> ## 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-57/
- Published: 2021-10-03T12:00:00.000Z
- Updated: 2026-09-14T17:17:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150283

**Draft Guide on Investigator Safety Reporting**  
9/30/2021 *Federal Register* notice: FDA has released a draft guidance entitled *Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices*. The document is intended to help clinical investigators to identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to IRBs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21316.pdf?ref=fdaweb.com).

**Draft Guide on Drug Benefit-Risk Assessments**  
9/30/2021 *Federal Register* notice: FDA has made available a draft guidance entitled *Benefit-Risk Assessment for New Drug and Biological Products*. The document is intended to provide drug sponsors and other stakeholders with a clearer understanding about how considerations about a drug’s benefits, risks, and risk management options factor into certain FDA pre- and postmarket regulatory decisions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21194.pdf?ref=fdaweb.com).

**Micro Considerations for Non-sterile Drugs**  
9/30/2021 *Federal Register* notice: FDA is making available a draft guidance entitled *Microbiological Quality Considerations in Non-Sterile Drug Manufacturing*. The document discusses product development considerations, risk assessments, and certain GMP requirements that are particularly relevant to microbiological control in a manufacturing operation for such products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21222.pdf?ref=fdaweb.com).

**Tropical Disease Review Voucher Fee Rate**  
9/29/2021 *Federal Register* notice: FDA has announced the fee rates for using a tropical disease priority review voucher for fiscal year 2022 — $1,266,651\. The vouchers are awarded to the sponsors of certain tropical disease product applications submitted after 9/27/2007, upon approval. The notice also outlines the payment procedures for such fees. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-21328.pdf?ref=fdaweb.com).

**Rare Pediatric Disease Priority Voucher Fee**  
9/29/2021 *Federal Register* notice: FDA has announced the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2022 — $1,266,651\. The notice also outlines the payment procedures for such fees. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-21329.pdf?ref=fdaweb.com).

**Guide on Nontuberculous Mycobacterial Pulmonary Disease**  
9/28/2021 *Federal Register* notice: FDA has made available a draft guidance entitled *Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment*. The document addresses FDA’s current thinking on clinical trial design issues, choice of study population, and endpoints for the treatment of naïve and refractory nontuberculous mycobacterial pulmonary disease caused by *Mycobacterium avium* complex.

**Draft 510(k) eSubmission Template**  
9/29/2021 *Federal Register* notice: FDA has made available a draft guidance entitled *Electronic Submission Template for Medical Device 510(k) Submissions*. The document is part of FDA’s commitment to develop electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-21135.pdf?ref=fdaweb.com).