Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?

There has been a spate of recent news articles about the potential use of the Congressional Review Act (CRA) to overturn final rules issued toward the end of the Obama Administration. That prompted us to see which of FDA’s recently issued final rules might be vulnerable.

By way of background, the CRA established a mechanism for Congress to disapprove a final rule issued by a federal agency. In relevant part, the CRA provides that a final rule submitted to Congress on or after the 60th day before adjournment is subject to review in the next session of Congress. A disapproval resolution requires a simple majority vote, but can be vetoed by the President; thus, as a practical matter, a disapproval resolution requires a supermajority vote for enactment. However, given the pending change in administrations, there is an opportunity for the next Congress to work with President-elect Trump to invalidate rules issued by the Obama administration in the last 60 days of this Congressional session. Because the 60 days are measured not as calendar days, but as days of session in the Senate and legislative days in the house, the Congressional Research Service (CRS) has estimated that final rules submitted to Congress after June 2, 2016 could be subject to disapproval under the CRA.

Below is a list of all FDA final rules issued between May 15 and last Friday, December 2. We opted to go back to May 15 because of uncertainty associated with CRS’s estimation of the date as of which disapproval might be an option. For the sake of clarity, we marked with an asterisk those rules issued between May 15 and June 2. Many of the rules are of interest mainly as an illustration of the many types of FDA actions that require rulemaking. However, some significant rules are potentially affected, such as the rule on safety and effectiveness of OTC topical antimicrobial drug products issued on September 6. Some significant rules – such as FDA’s nutrition labeling rule – were issued before June 2, but might not be entirely out of the woods given the softness of that date.

Food/Supplements:

• Uniform Compliance Date for Food Labeling Regulations
• 21 CFR Part 101 Food Labeling CFR Correction
• Indirect Food Additives: Paper and Paperboard Components
• Food Additives: Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
• Food Additives: Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
• Indirect Food Additives: Adhesives and Components of Coatings
• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Announcement of Effective Date
• Food Labeling: Technical Amendments
• The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
• Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date
• Emergency Permit Control Regulations; Technical Amendments
• Food Additives Permitted for Direct Addition to Food for Human Consumption: Vitamin D2 and Vitamin D3
• Amendments to Registration of Food Facilities
• Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate; Extension of the Comment Period
• Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
• Substances Generally Recognized as Safe
• Substances Generally Recognized as Safe – Correction
• *Food Labeling: Revision of the Nutrition and Supplement Facts Labels
• *Mitigation Strategies to Protect Food Against Intentional Adulteration
• *Food Labeling: Serving Sizes of Foods that Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments

Drugs/Biologics:

• Use of Ozone-Depleting Substances
• New Animal Drugs for Use in Animal Feed; Category Definitions; Confirmation of Effective Date
• Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
• Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
• Abbreviated New Drug Applications and 505(b)(2) Applications
• New Animal Drugs: Approval of New Animal Drug Applications; Change of Sponsor’s Address
• New Animal Drugs for Use in Animal Feeds: Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine
• Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use
• Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That are Regulated Under a Biologics License Application, and Animal Drugs
• New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application
• New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor’s Name and Address; Change of Sponsor’s Address
• New Animal Drugs for Use in Animal Feed; Category Definitions
• New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction
• Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date
• New Animal Drugs: Change of Sponsor
• Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Technical Amendment
• New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
• New Animal Drugs: Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
• Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products

Medical Devices:

• Listing of Color Additives Exempt from Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper
• Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
• Medical Devices: Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
• Medical Devices: Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components
• Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device
• Medical Devices: Custom Devices; Technical Amendment
• Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
• Medical Devices: Neurological Devices; Classification of the Evoked Photon Image Capture Device
• Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device
• Medical Devices: General and Plastic Surgery Devices; Classification of Magnetic Surgical Instrument System
• Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment
• Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
• Medical Devices: Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures
• Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia
• Medical Devices: General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
• Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System
• Use of Symbols in Labeling
• Medical Devices: Ophthalmic Devices; Classification of Nasolacrimal Compression Device
• *Medical Devices: Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System
• *Cardiovascular Devices: Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids

Tobacco:

• Refuse to Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal
• Refuse to Accept Procedures for Premarket Tobacco Product Submissions

Other:

• Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets
• Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
• Revision of Organization and Conforming Changes to Regulation
• Maximum Civil Money Penalty Amounts; Technical Amendment
• Change of Address; Technical Amendment
• Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date
• Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; Termination