Department of Health and Human Services September 16, 2014 – Federal Register Recent Federal Regulation Documents

This document provides interim guidance on the implementation of section 301(f) of the Leadership Act in light of the Supreme Court's decision in Agency for Int'l Dev. v. Alliance for Open Soc'y Int'l, Inc., 133 S. Ct. 2321 (2013) (``AOSI decision''). While HHS awarding agencies have implemented the AOSI decision since its issuance, this document serves to clarify HHS policy. HHS is also currently developing an amendment to its regulations listed under ``Organizational Integrity of Entities Implementing Programs and Activities under the Leadership Act'' to ensure consistency with the decision. HHS has been coordinating its implementation activities with the Department of State, Office of the Global AIDS Coordinator (OGAC) and with the United States Agency for International Development (USAID). While issued through OGA, this guidance represents the views of the various agencies within HHS that issue awards with Leadership Act HIV/AIDS funds, namely, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Health Resources and Services Administration.

The Food and Drug Administration is correcting a notice entitled ``Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability'' that appeared in the Federal Register of August 29, 2014 (79 FR 51576). The document announced the availability of a draft guidance entitled ``Guidance for Industry: Electronic Submission of Lot Distribution Reports'' dated August 2014. The document was published with the incorrect docket number. This document corrects that error.