CABI U.S. Government Accountability Office · Audits audits
What GAO Found In 2016, the Food and Drug Administration (FDA) expanded its authority to oversee all tobacco products, including millions of e-cigarettes that were already on the market. In response, it received a surge of applications from manufacturers in 2020 for products seeking authorization to remain on the market legally. Specifically, it received over 25 million applications in 2020 and 2021, compared to just over 1 thousand applications in 2018 and 2019. This led to a backlog of applications. While FDA has since reviewed most of the applications submitted during this period, almost 132 thousand remained without a completed review as of December 31, 2025. (See figure.) Figure: FDA T.
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Food and Drug Administration | Rule | The Food and Drug Administration (FDA) is classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the flushing and storage solution for vascular autografts at room temperature. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' acces.
CABI U.S. Government Accountability Office · Audits audits
What GAO Found The U.S. faces a maternal mortality crisis, with mortality rates that exceed every other high-income country. More than 600 women die during pregnancy or from causes aggravated by pregnancy each year in the U.S.; over 80 percent of these deaths are preventable, according to the Centers for Disease Control and Prevention (CDC). To help prevent these kinds of deaths, CDC provides funding for Maternal Mortality Review Committees (MMRCs). These committees, typically supported and maintained by state and local health agencies, identify factors contributing to pregnancy-related deaths and make recommendations to patients and their families, providers, hospitals, or state policymake.
CABI U.S. Government Accountability Office · Audits audits
What GAO Found Under the Controlled Substances Act, substances that pose a risk of abuse and dependence are placed in categories—referred to as schedules. To carry out certain scheduling actions, the Drug Enforcement Administration (DEA) is required to obtain a scheduling recommendation from the Department of Health and Human Services (HHS) based on a scientific and medical evaluation from the Food and Drug Administration (FDA). Evaluations and recommendations from HHS or DEA are not required for substances scheduled through legislation. Of the 208 substances for which DEA took scheduling actions from 2020 through 2025, DEA considered HHS evaluations and recommendations for all 95 substance.
CABI U.S. Government Accountability Office · Audits audits
What GAO Found The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) administers the Third Party Review Program, a voluntary alternative review process for selected low-to-moderate risk medical devices, such as diagnostic ultrasound systems and surgical lasers. Under this program, which is intended to facilitate faster reviews, device sponsors can contract with FDA-accredited entities. These entities, known as Third Party Review Organizations (third parties), conduct the initial review of certain premarket applications, known as 510(k) submissions. These third party reviews occur prior to agency officials making the final decision about whether the devic.
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Children and Families Administration | Notice | The Family and Youth Services Bureau's (FYSB) Runaway and Homeless Youth Division has a legislative requirement to fund a National Communication System, which is currently operated by the National Runaway Safeline (NRS). The NRS provides information, referral services, crisis intervention, and prevention resources to vulnerable youth at risk of running away and/or becoming homeless and their families or legal guardians at no cost. When necessary, the NRS refers runaway and homeless youth to shelters, counseling, medical assistance, and other vital services. The NRS collects information from all contacts wi.
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Children and Families Administration | Notice | The ACF, ORR announces the intent to award a single-source cooperative agreement in an amount of up to $150,000,000 to Burke Law Group, a law firm headquartered in Houston, Texas. The purpose of this proposed award is to provide legal orientation, legal consultation, and attorney-of-record representation services for eligible unaccompanied alien children (UACs) during immigration proceedings before the Executive Office for Immigration Review (EOIR) and in hearings and proceedings before the U.S. Citizenship and Immigration Services (USCIS) while children remain in ORR care. The proposed award also includes.
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Food and Drug Administration | Rule | The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the..
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Centers for Medicare & Medicaid Services | Rule | This final rule will revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy- related changes. ONC also adopts certain health information technology (health IT).
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Children and Families Administration | Notice | In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), ACF Tech, is providing notice of a re-established matching program between the Department of Veterans Affairs (VA) and State Public Assistance Agencies (SPAAs) participating in the Public Assistance Reporting Information System (PARIS) Program. The matching program provides the SPAAs with VA's compensation and pension data on a periodic basis to use in determining public assistance applicants' and recipients' eligibility for certain.
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Centers for Medicare & Medicaid Services | Notice | 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 collecti.
CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits
Health and Human Services Department, Centers for Medicare & Medicaid Services | Notice | 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 collecti.
