Department of Health and Human Services December 14, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 6 of 6
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
340B Drug Pricing Program; Administrative Dispute Resolution Regulation
The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The final rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution (ADR) process.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS (Secretary), through the Assistant Secretary for Health, on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary on October 1, 2002. OHRP is seeking >nominations of qualified candidates to fill four positions on the Committee membership that will be vacated during the 2021 and 2022 calendar years.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
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.
Proposed Information Collection Activity; Refugee Assistance Program Estimates: CMA-ORR-1
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is requesting a 1-year extension of the form ORR-1, Cash and Medical Assistance (CMA) Program Estimates (OMB #0970-0030, expiration 2/28/2021). There are no changes requested to the form or instructions.
Confidentiality of Substance Use Disorder Patient Records
This final rule amends the Substance Abuse and Mental Health Services Administration's (SAMHSA) regulation governing the Confidentiality of Substance Use Disorder Patient Records, to clarify one of the conditions under which a court may authorize disclosure of confidential communications made by a patient to a part 2 program as defined in this regulation. This change to the regulation is intended to clarify that a court has the authority to permit disclosure of confidential communications when the disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, such as one that directly threatens loss of life or serious bodily injury, where the extremely serious crime was allegedly committed by either a patient or an individual other than the patient.
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