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

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CIBINQO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), in the Department of Health and Human Services, announces an opportunity for the public to provide information about approaches to assess and control the hazards of wildland fire smoke to outdoor workers. Wildland fire smoke is a complex mixture of potentially toxic gases and particles that can vary depending on factors in the wildland or wildland urban interface environment, such as weather, fire behavior, and the type of materials or vegetation burning. Because of this, outdoor workers may be exposed to varying types and amounts of compounds in wildland fire smoke throughout their work shift or during different fire events and job tasks. NIOSH is seeking information to develop a hazard review document that summarizes the scientific literature about the health effects from exposures to wildland fire smoke and provides recommendations to protect outdoor workers.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PYRUKYND and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human drug product.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. The information collection activities provide a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Federal Government's commitment to improving service delivery.

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 the draft guidance entitled ``Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.'' This draft guidance proposes select updates to the final guidance ``Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.'' This draft guidance, when finalized, will identify the information FDA generally considers to be necessary for cyber devices to support obligations under the new amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) for ensuring cybersecurity of devices. This draft guidance is not final nor is it for implementation at this time.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products.'' This draft guidance provides recommendations to applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for nonprescription drug products on documenting minor labeling changes in the next annual report and provides examples of minor labeling changes that may be submitted in an annual report. The recommendations in this draft guidance address the types of minor labeling changes that may be appropriate to submit in an annual report to ensure that consumers have timely access to the most current labeling for a nonprescription drug product to ensure the product's safe and effective use. We anticipate that these recommendations may assist industry in understanding the circumstances in which it would be appropriate to document minor changes in the applicant's next annual report rather than submitting a prior approval supplement or ``changes being effected'' supplement, thereby reducing burden on industry and FDA.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAURISMO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed revision for the information collection requirements related to the National Survey of Older Americans Act Participants.

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 the information collection provisions of FDA's procedures for early food safety evaluation and consultations for new plant varieties intended for food use, including biotechnology-derived food plants.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Phytolon Ltd., proposing that the color additive regulations be amended to provide for the safe use of beetroot red for the coloring of foods generally in amounts consistent with current good manufacturing practice.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LIGHT ADJUSTABLE LENS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) is proposing to revise the requirements for the content and format of labeling for approved or conditionally approved new animal drugs to provide for a more comprehensive set of requirements in one location in the Code of the Federal Register (CFR). As part of this revision, certain current requirements would be updated and moved, and certain obsolete requirements would be removed. The proposed requirements would apply to the labeling of prescription and over-the-counter (OTC) new animal drugs, as well as new animal drugs for use in animal feeds.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues regarding blood and blood products. At this meeting the Committee will consider strategies to reduce the risk of transfusion-transmitted malaria by testing blood donations from donors at risk of malaria exposure. The meeting will be open to the public. FDA is establishing a docket for public comment on this topic.