Department of Health and Human Services January 2023 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 277
Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance describes FDA's regulatory and enforcement priorities regarding compounding certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.
National Institutes of Health Loan Repayment Programs
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is updating the existing regulation for NIH Loan Repayment Programs (LRPs) to reflect the consolidation of NIH LRPs into two programs, the Intramural Loan Repayment Program (for NIH researchers) and the Extramural Loan Repayment Program (for non-NIH researchers); the direct authority of the NIH Director to administer the NIH LRPs (formerly the duty of the Secretary, HHS); and the increase in the annual loan repayment amount from a maximum of $35,000 to a maximum of $50,000.
Poornanand Palaparty; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA, Agency, or we) is denying Poornanand Palaparty's (Dr. Palaparty's) request for a hearing and issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Palaparty for 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Palaparty was convicted of a misdemeanor under Federal law for causing the introduction or delivery for introduction into interstate commerce of drugs that were misbranded under the FD&C Act. Additionally, FDA finds that the type of conduct underlying Dr. Palaparty's conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Palaparty's debarment, FDA considered the relevant factors listed in the FD&C Act. Dr. Palaparty failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Meeting Notice Correction
HRSA published a document in the Federal Register of December 20, 2022, concerning a meeting of the National Advisory Council on the National Health Service Corps (NACNHSC). The document referenced the incorrect year. The meeting date erroneously stated a meeting will occur in November 2022 when it should state November 2023.
Mark Moffett; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Mark Moffett and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Mr. Moffett from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Moffett was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Mr. Moffett was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Moffett submitted a request for hearing but failed to file with the Agency information and analysis sufficient to create a basis for a hearing.
National Biodefense Science Board; Public Meeting
The National Biodefense Science Board (NBSB or the Board), authorized under Section 319M of the Public Health Service (PHS) Act, as added by Section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by Section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act, will hold a virtual, public meeting on March 9, 2023. The NBSB provides expert advice and guidance to the Department of Health and Human Services (HHS) regarding current and future chemical, biological, radiological, and nuclear threats, as well as other matters related to disaster preparedness and response. The Administration for Strategic Preparedness and Response (ASPR) manages and convenes the NBSB on behalf the Secretary of HHS. The NBSB public meeting will beginning at 11:00 a.m. Eastern time. A detailed agenda and Zoom registration instructions will be available on the ASPR website. Procedures for Public Participation: The link to pre-register for the public meeting will be posted on the meeting website. The online meeting, which use a webinar format, will include American Sign Language interpretation and live captioning. Members of the public may provide written comments or submit questions at any time via email to NBSB@hhs.gov. Additionally, the NBSB invites stakeholders to request up to seven minutes to address the Board in-person during the meeting. The Board wishes to hear from experts from relevant biomedical, biodefense, or health industries; faculty or researchers at academic institutions; health professionals, health system experts, or those who work in health care consumer organizations; or experts in state, Tribal, territorial, or local government agencies. Requests to provide remarks to the NBSB during the public meeting must be sent to NBSB@hhs.gov by March 2, 2023. In that request, please provide the speaker's name, title, position, and organization, with a brief description of the topic that they will address. Requests to speak to the Board will be approved in consultation with the Board Chair and based on time available during the meeting.
Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry.'' The draft guidance, when finalized, would establish the following action levels for lead in processed food intended for babies and young children: 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats; 20 ppb for root vegetables (single ingredient); and 20 ppb for dry cereals.
Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of October 28, 2022, for the final rule that appeared in the Federal Register of September 27, 2022, and that amended the color additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules.
Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra; Notification
The Food and Drug Administration (FDA or Agency) is publishing this notification in light of the recent decision by the U.S. Court of Appeals for the Eleventh Circuit in Catalyst Pharms., Inc. v. Becerra. The Catalyst decision addressed the orphan-drug exclusivity provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Orphan Drug Act and subsequent amendments, and concluded that FDA's approval of Jacobus Pharmaceutical Company's (Jacobus's) drug (the drug at issue in the litigation) must be set aside. Consistent with the court's decision, FDA has set aside its approval of Jacobus's drug. This notification announces that, at this time, while complying with the court's order in Catalyst, FDA intends to continue to apply its regulations tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved to matters beyond the scope of that order.
Determination of Regulatory Review Period for Purposes of Patent Extension; BYFAVO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BYFAVO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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.
Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Technical Electronic Product Radiation Safety Standards Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Technical Electronic Product Radiation Safety Standards Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 24, 2024.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Ryan White HIV/AIDS Program Parts A and B Unobligated Balances and Rebate Addendum Tables
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.
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.'' This guidance outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research; general quality considerations for developing human drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, intermediates, drug substances, and drug products to determine their control status. This guidance is being issued to support clinical research for development of cannabis and cannabis-derived human drugs. This guidance finalizes the draft guidance of the same title issued on July 22, 2020.
Color Additive Certification; Increase in Fees for Certification Services; Reopening of the Comment Period
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 in response to a request from stakeholders to extend the comment period to allow additional time for interested parties to collect, analyze, and incorporate data to develop comments for this proposed rule.
Agency Information Collection Request. 30-Day Public Comment Request
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.
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