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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-107/
- Published: 2016-09-11T12:00:00.000Z
- Updated: 2026-09-14T21:30:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136781

**BIOLOGICS**

**Blood Products Panel to Meet**  
*Federal Register* Notice: FDA will hold a meeting of the Blood Products Advisory Committee 11/17 from 8 a.m. to 5:30 p.m. and 11/18, from 8:30 a.m. to 1 p.m. at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact **Bryan Emery** or **Joanne Lipkind**, (240) 402-8054, bryan.emery@fda.hhs.gov and (240) 402-8106, joanne.lipkind@fda.hhs.gov. The committee will meet in open session to discuss strategies to manage iron deficiency associated with blood donation. On 11/18, the committee will meet to hear an informational session on Zika virus and blood safety in the U.S. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-09/pdf/2016-21687.pdf?ref=fdaweb.com).

**DEVICES**

**Info On Postmarket Surveillance Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information “Postmarket Surveillance — 21 CFR Part 822,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-08/pdf/2016-21554.pdf?ref=fdaweb.com)

**Comments Sought on Device Recordkeeping Requirements**  
*Federal Register* Notice: FDA seeks comments on recordkeeping requirements related to the medical devices current good manufacturing practice quality system regulation. The CGMP/QS regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies requirements for verifying/validating production processes and process or product changes, and clarifies requirements for product acceptance activities quality data evaluations and corrections of nonconforming product/quality problems. Comments should be submitted by 11/7\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-08/pdf/2016-21553.pdf?ref=fdaweb.com)

**Info on Clinical Laboratory Improvement Amendments**  
*Federal Register* Notice: FDA’s proposed collection of information, “Requests for Clinical Laboratory Improvement Amendments of 1988 Categorization — 42 CFR 493.17,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-07/pdf/2016-21352.pdf?ref=fdaweb.com)

**FDA Issues Emergency Use Authorization for Zika D**iagnostic  
*Federal Register* Notice: FDA is issuing an Emergency Use Authorization for a Viracor-IBT Laboratories’ in vitro diagnostic device for detecting the Zika virus in response to the Zika virus outbreak in the Americas. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-07/pdf/2016-21353.pdf?ref=fdaweb.com)

**Info on Product Jurisdiction Sent to OMB**  
*Federal Register* Notice: FDA’s proposed collection of information, “Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications — 21 CFR Part 3,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-06/pdf/2016-21228.pdf?ref=fdaweb.com)

**DRUGS**

**Guidance on Planning/Design of Multi-Regional Trials**  
*Federal Register* Notice: FDA is making available a draft guidance entitled *E17 General Principles for Planning and Design of Multi-Regional Clinical Trials*. It was prepared under the auspices of the International Council for Harmonization. The draft guidance is intended to increase the acceptability of data from such trials as the primary source of evidence supporting marketing approval in global regulatory submissions and to thereby facilitate more efficient drug development and earlier access to medicines. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM519603.pdf?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-09/pdf/2016-21689.pdf?ref=fdaweb.com)

**Prevacid IV Not Withdrawn For S&E**  
*Federal Register* Notice: FDA has determined that Prevacid IV (lansoprazole) intravenous injection, 30 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow the agency to approve ANDAs for lansoprazole intravenous injection, 30 mg/vial, if all other legal and regulatory requirements are met. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-08/pdf/2016-21551.pdf?ref=fdaweb.com)

**FDA Finds 25 Drug Products 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. It will allow the agency to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. These products include Teligent Pharmaceutical’s Aquamephyton, Merck’s Clinoril, Luitpold Pharmaceutical’s Furosemide, and Schering-Plough’s Normodyne. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-06/pdf/2016-21227.pdf?ref=fdaweb.com)

**FDA Establishes Antiseptic Ingredients Are Not GRAS/E**  
*Federal Register* Final rule: FDA is issuing a final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water are not generally recognized as safe and effective and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee; public comments on the agency’s notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to its attention. This final rule amends the 1994 tentative final monograph for OTC antiseptic drug products that published in the 6/17/94 *Federal Register.* To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-06/pdf/2016-21337.pdf?ref=fdaweb.com)

**FDA GENERAL** 
  
**FDA Removes Civil Money Penalties Info from Regs**  
*Federal Register* Final rule: FDA is amending 21 CFR 17.2 to remove the maximum civil money penalties table associated with statutory provisions authorizing civil money penalties under the FD&C Act or the Public Health Service Act. This information will be included in the HHS regulations. The agency is taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 2015\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-09/pdf/2016-21705.pdf?ref=fdaweb.com)

**Comments Sought on Vinpocetine**  
*SFederal Register* Notice: FDA is requesting comments on its tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the FD&C Act. Comments should be submitted by 11/7\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-07/pdf/2016-21350.pdf?ref=fdaweb.com)

**TOBACCO**

**Draft Guidance on Tobacco Product Submissions** 
*Federal Register* Notice: FDA is making available a revised draft guidance for industry entitled *Health Document Submission Requirements for Tobacco Products*. It is intended to assist persons making certain document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act. The revised draft guidance includes guidance for manufacturers or importers of products that are newly deemed as tobacco products that are subject to Chapter IX of the FD&C Act. To download this guidance, click [here](http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm208913.htm?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-09-09/pdf/2016-21686.pdf?ref=fdaweb.com)