Federal Register Notices 12/20-12/30

FDA Review is posting the following Federal Register notices that published during our annual holiday break.

12/30/2021

Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are:

• Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet
• Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials
• Medical Device Labeling Regulations
• Establishment and Operation of Clinical Trial Data Monitoring Committees
• Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food for Animals
• Federal-State Regulatory Program Standards
• Electronic User Fee Payment Form

To view the notice, click here.

12/29/2021

Federal Register notice: FDA is publishing a list of information collections that recently have been approved by OMB. They are:

• Request for Samples and Protocols
• Medical Device Recall Authority
• Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
• Human Drug Compounding, Repackaging and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

To view the notice, click here.

Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Reclassification Petitions for Medical Devices” (OMB Control Number 0910-0138). To view the notice, click here.

12/28/2021

Federal Register notice: FDA is classifying the retrograde intubation device into Class 2 (special controls). The action is in response to a Cook Inc. de novo classification request for its Retrograde Intubation Set. The agency has identified the prescription device as being for use in performing retrograde intubation via the cricothyroid membrane. To view the notice, click here.

12/27/2021

Federal Register notice: FDA is making available a final guidance entitled Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH). The document identifies the key features of non-clinical and clinical investigational plans used to support device submissions. To view the notice, click here.

Federal Register notice: FDA is making available a final guidance entitled Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers. The document discusses the management and conduct of pathology peer review performed during good laboratory practice compliant toxicology studies. To view the notice, click here.

12/23/2021

Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device User Fee Small Business Qualification and Certification” (OMB Control Number 0910-0508). Under the user fee program, a small business is eligible for reduced or waived fees. To view the notice, click here.

Federal Register notice: FDA is making available a draft guidance entitled Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (Covid–19) Public Health Emergency. The document describes general recommendations for the transition process for devices issued EUAs, including recommendations regarding submitting a marketing submission. To view the notice, click here.

Federal Register notice: FDA is making available a draft guidance entitled Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (Covid–19) Public Health Emergency. The document describes general recommendations for a phased transition process with respect to devices that fall within enforcement policies issued during the health emergency. To view the notice, click here.

Federal Register notice: FDA is making available a final guidance entitled Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use — Premarket Notification(510(k)) Submissions. The guidance outlines the device design considerations, risk mitigation strategies, and testing recommendations for arthroscopy pump tubing sets intended for multiple patient use. To view the notice, click here.

Federal Register notice: FDA is making available a draft guidance entitled Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The document provides a risk-based framework that can be used in the credibility assessment of computational modeling and simulation for devices. To view the notice, click here.

Federal Register notice: FDA is making available a draft guidance entitled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The document provides recommendations on the use of digital health technologies to acquire data remotely from participants in clinical investigations. To view the notice, click here.

Federal Register notice: FDA is making available a draft guidance entitled Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology. Such devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. To view the notice, click here.

12/22/2021

Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Biosimilars User Fee Program” (OMB Control Number 0910-0718). To view the notice, click here.

Federal Register notice: FDA has determined that Par Pharmaceuticals’ Antizol (fomepizole) Injection, 1.5g/1.5mL, was not withdrawn for safety or effectiveness reasons. The determination allows the agency to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Antizol is indicated as an antidote for ethylene glycol (antifreeze) or methanol poisoning. To view the notice, click here.

12/21/2021

Federal Register notice: FDA is extending the comment period for a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-World Data. Comments can now be submitted until 2/4. To view the notice, click here.

12/20/2021

Federal Register notice: FDA is announcing a 4/28-29 public workshop entitled “Wound Healing Scientific Workshop.” Its purpose is to discuss nonhealing chronic wounds. To view the notice, click here.