Department of Health and Human Services May 25, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) 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 extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic collection of information through which we intend to seek insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services.

The Food and Drug Administration (FDA or Agency) has determined that Chirocaine (levobupivacaine) injection, 2.5 milligrams (mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levobupivacaine injection, 2.5 milligrams (mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers.'' This guidance represents FDA's current thinking on the use of whole slide images during good laboratory practice (GLP)-compliant toxicology studies. Documentation practices during generation, use, and retention of whole slide images have not been clearly defined and vary among nonclinical testing facilities. This question-and-answer document is intended to clarify FDA's recommendations concerning the management, documentation, and use of whole slide images in histopathology assessment and/or pathology peer review for nonclinical studies conducted in compliance with the GLP regulations. This guidance finalizes the draft guidance of the same title issued on April 8, 2022.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information.'' This draft guidance is intended to assist sponsors in determining whether it may be appropriate to rely on generally accepted scientific knowledge (GASK) to fulfill certain legal and regulatory requirements applicable to the new drug application (NDA) or biologics licensing application (BLA) in question. When final, this guidance will represent the Agency's current thinking on this topic.