| 2399d | 10/06 | Dairy Plant - Milk Sample Collector Evaluation Record | |
Robert Hennes 301-436-2175 |
| 2400 | 03/01 | Cultural Procedures - General Requirements | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400d | 03/01 | MLEF Direct Microscopic Somatic Cell Count | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400a-1 | 03/01 | Milk Laboratory Evaluation Form: Spiral Plate Count Methods | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400b | 05/87 | MLEF Detention of Inhibitory Substances in Milk | Not Yet Electronic | Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400b-1 | 03/01 | MLEF Detection of Inhibitory Substances in Milk Bacillus Stearothermophilus | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400b-3 | 03/01 | MLEF Detection of Inhibitory Substances in Milk Delvotest 5 Pack | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400d | 03/01 | MLEF Direct Microscopic Somatic Cell Count | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400 h-1 | 03/01 | MLEF Electronic Somatic Cell Count Foss 250/300/360/400 | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400h-2 | 03/01 | MLEF Electronic Somatic Cell Count Bentley Somacount 150/300/500 | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400h-3 | 03/01 | MLEF Electronic Somatic Cell Count Fossmatic 5000 | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400i | 03/01 | Pasteurized Milk Containers | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400j | 03/01 | Phosphatase Test | |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400k | 03/01 | MLEF Flat Lid Methods | |
Thomas E. Graham,
Ph.D. 708-728-4114 |
| 2400l | 03/01 | MLEF Disintegration Method for Paper, etc. |
|
Thomas E. Graham,
Ph.D. 708-728-4114 |
| 2400m | 03/01 | MLEF Dairy Waters |
|
Thomas E. Graham,
Ph.D. 708-728-4114 |
| 2511 | 06/06 | Registration of Cosmetic Product Establishment {Instructions} |
|
VCRP 301-436-1257 |
| 2512 | 06/06 | Cosmetic Product Ingredient Statement {Instructions} |
|
VCRP 301-436-1257 |
| 2512a | 06/06 | Cosmetic Product Ingredient Statement{Instructions} |
|
VCRP 301-436-1257 |
| 2514 | 06/06 | Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation {Instructions} |
|
VCRP 301-436-1257 |
| 2541 | 10/05 | Food Canning Registration {Instructions} | |
LACF Coordinator 301-436-2411 |
| 2541a | 08/05 | Food Process Filing For All Methods Except Low-Acid Aseptic {Instructions} |
|
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541c | 08/05 | Food Process Filing For Low-Acid Aseptic Systems {Instructions} | |
LACF Coordinator 301-436-2411 |
| 2567 | 10/05 | Transmittal of Labels and Circulars |
|
CBER MATT 301-827-2000 |
| 2579 | 06/08 | 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 | 08/07 | Registration of Drug Establishment/Labeler Code Assignment {Instructions} THIS FORM MUST BE SUBMITTED IN TRIPLICATE |
|
DRLS 301-210-2840 |
| 2657 | 08/07 | Drug Product Listing{Instructions} | |
DRLS 301-210-2840 |
| 2658 | 08/07 | Registered Establishments Report of Private Label Distributors{Instructions} |
|
DRLS drls@fda.hhs.gov or 301-210-2840 |
| 2675 | 08/90 | Investigational New Drug Folder (Red) | Not Yet Electronic | GPO |
| 2675a | 10/86 | Investigational New Drug Folder (Green) | Not Yet Electronic | GPO |
| 2675b | 10/86 | 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 | 04/02 | State Contract Monthly Food Report | |
Preet Sudhaker 301-827-2908 |
| 2684a | 04/02 | State Contract Monthly Feed Establishment Report | |
Preet Sudhaker 301-827-2908 |
| 2767 | 05/07 | Notice of Availability of Sample Electronic Product |
|
DMQRP 240-276-3332 |
| 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 {2784.1-Pg1, 2784.2-Pg2, 2784.3-Pg3} Systems | |
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 |
|
Richard Barnes
301-827-2905 |
| 2814 | 08/93 | Field Equipment Request | |
William Campanaro 301-827-1036 |
| 2830 | 07/06 | Blood Establishment Registration and Product Listing |
|
bloodregis@fda.hhs.gov |
| 2877 | 12/03 | Declaration of Products Subject to Radiation Control Standards | |
DMQRP 240-276-3332 |
| 2914 | 11/06 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary |
|
RDRC 301-796-2050 |
| 2915 | 11/06 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary | |
RDRC 301-796-2050 |
| 2966 | 10/88 | Food GMP Inspection Report | |
PPF |
| 3038 | 03/07 | Interstate Shellfish Dealer's Certificate {ICSSL definition page link } | {Not for public use, only for approved
State shellfish officials to log into to set up a shellfish shipper
user account to be able to fill out and submit the FDA 3038
electronically} |
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 | 04/01 | General Information Field Test Record | |
PPF |
| 3131 | 08/01 | Contract Property Administration Completion Report | |
Mike McGrath 301-827-7105 |
| 3147 | 05/07 | Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device | |
DMQRP 240-276-3332 |
| 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 | 04/01 | Head and Neck Radiographic Systems Field Test Record |
|
PPF |
| 3316 | 08/85 | Red - DRUG MASTER FILE ARCHIVAL BINDER | Not Yet Electronic | GPO |
| 3316a | 08/85 | Blue - DRUG MASTER FILE BINDER | Not Yet Electronic | GPO |
| 3331 | 04/06 | NDA Field Alert Report |
|
Juliaette
Johnson 301-827-8928 |
| 3356 | 11/07 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | |
tissuereg@fda.hhs.gov |
| 3397 | 01/07 | User Fee Cover Sheet |
|
Mike Jones 301-443-5151 |
| 3410 | 10/01 | Confidential Financial Disclosure Report | |
Jenny Slaughter 301-827-5511 |
| 3417 | 03/07 | Medical Device Reporting- Baseline Report- Part 1 {Instructions} | |
OSB/CDRH/RSMB 240-276-3464 |
| 3419 | 10/07 | Medical Device Reporting Annual User Facility Report {Instructions} |
|
OSB/CDRH/RSMB 240-276-3464 |
| 3422 | 08/07 | Government Entity Declaration |
|
Denise Robinson
240-276-3278 |
| 3427 | 01/03 | Supplemental Data Sheet |
|
Marjorie
Shulman 240-276-4040 |
| 3429 | 01/03 | General Device Classification Questionnaire | |
Marjorie Shulman 301-594-1190 |
| 3437 | 06/95 | CDER Pediatric Use Supplement | |
CDR 301-827-4210 |
| 3448 | 09/07 | Medicated Feed Mill License Application | |
Jo W. Gulley 240-453-6858 |
| 3452 | 04/03 | Export Certificate to Foreign Governments | |
Gloria Dunnavan 301-827-1166 |
| 3454 | 04/06 | Certification: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-796-1282 |
| 3455 | 04/06 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-796-1282 |
| 3458 | 07/07 | Notice of Claimed Investigational Exemption (electronic) {Instructions} | |
Margaret Zabriski 240-276-9143 |
| 3463 | 07/00 | EDI Gateway Training Partner Agreement | Not Yet Electronic | Bill Taylor 301-827-6504 |
| 3479 | 03/05 | Notification for a Food Contact Substance Formulation |
|
Francis Linn 301-436-1215 |
| 3480 | 09/05 | Notification For New Use Of A Food Contact Substance |
|
Francis Linn 301-436-1215 |
| 3486 | 08/07 | Biological Product Deviation Report{Instructions} |
|
CBER Program Surveillance Branch 301-827-6220 |
| 3487 | 07/07 | Notice of Final Disposition of Animals not Intended for Immediate Slaughter {Instructions} |
|
Margaret Zabriski 240-276-9143 |
| 3488 | 07/07 | Notice of Intent to Slaughter for Human Food Purposes {Instructions} |
|
Margaret Zabriski 240-276-9143 |
| 3489 | 07/07 | Request for a Meeting or Teleconference {Instructions} |
|
Margaret Zabriski 240-276-9143 |
| 3500 | 02/06 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3500A | 02/06 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3501 | 01/07 | Domestic Seafood (HACCP) Report |
|
Roshelle King 301-436-1416 |
| 3502 | 01/01 | Importer Seafood HACCP Report | Not Yet Electronic | Roshelle King 301-436-1416 |
| 3503 | 09/07 | Food Additive Petition Submission |
|
Maribeth LaVecchi 301-436-1211 |
| 3504 | 09/07 | Color Additive Petition Submission |
|
Maribeth LaVecchi 301-436-1211 |
| 3511 | 03/07 | FDA LACF Inspection Report | |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511-2 | 03/07 | FDA Acidified Food Inspection Report | |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511-3 | 03/07 | Aseptic Processing & Packaging Report | |
Brian Hendrickson 317-226-6500 Ext. 12 |
| 3511a | 03/07 | Processing in Steam in Still Retorts |
|
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511b | 03/07 | Processing in Water in Still Retorts |
|
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511c | 03/06 | Processing in Steam in Continuous Agitating Retorts |
|
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511d | 03/06 | Processing in Steam in Discontinuous Agitating Retorts |
|
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511e | 03/07 | Processing in Water in Discontinuous Agitating Retorts |
|
Brian Hendrickson
317-226-6500 Ext. 104 |
| 3511f | 03/07 | Processing in Steam in Hydrostatic Retorts |
|
Brian Hendrickson
317-226-6500 Ext. 104 |
| 3511g | 03/07 | Processing in Cascading/Spray Water Retort |
|
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511h | 03/07 | Processing in Steam-Air Retorts |
|
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511i | 03/06 | Processing in Other Unique Retort Systems |
|
Brian Hendrickson
317-226-6500 Ext. 104 |
| 3514 | 09/07 | CDRH Premarket Review Submission Cover Sheet | |
Bob Gatling 240-276-4015 |
| 3536 | 07/07 | Protocol for Non-Clinical Laboratory and Effectiveness Studies{Instructions} |
|
Margaret Zabriski 240-276-9143 |
| 3537 | 05/07 | Food Facility Registration {Instructions} |
|
FDA Industry Systems Help
Desk 800-216-7331 301-575-0156 |
| 3537a | 05/07 | Cancellation of Food Facility Registration {Instructions} |
|
FDA Industry Systems Help
Desk 800-216-7331 301-575-0156 |
| 3538 | 07/07 | Electronic Submission System Participant Password or Addition {Instructions} |
|
Margaret Zabriski 240-276-9143 |
| 3539 | 04/06 | Review/Approval of Free Attendance at Widely Attended Gatherings (WAG) |
|
Vincent Tolino 301-827-5514 |
| 3540 | 05/07 | Prior Notice Submission {Instructions} |
|
Prior Notice Center 866-521-2297 |
| 3541 | 09/07 | Premarket Notification [510(K)] Status Request and Response |
|
John Stigi 240-276-3150 EX 124 |
| 3542 | 07/07 | Patent Information Submitted Upon and After Approval of An NDA or Supplement |
|
Mary Ann Holovac 240-276-8971 |
| 3542a | 07/07 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement |
|
Mary Ann Holovac 240-276-8971 |
| 3543 | 12/03 | Certificate of a Pharmaceutical Product | |
Jocelyn Harris 301-827-8983 |
| 3546 | 02/04 | Animal Drug User Fee Cover Sheet | |
Helio Chaves 301-827-3912 |
| 3570 | 02/07 | Model Small Business Food Labeling Exemption Notice |
|
SBusiness 301-436-2375 |
| 3571 | 06/06 | Infusion Pump Information Submission Report {Instructions} |
|
Morgan Warner 240-276-3461 |
| 3601 | 01/07 | Medical Device User Fee Cover Sheet |
|
User Fees Financial Support
Team 301-827-9539 |
| 3602 | 10/07 | FY MDUFMA Small Business Qualification Certification For a Business Headquarter in the United States | |
James G. Norman 240-276-3806 |
| 3602a | 10/07 | FY MDUFMA Small Business Qualification Certification For a Business Headquarter Outside the United States | |
James G. Norman 240-276-3806 |
| 3608 | 06/05 | Medical Device Fellowship Program Student Application {Instructions} |
|
Medical Device Fellowship
Program 240-276-3816 |
| 3610 | 10/03 | Contract Audit |
|
Beverly Kent 716-541-0331 |
| 3611 | 09/03 | Audit Report |
|
Beverly Kent 716-541-0331 |
| 3613 | 09/06 | Supplementary Information Certificate to Foreign Government Requests |
|
Import/Export Team CBER 301-827-6201 or CDRH 240 276-0132 or CVM 240-276-0132 |
| 3613a | 09/06 | Supplementary Information Certificate of Exportability Requests |
|
Import/Export Team CBER 301-827-6201 or CDRH 240 276-0132 or CVM 240-276-0132 |
| 3613b | 06/06 | Supplementary Information Certificate of a Pharmaceutical Product |
|
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 or CVM 240-276-0132 |
| 3613c | 09/06 | Supplementary Information Non-Clinical Research Use Only Certificate |
|
Import/Export Team CBER 301-827-6201 or CDRH 240 276-0132 |
| 3613d | 02/06 | Office of Cosmetics and Colors "Certificate" Export Application |
|
Import/Export Team CFSAN 301-436-2776 |
| 3613e | 02/06 | Food Export Certificate Application | |
Import/Export Team 301-436-2776 |
| 3623 | 11/05 | Farm Investigation Questionnaire |  |
Barbara Marcelletti 301-827-5635 |
| 3623a | 11/05 | Additional Water Sources | |
Barbara Marcelletti 301-827-5635 |
| 3623b | 11/05 | Additional Sets of Workers | |
Barbara Marcelletti 301-827-5635 |
| 3626 | 07/07 | A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components | |
DMQRP 240-276-3332 |
| 3627 | 07/07 | Diagnostic X-Ray CT Products Radiation Safety Report | |
DMQRP 240-276-3332 |
| 3630 | 07/07 | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products | |
DMQRP 240-276-3332 |
| 3631 | 07/07 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products | |
DMQRP 240-276-3332 |
| 3632 | 07/07 | Guide for Preparing Product Reports on Lasers and Products Containing Lasers | |
DMQRP 240-276-3332 |
| 3634 | 07/07 | Television Products Annual Report | |
DMQRP 240-276-3332 |
| 3636 | 07/07 | Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show | |
DMQRP 240-276-3332 |
| 3638 | 07/07 | Guide for Filling Annual Reports for X-Ray Components and Systems | |
DMQRP 240-276-3332 |
| 3639 | 07/07 | Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 | |
DMQRP 240-276-3332 |
| 3640 | 07/07 | Reporting Guide for Laser Light Shows and Displays | |
DMQRP 240-276-3332 |
| 3641 | 07/07 | Cabinet X-Ray Annual Report | |
DMQRP 240-276-3332 |
| 3643 | 07/07 | Microwave Oven Products Annual Report | |
DMQRP 240-276-3332 |
| 3644 | 07/07 | Guide for Preparing Product Reports for Ultrasonic Therapy Products | |
DMQRP 240-276-3332 |
| 3645 | 07/07 | Guide for Preparing Annual Reports for Ultrasonic Therapy Products | |
DMQRP 240-276-3332 |
| 3646 | 07/07 | Mercury Vapor Lamp Products Radiation Safety Report | |
DMQRP 240-276-3332 |
| 3647 | 07/07 | Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps | |
DMQRP 240-276-3332 |
| 3654 | 09/07 | Standards Data Report for 510(K)s | |
Bob Gatling 240-276-4015 |
| 3659 | 07/07 | Reporting and Compliance Guide for Television Products | |
DMQRP 240-276-3332 |
| 3660 | 07/07 | Guidance for Preparing Reports on Radiation Safety of Microwave Ovens | |
DMQRP 240-276-3332 |
| 3661 | 07/07 | A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use | |
DMQRP 240-276-3332 |
| 3662 | 07/07 | A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use | |
DMQRP 240-276-3332 |
| 3663 | 07/07 | Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) | |
DMQRP 240-276-3332 |
| 3664 | 07/07 | My Medicine Record {Instructions} | |
Cindi Fitzpatrick 301-827-1672 |
| 3670 | 03/08 | MedSun (Medical Product Surveillance Network) |
|
Marilyn Flack 240-276-2391 |
| 3671 | 11/07 | Common EMEA/FDA Application for Orphan Medicinal Product Designation | |
Kathy Needleman 301-827-3666 |
| 3674 | 01/08 | Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) | |
Jarilyn Dupont 301-827-5906 |
| 3677v | 1/06 | Minor Species Index File (MIF) | Not Electronic Yet | Joan C. Gotthardt 240-276-9331 |
| 3717 | 4/08 | Report of Inspection for Compliance with 21 CFR 589.2000 | |
Shannon Jordre 240-276-9229 |
| VAERS-1 | Vaccine Adverse Event Reporting System{Instructions} | |
VAERS 800-822-7967 | |
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Edition: Augiust 4, 2008