Department of Health and Human Services February 23, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: https://www.dhhs.gov/ ohrp/sachrp-committee/meetings/.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Annual Long-Term Care Ombudsman Report Known as the National Ombudsman Reporting System (NORS) and Instructions (OMB No: 0985-0005)
The Administration for Community Living/Administration on Aging (ACL/AoA) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the Long-Term Care Ombudsman Program (Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)).
Findings of Research Misconduct
Findings of research misconduct have been made on the part of Colleen T. Skau, Ph.D., former postdoctoral fellow in the Cell Biology and Physiology Center, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Dr. Skau engaged in research misconduct in research supported by NHLBI, NIH. The administrative actions, including three (3) years of supervision, were implemented beginning on January 25, 2018, and are detailed below.
Patient Safety Organizations: Expired Listing for Quality Solutions
The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. The listing for Quality Solutions has expired and AHRQ has delisted the PSO accordingly.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-New Drug Application 206545
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZYDELIG based on new drug application (NDA) 206545 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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