Federal Register Notice: FDA is making available a guidance for industry entitled User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR. This guidance describes the circumstances under which user fees will not be assessed for certain applications for fixed dose combination and co-packaged versions of previously approved antiretroviral therapies for treating HIV under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief (PEPFAR). The guidance also describes some circumstances under which most of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver. To download this guidance, click here. To view this notice, click here.