Department of Health and Human Services March 16, 2021 – Federal Register Recent Federal Regulation Documents

The Office of Family Assistance (OFA), Administration for Children and Families, is requesting a 3-year extension of the form ACF-4125: Annual Report on Children in Foster Homes and Children in Families Receiving Payment in Excess of the Poverty Income Level from a State Program Funded Under Part A of Title IV of the Social Security Act (OMB #0970-0004, expiration 3/21/2021). There are no changes requested to the form.

The Administration for Children and Families (ACF) is requesting a revision to the Social Services Block Grant (SSBG) Post- Expenditure Report, Pre-Expenditure Report, and Intended Use Plan (OMB #0970-0234, previously titled, ``Social Services Block Grant (SSBG) Post-Expenditure Report''). ACF is proposing to expand the information collection to include the collection of states' Intended Use Plans and retitle the information collection to clarify the role of the Pre- Expenditure Report.

The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for OCS LUNG SYSTEM 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 medical device.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Potential Medication Error Risks with Investigational Drug Container Labels.'' This public meeting is being convened and supported by a partnership between the Reagan-Udall Foundation and FDA. The purpose of the public meeting is to solicit input from stakeholders (e.g., sponsors, clinical sites, entities that supply or otherwise label investigational drugs) on the risk of medication errors potentially related to the content and format of information on investigational drug container labels, the prevalence and nature of such errors, and to gather information on practices that minimize the potential for medication errors.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 19 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

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 (PRA).

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types.''

The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled ``Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of December 9, 2020. The Agency is taking this action to allow interested persons additional time to submit comments.