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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

42 rows where docket_id = "FDA-2021-N-0555" and posted_year = 2022 sorted by posted_date descending

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document_type 4

  • Supporting & Related Material 39
  • Notice 1
  • Other 1
  • Rule 1

posted_year 1

  • 2022 · 42 ✖

agency_id 1

  • FDA 42
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0555-1173 FDA None FDA-2021-N-0555 Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Notice General Notice 2022-12-15T05:00:00Z 2022 12 2022-12-15T05:00:00Z   2022-12-15T21:57:11Z 2022-27192 0 0 0900006485534831
FDA-2021-N-0555-1169 FDA None FDA-2021-N-0555 TAB B 2022-111 OTC Hearing Aids Final Rule Track Changes RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule Supporting & Related Material Background Material 2022-09-06T04:00:00Z 2022 9     2022-09-06T18:49:53Z   0 0 09000064852b4f21
FDA-2021-N-0555-1170 FDA None FDA-2021-N-0555 TAB B 2022-111 OTC Hearing Aids RIA Track Changes RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule Supporting & Related Material Background Material 2022-09-06T04:00:00Z 2022 9     2022-09-06T18:49:59Z   0 0 09000064852b4f4d
FDA-2021-N-0555-1167 FDA None FDA-2021-N-0555 TAB A 2022-111 OTC Hearing Aids Final Rule as Submitted to OMB RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule Supporting & Related Material Background Material 2022-09-06T04:00:00Z 2022 9     2022-09-06T18:49:37Z   0 0 09000064852b4809
FDA-2021-N-0555-1171 FDA None FDA-2021-N-0555 TAB C 2022-111 OTC Hearing Aids Final Rule as Cleared by OMB RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule Supporting & Related Material Background Material 2022-09-06T04:00:00Z 2022 9     2022-09-06T18:50:06Z   0 0 09000064852b4f4f
FDA-2021-N-0555-1168 FDA None FDA-2021-N-0555 TAB A 2022-111 OTC Hearing Aids RIA as Submitted to OMB RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule Supporting & Related Material Background Material 2022-09-06T04:00:00Z 2022 9     2022-09-06T18:49:46Z   0 0 09000064852b4f1a
FDA-2021-N-0555-1172 FDA None FDA-2021-N-0555 TAB C 2022-111 OTC Hearing Aids RIA as Cleared by OMB RE Memorandum to FDA DMS on OTC Hearing Aids Final Rule Supporting & Related Material Background Material 2022-09-06T04:00:00Z 2022 9     2022-09-06T18:50:13Z   0 0 09000064852b5038
FDA-2021-N-0555-1166 FDA None FDA-2021-N-0555 Memorandum to FDA DMS on OTC Hearing Aids Final Rule Other Memorandum 2022-09-06T04:00:00Z 2022 9 2022-09-06T04:00:00Z   2022-09-06T18:47:29Z   0 0 09000064852b4807
FDA-2021-N-0555-1164 FDA None FDA-2021-N-0555 EA Reference 13 - FN - Hearing Aids Cost More Than Their Weight in Gold RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:42:33Z   0 0 0900006485247a41
FDA-2021-N-0555-1148 FDA None FDA-2021-N-0555 RIA Reference 1 - The Big Six Hearing Aid Companies RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:01Z   0 0 09000064852479be
FDA-2021-N-0555-1132 FDA None FDA-2021-N-0555 Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Rule Final Rule 2022-08-17T04:00:00Z 2022 8 2022-08-17T04:00:00Z   2022-08-17T13:33:48Z 2022-17230 0 0 09000064852454dd
FDA-2021-N-0555-1134 FDA None FDA-2021-N-0555 Reference 1 - Hearing Loss Prevalence in the US RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:39:36Z   0 0 0900006485247969
FDA-2021-N-0555-1136 FDA None FDA-2021-N-0555 Reference 3 - NIH Fact Sheet - Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:39:53Z   0 0 090000648524796d
FDA-2021-N-0555-1142 FDA None FDA-2021-N-0555 Reference 9 - Occupational Noise Exposure NIOSH 98-126 RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:27Z   0 0 090000648524798f
FDA-2021-N-0555-1155 FDA None FDA-2021-N-0555 Environmental Assessment FONSI RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:38Z   0 0 09000064852479f8
FDA-2021-N-0555-1141 FDA None FDA-2021-N-0555 Reference 8 - ANSI-CTA 2051 2017 (FINAL) RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:22Z   0 0 090000648524798b
FDA-2021-N-0555-1146 FDA None FDA-2021-N-0555 Reference 13 - New HRCT-Based Measurements of Human Ear Canal RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:49Z   0 0 09000064852479ba
FDA-2021-N-0555-1165 FDA None FDA-2021-N-0555 EA Reference 14 - FN - Duracell Hearing Aid Batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:42:38Z   0 0 0900006485247a42
FDA-2021-N-0555-1133 FDA None FDA-2021-N-0555 List of References (Final Rule) RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:39:15Z   0 0 0900006485247968
FDA-2021-N-0555-1145 FDA None FDA-2021-N-0555 Reference 12 - External Auditory Canal Measurements RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:43Z   0 0 09000064852479b9
FDA-2021-N-0555-1149 FDA None FDA-2021-N-0555 RIA Reference 2 - 20Q - 25 Years of MarkeTrak RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:07Z   0 0 09000064852479bf
FDA-2021-N-0555-1137 FDA None FDA-2021-N-0555 Reference 4 - Longitudinal Relationship Between Hearing Aid Use and Cognitive Function in Older Americans RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:39:59Z   0 0 090000648524796f
FDA-2021-N-0555-1143 FDA None FDA-2021-N-0555 Reference 10 - Safety Limit Warning Levels RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:32Z   0 0 0900006485247991
FDA-2021-N-0555-1150 FDA None FDA-2021-N-0555 RIA Reference 3 - Online Shopping and E-Commerce RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:12Z   0 0 09000064852479c0
FDA-2021-N-0555-1152 FDA None FDA-2021-N-0555 RIA Reference 5 - How Long Do Hearing Aids Last RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:22Z   0 0 09000064852479f5
FDA-2021-N-0555-1154 FDA None FDA-2021-N-0555 RIA Reference 8 - NAICS 325400 – Pharmaceutical and Medical Manufacturing RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:33Z   0 0 09000064852479f7
FDA-2021-N-0555-1144 FDA None FDA-2021-N-0555 Reference 11 - Real World Evidence on Gain and Output Settings RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:38Z   0 0 09000064852479b8
FDA-2021-N-0555-1153 FDA None FDA-2021-N-0555 RIA Reference 7 - FDA Labeling Cost Model RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:27Z   0 0 09000064852479f6
FDA-2021-N-0555-1158 FDA None FDA-2021-N-0555 EA Reference 7 - FN - Universal Waste RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:42:00Z   0 0 09000064852479fb
FDA-2021-N-0555-1160 FDA None FDA-2021-N-0555 EA Reference 9 - FN - What are the benefits of rechargeable batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:42:11Z   0 0 09000064852479fd
FDA-2021-N-0555-1139 FDA None FDA-2021-N-0555 Reference 6 - Why do people fitted with hearing aids not wear them RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:10Z   0 0 0900006485247988
FDA-2021-N-0555-1157 FDA None FDA-2021-N-0555 EA Reference 5 - Advancing Sustainable Materials Management RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:54Z   0 0 09000064852479fa
FDA-2021-N-0555-1159 FDA None FDA-2021-N-0555 EA Reference 8 - FN - Mercury in Batteries RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:42:06Z   0 0 09000064852479fc
FDA-2021-N-0555-1151 FDA None FDA-2021-N-0555 RIA Reference 4 - MarkeTrak VIII - 25-Year Trends in the Hearing Health Market RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:17Z   0 0 09000064852479c1
FDA-2021-N-0555-1162 FDA None FDA-2021-N-0555 EA Reference 11 - FN - FAQ About Hearing Aids RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:42:21Z   0 0 0900006485247a3e
FDA-2021-N-0555-1161 FDA None FDA-2021-N-0555 EA Reference 10 - FN - How Long Do Hearing Aid Batteries Last RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:42:16Z   0 0 09000064852479fe
FDA-2021-N-0555-1163 FDA None FDA-2021-N-0555 EA Reference 12 - FN - Hearing Loss and Hearing Aid Use Infographic RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:42:27Z   0 0 0900006485247a40
FDA-2021-N-0555-1138 FDA None FDA-2021-N-0555 Reference 5 - Can Hearing Aids Delay Time to Diagnosis of Dementia etc RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:05Z   0 0 0900006485247970
FDA-2021-N-0555-1140 FDA None FDA-2021-N-0555 Reference 7 - Hearing Health Care for Adults Priorities for Improving Access and Affordability RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:15Z   0 0 0900006485247989
FDA-2021-N-0555-1147 FDA None FDA-2021-N-0555 Reference 16 - Regulatory Impact Analysis RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:40:55Z   0 0 09000064852479bb
FDA-2021-N-0555-1156 FDA None FDA-2021-N-0555 EA Reference 4 - Electronic Waste Management Approaches RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:41:44Z   0 0 09000064852479f9
FDA-2021-N-0555-1135 FDA None FDA-2021-N-0555 Reference 2 - Impact of Hearing Loss on Quality of Life in Older Adults RE Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the Counter Hearing Aids Supporting & Related Material Background Material 2022-08-17T04:00:00Z 2022 8     2022-08-17T17:39:47Z   0 0 090000648524796b

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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