Food and Drug Administration

FDA

Federal Forms

Forms
OMB NumberTitle
0910-0893 Right to Try Act: Reporting Requirements
0910-0892 Health Care Providers Understanding of Opioid Analgesic Abuse-Deterrent Formulations: Phase 2 and 3 Surveys
0910-0891 Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
0910-0890 Healthcare Provider Perception of Boxed Warning Information Survey
0910-0889 Accreditation Scheme for Conformity Assessment Pilot Program
0910-0888 Importation of Prescription Drugs
0910-0887 Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar Survey
0910-0886 Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments
0910-0885 Study of Oncology Indications in Direct-to-Consumer Television Advertising
0910-0884 List of US Manufacturers of Specific CVM-Regulated Products with Interest in Exporting Covered Products to China
0910-0883 Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
0910-0882 Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
0910-0881 Web-Based Pilot Survey to Assess Allergy to Cosmetics in the United States
0910-0880 Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Products and Tobacco Smoke
0910-0879 Premarket Tobacco Product Applications and Recordkeeping Requirements
0910-0878 Sunlamp Products; Proposed Amendment to § 1002.1 (Record and Reporting Requirements) and § 1040.20 (Performance Standard)
0910-0877 Required Warnings for Cigarette Packages and Advertisements
0910-0876 Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
0910-0875 Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces
0910-0874 Disease Awareness and Prescription Drug Promotion on Television
0910-0873 Investigation of Consumer Perceptions of Expressed Modified Risk Claims
0910-0872 Experimental Study of an Accelerated Approval Disclosure
0910-0871 Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
0910-0870 Electronic Format for Submissions; Promotional Labeling and Advertising Materials for Human Prescription Drugs
0910-0869 Healthcare Professional Survey of Professional Prescription Drug Promotion
0910-0868 Assessment of Combination Product Review Practices
0910-0867 Survey of Current Manufacturing Practices for the Cosmetics Industry
0910-0866 Experimental Study of Cigarette Warnings
0910-0865 Generic Clearance for Quantitative Testing for the Development of FDA Communications (CFSAN)
0910-0864 Disclosures of Descriptive Presentation in Professional Oncology Prescription Drug Promotion
0910-0863 Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act
0910-0862 Labeling of Red Blood Cell Units with Historical Antigen Typing Results
0910-0861 Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads
0910-0860 Disclosures in Professional and Consumer Prescription Drug Promotion
0910-0859 Drug Supply Chain Security Act (DSCSA) Pilot Progam
0910-0858 GFI: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities
0910-0857 GFI: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities Questions and Answers
0910-0856 GFI: Medical Product Communications That Are Consistent With the Food and Drug Administration Required Labeling -Questions and Answers
0910-0855 National Agriculture and Food Defense Strategy Survey
0910-0854 Quality Facility Attestation
0910-0853 Utilization of Adequate Provision Among Low to Non-Internet Users
0910-0852 Transfer of a Premarket Notification Clearance
0910-0851 Evaluation of the Food and Drug Administration’s Point-of-Sale Campaign
0910-0850 Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based in Vitro Diangostics
0910-0849 Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion
0910-0848 Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
0910-0847 Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
0910-0846 Character-Space-Limited Online Prescription Drug Communications
0910-0845 Draft Guidance for Industry; How to Prepare a Pre-Request for Designation (Pre-RFD)
0910-0844 De Novo Classification Process (Evaluation of Automatic Class III Designation)
0910-0843 GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation
0910-0842 Import Trade Auxiliary Communication System
0910-0841 Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute - Sponsored Transfusion-Transmissible Infections Monitoring System - Risk Factor Elicitation
0910-0840 FDA’s Voluntary Qualified Importer Program; Guidance for Industry
0910-0839 Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood,Infant Formula, and Formula for Young Children Manufacturers/Processorswith Interest in Exporting to China
0910-0838 Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
0910-0837 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
0910-0836 REPORTING INFORMATION REGARDING FALSIFICATION OF DATA
0910-0835 Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner
0910-0834 Postmarketing Safety Reporting for Combination Products
0910-0833 FDA Advisory Committee Membership Nominations
0910-0832 Certification of Identity for Freedom of Information and Privacy Act Requests
0910-0831 STUDY: Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs
0910-0830 Tobacco Product Standard: NNN Level of Finished Smokeless Tobacco Products
0910-0829 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Inlcuding Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Final Rule
0910-0828 National Survey of Health Information and Communication
0910-0827 Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
0910-0826 Animation in Direct-to-Consumer Advertising
0910-0825 Restricted Sale, Distribution, and Use of Sunlamp Products
0910-0824 Market Claims in Direct-to-Consumer Prescription Drug Print Ads
0910-0823 Medical Device Accessories
0910-0822 Guidance for Industry on Tropical Disease Priority Review Vouchers
0910-0821 Quantitative Information in Direct-to-Consumer Television Advertisements Survey
0910-0820 Comparing Food Safety Knowledge, Attitude and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers
0910-0819 Experimental Study on Consumer Perceptions of Modified Risk Tobacco Products (MRTP)
0910-0818 Hearing, Aging, and Direct-to-Consumer Television Advertisements
0910-0817 Gluten-Free Labeling of Fermented or Hydrolyzed Foods
0910-0816 Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption
0910-0815 National Panel of Tobacco Consumer Studies
0910-0814 Individual Patient Expanded Access Applications
0910-0813 Food Labeling: Nutrition Facts and Supplement Facts labels
0910-0812 Mitigation Strategies to Protect Food Against Intentional Adulteration
0910-0811 Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records
0910-0810 Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
0910-0808 Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco among LGBT (RESPECT)
0910-0807 Voluntary Labeling Indicating Whether Foods Have or Have Not BeenDerived from Genetically Engineered Plants
0910-0806 Implementation of the Drug Supply Chain Security Act - Identification of Suspect Product and Notification
0910-0805 Electronic User Fee Payment Form Requests
0910-0803 Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads
0910-0802 Guidance for Industry on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
0910-0801 Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions
0910-0800 Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
0910-0799 Survey on the Occurrence of Foodborne Illness Risks Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015-2025)
0910-0797 Controlled Correspondence Related to Generic Drug Development
0910-0796 Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
0910-0795 Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - Final Rule
0910-0794 Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - Proposed Rule
0910-0793 Food and Cosmetic Export Certificate Applications Process
0910-0792 Food Allergen Labeling and Reporting
0910-0791 Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements
0910-0790 Survey of Health Care Practitioners for Device Labeling Format and Content
0910-0789 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
0910-0788 Evaluation of the Food and Drug Administration's 'Fresh Empire' Multicultural Youth Tobacco Prevention Campaign.
0910-0787 Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development
0910-0786 Abbreviated New Drug Applications and 505(b)(2) Applications
0910-0785 Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements
0910-0784 Risk and Benefit Perception Scale Development
0910-0783 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
0910-0782 Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
0910-0781 Information Request Regarding pH of Smokeless Tobacco Products
0910-0780 Application for Participation in Food and Drug Administration Fellowship Programs
0910-0779 Antiparasitic Drug Use and Antiparasitic Resistance Survey
0910-0778 Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents
0910-0777 GFI: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
0910-0776 Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K
0910-0775 Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States As of February 15, 2007
0910-0774 Experimental Study of Proposed Changes to the Nutrition Facts Label Formats
0910-0773 Sanitary Transportation of Human and Animal Food
0910-0772 Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
0910-0771 GFI: Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
0910-0770 Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements - Final Rule
0910-0769 Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices
0910-0768 Deeming Tobacco Products To Be Subject to the FD&C Act
0910-0767 Annual Reporting for Custom Device Exemption
0910-0766 Safety Assurance Case
0910-0765 Expedited Programs for Serious Conditions-Drugs and Biologics
0910-0764 Study; Consumer Responses to Nutrition Facts Labels w/Various Footnote Formats and Declaration of Added Sugars
0910-0763 Experimental Studies on Consumer Responses to Nutrient Content Claims on Fortified Foods
0910-0762 Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug and Cosmetic Act
0910-0761 Eye Tracking Experimental Studies to Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys
0910-0760 Animal Feed Regulatory Program Standards
0910-0759 Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products
0910-0758 Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports
0910-0757 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Proposed Rule
0910-0756 Requests for Feedback on Medical Device Submissions
0910-0755 Protection of Human Subjects: Informed Consent; Institutional Review Boards
0910-0754 Dear Health Care Provider Letters; Improving Communication of Important Safety Information
0910-0753 Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
0910-0752 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
0910-0751 Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food
0910-0750 Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications
0910-0749 Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
0910-0748 Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
0910-0747 Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages
0910-0746 Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act
0910-0745 Guidance for Industry on Tobacco Retailer Training Programs
0910-0744 Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
0910-0743 Communicating Composite Scores in Direct-to-Consumer (DTC) Prescription Drug Advertising
0910-0742 Proposed Amendment to Laser Product Performance Standard
0910-0741 Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices
0910-0740 Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling
0910-0739 Product Safety Standards--Recordkeeping and Third Party Disclosure Requirements
0910-0738 Center for Devices and Radiological Health Appeals Processes
0910-0737 Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising
0910-0736 Experimental Study on the Public Display of Lists of Harmful and Potential Harmful Tobacco Constituents
0910-0735 Experimental Study on Consumer Responses to Labeling Statements on Food Packages
0910-0734 Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
0910-0733 Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
0910-0732 Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
0910-0731 Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products
0910-0730 Health Care Professional Survey of Prescription Drug Promotion
0910-0729 Secure Supply Chain Pilot Program (SSCPP)
0910-0728 Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA
0910-0727 Generic Drug User Fee Program
0910-0726 Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities
0910-0725 Experimental Study; Health Claims and Disclaimers About the Relationship Between Selenium and Risk of Various Cancers
0910-0724 Experimental Study: Disease Information in Branded Promotional Material
0910-0723 Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
0910-0722 Medical Device Decision Analysis: A Risk-Tolerance Pilot Study
0910-0721 Animal Food Labeling; Declaration of Certifiable Color Additives
0910-0720 Unique Device Identification System
0910-0719 General Licensing Provisions; Section 351(k) Biosimilar Applications
0910-0718 Biosimilar User Fee Program
0910-0717 SPF Labeling and Testing Requirements for OTC Sunscreen Products
0910-0716 Potential Tobacco Product Violations Reporting Form
0910-0715 Survey of "Health Care Providers' Responses to Medical Device Labeling"
0910-0714 Examination of Online Direct-to-Consumer Prescription Drug Promotion
0910-0713 Experimental Study: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions
0910-0712 Data to Support Communications Usability Testing, as Used by the Food and Drug Administration
0910-0711 Real Time Surveys of Consumers` Knowledge, Perceptions and Reported Behavior Concerning Foodborne Illness Outbreaks or Food Recalls
0910-0710 Data to Support Food and Nutrition Product Communications as Used by the Food and Drug Administration
0910-0709 Changes to Reportable Food Registry Reports Under the FDA Food Safety Modernization Act
0910-0708 Data to Support Communications to Educate Consumers on How to Safely Purchase Drugs Online
0910-0707 Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising
0910-0706 Comparing Nutrition Knowledge, Attitude, and Behavior Among English Dominant Hispanics, Spanish Dominant Hispanics, and Other Consumers
0910-0705 Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
0910-0704 Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
0910-0703 Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements
0910-0702 Orphan Drug Regulations
0910-0701 Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance
0910-0700 Guidance Medical Device ISO 13485: 2003 Voluntary Audit Report Submission Pilot Program
0910-0699 Applications for Food and Drug Administration Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements--Discontinuance
0910-0698 National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products
0910-0697 Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery
0910-0696 Followup Study for Infant Feeding Practices Study II
0910-0695 Data to Support Drug Product Communications
0910-0694 SPF Labeling and Testing Requirements for OTC Sunscreen Products with SPF Values Greater Than 50
0910-0693 Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
0910-0692 Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs
0910-0691 Experimental Study of Patient Information Prototypes
0910-0690 Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products
0910-0689 TESTING COMMUNICATIONS ON FDA-REGULATED PRODUCTS USED IN ANIMALS
0910-0688 Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
0910-0687 Testing Communications on Biological Products
0910-0686 Prescription Drug Advertisements
0910-0685 Information Request Regarding Dissolvable Tobacco Products
0910-0684 Tobacco Products, Exemptions From Substantial Equivalence Requirements
0910-0683 Information Required in Prior Notice of Imported Food
0910-0682 Experimental Study of Nutrition Facts Label Formats
0910-0681 Recommendations to Reduce the Risk of Transfusion-Transmitted Infection in Whole Blood and Blood Components
0910-0680 Tracking Network for PETNet, LivestockNet, and SampleNet
0910-0679 Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
0910-0678 Testing Communications On Medical Devices and Radiation-Emitting Products
0910-0677 Focus Groups About Drug Products As Used by The Food and Drug Administration
0910-0675 Guidance for Industry (GFI): Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
0910-0674 Pretesting of Tobacco Communications
0910-0673 Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
0910-0672 Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
0910-0671 Requirements under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Family Smoking Prevention and Tobacco Control Act
0910-0670 GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims
0910-0669 Abbreviated New Animal Drug Applications
0910-0668 Experimental Study of Graphic Cigarette Warning Labels
0910-0667 Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs
0910-0666 Revision of the Requirements for Constituent Material
0910-0665 Section 4205 of the Patient Protection and Affordable Care Act Restaurant Menu Labeling; Recordkeeping and Mandatory Third Party Disclosure
0910-0664 Section 4205 of the Patient Protection and Affordable Care Act ( P.L. 111-148: Restaurant Menu Labeling : Registration For Small Chains
0910-0663 Experimental Study: Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer (DTC) Television and Print Advertisements for Prescription Drugs
0910-0662 Information Request Regarding Menthol in Cigarettes
0910-0661 Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
0910-0660 Production, Storage, and Transportation of Shell Eggs (preventing Salmonella Enteritidis (SE))
0910-0659 Antimicrobial Animal Drug Distribution Reports and Recordkeeping
0910-0658 Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
0910-0657 Evaluation of Potential Sources for the Sentinel Initiative
0910-0656 Gluten-Free Labeling of Food Products Expermental Study
0910-0655 Experimental Studies of Nutrition Symbols on Food Packages
0910-0654 Tobacco Health Document Submission
0910-0653 Expanded Access to Investigational Drugs for Treatment Use
0910-0652 Experimental Study: Toll-Free Number for Consumer Reporting of Drug Product Side Effects in Direct-to-Consumer Television Advertisements for Prescription Drugs
0910-0651 Charging for Investigation Drugs under an IND
0910-0650 Tobacco Product Establishment Registration and Submission of Certain Health Information
0910-0649 Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness
0910-0648 PDUFA Pilot Project Proprietary Name Review
0910-0647 Tobacco Product Standard on Flavored Cigarettes
0910-0646 Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
0910-0645 FDA Adverse Event and Products Experience Reports; Electronic Submissions
0910-0644 Survey to Evaluate FDA's Food Defense Awareness Initiative ALERT
0910-0643 Reporting and Recordkeeping Requirements for Reportable Food
0910-0642 Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
0910-0641 Labeling of Nonprescription Human Drug Products Marketed w/o an Approved App as Required by the Dietary Supp & Nonpresription Drug Consumer Protection Act
0910-0639 Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices
0910-0638 Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
0910-0637 Survey to Evaluate the Effectiveness of Mississippi Delta Fish Advisories
0910-0636 Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
0910-0635 Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
0910-0634 Experimental Evaluation of the Impact of Distraction
0910-0633 Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
0910-0632 Animal Generic Drug User Fee Cover Sheet
0910-0631 Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women with Chronic Conditions
0910-0630 Requirements for Submission of In Vivo Bioequivalence Data
0910-0629 Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
0910-0628 Survey of Current Manufacturing Practices in the Food Industry
0910-0627 Substances Prohibited From Use in Animal Food or Feed
0910-0626 Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act
0910-0625 Electronic Submission of Medical Device Registration and Listing
0910-0624 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling
0910-0623 Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
0910-0622 Foreign Clinical Studies Not Conducted Under an IND
0910-0621 Voluntary National Retail Food Regulatory Program Standards
0910-0620 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
0910-0618 Mental Models Study of Food Terrorism Risk Awareness
0910-0617 Survey of Food Safety and Nutrition Information Provided to Pregnant Women by Health Care Providers and WIC Educators
0910-0616 Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
0910-0615 FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication about Medical Products
0910-0614 Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
0910-0613 Medical Device User Fee Amendments of 2007; Foreign Small Business Certification Form FDA 3602 A
0910-0612 Label Comprehension Study
0910-0611 Experimental Evaluation of Variations in Content & Format of the Brief Summery in D-T-C Print Advertisements for Prescription Drugs
0910-0610 CGMP for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increadsed Risk of Transmitting HCV Infection ("Lookback")
0910-0609 Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables
0910-0608 Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
0910-0607 Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
0910-0606 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
0910-0605 Designation of New Animal Drugs for Minor Use or Minor Species
0910-0604 Pharmaceutical Development Study
0910-0603 Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension
0910-0602 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
0910-0601 Manufactured Food Regulatory Program Standards
0910-0600 Supplements and Other Changes to Approved New Animal Drug Applications - Final Rule
0910-0599 Cosmetic Labeling and Voluntary Cosmetic Registration
0910-0598 CLIA Waiver Applications
0910-0597 Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
0910-0596 Survey of Need for Online Medical Device Information
0910-0595 Guidance on Emergency Use Authorization of Medical Products and Related Authorities
0910-0594 Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
0910-0593 MedWatch - The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations - Survey
0910-0592 Experimental Study of Qualified Health Claims: Consumer Inferences About Monounsaturated Fatty Acids from Olive Oil, EPA and DHA Omega-3 Fatty Acids, and Green Tea
0910-0591 Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs: Study 1
0910-0588 Survey of Healthcare Practitioners Regarding Their Preferences for Public Health Notifications
0910-0586 Medical Devices; Exception from General Requirements for Informed Consent
0910-0585 Medical Gas Containers and Closures: Current Good Manufacturing Practice Requirements
0910-0584 Guidance for Reagents for Detection of Specific Novel Influenza A Viruses
0910-0583 Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
0910-0582 Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable
0910-0581 GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees
0910-0580 The Mammography Quality Standards Act Final Regulations: Modifications and Aditions to Policy Guidance Help System #9
0910-0579 Research Study Complaint Form
0910-0578 Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments
0910-0577 Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
0910-0575 Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles
0910-0574 Survey on Program Funding
0910-0572 Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
0910-0571 Guidance for Requesting an Extension to Use Existing Label Stock After The Trans Fat Labeling Effective Date of January 1, 2006
0910-0570 Experimental Study of Carbohydrate Content Claims on Food Labels
0910-0569 Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program
0910-0567 Allergen Labeling of Food Products Consumer Preference Survey and Experimental Study on Allergen Labeling of Food Products
0910-0566 Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM
0910-0565 Experimental Study of Health Claims on Food Packages
0910-0564 Performance Standard for Diagnostic X-Ray Systems and Their Major Components
0910-0563 Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
0910-0562 Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the EPA
0910-0560 Recordkeeping and Records Access Requirements for Food Facilities
0910-0559 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement
0910-0558 Infant Feeding Practices Study II
0910-0557 Guidance for Industry - Pharmacogenomic Data Submissions
0910-0555 SPresubmission Conferences - Final Rule
0910-0553 Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
0910-0551 Application for Participation in the Medical Device Fellowship Program; Form FDA 3608
0910-0549 Irradiation in the Production, Processing and Handling of Food
0910-0548 Requirements for Collection of Data Relating to Prevention of Medical Gas Mix-ups at Health Care Facilities
0910-0546 Food Additive Petitions, 21 CFR Part 571, Center for Veterinary Medicine
0910-0545 Health and Diet Survey
0910-0543 Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
0910-0541 Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
0910-0540 Animal Drug User Fee Program
0910-0539 Animal Drug User Fee Cover Sheet
0910-0538 Supplements and Other Changes to an Approved Application - Final Rule
0910-0537 Bar Code Label Requirements for Human Drug Products and Biological Products
0910-0533 Experimental Study of Trans Fat Claims on Foods
0910-0532 Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosures on the Nutrition Facts Panel (NFP)
0910-0531 Experimental Study of Health Claim disclaimers on Foods
0910-0530 Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
0910-0529 21 CFR Parts 510 and 558 Requirements for Liquid Medicated Animal Feed and Free-Choice Medicated Animal Feed - NPRM
0910-0528 Guidance for Industry - Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
0910-0527 Certain Biologics Labeling
0910-0524 Guidance for Industry: How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine
0910-0523 Product Jurisdiction and Combination Products
0910-0522 Evaluating the Safety of Antimicrobial New Aniam Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
0910-0521 Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora
0910-0520 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
0910-0519 Control of Communicable Diseases; Requests for Exemptions from the Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
0910-0518 Guidance for Industry: Continuous Marketing Applications: Pilot 2 Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
0910-0516 Impact of Risk Management Programs on the Practice of Pharmacy - Survey
0910-0515 Food Labeling: Trans Fatty Acids in Nutrition Labeling
0910-0514 Submission of Validation Data for Reprocessed Single-Use Devices
0910-0513 Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
0910-0511 Medical Device User Fee Cover Sheet - FDA Form 3601
0910-0510 Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
0910-0509 Establishing and Maintaining Lists of U.S.Product Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products
0910-0508 MDUFMA Small Business Qualification Certification
0910-0504 Revisions to the General Safety Requirements for Biological Products
0910-0502 Registration of Food Facilities
0910-0501 Telephone Questionnaire Administration to Control Subjects Recruited into FDA Lyme Vaccine Safety Study, "A Case-Control Study of HLA Type and T-Cell Reactivity to Recombinat Outer.....
0910-0500 Rapid Response Surveys
0910-0498 Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802
0910-0497 Focus Groups as Used by the Food and Drug Administration
0910-0495 Food Additives; Food Contact Substances Notification System
0910-0494 The Evaluation of Long-Term Antibiotic Drug Therapy for Persons Involved in Anthrax Remediation Activities
0910-0493 Salmonella Discovery System Pilot Study
0910-0492 Consumer Surveys on Food and Dietary Supplement Labeling Issues
0910-0491 Shortages Data Collection
0910-0489 Health and Diet Survey
0910-0486 Requirements for States as Certification Agencies
0910-0485 Medical Device Labeling Regulations
0910-0484 Suggested Documentation for Demonstrating Compliance with Channels of Trade Provision for Foods with Vinclozolin Residues
0910-0483 Foreign Establishment Registration and Listing
0910-0482 Export Notification and Recordkeeping Requirements
0910-0480 Providing Regulatory Submissions in Electronic Format for Food Additive and Color Additive Petitions
0910-0479 Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer (DTC) Promotion of Prescription Drugs
0910-0478 Consumer and Producer Surveys on Economic Issues
0910-0477 Survey of Single-Use Medical Device (SUD) Reuse and Reprocessing in Hospitals
0910-0474 General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification
0910-0472 Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicate Disease Agents; and Requirements for Donor Notification
0910-0471 Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))
0910-0470 Guidance for Industry (GFI): Special Protocol Assessment
0910-0469 Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
0910-0468 Focus Group Study of Radiation Disclosure Statement Options
0910-0467 Request for Review of Scientific Disputes Concerning the Regulation of Medical Devices
0910-0466 Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing of Juice
0910-0462 Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Stay of Act; Effective Date of Final Rule
0910-0461 Substances Approved for Use in the Preparatin of Meat and Poultry Products
0910-0459 Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
0910-0458 Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
0910-0457 Rapid Response Surveys
0910-0456 PHS Guideline on Infectious Disease Issues in Xenotransplantation
0910-0455 Documentation for demonstrating compliance with the Channels
0910-0454 Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway
0910-0453 Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Invest. Animals Not Intended for Immediate Slaughter
0910-0452 Guidance for Indusry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference in Electronic Format to the Center for Veterinary Medicine
0910-0450 Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes in Electronic Format to CVM
0910-0449 Postmarket Surveillance of Medical Devices
0910-0448 Adoption of FDA Food Code by Local, State and Tribal Governments
0910-0446 Survey of Incidence of gastroenterological Parasitic Infections
0910-0445 Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds
0910-0444 Food additives; Food Contact Substances Notification System
0910-0443 Survey of Incidence of Gastroenterolocial Parasitic Infections in the United States as a Result of Consumption of Raw Fish
0910-0442 Medical Devices; Device Tracking
0910-0439 Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition
0910-0437 Medical Device Reporting
0910-0435 Prescription Drug Marketing
0910-0433 Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Report
0910-0432 Medical Device Recall Authority
0910-0431 Changes to an Approved NDA or ANDA
0910-0430 Formal Dispute Resolutions; Appeals Above the Division Level
0910-0429 Formal Meetings with Sponsors and Applicants for PDUFA Products
0910-0428 Record Retention Requirements for the Soy Protein/CHD Health Claim
0910-0427 Biological Product Regulated under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License
0910-0426 Quality Mammography Standards: Lay Summaries for Patients
0910-0425 Survey of Food Manufacturers for Year 2000 Compliance
0910-0423 New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal Or Permanently Disabling Toxic Substances When Efficacy Studies....
0910-0422 Survey of Manufacturing Practices in the Dietary Supplement Industry
0910-0417 Survey of Biomedical Equipment Manufacturers for Year 2000 Compliance
0910-0416 Investigational New Drug Applications and New Drug Applications
0910-0411 Study of Manufacturers of Computer-Controlled, Potentially High-Risk Medical Devices Regarding Year 2000 Status
0910-0409 Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
0910-0408 Survey of Licensed Biologics Manufacturers and Registered Blood Establishments for Year 2000 Compliance
0910-0405 Survey of Medical Device Manufacturers for Year 2000 Compliance of Manufacturing Processes
0910-0402 Survey of Drug Manufacturers, Distributors, Repackagers, and Other Drug Distribution Facilities for Year 2000 Compliance
0910-0399 Attitudinal and Behavioral Effects of Direct-to-Consumer (DTC) Advertising of Prescription Drugs (Survey)
0910-0398 Labeling for Menstrual Tampons; Absorbency Range of 15-18 Grams
0910-0397 Survey of Biomedical Equipment Manufacturers for Year 2000 Compliant Products
0910-0396 Financial Disclosure by Clinical Investigators
0910-0395 Food Labeling: Nutrition Labeling of Dietary Supplements on a "Per Day" Basis
0910-0393 Prescription Drug Product Labeling; Medication Guide Requirements
0910-0392 Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients
0910-0391 Investigational Device Exemptions, Modifications
0910-0390 Dissemination of Information on Unapproval/New Uses for Marketed Drugs, Biologics, and Devices
0910-0389 Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review
0910-0388 Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly....
0910-0387 Medical Devices Registration and Listing
0910-0385 Supplements to Premarket Approval Applications for Medical Devices
0910-0384 Medical Devices: Humanitarian Use Devices
0910-0383 Access to Mammography Services Survey
0910-0381 Food Labeling Regulations
0910-0378 Medical Devices, Third Party Premarket Submission Review and Quality System Inspections Under U.S./E.C. MRA
0910-0376 Transmittal of Advertising and Promotional Labeling for Drugs and Biologics for Human Use
0910-0375 510(k) Third-Party Review Program
0910-0374 Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
0910-0372 Manufacturers of Human Cellular and Tissue-Based Products
0910-0370 Specific Requirements on the Content and Format of Labeling for Human Prescription Drugs; Addition of Geriatric Use Subsection
0910-0369 Tobacco Retailer Tracker Study
0910-0368 OTC Test Sample Collection Systems for Drugs of Abuse Testing - 21 CFR Part 809
0910-0367 Performance Standard for Electrode Lead Wires and Patient
0910-0366 Financial Disclosure by Clinical Investigators -- 21 CFR Part 54
0910-0365 Serving Sizes: Reference Amount for Candies
0910-0364 Nutrition Labeline: Declaration of Caloric Amounts and Serving Sizes for Breath Mints
0910-0363 Veterinary Feed Directive
0910-0362 Serving Sizes: Reference Amount for Salt, Salt Substitutes,
0910-0361 Classification/reclassification; Restricted Devices; Analyte Specific Reagents
0910-0360 Customer/Partner Service Surveys
0910-0359 Medical Devices; Reports of Corrections and Removals
0910-0358 Tobacco Retailer Tracking Study
0910-0357 Serving Sizes: Reference Amount for Baking Powder, Baking Soda, and Pectin
0910-0356 Substantial Evidence of Effectiveness of New Animal Drugs
0910-0355 Survey of Food Safety Practices of Food Processing Firms
0910-0354 Procedures for the Safe Processing and Importing of Fish and Fishery Products
0910-0353 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation; final rule
0910-0352 Latex Condoms; User Labeling - Expiration Dating (21 CFR 801.435)
0910-0351 Food Labeling: Statement of Identity, Nutrition Labeling,
0910-0349 Nutrient Content Claims and Health Claims, Restaurant Foods
0910-0348 Medical Devices, Investigational Device Exemptions, Treatment
0910-0345 Food Safety, Health, and Diet Survey
0910-0343 Evaluation of Revised Formats for Over-the-Counter (OTC) Drugs
0910-0342 Substances Generally Recognized as Safe: Notification Procedure
0910-0341 FDA Safety Communication Readership Survey
0910-0340 Format and Content Requirements for Over-the-Counter Drug Product Labeling
0910-0339 Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
0910-0338 General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension
0910-0337 Medicated Feed Mill License Application
0910-0336 Current Good Manufacturing Practices for Blood and Blood Components; Notification of Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV
0910-0335 Gender Differences in Perception of Risks Communicated by Prescription and Over-the-Counter Drug Labels, Survey
0910-0334 Notification of Nutrient Content Claims for Fat or Fatty Acids
0910-0332 Medical Devices; Humanitarian Use Devices
0910-0331 Food Labeling: Notification Procedures for Statements on Dietary Supplements
0910-0330 Premarket Notification for a New Dietary Ingredient
0910-0325 Extra Label Drug Use in Animals
0910-0324 Small Business Exemption Notices -- 21 CFR Part 101
0910-0323 Current Good Manufacturing Practice, Proposed Amendment of
0910-0322 Environmental Impact Considerations
0910-0320 Request for Information from U.S. Processors that Export to the European Community
0910-0318 Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program
0910-0317 Permanent Listing of Color Additive Lakes
0910-0316 Well-Characterized Biotechnology Products, Elimination of
0910-0315 General Licensing Provisions: Changes to an Approved Application; Labeling; and Revocation and Suspension
0910-0312 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
0910-0311 Use of Auditory Canal Thermometers in Pediatric and Family practice Offices.
0910-0310 Joint FDA/NHLBI Health and Diet Survey, Cycle VI
0910-0309 Mammography Facilities, Standards, and Lay Summaries for Patients
0910-0308 Biological Products - general records and postmarket adverse experience reporting
0910-0306 Pesticide Residue Study of Monthly Rice Production Volumes from Operating U.S. Rice Mills
0910-0305 Abbreviated New Drug Application Regulations; Patent and Exclusivity Provisions
0910-0303 Electronic Records: Electronic Signatures
0910-0302 Human Tissue Intended for Transplantation
0910-0301 TISSUE BANK SURVEY
0910-0300 FOOD LABEL USE AND NUTRITION EDUCATION SURVEY
0910-0299 INVESTIGATIONAL DEVICE EXEMPTIONS, DISQUALIFICATION OF CLINICAL INVESTIGATORS (PROPOSED RULE)
0910-0298 Threshold of Regulation for Substances Used in Food-Contact Articles
0910-0297 Prescription Drug User Fee Program
0910-0296 MEDICAL DEVICE INNOVATION SURVEY
0910-0293 MEDICAL DEVICE RECALL COST SURVEY
0910-0291 MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)
0910-0290 NATIONAL SURVEY OF PHYSICIANS CONCERNING PERCEPTIONS OF DRUG PRODUCT LABELING AND THE BRIEF SUMMARY
0910-0289 NEW ANIMAL DRUG REGULATIONS -- 21 CFR PART 514 (PROPOSED RULE)
0910-0288 FOOD LABELING: NUTRIENT CONTENT CLAIMS, GENERAL PRINCIPLES, PETITIONS, DEFINITION OF TERMS, DEFINITIONS OF NUTRIENT CONTENT CLAIMS FOR THE FATTY ACID & CHOLESTEROL CONTENT, ETC
0910-0287 FOOD LABELING: GENERAL REQUIREMENTS FOR HEALTH CLAIMS FOR FOOD -- 21 CFR PART 101
0910-0286 Reference Amount Petitions -- 21 CFR 100.12(h)
0910-0284 Records and Reports Concerning Experience with Approved New Animal Drugs
0910-0282 INFANT FEEDING PRACTICES SURVEY
0910-0281 Medical Devices: Substantial Equivalence, 510(k) Summaries
0910-0280 CONSUMER FOOD HANDLING PRACTICES AND AWARENESS OF MICROBIOLOGICAL HAZARDS
0910-0279 Year 2004 Updates on the National Survey of Prescription Drug Information Provided to Patients
0910-0277 State Petitions for Exemption from Preemption
0910-0275 State Enforcement Notifications
0910-0271 STUDY OF FOOD LABEL FORMATS: PHASE II
0910-0268 STUDY OF FOOD LABEL FORMATS - MAIN STUDY
0910-0267 WEIGHT LOSS PRACTICES SURVEY
0910-0266 JOINT FDA/NHLBI HEALTH AND DIET SURVEY, CYCLE V
0910-0265 FOOD LABELING COST SURVEY
0910-0264 Export of Medical Devices - Foreign Letters of Approval
0910-0263 READERSHIP EVALUATION OF THE FDA DRUG BULLETIN
0910-0262 CONSUMER SURVEY OF COSMETIC USAGE PATTERNS FOR RISK ASSESSMENT
0910-0261 AUTOMATIC DETENTION AND PRIVATE LABORATORY TESTING OF FDA-REGULATED PRODUCTS FOR IMPORT ENTRY
0910-0260 TREATMENT OF NARCOTIC ADDICTS, JOINT REVISION OF CONDITIONS FOR USE, INTERIM MAINTENANCE TREATMENT -- 21 CFR PART 291
0910-0259 TEA CHOP LIST AND APPELLANT'S APPLICATION FOR REVIEW OF EXAMINER'S RETURN
0910-0258 APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTIONS
0910-0257 LABELING FOR MENSTRUAL TAMPONS - RANGES OF ABSORBENCY 21 CFR 801.430(E),(F)
0910-0256 Infant Formula Requirements
0910-0255 INTERNAL ANALGESIC, ANTIPYRETIC, ANTIRHEUMATIC DRUG PRODUCTS FOR OTC HUMAN USE - NPRM
0910-0254 LABEL DECLARATIONS: CHOLESTEROL CONTENT OF FOODS (NPRM)
0910-0253 MEDICAL DEVICE CONFORMANCE ASSESSMENT TO VOLUNTARY STANDARDS
0910-0251 PRESCRIPTION DRUG MARKETING ACT OF 1987, GUIDELINES FOR STATE LICENSING OF WHOLESALE DRUG DISTRIBUTORS - FINAL RULE
0910-0250 LABELING REQUIREMENTS FOR SULFITING AGENTS IN STANDARDIZED FOODS - NPRM 21 CFR 130
0910-0249 FDA Recall Regulations
0910-0248 SURVEY OF JAPANESE PHARMACEUTICAL FIRMS REGARDING NEW BIOTECHNOLOGY PRODUCTS
0910-0247 HUMAN FACTORS REGARDING THE USE OF GLUCOSE MONITORING EQUIPMENT
0910-0245 SURVEY OF CONSUMER FOOD-HANDLING PRACTICES AND AWARENESS OF MICROBIOLOGICAL HAZARDS
0910-0242 Aspartame as an Inactive Ingredient in Human Drug Products, Labeling Requirements
0910-0241 SURVEY TO DETERMINE PATIENT KNOWLEDGE AND PERCEPTIONS ON HEMODIALYSIS REUSE
0910-0240 JOINT FDA/NHLBI/NCI HEALTH AND DIET SURVEY, CYCLE IV
0910-0238 DECLARATION OF NET QUANTITY
0910-0237 BRONCHODILATOR DRUG PRODUCTS FOR OTC HUMAN USE
0910-0235 Foreign Language Disclosure Labeling
0910-0234 CARDIAC PACEMAKER REGISTRY
0910-0233 Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
0910-0232 Antheimintic Drug Products for OTC Human Use
0910-0231 Premarket Approval of Medical Devices - 21 CFR Part 814
0910-0230 Postmarketing Adverse Drug Experience Reporting
0910-0229 APPROVAL OF BULK NEW ANIMAL DRUG SUBSTANCES FOR USE BY LICENSED VETERINARIANS - NPRM
0910-0228 SPONSORED COMPOUNDS IN FOOD-PRODUCING ANIMALS, CRITERIA AND PROCEDURES FOR EVALUATING THE SAFETY OF CARCINOGENIC RESIDUES
0910-0227 TEST FOR ANTIBODY TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) -- 21 CFR 640
0910-0226 INTERNATIONAL DRUG SCHEDULING, CONVENTION ON PSYCHOTROPIC SUBSTANCES, NON-BARBITURATE SEDATIVES - VOLUNTARY SUBMISSION OF DATA AND COMMENTS ON THE ABUSE POTENTIAL, ACTUAL ABUSE...
0910-0225 EXOCRINE PANCREATIC INSUFFICIENCY DRUG PRODUCTS FOR OTC HUMAN USE - NPRM
0910-0224 CHOLESTEROL, FAT AND FATTY ACIDS LABELING, 21 CFR PART 101
0910-0223 21 CFR 101.3(E)(1) AND 21 CFR 101.3(E)(2) - IDENTIFY LABELING OF FOOD IN PACKAGE FORM - 21 CFR 101.3
0910-0222 COMMON OR USUAL NAME: LABELING OF PEANUT SPREADS (21 CFR PART 102)
0910-0221 FOLLOW UP OF GROWTH HORMONE RECIPIENTS
0910-0220 INFANT FEEDING PRACTICES STUDY
0910-0219 Medical Devices Standards Activities Report
0910-0218 LABELING OF WEIGHT CONTROL FOODS
0910-0216 Color Additive Certification Requests and Recordkeeping
0910-0215 QUICK TURNAROUND RESEARCH SERVICES - FDA 1986 MULTIPURPOSE SURVEY
0910-0213 Recordkeeping for Electronic Products, Specific Product
0910-0212 Regulations Under the Federal Import Milk Act
0910-0211 PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF HUMAN T-LYMPHOTROPIC VIRUS FOR IN-VITRO DIAGNOSTIC USE
0910-0210 PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS
0910-0209 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS, PROPOSED AMENDMENTS OF REQUIREMENTS FOR BLOOD GROUPING SERUM-NPRM
0910-0208 ADDITIONAL STANDARDS FOR ANTI-HUMAN GLOBULIN - 21 CFR 660 SUBPART F
0910-0207 LAXATIVE DRUG PRODUCTS FOR OTC HUMAN USE - NPRM
0910-0206 Request for Samples and Protocols
0910-0205 NEW ANIMAL DRUG REQUIREMENTS FOR MEDICATED FREE-CHOICE FEEDS 21 CFR 510.455
0910-0204 EXPORT OF INVESTIGATIONAL NEW ANIMAL DRUGS, TENTATIVE FINAL RULE
0910-0203 GOOD LABORATORY PRACTICE REGULATIONS FOR NONCLINICAL LABORATORY STUDIES
0910-0201 MEDICAL DEVICE REPORTING
0910-0200 LABELING - FOODS AND COSMETICS
0910-0198 FOOD LABELING: DECLARATION OF SODIUM CONTENT OF FOODS AND LABEL CLAIMS FOR FOODS ON THE BASIS OF SODIUM CONTENT 21 CFR PART 101
0910-0197 "REQUEST FOR EXTENSION OF COMMENT PERIOD"
0910-0196 GENERAL STANDARD OF IDENTITY FOR "CERTAIN OTHER CHEESES', NPRM, 21 CFR PART 133
0910-0195 LABELING REQUIREMENTS FOR MEDICAL DEVICES AND RADIOLOGICAL PRODUCTS
0910-0194 Petition for Administrative Stay of Action - 21 CFR 10.35
0910-0193 Advisory Opinions
0910-0192 Petition for Administrative Reconsideration of Action - 21 CFR 10.33
0910-0191 Administrative Practices and Procedures; Formal Evidentiary Public Hearing
0910-0190 NATIONAL ENVIRONMENTAL POLICY ACT: POLICIES AND PROCEDURES -- 21 CFR PART 25
0910-0188 Infant Formula Recall Regulations
0910-0187 LABELING REQUIREMENTS FOR HUMAN DRUGS, BIOLOGICS AND VETERINARY DRUGS
0910-0186 Irradiation in the Production, Processing and Handling of Food
0910-0185 Labeling Requirements for Color Additives (other than hair dyes) and Petitions
0910-0184 Filing Objections and Requests for a Hearing on a Regulation or Order
0910-0183 General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
0910-0182 Use of Impact Resistant Lenses in Eyeglasses and Sunglasses OMB No. 0910-0182
0910-0181 REQUEST FOR CERTIFICATION OF AN INSULIN BATCH
0910-0179 INFANT FORMULA QUALITY CONTROL AND LABELING
0910-0178 FOOD AND DRUG ADMINISTRATION FY '84 CONSUMER FOOD SURVEY
0910-0177 NUTRITION LABELING, 21 CFR 101.9 (B) & (C)
0910-0176 AMENDMENTS TO PERFORMANCE STANDARD FOR LASER PRODUCTS
0910-0171 Hearing Aid Devices: Professional and Patient Labeling and Conditions for Sale
0910-0168 Shipment of a Blood Product Prior to Completion of Testing for Products Known Reactive for HBsAg
0910-0167 Orphan Drugs
0910-0164 PRESCRIPTION DRUG ADVERTISING TO CONSUMERS STUDY
0910-0163 MEDICATED FEED APPLICATION - NPRM
0910-0162 INVESTIGATIONAL NEW DRUG APPLICATION
0910-0161 ALLERGENIC PRODUCTS, LIST OF SOURCE MATERIALS
0910-0159 INFANT FORMULA, LABELING REQUIREMENTS
0910-0158 EXEMPT INFANT FORMULA
0910-0155 REPORTING REQUIREMENTS APPLICABLE TO NORMAL SERUM ALBUMIN AND PLASMA PROTEIN FRACTION
0910-0154 Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226
0910-0152 Current Good Manufacturing Practice Regulations for Medicated Feed
0910-0151 TEMPORARY EXEMPTIONS FROM CERTAIN FOOD LABELING REQUIREMENTS FOR PURPOSE OF CONDUCTING AUTHORIZED FOOD LABELING EXPERIMENTS -- 21 CFR 101.108(B)
0910-0150 TAMPER RESISTANT PACKAGING REQUIREMENTS FOR CONTACT LENS SOLUTIONS AND TABLETS
0910-0149 Tamper-Resistant Packaging Requirements for OTC Human Drug Products
0910-0148 FORMALDEHYDE CLEARINGHOUSE DATA FORM
0910-0147 FDA FY '82 CONSUMER SURVEY
0910-0145 QUANTITY AND NATURE OF PATIENT INTERACTIONS WITH PHYSICIANS AND PHARMACISTS RE: PRESCRIPTIONS
0910-0144 STATE AGENCY OPINION SURVEY
0910-0143 MEDICAL DEVICE AND LABORATORY PRODUCT PROBLEM REPORTING PROGRAM
0910-0141 PHYSICIAN RESPONSE TO REDUCED INFORMATION REQUIREMENTS IN PRESCRIPTION DRUG ADVERTISING
0910-0140 Conditions for the Use of Narcotic Drugs for Treatment of Narcotic Addiction, Reporting and Recordkeeping Requirements
0910-0139 Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases
0910-0138 Reclassification Petitions for Medical Devices
0910-0137 REPORTING REQUIREMENTS APPLICABLE TO THE MANUFACTURE OF BLOOD GROUPING SERUM
0910-0136 HEPATITIS REPORTING REQUIREMENTS - 21 CFR 610
0910-0135 RECORDKEEPING REQUIREMENTS FOR EXEMPTION FROM FDA APPROVAL FOR NEW DRUGS USED IN NONHUMAN RESEARCH
0910-0134 REPORTING AND RECORDKEEPING REQUIREMENTS APPLICABLE TO THE EXEMPTIONS FROM ANTIBIOTIC CERTIFICATION AND LABELING PROGRAM
0910-0133 Temporary Marketing Permit Applications
0910-0132 Affirmation of Generally Recognized as Safe GRAS Status
0910-0131 Agreement for Shipments of Devices for Sterilization
0910-0130 Protection of Human Subjects and Institutional Review Boards
0910-0129 Applications for Exemption From Federal Preemption of State and Local Medical Device Requirements - 21 CFR Part 808
0910-0128 MEASURING TIMELINESS AND RESPONSIVENESS OF LETTERS TO CONSUMERS
0910-0127 NATIONAL CONSUMER AWARENESS AND ACCESS PROJECT EVALUATION
0910-0126 SURVEY OF SMALL MANUFACTURERS (REGULATORY FLEXIBILITY)
0910-0124 Establishment and Product License Applications
0910-0120 Premarket Notification Submission 510(k), Subpart E
0910-0119 Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies
0910-0117 New Animal Drugs for Investigational Use
0910-0116 Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"
0910-0115 BUREAU OF MEDICAL DEVICES STANDARDS SURVEY
0910-0114 Administrative Detention and Banned Medical Devices
0910-0112 FY '80 MULTI-PURPOSE FOOD SURVEY
0910-0111 PHYSICIAN INTERPRETATION OF RESEARCH DATA
0910-0110 POISON CONTROL QUESTIONNAIRE - PART I
0910-0106 NATIONAL SURVEY OF CHEST X-RAY SCREENING POLICIES
0910-0105 CONSUMER COMPREHENSION OF OTC DRUG LABELING
0910-0101 COMPUTED TOMOGRAPHY USE AND QUALITY ASSURANCE SURVEY
0910-0098 NUCLEAR MEDICINE QUALITY ASSURANCE PROJECT
0910-0097 SURVEY OF NUTRITION VOCABULARY AND QUANTITATIVE DECLARATIONS
0910-0096 SPECIAL DIETARY FOODS SURVEY
0910-0091 EFFECT OF PPI'S AS A FUNCTION OF CRITICAL VARIATIONS
0910-0083 NEXT IMAGE RECEPTOR MODULE
0910-0081 A FOLLOW-UP STUDY OF PERSONS WHO HAD 131 IODINE AND OTHER THYROID TESTS
0910-0079 SOURCE PLASMA (HUMAN) AMENDMEND TO STORAGE TEMPERATURE REQUIREMENTS
0910-0078 Investigational Device Exemptions Reports and Records - 21 CFR 812
0910-0077 PRODUCT APPLICATION FOR THE MANUFACTURE OF WHOLE BLOOD AND BLOOD COMPONENTS
0910-0076 MEDICATED FEED APPLICATION FDA-1900
0910-0075 OBLIGATIONS OF SPONSORS AND MONITORS OF CLINICAL INVESTIGATIONS
0910-0074 COLOR ADDITIVE PETITION
0910-0073 Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation
0910-0072 PERFORMANCE STANDARDS DEVELOPMENT
0910-0071 RADIATION INCIDENTS REGISTRY REPORTING PROGRAM
0910-0070 REIMBURSEMENT FOR PARTICIPATION IN ADMINISTRATIVE PROCEEDINGS
0910-0069 RADIATION EXPERIENCE DATA STUDY
0910-0068 PRODUCT LICENSE APPLICATION FOR THE MANUFACTURER OF SINGLE DONOR PLASMA
0910-0067 INTRAOCULAR LENS INVESTIGATIONAL DEVICE EXEMPTION APPLICATION
0910-0066 INVESTIGATIONAL SHIPMENT OF IN VITRO DIAGNOSTIC DEVICES
0910-0065 PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF ANTI-HUMAN GLOBULIN SERA
0910-0064 HIGH-YIELD CRITERIA FORM
0910-0063 USER EXPERIENCES WITH EXTENDED-WEAR AND OTHER TYPES OF CONTACT LENSES
0910-0062 PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF REAGENT RED BLOOD CELLS
0910-0061 PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF BLOOD GROUPING SERA
0910-0060 MEDICAL DEVICE REGISTRATION
0910-0059 Medical Devices: Medical Device Reporting, Certification
0910-0058 BLOOD SAMPLE IDENTIFICATION CARD
0910-0057 MEDICAL DEVICE LISTING
0910-0055 NEW DRUG AND ANTIBIOTIC REGULATIONS
0910-0054 ASHP/FDA DRUG SHORTAGE MONITORING PROGRAM
0910-0053 Radioactive Drug Research Committees
0910-0052 Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
0910-0051 DECLARATION FOR PRODUCTS SUBJECT TO RADIATION CONTROL STANDARDS
0910-0050 NATIONAL/REGIONAL/STATE TELECOMMUNICATIONS NETWORK TRAFFIC LOG
0910-0049 ANNUAL REVIEW OF STATE AND LOCAL RADIOLOGICAL HEALTH PROGRAMS
0910-0048 Notice of Availability of Sample Electronic Product
0910-0047 COSMETIC PRODUCT EXPERIENCE REPORTS -- 21 CFR PART 730
0910-0046 Imports and Electronic Import Entries
0910-0045 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
0910-0044 HOSPITAL REQUEST FOR METHADONE FOR DETOXIFICATION AND TEMPORARY MAINTENANCE TREATMENT
0910-0043 APPLICATION FOR APPROVAL OF USE OF METHADONE IN A TREATMENT PROGRAM
0910-0042 MEDICAL RESPONSIBILITY STATEMENT FOR USE OF METHADONE IN A TREATMENT PROGRAM
0910-0041 ESTABLISHMENT LICENSE APPLICATION AND SUPPLEMENTAL LICENSE APPLICATION FOR THE MANUFACTURE OF BLOOD AND BLOOD COMPONENTS
0910-0040 PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF SOURCE PLASMA
0910-0039 Transmittal of Labels and Circulars
0910-0038 CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS NEXT SURVEY
0910-0037 Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods
0910-0036 REGULATORY REQUIREMENTS FOR LOW-ACID AND ACIDIFIED CANNED FOOD PROCESSORS, 21 CFR PARTS 108, 113, AND 114
0910-0035 FOOD CANNING AND PROCESS FILING FOR OTHER THAN STILL RETORT AND AGITATING PROCESSES
0910-0034 FOOD CANNING ESTABLISHMENT AND PROCESS FILING FOR AGITATING PROCESSES
0910-0033 FOOD CANNING ESTABLISHMENT AND PROCESS FILING FOR STILL RETO RT PROCESSES
0910-0032 Reporting Associated with New Animal Drug Applications and Veterinary Master Files
0910-0031 COSMETIC RAW MATERIAL COMPOSITION STATEMENT
0910-0030 Cosmetic Product Voluntary Reporting Program
0910-0029 NOTICE OF DISCONTINUANCE OF COMMERCIAL DISTRIBUTION OF COSMETIC PRODUCT OR COSMETIC RAW MATERIAL
0910-0028 REPORT OF ASSEMBLY OF A DIAGNOSTIC X-RAY SYSTEM
0910-0027 Voluntary Cosmetic Registration Program
0910-0026 DRUG EXPERIENCE REPORT (SHORT FORM)
0910-0025 Reporting and Recordkeeping for Electronic Products - General Requirements
0910-0024 DRUG QUALITY REPORTING SYSTEM
0910-0023 POISONING REPORT
0910-0022 SHELLFISH CERTIFICATION CANCELLATION
0910-0021 Interstate Shellfish Dealer's Certificate
0910-0020 RESOURCE DATA FOR STATE FOOD AND DRUG PROGRAMS
0910-0019 TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS -- 21 CFR PART 510
0910-0018 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR HUMAN USE
0910-0017 TRANSMITTAL OF PERIODIC REPORTS FOR DRUGS FOR HUMAN USE
0910-0016 Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions, and Electronic Submission Using FDA Form 3503
0910-0015 STATEMENT OF INVESTIGATOR (CLINICAL PHARMACOLOGY)
0910-0014 Investigational New Drug Regulations
0910-0013 STATEMENT OF INVESTIGATOR
0910-0012 Veterinary Adverse Drug Reaction, Lack of Effectivenesss, Product Defect Report, and Transmittal of Periodic Reports and Promotional Material for New Animl Drugs, 21 CFR Part 510
0910-0011 Medicated Feed Application
0910-0010 APPLICATION FOR COMMISSION
0910-0009 REQUEST FOR SUPPLEMENTAL CERTIFICATION OF A BATCH OF ANTIBIOTIC DRUGS
0910-0008 APPLICATION FOR EXEMPTION FOR REPACKING OF ANTIBIOTICS
0910-0007 REQUEST FOR CERTIFICATION OR TESTING OF AN ANTIBIOTIC BATCH
0910-0006 APPLICATION FOR EXEMPTION FOR MANUFACTURING USE OF ANTIBIOTICS
0910-0005 APPLICATION FOR EXEMPTION FOR LABELING OF ANTIBIOTIC DRUGS
0910-0004 APPLICATION FOR EXEMPTION FOR PROCESSING OF ANTIBIOTIC DRUGS
0910-0003 APPLICATION FOR EXEMPTION FOR STORAGE OF ANTIBIOTIC DRUGS
0910-0002 DRUG EXPERIENCE REPORT
0910-0001 Applications for FDA Approval to Market a New Drug

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