The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal years 2026 through 2030. This notice publishes the OTC monograph drug facility (MDF) fee rates for fis

Original title: “Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026”

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs." This guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes (referred to as "topical products"). This guid

Original title: “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications; Guidance for Industry, Availability”

The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register on January 22, 2026. In the notice, FDA requested data and information on the issues raised in and specific questions related to a citizen petition from Celiac Journey related to labeling and preventing cross- contact of gluten for packaged foods. We are taking this action in response to a request for an extension to allow interested persons additional time to submit

Original title: “Labeling and Preventing Cross-Contact of Gluten for Packaged Foods; Request for Information; Extension of Comment Period”

The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in

Original title: “Medical Devices; Radiology Devices; Classification of Blood Irradiators”

The Food and Drug Administration (FDA or Agency) has determined that METHERGINE (methylergonovine maleate) injection, 0.2 milligram (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylergonovine maleate injection, 0.2 mg/mL, if all other legal and regulatory requirements are met.

Original title: “Determination That METHERGINE (Methylergonovine Maleate) Injection, 0.2 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness”

The Food and Drug Administration (FDA) is announcing the renewal of the Obstetrics, Reproductive and Urologic 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 Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the March 23, 2028, expiration date.

Original title: “Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Renewal”

The National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC), an Operating Division of the Department of Health and Human Services (HHS), requests public comment on the draft Immediately Dangerous to Life or Health (IDLH) Value Profile document for the chemical lewisite (CAS# 541-25-3). NIOSH develops IDLH values for workplace chemical concentrations and conditions carrying immediate, unacceptable health risks. IDLH values are based on

Original title: “Request for Public Comment on the Draft Immediately Dangerous to Life or Health (IDLH) Value Document for Lewisite”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Submission for OMB Review; 30-Day Comment Request Hazardous Waste Worker Training-42 CFR Part 65, National Institute of Environmental Health Sciences (NIEHS)”

Original title: “National Institute of General Medical Sciences; Notice of Partially Closed Meetings”

The Food and Drug Administration (FDA, the Agency, or we) is soliciting comments from the public on various topics pertaining to the regulation of cosmetics in preparation for the twentieth International Cooperation on Cosmetics Regulation annual meeting (ICCR-20). We may use this input to help us prepare for the ICCR-20 meeting that will be held July 7 to 9, 2026, in Tokyo, Japan.

Original title: “Preparation for International Cooperation on Cosmetics Regulation Twentieth Annual Meeting (ICCR-20); Request for Comments”

Washington, D.C. Today, Congresswoman Maria Elvira Salazar (FL-27), alongside Representatives Mike Lawler (NY-17), Yvette Clarke (NY-09), and Sanford Bishop (GA-02), introduced the H1Bs for Physicians and the Healthcare Workforce Act, bipartisan legislation to help address critical healthcare ... Washington, D.C. Today, Congresswoman Maria Elvira Salazar (FL-27), alongside Representatives Mike Lawler (NY-17), Yvette Clarke (NY-09), and Sanford Bishop (GA-02), introduced the H1Bs for Physicians and the Healthcare Workforce Act, bipartisan legislation to help address critical healthcare workforce shortages nationwide. Physicians and the Healthcare Workforce Act, bipartisan legislation to help address critical healthcare workforce shortages nationwide. The bill exempts healthcare professionals from the proposed $100,000 H-1B petition fee and prevents additional costs beyond those already established under federal law, ensuring hospitals can continue recruiting the talent patients depend on. In many such communities, international medical graduates play an important role in providing care and ensuring patients can see a doctor when they need one. The AMA supports this legislation to ensure the new $100,000 fee does not make it harder to recruit highly skilled physicians. We thank Reps. Lawler (R-NY), Bishop (D-GA), Salazar (R-FL), and Clarke (D-NY), for introducing this bipartisan bill. The AMA urges Congress to act quickly to protect patients’ access to care." Physicians for American Healthcare Access (PAHA) applauds Reps. Lawler (R-NY), Bishop (D-GA), Salazar (R-FL), and Clarke (D-NY) for this bipartisan legislation, and we urge Congress to pass the H-1Bs for Physicians and the Healthcare Workforce Act to safeguard patients' access to care."

Original title: “SALAZAR, LAWLER, BISHOP, AND CLARKE INTRODUCE BIPARTISAN BILL TO PROTECT PATIENT ACCESS AND STRENGTHEN HEALTHCARE WORKFORCE | Representative Maria Salazar”

Referred to the House Committee on Rules.

Original title: “HRES 830: Providing for consideration of the bill (H.R. 999) to protect an individual's ability to access contraceptives and to engage in contraception and to protect a health care providers ability to provide contraceptives, contraception, and information related to contraception.”

Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label expansion for leucovorin to treat the ultrarare cerebral folate deficiency. The regulatory process, which relied on a literature review rather than new evidence, stands in contrast to recent rare disease rejections in which the FDA cited a need for more rigorous evidence.

Original title: “What the Leucovorin Approval Signals—or Doesn’t—About the FDA’s Rare Disease Stance”

The ruling, related to a lawsuit from several major medical organizations, stated that HHS ignored established protocols in altering the childhood immunization schedule and overhauling a key CDC panel.

Original title: “Federal court blocks RFK Jr.’s moves to upend US vaccine policy”

Washington, D.C. — Congresswoman Julie Fedorchak (R-ND) and Congressman Troy Carter Sr. SORHs form the backbone of both strategic planning and on-the-ground support for rural health, and Representative Fedorchak's State Offices of Rural Health Program Reauthorization Act of 2026 will sustain the impact of decades of investment in the SORH initiative, helping ensure that the health of rural America continues to be an explicit priority of all states.” - Jacob Warren, Director, Center for Rural Health, University of North Dakota State Offices of Rural Health Program Reauthorization Act of 2026, bipartisan legislation to strengthen rural health care. "The National Rural Health Association (NRHA) is elated to see Congressman Fedorchak and Congressman Carter introduce the State Offices of Rural Health Program Reauthorization Act. The 50 State Offices of Rural Health (SORHs) across the country play a vital role as the backbone of rural health coordination within their respective states. “As North Dakota's State Office of Rural Health, the Center for Rural Health stands in full support of Representative Fedorchak's introduction of the State Offices of Rural Health Program Reauthorization Act of 2026. As one of the nation's oldest State Offices of Rural Health, the Center for Rural Health has seen the undeniable impact that the SORH program has across our state and the nation.

Original title: “Fedorchak, Carter introduce bipartisan legislation to strengthen rural health offices nationwide | Representative Julie Fedorchak”

Read twice and referred to the Committee on Energy and Natural Resources.

Original title: “S 4103: A bill to improve the health and resiliency of giant sequoias, and for other purposes.”

Referred to the Committee on Oversight and Government Reform, and in addition to the Committee on Veterans' Affairs, 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 7948: To deem certain individuals as parents of Department of Veterans Affairs employees for purposes of determining entitlement to certain family and medical leave for such employees.”

A Massachusetts judge called Kennedy’s efforts to reform the CDC’s vaccines advisory panel a “procedural failure,” adding that the new committee members do not “comport with governing law.”

Original title: “Kennedy’s Vaccine Policy Overhaul Stymied by Federal Judge”

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

Original title: “S 3944: Women’s Heart Health Expansion Act of 2026”

STI testing type and frequency recommendations.

Original title: “Getting Tested for STIs”