Department of Health and Human Services July 11, 2019 – Federal Register Recent Federal Regulation Documents
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Harmonizing Compendial Standards With Drug Application Approval Using the United States Pharmacopeial Convention Pending Monograph Process; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.''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.
Using the Inactive Ingredient Database; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Using the Inactive Ingredient Database.'' This draft guidance describes FDA's Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products. It is intended to give applicants a clearer understanding of the information provided in the IID and its terminology.
Allergenic Products Advisory Committee; Notice of Meeting; Correction
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.
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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' This proposed information collection was previously published in the Federal Register on May 1, 2019 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Live Case Presentations During Investigational Device Exemption Clinical Trials; Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff; Availability
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.
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory- committees/heritable-disorders/.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Children's Hospitals Graduate Medical Education Payment Program, OMB No. 0915-0247, Extension
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.
New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
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.
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