Latest Federal Register Notices

ANIMAL DRUGS

Guide on Animal Drug User Fees/Waivers
Federal Register Notice: FDA has made available a draft revised guidance on “Animal Drug User Fees and Fee Waivers and Reductions.” The document describes the types of fees FDA is authorized to collect under the Animal Drug User Fee Act of 2003, as amended, and how to request waivers and reductions from these fees. To view the guidance, click here. To view the notice, click here.

DEVICES

Two Zika Tests Granted Emergency Use Authorizations
Federal Register Notice. FDA has announced the issuance of two emergency use authorizations (EUAs) for in vitro diagnostic devices for detecting the Zika virus in response to the Zika virus outbreak. The EUAs were issued to Vela Diagnostics for its Sentosa test and Arup Laboratories for its Zika Virus Detection test. To view the notice, click here.

DRUGS

Comments Sought on Patent Term Revision Petition Extension
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection on “Patent Term Restoration Due Diligence Petitions.” Such petition are filed to request revisions to the regulatory review period used to determine patent term restorations. For 2013, 2014 and 2015, a total of five petition requests were submitted. To view the notice, click here.

FDA Seeks Comments to Extend Guidance on CV Outcomes
Federal Register Notice: FDA is asking for comments on an OMB submission seeking to extend an information collection related to a guidance on “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.” To view the notice, click here.

GENERAL

Comments Sought on Informed Consent Requirements Estension
Federal Register Notice: FDA is asking for comments on a request for OMB to extend an information collection on “The Protection of Human Subjects: Informed Consent; Institutional Review Boards.” The extension request applies to exceptions from informed consent requirements for emergency research, the elements of informed consent, and documentation of informed consent. To view the notice, click here.

Comments Sought on Emergency Plan Guidance Extension
Federal Register Notice: FDA is asking for comments on an OMB submission seeking an information collection extension on the guidance “Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products.” The document recommends that manufacturers of drug and therapeutic biological products and manufacturers of raw materials and components used in those products develop a written emergency plan for maintaining an adequate supply of medically necessary drug products during an emergency that results in high employee absenteeism. To view the notice, click here.

Science Board to Review Opioids Plan, CBER Strategic Goals
Federal Register Notice: FDA has announced a 11/5 Science Board advisory committee meeting at the agency’s White Oak campus (Silver Spring, MD). The board will receive updates on CBER’s strategic goals for regulatory science, FDA’s Opioid Action Plan and the Bovine Heparin Initiative. It will also receive a response from the Office of Scientific Professional Development on the board’s report on the Commissioner’s Fellowship Program. To view the notice, click here.