Department of Health and Human Services February 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for MIRCERA 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 which claims that human biological product.

The Food and Drug Administration (FDA) is extending to March 19, 2009, the comment period for the draft guidance for industry entitled ``Bioequivalence Recommendation for Vancomycin HCl'' that published in the Federal Register of December 16, 2008 (73 FR 76362). The draft guidance provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules. FDA is taking this action in response to requests for an extension of the comment period to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) published in the Federal Register of September 29, 2008 (73 FR 56487), a direct final rule amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report to a central office in the agency. The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Kazuhiro Tanaka, M.D., Ph.D., National Institute of Dental and Craniofacial Research, National Institutes of Health: Based on the report of an investigation conducted by the National Institutes of Health (NIH) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, the U.S. Public Health Service (PHS) found that Dr. Kazuhiro Tanaka, former Visiting Postdoctoral Fellow, Molecular Biology Section, Craniofacial Developmental and Biology and Regeneration Branch (CDBRB), National Institute of Dental and Craniofacial Research (NIDCR), NIH, engaged in scientific misconduct in research supported by PHS funds from the NIDCR, NIH Intramural Program. PHS found that Respondent engaged in scientific misconduct by falsifying data that were included in three published papers: Kazuhiro Tanaka, Yoshihiro Matsumoto, Fumihiko Nakatani, Yukihide Iwamoto, and Yoshihiko Yamada, ``A zinc finger transcription [alpha]A-crystallin binding protein 1, is a negative regulator of the chondrocyte-specific enhancer of the [alpha]1(II) collagen gene,'' Molecular and Cellular Biology (MCB) 20:4428-4435, 2000; Kazuhiro Tanaka, Noriyuki Tsumaki, Christine A. Kozak, Yoshihiro Matsumoto, Fumihiko Nakatani, Yukihide Iwamoto, and Yoshihiko Yamada, ``A Kr[uuml]ppel-associated box-zinc finger protein, NT2, represses cell-type-specific promoter activity of the [alpha]2(XI) collagen gene,''Molecular and Cellular Biology 22:4256-4267, 2002; and Ying Liu, Haochuan Li, Kazuhiro Tanaka, Noriyuki Tsumaki, and Yoshihiko Yamada, ``Identification of an enhancer sequence with the first intron required for cartilage-specific transcription of the [alpha]2(XI) collagen gene,'' Journal of Biological Chemistry (JBC) 275:12712-12718, 2000. Specifically, PHS found that Respondent: Falsified the results for CRYBP1 or Sox9 binding to the Col2a1 DNA sequence in electrophoretic mobility shift assays in Figure 1D and Figure 7 in MCB 20:4428-4435, 2000. He used duplicate copies of bands or duplicate copies of parts of lanes to falsely represent results from reportedly different experimental conditions; Falsified the results for NT2 binding to the Col11a2 DNA sequence in electrophoretic mobility shift assays in Figures 2D and 6B, and falsified the Western blot for NT2 mutant proteins in Figure 8B in MCB 22:4256-4267, 2002. He used duplicate copies of bands, parts of bands, or duplicate copies of parts of lanes to falsely represent results from reportedly different experimental conditions in Figures 2D and 6B; and falsely represented results for the Figure 8B Western blot by using duplicate copies of bands to represent NT2[Delta]1 (lane 2) and NT2[Delta]4 (lane 5) mutant proteins; Falsified the Western blot for Sox9 protein expression in Figure 4B, JBC 275:12712-12718, 2000, by using duplicate copies of lanes 1 and 2 to represent the Sox9 expression in cell extracts from both Balb 3T3 and undifferentiated ATDC5 cells; and Falsified the Northern blots in multiple panels of Figure 3, MCB 20:4428-4435, 2000. He used duplicate copies of bands for CRYBP1, for Type II collagen, for Type X collagen, and for GAPDH and 18S EtBr stained control bands to falsely represent results of RNA expression from these different genes in ATDC5 cells. He also used duplicate copies of bands to falsely represent the RNA expression in ATDC5 cells grown under different conditions for either collagen Type II in Figure 3, MCB 2000 or collagen [alpha]1(X) in Figure 5 in MCB 22:4256-4267, 2002. Similarly, duplicate copies of 18S EtBr stained control bands were used in both figures with reportedly different experimental conditions. Both Respondent and PHS are desirous of concluding this matter without further expense of time and other resources, and the parties have entered into a Voluntary Exclusion Agreement (Agreement). The settlement is not an admission of liability on the part of the Respondent. Respondent neither admits nor denies ORI's finding of scientific misconduct. Respondent acknowledges that original data relating to the above referenced falsified figures are missing. Dr. Tanaka has voluntarily agreed, for a period of three (3) years, beginning on January 14, 2009: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR Part 376 et seq.) of OMB Guidelines to Agencies on Government wide Debarment and Suspension (2 CFR, Part 180); and (2) To exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

The Food and Drug Administration (FDA) has determined the regulatory review period for VETMEDIN 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 which claims that animal drug product.

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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Reducing Waste and Inefficiency through Process Redesign: Lean/Toyota Production System (TPS) Implementation.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 21, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Bliss & Laughlin Steel facility, in Buffalo, NY, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Bliss & Laughlin Steel facility. Location: Buffalo, NY. Job Titles and/or Job Duties: All employees. Period of Employment: January 1, 1948 through December 31, 1998.