Department of Health and Human Services August 10, 2021 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-17045
Type: Notice
Date: 2021-08-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Center for Scientific Review; Notice of Meeting
Document Number: 2021-17043
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, National Institutes of Health
Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments
Document Number: 2021-17041
Type: Notice
Date: 2021-08-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between September 2, 2020, and September 2, 2021, on FDA's website but not presented at the September 17, 2021, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2021 Performance Review Board (PRB)
Document Number: 2021-17039
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2021 Performance Review Board.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2021-17012
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Multi-Domain Amphipathic Helical Peptide for Use as A Human Therapeutic in Patients With Atherosclerotic Cardiovascular Disease, Including Patients Undergoing Cardiovascular Surgery Who Are at risk of Acute Kidney Injury
Document Number: 2021-17011
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung, and Blood 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 Phyxius Therapeutics, Inc., a start-up company incorporated as a C corporation under the laws of the state of Delaware, to practice the inventions covered by the patent estate listed in the Supplementary Information section of this notice. This is a first notice intended to apprise the public of a change in prospective licensee of the subject intellectual property rights in the stated field of use.
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-16984
Type: Notice
Date: 2021-08-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Submission for OMB Review; Survey of the National Survey of Child and Adolescent Well-Being (NSCAW) Adopted Youth, Young Adults, and Adoptive Parents (0970-0555)
Document Number: 2021-16979
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for an extension with no changes to a one-time study to examine familial outcomes 8 years or more after a child's adoption from the child welfare system. The primary objective of this study is to estimate the prevalence of instability events that occur in families who have adopted children who have exited the foster care system. The second objective is to understand risk and protective factors associated with post adoption instability. Office of Management and Budget (OMB) approval expires September 30, 2021, and this request is to extend approval to allow for the completion of data collection.
Notice of Final Issuance on the Administration for Native Americans Program Policies and Procedures
Document Number: 2021-16959
Type: Notice
Date: 2021-08-10
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to section 814 of the Native American Programs Act of 1974 (NAPA), as amended, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. On February 19, 2021, ANA published a Notice of Public Comment (NOPC) in the Federal Register regarding its proposed interpretive rules and general statements of policy relative to its six FY 2021 Funding Opportunity Announcements (FOAs): Environmental Regulatory Enhancement (HHS-2021-ACF-ANA-NR-1907); Native American Language Preservation and MaintenanceEsther Martinez Immersion (HHS-2021-ACF-ANA-NB-1958); Native American Language Preservation and Maintenance (HHS-2021-ACF-ANA-NL-1924); Social and Economic Development Strategies (HHS-2021-ACF-ANA-NA-1906); Social and Economic Development StrategiesAlaska (HHS-2021-ACF-ANA-NK-1902); and Social and Economic StrategiesGrowing Organizations (HHS-2021-ACF- ANA-NN-1918). This Notice of Issuance responds to the public comments received from the NOPC.
Most Favored Nation (MFN) Model
Document Number: 2021-16886
Type: Proposed Rule
Date: 2021-08-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule proposes to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, Federal Register.