# Health and Human Services Department 218 documents across 24 days of the archive, 14 of them final rules. The five most recent days are below. [HTML](https://downstream.sh/daily/agency/health-and-human-services-department/) · [the long-form archive](https://downstream.sh/daily/agency/health-and-human-services-department/archive.md) · [the daily issue](https://downstream.sh/daily/index.md) ## Dates this agency has set that have not yet arrived | Date | Offset | What | Document | Agency | |---|---|---|---|---| | 2026-09-11 | today | Takes effect | [Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software](https://www.federalregister.gov/documents/2026/09/11/2026-18612/medical-devices-cardiovascular-devices-classification-of-the-cardiovascular-machine-learning-based) | Health and Human Services Department · Food and Drug Administration | | 2026-09-16 | +5d | Comments close | [Agency Information Collection Request; 30-Day Public Comment Request; Submission for Office of Management and Budget Review; Generic Clearance for the Trusted Exchange Framework and Common Agreement (TEFCA) Monitoring Activities](https://www.federalregister.gov/documents/2026/08/17/2026-16766/agency-information-collection-request-30-day-public-comment-request-submission-for-office-of) | Health and Human Services Department | | 2026-09-16 | +5d | Takes effect | [Proposed Collection: 30-Day Comment Request; Specimen Resource Locator (National Cancer Institute)](https://www.federalregister.gov/documents/2026/08/17/2026-16761/proposed-collection-30-day-comment-request-specimen-resource-locator-national-cancer-institute) | Health and Human Services Department · National Institutes of Health | | 2026-09-16 | +5d | Takes effect | [Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product](https://www.federalregister.gov/documents/2026/08/17/2026-16727/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with) | Health and Human Services Department · Food and Drug Administration | | 2026-09-16 | +5d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements](https://www.federalregister.gov/documents/2026/08/17/2026-16715/agency-information-collection-activities-proposed-collection-comment-request-investigational-new) | Health and Human Services Department · Food and Drug Administration | | 2026-09-17 | +6d | Comments close | [Submission for Office of Management and Budget Review; ACF-700 Tribal Annual Report](https://www.federalregister.gov/documents/2026/08/18/2026-16793/submission-for-office-of-management-and-budget-review-acf-700-tribal-annual-report) | Health and Human Services Department · Children and Families Administration | | 2026-09-17 | +6d | Comments close | [Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mifepristone and Analogues To Treat Hypercortisolism-Related Insulin Resistance Disorders](https://www.federalregister.gov/documents/2026/09/02/2026-17991/prospective-grant-of-an-exclusive-patent-license-development-and-commercialization-of-mifepristone) | Health and Human Services Department · National Institutes of Health | | 2026-09-18 | +7d | Comments close | [International Association of Color Manufacturers; Filing of Color Additive Petition](https://www.federalregister.gov/documents/2026/08/19/2026-16943/international-association-of-color-manufacturers-filing-of-color-additive-petition) | Health and Human Services Department · Food and Drug Administration | | 2026-09-18 | +7d | Comments close | [Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate](https://www.federalregister.gov/documents/2026/08/19/2026-16942/food-additives-permitted-in-feed-and-drinking-water-of-animals-chromium-dl-methionine-chelate) | Health and Human Services Department · Food and Drug Administration | | 2026-09-18 | +7d | Comments close | [Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Professions Student Loan Program, Loans for Disadvantaged Students Program, Primary Care Loan Program, and Nursing Student Loan Program Administrative Requirements, OMB No. 0906-0088-Extension](https://www.federalregister.gov/documents/2026/08/19/2026-16878/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment) | Health and Human Services Department · Health Resources and Services Administration | | 2026-09-20 | +9d | Comments close | [Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making](https://www.federalregister.gov/documents/2026/08/24/2026-17250/request-for-information-categories-used-in-federal-vaccine-recommendations-and-the-role-of-shared) | Health and Human Services Department · Office of the Secretary | | 2026-09-21 | +10d | Comments close | [Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Black Lung Clinics Program Performance Measures](https://www.federalregister.gov/documents/2026/08/20/2026-17009/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment) | Health and Human Services Department · Health Resources and Services Administration | | 2026-09-21 | +10d | Comments close | [Agency Information Collection Activities: Proposed Collection; Comment Request](https://www.federalregister.gov/documents/2026/08/21/2026-17164/agency-information-collection-activities-proposed-collection-comment-request) | Health and Human Services Department · Agency for Healthcare Research and Quality | | 2026-09-28 | +17d | Comments close | [Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs](https://www.federalregister.gov/documents/2026/08/28/2026-17603/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) | Health and Human Services Department · Food and Drug Administration | | 2026-09-28 | +17d | Comments close | [Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees](https://www.federalregister.gov/documents/2026/08/28/2026-17601/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) | Health and Human Services Department · Food and Drug Administration | | 2026-09-28 | +17d | Comments close | [Submission for Office of Management and Budget Review; National and State Survey of Child and Adolescent Well-Being (NSSCAW): Site Recruitment and Baseline Data Collection](https://www.federalregister.gov/documents/2026/08/28/2026-17545/submission-for-office-of-management-and-budget-review-national-and-state-survey-of-child-and) | Health and Human Services Department · Children and Families Administration | | 2026-09-30 | +19d | Comments close | [Submission for Office of Management and Budget Review; Head Start State Collaboration Office Grant Application](https://www.federalregister.gov/documents/2026/08/31/2026-17745/submission-for-office-of-management-and-budget-review-head-start-state-collaboration-office-grant) | Health and Human Services Department · Children and Families Administration | | 2026-09-30 | +19d | Comments close | [Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form](https://www.federalregister.gov/documents/2026/08/31/2026-17677/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) | Health and Human Services Department · Food and Drug Administration | | 2026-10-01 | +20d | Takes effect | [Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027](https://www.federalregister.gov/documents/2026/09/10/2026-18464/fee-rate-for-using-a-priority-review-voucher-in-fiscal-year-2027) | Health and Human Services Department · Food and Drug Administration | | 2026-10-02 | +21d | Comments close | [Submission for Office of Management and Budget Review; TANF Contingency Fund Application](https://www.federalregister.gov/documents/2026/09/02/2026-17982/submission-for-office-of-management-and-budget-review-tanf-contingency-fund-application) | Health and Human Services Department · Children and Families Administration | | 2026-10-02 | +21d | Comments close | [Agency Information Collection Activities: Submission for OMB Review; Comment Request](https://www.federalregister.gov/documents/2026/09/02/2026-17970/agency-information-collection-activities-submission-for-omb-review-comment-request) | Health and Human Services Department · Centers for Medicare & Medicaid Services | | 2026-10-02 | +21d | Comments close | [Privacy Act of 1974; Matching Program](https://www.federalregister.gov/documents/2026/09/02/2026-17907/privacy-act-of-1974-matching-program) | Health and Human Services Department | | 2026-10-02 | +21d | Takes effect | [Proposed Collection; 60-Day Comment Request; Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report (Office of the Director)](https://www.federalregister.gov/documents/2026/09/02/2026-17899/proposed-collection-60-day-comment-request-assurance-interinstitutional-foreign-and-domestic-and) | Health and Human Services Department · National Institutes of Health | | 2026-10-05 | +24d | Comments close | [Agency Information Collection Request. 30-Day Public Comment Request](https://www.federalregister.gov/documents/2026/09/03/2026-18060/agency-information-collection-request-30-day-public-comment-request) | Health and Human Services Department | | 2026-10-05 | +24d | Comments close | [Reducing Bureaucracy and Burden for the Repatriation of Mentally Ill Nationals](https://www.federalregister.gov/documents/2026/09/04/2026-18167/reducing-bureaucracy-and-burden-for-the-repatriation-of-mentally-ill-nationals) | Health and Human Services Department · Children and Families Administration | | 2026-10-05 | +24d | Comments close | [Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-XXXX-New](https://www.federalregister.gov/documents/2026/09/04/2026-18115/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment) | Health and Human Services Department · Health Resources and Services Administration | | 2026-10-08 | +27d | Takes effect | [Submission for OMB Review; 30-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)](https://www.federalregister.gov/documents/2026/09/08/2026-18191/submission-for-omb-review-30-day-comment-request-data-and-specimen-hub-dash-eunice-kennedy-shriver) | Health and Human Services Department · National Institutes of Health | | 2026-10-09 | +28d | Comments close | [Radiology Devices; Reclassification of Digital Breast Tomosynthesis System](https://www.federalregister.gov/documents/2026/08/10/2026-16209/radiology-devices-reclassification-of-digital-breast-tomosynthesis-system) | Health and Human Services Department · Food and Drug Administration | | 2026-10-09 | +28d | Takes effect | [Privacy Act of 1974; System of Records](https://www.federalregister.gov/documents/2026/09/09/2026-18316/privacy-act-of-1974-system-of-records) | Health and Human Services Department · Centers for Medicare & Medicaid Services | | 2026-10-13 | +32d | Comments close | [Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway](https://www.federalregister.gov/documents/2026/08/11/2026-16368/medicare-program-regulatory-alignment-for-predictable-and-immediate-device-rapid-coverage-pathway) | Health and Human Services Department · Centers for Medicare & Medicaid Services | ## 11 September 2026 — 13 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-11.md) > The Food and Drug Administration classified cardiovascular machine learning-based notification software as class II medical devices, effective September 11, 2026. — via Downstream, https://downstream.sh/daily/agency/health-and-human-services-department/#s-2026-09-11 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### National Heart, Lung, and Blood Institute; Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 57900 · FR Doc. 2026-18615 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18615.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18615/national-heart-lung-and-blood-institute-notice-of-meeting) ### Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software 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 cardiovascular machine learning- based notification software. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 11 September 2026 (today) 91 FR 57785 · FR Doc. 2026-18612 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18612.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18612/medical-devices-cardiovascular-devices-classification-of-the-cardiovascular-machine-learning-based) ### Agency Information Collection Activities: Submission for OMB Review; Comment Request *Notice* — Health and Human Services Department · Centers for Medicare & Medicaid Services 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. - **Comments close** 13 October 2026 (in 32 days) 91 FR 57892 · FR Doc. 2026-18611 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18611.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18611/agency-information-collection-activities-submission-for-omb-review-comment-request) ### Notice of Supplemental Funding, Appalachian Region Healthcare Support Program *Notice* — Health and Human Services Department · Health Resources and Services Administration HRSA is providing additional funding under the Appalachian Region Healthcare Support Program to one award recipient in fiscal year (FY) 2026. This supplemental funding will support additional technical assistance (TA) to help rural healthcare organizations located in the rural counties served by the Appalachian Regional Commission to strengthen healthcare delivery in the region. 91 FR 57897 · FR Doc. 2026-18570 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18570.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18570/notice-of-supplemental-funding-appalachian-region-healthcare-support-program) ### Notice of Supplemental Funding, Infant-Toddler Court Program-State Awards *Notice* — Health and Human Services Department · Health Resources and Services Administration HRSA is providing additional award funds to 11 current ITCP-- State Award recipients previously funded under HRSA-22-73 to support the continuation and expansion of existing activities to build state and local capacity and implement the infant-toddler court approach in federal fiscal year (FY) 2026. 91 FR 57898 · FR Doc. 2026-18568 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18568.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18568/notice-of-supplemental-funding-infant-toddler-court-program-state-awards) ### Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Health Network Development Program Performance Improvement and Measurement System, OMB No. 0906-0010-Revision *Notice* — Health and Human Services Department · Health Resources and Services Administration In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. - **Comments close** 10 November 2026 (in 60 days) 91 FR 57897 · FR Doc. 2026-18553 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18553.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18553/agency-information-collection-activities-proposed-collection-public-comment-request-information) ### Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate." This final order amends "Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use" (Over- the-Counter (OTC) Monograph M020) to remove PABA and trolamine salicylate as sunscreen active ingredients. A sunscreen drug product containing PABA or trolamine salicylate is not generally recognized as safe and effective (GRASE). 91 FR 57892 · FR Doc. 2026-18551 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18551.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18551/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use-and) ### Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices. - **Comments close** 10 November 2026 (in 60 days) 91 FR 57893 · FR Doc. 2026-18529 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18529.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18529/agency-information-collection-activities-proposed-collection-comment-request-medical-device-tracking) ### Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. - **Comments close** 13 October 2026 (in 32 days) 91 FR 57895 · FR Doc. 2026-18528 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18528.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18528/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) ### Notice of Supplemental Funding, Rural Hospital Stabilization Pilot Program *Notice* — Health and Human Services Department · Health Resources and Services Administration HRSA is awarding supplemental funding under the Rural Hospital Stabilization Pilot Program to two award recipients in fiscal year (FY) 2026 to provide in-depth technical assistance (TA) to rural hospitals to enhance and/or expand service lines to meet local needs and keep health care services available locally. 91 FR 57899 · FR Doc. 2026-18518 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18518.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18518/notice-of-supplemental-funding-rural-hospital-stabilization-pilot-program) ### National Institute on Aging; Amended Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 57901 · FR Doc. 2026-18514 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18514.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18514/national-institute-on-aging-amended-notice-of-meeting) ### National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 57900 · FR Doc. 2026-18513 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18513.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18513/national-institute-of-diabetes-and-digestive-and-kidney-diseases-amended-notice-of-meeting) ### Center for Scientific Review; Notice of Closed Meetings *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 57900 · FR Doc. 2026-18512 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18512.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18512/center-for-scientific-review-notice-of-closed-meetings) ## 10 September 2026 — 14 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-10.md) > The Food and Drug Administration published eight medical device classifications, one food additive petition withdrawal, one priority review voucher fee notice, and three funding or programmatic notices. — via Downstream, https://downstream.sh/daily/agency/health-and-human-services-department/#s-2026-09-10 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use) *Proposed Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2323) proposing that the food additive regulations be amended to provide for the safe use of hydrolyzed lignin as a source of neutral detergent soluble fiber in food for broiler chickens, laying hens, turkeys, growing swine, sows, lactating dairy cows, beef cattle, sheep, goats, salmonids, and adult dogs at no more than 1% of the food on a weight basis or 10 kilograms per metric ton of food. 91 FR 57531 · FR Doc. 2026-18469 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18469.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18469/green-innovation-gmbh-withdrawal-of-food-additive-petition-animal-use) ### Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027 *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2027 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a tropical disease, rare pediatric disease, or material threat MCM priority review voucher and outlines the payment procedures for such fees. - **Takes effect** 1 October 2026 (in 20 days) 91 FR 57617 · FR Doc. 2026-18464 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18464.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18464/fee-rate-for-using-a-priority-review-voucher-in-fiscal-year-2027) ### Center for Scientific Review; Notice of Closed Meetings *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 57620 · FR Doc. 2026-18441 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18441.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18441/center-for-scientific-review-notice-of-closed-meetings) ### National Center for Advancing Translational Sciences; Notice of Public Online Roundtable *Notice* — Health and Human Services Department · National Institutes of Health The National Center for Advancing Translational Sciences (NCATS) will host a public online roundtable to share the latest updates on how NCATS is advancing translational science research and provide an opportunity for an interactive discussion with NCATS director Dr. Joni Rutter. 91 FR 57621 · FR Doc. 2026-18440 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18440.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18440/national-center-for-advancing-translational-sciences-notice-of-public-online-roundtable) ### Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures 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 mechanical deviation device for esophageal protection during cardiac ablation procedures. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57495 · FR Doc. 2026-18433 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18433.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18433/medical-devices-cardiovascular-devices-classification-of-the-mechanical-deviation-device-for) ### Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures 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 temperature regulation device for esophageal protection during cardiac ablation procedures. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57500 · FR Doc. 2026-18432 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18432.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18432/medical-devices-cardiovascular-devices-classification-of-the-temperature-regulation-device-for) ### Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access 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 extravascular support for an arteriovenous fistula for vascular access. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57498 · FR Doc. 2026-18431 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18431.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18431/medical-devices-cardiovascular-devices-classification-of-the-extravascular-support-for-an) ### Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease 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 anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57493 · FR Doc. 2026-18430 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18430.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18430/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-anti-tumor) ### Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery 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 cooperative powered surgical assist device for ENT surgery. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57502 · FR Doc. 2026-18429 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18429.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18429/medical-devices-ear-nose-and-throat-devices-classification-of-the-cooperative-powered-surgical) ### Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device 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 implanted tibial electrical urinary continence device. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57504 · FR Doc. 2026-18428 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18428.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18428/medical-devices-gastroenterology-urology-devices-classification-of-the-implanted-tibial-electrical) ### Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing system 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 vaginal hydrogel packing system. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57509 · FR Doc. 2026-18427 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18427.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18427/medical-devices-radiology-devices-classification-of-the-vaginal-hydrogel-packing-system) ### Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device 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 whole room microbial reduction device. 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' access to beneficial innovative devices, in part by reducing regulatory burdens. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57507 · FR Doc. 2026-18426 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18426.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18426/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-whole-room-microbial) ### Notice of Supplemental Funding, Medicare Rural Hospital Flexibility Program *Notice* — Health and Human Services Department · Health Resources and Services Administration HRSA is providing additional fiscal year 2026 funding under the Medicare Rural Hospital Flexibility (Flex) Program using the program's established funding methodology, including a baseline increase for all recipients and an additional adjustment for states with newly designated Critical Access Hospitals (CAHs). This funding will support state efforts to strengthen CAHs, improve quality and performance, and sustain access to essential rural health care services. 91 FR 57619 · FR Doc. 2026-18425 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18425.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18425/notice-of-supplemental-funding-medicare-rural-hospital-flexibility-program) ### Announcing the Intent To Award a Single-Source Supplement to the Senior Medicare Patrol (SMP) Resource Center *Notice* — Health and Human Services Department · Community Living Administration The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Northeast Iowa Area Agency on Aging (NEI3A) for the SMP Resource Center. The administrative supplement for FY 2026 will be in the amount of $226,000, bringing the total award for FY 2026 to $1,226,000. The supplement will allow the grantee to expand activities that began in FY 2025, which includes testing new communications strategies, expanding the functionality of their SMP smart phone app, exploring partnerships with technology companies, and other activities all aimed at expanding the reach of SMP messaging. 91 FR 57616 · FR Doc. 2026-18415 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18415.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18415/announcing-the-intent-to-award-a-single-source-supplement-to-the-senior-medicare-patrol-smp-resource) ## 9 September 2026 — 10 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-09.md) > The Food and Drug Administration published guidance on temporary policies for compounding starter parenteral nutrition drug products for neonates. — via Downstream, https://downstream.sh/daily/agency/health-and-human-services-department/#s-2026-09-09 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States. 91 FR 57358 · FR Doc. 2026-18368 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18368.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18368/temporary-policies-for-compounding-certain-starter-parenteral-nutrition-drug-products-for-neonates) ### Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 Southern Hemisphere Influenza Virus Vaccines *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. 91 FR 57359 · FR Doc. 2026-18349 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18349.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18349/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a) ### Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with statutory and regulatory requirements that govern certain human cells, tissues, and cellular and tissue-based products (HCT/Ps). - **Comments close** 9 November 2026 (in 59 days) 91 FR 57347 · FR Doc. 2026-18333 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18333.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18333/agency-information-collection-activities-proposed-collection-comment-request-human-cells-tissues-and) ### Privacy Act of 1974; System of Records *Notice* — Health and Human Services Department · Centers for Medicare & Medicaid Services In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Centers for Medicare & Medicaid Services (CMS), titled "Hospice Item Set (HIS) System," System No. 09-70-0548. The amended System of Records Notice (SORN) reflects changes to now include real time data collection at the time of patient assessments to improve the understanding of patient care needs and care coordination. CMS is also changing the name of the system of records to "Hospice Outcomes and Patient Evaluation (HOPE)" and making other modifications which are explained in the Supplementary Information section. The HOPE system collects standardized hospice patient data to measure and improve care quality, support regulatory and reporting requirements, and enable research and policy functions. - **Takes effect** 9 October 2026 (in 28 days) 91 FR 57344 · FR Doc. 2026-18316 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18316.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18316/privacy-act-of-1974-system-of-records) ### Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product. - **Comments close** 8 March 2027 (in 178 days) 91 FR 57356 · FR Doc. 2026-18300 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18300.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18300/determination-of-regulatory-review-period-for-purposes-of-patent-extension-andembry) ### Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled "Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications." - **Comments close** 9 November 2026 (in 59 days) 91 FR 57352 · FR Doc. 2026-18299 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18299.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18299/agency-information-collection-activities-proposed-collection-comment-request-pregnancy-exposure) ### Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANZUPGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. - **Comments close** 8 March 2027 (in 178 days) 91 FR 57355 · FR Doc. 2026-18298 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18298.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18298/determination-of-regulatory-review-period-for-purposes-of-patent-extension-anzupgo) ### Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANKTIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product. - **Comments close** 8 March 2027 (in 178 days) 91 FR 57350 · FR Doc. 2026-18297 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18297.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18297/determination-of-regulatory-review-period-for-purposes-of-patent-extension-anktiva) ### National Vaccine Injury Compensation Program; List of Petitions Received *Notice* — Health and Human Services Department · Health Resources and Services Administration 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. 91 FR 57361 · FR Doc. 2026-18283 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18283.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18283/national-vaccine-injury-compensation-program-list-of-petitions-received) ### Reorganization of the National Center for Immunization and Respiratory Diseases *Notice* — Health and Human Services Department · Centers for Disease Control and Prevention CDC has modified its structure. This notice announces the reorganization of the National Center for Immunization and Respiratory Diseases (NCIRD). NCIRD has consolidated offices, retitled divisions and branches, and modified mission and function statements. - **Takes effect** 4 September 2026 (7 days ago) 91 FR 57343 · FR Doc. 2026-18263 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18263.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18263/reorganization-of-the-national-center-for-immunization-and-respiratory-diseases) ## 8 September 2026 — 6 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-08.md) > The Department of Health and Human Services published six notices on September 8, 2026, including information collection requests and a Medicare town hall meeting announcement. — via Downstream, https://downstream.sh/daily/agency/health-and-human-services-department/#s-2026-09-08 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0906-0086-Revision *Notice* — Health and Human Services Department · Health Resources and Services Administration In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. - **Comments close** 9 November 2026 (in 59 days) 91 FR 57155 · FR Doc. 2026-18235 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-08/pdf/2026-18235.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/08/2026-18235/agency-information-collection-activities-proposed-collection-public-comment-request-information) ### Medicare Program; Town Hall Meeting on the Fiscal Year 2028 Applications for New Technology Add-On Payments *Notice* — Health and Human Services Department · Centers for Medicare & Medicaid Services This notice announces a town hall meeting in accordance with section 1886(d)(5)(K)(viii)(III) of the Social Security Act (the Act) to discuss fiscal year (FY) 2028 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this virtual meeting to present their comments, recommendations, and data regarding whether the FY 2028 applications for new technology add- on payments meet the substantial clinical improvement criterion. 91 FR 57153 · FR Doc. 2026-18226 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-08/pdf/2026-18226.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/08/2026-18226/medicare-program-town-hall-meeting-on-the-fiscal-year-2028-applications-for-new-technology-add-on) ### Proposed Data Collection Submitted for Public Comment and Recommendations *Notice* — Health and Human Services Department · Centers for Disease Control and Prevention 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 Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73). This data collection allows CDC and APHIS have to collect information on the possession, use, and transfer of select agents and toxins. - **Comments close** 9 November 2026 (in 59 days) 91 FR 57150 · FR Doc. 2026-18217 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-08/pdf/2026-18217.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/08/2026-18217/proposed-data-collection-submitted-for-public-comment-and-recommendations) ### Center for Scientific Review; Amended Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 57159 · FR Doc. 2026-18215 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-08/pdf/2026-18215.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/08/2026-18215/center-for-scientific-review-amended-notice-of-meeting) ### Center for Scientific Review; Notice of Closed Meetings *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 57156 · FR Doc. 2026-18193 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-08/pdf/2026-18193.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/08/2026-18193/center-for-scientific-review-notice-of-closed-meetings) ### Submission for OMB Review; 30-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development) *Notice* — Health and Human Services Department · National Institutes of Health In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. - **Takes effect** 8 October 2026 (in 27 days) 91 FR 57157 · FR Doc. 2026-18191 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-08/pdf/2026-18191.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/08/2026-18191/submission-for-omb-review-30-day-comment-request-data-and-specimen-hub-dash-eunice-kennedy-shriver) ## 4 September 2026 — 4 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-04.md) ### Reducing Bureaucracy and Burden for the Repatriation of Mentally Ill Nationals *Proposed Rule* — Health and Human Services Department · Children and Families Administration The Department of Health and Human Services, Administration for Children and Families proposes to remove the Care and Treatment of Mentally Ill Nationals of the United States, Returned from Foreign Countries regulations to streamline regulations and to renumber it under a different Part. - **Comments close** 5 October 2026 (in 24 days) 91 FR 56826 · FR Doc. 2026-18167 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-04/pdf/2026-18167.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/04/2026-18167/reducing-bureaucracy-and-burden-for-the-repatriation-of-mentally-ill-nationals) ### Advancing Development of Botanical Drug Products; Request for Information *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is opening a public docket to solicit comments on FDA's efforts to advance development of botanical drug products (BDPs). FDA is publishing this request for information to better understand stakeholders' perspectives on the state of BDP development in the United States, challenges encountered, and potential solutions to gathering the information required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). - **Comments close** 3 November 2026 (in 53 days) 91 FR 56887 · FR Doc. 2026-18133 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-04/pdf/2026-18133.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/04/2026-18133/advancing-development-of-botanical-drug-products-request-for-information) ### Performance Review Board Members *Notice* — Health and Human Services Department The Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members (PRB) who are reviewing performance of Senior Executive Service members, Title 42 executives, Senior Level, and Scientific Professional employees for Fiscal Year 2026. 91 FR 56890 · FR Doc. 2026-18120 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-04/pdf/2026-18120.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/04/2026-18120/performance-review-board-members) ### Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-XXXX-New *Notice* — Health and Human Services Department · Health Resources and Services Administration In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed. - **Comments close** 5 October 2026 (in 24 days) 91 FR 56889 · FR Doc. 2026-18115 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-04/pdf/2026-18115.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/04/2026-18115/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment) ## Earlier 19 further days are in the [long-form archive](https://downstream.sh/daily/agency/health-and-human-services-department/archive.md). ## Ask an assistant instead Everything on this page is also a tool call. Add `mcp.downstream.sh` as an MCP server — no key, no account — then paste this: ``` Using the Downstream MCP server at mcp.downstream.sh, call whats_new_since with agency "Health and Human Services Department" since 2026-09-04, then summarise what changed and list every deadline it created. ``` Reaches `whats_new_since`. The response carries its own citations and states what it is missing, including which dates it has no record for. --- Every document linked here is a work of the United States government and in the public domain. The Federal Register's HTML and XML renderings are unofficial; the PDF on each item is the official text, and that is the one to cite. Counts are arithmetic over published fields, dates are printed as filed, and titles are verbatim. Where we have nothing, this says nothing rather than estimating. The one-sentence agency summaries are machine-written from those same fields and are labelled where they appear. [Downstream](https://downstream.sh/) · [the essay](https://downstream.sh/essays/a-country-that-can-see.html) · [the daily issue](https://downstream.sh/daily/) · [MCP endpoint](https://mcp.downstream.sh)