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withdrawn,object_id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-2002-2054,FDA,FDA-2015-N-2002,Regulations Regarding ‘‘Intended Uses’’,Rule,Final Rule,2021-08-02T04:00:00Z,2021,8,2021-08-02T04:00:00Z,,2021-08-02T16:56:29Z,2021-15980,0,0,0900006484c2027a
FDA-2015-N-2002-2038,FDA,FDA-2015-N-2002,Request for Extension from Medical Information Working Group (MIWG),Other,Request for Extension,2020-12-15T05:00:00Z,2020,12,2020-12-15T05:00:00Z,,2020-12-15T22:20:25Z,,0,0,09000064848b8379
FDA-2015-N-2002-2037,FDA,FDA-2015-N-2002,Request for Extension from Advanced Medical Technology Association (AdvaMed),Other,Request for Extension,2020-12-15T05:00:00Z,2020,12,2020-12-15T05:00:00Z,,2020-12-15T22:18:20Z,,0,0,09000064848a3295
FDA-2015-N-2002-2036,FDA,FDA-2015-N-2002,Intended Use PR - Response to MIWG Request to Extend Comment Period,Other,Letter(s),2020-11-17T05:00:00Z,2020,11,2020-11-17T05:00:00Z,,2020-11-17T15:01:04Z,,0,0,09000064849619c9
FDA-2015-N-2002-2035,FDA,FDA-2015-N-2002,Intended Use PR - Response to AdvaMed Request to Extend Comment Period,Other,Letter(s),2020-11-17T05:00:00Z,2020,11,2020-11-17T05:00:00Z,,2020-11-17T15:00:53Z,,0,0,09000064849619c7
FDA-2015-N-2002-2031,FDA,FDA-2015-N-2002,"REFERENCE 1 - Plaintiff’s Memorandum of Law at 38–40, Allergan Inc. v. United States RE Regulations Regarding Intended Uses",Supporting & Related Material,Background Material,2020-09-23T04:00:00Z,2020,9,,,2020-09-23T16:38:10Z,,0,0,0900006484873dc9
FDA-2015-N-2002-2034,FDA,FDA-2015-N-2002,"REFERENCE 10 - Eguale, T., D.L. Buckeridge, A. Verma, et al RE Regulations Regarding Intended Uses",Supporting & Related Material,Background Material,2020-09-23T04:00:00Z,2020,9,,,2020-09-23T16:38:36Z,,0,0,0900006484873f3b
FDA-2015-N-2002-2032,FDA,FDA-2015-N-2002,"REFERENCE 2 -  Complaint at 35–37, Par Pharmaceutical Inc. v. United States RE Regulations Regarding Intended Uses",Supporting & Related Material,Background Material,2020-09-23T04:00:00Z,2020,9,,,2020-09-23T16:38:19Z,,0,0,0900006484873dca
FDA-2015-N-2002-2030,FDA,FDA-2015-N-2002,Regulations Regarding Intended Uses,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2020-09-23T04:00:00Z,2020,9,2020-09-23T04:00:00Z,2020-10-24T03:59:59Z,2020-12-16T02:02:47Z,2020-20437,0,0,0900006484872e2d
FDA-2015-N-2002-2033,FDA,FDA-2015-N-2002,REFERENCE 3 -  Citizen Petition from the Medical Information Working Group at 18 RE Regulations Regarding Intended Uses,Supporting & Related Material,Background Material,2020-09-23T04:00:00Z,2020,9,,,2020-09-23T16:38:27Z,,0,0,0900006484873dcb
FDA-2015-N-2002-2029,FDA,FDA-2015-N-2002,Kalb et al_IU Final Rule_Response_3-26-18,Other,Agency Response,2018-04-09T04:00:00Z,2018,4,2018-04-09T04:00:00Z,,2018-04-09T21:10:24Z,,0,0,09000064830e95e3
FDA-2015-N-2002-2028,FDA,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’’; Partial Delay of Effective Date",Rule,Final Rule,2018-03-16T04:00:00Z,2018,3,2018-03-16T04:00:00Z,,2018-03-16T14:18:37Z,2018-05347,0,0,090000648301bfb5
FDA-2015-N-2002-2008,FDA,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’’; Proposed Partial Delay of
Effective Date",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2018-01-16T05:00:00Z,2018,1,2018-01-16T05:00:00Z,2018-02-06T04:59:59Z,2018-02-06T14:02:16Z,2018-00555,0,0,0900006482e0b3c7
FDA-2015-N-2002-2005,FDA,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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
FDA-2015-N-2002-0023,FDA,FDA-2015-N-2002,Request for Extension from Campaign for Tobacco Free Kids et al.,Other,Request for Extension,2016-01-15T05:00:00Z,2016,1,2016-01-15T05:00:00Z,,2016-01-15T19:16:26Z,,0,0,0900006481d4062e
FDA-2015-N-2002-0008,FDA,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’’; Reopening of the Comment
Period",Proposed Rule,Reopening of Comment Period,2015-11-30T05:00:00Z,2015,11,2015-11-30T05:00:00Z,2015-12-31T04:59:59Z,2015-12-31T22:00:26Z,2015-30271,0,0,0900006481d7964a
FDA-2015-N-2002-0002,FDA,FDA-2015-N-2002,"List of References re Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products Amendments to Regulations Regarding Intended Uses Proposed Rule",Supporting & Related Material,Background Material,2015-09-25T04:00:00Z,2015,9,,,2015-12-03T12:44:54Z,,0,0,0900006481c965b1
FDA-2015-N-2002-0003,FDA,FDA-2015-N-2002,"Reference 1 - U.S. Dept of Commerce, Bureau of Economic Analysis Natiuonal Income and Product Accounts",Supporting & Related Material,Background Material,2015-09-25T04:00:00Z,2015,9,,,2015-12-03T12:45:11Z,,0,0,0900006481c965b2
FDA-2015-N-2002-0005,FDA,FDA-2015-N-2002,"Reference 3 - Easley, David, and OHara - Ambiguity and Nonparticipation, The Role of Regulation- Review of Financial Studies",Supporting & Related Material,Background Material,2015-09-25T04:00:00Z,2015,9,,,2015-12-03T12:45:51Z,,0,0,0900006481c965b4
FDA-2015-N-2002-0001,FDA,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''",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2015-09-25T04:00:00Z,2015,9,2015-09-25T04:00:00Z,2015-11-25T04:59:59Z,2016-01-15T22:00:58Z,2015-24313,0,0,0900006481c95e75
FDA-2015-N-2002-0004,FDA,FDA-2015-N-2002,"Reference 2 - Ellsberg, Daniel -Risk, Ambiguity, and the Savage Axioms- The Quarterly Journal of Economics",Supporting & Related Material,Background Material,2015-09-25T04:00:00Z,2015,9,,,2015-12-03T12:45:34Z,,0,0,0900006481c965b3
FDA-2015-N-2002-0006,FDA,FDA-2015-N-2002,"Reference 4 - Dimmock et al - Ambiguity Aversion and Household Portfolio Choice, Empirical Evidence- NBER Working Paper Series",Supporting & Related Material,Background Material,2015-09-25T04:00:00Z,2015,9,,,2015-12-03T12:46:10Z,,0,0,0900006481c9622e
FDA-2015-N-2002-0007,FDA,FDA-2015-N-2002,"Reference 5 - Defendant's Memorandum of Points and Authorities in Support of Motion to Dismiss or Summary Judgment, Allergan Inc., v. U.S.",Supporting & Related Material,Background Material,2015-09-25T04:00:00Z,2015,9,,,2015-12-03T12:46:32Z,,0,0,0900006481c9622f