Department of Health and Human Services December 30, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011. The guidance document provides recommendations to establishments for complying with CGTP and additional requirements for manufacturers of HCT/Ps. The guidance is intended for any HCT/P establishment that performs a manufacturing step and is responsible for complying with CGTP requirements. The guidance also addresses whether the establishment registration and HCT/P listing requirements apply in certain instances. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2009.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on certain labeling requirements for blood and blood components, including Source Plasma. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a system for labeling blood and blood components, and the use of new labeling systems that may be developed in the future. Additionally, these requirements are issued to help ensure the continued safety of the blood supply and facilitate consistency in labeling.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.'' This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off- label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA's policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.