Department of Health and Human Services November 20, 2012 – 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: Eric J. Smart, Ph.D., University of Kentucky: Based on the report of an investigation conducted by the University of Kentucky (UK) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Eric J. Smart, former Professor of Pediatrics and Physiology, Department of Pediatrics and Physiology, UK, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants R01 HL062844, R01 HL058475, R01 HL064056, R01 HL068059, and R01 HL073693, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant R56 DK063025, and National Center for Research Resources (NCRR), NIH, grant P20 RR105592. ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in ten (10) published papers, one (1) submitted manuscript, seven (7) grant applications, and three (3) progress reports over a period of ten (10) years. Respondent reported experimental data for knockout mice that did not exist in five (5) grant applications and three (3) progress reports and also falsified and/or fabricated images in 45 figures included in the following:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document revises and updates the draft guidance entitled ``Electronic Source Documentation in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA- regulated clinical investigations. The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is announcing the availability of guidance for industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The guidance provides guidance to industry for designing and conducting clinical effectiveness studies and describes criteria that the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of anticoccidial drugs intended for use in poultry and other food-producing animals. The guidance suggests times during the evaluation of effectiveness when sponsors may wish to consult with CVM.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.

As required by section 423(c) of the Social Security Act (42 U.S.C. 623(c)), the Department is publishing the allotment percentage for each State under the Title IV-B Subpart 1, Child Welfare Services State Grants Program. Under section 423(a), the allotment percentages are one of the factors used in the computation of the Federal grants awarded under the Program.