Latest Federal Register Notices
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.
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.
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.
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.
FDA Issues Emergency Use Authorization for Zika Diagnostic
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.
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.
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. To view this notice, click here.
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.
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.
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.
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.
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.
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. To view this notice, click here.