Department of Health and Human Services May 31, 2016 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Ricky Malhotra, Ph.D., University of Michigan and University of Chicago: Based on the Respondent's admission to committing research misconduct at the University of Michigan (UM) and subsequently at the University of Chicago (UC), the reports of separate investigations conducted by UM and UC, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Ricky Malhotra, former Research Assistant Professor, Department of Internal Medicine, UM, from 2005- 2006, and Research Assistant Professor, Department of Surgery, UC, from 2007-2011, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants K08 HL081472 and R01 HL107949. ORI found that falsified and/or fabricated data were included in the following three (3) NIH grant applications, one (1) NIH grant progress report, one (1) publication, seven (7) presentations, and one (1) image file:

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

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 a 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.

The Food and Drug Administration (FDA) is announcing a public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. FDA is interested in discussing the scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs, and trial population. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government Agencies, public health organizations, academic experts, and industry on various aspects of drug development for new antibacterial drugs for patients with unmet need and new antibacterial drugs that target a single species. The input from this public workshop will also help in developing topics for future discussion.

The Food and Drug Administration (FDA) is announcing the renewal of the Science Advisory Board to the National Center for Toxicological Research (NCTR) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Advisory Board to the National Center for Toxicological Research for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 2, 2018.

The Food and Drug Administration (FDA or Agency) has determined that LEVOTHROID (levothyroxine sodium) tablets, 0.025 milligram (mg), 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LEVOTHROID (levothyroxine sodium) tablets, 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.112 mg, 0.125 mg, 0.137 mg, 0.15 mg, 0.175 mg, 0.1 mg, 0.2 mg, and 0.3 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA, we, or the Agency) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collections of information marked as ``ADDENDUM'' in the draft guidance entitled ``E6(R2) Good Clinical Practice'' (E6(R2) draft guidance). The E6(R2) draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The E6(R2) draft guidance amends the guidance entitled ``E6 Good Clinical Practice: Consolidated Guidance'' (E6(R1) consolidated guidance), issued in April 1996, to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and data integrity. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated. The E6(R2) draft guidance was intended to improve clinical trial quality and efficiency while maintaining human subject protection. This notice solicits comments on the collection of information in the draft guidance concerning the development of a system to manage quality, as well as information to include in a clinical study report about the quality management approach.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing the renewal of the Allergenic Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Allergenic Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 9, 2018.