{"description":"Documents matching '\"TB-500\"'","count":2,"total_pages":1,"results":[{"title":"Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding 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.","document_number":"2026-07361","html_url":"https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-16/pdf/2026-07361.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07361.pdf?1776257113","publication_date":"2026-04-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: BPC-157-related bulk drug substances (BPC-157 (free base)/BPC-157 acetate), KPV-related bulk drug substances (KPV (free base)/KPV acetate), <span class=\"match\">TB-500</span>-related bulk drug substances (<span class=\"match\">TB-500</span> (free base)/<span class=\"match\">TB-500</span> acetate), and MOTs-C-related bulk drug substances (MOTs-C (free base)/MOTs-C acetate). The chart below identifies the use(s) FDA reviewed for each of the bulk drug substances being discussed at this advisory committee meeting. For nominated bulk"},{"title":"Proposed Information Collection Activity; Medical Health Assessment Form and Public Health Investigation Forms, Tuberculosis and Non-Tuberculosis Illness (Office of Management and Budget 0970-0509)","type":"Notice","abstract":"The Administration for Children and Families (ACF) is requesting a 3-year extension of the Mental Health Assessment Form (formerly the Health Assessment Form) and Public Health Investigation Forms, Active Tuberculosis (TB) and Non-TB Illness (Office of Management and Budget (OMB) #0970-0509, expiration December 31, 2023. Changes are proposed to the currently approved forms.","document_number":"2023-11627","html_url":"https://www.federalregister.gov/documents/2023/06/01/2023-11627/proposed-information-collection-activity-medical-health-assessment-form-and-public-health","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-06-01/pdf/2023-11627.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-11627.pdf?1685537131","publication_date":"2023-06-01","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Administration for Children and Families","name":"Children and Families Administration","id":49,"url":"https://www.federalregister.gov/agencies/children-and-families-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/49","parent_id":221,"slug":"children-and-families-administration"}],"excerpts":"responses per \n respondent \n \n \n Average\n burden \n hours per \n response \n \n \n Total\n burden \n hours \n \n \n Annual\n burden \n hours \n \n \n \n Mental Health Assessment Form \n Care provider program staff \n 500 \n 6.8 \n 0.21 \n 2,142 \n 714 \n \n \n Public Health Investigation Form: Active <span class=\"match\">TB \n \n 500</span> \n 1 \n 0.08 \n 1200 \n 400 \n \n \n Public Health Investigation Form: Non-TB Illness \n \n 500 \n 200 \n 0.08 \n 24,000 \n 8,000 \n \n \n Estimated Total Annual Burden Hours \n \n \n \n \n \n 9,114 \n \n \n \n Comments: \n The Department specifically requests comments on (a) whether the proposed"}]}