Department of Health and Human Services March 2023 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,000,000, for Year 1 funding to the Public Health Institute of Malawi (PHIM). The award will allow PHIM to efficiently execute Malawi's essential public health functions at national and subnational levels and sustain gains achieved for HIV.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the award of approximately $10,000,000, for Year 1 funding to the Government of Botswana (GOB). The award will strengthen GOB capacity to develop and implement programmatic activities that orient the Ministry of Health (MOH) towards ensuring ownership, accountability, and capacity to manage a sustained HIV national response, decrease TB/HIV morbidity and mortality, and improve capacity to effectively respond to emerging diseases of public health interest.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

This final notice announces our decision to approve the Accreditation Commission for Health Care, Inc for continued recognition as a national accrediting organization for end stage renal disease facilities that wish to participate in the Medicare or Medicaid programs.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an information collection request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) plans to submit a generic information collection (GenIC) request under the umbrella generic: Generic Clearance for Financial Reports used for ACF Mandatory Grant Programs (0970-0510). This request is to include instructions for ORR Refugee Support Services grant recipients to provide supplemental financial information when submitting the already required Federal Financial Report (Standard Form (SF)-425), which is approved under Office of Management and Budget (OMB) number 4040-0014.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ESPEROCT 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.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during October, November, and December 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.

The Food and Drug Administration (FDA, Agency, or we) is announcing conforming changes to its guidances issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as required by the Consolidated Appropriations Act of 2022, which amended the term ``tobacco product'' in the FD&C Act to include products that contain nicotine from any source.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for JIVI 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.

Pursuant to Public Law 92-463, notice is hereby given of the meeting on April 25, 2023, of the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services National Advisory Council (CMHS NAC). The meeting is open to the public and will include consideration of the meeting minutes from the August 18, 2022, SAMHSA, CMHS NAC meeting; updates from the CMHS Director; a discussion from SAMHSA's Assistant Secretary; a discussion on Certified Community Behavioral Health Clinic; a discussion on School Based Mental Health Services; a discussion on Mental Health Block Grant; a discussion on Black Youth Suicide Prevention Activities; and a discussion on CMHS/SAMHSA Response to Disasters. The meeting will be held at SAMHSA, 5600 Fishers Lane, 5N54, Rockville, MD 20857. Attendance by the public will be limited to space available and will be limited to the open sessions of the meeting. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council. Presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making public comment must notify the contact person, Pamela Foote, CMHS NAC Designated Federal Officer (DFO) on or before April 14, 2023. Up to three minutes will be allotted for each public comment as time permits. Written comments received in advance of the meeting will be considered for inclusion in the official record. The open meeting session may also be accessed virtually. Please register on-line at https://snacregister.samhsa.gov, to attend on either on site or virtually, submit written or brief oral comments, or request special accommodations for persons with disabilities. To communicate with the CMHS NAC DFO please see the contact information below. Meeting information and a roster of Council members may be obtained by accessing the SAMHSA Committee website at https://www.samhsa.gov/about-us/advisory-councils/cmhs- national-advisory-council or by contacting the DFO. Council Name: SAMHSA's Center for Mental Health Services National Advisory Council. Date/Time/Type: April 25, 2023, 9 a.m. to 4:30 p.m. EDT, Open. Place: SAMHSA, 5600 Fishers Lane, Rockville, Maryland 20857. Contact: Pamela Foote, Designated Federal Officer, CMHS National Advisory Council, 5600 Fishers Lane, Rockville, Maryland 20857 (mail), Telephone: (240) 276-1279, Email: pamela.foote@samhsa.hhs.gov.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IC-8 APTHERA INTRAOCULAR LENS 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.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC or Board). This meeting is partially open to the public.

The Children's Bureau, the Administration for Children and Families (ACF), in the United States (U.S.) Department of Health and Human Services (HHS) is requesting a three-year extension of the National Child Abuse and Neglect Data System (NCANDS) collection (Office of Management and Budget (OMB) #0970-0424, expiration August 31, 2023). There are no changes requested to this data collection.

In compliance with of 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.

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.