Health Care Week in Review | Dr. Heidi Overton Nominated for FDA Commissioner; HHS Seeks Comment on Federal Vaccine Recommendations

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news. 

Regulations, Notices & Guidance

• On August 17, 2026, the Food and Drug Administration (FDA) released a notice entitled, Determining Whether to Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability. FDA is announcing the availability of a draft guidance for industry entitled, Determining Whether to Submit an ANDA or a 505(b)(2) Application. This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. This draft guidance revises the guidance for industry entitled, Determining Whether to Submit an ANDA or a 505(b)(2) Application issued in May 2019 and, if finalized, will replace the 2019 guidance for industry.
• On August 18, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Notice of Award of a Sole Source Cooperative Agreement to Fund Ministry of Health Zambia. The CDC is announcing the award of approximately $15,000,000 for fiscal year (FY) 2026 funding to Ministry of Health (MOH) Zambia, subject to the availability of funds. Funding amounts for years two through five will be set at continuation. The award will support Zambia through the MOH to lead and oversee the national HIV response in alignment with the U.S. Government’s (USG) goal to transition to the host government by 2030.
• On August 18, 2026, CDC released a notice entitled, Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee. CDC is seeking nominations for membership on the World Trade Center (WTC) Health Program Scientific/Technical Advisory Committee (STAC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010, as amended. The STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, and mental health, and representatives of WTC responders as well as representatives of certified-eligible WTC survivors. Nominations for membership on the STAC must be received no later than November 13, 2026.
• On August 19, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Privacy Act of 1974; System of Records. In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new system of records to be maintained by CMS, entitled Nurses for Nursing Homes Program (NNHP). The new system of records will cover the collection of records on individuals who apply for, participate in, or otherwise support the NNHP. Records maintained in the system will include personally identifiable information (PII), including demographic, professional licensure and credential information, education and training information, employment and nursing facility affiliation, payment information, tax reporting, audit records, and other records necessary to administer the program. CMS will use these records to support the administration of a nursing workforce incentive program designed to strengthen the workforce serving Medicare and Medicaid-certified nursing homes with a focus on underserved and rural communities. The scope of the new system of records will be commensurate with the purpose of supporting the Nursing Home Staffing Campaign/Nursing Incentive Program (NHSC/NIP).
• On August 19, 2026, the Administration for Children and Families (ACF) released a notice entitled, Privacy Act of 1974; System of Records. HHS is delaying the effective date of the new routine use under the modified system of records maintained by the Office of Family Assistance (OFA) within the ACF’s Temporary Assistance for Needy Families (TANF) Data that appeared in the Federal Register on June 23, 2026, entitled, Privacy Act of 1974; System of Records.
• On August 19, 2026, FDA released a notice entitled, Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs. The new charter will be in effect for an additional two years, with a charter expiration date of August 27, 2028.
• On August 19, 2026, FDA released a notice entitled, Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs. The new charter will be in effect for an additional two years, with a charter expiration date of August 27, 2028.
• On August 19, 2026, FDA released a notice entitled, Guidance: Frequently Asked Questions--Developing Potential Cellular and Gene Therapy Products. FDA is announcing the availability of a final guidance entitled, Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products. The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to FDA and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology.
• On August 19, 2026, FDA released a notice entitled, Guidance: Potency Assessment of Active Immunotherapy Products. FDA is announcing the availability of a draft document entitled, Potency Assessment of Active Immunotherapy Products. The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). When finalized, this guidance will describe FDA’s current thinking regarding design, validation, and evaluation of potency tests for ACTIMPs. FDA notes that this guidance is intended to supplement the December 2023 draft guidance for industry, if finalized, entitled, Potency Assurance for Cellular and Gene Therapy Products, with additional advice and considerations specifically for ACTIMPs, including peptide- and-protein based ACTIMPs that are not cellular or gene therapy products.
• On August 20, 2026, FDA released a notice entitled, Advisory Committee; Oncologic Drugs Advisory Committee; Renewal. FDA is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs. The new charter will be in effect for an additional two years, with a charter expiration date of September 1, 2028.
• On August 20, 2026, the National Institutes of Health (NIH) released a notice entitled, Government Owned Invention Available for License: Matched Patient-Derived 3D Isocitrate Dehydrogenase (IDH)-Mutant Glioma Cell Lines for Modeling Malignant Transformation. The National Cancer Institute (NCI) seeks licensees for matched patient-derived 3D Isocitrate Dehydrogenase (IDH)-mutant glioma cell lines, 403L and 403H, generated from the same patient before and after malignant transformation from WHO grade 2 to WHO grade 4 disease. This research material provides an opportunity to study IDH-mutant glioma progression, temozolomide-associated hypermutation, invasion, metabolism, and treatment resistance.
• On August 21, 2026, HHS released a request for information (RFI) entitled, Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making. HHS seeks public comment on whether the categories currently used in federal vaccine recommendations are adequate in support of the Task Force on Safer Childhood Vaccines and in furtherance of the Executive Order (EO) of August 10, 2026, Delivering Gold Standard Childhood Vaccine Recommendations for Americans. HHS seeks comment on these categories and whether additional or different categories should be adopted. Additionally, HHS seeks comment on the considerations that should be relied upon in setting vaccine recommendations, including the availability and strength of available scientific evidence, the appropriate approach when randomized controlled trial evidence is limited or absent, a presumption in favor of individual autonomy and religious freedom, the downstream legal and programmatic consequences of category assignment, and the communication practices necessary to earn and maintain public trust. Comments are due no later than September 20, 2026.
• On August 21, 2026, FDA released a notice entitled, Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 066. FDA is announcing a publication containing modifications FDA is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 066” (Recognition List Number: 066), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
• On August 21, 2026, FDA released a notice entitled, Evaluation of Therapeutic Equivalence; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance for industry entitled, Evaluation of Therapeutic Equivalence. This guidance explains FDA’s reasoning on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA’s therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the FD&C Act in the active section of the Approved Drug Products With Therapeutic Equivalence Evaluations. These therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. This guidance finalizes the draft guidance entitled, Evaluation of Therapeutic Equivalence; Draft Guidance for Industry, issued in July 2022.
• On August 21, 2026, NIH released a notice entitled, Government Owned Invention Available for License: T CELL RECEPTORS TARGETING HPV 6 OR HPV 11. NCI is seeking research co-development partners and/or licensees for a collection of T cell receptors (TCRs) that specifically target HPV 6 or HPV 11 antigens.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• August 24, 2026: NIH announced a meeting of the Advisory Council on Parkinson's Research, Care, and Services (ACPRCS). This is a virtual meeting open to the public.
• August 24, 2026: CMS announced a meeting of the Advisory Panel on Hospital Outpatient Payment. This is a virtual meeting open to the public.
• August 25, 2026: FDA announced a meeting entitled, Patient-Focused Drug Development for Nonhealing Chronic Wounds. This is a hybrid meeting open to the public.
• August 26, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a hybrid meeting open to the public.
• August 26, 2026: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). This is a virtual meeting open to the public.
• August 31, 2026: NIH announced a meeting of the National Institute on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• September 2, 2026: NIH announced a meeting of NCI. This is a virtual meeting with some sessions open to the public.
• September 4, 2026: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a hybrid meeting open to the public.
• September 9, 2026: NIH announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a virtual meeting with some sessions open to the public.
• September 9-10, 2026: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a hybrid meeting open to the public.
• ** September 9-10, 2026: NIH announced a meeting of the National Advisory Neurological Disorders and Stroke Council. This is a virtual meeting with some sessions open to the public.
• September 10, 2026: NIH announced a meeting of the National Advisory Environmental Health Sciences Council (NAEHSC). This is a virtual meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a virtual meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• September 11, 2026: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health (NCCIH). This is a hybrid meeting with some sessions open to the public.
• September 14, 2026: FDA announced a hearing on the potential future therapeutic use of psychedelic drugs. This is a hybrid hearing open to the public.
• September 14-15, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• September 15, 2026: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
• September 15, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• September 15, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a virtual meeting with some sessions open to the public.
• September 15-16, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (CDLTs). This is a virtual meeting open to the public.
• September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
• September 15-16, 2026: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
• September 16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is an in-person meeting with some sessions open to the public.
• **September 16, 2026: ACF announced a meeting between HHS/ACF Office of Head Start (OHS) leadership and Tribal government leadership. This is a virtual meeting with some sessions open to the public.
• September 16, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for FYs 2028 through 2032. This is a hybrid meeting open to the public.
• September 17, 2026: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for FYs 2028 to 2032. This is a hybrid meeting open to the public.
• September 17, 2026: NIH announced a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
• ** September 17, 2026: FDA announced a meeting of the Office of Women’s Health and the Center for Drug Evaluation and Research. This is a hybrid meeting open to the public.
• September 18, 2026: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). This is a hybrid meeting open to the public.
• September 18, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences Advisory Council. This is a virtual meeting with some sessions open to the public.
• September 23, 2026: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
• September 23, 2026: NIH announced a meeting of the AIDS Research Advisory Committee. This is a virtual meeting open to the public.
• September 24, 2026: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health Information Technology Advisory Committee (HITAC). This is a virtual meeting open to the public.
• September 25, 2026: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• September 28-29, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a hybrid meeting with some sessions open to the public.
• October 8, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
• October 14, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
• October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• October 28, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.
• October 28, 2026: CDC announced a meeting of the Subcommittee on Procedures Reviews (SPR) of the ABRWH. This is a virtual meeting open to the public.
• November 5, 2026: ONC announced a meeting of HITAC. This is a virtual meeting open to the public.
• December 1, 2026: NIH announced a meeting of NCI. This is an in-person meeting with some sessions open to the public.
• December 7-8, 2026: NIH announced a meeting of NICHD. This is a hybrid meeting open to the public.
• December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
• January 16, 2027: HHS announced a meeting of PACCARB. This is a virtual meeting open to the public.

Reports, Studies & Analyses

• On August 20, 2026, the HHS Office of Inspector General (OIG) released a report entitled, The Nation’s Challenge to Combat Durable Medical Equipment Fraud in Medicare. In the report, OIG highlights that individuals continue to defraud Medicare by billing for durable medical equipment (DME) that enrollees either do not need or never receive. OIG identifies the three elements necessary to commit fraud: (1) a Medicare-enrollee supplier, (2) a physician order, and (3) an enrollee identification number. OIG also presents actions for CMS and other relevant government agencies to take to prevent exploitation of Medicare. Specifically, OIG recommends strengthening Medicare supply-side enrollment, harnessing new technologies to better detect and stop payments for fraudulent claims, and protecting Medicare enrollee identification numbers.

Other Health Policy News

USCIS Updates Public Charge Guidance for Green Card Applicants

On August 18, 2026, U.S. Citizenship and Immigration Services (USCIS) issued updated guidance for adjudicating whether certain immigrants seeking lawful permanent residence are likely to become a “public charge,” following a July 2026 final rule from the Department of Homeland Security (DHS), entitled, Public Charge Ground of Inadmissibility (hereinafter “July 2026 final rule”), rescinding the 2022 Public Charge Ground of Inadmissibility final rule (hereinafter “2022 final rule”). The new framework, which takes effect September 18, 2026, provides immigration officers with broader discretion to consider an applicant’s “totality of the circumstances,” including age, health, family status, assets, resources, financial status, education, skills, and evidence of past or current use of taxpayer-funded benefits. The 2022 final rule restricted which public benefits DHS was able to consider for this determination. These restrictions are lifted so that the receipt of means-tested benefits, including Medicaid, can be considered in public-charge determinations. DHS has noted that benefits received before September 18, 2026, will continue to be evaluated under the 2022 rule, but applications for admission or adjustment of status filed on or after that date will be subject to the new standard.

A press release from USCIS on the guidance can be found here. The July 2026 final rule may be found here.

FDA Seeks Feedback on Regulatory Framework for AI-Enabled Medical Devices

On August 18, 2026, FDA released a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices in alignment with one of the Trump Administration’s key priorities to harness AI to accelerate the delivery of innovative medical products to market. The Digital Health Center of Excellence (DHCoE), within the FDA’s Center for Devices and Radiological Health, is leading this discussion paper which supports the FDA’s Public Health Pillar on Innovation and Global Leadership.

The discussion paper outlines a possible two-axis framework for risk assessment that might be used to inform regulatory expectations, discusses a potential approach to premarket evaluation built on the concept of competency assessment, and describes several potential approaches to risk-proportionate post-market monitoring. For each of these areas, FDA poses questions to inform the development of a regulatory framework that is scientifically rigorous, prioritizes patient safety, and aligns with the novel capabilities of GenAI-enabled medical devices. FDA seeks feedback on the discussion paper from device manufacturers, clinicians, consumers, researchers, the public, and other interested parties.

Comments must be submitted by October 19, 2026.

The discussion paper may be found here. The FDA press release may be found here. The affiliated FDA Public Health Pillar on Innovation and Global Leadership may be found here.

Trump Nominates Heidi Overton as FDA Commissioner

On August 19, 2026, President Donald Trump announced the nomination of White House aide Dr. Heidi Overton for FDA Commissioner through a Truth Social post. Dr. Overton currently serves as Deputy Director of the White House Domestic Policy Council, a role she has been in since President Trump began his second term, and is a board-certified physician in public health and general preventative medicine. If confirmed, Dr. Overton would fill the vacancy created when former commissioner Marty Makary left the agency in May of this year.

The Truth Social post announcing the nomination may be found here.  

HHS Seeks Public Input on Federal Vaccine Recommendation Framework

On August 21, 2026, HHS released an RFI seeking public comment on the categories currently used in federal vaccine recommendations and the role of shared clinical decision-making. This RFI follows the EO released August 10, 2026, entitled, Delivering Gold Standard Childhood Vaccine Recommendations for Americans. HHS seeks input on whether the three categories currently used in federal vaccine recommendations (routine (universal), risk-based, and shared clinical decision-making) are adequate, clear, and well understood. HHS seeks further comment on the considerations that should be relied upon in setting vaccine recommendations, including the availability and strength of available scientific evidence; the appropriate approach when randomized controlled trial evidence is limited or absent; a presumption in favor of individual autonomy and religious freedom; the downstream legal and programmatic consequences of category assignment; and the communication practices necessary to earn and maintain public trust.

Comments must be submitted by September 20, 2026.

The RFI as published in the Federal Register may be found here. The HHS press release may be found here.

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