Department of Health and Human Services March 4, 2008 – Federal Register Recent Federal Regulation Documents

The Office of Inspector General (OIG) proposes to revise and update the existing system of records, entitled ``Criminal Investigative Files'' (09-90-0003). This proposed notice is in accordance with the Privacy Act requirement that agencies publish their amended systems of records in the Federal Register when there is a revision, change, or addition. This system of records, maintained by OIG, was last revised and updated on December 8, 2006.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing system of records titled ``Links of Social Security Administration (SSA) and Health Care Financing Administration (HCFA) Data (LOD), System No. 09-70-0069, established at 65 Federal Register 50544 (August 18, 2000). The system name reflects the former name of the Agencythe Health Care Financing Administration. For this reason, we propose to change the name of the system to read: the ``Links of Social Security Administration (SSA) and the Centers for Medicare & Medicaid Services Data (LOD).'' 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- 70-0512. 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. 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 another Federal and state agencies to: (1) Allow such agency to comply with Title XI, Part C of the Act; (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; and (3) support data exchanges between the cooperating agencies. The new routine use will be numbered as routine use number 2. We will broaden the scope of this system by including the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' apply whenever the system collects or maintains PHI. This system may contain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' will apply to the data disclosed from this system. 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 the LOD is to collect and maintain information that will be used to conduct research, perform policy analysis, and improve program management for populations served by both SSA and CMS. Information maintained in this system 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 or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) facilitate research on the quality and effectiveness of care provided, as well as epidemiological projects; and (4) support litigation involving the Agency. 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. Effective Dates: CMS filed a modified or altered system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on February 26, 2008. To ensure that all parties have adequate time in which to comment, the modified system, including routine uses, will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and Congress, whichever is later, unless CMS receives comments that require alterations to this notice.

This notice announces an administrative hearing to be held on April 4, 2008, at the CMS Chicago Regional Office, 233 N. Michigan Avenue, Suite 600, the Illinois Room, Chicago, IL 60601-5519, to reconsider CMS' decision to disapprove Ohio SPA 07-014. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by March 19, 2008.

The Food and Drug Administration (FDA) 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 reporting requirements contained in existing FDA regulations governing State petitions for exemption from preemption.