Privacy Act of 1974; Revisions to OIG's Privacy Act System of Records: Criminal Investigative Files
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.
Privacy Act of 1974; Report of a Modified or Altered System of Records
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.
Privacy Act of 1974; Report of a New System of Records
In accordance with the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Medicaid Integrity Program System (MIPS),'' System No. 09-70-0599. With passage of the Deficit Reduction Act (DRA) of 2005, the Secretary of HHS was directed to establish a Medicaid Integrity Program (MIP) designed to provide CMS the resources necessary to combat fraud, waste and abuse in the Medicaid program. The DRA takes the partnership between CMS and the State Medicaid agencies to a new level. The MIP represents CMS' first national strategy to combat fraud and abuse in the 41-year history of the Medicaid program. MIP offers a unique opportunity to identify, recover and prevent inappropriate Medicaid payments. It will also support the efforts of State Medicaid agencies through a combination of oversight and technical assistance. Although individual States work to ensure the integrity of their respective Medicaid programs, MIP provides CMS with the ability to more directly ensure the accuracy of Medicaid payments and to deter those who would exploit the program. It advances these goals which are shared by the States and the Federal government. The combined Federal and State resources for preventing fraud will be marshaled more effectively than ever. The primary purpose of this system is to establish an accurate, current, and comprehensive database containing standardized enrollment, eligibility, and paid claims of Medicaid beneficiaries to assist in the detection of fraud, waste and abuse in the Medicare and Medicaid programs. 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, consultant or a CMS grantee; (2) assist another Federal or state agency with information to 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 a research or evaluation project; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in a federally-funded health benefit program. 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 routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Notice of Hearing: Reconsideration of Disapproval of Ohio State Plan Amendment (SPA) 07-014
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
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 and recordkeeping requirements for firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers.
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
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.
Organ Procurement and Transplantation Network
HRSA, Healthcare Systems Bureau, Division of Transplantation (DoT) is in the process of information- gathering to assist in determining whether it should engage in rulemaking with respect to vascularized composite allografts, described more fully below. The purpose of this solicitation is to receive feedback from stakeholders and the public on the following questions: (1) Whether vascularized composite allografts should be included within the definition of organs covered by the regulations governing the operation of the Organ Procurement and Transplantation Network (OPTN) (referred to here as the ``final rule''), and regulated as such, and the likely impact of such an amendment; (2) whether vascularized composite allografts should be added to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended, (NOTA) and the likely impact of such an addition; and (3) if either of these changes are pursued, the optimal way to define vascularized composite allografts for the above-described purposes. This Request for Information is limited to information-gathering and is not a proposal to make any determinations regarding Federal oversight of vascularized composite allografts.
Draft Guidance for Industry on Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention.'' The draft guidance provides recommendations for industry for developing drugs and therapeutic biologics for the prevention and treatment of diabetes mellitus. Because diabetes mellitus has reached epidemic proportions in the United States, FDA recognizes the need for new products that can be used as part of a comprehensive treatment strategy in the treatment and prevention of diabetes. In addition to the draft guidance, FDA plans to convene a public advisory committee meeting to specifically discuss new approaches for the development of products for the treatment of diabetes, with particular emphasis on the design and implementation of studies to assess long-term cardiovascular risks and benefits of these new products. FDA plans to announce the meeting date in a future issue of the Federal Register.