Department of Health and Human Services March 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``E18 Genomic Sampling and Management of Genomic Data.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance focuses on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data in clinical studies. The guidance is intended to provide harmonized principles of genomic sampling and of management of genomic data in clinical studies to foster interactions amongst stakeholders, including drug developers, investigators, and regulators; and to encourage genomic research within clinical studies.

The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification from NCH Healthcare System of the voluntary relinquishment of its status as a PSO and has delisted it accordingly.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Standardization of Data and Documentation Practices for Product Tracing.'' The draft guidance elaborates on the standards for the interoperable exchange of transaction information, transaction history, and transaction statements (product tracing information) provided under the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is intended to assist trading partners in standardizing the data contained in the product tracing information that trading partners must provide, capture, and maintain under the FD&C Act. In addition, this guidance includes recommendations for documentation practices that a trading partner can use to meet its product tracing obligations, including in situations where a trading partner is permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required.

The Food and Drug Administration (FDA or the Agency) is reopening a docket for public comment on the susceptibility test interpretive criteria for antibacterial and antifungal drugs provided by FDA on its Susceptibility Test Interpretive Criteria web page (Interpretive Criteria web page) established on December 13, 2017. On the Interpretive Criteria web page, FDA recognizes, in whole or in part, susceptibility test interpretive criteria standards established by Standard Development Organizations (SDOs) and lists other susceptibility test interpretive criteria identified by FDA outside of the SDO process.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1).'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance amends the guidance entitled ``E6 Good Clinical Practice: Consolidated Guidance (E6(R1))'' to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The guidance is intended to improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results.

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 the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER), formerly the Questionnaire Design Research Laboratory (QDRL), generic clearance request, which encompasses general questionnaire development, pre- testing, and measurement-error reduction activities to be carried out in 2018-2020.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services, has been renewed for a 2-year period through February 1, 2020.