> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-73/
- Published: 2022-03-20T12:00:00.000Z
- Updated: 2026-09-14T17:37:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151412

**EUA for Abbott’s BinaxNow Revoked**  
3/18/2022 *Federal Register* notice: FDA has revoked an Emergency Use Authorization (EUA) issued to Abbott Diagnostics Scarborough for the BinaxNOW Covid-19 Ag Card 2 Home Test. FDA says Abbott never marketed the test under the EUA, and the product is subsequently marketed and covered by a subsequent EUA. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-05892.pdf?ref=fdaweb.com).

**Info Collection on User Fee Program Evaluation**  
3/18/2022 *Federal Register* notice: FDA is seeking comments on an information collection extension entitled “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original 351(a) Biologics License Applications in Prescription Drug User Fee Acts and 351(k) Biologics License Applications in Biosimilar User Fee Acts” (OMB Control Number 0910-0746). The collection is intended to support the evaluation of certain performance goals and procedures set forth in what is known as FDA’s “goals letter” or “commitment letter” under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) and the second authorization of the Biosimilar User Fee Act (BsUFA II). To view the notice, click [here](https://public-inspection.federalregister.gov/2022-05814.pdf?ref=fdaweb.com).

**Comments Sought on Pharma Quality/CMC Data Exchange**  
3/17/2022 *Federal Register* notice: FDA is seeking comments on its draft “Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange” for electronically submitting PQ/CMC data. The document provides a draft design of Health Level 7 (HL7) “Fast Health Interoperability Resources” (FHIR) profiles that contain the data elements and terminologies associated with submission. The agency says it cover only those concepts that are considered amenable to structuring and would bring value to the quality review process. The agency says it is seeking comment on the mapping of the PQ/CMC data elements to the various FHIR Resources. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-05790.pdf?ref=fdaweb.com).

**Medwatch Information Collection Revised on eSubmissions**  
3/15/2022 *Federal Register* notice: FDA has submitted to OMB and information collection revision entitled “MedWatch: The FDA Safety Information and Adverse Event Reporting Program” (OMB Control Number 0910-0291). The agency is revising the collection to include electronic submission of adverse event reports. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-03-16/pdf/2022-05514.pdf?ref=fdaweb.com).

**Guide on CAR T Cell Product Development**  
3/15/2022 *Federal Register* notice: FDA has made available a draft guidance entitled “Considerations for the Development of Chimeric Antigen Receptor T Cell Products.” The document includes CAR T cell-specific recommendations regarding chemistry, manufacturing, and control, pharmacology and toxicology, and clinical study design. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-03-16/pdf/2022-05539.pdf?ref=fdaweb.com).