> ## Content Index
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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-115/
- Published: 2016-11-20T12:00:00.000Z
- Updated: 2026-09-14T21:49:15.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137332

**DEVICES**

**Comments Sought on Radiation Product Requirements**  
*Federal Register* Notice: FDA is seeking comments on an OMB submission to extend an information collection on reporting and recordkeeping requirements for manufacturers and distributors of electronic products. The requirements are outlined under the agency’s electronic product radiation control program, including the development, issuance, and administration of performance standards to control the emission of electronic product radiation from electronic products. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-10/pdf/2016-27199.pdf?ref=fdaweb.com).

**Draft Guide on Surgical Aspirator Device Labeling**  
*Federal Register* Notice: FDA has made available a draft guidance on “Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.” The document provides a specific labeling recommendation to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made due to a risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroid. To view the guidance, click [here](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM528182.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-10/pdf/2016-27106.pdf?ref=fdaweb.com).

**DRUGS** 
  
**Rule Discourages Petitions Seeking to Delay ANDAs**  
*Federal Register* Final Rule. FDA has amended certain regulations relating to citizen petitions, petitions for stay of actions and the submission of documents to the agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act that implement a congressional desire that petitions not be used to improperly delay approval of ANDAs. To view the rule, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-08/pdf/2016-26912.pdf?ref=fdaweb.com).

**Guidance on Non-inferiority Trials**  
*Federal Register* Notice: FDA has made available a guidance on “Non-Inferiority Clinical Trials to Establish Effectiveness.” The document discusses the appropriate use of such study designs to provide evidence on the effectiveness of a drug or biologic. It says that a non-inferiority design is usually used because a superiority study design (drug versus placebo, dose response, or superiority to an active drug) cannot be used. It also gives advice on when non-inferiority (NI) studies intended to demonstrate effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-08/pdf/2016-26931.pdf?ref=fdaweb.com).

**Comments Sought on Standardized Study Data Template**  
*Federal Register* Notice: FDA has established a public docket to collect comments related to a proposed Study Data Standardization Plan template. The template was developed by a working group under an ongoing collaboration with the Pharmaceutical Users Software Exchange, an independent, non-profit consortium addressing computational science issues. The template will be reviewed to determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. To view the template, click [here](http://www.phusewiki.org/wiki/images/e/ea/SDSP%5FTemplate.pdf?ref=fdaweb.com). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-08/pdf/2016-26913.pdf?ref=fdaweb.com).