Department of Health and Human Services February 10, 2009 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)
In accordance with the memorandum of January 20, 2009 from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review,'' CMS is seeking public comment on a contemplated delay of 60 days in the effective date of the rule entitled ``Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA),'' published in the Federal Register on January 16, 2009 (74 FR 2873). That rule implements certain MIPPA provisions that delay implementation of Round 1 of the competitive bidding program; requires CMS to conduct a second Round 1 competition (the ``Round 1 rebid'') in 2009; and mandates certain changes for both the Round 1 rebid and subsequent rounds of the program, including a process for providing feedback to suppliers regarding missing financial documentation and requiring contractors to disclose to CMS information regarding subcontracting relationships. CMS is considering a temporary 60-day delay in effective date to allow CMS officials the opportunity for further review of the issues of law and policy raised by this rule, consistent with the Chief of Staff's memorandum of January 20, 2009. CMS solicits comments specifically on the contemplated delay in effective date and generally on the rule entitled ``Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).''
Determination of Regulatory Review Period for Purposes of Patent Extension; SELZENTRY
The Food and Drug Administration (FDA) has determined the regulatory review period for SELZENTRY 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 drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; MIRCERA
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.
Food Labeling Workshop; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas, is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on April 21, 2009, from 8 a.m. to 5 p.m., and on April 22, 2009, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Continuing Education Center, Two East Center St., Fayetteville, AR (located downtown). Contact: David Arvelo, Small Business Representative, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253- 4970, or e-mail: david.arvelo@fda.hhs.gov. For information on accommodation options, contact Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575- 4221, FAX: 479-575-2165, or e-mail: seideman@uark.edu. Registration: You are encouraged to register by April 10, 2009. The University of Arkansas has a $250 registration fee to cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $350 payable to: ``The University of Arkansas.'' If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 14 days in advance. Registration Instructions: To register, please submit your name, affiliation, mailing address, phone/fax number, and e-mail, along with a check or money order for $250 payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested at cost through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.
Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Extension of Comment Period
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.
Oral Dosage Form New Animal Drugs; Ivermectin Paste
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides for use of ivermectin oral paste for the treatment and control of additional species of gastrointestinal parasites in horses.
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs; Withdrawal
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.
Findings of Scientific Misconduct
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.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Determination of Regulatory Review Period for Purposes of Patent Extension; VETMEDIN
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; LETAIRIS
The Food and Drug Administration (FDA) has determined the regulatory review period for LETAIRIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; LUNESTA
The Food and Drug Administration (FDA) has determined the regulatory review period for LUNESTA 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 drug product.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Evaluation of Phase I Demonstrations of the Pharmacy Quality Alliance.'' 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.
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