Department of Health and Human Services October 23, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2008 (73 FR 22720). The document amended the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). The document was inadvertently published with incorrect dollar amounts in two separate areas: The summary of economic impacts and the paperwork burden table. This document corrects those errors.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the record retention requirement of the soy protein/coronary heart disease health claim.

NICEATM announces the availability of the ``Biennial Progress Report: Interagency Coordinating Committee on the Validation of Alternative Methods: 2006-2007.'' In accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), this report describes progress and activities during 2006-2007 by ICCVAM and NICEATM. The report is available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm. Copies can also be requested from NICEATM at the address given below.

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 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 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 the use of MedWatch\Plus\ Portal and Rational Questionnaire to collect electronically all adverse event, consumer complaint/product problem and medication use error data submitted to FDA.

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, ``OHRP Guidance on Engagement of Institutions in Human Subjects Research.'' The guidance document describes: (1) Scenarios that, in general, would result in an institution being considered engaged in a human subjects research project; (2) scenarios that would result in an institution being considered not engaged in a human subjects research project; and (3) IRB review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project. The guidance document is intended primarily for institutional review boards (IRBs), research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by the Department of Health and Human Services (HHS). The guidance document announced in this notice finalizes the draft guidance with the same title that was made available for public comment in the Federal Register on December 8, 2006 (71 FR 71169). OHRP received twenty-four comments on the draft guidance document, and those comments were considered as the guidance was finalized. The final guidance document replaces two existing OHRP guidance documents on the engagement of institutions in human subjects research: (1) The January 26, 1999, document on ``Engagement of Institutions in Research,'' and (2) the December 23, 1999, document on ``Engagement of Pharmaceutical Companies in HHS Supported Research.''