Department of Health and Human Services 2024 – Federal Register Recent Federal Regulation Documents

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 a revision of the currently approved information collection project: "The AHRQ Safety Program for Telemedicine: Improving the Diagnostic Process and Improving Antibiotic Use." In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). This meeting is open to the public. The meeting will be webcast live via the World Wide Web.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling." This guidance is intended to assist new drug application (NDA) and abbreviated new drug application (ANDA) applicants in submitting an accurate and complete composition statement in their applications and corresponding statement of ingredients in the labeling, when applicable. This guidance describes best practices for writing the composition statement and corresponding statement of ingredients in labeling. This guidance recommends how applicants can provide complete information with the goal of minimizing the number of assessment cycles and communications that are necessary for approval, as well as ensuring product labels are written clearly.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #120 entitled "Veterinary Feed Directive Regulation Questions and Answers." This revised guidance document will aid industry in complying with the requirements of the veterinary feed directive (VFD) regulation.

This notice acknowledges the receipt of an application from the National Association of Boards of Pharmacy (NABP) for continued approval by the Centers for Medicare & Medicaid Services (CMS) of NABP's national accrediting organization program for suppliers providing home infusion therapy (HIT) services and that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, CMS will publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled "Electronic Records: Electronic Signatures" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or we) is reopening the comment period for the proposed rule, "Color Additive Certification; Increase in Fees for Certification Services," which published in the Federal Register of November 2, 2022. We are taking this action to add supporting information to the administrative record and to adjust the record to reflect the same cost and benefits figures that were published in the preliminary regulatory impact analysis. We are reopening the comment period for 30 days specifically to invite public comments on the new information being added to the administrative record.

HRSA's Federal Office of Rural Health Policy (FORHP) utilizes clear, consistent, and data-driven methods of defining rural areas in the United States for the purposes of determining eligibility for its rural health grant programs. FORHP monitors ongoing national research and, as appropriate, considers updates to its definition. Because access to needed health care is likely to be reduced when roads are most difficult to traverse, with this notice, FORHP proposes to modify the definition of rural areas by integrating the new Road Ruggedness Scale (RRS) released in 2023 by the Economic Research Service (ERS) of the U.S. Department of Agriculture, which characterizes topographic variability, or ruggedness, of roads. This proposal does not impact rural areas included in the current FORHP definition. This notice seeks public comment on FORHP's proposal. This notice also includes a technical clarification explaining how FORHP will use Census data to identify outlying Metropolitan Statistical Area counties that qualify as rural in future updates given the U.S. Census Bureau's 2020 Census terminology changes that removed the categories of Urban Clusters and Urbanized Areas.

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene.

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 (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 draft guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status.

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 (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 invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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.

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.