# Health and Human Services Department 175 documents across 20 days of the archive, 5 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 | |---|---|---|---|---| | 2026-09-07 | +3d | Takes effect | [Proposed Collection; 60-Day Comment Request Generic Clearance for the Collection of Customer Participation and Performance Management With NIH Programs, Products, and Services (Office of the Director)](https://www.federalregister.gov/documents/2026/08/11/2026-16300/proposed-collection-60-day-comment-request-generic-clearance-for-the-collection-of-customer) | Health and Human Services Department · National Institutes of Health | | 2026-09-09 | +5d | Comments close | [Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Transforming Pediatrics for Early Childhood Program Performance Measures](https://www.federalregister.gov/documents/2026/08/10/2026-16227/agency-information-collection-activities-submission-to-omb-for-review-and-approval-public-comment) | Health and Human Services Department · Health Resources and Services Administration | | 2026-09-10 | +6d | Comments close | [Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period](https://www.federalregister.gov/documents/2026/08/26/2026-17409/hydroxymitragynine-above-a-specified-threshold-in-schedule-i-extension-of-comment-period) | Health and Human Services Department | | 2026-09-16 | +12d | 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 | +12d | 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 | +12d | 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 | +12d | 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 | +13d | 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 | +13d | 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 | +14d | 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 | +14d | 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 | +14d | 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 | +16d | 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 | +17d | 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 | +17d | 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 | +24d | 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 | +24d | 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 | +24d | 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 | +26d | 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 | +26d | 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 | | 2026-10-02 | +28d | 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 | +28d | 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 | +28d | 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 | +28d | 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 | +31d | 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 | +31d | 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 | +31d | 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 | | 2026-10-09 | +35d | 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 | | 2026-10-13 | +39d | 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 | | 2026-10-13 | +39d | Comments close | [Agency Information Collection Activities: Proposed Collection; Comment Request](https://www.federalregister.gov/documents/2026/08/12/2026-16386/agency-information-collection-activities-proposed-collection-comment-request) | Health and Human Services Department · Centers for Medicare & Medicaid Services | ## 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 31 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 60 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 31 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) ## 3 September 2026 — 4 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-03.md) > The Department of Health and Human Services published four notices including an information collection request, a drug withdrawal determination, an emergency use authorization declaration, and a meeting notice. — via Downstream, https://downstream.sh/daily/agency/health-and-human-services-department/#s-2026-09-03 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Agency Information Collection Request. 30-Day Public Comment Request *Notice* — Health and Human Services Department In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. - **Comments close** 5 October 2026 (in 31 days) 91 FR 56656 · FR Doc. 2026-18060 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-03/pdf/2026-18060.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/03/2026-18060/agency-information-collection-request-30-day-public-comment-request) ### Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, if all other legal and regulatory requirements are met. 91 FR 56654 · FR Doc. 2026-18023 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-03/pdf/2026-18023.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/03/2026-18023/determination-that-phenaphen-with-codeine-no-3-acetaminophen-codeine-phosphate-oral-capsules-325) ### Emergency Use Authorization Declaration *Notice* — Health and Human Services Department The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On July 15, 2026, the Secretary of War determined under the FD&C that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of an attack with a chemical, biological, radiological, or nuclear agent or agents; or an attack by an agent or agents that may cause, or are otherwise associated with an imminently life-threatening and specific risk to those forces. Injuries arising from these attacks may cause those forces to experience moderate to severe acute pain and place them at risk of developing life-threatening hemodynamic instability, including shock or respiratory distress. On the basis of this determination, the Secretary of HHS declared on August 31, 2026, pursuant to the FD&C Act, that circumstances exist justifying the authorization of emergency use of drugs identified and supported by the Department of War (DOW) as addressing an unmet military operations- related medical need for use to manage moderate to severe acute pain in casualties caused by, or associated with, an emergency involving biological, chemical, radiological, or nuclear agent or agents, or agents of military combat, including firearms, projectiles, and explosive devices, that may cause, or may otherwise be associated with, an imminently life-threatening and specific risk to U.S. military forces, subject to the terms of any authorization issued under that section. - **Takes effect** 15 July 2026 (51 days ago) 91 FR 56655 · FR Doc. 2026-18008 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-03/pdf/2026-18008.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/03/2026-18008/emergency-use-authorization-declaration) ### National Institute of Mental Health; Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 56657 · FR Doc. 2026-17989 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-03/pdf/2026-17989.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/03/2026-17989/national-institute-of-mental-health-notice-of-meeting) ## 2 September 2026 — 12 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-02.md) > The Department of Health and Human Services published twelve notices in the Federal Register on September 2, 2026. — via Downstream, https://downstream.sh/daily/agency/health-and-human-services-department/#s-2026-09-02 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mifepristone and Analogues To Treat Hypercortisolism-Related Insulin Resistance Disorders *Notice* — Health and Human Services Department · National Institutes of Health The National Institute of Diabetes and Digestive and Kidney Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the invention embodied in the patents and patent applications listed in the Supplementary Information section of this notice to Nulyn Science ("Nulyn"), a company located in Paris, France. - **Comments close** 17 September 2026 (in 13 days) 91 FR 56458 · FR Doc. 2026-17991 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17991.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17991/prospective-grant-of-an-exclusive-patent-license-development-and-commercialization-of-mifepristone) ### Submission for Office of Management and Budget Review; TANF Contingency Fund Application *Notice* — Health and Human Services Department · Children and Families Administration The Office of Family Assistance, Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to collect data for state requests of Temporary Assistance for Needy Families (TANF) Contingency Fund provisional payments through the TANF Contingency Fund Application. - **Comments close** 2 October 2026 (in 28 days) 91 FR 56449 · FR Doc. 2026-17982 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17982.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17982/submission-for-office-of-management-and-budget-review-tanf-contingency-fund-application) ### 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** 2 October 2026 (in 28 days) 91 FR 56447 · FR Doc. 2026-17970 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17970.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17970/agency-information-collection-activities-submission-for-omb-review-comment-request) ### Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA, Agency, or we) has determined that CARAFATE (sucralfate) oral suspension, 1 gram (g)/10 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. 91 FR 56455 · FR Doc. 2026-17968 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17968.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17968/determination-that-carafate-sucralfate-oral-suspension-1-gram10-milliliters-was-not-withdrawn-from) ### Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage; Draft Guidance for Industry; Availability *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This guidance assists sponsors in the design and analysis of studies that assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, the pharmacodynamics of a drug, including therapeutic biological products. When final, this guidance will represent FDA's current thinking. FDA is also withdrawing the guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling" (May 2003), which formerly provided FDA's thinking relating to studies to assess the effect of hepatic impairment on the pharmacokinetics or pharmacodynamics of a drug and recommendations to include hepatic impairment information in labeling. - **Comments close** 1 December 2026 (in 88 days) 91 FR 56449 · FR Doc. 2026-17961 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17961.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17961/pharmacokinetics-in-patients-with-impaired-hepatic-function-study-design-data-analysis-and-impact-on) ### Announcement of the Intent To Award a Single-Source Cooperative Agreement to Spaulding for Children for the National Training and Development Curriculum for Foster/Adoptive Parents (NTDC) in Southfield, Michigan *Notice* — Health and Human Services Department · Children and Families Administration The ACF, CB announces the intent to award a single-source cooperative agreement in the amount of up to $1 million to Spaulding for Children in Southfield, MI. The purpose of this award is to continue the implementation and dissemination efforts of the National Training and Development Curriculum for Foster/Adoptive Parents (NTDC), a state-of-the-art training program to prepare foster, adoptive, and kinship caregivers to effectively parent children and to provide these families with ongoing skill development needed to understand and promote healthy child development. 91 FR 56448 · FR Doc. 2026-17959 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17959.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17959/announcement-of-the-intent-to-award-a-single-source-cooperative-agreement-to-spaulding-for-children) ### Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances titled "Dental Composite Resin Devices--Premarket Notification (510(k)) Submissions" and "Dental Curing Lights--Premarket Notification (510(k)) Submissions." These guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. These guidances supersede the guidances "Dental Composite Resin Devices-- Premarket Notification [510(k)] Submissions" dated October 26, 2005 and "Dental Curing Lights--Premarket Notification [510(k)] Submissions" dated March 27, 2006. The recommendations in these guidances are intended to promote consistency and facilitate efficient review of these submissions. 91 FR 56452 · FR Doc. 2026-17933 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17933.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17933/dental-composite-resin-devices-and-dental-curing-lights-premarket-notification-510k-submissions) ### Issuance of Priority Review Voucher; Rare Pediatric Disease Product; GENGLYCOS (parisglasgene brecaparvovec-opnr) *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that GENGLYCOS (parisglasgene brecaparvovec-opnr), approved on August 19, 2026, manufactured by Ultragenyx Pharmaceutical, Inc., meets the criteria for a priority review voucher. 91 FR 56456 · FR Doc. 2026-17932 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17932.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17932/issuance-of-priority-review-voucher-rare-pediatric-disease-product-genglycos-parisglasgene) ### International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #116 (VICH GL23(R2)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of genotoxicity testing of veterinary drug residues. 91 FR 56454 · FR Doc. 2026-17928 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17928.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17928/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary) ### International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Guidance for Industry; Availability *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #115 (VICH GL22(R)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of reproduction testing that is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures; these effects may be encountered from the presence of veterinary drug residues in food. 91 FR 56451 · FR Doc. 2026-17927 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17927.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17927/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary) ### Privacy Act of 1974; Matching Program *Notice* — Health and Human Services Department In accordance with the Privacy Act of 1974, as amended, and Office of Management and Budget (OMB) guidance on computer matching, the Department of Health and Human Services (HHS) is providing notice of the establishment of a new matching program. Pursuant to the Payment Integrity Information Act of 2019, HHS, including its component divisions and program offices, is establishing a new matching program consisting of the computerized comparison of an HHS system of records with the Do Not Pay (DNP) Working System, which is administered by Treasury's Bureau of the Fiscal Service. This matching program will enable HHS to compare records maintained in an HHS system of records covering HHS grantees and grant payments with records maintained in the DNP Working System for the purposes of identifying and preventing improper payments and conducting any related recovery activities. - **Comments close** 2 October 2026 (in 28 days) - **Takes effect** 10 September 2029 (in 1102 days) 91 FR 56457 · FR Doc. 2026-17907 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17907.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17907/privacy-act-of-1974-matching-program) ### Proposed Collection; 60-Day Comment Request; Assurance (Interinstitutional, Foreign, and Domestic) and Annual Report (Office of the Director) *Notice* — Health and Human Services Department · National Institutes of Health In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Laboratory Animal Welfare (OLAW) in the Office of Extramural Research (OER) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. - **Takes effect** 2 October 2026 (in 28 days) 91 FR 56458 · FR Doc. 2026-17899 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-02/pdf/2026-17899.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/02/2026-17899/proposed-collection-60-day-comment-request-assurance-interinstitutional-foreign-and-domestic-and) ## 1 September 2026 — 10 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-01.md) > The Department of Health and Human Services published ten notices, including meeting notices for multiple institutes, an information collection request comment period closing November 2, and a list of certified drug testing laboratories. — via Downstream, https://downstream.sh/daily/agency/health-and-human-services-department/#s-2026-09-01 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 56151 · FR Doc. 2026-17897 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17897.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17897/national-institute-on-alcohol-abuse-and-alcoholism-notice-of-closed-meeting) ### Center for Scientific Review; Notice of Closed Meetings *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 56151 · FR Doc. 2026-17896 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17896.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17896/center-for-scientific-review-notice-of-closed-meetings) ### National Institute on Drug Abuse; Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 56150 · FR Doc. 2026-17879 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17879.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17879/national-institute-on-drug-abuse-notice-of-meeting) ### Agency Information Collection Activities: Proposed Collection; 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this 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** 2 November 2026 (in 59 days) 91 FR 56147 · FR Doc. 2026-17875 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17875.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17875/agency-information-collection-activities-proposed-collection-comment-request) ### Emergency Office of Management and Budget Review and Public Comment: Questionnaire for the Refugee Outreach and Well-Being Initiative *Notice* — Health and Human Services Department · Children and Families Administration The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services, is requesting emergency review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on and extension to the proposed collection. This questionnaire is used during brief telephone interviews with Afghan arrivals who might have received ORR benefits and services, to identify any additional service needs that may support assimilation, self- sufficiency, and citizenship for eligible populations. - **Comments close** 2 November 2026 (in 59 days) 91 FR 56148 · FR Doc. 2026-17856 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17856.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17856/emergency-office-of-management-and-budget-review-and-public-comment-questionnaire-for-the-refugee) ### Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies *Notice* — Health and Human Services Department · Substance Abuse and Mental Health Services Administration The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid. 91 FR 56152 · FR Doc. 2026-17852 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17852.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17852/current-list-of-hhs-certified-laboratories-and-instrumented-initial-testing-facilities-which-meet) ### Center for Scientific Review; Amended Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 56150 · FR Doc. 2026-17850 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17850.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17850/center-for-scientific-review-amended-notice-of-meeting) ### National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 56152 · FR Doc. 2026-17849 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17849.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17849/national-institute-of-allergy-and-infectious-diseases-amended-notice-of-meeting) ### Determination That NAMENDA (Memantine Hydrochloride) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA, Agency, or we) has determined that NAMENDA (memantine hydrochloride) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as the ANDAs meet relevant legal and regulatory requirements. 91 FR 56149 · FR Doc. 2026-17812 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17812.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17812/determination-that-namenda-memantine-hydrochloride-tablets-5-milligrams-and-10-milligrams-were-not) ### Meeting of the Microbiome Subcommittee of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria; Correction *Notice* — Health and Human Services Department The Department of Health and Human Services published a document in the Federal Register of August 26, 2026 concerning the first public meeting of the Microbiome Subcommittee of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The document contained incorrect time for the meeting. 91 FR 56150 · FR Doc. 2026-17793 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-01/pdf/2026-17793.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/01/2026-17793/meeting-of-the-microbiome-subcommittee-of-the-presidential-advisory-council-on-combating) ## 31 August 2026 — 10 documents [the whole issue for this day](https://downstream.sh/daily/2026-08-31.md) > The Health and Human Services Department published ten notices on August 31, 2026, including authorizations for emergency use of animal drugs for New World screwworm treatment. — via Downstream, https://downstream.sh/daily/agency/health-and-human-services-department/#s-2026-08-31 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Notice of Interest Rate on Overdue Debts *Notice* — Health and Human Services Department · Office of the Secretary 91 FR 55890 · FR Doc. 2026-17759 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17759.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17759/notice-of-interest-rate-on-overdue-debts) ### Submission for Office of Management and Budget Review; Head Start State Collaboration Office Grant Application *Notice* — Health and Human Services Department · Children and Families Administration The Office of Head Start (OHS), Administration for Children and Families (ACF) is proposing a new information collection activity for the Head Start State Collaboration Office (HSCO) Grant Application. HSCO grants are authorized under the Head Start Act and support coordination between Head Start agencies and state systems serving young children and families. OHS has developed new application instructions to align HSCO grant activities with states and federal priorities, including improving outcomes in child welfare, strengthening family formation, supporting effective service delivery, and enhancing early childhood education. This proposed information collection is necessary to support consistent implementation of program objectives and alignment across all states. - **Comments close** 30 September 2026 (in 26 days) 91 FR 55855 · FR Doc. 2026-17745 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17745.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17745/submission-for-office-of-management-and-budget-review-head-start-state-collaboration-office-grant) ### Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) is announcing the issuance of three Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an animal product as requested by Zoetis Inc. for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS) larvae (myiasis) in dairy cattle, horses, swine, sheep, and deer. FDA has issued one EUA for an animal product as requested by Felix Pharmaceuticals Pvt. Ltd. for the treatment of infestations caused by NWS myiasis in dogs, puppies, cats, and kittens. FDA has issued one EUA for an animal product as requested by Alberta Vet Labs Ltd for the short-term prevention of infestations caused by NWS myiasis in horses. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the August 18, 2025, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves NWS. On the basis of such determination, the Secretary of HHS declared on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document. - **Takes effect** 19 May 2026 (108 days ago) 91 FR 55861 · FR Doc. 2026-17719 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17719.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17719/authorization-of-emergency-use-for-three-animal-drugs-for-the-prevention-and-treatment-of-new-world) ### Center for Scientific Review; Notice of Closed Meetings *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 55890 · FR Doc. 2026-17687 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17687.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17687/center-for-scientific-review-notice-of-closed-meetings) ### National Center for Advancing Translational Sciences; Amended Notice of Meeting *Notice* — Health and Human Services Department · National Institutes of Health 91 FR 55890 · FR Doc. 2026-17686 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17686.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17686/national-center-for-advancing-translational-sciences-amended-notice-of-meeting) ### Notice of Public Hearing: NIAID Proposed Reorganization *Notice* — Health and Human Services Department · National Institutes of Health Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) will be accepting comments on a proposed reorganization involving the Division of Clinical Research (DCR). 91 FR 55891 · FR Doc. 2026-17685 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17685.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17685/notice-of-public-hearing-niaid-proposed-reorganization) ### Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) 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** 30 September 2026 (in 26 days) 91 FR 55856 · FR Doc. 2026-17677 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17677.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17677/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) ### Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees *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 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 the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees. - **Comments close** 30 October 2026 (in 56 days) 91 FR 55857 · FR Doc. 2026-17676 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17676.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17676/agency-information-collection-activities-proposed-collection-comment-request-registration-of-human) ### Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections *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 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 associated with reports of removals and corrections for medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health (CDRH). - **Comments close** 30 October 2026 (in 56 days) 91 FR 55859 · FR Doc. 2026-17675 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17675.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17675/agency-information-collection-activities-proposed-collection-comment-request-medical-devices-reports) ### Rahim Shafa; Denial of Hearing; Final Debarment Order *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Rahim Shafa (Dr. Shafa) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Dr. Shafa from providing services in any capacity to a person that has an approved or pending drug product application and debarring Dr. Shafa for 20 years from importing or offering for import any drug into the United States. FDA bases this order on the findings that Dr. Shafa was convicted of multiple felonies under Federal law that relate to the regulation of any drug product under the FD&C Act and the importation into the United States of any drug or controlled substance under the FD&C Act. FDA provided notice to Dr. Shafa of the proposed debarment and an opportunity to request a hearing. Dr. Shafa submitted a request for a hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing. 91 FR 55886 · FR Doc. 2026-17659 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17659.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/08/31/2026-17659/rahim-shafa-denial-of-hearing-final-debarment-order) ## Earlier 15 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 2026-08-31, 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)