Department of Health and Human Services February 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.'' It was developed as a special control to support the reclassification of intervertebral body fusion devices that contain bone grafting material from class III (premarket approval) into class II (special controls). This draft guidance document describes a means by which these intervertebral body fusion devices may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the intervertebral body fusion device that contains bone grafting material from class III into class II (special controls) and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. This draft guidance is not final, nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.'' The guidance document describes a means by which these in vitro diagnostic devices for the laboratory diagnosis of hepatitis A virus (HAV) may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III (premarket approval) into class II (special controls). HAV serological assays are in vitro diagnostic devices used to test for specific antibodies to support the clinical laboratory diagnosis of HAV.

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 Bayer HealthCare LLC, Animal Health Division. The supplemental NADA provides for the use of flavored, chewable praziquantel/pyrantel pamoate/febantel tablets for the removal of several species of internal parasites in dogs.

The Indian Health Service published a document in the Federal Register on December 30, 2005. The document contained an error.

This notice announces the second meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the second meeting of the American Health Information Community Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the (1) U.S. Provisional Patent Application 60/195,507, filed April 6, 2000, entitled ``Aminoflavone Compounds, Compositions, and Methods of Use Thereof'' and all related foreign patents/patent applications (HHS Ref. No. E-279-1999/0); (2) U.S. Patent Application 08/014,696, filed February 8, 1993, entitled ``5-Aminoflavone Derivatives'' and all related foreign patents/patent applications (HHS Ref. No. E-296-2005/1); (3) PCT Patent Application PCT/US96/00181, filed August 10, 1994, entitled ``5-Aminoflavone Derivatives, Their Preparation and Their Use as Antibacterial, Anti-estrogenic and/or Antitumor Agent'' and all related foreign patents/patent applications (HHS Ref. No. E-295-2005/ 0), with the exception of the JP patent application JP204356/93, filed on August 18, 1993;

The Food and Drug Administration (FDA) has determined the regulatory review period for ALIMTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a report entitled ``Independent Evaluation of FDA's First Cycle Review PerformanceRetrospective Analysis Final Report.'' This report describes an independent evaluation of the issues associated with FDA's conduct of first cycle reviews of new molecular entities for new drug applications (NMEs for NDAs), and biological license applications (BLAs). Applications covered by the report are those submitted to FDA in fiscal years 2002 to 2004. This independent study was conducted in relation to the Prescription Drug User Fee Amendments of 2002 (PDUFA III). This assessment includes a detailed evaluation of the events that occurred during the review process with a focus on identifying the best practices by FDA and industry that facilitated that process.

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.

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 reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an experimental study of possible footnotes and cueing schemes intended to help consumers understand and apply quantitative trans fat information they might see on the Nutrition Facts Panel of a food product. The experimental study will estimate the communication effectiveness of quantitative trans fat information in terms of its ability to help consumers make heart-healthy product decisions in realistic label usage situations for a range of products.