Department of Health and Human Services December 8, 2021 – Federal Register Recent Federal Regulation Documents
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Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport
The Food and Drug Administration (FDA or Agency) is publishing an order setting forth the final determination of a petition requesting exemption from premarket notification (510(k)) requirements for the generic device type, powered patient transport, all other powered patient transport (product code ILK), classified as class II devices. These devices are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs. These devices do not include motorized three-wheeled vehicles or wheelchairs, and are distinct from the device type, powered patient transport, powered patient stairway chair lifts, which is classified separately within the same regulation (product code PCD). FDA is publishing this order in accordance with procedures established in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Health Information Technology Advisory Committee 2022 Schedule of Meetings
The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2022. See list of public meetings below.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; COVID-19 Provider Relief Programs Application and Attestation Portal, and Claims Reimbursement Submission Activities, OMB No. 0906-XXXX-NEW
In compliance with 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``AHRQ's National Nursing Home COVID-19 Coordinating Center.''
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Environmental Information and Documentation, OMB No. 0915-0324, Extension
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 Activities: Proposed Collection: Public Comment Request; Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-0044, Revision
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.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.'' This draft guidance provides FDA's recommendations on the chemistry, manufacturing, and controls (CMC) information needed to support an investigational new drug application (IND) submitted by a sponsor-investigator developing an individualized antisense oligonucleotide (ASO) drug product for a severely debilitating or life-threatening (SDLT) disease caused by a unique genetic variant affecting a small number of individuals (typically one or two).
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations; Draft Guidance for Sponsor-Investigators; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for sponsor-investigators entitled ``IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.'' FDA is publishing this draft guidance to provide sponsor-investigators (hereafter referred to as sponsors) who are interested in developing individualized antisense oligonucleotide (ASO) drug products for a rapidly progressive, severely debilitating, or life-threatening (SDLT) genetic disease (caused by a unique genetic variant or variants), with clinical recommendations for submission of investigational new drug applications (INDs). These recommendations specifically address the following clinical considerations: Ethical and human subject protection, diagnostic and genetic, dosing, administration, safety, and assessment of clinical response to treatment.
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