Department of Health and Human Services August 14, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
The Food and Drug Administration (FDA, Agency, or we) 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 the information collection provisions of existing FDA regulations concerning FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle.
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.
Findings of Research Misconduct
Findings of research misconduct have been made against Rahul Dev Jayant, Ph.D. (Respondent), Assistant Professor Pharmaceutical Sciences, School of Pharmacy, Texas Tech University Health Science Center (TTUHSC). Dr. Jayant engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), grant R03 DA044877. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on July 27, 2020, and are detailed below.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Office for the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311-Revision
In compliance with of the Paperwork Reduction Act of 1995, HRSA has 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.
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of July 23, 2020. The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.
Safety and Performance Based Pathway Device-Specific Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of two final device-specific guidance documents for the Safety and Performance Based Pathwayspecifically, ``Cutaneous Electrode for Recording PurposesPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff'' and ``Conventional Foley CathetersPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled ``Safety and Performance Based Pathway.''
Advisory Committee on Immunization Practices
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.
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