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48 rows where docket_id = "FDA-2015-N-2002" and posted_year = 2017 sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2015-N-2002-2005 | FDA | None FDA-2015-N-2002 | Petition Interim Response from FDA OP to MIWG | Other | Letter(s) | 2017-08-01T04:00:00Z | 2017 | 8 | 2017-08-01T04:00:00Z | 2017-08-01T14:11:37Z | 0 | 0 | 090000648299066a | ||
| FDA-2015-N-2002-1990 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’; Further Delayed Effective Date; Request for Comments; Extension of Comment Period | Rule | Extension of Comment Period | 2017-05-18T04:00:00Z | 2017 | 5 | 2017-05-18T04:00:00Z | 2017-07-19T03:59:59Z | 2017-07-19T01:01:40Z | 2017-10036 | 0 | 0 | 09000064825dcd61 |
| FDA-2015-N-2002-1988 | FDA | None FDA-2015-N-2002 | Request for Extension from MIWG, PhRMA, and BIO | Other | Request for Extension | 2017-04-05T04:00:00Z | 2017 | 4 | 2017-04-05T04:00:00Z | 2017-04-05T20:52:17Z | 0 | 0 | 090000648253db32 | ||
| FDA-2015-N-2002-1981 | FDA | None FDA-2015-N-2002 | Reference 1 United States v. LA Rush, 213-cr-00249, First Superseding Information (C.D. Cal. April 3, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:11:06Z | 0 | 0 | 090000648250ead8 | |||
| FDA-2015-N-2002-1987 | FDA | None FDA-2015-N-2002 | Reference 7 DOJ_Atlanta Man Convicted of Illegally Importing and Distributing Male Enhancement Products from China re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:20:58Z | 0 | 0 | 090000648250ef2e | |||
| FDA-2015-N-2002-1983 | FDA | None FDA-2015-N-2002 | Reference 3 United States v. Carlson, 12-cr-00305-DSD-LIB, Court’s Instructions to the Jury, (D. Minn. Oct. 8, 2013) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:13:17Z | 0 | 0 | 090000648250eada | |||
| FDA-2015-N-2002-1979 | FDA | None FDA-2015-N-2002 | Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Rule | Delay of Effective Date | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T04:00:00Z | 2017-05-20T03:59:59Z | 2017-05-20T01:00:19Z | 2017-05526 | 0 | 0 | 090000648251322d |
| FDA-2015-N-2002-1984 | FDA | None FDA-2015-N-2002 | Reference 4 United States v. Bowen, 14-cr-00169-PAB, Indictment (D. Colo. May 5, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:14:17Z | 0 | 0 | 090000648250eadb | |||
| FDA-2015-N-2002-1980 | FDA | None FDA-2015-N-2002 | List of References for Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:10:16Z | 0 | 0 | 090000648250e0c7 | |||
| FDA-2015-N-2002-1985 | FDA | None FDA-2015-N-2002 | Reference 5 United States v. Bowen, 14-cr-00169-PAB, Rule 11(c)(1)(A) and (B) Plea Agreement and Statement of Facts Relevant to Sentencing (D. Colo. Jan. 29, 2015) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:18:51Z | 0 | 0 | 090000648250eadc | |||
| FDA-2015-N-2002-1982 | FDA | None FDA-2015-N-2002 | Reference 2 United States v. Carlson, 12-cr-00305-DSD-LIB, Amended Superseding Indictment (D. Minn. Sept. 11, 2013) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:12:21Z | 0 | 0 | 090000648250ead9 | |||
| FDA-2015-N-2002-1986 | FDA | None FDA-2015-N-2002 | Reference 6 United States v. Zeyid, 114-cr-0197, First Superseding Indictment (N.D. Ga. June 24, 2014) re Regulations Regarding Intended Uses Amendments: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products | Supporting & Related Material | Background Material | 2017-03-20T04:00:00Z | 2017 | 3 | 2017-03-20T15:19:51Z | 0 | 0 | 090000648250ef2d | |||
| FDA-2015-N-2002-1977 | FDA | None FDA-2015-N-2002 | Petition to Stay and for Reconsideration | Other | Petition(s) | 2017-02-09T05:00:00Z | 2017 | 2 | 2017-02-09T05:00:00Z | 2017-02-09T15:45:28Z | 0 | 0 | 09000064824b6b0e | ||
| FDA-2015-N-2002-1978 | FDA | None FDA-2015-N-2002 | Acknowledgment Letter From FDA DDM to Sidley Austin LLP and Ropes & Gray LLP | Other | Acknowledgement Letter/Receipt | 2017-02-09T05:00:00Z | 2017 | 2 | 2017-02-09T05:00:00Z | 2017-02-09T16:48:37Z | 0 | 0 | 09000064824b6e4e | ||
| FDA-2015-N-2002-1976 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ``Intended Uses''; Delayed Effective Date | Rule | Delay of Effective Date | 2017-02-07T05:00:00Z | 2017 | 2 | 2017-02-07T05:00:00Z | 2017-02-07T14:31:31Z | 2017-02485 | 0 | 0 | 09000064824afc98 | |
| FDA-2015-N-2002-1975 | FDA | None FDA-2015-N-2002 | TAB C 2016-308 Jurisdiction RIA as Cleared by OMB.docx | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:20:57Z | 0 | 0 | 090000648245bac6 | |||
| FDA-2015-N-2002-1973 | FDA | None FDA-2015-N-2002 | TAB B 2016-308 Jurisdiction Final Rule Redline Changes | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:19:38Z | 0 | 0 | 090000648245bac4 | |||
| FDA-2015-N-2002-1974 | FDA | None FDA-2015-N-2002 | TAB C 2016-308 Jurisdiction Final Rule as Cleared by OMB | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:20:30Z | 0 | 0 | 090000648245bac5 | |||
| FDA-2015-N-2002-1972 | FDA | None FDA-2015-N-2002 | TAB A 2016-308 Jurisdiction Final Rule as Submitted to OMB | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:19:47Z | 0 | 0 | 090000648245bac3 | |||
| FDA-2015-N-2002-1971 | FDA | None FDA-2015-N-2002 | Memorandum to FDA DDM Tobacco Jurisdiction Final Rule | Supporting & Related Material | Background Material | 2017-01-11T05:00:00Z | 2017 | 1 | 2017-01-11T16:20:00Z | 0 | 0 | 090000648245bac2 | |||
| FDA-2015-N-2002-1945 | FDA | None FDA-2015-N-2002 | Reference 1 - Defendant's Memorandum of Points and Authorities in Support of Motion to Dismiss or Summary Judgment, Allergan Inc., v. U.S. re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:15Z | 0 | 0 | 0900006482453a8a | |||
| FDA-2015-N-2002-1958 | FDA | None FDA-2015-N-2002 | Reference 14 - NCI, President's Cancer Panel re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:18Z | 0 | 0 | 0900006482453ea0 | |||
| FDA-2015-N-2002-1950 | FDA | None FDA-2015-N-2002 | Reference 6 - Good-2016-Off-Label Drug Use and Adverse Drug re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:33Z | 0 | 0 | 090000648245417e | |||
| FDA-2015-N-2002-1952 | FDA | None FDA-2015-N-2002 | Reference 8 - Avorn-2015-Forbidden and Permitted Statements re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:46Z | 0 | 0 | 0900006482454180 | |||
| FDA-2015-N-2002-1953 | FDA | None FDA-2015-N-2002 | Reference 9 - Kapczynski-2016-Free Speech and Pharmaceutical re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:54Z | 0 | 0 | 0900006482454181 | |||
| FDA-2015-N-2002-1947 | FDA | None FDA-2015-N-2002 | Reference 3 - Byron, Adolescents and Adults Perceptions of Natural Organic and re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:22Z | 0 | 0 | 090000648245417a | |||
| FDA-2015-N-2002-1944 | FDA | None FDA-2015-N-2002 | Jurisdiction References List re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-19T15:02:07Z | 0 | 0 | 0900006482453a89 | |||
| FDA-2015-N-2002-1959 | FDA | None FDA-2015-N-2002 | Reference 15 - IOM_Blueprint_2007 re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:21Z | 0 | 0 | 0900006482453ea1 | |||
| FDA-2015-N-2002-1965 | FDA | None FDA-2015-N-2002 | Jurisdiction FRIA references_final2 re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:44Z | 0 | 0 | 0900006482453ebd | |||
| FDA-2015-N-2002-1969 | FDA | None FDA-2015-N-2002 | Reference 4 - Size Standards Table re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:59Z | 0 | 0 | 0900006482453ec1 | |||
| FDA-2015-N-2002-1948 | FDA | None FDA-2015-N-2002 | Reference 4 - Green, Evidence of the Effects of Mandatory Disclaim re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:26Z | 0 | 0 | 090000648245417b | |||
| FDA-2015-N-2002-1951 | FDA | None FDA-2015-N-2002 | Reference 7 - Eguale-2016-Association of Off-Label Drug Use re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:36Z | 0 | 0 | 090000648245417f | |||
| FDA-2015-N-2002-1956 | FDA | None FDA-2015-N-2002 | Reference 12 - Kesselheim, ProspectsforRegulationofOffLabelDr re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:11Z | 0 | 0 | 0900006482453e9e | |||
| FDA-2015-N-2002-1970 | FDA | None FDA-2015-N-2002 | Reference 5 - U.S. Census - Tobacco and Tobacco Product re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:47:03Z | 0 | 0 | 0900006482453ec2 | |||
| FDA-2015-N-2002-1960 | FDA | None FDA-2015-N-2002 | Reference 16 - Roditis-2015-Adolescents' Perceptions of Risks re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:25Z | 0 | 0 | 0900006482453ea2 | |||
| FDA-2015-N-2002-1954 | FDA | None FDA-2015-N-2002 | Reference 10 - Cardarelli-2006-A cross-sectional evidence-bas re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:00Z | 0 | 0 | 0900006482454182 | |||
| FDA-2015-N-2002-1957 | FDA | None FDA-2015-N-2002 | Reference 13 - Stafford-2008-Regulating off-label drug use--r re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:14Z | 0 | 0 | 0900006482453e9f | |||
| FDA-2015-N-2002-1961 | FDA | None FDA-2015-N-2002 | Reference 17 - Vickerman-2013-Use of electronic cigarettes am re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:29Z | 0 | 0 | 0900006482453ea3 | |||
| FDA-2015-N-2002-1963 | FDA | None FDA-2015-N-2002 | Reference 19 - Jurisdiction Final Rule re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:35Z | 0 | 0 | 0900006482453ea5 | |||
| FDA-2015-N-2002-1966 | FDA | None FDA-2015-N-2002 | Reference 1 - Deeming Rule_FRIA re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:47Z | 0 | 0 | 0900006482453ebe | |||
| FDA-2015-N-2002-1946 | FDA | None FDA-2015-N-2002 | Reference 2 - Etter-2011-Electronic cigarette_ users profile re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:19Z | 0 | 0 | 0900006482454179 | |||
| FDA-2015-N-2002-1943 | FDA | None FDA-2015-N-2002 | Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Rule | Final Rule | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T05:00:00Z | 2017-01-09T15:27:31Z | 2016-31950 | 0 | 0 | 0900006482452b42 | |
| FDA-2015-N-2002-1955 | FDA | None FDA-2015-N-2002 | Reference 11 - Eisenberg, The Role of the FDA in Innovation P | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T22:50:08Z | 0 | 0 | 0900006482453e9d | |||
| FDA-2015-N-2002-1962 | FDA | None FDA-2015-N-2002 | Reference 18 - Gallup Consumption Habits re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:32Z | 0 | 0 | 0900006482453ea4 | |||
| FDA-2015-N-2002-1964 | FDA | None FDA-2015-N-2002 | Reference 20 - Janssen, Outline of the History of U.S. Drug re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:39Z | 0 | 0 | 0900006482453ea6 | |||
| FDA-2015-N-2002-1967 | FDA | None FDA-2015-N-2002 | Reference 2, FDA, Safety and Effectiveness of Consumer Antiseptics Rub Products re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:51Z | 0 | 0 | 0900006482453ebf | |||
| FDA-2015-N-2002-1949 | FDA | None FDA-2015-N-2002 | Reference 5 - Kesselheim-2008-Pharmaceutical Promotion to Ph re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:45:29Z | 0 | 0 | 090000648245417d | |||
| FDA-2015-N-2002-1968 | FDA | None FDA-2015-N-2002 | Reference 3 - RTI, FDA Labeling Cost ModelFINAL re Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" | Supporting & Related Material | Background Material | 2017-01-09T05:00:00Z | 2017 | 1 | 2017-01-09T18:46:54Z | 0 | 0 | 0900006482453ec0 |
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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;