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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers." FDA is issuing this revised draft guidance to address questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). In conjunction with the enactment of the Biosimilar User Fee Amendments of 2022 (BsUFA III), FDA agreed to publish a draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products, as described in the document titled "Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027." The revised draft guidance is consistent with this commitment and replaces the draft guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers" issued on February 4, 2020.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

In compliance with the Paperwork Reduction Act of 1995, HRSA 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 the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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 or Agency) is withdrawing approval of 23 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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 a generic clearance to collect information to support social and behavioral research used by FDA about drug products.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Direct Reading Methodologies, Sensors, and Robotics Technology Assessment in Lab/Simulator-based Settings. The proposed data collection will allow NIOSH to assess the safety and health considerations of these rapidly changing direct reading methods, sensor, and robotics technologies.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluation of HIV Self-Testing and Clinical Testing Guidelines Implementation. This project is designed to collect data from HIV healthcare providers, working in various settings, on the awareness and uptake of HIV-related guidelines.

The Office of Community Services (OCS), Administration for Children and Families (ACF), requests an approval of the Community Services Block Grant (CSBG) Model Tribal Plan.

This notice announces the dates and times of the virtual Healthcare Common Procedure Coding System (HCPCS) public meeting to be held from May 28, 2024, through May 30, 2024, to discuss CMS' preliminary coding, Medicare benefit category, and payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non-biological items and services, as well as how to register for those meetings.

HRSA is updating income levels used to identify a "low-income family" for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in titles III, VII, and VIII of the Public Health Service Act. HHS periodically publishes in the Federal Register low-income levels to be used by institutions receiving grants or cooperative agreement awards to determine eligibility for programs providing training for disadvantaged individuals, individuals from disadvantaged backgrounds, or individuals from low-income families.