Department of Health and Human Services June 18, 2018 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio phone lines (100 audio lines available and 100 web conference lines available).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``S9 Nonclinical Evaluation for Anticancer PharmaceuticalsQuestions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance consists of questions and answers that were developed to provide additional clarity about anticancer pharmaceutical development described in the ICH guidance ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' that was published in 2010 (ICH S9 (2010)), as well as to continue progress in the 3Rs of Reduction, Refinement, and Replacement in the use of animals.

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 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 formal meetings between FDA and biosimilar biological product sponsors or applicants.