2006 – Federal Register Recent Federal Regulation Documents

The CERHR announces the availability of the draft expert panel report for bisphenol A on December 15, 2006, from the CERHR Web site (https://cerhr.niehs.nih.gov) or in printed text from CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR invites the submission of public comments on sections 1-4 of the draft expert panel report (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on March 5-7, 2007, at the Radisson Hotel Old Town in Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to bisphenol A is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the final report on its Web site and solicit public comment on it through a Federal Register notice.

NICEATM in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces an independent scientific peer review meeting to evaluate the validation status of five in vitro pyrogenicity test methods: (1) Human PBMC/IL-6 in vitro pyrogen test (PBMC/IL-6), (2) human whole blood/IL-1 in vitro pyrogen test (WB/IL-1), (3) human whole blood/IL-1 in vitro pyrogen test: application of cryopreserved human whole blood (cryo WB/ IL-1), (4) the human whole blood/IL-6 in vitro pyrogen test (WB/IL-6), and (5) an alternative in vitro pyrogen test using the human monocytoid cell line MONO MAC-6 (MM6/IL6). These five in vitro test methods are proposed as replacements for the in vivo rabbit pyrogen test (RPT). At this meeting, a scientific panel will peer review the draft background review document (BRD) on each test method, evaluate the extent that the BRD addresses established validation and acceptance criteria for each test method, and provide comment on draft ICCVAM recommendations on the proposed use of these test methods, draft test method protocols, and draft performance standards. NICEATM invites public comments on the draft BRDs, draft ICCVAM test method recommendations, draft test method protocols, and draft performance standards.

The Federal Crop Insurance Corporation (FCIC) finalizes the Common Crop Insurance Regulations, Nursery Crop Insurance Provisions by amending the definition of ``liners.'' FCIC also finalizes the Nursery Peak Inventory Endorsement to clarify that the peak amount of insurance is limited to 200 percent of the amount of insurance established under the Nursery Crop Insurance Provisions. The amendments will be applicable to the 2008 and succeeding crop years.

In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations relating to the reduction in taxable income under section 302 of the Katrina Emergency Tax Relief Act of 2005. The regulations affect taxpayers that provide housing in their principal residences to individuals displaced by Hurricane Katrina. The text of those regulations also serves as the text of these proposed regulations.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The United States Consumer Product Safety Commission (Commission or CPSC) has received a petition (HP 07-1) requesting that the Commission amend its regulation under the Federal Hazardous Substances Act (FHSA) to allow the use of the term ``detonator'' to be used interchangeably with the term ``blasting cap.'' The Commission solicits written comments concerning the petition.\1\

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for an alternate feeding regimen for tylosin phosphate in Type C medicated swine feeds used for the control of swine proliferative enteropathies.

The Food and Drug Administration (FDA) is proposing to amend its final rule that established standardized format and content requirements for the labeling of over-the-counter (OTC) drug products (Drug Facts Rule, codified at 21 CFR 201.66). This amendment proposes a definition and the option of alternative labeling requirements for ``convenience-size'' OTC drug packages.