Department of Health and Human Services July 9, 2021 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-14671
Type: Notice
Date: 2021-07-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives
Document Number: 2021-14655
Type: Notice
Date: 2021-07-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; AJOVY
Document Number: 2021-14652
Type: Notice
Date: 2021-07-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AJOVY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 biological product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificates
Document Number: 2021-14650
Type: Notice
Date: 2021-07-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation; Withdrawal
Document Number: 2021-14637
Type: Notice
Date: 2021-07-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Department of Health and Human Services (Department or HHS) is announcing the withdrawal of a notice published in the Federal Register on January 21, 2021, entitled ``Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation.'' HHS also withdraws the requests for proposals issued on its website on September 24, 2020, and revised on January 13, 2021, and ends the period for submission of proposals in response to the requests for proposals.
Proposed Collection; 30-Day Comment Request: Generic Clearance To Collect Stakeholder Feedback on the Research Domain Criteria (RDoC) Initiative, (NIMH)
Document Number: 2021-14630
Type: Notice
Date: 2021-07-09
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14617
Type: Notice
Date: 2021-07-09
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
Document Number: 2021-14250
Type: Proposed Rule
Date: 2021-07-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rulemaking also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rulemaking proposes to update requirements for the ESRD Quality Incentive Program (QIP), including a proposed measure suppression policy for the duration of the coronavirus disease 2019 (COVID-19) public health emergency (PHE) and as well as proposals to suppress individual ESRD QIP measures under that proposed measure suppression policy. This proposed rule also announces an extension of time for facilities to report September through December 2020 ESRD QIP data under our Extraordinary Circumstances Exception (ECE) policy due to CMS operational issues, and proposes to not score facilities or reduce payment to any facility in PY 2022. In addition, this proposed rule includes requests for information on topics that are relevant to the ESRD QIP. Further, this rule also proposes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries. Finally, this proposed rule includes several requests for information to inform payment reform under the ESRD PPS.