Department of Health and Human Services January 23, 2007 – Federal Register Recent Federal Regulation Documents
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Hydrogen Peroxide Solution for Control of Various Fungal and Bacterial Diseases in Fish; Availability of Data
The Food and Drug Administration (FDA) is announcing the availability of effectiveness, target animal safety, and environmental data that may be used in support of a new animal drug application (NADA) or supplemental NADA for use of a 35 percent solution of hydrogen peroxide by immersion for control of mortality in several life stages of certain freshwater-reared finfish species due to various fungal and bacterial diseases. The data, contained in Public Master File (PMF) 5639, were compiled by the United States Geological Survey, Biological Resources Section, Upper Midwest Environmental Sciences Center.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products
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 review and clearance under the Paperwork Reduction Act of 1995.
Establishment of Advisory Council on Blood Stem Cell Transplantation and Solicitation of Nominations for Membership
Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended) and the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Administrator, HRSA, announces the establishment of the Advisory Council on Blood Stem Cell Transplantation by the Secretary, HHS. The Council will advise the Secretary on proposed C.W. Bill Young Cell Transplantation Program policies and other such matters as the Secretary determines. Duration of this Council is for two years unless renewed by the Secretary, HHS. This notice also requests nominations for membership on the Council.
Food Labeling; Gluten-Free Labeling of Foods
The Food and Drug Administration (FDA) is proposing to define the term ``gluten-free'' for voluntary use in the labeling of foods, to mean that the food does not contain any of the following: An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (all noted grains are collectively referred to as ``prohibited grains''); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten. A food that bears the claim ``gluten-free'' or similar claim in its labeling and fails to meet the conditions specified in the proposed definition of ``gluten-free'' would be deemed misbranded. FDA also is proposing to deem misbranded a food bearing a gluten-free claim in its labeling if the food is inherently free of gluten and if the claim does not refer to all foods of that same type (e.g., ``milk, a gluten-free food'' or ``all milk is gluten-free''). In addition, a food made from oats that bears a gluten-free claim in its labeling would be deemed misbranded if the claim suggests that all such foods are gluten-free or if 20 ppm or more gluten is present in the food. Establishing a definition of the term ``gluten-free'' and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. This proposed action is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).
The Data Measures, Data Composites, and National Standards To Be Used in the Child and Family Services Reviews; Corrections
The Administration for Children and Families (ACF) published a notice in the Federal Register of June 7, 2006 (Vol. 71, No. 109), pages 32969-32987, presenting the data measures, data composites, and national standards to be used in the Child and Family Services Review (CFSR). This notice provides corrections to this notice. A consolidated version of the June 7 Federal Register Announcement incorporating these corrections is provided on the Children's Bureau's Web site (address). The following are the key changes in the document and the reasons for the changes: There are new specifications for each of the individual measures included in each composite. After publication of the June 7, Federal Register Announcement, ACF conducted trainings on the CFSR data indicators at each of the 10 ACF Regional Offices. The trainings were provided to key administrators and staff of State child welfare agencies. During these trainings, issues were identified and questions were raised regarding the individual measures included in the composite. After reviewing these issues and questions, ACF determined that more specific information about the measures was needed and that some measures required revision in order to better target the outcome being assessed. The increased specification includes using the precise terminology that is used in the Adoption and Foster Care Analysis and Reporting System (AFCARS) and describing in greater detail the children who are in the denominator and numerator of each measure. The revisions to some of the measures required changes in the syntax used to calculate the measures. There is a new definition of foster parent used by the National Child Abuse and Neglect Data System (NCANDS). The change was made in this definition because the definition of a foster parent used by NCANDS was recently revised. There is a new version of the table of ranges, percentiles, and national standards for the data indicators and measures to be used in the second round of the Child and Family Services Review. This table replaces the Table 1 provided in the June 7, 2006 Federal Register. It was revised to reflect new data and new national standards for all of the CFSR data indicators. The data in the table and the national standards for all of the data indicators and measures are different than those presented in the June 7 Federal Register notice. This difference is due to one or both of the following reasons: (1) A change in the syntax for calculating some of the measures, and (2) a change in the process for calculating the national standards. The reason for the change in the procedures for calculating the national standards is provided in the following bullet. There are revisions and corrections to Attachment B: Methodology for Developing the Composites. The revisions in Attachment B were made to (1) correct an error in the original attachment B, (2) provide the new coefficients (weights) for the composite measures that resulted from the changes in the syntax, and (3) explain the new procedure for calculating the national standards. The error in the original attachment B occurred in Step 10 of the process of calculating the composite scores. The new coefficients (weights) for each of the measures included in the composites are presented in Table 1 of the attachmentCoefficients (Weights) for the Measures Included in the Permanency Related Data Composites. The coefficients/weights changed due to changes in the syntax used to calculate some of the individual measures. The new procedure for calculating the national standards involved changes in the statistical requirements for fitting the data to a normal curve and to changes in the parameters used in calculating the sampling error.
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