Department of Health and Human Services May 29, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products in timed-release dosage forms containing guaifenesin and persons who cause the manufacture or interstate shipment of such products. Hundreds of unapproved drug products in timed-release form containing guaifenesin, alone or in combination with other ingredients, are marketed to relieve the symptoms associated with cough, cold, and similar conditions. Such drug products require approved applications because they are not generally recognized as safe and effective for these uses. One firm has obtained approved applications to market timed-release products containing guaifenesin. Other firms who wish to market a drug product in timed-release form containing guaifenesin must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).

The NIOSH National Personal Protective Technology Laboratory (NPPTL) will hold a public meeting to discuss a proposed Total Inward Leakage (TIL) program for half-mask air-purifying particulate filtering respirator certification with plans to later include similar requirements for all respirator certifications.

This regulation clarifies that entities involved in the financing of the non-Federal share of Medicaid payments must be a unit of government; clarifies the documentation required to support a Medicaid certified public expenditure; limits Medicaid reimbursement for health care providers that are operated by units of government to an amount that does not exceed the health care provider's cost of providing services to Medicaid individuals; requires all health care providers to receive and retain the full amount of total computable payments for services furnished under the approved Medicaid State plan; and makes conforming changes to provisions governing the State Child Health Insurance Program (SCHIP) to make the same requirements applicable, with the exception of the cost limit on reimbursement. The Medicaid cost limit provision of this regulation does not apply to: Stand-alone SCHIP program payments made to governmentally-operated health care providers; Indian Health Service (IHS) facilities and tribal 638 facilities that are paid at the all-inclusive IHS rate; Medicaid Managed Care Organizations (MCOs), Prepaid Inpatient Health Plans (PIHPs), and Prepaid Ambulatory Health Plans (PAHPs); Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs). Moreover, disproportionate share hospital (DSH) payments and payments authorized under Section 701(d) and Section 705 of the Benefits Improvement Protection Act of 2000 are not subject to the newly established Medicaid cost limit for governmentally-operated health care providers. Except as noted above, all Medicaid payments and SCHIP payments made under the authority of the State plan and under waiver and demonstration authorities, as well as associated State Medicaid and SCHIP financing arrangements, are subject to all provisions of this regulation. Finally, this regulation solicits comments from the public on issues related to the definition of the Unit of Government.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the presidential Advisory Council on HIV/AIDS (PASCHA) will hold a meeting. the meeting will be open to the public.