Department of Health and Human Services May 16, 2006 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. This meeting is open to the public. A description of the Council's functions is included also with this notice.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.

CERHR announces the availability of the genistein and soy formula expert panel reports on the CERHR Web site (https:// cerhr.niehs.nih.gov) or in print from CERHR (see ADDRESSES below). These expert panel reports are evaluations of the reproductive and developmental toxicity of genistein and soy formula conducted by a 14- member expert panel composed of scientists from the federal government, universities, and private organizations. CERHR invites the submission of public comments on these expert panel reports.

On Monday, October 7, 2002, CDC published final criteria for consideration of chemicals or categories of chemicals for possible inclusion in future releases of CDC's ``National Report on Human Exposure to Environmental Chemicals (the ``Report'') and also solicited chemicals for possible inclusion in future editions of the ``Report'' (See Federal Register, 67 FR 62477). The final selection criteria have remained the same since the issuance of the 2002 notice. They are as follows: (1) Independent scientific data which suggest that the potential for exposure of the U.S. population to a particular chemical is changing (i.e., increasing or decreasing) or persisting; (2) seriousness of health effects known or suspected to result from exposure to the chemical (for example, cancer, birth defects, or other serious health effects); (3) proportion of the U.S. population likely to be exposed to levels of chemicals of known or potential health significance; (4) need to assess the efficacy of public health actions to reduce exposure to a chemical in the U.S. population or a large component of the U.S. population (for example, among children, women of childbearing age, the elderly); (5) existence of an analytical method that can measure the chemical or its metabolite in blood or urine with adequate accuracy, precision, sensitivity, and speed; and (6) incremental analytical cost (in dollars and personnel) to perform the analyses (preference is given to chemicals that can be added readily to existing analytical methods). On Tuesday, September 30, 2003, CDC published a record of the nominated chemicals of interest that were scored by a panel of experts in accordance with the published selection criteria. (See Federal Register, 68 FR 56296.) All of this information is available on CDC's Web site at https://www.cdc.gov/exposurereport/chemical nominations.htm. Past and future nominations do not result in obligatory laboratory analysis or inclusion of nominated chemicals in the ``Report,'' but rather serve to better inform CDC about which chemicals are of concern to the public. CDC now requests public comment on proposed criteria for removing chemicals from future editions of the ``Report.'' These removal criteria (given below) will become part of a combined process of nominating chemicals for inclusion in or removal from the ``Report.'' This process will include (a) nominations from the public of chemicals to include or remove from the ``Report,''(b) an external scoring of nominations in accord with the published nomination and removal criteria, and (c) assistance from the Board of Scientific Counselors of CDC's National Center for Environmental Health/Agency for Toxic Substances and Disease Registry in reviewing plans for including or removing chemicals and identifying alternatives for monitoring specific at-risk population subgroups. This combined process for nomination and removal would occur periodically (e.g., every six years). The criteria for selecting and removing chemicals apply only to those chemicals published in the ``Report,'' not those merely nominated. The proposed removal criteria are as follows: A chemical may be removed from the ``Report'': (1) If a new replacement chemical (i.e., a metabolite) is more representative of exposure than the chemical currently being measured or; (2) if after three survey periods (or not less than six years), detection rates for all chemicals within a methodological and chemically-related group* are less than 5 percent for all population subgroups (two sexes, three race/ethnicity, and three age groups) or; (3) if after three survey periods (or not less than six years), levels of chemicals within a methodological and chemically- related group are unchanged or declining in all the specific subgroups as documented in the ``Report.'' A chemical would continue to be measured and not be removed from the ``Report'' if it met either of two proposed exceptions to these criteria: (a) It is a chemical for which there is an established biomonitoring health threshold (e.g., CDC's level of concern for blood lead levels in children) or any chemical for which there is widespread public health concern (e.g., mercury) or (b) three survey periods (or not less than six years) have passed, which constitute the minimum time before a chemical could be removed; a longer period may be necessary to account for the half-life of a particular chemical or to account for a recent change (e.g., the removal of a chemical from commerce) that would necessitate monitoring of the population. Note that the criteria for removing a chemical from the ``Report'' are not the corollaries of the criteria for adding chemicals to the ``Report.'' After reviewing and incorporating public comments from this announcement, CDC will publish the criteria in their final form in the Federal Register.

The Food and Drug Administration (FDA) is seeking volunteers to participate in a pilot project involving the testing of a Health Level 7 (HL7) data interchange standard for the submission of product stability data to FDA to facilitate the review of this data. Using the data interchange standards and the analytical tools will allow consistent data presentation to the agency and allow a reviewer to more efficiently and consistently display and evaluate product stability data submitted in electronic format.

The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for members of an AHRQ-convened Workgroup on risk adjustment specifically aimed at the AHRQ Quality Indicators (QIS). This Workgroup is being formed as part of a structured approach for evaluating risk-adjustment and the appropriateness of hierarchical modeling methodology for the AHRQ Quality Indicators at the area and/or provider levels. The Workgroup will evaluate appropriate technical and methodological approaches currently available, and will also discuss and suggest strategies as to what risk adjustment approach(s), if any, would best fit AHRQ QI user needs. As part of this effort and using the AHRQ QIs, the Workgroup member will be addressing several key issues for the development of a risk adjustment methodology, including but not limited to: Statistical and methodological issues related to the development and validation of risk adjusted models that predict patient outcomes using administrative data, and are suitable for assessing quality at different levels (individual hospital, State, region). Methods for comparing the performance of hierarchical methods with previously employed methods based on administrative data to improve predictive and discriminant ability, and overall fit. Appropriate use of sub-sampling techniques for model validation. Computation of confidence intervals for assessing provider-specific and State-level performance in comparison to national summary statistics (means or percentiles). For additional information about the AHRQ QIs, please visit the AHRQ Web site at https://www.qualityindicators.ahrq.gov. Specifically, the AHRQ QIs Risk Adjustment Workgroup will consist of up to 9 individuals who are familiar with different risk adjustment methodologies including hierarchical modeling approaches. The Workgroup will have a series of conference calls to discuss the technical and policy issues surrounding risk adjustment for the AHRQ QIs and will then assist AHRQ in developing a report that will aim to summarize the discussions and suggestions of the workgroup, which will be made available for public comment.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for fomepizole solution for injection from Orphan Medical, Inc., to Jazz Pharmaceuticals, Inc. The regulations are also being amended to reflect approval of a supplemental NADA to remove a vial of saline diluent from this product.