Department of Health and Human Services September 17, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is extending to October 24, 2007, the comment period for the interim final rule (IFR) that appeared in the Federal Register of June 25, 2007 (72 FR 34959). In the IFR, FDA requested comments on a procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is reopening until October 17, 2007, the comment period for ``Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays'' published in the Federal Register of July 26, 2007 (72 FR 41081). That guidance was a revised version of the original draft, which was published on September 7, 2006, with a 90-day comment period that was extended to 180 days. In addition, FDA held a public meeting on the draft guidance in February 2006. FDA is reopening the comment period on the revised draft to allow sufficient time for stakeholder comment.

The Food and Drug Administration (FDA) is issuing this interim final rule to amend the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth decay, to include isomaltulose, a noncariogenic sugar. FDA is taking this action in response to a health claim petition submitted on behalf of Cargill, Inc. Based on the totality of publicly available scientific evidence, FDA now has determined that the nutritive sweetener isomaltulose, like other noncariogenic carbohydrate sweeteners listed in the dental caries health claim regulation, is not fermented by oral bacteria to an extent sufficient to lower dental plaque pH to levels that would contribute to the erosion of dental enamel. Therefore, FDA has concluded that isomaltulose does not promote dental caries, and it is amending the regulation authorizing a health claim relating certain noncariogenic sweeteners and the nonpromotion of dental caries to include isomaltulose as a substance eligible for the claim.

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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) re-authorize the information collection project ``AHRQ Grants Reporting System (GRS).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.