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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-119/
- Published: 2017-01-16T12:00:00.000Z
- Updated: 2026-09-14T22:00:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137736

**BIOLOGICS**

**Vaccine Advisory Committee to Review Influenza Vaccines**  
*Federal Register* Notice: FDA has announced a 3/9 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2017–2018 influenza season. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-12/pdf/2017-00476.pdf?ref=fdaweb.com). 

**FDA GENERAL** 
  
**Comments Sought on Combination Product Policies**  
*Federal Register* Notice: FDA has established a docket to receive comments about policy issues that may be considered by the FDA Combination Product Policy Council. The comments are intended to help the agency identify and address combination product policy issues that need clarification through guidance, notice and comment procedures, or other means. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-13/pdf/2017-00646.pdf?ref=fdaweb.com). 

**Comments Sought on Rapid Response Surveys**  
*Federal Register* Notice: FDA is seeking comments on an information collection extension related to its use of rapid response surveys of community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.), other health care professionals, patients, consumers, and risk managers working in medical facilities. FDA uses the information gathered from these to quickly obtain vital information about medical product risks and interventions so it may take appropriate public health or regulatory actions. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-13/pdf/2017-00632.pdf?ref=fdaweb.com). 

**Guide on Emergency Use Authorizations**  
*Federal Register* Notice: FDA has made available a guidance on “Emergency Use Authorization of Medical Products and Related Authorities.” The document outlines FDA’s current thinking on the authorization of the emergency use of certain medical products under sections of the Federal Food, Drug, and Cosmetic Act as amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). 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 agents, including emerging infectious disease threats. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-13/pdf/2017-00721.pdf?ref=fdaweb.com). 

**DEVICES** 

**Influenza Virus Antigen Detection Tests Reclassified**  
*Federal Register* Final Order: FDA has reclassified antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from Class 1 into Class 2 with special controls and into a new device classification regulation. FDA notes that the reclassification is intended to help improve the overall quality of testing for influenza. New minimum performance requirements for the tests are expected to lower the number of misdiagnosed influenza infections by increasing the number of devices that can reliably detect the influenza virus. In addition, the special controls requiring annual and emergency analytical reactivity testing provide a process for continued monitoring of the performance of antigen based RIDTs. As part of that process, the Centers for Disease Control and Prevention and FDA will collaborate in efforts to ensure that there is an influenza virus analytical reactivity test panel available to all manufacturers of antigen based tests for evaluation of the analytical reactivity of their assays with circulating viruses on an annual basis. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-12/pdf/2017-00199.pdf?ref=fdaweb.com). 

**Panel to Review Peroxide-based Contact Lens Products**  
*Federal Register* Notice: FDA has announced a 3/17 joint Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee meeting. Panel members will discuss and make recommendations on potential risks related to misuse of peroxide-based contact lens products. Specific issues to be discussed include adequate labeling and packaging of the over-the-counter products. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-12/pdf/2017-00496.pdf?ref=fdaweb.com).

**DRUGS** 

**Guide on ‘Comparative Analyses’ for Generic Combination Products**  
FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536959.pdf?ref=fdaweb.com) on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” The document provides recommendations that focus on the analysis of the proposed user interface for any proposed generic drug-device combination product when compared to the user interface for the reference listed drug (RLD). This includes the delivery device constituent part of the combination product and any associated controls and displays, as well as product labeling and packaging. “In the early stages of development, potential applicants should carefully consider the design of the user interface of a proposed generic combination product and seek to minimize differences from the user interface for the RLD,” it says. To facilitate that process, the guidance provides general principles, including how to conduct threshold analyses for the identification and the assessment of differences in the design of the user interface for the proposed generic combination product when compared to its RLD. 

**Draft Guide on OTC Aspirin-Containing Products**  
*Federal Register* Notice: FDA has announced the availability of a draft guidance entitled “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.” The document is intended to promote the safe use of nonprescription aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular-related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-11/pdf/2017-00374.pdf?ref=fdaweb.com). 

**Comments Sought on WHO Recommendations for Narcotic Scheduling**  
*Federal Register* Notice: FDA is seeking comments on recommendations by the World Health Organization to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The drug substances are recommended to be placed in Schedule I of the Single Convention on Narcotic Drugs (1961). To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-11/pdf/2017-00373.pdf?ref=fdaweb.com). 

**Joint Panel to Review Opana ER Safety Concerns**  
*Federal Register* Notice: FDA has announced a 3/13 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. Panel members will be asked to discuss safety issues related to Endo Pharmaceuticals’ Opana ER (oxymorphone hydrochloride) extended-release tablets, indicated to manage pain severe enough to require daily, around-the- clock, long-term opioid treatment and for which alternative treatment options are inadequate. They will also be asked to discuss pre- and post-marketing data about the abuse of Opana ER, and the overall risk- benefit of this product. Additionally, the committees will discuss abuse of generic oxymorphone ER and oxymorphone immediate-release products. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-01-11/pdf/2017-00463.pdf?ref=fdaweb.com).