Energy Policy and New Uses Office, Agriculture Department July 23, 2015 – Federal Register Recent Federal Regulation Documents
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Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Julia Bitzegeio, Ph.D., Aaron Diamond AIDS Research Center: Based on the Respondent's admission, an assessment conducted by the Aaron Diamond AIDS Research Center (ADARC), and analysis conducted by ORI in its oversight review, ORI found that Dr. Julia Bitzegeio, former Postdoctoral Fellow, ADARC, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI078788, R21 AI093255, and R37 AI064003. ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in one (1) publication, two (2) unfunded grant applications, and one (1) unpublished manuscript: Journal of Virology 87:3549-3560, 2013 (hereafter referred to as ``JVI 2013'').
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices; Correction
The Food and Drug Administration is correcting a notice entitled ``Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices'' that appeared in the Federal Register of June 12, 2015 (80 FR 33524). The document announced 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 document inadvertently contained inaccurate information regarding communications with industry, including inaccurate contact information. This document corrects that error.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Intent To Review a Study Data Reviewer's Guide Template
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is establishing a public docket to collect comments related to a proposed Study Data Reviewer's Guide (SDRG) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non- profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SRDG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDRG template for regulatory submissions.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sun Protection Factor Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products
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.
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 30, 2015 (80 FR 37273). The document announced the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The document was published with an incorrect table title and contents. This document corrects those errors.
Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' This draft guidance is intended to provide FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis.
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