Department of Health and Human Services November 14, 2019 – Federal Register Recent Federal Regulation Documents

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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop to convene a discussion on incorporating clinical outcome assessments (COAs) into endpoints for regulatory decision making. This workshop will inform development of patient- focused drug development guidance as required by the 21st Century Cures Act (Cures Act) and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Amendments (PDUFA VI). The Agency will publish a discussion document approximately 1 month before the workshop date. FDA is interested in seeking information and comments on the approaches proposed in the discussion document, as well as input on examples that could be illustrated in the forthcoming draft guidance, where approaches proposed in the discussion document have been successfully applied.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR have been provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this Notice has closed.

Findings of research misconduct have been made against Dr. Sudhakar Yakkanti (Respondent) (formerly named Sudhakar Akulapalli),\1\ former staff scientist and Director of the Cell Signaling, Retinal & Tumor Angiogenesis Laboratory, Boys Town National Research Hospital (BTNRH). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically, National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA143128, National Eye Institute (NEI), NIH, grants R01 EY018179 and R01 EY16695, and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grants R01 DK055000, R01 DK055001, R01 DK062987, and R01 DK051711. The administrative actions, including debarment for a period of five (5) years, were implemented beginning on August 24, 2019, and are detailed below.