Department of Health and Human Services April 5, 2023 – Federal Register Recent Federal Regulation Documents
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Solicitation of Nominations for Appointment to the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA)
The Office of the Assistant Secretary for Health (OASH) is seeking nominations for membership on the Advisory Committee on Blood and Tissue Safety and Availability (referred to as ACBTSA and/or the Committee). This announcement is to solicit nominations of qualified candidates to five public member positions on the ACBTSA. The ACBTSA is a federal advisory committee within the U.S. Department of Health and Human Services (HHS). Qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members are invited to serve on the Committee for up to four-year terms. The Committee was established to provide advice to the Secretary on a range of policy issues related to blood, blood products, and tissues. The functions of the Committee are solely advisory in nature.
Meeting of the Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention National Advisory Council
Notice is hereby given for the meeting on April 25, 2023, of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC). The meeting is open to the public and can also be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings. The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of August 8, 2022; presentations on substance use prevention priorities and CSAP program developments; Council discussion and public comments.
Laboratory Recommendations for Syphilis Testing in the United States
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the proposed Laboratory Recommendations for Syphilis Testing in the United States. The proposed recommendations for syphilis testing include laboratory-based tests, point-of-care tests, processing of samples, and reporting of test results. The recommendations are intended to aid laboratorians and clinicians in the diagnosis of syphilis. These proposed recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients in the United States.
Human User Safety in New and Abbreviated New Animal Drug Applications; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #278 (GFI #278) entitled ``Human User Safety in New and Abbreviated New Animal Drug Applications.'' Human User Safety (HUS) is an integral component of the overall safety evaluation of proposed new animal drugs. FDA is issuing this guidance to clarify the current approaches and recommendations of FDA's Center for Veterinary Medicine (CVM) for HUS assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The National Health Service Corps and Nurse Corps Interest Capture Form-Revision
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.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-October Through December 2022
This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from October through December 2022. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Request for Nominations to the Advisory Council on Alzheimer's Research, Care, and Services
The Secretary of HHS established the Advisory Council on Alzheimer's Research, Care, and Services to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Secretary signed the charter establishing the Advisory Council on May 23, 2011. HHS is soliciting nominations for six (6) new non-federal members of the Advisory Council to replace the six (6) members whose terms will end September 30, 2023. Nominations should include, at a minimum, the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
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