Department of Health and Human Services July 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration is announcing the cancellation of a public workshop entitled ``Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients'' that was previously scheduled for August 8, 2019, from 8:30 a.m. to 4:30 p.m. This public workshop was announced in the Federal Register of May 2, 2019. The meeting has been cancelled due to unforeseen changes in the adenovirus drug development landscape.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Population Pharmacokinetics.'' This revised draft guidance assists sponsors in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use and includes FDA's current thinking on the data and model requirements for population PK analyses submitted as part of new drug applications (NDAs) and biologic license applications (BLAs). The revised draft guidance also provides expectations regarding the format and content of the population PK report as well as any labeling recommendations resulting from such analyses.

The Administration for Children and Families (ACF) is requesting a three year extension of the form National Medical Support Notice (NMSN) Part A (OMB #0970-0222 expiration 8/31/2019). Changes were made to the form based on comments received during the 60 day Notice.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA.

HHS gives notice of a decision to designate a class of employees from the Idaho National Laboratory in Scoville, Idaho, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.'' This guidance assists applicants (or drug substance master file (MF) holders referenced in an application) in the initiation of either revisions to an existing monograph(s) or development of a new monograph(s) under the United States Pharmacopeial Convention Pending Monograph Process (USP-PMP) during FDA's evaluation of a drug substance master file or drug product application. This guidance describes the process that allows for the revision of compendial standards that are harmonized with the approved quality and labeling requirements for a drug product application.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Allergenic Products Advisory Committee; Notice of Meeting'' that appeared in the Federal Register of June 24, 2019. The document announced a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The document was published with the incorrect name of the committee in the Agenda portion of the notice. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.'' The purpose of this guidance is to provide institutional review boards (IRBs), industry, clinical investigators, and FDA staff with factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an investigational device exemption (IDE) application. This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation.

In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, 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.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revise the animal drug regulations for tolerances for residues of approved new animal drugs. This final rule is necessary to standardize, simplify, and clarify the determination standards of tolerances and provide definitions for key terms. This final rule will enhance understanding of tolerance determination and improve the overall readability of the relevant regulations.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Risk Evaluation and Mitigation Strategies: Modifications and Revisions.'' This guidance provides information on how FDA will define and process submissions for modifications and revisions of risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications or revisions of the REMS. The guidance also provides instructions to application holders related to procedures for submission of REMS modifications and revisions to FDA as well as different timeframes for FDA's review of and action on such changes. The definitions of REMS modifications and revisions apply to all types of REMS. This guidance updates the guidance of the same name, issued April 7, 2015, including finalizing the portion that sets forth the submission procedures for REMS revisions.

This document corrects the information provided for [Document Identifier: CMS-10328] titled ``Medicare Self-Referral Disclosure Protocol.''

NIOSH announces the availability of Technical Report: The NIOSH Occupational Exposure Banding Process for Chemical Risk Management.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Proposed Revision and solicits comments on the information collection requirements related to ACL's Chronic Disease Self-Management Education grant program.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs.'' This public meeting and request for comments is intended to support FDA guidance development as required by the Animal Drug and Animal Generic Drug User Fee Amendments of 2018. The topics to be discussed will inform the development of guidance to assist sponsors in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is seeking comments from stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers.