Energy Policy and New Uses Office, Agriculture Department July 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #198 entitled ``Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products'' (VICH GL45). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance is an annex to a VICH guidance GFI #73 entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)'' VICH GL3(R). This VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Julie Mass[egrave], Pennsylvania State University (PSU): Based on an assessment conducted by the Pennsylvania State University College of Medicine (PSU-COM) and the Respondent's admission, ORI and PSU found that Ms. Julie Mass[egrave], former postdoctoral scholar, PSU-COM, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant 4 R00 CA138498. ORI found that the Respondent knowingly engaged in research misconduct by falsifying and/or fabricating Western blot data and analyses that were including in the following manuscript: ``Cellular invasion following p120-catenin loss is mediated by AP-1, ITGA2 and MMP11,'' submitted to Molecular Cancer Research (hereafter referred to as the ``Molecular Cancer Research manuscript''). ORI found that the Respondent knowingly falsified and/or fabricated Western blot images, by manipulating the images to give the desired results, and quantitative PCR data and cell invasion and migration data, which were included in Figures 2, 3, S1, and S2 in the Molecular Cancer Research manuscript. Specifically, ORI found that the Respondent included falsified and/ or fabricated data and images in the following figures, and the corresponding text, in the Molecular Cancer Research manuscript: 1. Bands were cut and pasted from different Western blots for the following figures: a. Figures 2A, lanes 2 and 3, for P-cJun (S73) b. Figure 2D, lanes 4 and 6, bands identified as ITGA2 c. Figure 3B, bands identified as ITGA2 and MMP11 d. Figure 3D, bands identified as ITGA2 and MMP11 for lanes M2Neo- [uarr]ITGA2 control and [darr]MMP1 e. Figure 3E, bands identified as ITGA2 and MMP11 for lanes M2KO- [darr]ITGA2 control and M2KO-[darr]ITGA2-[uarr]MMP11 f. Figure S1A, bands identified as P-cJun (S73) g. Figure S2A, bands identified as P-cJun (S73) h. Figure S2C, bands identified as P-cJun (S73) i. Figure S2E, bands identified ITGA2 and MMP11 j. Figures S4B and C, identical bands were used for [beta]-actin 2. Numbers were increased or decreased in cell invasion and migration assays to give the desired results in the following figures: a. Figure 2B, for M2KO-DMSO cells and M2KO-SR11302 cells b. Figure 3F, for M2Neo-[uarr]ITGA2 [darr]MMP11 c. Figure 3G, for M2KO-[darr]ITGA2 [uarr]MMP11 d. Figure S1B, for F2KO-cJun peptide e. Figure S2B, for F2KO-cJun DMSO and F2KO-cJun SR11302 f. Figure S2D, for F2KO-cJun peptide g. Figure S2F, for F2Tom-[uarr]ITGA2 and F2KO-[darr]ITGA2 peptide h. Figures S4A, B, C, and D, for the migration for M2KO and F2KO cells 3. qPCR numbers were altered in Figure 2C, for M2KO-DMSO-PcJun ChIP and for M2KO-SR11302-PcJun ChIP, to give the desired result of PcJun binding to ITGA2 promoter. Ms. Mass[egrave] has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of two (2) years, beginning on July 6, 2015: (1) To have her research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (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.

The Food and Drug Administration (FDA or we) is extending the comment period for the risk assessment entitled ``Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.'' A notice of the availability of the risk assessment and our request for comments appeared in the Federal Register of April 30, 2015. We initially established July 29, 2015, as the deadline for the submission of requested comments that can help improve the ranking model approach, including the specific criteria, scoring, and weighting scheme; the scientific data and assumptions used to inform scoring used in the model; the selection of animal drugs evaluated; and the clarity and the transparency of the risk assessment. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Veterinary Feed Directive'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0331, scheduled to expire on 08/31/2015. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled Monitoring and Reporting System for the Prescription Drug Overdose Prevention for States Cooperative Agreement. CDC will use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), is announcing the availability of a draft guidance for industry entitled ``Request for Quality Metrics'' and a public meeting regarding the Agency's plans associated with a quality metrics reporting program. The draft guidance and public meeting are intended to gain stakeholders' perspectives on various aspects of the development and planned implementation of a quality metrics program launched under the authority of the Food, Drug, and Cosmetic Act (the FD&C Act). The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for postapproval manufacturing changes. FDA intends to consider the input from this public meeting as we finalize this guidance and the planned implementation of this program, including FDA's initial set of requests for quality metrics data.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.

This document announces the extension of temporary moratoria on the enrollment of new ambulance suppliers and home health agencies, subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection pertaining to the collection of tuberculosis-related information from United States Panel Physicians.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Analytical Procedures and Methods Validation for Drugs and Biologics.'' This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on ``Analytical Procedures and Methods Validation'' and the 1987 FDA guidance for industry on ``Submitting Samples and Analytical Data for Methods Validation.'' This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

The Food and Drug Administration (FDA or we) is reopening, as to specific documents, the comment period regarding our proposed rule to revise the Nutrition Facts and Supplement Facts labels. We are reopening the comment period for 60 days for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats.