Department of Health and Human Services May 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for TUDORZA PRESSAIR 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for CAMERON HEALTH S-ICD SYSTEM 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled ``Medical Devices; Physical Medicine Devices; Classification of the Powered Lower Extremity Exoskeleton'' that published in the Federal Register on February 24, 2015. FDA is republishing to correct an inadvertent omission of information. FDA is classifying the powered lower extremity exoskeleton into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the powered lower extremity exoskeleton's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

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. 209 and 37 CFR part 404 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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting a public review of the draft immediately dangerous to life or health (IDLH) values and support technical documents, entitled IDLH Values Profiles, for 14 chemicals. NIOSH is requesting technical reviews of the draft IDLH Value Profiles.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 5, 2015, Vol. 80, page 6521 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Venkata J. Reddy, University of Minnesota: Based upon the evidence and findings of an investigation report by the University of Minnesota (UMN), an investigation conducted by another Federal agency, and additional information obtained by the Office of Research Integrity (ORI) during its oversight review of the UMN investigation, ORI found that Mr. Venkata J. Reddy, former Graduate Student, Department of Chemistry, UMN, engaged in research misconduct in research that was included in grant application R01 GM095559-01A1, submitted to the National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH). ORI found by a preponderance of the evidence that the Respondent intentionally and knowingly engaged in research misconduct by falsifying and/or fabricating data that was provided to his mentor to include in grant application R01 GM095559-01A1 submitted to NIGMS, NIH, to obtain U.S. Public Health Service (PHS) funds. Specifically, ORI found that the Respondent falsified data included in Figures 4, 9, 11, 15, and 25 in R01 GM095559-01A1 for enantiomeric excess (``ee'') to falsely show a high degree of selectivity for one enantiomer over another by a cut-and-paste method and manipulation of the instrument to give the desired result. Respondent also falsified the underlying nuclear magnetic resonance spectroscopy (NMR) data for Compound 22 reported in Figure 15 in R01 GM095559-01A1 by a cut-and-paste method to manipulate the NMR spectra and give the desired result. Dr. Reddy has been debarred by the Federal agency with joint jurisdiction for a period of five (5) years, ending on August 26, 2018. ORI has implemented the following administrative action to coincide with the government-wide debarment: (1) Respondent is prohibited 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) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being generally recognized as safe for use in health care settings based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for these uses. We also are proposing that all health care antiseptic active ingredients have in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.