{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP).\" The draft guidance is intended to aid drug manufacturers and ancillary testing laboratories in using mechanical calibration as an alternate approach to the use of calibrator tablets in calibrating an apparatus used for dissolution testing. The guidance provides references to information on critical tolerances that should be achieved with mechanical calibration.","action":"Notice.","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2007/10/19/E7-20664.html","cfr_references":[],"citation":"72 FR 59298","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 17, 2008.","disposition_notes":null,"docket_ids":["Docket No. 2007D-0365"],"dockets":[],"document_number":"E7-20664","effective_on":null,"end_page":59299,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2007/10/19/E7-20664.xml","html_url":"https://www.federalregister.gov/documents/2007/10/19/E7-20664/draft-guidance-for-industry-on-the-use-of-mechanical-calibration-of-dissolution-apparatus-1-and-2--","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E7-20664?publication_date=2007-10-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2007-10-19/E7-20664/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":67,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2007-10-19/pdf/E7-20664.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2007-10-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2007/10/19/E7-20664.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-13T06:16:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59298,"subtype":null,"title":"Draft Guidance for Industry on the Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice; Availability","toc_doc":"Mechanical Calibration of Dissolution Apparatus 1 and 2; current good manufacturing practice; industry guidance","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":72}