Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability entitled ``Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of June 4, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Submission for OMB Review; ORR-2 Quarterly Report on Expenditures and Obligations (OMB #0970-0407)
The Office of Refugee Resettlement (ORR) is requesting a three-year extension of the ORR-2 Quarterly Report on Expenditures and Obligations (OMB #0970-0407, expiration 8/31/2021). There are no changes requested to the form.
Prospective Grant of Exclusive Patent License: Improved Live-Attenuated Vaccine for Respiratory Syncytial Virus
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Codagenix, Inc. (Codagenix), having a place of business in Farmingdale, New York, U.S.A.
Medicaid Program; Reassignment of Medicaid Provider Claims
This proposed rule would reinterpret the scope of the general requirement that state payments for Medicaid services under a state plan must be made directly to the individual practitioner providing services, in the case of a class of practitioners for which the Medicaid program is the primary source of revenue. Specifically, this proposal, if finalized, would explicitly authorize states to make payments to third parties to benefit individual practitioners by ensuring health and welfare benefits, training, and other benefits customary for employees, if the practitioner consents to such payments to third parties on the practitioner's behalf.