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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-61/
- Published: 2021-11-29T12:00:00.000Z
- Updated: 2026-09-14T17:23:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150667

**FDA Reclassifying HIV Viral Load Tests**  
11/24/2021*Federal Register* notice: FDA is proposing to reclassify human immunodeficiency virus viral load monitoring tests, a postamendments Class 3 device with the product code MZF, into Class 2 (special controls), subject to premarket notification. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-24/pdf/2021-25372.pdf?ref=fdaweb.com).  

**Info Collection Revision on INDs**  
*11/24/2021 Federal Register* notice: FDA is seeking comments on an information collection revision entitled “Investigational New Drug Applications — 21 CFR Part 312” (OMB Control Number 0910-0014). The collection supports Section 505 of the Federal Food, Drug, and Cosmetic Act and the licensing provisions of the Public Health Service Act that govern investigational new drugs and investigational new drug applications. It is being revised to account for some burden that may be associated with recommendations found in agency guidance documents. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-24/pdf/2021-25615.pdf?ref=fdaweb.com).  

**Lledo Debarred Over Clinical Trial Wrongdoings**  
*11/23/2021 Federal Register* notice: FDA is issuing an order permanently debarring **Maytee Lledo** from providing services in any capacity to a person that has an approved or pending drug product application. The agency contends that while LLedo was employed at Sacred Heart Medical Office in Florida during 2013 through 2016, she and others enriched themselves by making materially false representations about clinical trials, fabricating data and the participation of subjects in those clinical trials, concealing from FDA, sponsors, and contract research organizations the fact that the data and participation of subjects had been fabricated, and inducing sponsors and contract research organizations to pay money for Lledo and her co-conspirators’ own benefit. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-23/pdf/2021-25589.pdf?ref=fdaweb.com).  

**Laparoscopic Power Morcellation Containment is Class 2**  
*11/23/2021 Federal Register* notice: FDA is classifying the general laparoscopic power morcellation containment system into Class 2 (special controls). FDA is also codifying the classification by adding 21 CFR 878.4825.1, which is identified as a prescription device consisting of an instrument port and tissue containment method that creates a working space allowing for direct visualization during a power morcellation procedure following a laparoscopic procedure for the excision of benign tissue that is not suspected to contain malignancy. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-23/pdf/2021-25585.pdf?ref=fdaweb.com).