Department of Health and Human Services August 8, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing its intent to accept and consider a single source application (RFA-FDA-07- 006) for the awarding of a Cooperative Agreement to the National Alliance for Hispanic Health (the Alliance). The purpose of the agreement is to empower consumers to improve their health by providing better consumer health information; ensure that health information available to consumers is clear, informative, and effective; leverage opportunities to eliminate health disparities in subpopulations; respond to the health promotion and disease prevention objectives of the Department of Health and Human Services (HHS) ``Healthy People 2010'' document; and improve health literacy for Hispanic Americans. FDA anticipates providing $ 35,000.00 (direct and indirect costs) in fiscal year (FY) 2007 in support of this project. Subject to the availability of funds and successful performance, two additional years of support up to $35,000.00 per year (direct and indirect) will be available.

The Food and Drug Administration (FDA) has determined that MIVACRON (mivacurium chloride) injection equivalent to (EQ) 2 milligrams (mg) base/milliliter (mL) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mivacurium chloride injection EQ 2 mg base/mL.

The Food and Drug Administration (FDA) is classifying an in vitro human immunodeficiency virus (HIV) drug resistance genotype assay into class II (special controls). The special control that will apply to this device is the guidance document entitled ``Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.'' FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.