Department of Health and Human Services January 25, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
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.
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