Department of Health and Human Services June 17, 2010 – Federal Register Recent Federal Regulation Documents

This document corrects technical and typographical errors in the supplementary proposed rule entitled ``Medicare Program; Supplemental Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Supplemental Proposed Fiscal Year 2011 Rates'' which appeared in the June 2, 2010 Federal Register.

The Food and Drug Administration (FDA) is announcing the following public meeting: ``Oversight of Laboratory Developed Tests.'' The purpose of the public meeting is to create a forum for interested stakeholders to discuss the agency's oversight of laboratory developed tests (LDTs). FDA is seeking input and requesting comments on this topic.

The Food and Drug Administration (FDA) is providing notice to correct the effective date of the memorandum of understanding (MOU) between FDA and Drugs.Com that published in the Federal Register of May 26, 2010 (75 FR 29561). The purpose of the cooperative program is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls.

The Presidential Commission for the Study of Bioethical Issues (Amy Gutmann, PhD, Chair, and James Wagner, PhD, Vice Chair), will conduct its first meeting to discuss the implications of synthetic biology.

The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biological products. As FDA has taken steps to implement the REMS provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), some stakeholders have raised concerns about the impact of various REMS, and the growing number of REMS on the health care system, as well as on individual prescribers, pharmacists, distributors, and other affected stakeholders. To obtain public input about the REMS program and its impact, and to gather additional input on a draft guidance for industry issued on October 1, 2009 entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,'' FDA has decided to hold this public meeting. FDA wishes to give a wide range of stakeholders the opportunity to provide input in this area, and will take the information it obtains from the meeting into account in its implementation of the REMS program and in the development of the final guidance and future REMS guidances.