id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2021-N-0862-0177,FDA,FDA-2021-N-0862,FDA Listening Session with APhA Stakeholders--High-Level Notes,Other,Meeting Exhibits,2022-11-22T05:00:00Z,2022,11,2022-11-22T05:00:00Z,2022-11-26T04:59:59Z,2022-11-22T20:15:53Z,,0,0,09000064854fc3fd FDA-2021-N-0862-0140,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period,Proposed Rule,Extension of Comment Period,2022-10-24T04:00:00Z,2022,10,2022-10-24T04:00:00Z,,2022-11-22T18:58:05Z,2022-23033,0,0,090000648544cb97 FDA-2021-N-0862-0043,FDA,FDA-2021-N-0862,Request for Extension from Consumer Healthcare Products Association,Other,Request for Extension,2022-10-06T04:00:00Z,2022,10,2022-10-06T04:00:00Z,,2022-11-22T18:57:53Z,,0,0,09000064853bd957 FDA-2021-N-0862-0039,FDA,FDA-2021-N-0862,Request for Extension from American Pharmacists Association,Other,Request for Extension,2022-09-26T04:00:00Z,2022,9,2022-09-26T04:00:00Z,,2022-11-22T18:57:40Z,,0,0,090000648536e90d FDA-2021-N-0862-0001,FDA,FDA-2021-N-0862,Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2022-06-28T04:00:00Z,2022,6,2022-06-28T04:00:00Z,2022-11-26T04:59:59Z,2024-08-23T01:00:37Z,2022-13309,0,0,09000064851a6c55 FDA-2021-N-0862-0008,FDA,FDA-2021-N-0862,Reference 6- Engelberg Expert Workshop--Exploring Implications of the Nonprescription Drug Safe Use Regulatory Expansion Initiative on Reimbursement and Access_2013 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:48:58Z,,0,0,09000064851a6e08 FDA-2021-N-0862-0011,FDA,FDA-2021-N-0862,Reference 9 - 70 FR 52050 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:46:47Z,,0,0,09000064851a6e05 FDA-2021-N-0862-0004,FDA,FDA-2021-N-0862,Reference 2- Journal of Research in Pharmacy Practice re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:32:38Z,,0,0,09000064851a6e07 FDA-2021-N-0862-0010,FDA,FDA-2021-N-0862,Reference 8- 83 FR 13394 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:45:35Z,,0,0,09000064851a6e03 FDA-2021-N-0862-0009,FDA,FDA-2021-N-0862,Reference 7- FDA Preliminary Regulatory Impact Analysis_Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:43:52Z,,0,0,09000064851a6e04 FDA-2021-N-0862-0005,FDA,FDA-2021-N-0862,Reference 3- Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:34:10Z,,0,0,09000064851a56d6 FDA-2021-N-0862-0007,FDA,FDA-2021-N-0862,Reference 5- Engelberg Expert Workshop--Innovative Technologies and Nonprescription Medications--Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:39:56Z,,0,0,09000064851a6e0a FDA-2021-N-0862-0003,FDA,FDA-2021-N-0862,"Reference 1- Guidance for Industry Self-Selection Studies for Nonprescription Drug Products re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use",Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:30:20Z,,0,0,09000064851a56d8 FDA-2021-N-0862-0013,FDA,FDA-2021-N-0862,Reference 11 - 83 FR 33938 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:49:29Z,,0,0,09000064851a6e02 FDA-2021-N-0862-0002,FDA,FDA-2021-N-0862,Reference List re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:28:40Z,,0,0,09000064851a56d7 FDA-2021-N-0862-0006,FDA,FDA-2021-N-0862,Reference 4- Engleberg Expert Workshop--Nonprescription Medications With Conditions of Safe Use as a Novel Solution for Undertreated Diseases or conditions re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:38:18Z,,0,0,09000064851a6e06 FDA-2021-N-0862-0012,FDA,FDA-2021-N-0862,Reference 10 - 77 FR 12059 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use,Supporting & Related Material,Background Material,2022-06-28T04:00:00Z,2022,6,,,2022-06-28T13:49:16Z,,0,0,09000064851a6e09