Department of Health and Human Services April 23, 2020 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-08651
Type: Notice
Date: 2020-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On Wednesday, April 15, 2020, the Centers for Medicare & Medicaid Services (CMS) published a notice entitled, ``Agency Information Collection Activities: Submission for OMB Review; Comment Request.'' That notice invited public comments on two separate information collection requests specific to document identifiers: CMS- 10716 and CMS-R-262. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled ``CMS Plan Benefit Package (PBP) and Formulary CY 2021.'' Form number CMS-R-262 (OMB control number 0938-0673).
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry; Extension of Comment Period
Document Number: 2020-08609
Type: Notice
Date: 2020-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability entitled ``Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry'' that appeared in the Federal Register of January 30, 2020. The Agency is taking this action to allow interested persons additional time to submit comments.
Notice of Interest Rate on Overdue Debts
Document Number: 2020-08564
Type: Notice
Date: 2020-04-23
Agency: Department of Health and Human Services, Office of the Secretary
Government-Owned Inventions; Availability for Licensing
Document Number: 2020-08562
Type: Notice
Date: 2020-04-23
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2020-08561
Type: Notice
Date: 2020-04-23
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of an Exclusive Patent License: Thio Compounds and Thalidomide Analogues for the Treatment of Neurological Diseases
Document Number: 2020-08560
Type: Notice
Date: 2020-04-23
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute on Aging and the National Cancer Institute, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to AevisBio, Inc. located in 814 W Diamond Ave., Suite 203, Gaithersburg, MD 20870.
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