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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-68/
- Published: 2022-02-13T12:00:00.000Z
- Updated: 2026-09-14T17:32:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151156

**Spore Test Strip Put Into Class 2**  
2/11/2022 *Federal Register* notice: FDA is classifying the spore test strip into medical device Class 2 (special controls). The action was taken in response to a Steris de novo classification request for its Verify Spore Test Strip for S40\. It consists of a carrier or strip with a known number of spores of known resistance to a particular liquid chemical sterilant in a liquid chemical sterilant processing system. A “no growth” result from the spore test strip indicates that the liquid chemical sterilization process achieved the conditions necessary to kill the specified minimum number of viable spores. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-03104.pdf?ref=fdaweb.com).

**Class 2 for Predictive Cardiovascular Indicator**  
2/11/2022 *Federal Register* notice: FDA has classified the adjunctive predictive cardiovascular indicator into medical device Class 2 (special controls). The action is in response to an Edwards Lifesciences de novo classification request for its Acumen Hypotension Prediction Index Feature Software. The agency has identified it as being a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. To view the notice, click [here](https://public-inspection.federalregister.gov/2022-03096.pdf?ref=fdaweb.com).

**Draft Guide on Non-Opioid Analgesics**  
2/10/2022 *Federal Register* notice: FDA has made available a draft guidance entitled “Development of Non-Opioid Analgesics for Acute Pain.” The document provides information about product development-related issues, “opioid-sparing” claims, and expedited programs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-10/pdf/2022-02858.pdf?ref=fdaweb.com).

**Patent Infringement Notice on Alvotech Biosimilar BLA**  
2/10/2022 *Federal Register* notice: FDA is posting notice that a BLA applicant for a biosimilar product has notified the agency that an action for patent infringement was filed in connection with the applicant’s BLA. FDA is required to publish notice of any complaint received under Section 351(l)(6)(C) of the PHS Act. The notice the agency received concerned AbbVie Inc. and AbbVie Biotechnology Ltd. v. Alvotech HF — 1:21–cv–02258 (Northern IL District, filed 4/27/2021). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-10/pdf/2022-02799.pdf?ref=fdaweb.com).

**Info Collection on Generic User Fee Program Revised**  
2/9/2022 *Federal Register* notice: FDA has submitted to OMB an information collection revision entitled “Generic Drug User Fee Program” (OMB Control Number 0910-0727). The collection is being revised to include the current generic drug user fee agreement, or ‘‘goalsletter,’’ as reflected in the document “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018–2022.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-09/pdf/2022-02689.pdf?ref=fdaweb.com).

**Drug User Fee Info Collection Revision**  
2/8/2022 *Federal Register* notice: FDA has submitted to OMB an information collection revision entitled “Prescription Drug User Fee Program” (OMB Control Number 0910–0297). The agency is revising the collection to include its current commitment goals as set forth in the document “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-08/pdf/2022-02617.pdf?ref=fdaweb.com).