Department of Health and Human Services October 3, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods'' dated September 2005. The draft guidance provides blood establishments and FDA staff revised recommendations for the collection of Platelets by automated methods (plateletpheresis). The draft guidance is intended to help blood establishments ensure donor safety and the safety, purity, and potency of Platelets collected by an automated blood cell separator device. For the purpose of this document, Platelets collected by automated methods will be referred to by the product name ``Platelets, Pheresis.'' The draft guidance contains recommendations for appropriate criteria for a biologics license application or supplement for manufacturing Platelets, Pheresis. When finalized, this draft guidance will replace the October 1988 ``Revised Guideline for the Collection of Platelets, Pheresis.''

In accordance with the requirements of the Privacy Act of 1974, we are proposing to create a new system titled, ``Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities (CPTD) System, System No. 09-70-0560.'' Section 122 of the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) Benefits Improvement and Protection Act of 2000 (BIPA) (Public Law (Pub. L.) 106-554) grants CMS the authority to award at least nine cooperative agreement demonstration projects that will identify methods to reduce disparities in early cancer screening, diagnosis, and treatment for Black, Hispanic, Asian American and Pacific Islander, and American Indian (including Alaskan Native, Eskimo, and Aleut) Medicare beneficiary populations. Demonstration sites will use the best available scientific evidence to identify promising models of cancer screening, diagnosis and treatment interventions to promote health and appropriate utilization of Medicare covered services, eliminate disparities in cancer detection and treatment among ethnic and racial populations of Medicare beneficiaries, and provide information to improve the effectiveness of the Medicare program. The purpose of this system is to collect and maintain demographic and cancer health-related data on Medicare target population beneficiaries who voluntarily enroll in the CPTD Project for Ethnic and Racial Minorities. This system will enable CMS to enroll eligible participants in the demonstration project; randomize participants into intervention and control groups; reimburse demonstration site service claims; and develop, maintain and analyze/evaluate research information showing the potential impact of providing cancer screening, diagnosis and treatment facilitation services to underserved Medicare 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 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) assist an individual or organization engaged in the performance activities of the demonstration or in 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 constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain 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 Dates section for comment period.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Iowa Army Ammunition Plant (IAAP), in Burlington, Iowa as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 25, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Administration on Children, Youth and Families herein announces an urgent grant award to the National Association of Child Care Resource and Referral Agencies (NACCRRA) to provide technical assistance to reestablish the operations of the resource and referral agencies in Mississippi and Louisiana whose operations have been disrupted by Hurricane Katrina. This grant will help to re-establish child care referral services so that families along the Gulf Coast can find child care. This grant will also support local and Statewide inventories of child care need and availability. The amount of the proposed grant to NACCRRA is $99,500 in FY 2005 child care funds. The duration of the grant is 12 months.