> ## Content Index
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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-86/
- Published: 2016-04-10T12:00:00.000Z
- Updated: 2026-09-14T20:53:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135325

**BIOLOGICS** 
  
**Guidance on Biosimilar Product Labeling**  
*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Labeling for Biosimilar Products*. It is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products and pertains only to the prescribing information (commonly referred to as the package insert). To download this draft guidance, click [here.](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm493439.pdf?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07611.pdf?ref=fdaweb.com)  
  
**DEVICES** 
  
**FDA Releases List of Recognized Device Standards**  
*Federal Register* Notice: FDA is making available “Modifications to the List of Recognized Standards, Recognition List Number: 041”containing modifications it is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07467.pdf?ref=fdaweb.com)

  
**HUMAN DRUGS**  
  
**Review Period Set for Brintellix**  
*Federal Register* Notice: FDA has determined the regulatory review period for Brintellix (vortioxetine hydrobromide) is 2,343 days for extending a patent that claims the human drug product. Brintellix is indicated for treating major depressive disorder. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07477.pdf?ref=fdaweb.com)  
  
**FDA Determines 10 ANDAs Not Withdrawn for S&E**  
*Federal Register* Notice: FDA has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency will not begin procedures to withdraw approval of ANDAs that refer to these drug products, and it will allow it to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. These products are Pronestyl, Symmetrel, Ovcon-35, Topicort LP, Campral, Oxacilllin Sodium, Bactocill, Thiotepa, Sulfamethoxazole, and Trimethoprim. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07610.pdf?ref=fdaweb.com)  
  
**FDA Proposes Performance Metrics for OTC Drug Regs**  
*Federal Register* Proposed rule: FDA is proposing to amend its nonprescription drug regulations (over-the-counter (OTC) regulations. If finalized as proposed, the rule would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA’s review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act. FDA is also proposing other changes to make the TEA process more efficient. Comments should be submitted by 6/3\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07612.pdf?ref=fdaweb.com).  
  
**Bone, Reproductive, Urologic Panel Renewed**  
*Federal Register* Notice: The FDA commissioner is renewing the Bone, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/18\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-06/pdf/2016-07908.pdf?ref=fdaweb.com).  
  
**FDA Changes Date of Endocrinologic/Metabolic Drugs Panel Meeting**  
*Federal Register* Notice: FDA is amending the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to reflect a change in date to 5/25 from 8 a.m. to 5 p.m. This meeting was announced in the 3/16 Federal Register and is scheduled to discuss Sanof-aventis NDAs for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist proposed for treating adults with Type 2 diabetes mellitus. Contact **LaToya Bonner**, (301) 796-9001 or Latoya.Bonner@fda.hhs.gov. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-06/pdf/2016-07899.pdf?ref=fdaweb.com).  
  
**FDA Changes Date of Panel Meeting**  
*Federal Register* Notice: FDA is amending a notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee announced in the 3/17 Federal Register. The date of the meeting is changed to from 3/25 to 3/24\. The committee will discuss the safety and efficacy of a Novo Nordisk NDA for insulin degludec and liraglutide injection for the proposed indication: adjunct to diet and exercise to improve glycemic control in treating adults with Type 2 diabetes mellitus. Contact **LaToya** **Bonner**, (301) 796-9001\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-06/pdf/2016-07906.pdf?ref=fdaweb.com)  
  
**VETERINARY** 
  
**Guidance on Animal Drug Comparability Protocols**  
*Federal Register* Notice: FDA is making available a final guidance entitled *Comparability Protocols —Chemistry, Manufacturing, and Controls Information for New Animal Drugs.* This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations to industry on comparability protocols that would be submitted in NADAs, ANADAs, or supplements to these applications. This guidance also applies to comparability protocols submitted in investigational new animal drug, generic investigational new animal drug, and veterinary master file submissions that are referenced in applications. To download this guidance, click here. To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07573.pdf?ref=fdaweb.com)  
**Comments Sought on E-Submissions to CVM**  
*Federal Register* Notice: FDA seeks comments on extending Office of Management and Budget approval on the existing reporting requirements related to submitting information electronically to the Center for Veterinary Medicine using the FDA Electronic Submissions Gateway. Comments should be submitted by 6/7\. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-04-08/pdf/2016-08075.pdf?ref=fdaweb.com).   
  
**GENERAL** 
  
**Guidance on Emergency Use Authorizations**  
*Federal Register* Notice: FDA is making available a draft guidance for industry and public health stakeholders entitled *Emergency Use Authorization of Medical Products and Related Authorities*. Its purpose is to explain FDA’s current thinking about policies on the authorization of the emergency use of certain medical products under certain sections of the FD&C Act as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013\. The provisions in PAHPRA include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats. This guidance, when finalized, will replace the current guidance Emergency Use Authorization of Medical Products (7/2007) and Emergency Use Authorization Questions and Answers (April 2009). To download this draft guidance, click [here](http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery). To view this notice, click [here. ](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07478.pdf?ref=fdaweb.com)  
**FDA Proposes New Regs for Non-compliant IRBs**  
*Federal Register* Proposed rule: FDA is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA’s IRB regulations. It is clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions, until the noncompliance with regulations is corrected. To view this proposed rule, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07524.pdf?ref=fdaweb.com)  
  
**FDA Amends Regs on Non-compliant IRBs**  
*Federal Register* Direct final rule: FDA is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA’s IRB regulations. FDA is clarifying that it may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA’s IRB regulations is corrected. To view this direct final rule, click here.