Department of Health and Human Services December 10, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Viral Hepatitis Action Plan-Community Stakeholder Activities Request for Information
The Department of Health and Human Services (HHS) is seeking public input from state and local governments, community based organizations, academic institutions, professional organizations, advocacy groups, private industry, and other non-federal stakeholders on activities undertaken in 2014-2015 in support of the goals of the national Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis.
Agency Information Collection Activities: Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection involving interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug applications (NDAs) and original biologics license applications (BLAs) to FDA under the Program for Enhanced Review Transparency and Communication (the Program) during fiscal years (FYs) 2013-2017. The Program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for FYs 2013-2017.
Determination of Regulatory Review Period for Purposes of Patent Extension; VERAFLOX
The Food and Drug Administration (FDA) has determined the regulatory review period for VERAFLOX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; SIRTURO
The Food and Drug Administration (FDA) has determined the regulatory review period for SIRTURO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; FULYZAQ
The Food and Drug Administration (FDA) has determined the regulatory review period for FULYZAQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELIQUIS
The Food and Drug Administration (FDA) has determined the regulatory review period for ELIQUIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ARGUS II VISUAL STIMULATION SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for ARGUS II VISUAL STIMULATION SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Girija Dasmahapatra, Ph.D., Virginia Commonwealth University: Based on the report of an inquiry conducted by Virginia Commonwealth University (VCU), the willingness of the Respondent to settle this matter, and analysis conducted by ORI in its oversight review, ORI found that Dr. Girija Dasmahapatra, former Instructor, Department of Internal Medicine, VCU, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA063753, R01 CA093738, and R01 CA100866. ORI found that false data were included in the following eleven (11) publications:
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
