Department of Health and Human Services August 16, 2021 – Federal Register Recent Federal Regulation Documents
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Prescription Drug User Fee Rates for Fiscal Year 2022
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products, and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2022.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut; Reopening Comment Period
The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled ``International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut'' that appeared in the Federal Register of July 23, 2021. The Agency is taking this action to allow interested persons additional time to submit comments. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The HRSA Community-Based Outreach Reporting Module, OMB # 0906-0064, Extension
HRSA requests an extension to continue data collection for the Community-Based Workforce for COVID-19 Vaccine Outreach Programs (CBO Programs) (OMB # 0906-0064). 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.
Agency Information Collection Request; 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of proposed extensions of collections for public comment.
Needs and Challenges in Personal Protective Equipment (PPE) Use for Underserved User Populations; Extension of Comment Period
On June 24, 2021, NIOSH opened a notice to request information on the Needs and Challenges in Personal Protective Equipment (PPE) Use for Underserved User Populations. Written comments were to be received by August 23, 2021. NIOSH is extending the public comment period to October 15, 2021.
Countermeasures Injury Compensation Program: Smallpox Countermeasures Injury Table
HHS is establishing the Smallpox Countermeasures Injury Table (Table) as authorized by the Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). Through this final rule, the Secretary of the U.S. Department of Health and Human Services (Secretary) adds the Smallpox Countermeasures Injury Table to the agency's regulations. The Table includes a list of covered smallpox countermeasures, required time intervals for the first symptom or manifestation of onset of injuries, and the accompanying Qualifications and Aids to Interpretation (QAI), which set forth definitions and other requirements necessary to establish Table injuries.
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