Department of Health and Human Services May 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia Grant Program (PDCGP). The goal of the PDCGP is to promote pediatric device development by providing grants to nonprofit consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children. Although administered by the OOPD, this grant program is intended to encompass devices that could be used in all pediatric conditions or diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), the Office of Extramural Research, National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 27, 2009, Vol. 74, No. 38, page 8972 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after September 30, 2011, unless it displays a currently valid OMB control number.

This notice updates the payment rates for the Medicare prospective payment system (PPS) for inpatient psychiatric hospital services provided by inpatient psychiatric facilities (IPFs). These changes are applicable to IPF discharges occurring during the rate year beginning July 1, 2009 through June 30, 2010. We are also requesting comments on the IPF PPS teaching adjustment and the market basket.

This notice announces the establishment of the Children's Health Insurance Program Working Group and discusses the group's purpose and charter. It also solicits nominations for members.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 195 entitled ``Small Entities Compliance Guide for RenderersSubstances Prohibited From Use in Animal Food or Feed'' This small entities compliance guide aids renderers in complying with the requirements of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720). FDA's goal is to strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle and to reduce the risk of human exposure to the BSE agent.

The U.S. Department of Health and Human Services is hereby giving notice that the Working Group on Strengthening the Biosecurity of the United States will be holding a public consultation meeting. The meeting is open to the public.