Department of Health and Human Services December 21, 2007 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) of the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids (fat) and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement discretion (antioxidant vitamins and risk of certain cancers; selenium and certain cancers). The agency is undertaking a reevaluation of the scientific basis for these authorized health claims and qualified health claims because of new scientific evidence that has emerged for these substance-disease relationships. The new scientific evidence may have the effect of weakening the substance-disease relationship for these authorized health claims and either strengthening or weakening the scientific support for the substance-disease relationship for these qualified health claims.

NICEATM invites attendance at a public symposium to mark the tenth anniversary of ICCVAM. The symposium, entitled ``Celebrating Ten Years of Advancing Public Health and Animal Welfare With Sound Science: Envisioning New Directions in Toxicology'' will be held February 5, 2008, at the U.S. Consumer Product Safety Commission (CPSC) Headquarters in Bethesda, MD. The NICEATM-ICCVAM Five-Year Plan (2008- 2012) will also be discussed and made available on February 5.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Money Follows the Person (MFP) Demonstration (MFPD), System No. 09-70-0593.'' The demonstration, created by section 6071 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), provides to states a total of $1.75 billion in competitive grants. MFP demonstration grants have been awarded to 30 states and the District of Columbia. The states and the District of Columbia are using the grant funding to transition Medicaid beneficiaries who need long-term care services from institutional-based care to community-based care. The purpose of the demonstration is to help states continue their efforts to restructure their long-term care systems and shift the historical emphasis from institutional care to community-based care. The demonstration is based on the premise that many Medicaid beneficiaries currently residing in institutions want to live in the community and could do so if they had the adequate support, and that it would cost less than Medicaid currently spends to care for institutional care. The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, those who participate in the MFP demonstration and other comparable Medicaid recipients, and to collect and maintain program level information on grantee implementation of the MFP demonstration. 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, or consultant; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid 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 Notice provides notification that individuals who have been injured by pandemic, epidemic, or security countermeasures identified in a declaration issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d- 6d) have one (1) year from the time they receive the covered countermeasure to file requests for compensation for injuries directly resulting from administration or use of covered countermeasures under the Public Readiness and Emergency Preparedness Act (PREP Act).