Department of Health and Human Services October 29, 2015 – Federal Register Recent Federal Regulation Documents

The Office of Dietary Supplements (ODS) at the National Institutes of Health, in partnership with the National Library of Medicine (NLM), has developed a Dietary Supplement Label Database (DSLD) that is compiling all information from the labels of dietary supplements marketed in the United States. ODS welcomes comments about features to add and functionality improvements to make so the DSLD may become a more useful tool to users. A federal stakeholder panel for the DSLD will consider all comments received. The ODS requests input from academic researchers, government agencies, the dietary supplement industry, and other interested parties, including consumers. The DSLD can be accessed online at http:/ /dsld.nlm.nih.gov.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Dr. Maria C.P. Geraedts, University of Maryland, Baltimore: Based on the report of an investigation conducted by the University of Maryland, Baltimore (UMB) and analysis conducted by ORI in its oversight review, ORI and UMB found that Dr. Maria C.P. Geraedts, former postdoctoral fellow, Department of Anatomy and Neurobiology, UMB, engaged in research misconduct in research supported by National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), grant R01 DC010110. ORI found falsified and/or fabricated data included in the following two (2) publications: Am J Physiol Endocrinol Metab 303:E464-E474, 2012 (hereafter referred to as ``AJP 2012'') Journal of Neuroscience 33(17):7559-7564, 2013 (hereafter referred to as ``JN 2013'') As a result of the UMB investigation, JN 2013 and AJP 2012 have been retracted. ORI found that Respondent falsified and/or fabricated bar graphs in AJP 2012, by changing ELISA-based measurements to produce the desired result for secretion of glucagon-like peptide-1 (GLP-1) from intestinal explants from various mouse strains in: Figure 2 for GLP-1 release from duodenum (2A & D), jejunum (2B & E), and ileum (2C & F). Figure 3 for GLP-1 release from colon (3A & C) and rectum (3D). Figure 4 for GLP-1 release from ileum (4A) and colon (4C) in the presence or absence of an ATP-sensitive K+ channel inhibitor. ORI found that Respondent falsified and/or fabricated bar graphs in Figure 1, JN 2013 by changing ELISA-based measurements to produce the desired result for the secretion of peptides found in taste buds (GLP- 1, glucagon, or neuropeptide Y) from mouse lingual epithelium exposed to various concentrations of stimuli (glucose, sucralose, MSG, polycose). These bar graphs also were included as Figure 7 in grant application R01 DC010110-06. Both the Respondent and the U.S. Department of Health and Human Services (HHS) want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter. Respondent stated that she is not currently involved in U.S. Public Health Service (PHS)- supported research and has no intention of applying for or engaging in PHS-supported research or otherwise working with PHS. Dr. Geraedts has entered into a Voluntary Settlement Agreement with ORI and UMB, in which she voluntarily agreed to the administrative actions set forth below. The administrative actions are required for three (3) years beginning on the date of Dr. Geraedts employment in a position in which she receives or applies for PHS support on or after the effective date of the Agreement (September 22, 2015). If the Respondent has not obtained employment in a research position in which she receives or applies for PHS support within one (1) year of the effective date of the Agreement, the administrative actions set forth below will no longer apply. Dr. Geraedts has voluntarily agreed: (1) To have her research supervised as described below and notify her employer(s)/institution(s) of the terms of this supervision; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is proposed and prior to her participation in any capacity on PHS- supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; Respondent agreed that she will not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan; (2) that any institution employing her shall submit in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) to exclude herself voluntarily 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 for period of three (3) years beginning on September 22, 2015.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicant'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Survey on Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

A Plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State's Governor, and finally submit the plan on a five-year basis. On an annual basis, the Council must submit a Program Performance Report (PPR) to described the extent to which annual progress is being achieved on the 5 year state plan goals. The PPR will be used by (1) the Council as a planning document to track progress made in meeting state plan goals; (2) the citizenry of the State as a mechanism for monitoring progress and activities on the plans of the Council; (4) the Department as a stewardship tool, for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act, as one basis for monitoring and providing technical assistance (e.g., during site visits), and as a support for management decision making.

The Food and Drug Administration (FDA or we) is confirming the effective date of September 22, 2015, for the final rule that appeared in the Federal Register of August 21, 2015, and that amended the color additive regulations to expand the permitted use of spirulina extract as a color additive to include use in coating formulations applied to dietary supplement and drug tablets and capsules.