Department of Health and Human Services June 22, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 12, 2019. The document announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The document erroneously included ANDA 077736 for Polyethylene Glycol 3350 Powder for Oral Solution, 17 grams/scoopful, held by Breckenridge Pharmaceutical, Inc. (Breckenridge). This document corrects that error.

HRSA announces the award of a supplemental award of approximately $330,000 per year to the Education Development Center (EDC) for the Home Visiting Collaborative Improvement and Innovation Network 2.0 (HV CoIIN 2.0) for fiscal years (FY) 2020, 2021 and 2022. The supplement will allow the recipient to build a continuous quality improvement (CQI) health equity framework for the Maternal, Infant and Early Childhood Home Visiting Program (MIECHV).

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Emmaus Medical Inc. located in 21250 Hawthorne Boulevard, Suite 800, Torrance, CA, 90503.

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.