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

The Food and Drug Administration (FDA or we) is requesting comments and scientific data and information that would assist us in identifying and evaluating intervention measures that might have an effect on the presence of bacterial pathogens in cheeses manufactured from unpasteurized milk. We are taking this action in light of scientific data on potential health risks associated with consumption of cheese made from unpasteurized milk.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs.'' This draft guidance has been developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), and/ or abbreviated new drug applications (ANDAs), as appropriate, for immediate-release (IR) tablets and capsules that contain highly soluble drug substances. The draft guidance is intended to define when a standard release test and criteria may be used in lieu of extensive method development and specification-setting exercises. When final, this guidance will supersede the guidance for industry on ``Dissolution Testing of Immediate Release Solid Oral Dosage Forms'' (August 1997) for biopharmaceutics classification system (BCS) class 1 and 3 drug substances that meet the criteria in this draft guidance. For class 2 and 4 drug substances, applicants should still refer to the August 1997 guidance mentioned previously.

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 HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or 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.samhsa.gov/workplace.

The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for nontuberculous mycobacterial (NTM) lung infections. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of NTM lung infections on daily life and patient views on treatment approaches. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat NTM lung infections. In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat NTM lung infections. The input from this public meeting will help in developing topics for further discussion.

The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. This document establishes the fee rates for FY 2016.

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2016 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Amendments of 2013 (ADUFA III), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2016.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2016 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2016.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2016, which apply from October 1, 2015, through September 30, 2016. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2016, you should not submit a FY 2016 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2016 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2015, relating to the Medicare and Medicaid programs and other programs administered by CMS.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 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.