Department of Health and Human Services September 30, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for Industry: Using Electronic Means to Distribute Certain Product Information,'' dated September 2005. The draft guidance explains that persons can distribute certain product information, such as for recalls and drug safety, by electronic means. We encourage the use of electronic communications for conveying all such important product safety information. We are making clear in this draft guidance that manufacturers may disseminate communications by e-mail or other electronic methods.

This document corrects technical errors that appeared in the general notice with comment period published in the Federal Register on September 23, 2005 entitled ``Medicare Program; Criteria and Standards for Evaluating Intermediary, Carrier, and Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Regional Carrier Performance During Fiscal Year 2006.''

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 4, 2005, entitled ``Hospice Wage Index for Fiscal Year 2006.'' This document is effective on October 1, 2005, the effective date of the provisions of the final rule.

In this notice with public comment period, we announce the requests we have received from entities seeking review of the appropriateness of the Medicare payment amount for new technology lenses furnished by ambulatory surgical centers (ASCs). Interested parties submitted these requests for review in response to our May 27, 2005 Federal Register notice entitled ``Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs).'' We received one timely application for review by the June 27, 2005 due date listed in that Federal Register notice. In this notice with comment period, we summarize the timely application received and solicit public comments on the one intraocular lens (IOL) under review.

This interim final rule with comment period sets forth the criteria for implementing a loan program for qualifying hospitals engaged in research in the causes, prevention, and treatment of cancer as specified in section 1016 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Specifically, this rule establishes a loan application process by which qualifying hospitals including specified entities may apply for a loan for the capital costs of health care infrastructure improvement projects.