Department of Health and Human Services January 9, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA believes, and is preparing a guidance document explaining, that it is possible in certain circumstances for In Vitro Diagnostic (IVD) device studies to be conducted using leftover specimens obtained without informed consent while protecting the human subjects who are the source of such specimens. This notice solicits comments on the proposed collection of information associated with the guidance document entitled ``Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.''

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (166) entitled ``Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)Phase II'' (VICH GL38). This guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document provides recommendations for internationally harmonized test methods used to generate environmental fate and toxicity data.

The Food and Drug Administration (FDA) is proposing to reclassify herpes simplex virus (HSV) (types 1 and/or 2) serological assays from class III (premarket approval) to class II (special controls). HSV serological assays (types 1 and/or 2) are intended for testing specimens from individuals who have signs and symptoms of infection consistent with HSV 1 and/or 2 or for determining if an individual has been previously infected with HSV 1 and/or 2, as well as for providing epidemiological information about these infections. The detection of HSV antibodies, in conjunction with other clinical laboratory findings, aids in the clinical laboratory diagnosis of an infection by HSV 1 and/or 2. FDA is proposing this reclassification on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control, if FDA reclassifies this device.