The Administration for Children and Families (ACF) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Financial Report, Form ACF-196T (Office of Management and Budget (OMB) #: 0970-0345, expiration date: March 31, 2026. ACF is not proposing updates to the form but is proposing significant updates to streamline and improve the instructions. While the substance of the instructions remains the same, they are easier to read, with review time reduced by an estimate

Original title: “Submission for OMB Review; TANF Financial Report, ACF-196T”

Although the FDA has approved 599 orphan drugs since 1983, patent laws and other exclusivities keep most from any competition. “More than 9 out of 10 orphan products on the market today would never have been developed without the Orphan Drug Act,” said Peter L. Saltonstall, president and CEO of NORD, in a statement. “The vast majority of people with rare diseases still have no treatment, and we need government to provide a framework that helps patients by encouraging the development of innovative therapies, and spurs competition after a reasonable amount of time.” · Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics. Before the ODA, only 38 orphan products existed, the report said. During the time period of the study, 599 were approved; 552 were on the market as of July 2020. Three-quarters of the drugs treat 1 rare disease and have no other use. The report said that 154 orphan products were first approved to treat a single disease and later earned 1 or more orphan indications. However, 37 were initially cleared for non-rare uses and later earned orphan drug status. NORD said their findings "underscore the significance of the Orphan Drug Act in helping to bring novel rare disease treatments to market." Most rare diseases have no FDA-approved treatment.

Original title: “Report Lauds Orphan Drug Act but Notes Most Therapies Are Blocked From Competition | AJMC”

Referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8207)

Original title: “SRES 499: A resolution supporting the goals and ideals of "Creutzfeldt-Jakob Disease (CJD) Awareness Day".”

Referred to the House Committee on Energy and Commerce.

Original title: “HRES 872: Supporting the goals and ideals of "Creutzfeldt-Jakob Disease (CJD) Awareness Day".”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 7779: HEALTHY BRAINS Act of 2026”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 3206: Transgender Health Care Access Act”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 2487: Transgender Health Care Access Act”

Read twice and referred to the Committee on Finance.

Original title: “S 4070: Diabetes Foot Health Access and Modernization Act of 2026”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 7905: Diabetes Foot Health Access and Modernization Act of 2026”

Common early-phase pitfalls, from misaligned nonclinical strategy to gaps in CMC, bioanalysis, and species selection, can delay IND and CTA submissions. By aligning development plans with regulatory expectations from the outset and integrating cross-functional insight, sponsors can reduce rework, strengthen submissions, and maintain momentum toward first-in-human studies.

Original title: “Common Pitfalls That Delay Regulatory Submissions, and How to Prevent Them”

The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. FDA is also propo

Original title: “Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle." Patients provide valuable input to FDA in a variety of forms. This guidance describes the principles and concepts that FDA recommends sponsors and other interested parties consider when collecting and submitting patient preference information (PPI), discusses FDA's inclusion of PPI in its decision

Original title: “Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability”

The Administration for Children and Families (ACF) is requesting a revision of the Adoption and Foster Care Analysis and Reporting System (AFCARS) (Office of Management and Budget (OMB) #: 0970-0422, expiration June 30, 2026). Sixty-two data elements have been added to AFCARS, per a December 2024 final rule. This has increased the burden for reporting for state child welfare agencies only.

Original title: “Proposed Information Collection Activity; Adoption and Foster Care Analysis and Reporting System (AFCARS)”

Original title: “National Institute on Minority Health and Health Disparities; Notice of Partially Closed Meeting”

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. The public is also welcome to listen to the meeti

Original title: “Meeting of the Advisory Board on Radiation and Worker Health, Subcommittee for Procedure Reviews, National Institute for Occupational Safety and Health”

The Administration for Children, Youth and Families in the U.S. Department of Health and Human Services (HHS) is requesting a three-year extension of the National Child Abuse and Neglect Data System (NCANDS) collection (OMB #0970-0424, expiration 07/31/2026). There are no changes requested to this data collection.

Original title: “Proposed Information Collection Activity; National Child Abuse and Neglect Data System”

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting. It is open to the public, with a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. The public is also welcome to listen to the meeting by joining the audio conference (information below). The a

Original title: “Meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health”

Gene therapies cost $2.1M to $4.25M. Insurance barriers and Medicaid gaps are reshaping access for rare disease families. A single infusion for a child with this fatal neurodegenerative disease carries a price tag higher than most people will earn in a lifetime. Hemgenix, approved in 2022 for hemophilia B, costs $3.5 million. Lyfgenia, for sickle cell disease, is $3.1 million. Casgevy, the first CRISPR-based gene therapy by Vertex, is $2.2 million. Bluebird bio developed gene therapies for beta-thalassemia (Zynteglo), sickle cell disease (Lyfgenia), and cerebral adrenoleukodystrophy (Skysona). These were not failed therapies. They worked. Patients got better. NewsGene TherapyHealthcare AccessRare Disease PolicyMarch 29, 2026 · Gene therapies offer cures for previously untreatable rare diseases, but prices reaching $4.25 million create devastating access barriers. Therapies that literally cure genetic diseases once thought incurable are now available. But for the families who need them most, these breakthroughs have become locked behind a pricing wall so high it is often impenetrable. The gap between scientific innovation and patient access has never been wider. A therapy that works exists, yet most patients cannot access it. This is not a hypothetical problem. It is the daily reality for families navigating a rare disease diagnosis.

Original title: “Gene Therapy Pricing | Rare Disease Access Barriers | Trial Friend”

Referred to the Committee on Veterans' Affairs, and in addition to the Committee on Armed Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HR 8115: Precision Brain Health Research Act of 2026”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 8124: To amend the Public Health Service Act to establish a grant program to support models for providing stabilization services to individuals with serious thoughts of suicide, and for other purposes.”