Department of Health and Human Services December 19, 2005 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, titled ``Non-Medicare Beneficiary Workers' Compensation (WC) Set-aside File (WCSAF),'' System No. 09-70-0537, last published at 67 FR 36892 (May 28, 2002). We propose to expand the scope of this system to include non-Medicare beneficiaries whose applications for a WC Arrangement have not been approved (denied) as submitted. The disclosure provisions contained in published routine use number 2 and 3 are deemed to be duplicative of each other and as such require corrective action. This modified routine use will now be number 2 and will authorize disclosure to ``another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent.'' We are modifying the language in the remaining routine uses to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the non-Medicare beneficiary WCSAF is to maintain a file of individuals who were injured while employed; are not currently Medicare beneficiaries; whose WC Settlement included a WC Medicare Set-aside Arrangement that is intended to pay for future medical expenses in place of future Medicare benefits; and was approved or not approved (denied) by CMS as submitted. The information retrieved from this system will be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent to contribute to the accuracy of CMS' proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) an individual or organization for research, evaluation or epidemiological projects related to the prevention of disease or disability, the restoration or maintenance of health, or for understanding and improving payment projects; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in health benefits programs funded in whole or in part by Federal funds. We have provided background information about the modified system in the Supplementary Information section, below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See Effective Date section for comment period.

The Food and Drug Administration (FDA) proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the U.S. District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004 (69 FR 78281). The purpose of this final rule and final order is to amend the biologics regulations, issue a final order in response to the report and recommendations of the Panel; and, respond to comments on the previously published proposed rule and proposed order submitted to the Division of Dockets Management. This final rule and final order does not address Anthrax Vaccine Adsorbed (AVA). The final order concerning AVA is published elsewhere in this issue of the Federal Register. FDA is classifying these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for four approved new animal drug applications (NADAs) for oral dosage forms and feed uses of tiamulin from Boehringer Ingelheim Vetmedica, Inc., to Novartis Animal Health US, Inc.