Department of Health and Human Services September 13, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements." This guidance describes FDA's enforcement policy for the final rule, "Tobacco Products; Required Warnings for Cigarette Packages and Advertisements," which established new required cigarette health warnings for cigarette packages and advertisements. The guidance is intended to assist entities required to comply with the rule.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $4,450,000, for Year 1 funding to Northwestern Provincial Health Office (NWPHO) in Zambia. The award will provide NWPHO with CDC Technical Assistance and financial support to maintain and sustain the province's overall oversight and quality assurance for the implementation of high-impact HIV combination prevention, treatment, and support services, including clinical, surveillance, and laboratory services as well as to identify and mitigate emerging disease threats for people living with HIV (PLHIV). Funding amounts for years 2-5 will be set at continuation.

The ACF, ACYF, CB, Division of Capacity Building announces the intent to award a within scope awarding agency-initiated non- competitive supplement with extension in the amount of up to $1,600,000, to the American Public Human Services Association for its affiliate the Association of Administrators of the Interstate Compact on the Placement of Children (AAICPC) in Washington, DC, for the further implementation and support nationally of the National Electronic Interstate Compact Enterprise (NEICE) system. The NEICE is an inter-jurisdictional electronic system to improve administrative efficiency in implementing the Interstate Compact on the Placement of Children (ICPC), a process that ensures safe and suitable interstate placements for children in foster care.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 21, 2024. The document announced the withdrawal of approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 22, 2024. The document indicated that FDA was withdrawing approval of the ANDA 076648 for nitrofurantoin (monohydrate/macrocrystals) capsules, 75 milligrams (mg) and 25 mg, held by Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Rd., East Windsor, NJ 08520; and the ANDA 090723 for duloxetine hydrochloride capsules, delayed-release pellets, Equivalent to (EQ) 20 mg base, EQ 30 mg base, and EQ 60 mg base, held by Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., 150 Motor Pkwy., Suite 401, 4th Floor, Rm. 430, Hauppauge, NY 11788. Before FDA withdrew the approval of these ANDAs, Aurobindo Pharma USA Inc., and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., informed FDA that they did not want the approval of the ANDAs withdrawn. Because Aurobindo Pharma USA Inc. and Marksans Pharma, Inc., U.S. Agent for Marksans Pharma Ltd., timely requested that approval of their respective ANDAs not be withdrawn, the approvals are still in effect. This notice corrects these errors.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.