Department of Health and Human Services October 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components,'' dated October 2006. The guidance document provides licensed manufacturers of biological products other than blood and blood components with the FDA's current thinking related to the biological product deviation reporting requirements. The guidance document will assist the licensed manufacturers of biological products other than blood and blood components in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. This guidance finalizes the draft guidance document of the same title dated August 2001.

This notice announces an administrative hearing to be held on December 4, 2006, at 233 N. Michigan Avenue, Suite 600, the Illinois Room, Chicago, IL 60601, to reconsider CMS' decision to disapprove Minnesota State plan amendment 05-015B. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by November 2, 2006.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 20th set of toxicological profiles, which consists of one new draft and six updated drafts, prepared by ATSDR for review and comment.

The Administration on Aging (AoA) 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 the information collection requirements relating to the standard Program Announcement and Grant Application Instructions template for Older Americans Act Title IV Discretionary Grant Program.

This proposed rule would allow the Secretary to use the claims information that is now being collected for Part D payment purposes for other research, analysis, reporting, and public health functions. The Secretary needs to use this data because other publicly available data are not, in and of themselves, sufficient for the studies and operations that the Secretary needs to undertake as part of the Department of Health and Human Service's obligation to oversee the Medicare program, protect the public health, and respond to Congressional mandates.

This notice announces the third meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the eleventh meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

The Administration on Aging (AoA) is announcing an opportunity for public comment on the extension of 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 of public comment in response to the notice. This notice solicits comments on the information collection requirements relating to Title III and VII State Program Report.

The CERHR announces the availability of the draft expert panel report for hydroxyurea on November 1, 2006, from the CERHR Web site (https://cerhr.niehs.nih.gov) or in printed text from the CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR invites the submission of public comments on sections 1-4 of the draft expert panel report (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on January 24-26, 2007, at the Radisson Hotel Old Town in Alexandria, VA, to review and revise the draft expert panel report and reach conclusions regarding whether exposure to hydroxyurea is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the final report on its Web site and solicit public comment on it through a Federal Register notice.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Person-Level Medicaid Data System (PMDS),'' System No. 09-70-0033, established at 49 Federal Register (FR) 47573 (December 5, 1984) and last modified at 65 FR 37792 (June 16, 2000). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0507. We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will be renumbered as routine use number 1. We will delete routine use number 3 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We propose to broaden the scope of the disclosure provisions of this system by adding a routine use to permit the release of information to other Federal and State agencies to: (1) Contribute to the accuracy of CMS' proper payment of Medicare benefits; and (2) enable such agency to administer a Federal health benefits program, and/or as necessary to 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. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and 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 or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain individually-identifiable data to study Medicaid use and expenditures in order to increase CMS' understanding of the Medicaid and Medicare programs and to improve CMS' ability to conduct program evaluation, strengthen program management, evaluate policy alternatives, conduct and evaluate demonstration projects, and advise States in the area of Medicaid financing. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or grantee; (2) assist another Federal and/or State agency; (3) support an individual or organization for research, evaluation or epidemiological projects; and (4) support litigation involving the agency. 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See Effective Date section for comment period.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Senior Risk Reduction Demonstration and Evaluation (SRRDE), System No. 09-70- 0592.'' The program is authorized under provisions of the Social Security Act (42 U.S.C. 1395b-1(a)), which gives the Secretary the broad authority to, ``develop and engage in experiments and demonstration projects.'' The goal of the SRRDE is to determine whether risk reduction programs that have been developed and tested in the private sector can also be tailored to and work well with Medicare beneficiaries to improve their health and reduce avoidable health care utilization. The specific aims of the demonstration and evaluation are to: (1) Determine whether a senior risk reduction service provided by Medicare will be accepted by beneficiaries, achieve high participation rates, and be viewed positively by beneficiaries; (2) reduce health risk factors, improve health behaviors, improve functioning, and prevent disability; and (3) save money for Medicare. The purpose of this system is to collect and maintain demographic and health related data on the target population of non- institutionalized Medicare beneficiaries between the ages of 67 and 74 who are potential participants in the SRRDE program. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new 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.

This final rule sets forth the methodology and process used to compute and issue each State's allotments for fiscal years (FY) 2006 and FY 2007 that are available to pay Medicare Part B premiums for qualifying individuals. It also provides the final FY 2006 allotments and the preliminary FY 2007 allotments determined under this methodology. We are also confirming the April 28, 2006 interim final rule as final.