Pneumococcal bacteria are resistant to one or more antibiotics in many cases.

Original title: “Antibiotic-resistant <em>Streptococcus pneumoniae</em>”

Zika is a nationally notifiable disease. Suspected cases are reported to health departments.

Original title: “Zika Cases in the United States”

The Administration for Children and Families' (ACF) Office of Refugee Resettlement (ORR) intends to continue collecting demographic, programmatic, and outcome data on Services for Survivors of Torture (SOT) grant recipients and the clients they serve. ORR collects information from the grantee cohort under the Survivors of Torture Program Data Points (PDP) and Program Performance Progress Report (PPR) (Office of Management and Budget (OMB) #0970-0599; Expiration date: February 28, 2026) to learn

Original title: “Submission for Office of Management and Budget Review; Office of Refugee Resettlement Services for Survivors of Torture Program Data Points and Performance Progress Report”

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Original title: “National Vaccine Injury Compensation Program; List of Petitions Received”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The National Firefighter Registry for Cancer (NFR). In accordance with the Firefight

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

The Food and Drug Administration (FDA) is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the March 3, 2028, expiration date.

Original title: “Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled: National Wastewater Surveillance System for Infectious Diseases to Inform Public He

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Improving Performance Measurement and Monitoring by CDC Programs: The Performance Me

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Developmental Studies to improve the National Health Care Surveys. The goal of the p

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

This document corrects an error that appeared in the notice published in the February 9, 2026, Federal Register entitled "Findings of Research Misconduct."

Original title: “Findings of Research Misconduct; Correction”

The Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee. This meeting is open to the public, limited only by the number of audio lines available. Online registration is required.

Original title: “National Center for Health Statistics, Meeting of the ICD-10 Coordination and Maintenance Committee”

HRSA published a document in the Federal Register of December 2, 2025, concerning the Medical Student Education Program Non- Competitive Supplement. The document contained an incorrect project period. The project period in the notice stated July 1, 2026, to June 30, 2027, but should instead state July 1, 2025, to June 30, 2026.

Original title: “Medical Student Education Program Non-Competitive Supplement; Correction”

At an event on Monday, the agency officially unveiled long-awaited draft guidance meant to help speed the development of bespoke treatments for extremely rare diseases.

Original title: “FDA fleshes out new roadmap for testing personalized therapies”

Kennedy cited the successful treatment ... therapy at the Children’s Hospital of Philadelphia. “Every child facing a rare genetic disease deserves the same kind of treatment that KJ got,” Kennedy said. Under the new framework, a disease with 100 mutations of the same gene would no longer require 100 clinical trials, Kennedy said, ... Kennedy cited the successful treatment of KJ Muldoon, also known as Baby KJ, who was born in August 2024 with a fatal metabolic disorder and survived after being successfully treated with a customized gene-editing therapy at the Children’s Hospital of Philadelphia. “Every child facing a rare genetic disease deserves the same kind of treatment that KJ got,” Kennedy said. Under the new framework, a disease with 100 mutations of the same gene would no longer require 100 clinical trials, Kennedy said, adding that the guidelines require long-term safety monitoring. The FDA’s Center for Drug Evaluation and Research will conduct the reviews of so-called investigational new drugs, clustering treatments that work with similar mechanisms, such as gene editing, into a single clinical trial. “Our system is built for common diseases not for rare ones,” Makary said Monday. “Historically rare diseases have been at the FDA an afterthought. Rigorous, elaborate standards are so high that they’re just not practical for many of the therapies for rare diseases.” About 30 million Americans have a rare disease, according to FDA Commissioner Dr. Marty Makary Called the plausible mechanism framework, the draft FDA guidelines establish a new approval process for individualized therapies for rare disorders. “This framework aligns regulations with biology for ultra-rare conditions,” Health and Human Services Secretary Robert F. Kennedy Jr. said at an event where he was joined by FDA Commissioner Dr. Marty Makary and the parents of children with rare diseases. “Randomized control trials are mostly just not feasible.”

Original title: “FDA says it will speed up rare disease treatment approvals”

Kennedy cited the successful treatment ... therapy at the Children’s Hospital of Philadelphia. “Every child facing a rare genetic disease deserves the same kind of treatment that KJ got,” Kennedy said. Under the new framework, a disease with 100 mutations of the same gene would no longer require 100 clinical trials, Kennedy said, ... Kennedy cited the successful treatment of KJ Muldoon, also known as Baby KJ, who was born in August 2024 with a fatal metabolic disorder and survived after being successfully treated with a customized gene-editing therapy at the Children’s Hospital of Philadelphia. “Every child facing a rare genetic disease deserves the same kind of treatment that KJ got,” Kennedy said. Under the new framework, a disease with 100 mutations of the same gene would no longer require 100 clinical trials, Kennedy said, adding that the guidelines require long-term safety monitoring. The FDA’s Center for Drug Evaluation and Research will conduct the reviews of so-called investigational new drugs, clustering treatments that work with similar mechanisms, such as gene editing, into a single clinical trial. “Our system is built for common diseases not for rare ones,” Makary said Monday. “Historically rare diseases have been at the FDA an afterthought. Rigorous, elaborate standards are so high that they’re just not practical for many of the therapies for rare diseases.” About 30 million Americans have a rare disease, according to FDA Commissioner Dr. Marty Makary Called the plausible mechanism framework, the draft FDA guidelines establish a new approval process for individualized therapies for rare disorders. “This framework aligns regulations with biology for ultra-rare conditions,” Health and Human Services Secretary Robert F. Kennedy Jr. said at an event where he was joined by FDA Commissioner Dr. Marty Makary and the parents of children with rare diseases. “Randomized control trials are mostly just not feasible.”

Original title: “FDA says it will speed up rare disease treatment approvals”

The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay Prasad in November, was criticized for lacking detailed guidance. Agency leaders elucidated on the pathway for personalized medicines on Monday. However, that guidance did not cover individualized therapies where the clinical evidence is more limited, according to the draft guidance. The guidance focuses on genome editing and RNA-based treatments for rare diseases, but the FDA said the framework could also apply to other types of individualized therapies. In advance of a bipartisan Senate hearing scheduled for Thursday focused on the authorization process for rare disease therapies, the FDA has proposed a regulatory path for individualized therapies like the one that famously helped Baby KJ this summer. On Monday, the agency published draft guidance for personalized genetic medicines, setting out a route to market for bespoke treatments that address unmet medical needs. In a November article published in The New England Journal of Medicine introducing the Plausible Mechanism Pathway, FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Director Vinay Prasad cited the case of Baby KJ, who received a personalized CRISPR therapy last year, as an example of the type of care they want to facilitate through the pathway. ... Most of the 15 million children with a rare disease have no FDA-approved treatments available to them. In the FDA’s definition, individualized therapies target the “specific pathophysiologic abnormality serving as the root cause of a disease,” such as a genetic variant. Identifying the underlying cause of a disease and developing a drug that addresses it are the first steps in the framework. Beyond that, the FDA recommends that companies rely on a well-characterized natural history of the disease in an untreated population as a control and show improvements in clinical outcomes.

Original title: “FDA’s Bespoke Pathway To Focus on Gene Editing and RNA-Based Treatments for Rare Diseases - BioSpace”

The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay Prasad in November, was criticized for lacking detailed guidance. Agency leaders elucidated on the pathway for personalized medicines on Monday.

Original title: “FDA’s Bespoke Pathway To Focus on Gene Editing and RNA-Based Treatments for Rare Diseases”

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed regulatory pathway for individualized therapies, treatments for rare conditions that affect a very ... The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed regulatory pathway for individualized therapies, treatments for rare conditions that affect a very small population, with the proposal specifically focusing on genome editing and RNA-based therapies. The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed reg… The official acknowledged this move was mindful of China’s growing dominance in the world clinical testing, including for gene therapies. “We definitely want the United [States] … to lead in terms of innovation in, you know, the rare disease and the nonrare disease space and we hope that this is going to contribute to that happening,” the official said, adding that this single guidance proposal likely wouldn’t be enough for the U.S. The FDA unveiled draft guidance on a proposed regulatory pathway for individualized therapies, treatments for rare conditions that affect a very small population, with the proposal specifically focusing on genome editing and RNA-based therapies. The FDA left open the potential for the framework to be applied to other treatments. Developing these treatments is challenging because of the small number of patients who could feasibly take part in trials, limiting pretrial testing to support regulatory evaluation.

Original title: “FDA proposes new treatment approval pathway for ultrarare diseases”

The plan could provide patients earlier access to treatments that would otherwise stall because only limited data can be gathered. Washington – The U.S. Food and Drug Administration proposed on Monday a new framework to speed approvals of personalized treatments for rare and life-threatening genetic diseases, allowing drugmakers to rely on small, well-controlled studies when traditional trials are not possible. The plan aims to update approval standards for individualized genetic medicines, creating a pathway for therapies aimed at patient groups too small for traditional trials. For treatments targeting multiple mutations within the same gene, it recommended observational studies and "master protocol" designs to allow evidence-sharing across related products. "We anticipate that we're going to get a flood of applications for treatments of rare diseases," a senior FDA official told reporters.

Original title: “FDA proposes framework to speed rare disease gene therapy approvals”

The U.S. Food and Drug Administration proposed on Monday a new framework to speed approvals of personalized treatments for rare and life-threatening genetic diseases, allowing drugmakers to rely on small, well-controlled studies when traditional trials are not possible. WASHINGTON, Feb 23 (Reuters) - The U.S. Food and Drug Administration proposed on Monday a new framework to speed approvals of personalized treatments for rare and life-threatening genetic diseases, allowing drugmakers to rely on small, well-controlled studies when traditional trials are not possible. The plan aims to update approval standards for individualized genetic medicines, creating a pathway for therapies aimed at patient groups too small for traditional trials. The draft guidance, first outlined in November, would permit companies to seek approval based on early efficacy signals and a therapy's biological rationale, rather than full-scale randomized trials. It covers genome-editing and RNA-based therapies, and could extend to other targeted products. Drugmakers would still need to gather real-world evidence after approval to confirm effectiveness and monitor safety and must also ensure patient protections, including informed consent and oversight by review boards. The agency urged early collection of baseline and natural-history data. For treatments targeting multiple mutations within the same gene, it recommended observational studies and "master protocol" designs to allow evidence-sharing across related products. "We anticipate that we're going to get a flood of applications for treatments of rare diseases," a senior FDA official told reporters.

Original title: “US FDA proposes framework to speed rare disease gene therapy approvals | Reuters”