Department of Health and Human Services September 2008 – Federal Register Recent Federal Regulation Documents

In December 2005, the CERHR announced its intention to conduct an evaluation of the potential for bisphenol A to cause adverse effects on reproduction and development in humans (Federal Register: December 21, 2005: Vol. 70, No. 244, page 75827). The final results of this evaluation are now available in the NTP-CERHR Monograph on Bisphenol A that includes the (1) NTP Brief on Bisphenol A and (2) CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Bisphenol A. The NTP Brief provides the public, as well as government health, regulatory, and research agencies, with the NTP's conclusions regarding the potential for bisphenol A to adversely affect human reproductive health or children's development. The NTP Brief is based on information about bisphenol A provided in the expert panel report, public comments, comments from peer reviewers of the draft NTP Brief, and additional scientific information available since the expert panel meeting.

The Food and Drug Administration (FDA) is announcing that Zentox Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of monochloramine as an antimicrobial agent in poultry process chiller water.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Dr. Maria Anne Kirkman Campbell (Dr. Campbell) from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Campbell was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and conduct otherwise relating to the regulation of a drug product under the act. Dr. Campbell failed to request a hearing and, therefore, has waived her opportunity for a hearing concerning this action. Even assuming that any statement in Dr. Campbell's correspondence with FDA were to be construed as requesting a hearing, Dr. Campbell has failed to file with the agency information and analyses sufficient to create a basis for a hearing concerning this action. Therefore, we are, in the alternative, issuing an order denying any such assumed request for a hearing because we find that there is no genuine and substantial issue of fact to grant a hearing on the debarment, if a hearing were requested.

Under section 6021 of Public Law 109-171, the Deficit Reduction Act of 2005 (DRA), States may provide asset disregards (and related estate recovery offsets) for Medicaid applicants who receive benefits under qualified long term care insurance policies (Partnership policies) that were purchased in the same State. This notice sets forth standards for states that choose to enter into a reciprocity agreement under section 6021(b) of the DRA, under which they agree to provide the same disregards and offsets for qualified Partnership policies that a Medicaid applicant purchased in another State that participates in the reciprocity agreement.