CBER Proposed / Final Rules


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Proposed / Final Rules

2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 and earlier

horizonal rule
2004
FEDERAL REGISTER Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule - 11/18/2004 - (PDF)

Questions and Answers for Roll-Out of GTP Final Rule - (Text)

FDA Improves the Safety of Human Cells and Tissues by Finalizing New Rules for "Good Tissue Practice"

FEDERAL REGISTER Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications, Proposed Rule - 7/20/2004 - (PDF), (Text)
FEDERAL REGISTER Definition of Primary Mode of Action of a Combination Product; Proposed Rule; Extension of Comment Period - 6/24/2004 - (PDF), (Text)

FEDERAL REGISTER Definition of Primary Mode of Action of a Combination Product, Proposed Rule - 5/7/2004 - (PDF), (Text)

FEDERAL REGISTER Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Proposed Rule - 6/10/2004 - (PDF), (Text)
FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule - 5/25/2004 - (PDF), (Text)

Questions and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance - (Text)

FEDERAL REGISTER Revision of the Requirements for Spore-Forming Microorganisms; Direct Final Rule; Confirmation of Effective Date - 5/14/2004 - (PDF), (Text)

FEDERAL REGISTER Revision of the Requirements for Spore-Forming Microorganisms; Direct Final Rule - 12/30/2003 - (PDF), (Text)

FEDERAL REGISTER Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule; Proposed Rule - 12/30/2003 - (PDF), (Text)

FEDERAL REGISTER Supplements and Other Changes to an Approved Application; Final Rule - 4/8/2004 - (PDF), (Text)
FEDERAL REGISTER Bar Code Label Requirement for Human Drug Products and Biological Products; Final Rule; Correction - 4/7/2004 - (PDF), (Text)

FEDERAL REGISTER Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule - 2/26/2004 - (PDF), (Text)

FEDERAL REGISTER Emergency Use of an Investigational New Drug; Final Rule; Technical Amendment - 4/6/2004 (PDF), (Text)
FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date; Correction - 3/18/2004 - (PDF), (Text)

FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date - 2/19/2004 - (PDF), (Text)

FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date - 1/31/2003 - (PDF), (Text)

FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date - 2/13/2002 - (PDF), (Text)

FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date - 3/1/2001 - (PDF), (Text)

FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule; Delay of Effective Date; Reopening of Administrative Record. - 5/3/2000 - (PDF), (Text)

FEDERAL REGISTER Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Final Rule - 12/3/1999 - (PDF), (Text)

FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Final Rule and Final Order; Correction - 2/13/2004 - (PDF), (Text)

FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Correction - 1/8/2004 - (PDF), (Text)

FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Final Rule and Final Order - 12/30/2003 - (PDF), (Text)

FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Proposed Rule - 12/13/1985 - (PDF Part 1), (PDF Part 2), (PDF Part 3), (PDF Part 4), (PDF Part 5), (PDF Part 6), (PDF Part 7), (PDF Part 8), (PDF Part 9), (PDF Part 10), (PDF Part 11), (PDF Part 12), (PDF Part 13), (PDF Part 14), (PDF Part 15), (PDF Part 16), (PDF Part 17), (PDF Part 18), (PDF Part 19), (PDF Part 20), (PDF Part 21), (PDF Part 22), (PDF Part 23)

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Correction - 1/30/2004 - (PDF), (Text)

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Opportunity for Public Comment - 1/23/2004 - (PDF), (Text)

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final rule; delay of effective date - 1/21/2003 - (PDF), (Text)

FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final Rule - 1/19/2001- (PDF), (Text)

2003
FEDERAL REGISTER Neurological Devices; Classification of Human Dura Mater; Final Rule - 12/18/2003 - (PDF), (Text)
FEDERAL REGISTER Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format; Final Rule - 12/11/2003 - (PDF), (Text)
FEDERAL REGISTER Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay - Final Rule - 10/30/2003 - (PDF), (Text)
FEDERAL REGISTER Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma; Correction - Proposed Rule; correction - 10/27/2003 - (PDF), (Text)

FEDERAL REGISTER Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma - Proposed Rule - 7/30/2003 - (PDF), (Text)

FEDERAL REGISTER Assignment of Agency Component for Review of Premarket Applications - Final Rule - 6/23/2003 - (PDF), (Text)
FEDERAL REGISTER New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval; Technical Amendment - Final Rule; Technical Amendment - 6/11/2003 - (PDF), (Text)
FEDERAL REGISTER Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule - 3/14/2003 - (PDF), (Text)

Questions and Answers on Safety Reporting Requirements for Human Drug and Biological Products

FEDERAL REGISTER Revision to the General Safety Requirements for Biological Products; Final Rule - 3/4/2003 - (PDF), (Text)

FEDERAL REGISTER Revisions to the General Safety Test Requirements for Biological Products; Final Rule - 8/5/1998 - (PDF), (Text)

FEDERAL REGISTER Revisions to the General Safety Requirements for Biological Products; Direct Final Rule - 4/20/1998 - (PDF), (Text)

FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Reclassification of Automated Blood Cell Separator Device Operating by Filtration Principle from Class III to Class II; Final rule - 2/28/2003 - (PDF), (Text)
2002
FEDERAL REGISTER Import for Export; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export; Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission Into the United States; Withdrawal; Proposed Rules; Withdrawal - 8/21/2002 - (PDF), (Text)

FEDERAL REGISTER Import for Export; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export; Proposed Rule - 11/24/1998 - (PDF), (Text)

FEDERAL REGISTER Investigational New Drugs: Export Requirements for Unapproved New Drug Products; Proposed Rule - 6/19/2002 - (PDF), (Text)
FEDERAL REGISTER Postmarket Surveillance; Final Rule - 6/6/2002 - (PDF), (Text)
FEDERAL REGISTER New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule - 5/31/2002 - (PDF), (Text)
FEDERAL REGISTER Exports; Notification and Recordkeeping Requirements; Stay; Final Rule; Stay - 5/14/2002 - (PDF), (Text)

FEDERAL REGISTER Exports: Notification and Recordkeeping Requirements; Final Rule - 12/19/2001 - (PDF), (Text)

FEDERAL REGISTER Obtaining Timely Pediatric Studies of and Adequate Pediatric Labeling for Human Drugs and Biologics; Advanced Notice of Proposed Rulemaking - 4/24/2002 - (PDF), (Text)
FEDERAL REGISTER Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs; Final Rule - 2/1/2002 - (PDF), (Text)
2001
FEDERAL REGISTER Foreign Establishment Registration and Listing; Final Rule - 11/27/2001 - (PDF), (Text)
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Final Rule - 8/6/2001 - (PDF), (Text)
FEDERAL REGISTER Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents - 6/11/2001 - (PDF), (Text)

FEDERAL REGISTER General Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification - 6/11/2001 - (PDF), (Text)

FEDERAL REGISTER Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports; Delay of Effective Date; Final Rule; delay of effective date - 2/20/2001 - (PDF), (Text)
Final Rule published 10/30/2000
FEDERAL REGISTER Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation; Proposed Rule - 1/18/2001 - (PDF), (Text)
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Confirmation in Part and Technical Amendment - 1/10/2001
(PDF), (Text)
2000
FEDERAL REGISTER Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels; Proposed Rule - 12/22/2000 - (PDF), (Text)
FEDERAL REGISTER Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Final Rule - 12/12/2000 - (PDF), (Text)
FEDERAL REGISTER Revision to Requirements for Licensed Anti-Human Globulin and Blood Grouping Reagents; Companion to Direct Final Rule - 12/12/2000 - (PDF), (Text)
FEDERAL REGISTER Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection ("Lookback"); Proposed Rule - 11/16/2000 - (PDF), (Text)
FEDERAL REGISTER Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule - 11/7/2000 - (PDF), (Text)

Biological Product Deviation Reporting - Form, Instructions, Codes

FEDERAL REGISTER Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule
CORRECTION: Effective date is May 7, 2001 - 11/9/2000 - (PDF), (Text)

FEDERAL REGISTER Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports; Final Rule - 10/30/2000 - (PDF), (Text)
FEDERAL REGISTER Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients; Technical Amendment; Final Rule - 10/6/2000 - (PDF), (Text)
FEDERAL REGISTER Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Technical Amendment; Final Rule - 8/29/2000 - (PDF), (Text)

FEDERAL REGISTER Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Final Rule - 10/20/1999 - (PDF), (Text)

FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin (Human); Final Rule - 8/28/2000 - (PDF), (Text)
FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Confirmation in Part and Technical Amendment; Final Rule - 3/14/2000 - (PDF), (Text)
FEDERAL REGISTER New Drug Applications; Drug Master Files; Final Rule - 1/12/2000 - (PDF), (Text)

List of CBER Type 1 Master Files to be Closed Effective July 10, 2000

1999
FEDERAL REGISTER Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports; Proposed Rule - 12/1/1999 - (PDF), (Text)
FEDERAL REGISTER Human Drugs and Biologics; Determination That Informed Consent Is NOT Feasible or Is Contrary to the Best Interests of Recipients; Revocation of 1990 Interim Final Rule; Establishment of New Interim Final Rule -10/5/1999 - (PDF), (Text)
FEDERAL REGISTER Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents; Proposed Rule - 8/19/1999 - (PDF), (Text)
FEDERAL REGISTER General Requirements for Blood, Blood Components and Blood Derivatives; Notification of Deferred Donors; Proposed Rule - 8/19/1999 - (PDF), (Text)
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Direct Final Rule - 8/19/1999 - (PDF), (Text)
FEDERAL REGISTER Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma; Companion Document to Direct Final Rule; Proposed Rule - 8/19/1999 - (PDF), (Text)
FEDERAL REGISTER Plasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification; Advance Notice of Proposed Rulemaking - 8/19/1999 - (PDF), (Text)
FEDERAL REGISTER Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring - 5/17/1999 - (PDF), (Text)
FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Direct Final Rule - 5/14/1999 - (PDF), (Text)
FEDERAL REGISTER Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human); Companion Document to Direct Final Rule; Proposed Rule - 5/14/1999 - (PDF), (Text)
FEDERAL REGISTER Investigational New Drug Applications; Clinical Holds; Direct Final Rule; Confirmation of Effective Date - 4/21/1999 - (PDF), (Text)
1998
FEDERAL REGISTER Investigational New Drug Applications; Clinical Holds; Direct Final Rule - 12/14/1998 - (PDF), (Text)
FEDERAL REGISTER Investigational New Drug Applications; Clinical Holds; Companion Document to Direct Final Rule - 12/14/1998 - (PDF), (Text)
FEDERAL REGISTER Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics and Devices; Final Rule - 11/20/1998 - (PDF), (Text)
FEDERAL REGISTER Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics and Devices; Proposed Rule - 6/8/1998 - (PDF), (Text)
FEDERAL REGISTER Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring; Proposed Rule - 5/22/1998 - (PDF), (Text)
FEDERAL REGISTER Natural Rubber-Containing Medical Devices; User Labeling; Final Rule - 5/6/1998 - (PDF), (Text)
1997 and earlier
FEDERAL REGISTER Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule - 9/23/1997; Correction 11/3/1997 - (PDF), (Text)
FEDERAL REGISTER Revision of the Requirements for a Responsible Head for Biological Establishments; Final Rule - 10/15/1997 - (PDF), (Text)
FEDERAL REGISTER Expedited Safety Reporting Requirements for Human Drug and Biological Products; Final Rule - 10/7/1997 - (PDF), (Text)
FEDERAL REGISTER Human Tissue Intended for Transplantation; Final Rule - 7/29/1997 - (PDF), (Text)
FEDERAL REGISTER Current Good Manufacturing Practice: Amendment of Certain Requirements for Finished Pharmaceuticals; Proposed Rule - 5/3/1996
(PDF), (Text)