Department of Health and Human Services March 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is requesting comment on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange for the electronic submission of PQ/CMC data. This document provides draft design of Health Level 7 (HL7) Fast Health Interoperability Resources (FHIR) profiles that contain the data elements and terminologies associated with PQ/CMC subject areas and scoped to some of what is currently submitted in Module 3 of the electronic Common Technical Document (eCTD) submission. It is not intended to be comprehensive in covering all eCTD product quality information, only those concepts that were considered amenable to structuring and would bring value to the quality review process. The Agency is seeking comment on the mapping of the PQ/CMC data elements to the various FHIR Resources. This document should not be viewed as guidance, technical specification, or an implementation guide, as it is meant solely for comment. The FHIR mapping presented in this document is bound to the HL7 FHIR R5 draft release. As such, it is likely that some parts of the mapping presented in this document may change based on comments during the HL7 balloting and reconciliation process. However, since HL7 balloting has variable and extensive timelines, the Agency determined that it would be prudent to provide an early opportunity for comment that will inform final development of the exchange standard.

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.

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.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Assessment of Environmental Health and Land Reuse Certification Training. This certification is a joint collaboration between ATSDR and the National Environmental Health Association (NEHA) that is designed to increase participant awareness and knowledge, skills and feedback on environmental health and land reuse.

The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Generic Clearance for Disaster Information Collection Forms (OMB #0970-0476) and the five forms currently approved for ACF programs. There are no changes requested to the umbrella generic and no substantial changes to the currently approved forms.

Findings of research misconduct have been made against Shuo Chen, Ph.D. (Respondent), formerly a postdoctoral researcher, Department of Physics, University of California, Berkeley (UCB). Respondent engaged in research misconduct in research reported in a grant application submitted for U.S. Public Health Service (PHS) funds, specifically National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant application K99 NS116562-01. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on February 28, 2022, and are detailed below.

The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalty amounts in its regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015; adding references to new penalty authorities; and making technical changes to correct errors in the regulation.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. This notice publishes the OMUFA fee rates for FY 2022.

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 medical device accessory requests.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry.'' The draft guidance document provides recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, the guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application in order to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing, product testing, preclinical safety assessment, and clinical trial design.

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 an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting administrative supplements (in scope of the parent award) up to $249,999 (total costs) for the 166 CCBHC Expansion grant recipients funded in FY 2020 under the Certified Community Behavioral Health Clinic (CCBHC) Expansion (Title: CCBHC Expansion Grants, NOFO SM-20- 012, with a project end date of April 30, 2022) to cover unanticipated costs caused by the COVID-19 pandemic or related mitigation efforts that could not have been covered by rebudgeting existing funds. The supplemental funding is to assist CCBHC Expansion grant recipients that had unplanned administrative, staffing, labor, and other program costs due to the COVID-19 pandemic.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the webcast lines available. Check the CLIAC website on the day of the meeting for the web conference link https://www.cdc.gov/cliac. Time will be available for public comment.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Subcommittee for Dose Reconstruction Reviews (SDRR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below.

The Food and Drug Administration (FDA or we) is reopening the comment period for the draft Compliance Policy Guide entitled ``Compliance Policy Guide Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery ProductsDecomposition and Histamine'' that published in the Federal Register of December 27, 2021. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested parties to develop and submit data, other information, and comments before FDA begins work on the final guidance.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.