Department of Health and Human Services February 2011 – Federal Register Recent Federal Regulation Documents

HRSA will transfer funds and duties from Kaleida Health and University of Rochester to the Research Foundation of SUNY d.b.a. the Upstate New York Poison Control Center. HRSA will also transfer funds and duties from Winthrop University to the New York City Health & Hospitals Corporation d.b.a. the New York City Poison Control Center. These transfers are necessary in order to maintain poison control services and education efforts throughout the State of New York.

The Food and Drug Administration (FDA) is extending the period of time that it intends to exercise enforcement discretion, concerning the use of the health claim for phytosterols and risk of coronary heart disease (CHD), in a manner that is consistent with FDA's February 14, 2003, letter of enforcement discretion to Cargill Health and Food Technologies. In the proposed rule for this health claim that published on December 8, 2010 (75 FR 76526), the Agency provided a period of 75 days from the date of publication of the proposed rule during which FDA intended to exercise its enforcement discretion for the use of such claim consistent with the 2003 letter. FDA is extending this period during which the Agency intends to exercise enforcement discretion to February 21, 2012.

This proposed rule would implement section 2702 of the Patient Protection and Affordable Care Act of 2010 which directs the Secretary of Health and Human Services to issue Medicaid regulations effective as of July 1, 2011 prohibiting Federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions. It would also authorize States to identify other provider-preventable conditions for which Medicaid payment would be prohibited.

Rocky Mountain Patient Safety Organization: AHRQ has accepted a notification of voluntary relinquishment from Rocky Mountain Patient Safety Organization, a component entity of Colorado Hospital Association, of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21-b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

This document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.'' Date and Time: The public hearing will be held on March 4, 2011, from 11:30 a.m. to 1 p.m. Place: The public hearing will be held in Conference Room G in the Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies using electronic healthcare data sets. The Agency includes recommendations for documenting the design, analysis, and results of such studies and submitting pharmacoepidemiologic safety study protocols and reports to FDA.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 information collection provisions relating to FDA's electronic records and electronic signatures.