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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-63/
- Published: 2021-12-12T12:00:00.000Z
- Updated: 2026-09-14T17:25:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150537

**Info Collection Revision on Drug Reporting**  
12/10/2021 *Federal Register* notice: FDA has submitted to OMB an information collection revision for a guidance entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products” (OMB Control Number 0910-0230). The collection supports statutory provisions regarding the monitoring of FDA-regulated products. The guidance was revised to provide recommendations for recordkeeping applicable to any pandemic, not just influenza, including recommendations for planning, notification, and documentation for continuity of operations for firms that report postmarketing adverse events during any pandemic. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-05/pdf/2021-24236.pdf?ref=fdaweb.com).

**Guide on Device Software Submissions**  
12/09/2021 *Federal Register* notice: FDA has made available a draft guidance entitled *Content of Premarket Submissions for Device Software Functions*. The document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for the agency to evaluate device software functions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-04/pdf/2021-24061.pdf?ref=fdaweb.com).

**Adakveo Regulatory Review Period Determined**  
12/09/2021 *Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Adakveo (crizanlizumab-tmca), indicated to reduce the frequency of vaso-occlusive crises in adults and pediatric patients with sickle cell disease. The review period is 3,152 days, which includes 2,968 days that occurred during the testing phase and 184 days during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-24070.pdf?ref=fdaweb.com).

**Dengvaxia Regulatory Review Period Determined**  
12/08/2021 *Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Sanofi’s Dengvaxia (dengue tetravalent vaccine, live), indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4\. The review period is 5,710 days, which includes 5,466 days that occurred during the testing phase and 244 days during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-24067.pdf?ref=fdaweb.com).

**Draft Guide on Drug Reporting to FDA**  
12/07/2021 *Federal Register* notice: FDA has made available a draft guidance entitled *Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act*. The document addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-01/pdf/2021-23722.pdf?ref=fdaweb.com).