Department of Health and Human Services May 31, 2013 – Federal Register Recent Federal Regulation Documents

This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

The Food and Drug Administration (FDA or we) is issuing this proposed rule that would require domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with the data FDA needs to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA intends to cease collecting this information starting in fiscal year 2015 (October 2014). Consistent with the requirements of the FD&C Act, we are proposing to require the submission of this information to FDA instead of USDA. We are taking this action to ensure that FDA continues to have the information we need to calculate, assess, and collect user fees.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture'' dated June 2013. The draft guidance document provides manufacturers of licensed Whole Blood and blood components intended for transfusion or for further manufacture, including Source Plasma, with recommendations intended to assist with determining which reporting mechanism is appropriate for submission of changes to an approved biologics license application. The guidance document also provides manufacturers of licensed Whole Blood and blood components recommendations in connection with the applicability and content of comparability protocols and labeling changes. The draft guidance, when finalized, is intended to supersede the document of the same title dated July 2001 (July 2001 guidance).

In accordance with the requirements of the Privacy Act of 1974 (5 USC 552a), the Agency for Healthcare Research and Quality (AHRQ) within the Department of Health and Human Services is establishing a new system of records, ``Online Application Ordering for Products from the Healthcare Cost and Utilization Project (HCUP).'' This online electronic ordering system will streamline and facilitate the dissemination of HCUP databases and software to qualified researchers and result in a more efficient process for both the public and the Agency. The HCUP program and the system of records for the online application ordering process are more thoroughly described in the Supplementary Information section and System of Records Notice (SORN), below.