Department of Health and Human Services February 23, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collections associated with Shortages Data Collections and with notifications to FDA of an interruption or permanent discontinuance in manufacturing of certain medical devices as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Notice is hereby given of the meeting on March 22, 2021, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC). The meeting is open to the public and can only be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings. The meeting will include remarks and discussion with the Acting Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities, new grant opportunities and initiatives, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19).'' This guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. FDA is aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizers that were manufactured with methanol or methanol- contaminated ethanol and is concerned that other drug products containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which are widely used active ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination. As the COVID-19 pandemic has increased the demand for hand sanitizer products, the demand for pharmaceutical alcohol as the active ingredient of those products has also increased. The guidance outlines a policy intended to help pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding avoid the use of pharmaceutical alcohol that is contaminated with or substituted with methanol in drug products. Given the public health emergency presented by coronavirus disease 2019 (COVID-19), this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA, we, or Agency) is extending the comment period for the notice that appeared in the Federal Register of January 11, 2021. In that notice, FDA requested comments regarding a document entitled ``Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.