Department of Health and Human Services July 15, 2005 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Medicare Retiree Drug Subsidy Program (RDSP), System No. 09-70-0550.'' Under section 1860D-22 of the Social Security Act (the Act), employers and unions who continue to offer prescription drug coverage to their qualifying covered retirees are eligible to receive a tax-free subsidy for allowable drug costs. This amended provision of the Act is mandated by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). A qualifying covered retiree is a Part D eligible individual who is a participant or the spouse or dependent of a participant; covered under employment-based retiree health coverage that qualifies as a qualified retiree prescription drug plan; and not enrolled in a Part D plan. Employment- Based Retiree Health Coverage is defined as coverage of health care costs under a group health plan based on an individual's status as a retired participant in the plan, or as the spouse or dependent of a retired participant. The term includes coverage provided by voluntary insurance coverage as a result of a statutory or contractual obligation. The Medicare prescription drug benefit and retiree drug subsidy represent additional funding sources that can help employers and unions continue to provide high quality drug coverage for their retirees. The purpose of this system is to collect and maintain information on individuals who are qualifying covered retirees so that accurate and timely subsidy payments may be made to plan sponsors who continue to offer actuarially equivalent prescription drug coverage to the qualifying covered retirees. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor or consultant; (2) support constituent requests made to a congressional representative; (3) support litigation involving the agency; and (4) combat fraud and abuse in certain health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 9.'' The draft guidance document is intended to assist facilities and their personnel in meeting the Mammography Quality Standards Act (MQSA) final regulations.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption From Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.