Department of Health and Human Services September 7, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms'' dated September 2007. The guidance document is intended to provide guidance to manufacturers using spore- forming microorganisms in the production of certain biological products. The guidance document provides recommendations to industry in response to changes made to the requirements for spore-forming microorganisms to allow greater flexibility in manufacturing. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms'' dated February 2005.

In accordance with the requirement of the Privacy Act of 1974 (5 U.S.C. 552a), the Office of Child Support Enforcement (OCSE) is publishing notice of its amendment of its system of records entitled ``The Location and Collection System,'' No. 09-90-0074.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the University System of Maryland to establish terms of collaboration to support shared interests that can proceed through a variety of programs including collaborative research, public outreach, cooperative international initiatives, interdisciplinary training, and exchange of scientists and staff through sabbaticals, postdoctoral fellowships, and student internships.

Under the Medicaid program, Federal payment is available for the costs of administrative activities ``as found necessary by the Secretary for the proper and efficient administration of the State plan.'' The proposed rule would eliminate reimbursement under the Medicaid program for the costs of certain activities based on a Secretarial finding that these activities are not necessary for the proper and efficient administration of the State plan, nor do they meet the definition of an optional transportation benefit. Based on these determinations, under the proposed rule, Federal Medicaid payments would no longer be available for administrative activities performed by school employees or contractors, or anyone under the control of a public or private educational institution, and transportation from home to school and back for school-aged children with an Individualized Education Program (IEP) or an Individualized Family Services Plan (IFSP) established pursuant to the Individuals with Disabilities Education Act (IDEA).