Department of Health and Human Services March 18, 2022 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), 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 Generic Clearance for Lyme and other Tickborne Diseases (TBD) Knowledge, Attitudes, and Practices (KAP) Surveys. This data collection involves the administration of a set of surveys designed to understand KAPs related to prevention of Lyme and other TBDs and to inform implementation of future TBD prevention interventions.

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.