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

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27 rows where docket_id = "FDA-2013-N-0461" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-N-0461-1596 FDA None FDA-2013-N-0461 Reference 6 Cokkinides, V., M. Weinstock, D. Lazovich, et al., "Indoor Tanning Use Among Adolescents in the United States, 1998‐2004,"Cancer, vol. 115, pp. 190‐198, 2009 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:36:10Z   0 0 0900006481726b1f
FDA-2013-N-0461-1612 FDA None FDA-2013-N-0461 Reference16 Gallagher, R.P., J.J. Spinelli, and T.K. Lee, "Tanning Beds, Sunlamps, and Risk of Cutaneous Malignant Melanoma," Cancer Epidemiology, Biomarkers & Prevention, vol. 14(3), pp. 562‐566, 2005. Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:52:00Z   0 0 0900006481726b29
FDA-2013-N-0461-1593 FDA None FDA-2013-N-0461 Reference 3 Reed, K.B., J.D. Brewer, C.M. Lohse, et al., "Increasing Incidence of Melanoma Among Young Adults: An Epidemiological Study in Olmsted County, Minnesota," Mayo Clinic Proceedings, vol. 87, pp. 328‐334, 2012 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:33:37Z   0 0 0900006481726aef
FDA-2013-N-0461-1607 FDA None FDA-2013-N-0461 Reference 19 Differential Risk of Malignant Melanoma by Sunbed Exposure Type Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:46:00Z   0 0 0900006481726b2c
FDA-2013-N-0461-1592 FDA None FDA-2013-N-0461 Reference 2 Freedman, D.B., B.A. Miller, and M.A. Tucker, "New Malignancies Following Melanoma of Skin, Eye Melanoma, and Nonmelanoma Eye Cancer," New Malignancies Among Cancer Survivors: SEER Cancer Registries, 1973‐2000, pp. 339‐362, 2006 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:32:40Z   0 0 0900006481726aee
FDA-2013-N-0461-1603 FDA None FDA-2013-N-0461 Reference 14 SEER Stat Fact Sheets: Melanoma of the Skin Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:43:00Z   0 0 0900006481726b27
FDA-2013-N-0461-1590 FDA None FDA-2013-N-0461 List of References Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:30:25Z   0 0 0900006481726aec
FDA-2013-N-0461-1599 FDA None FDA-2013-N-0461 Reference 9 Agenda for Quarterly Meeting on MDUFA III (FY 2013-2017) Performance January 29, 2014 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:39:46Z   0 0 0900006481726b22
FDA-2013-N-0461-1594 FDA None FDA-2013-N-0461 Reference 4 Cust, A.E., B.K. Armstrong, C. Goumas, et al., "Sunbed Use During Adolescence and Early Adulthood Is Associated With Increased Risk of Early‐Onset Melanoma," International Journal of Cancer, vol. 128, pp. 2425‐2435, 2011 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:34:51Z   0 0 0900006481726af0
FDA-2013-N-0461-1604 FDA None FDA-2013-N-0461 Reference15 SEER Cancer Statistics Review 1975‐2010 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:43:54Z   0 0 0900006481726b28
FDA-2013-N-0461-1606 FDA None FDA-2013-N-0461 Reference 18 Doré, J. and M.C. Chignol, "Tanning Salons and Skin Cancer," Photochemical & Photobiological Sciences, vol. 11(1), pp. 30‐37, 2012 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:45:24Z   0 0 0900006481726b2b
FDA-2013-N-0461-1610 FDA None FDA-2013-N-0461 Reference 22 Mayer, J.A., S.I. Woodruff, D.J. Slymen, et al., "Adolescents' Use of Indoor Tanning: A Large‐Scale Evaluation of Psychosocial, Environmental, and Policy‐Level Correlates," American Journal of Public Health, vol. 101(5), pp. 930‐938, 2011 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:48:13Z   0 0 0900006481726b2f
FDA-2013-N-0461-1602 FDA None FDA-2013-N-0461 Reference 12 National Institutes of Health, Office of Dietary Supplements, "Dietary Supplement Fact Sheet: Vitamin D" (http://ods.od.nih.gov/factsheets/VitaminD‐HealthProfessional/) Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:41:39Z   0 0 0900006481726b25
FDA-2013-N-0461-1609 FDA None FDA-2013-N-0461 Reference 21 Zhang, M., A.A. Qureshi, A.C. Geller, et al., "Use of Tanning Beds and Incidence of Skin Cancer," Journal of Clinical Oncology, vol. 30, pp. 1588-1593, 2012 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:47:25Z   0 0 0900006481726b2e
FDA-2013-N-0461-1601 FDA None FDA-2013-N-0461 Reference11 Autier, P. and P. Boyle, "Artificial Ultraviolet Sources and Skin Cancers: Rationale for Restricting Access to Sunbed Use Before 18 Years of Age," Nature Clinical Practice Oncology, vol. 5(4), pp. 178‐179, 2008 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:41:05Z   0 0 0900006481726b24
FDA-2013-N-0461-1597 FDA None FDA-2013-N-0461 Reference 7 78 FR 27117, May 9, 2013 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:37:04Z   0 0 0900006481726b20
FDA-2013-N-0461-1598 FDA None FDA-2013-N-0461 Refence 8 Panel Roster General and Plastic Surgery Devices Advisory Panel Meeting Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:38:01Z   0 0 0900006481726b21
FDA-2013-N-0461-1611 FDA None FDA-2013-N-0461 Reference13 "IARC Working Group on Artificial Ultraviolet Light (UV) and Skin Cancer: The Association of Use of Sunbeds With Cutaneous Malignant Melanoma and Other Skin Cancers: A Systematic Review," International Journal of Cancer, vol. 120, pp. 1116‐1122, 2006 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:51:15Z   0 0 0900006481726b26
FDA-2013-N-0461-1608 FDA None FDA-2013-N-0461 Reference 20 Grant, W.B., "Critique of the International Agency for Research on Cancer's Meta‐Analyses of the Association of Sunbed Use With Risk of Cutaneous Malignant Melanoma," Dermatoendocrinology, vol. 1(6), pp. 294–299, 2009 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:46:46Z   0 0 0900006481726b2d
FDA-2013-N-0461-1591 FDA None FDA-2013-N-0461 Reference 1 Salama, A.K., N. de Rosa, R.P. Scheri, et al., "Hazard‐Rate Analysis and Patterns of Recurrence in Early Stage Melanoma: Moving Towards a Rationally Designed Surveillance Strategy," PLoS One, vol. 8, pp. e576‐e665, 2013 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:31:30Z   0 0 0900006481726aed
FDA-2013-N-0461-1595 FDA None FDA-2013-N-0461 Reference 5 Stapleton, J.L., J. Hillhouse, R. Turrisi, et al., "Erythema and Ultraviolet Tanning: Findings From a Diary Study," Translational Behavioral Medicine, vol. 3, pp. 10‐16, 2013 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:35:34Z   0 0 0900006481726b1e
FDA-2013-N-0461-1600 FDA None FDA-2013-N-0461 Reference10 Sivamani, R.K., L.A. Crane, R.P. Dellavalle, et al.,"The Benefits and Risks of Ultraviolet Tanning and Its Alternatives: The Role of Prudent Sun Exposure," Dermatologic Clinics, vol. 27, pp. 149‐154, 2009 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:40:31Z   0 0 0900006481726b23
FDA-2013-N-0461-1605 FDA None FDA-2013-N-0461 Reference 17 Boniol, M., P. Autier, P. Boyle, et al., "Cutaneous Melanoma Attributable to Sunbed Use: Systematic Review and Meta‐Analysis," British Medical Journal, vol. 345, p. e4757 July 24, 2012 Supporting & Related Material Background Material 2014-06-04T04:00:00Z 2014 6     2014-06-04T16:44:32Z   0 0 0900006481726b2a
FDA-2013-N-0461-1589 FDA None FDA-2013-N-0461 General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in Sunlamp Products Rule Final Rule 2014-06-02T04:00:00Z 2014 6 2014-06-02T04:00:00Z   2016-07-13T01:00:34Z 2014-12546 0 0 0900006481722b4c
FDA-2013-N-0461-1375 FDA None FDA-2013-N-0461 Supplement from Indoor Tanning Association ITA Other Supplemental Comment 2014-01-27T05:00:00Z 2014 1 2014-01-27T05:00:00Z   2014-01-28T00:59:28Z   0 0 0900006481390331
FDA-2013-N-0461-0562 FDA None FDA-2013-N-0461 Volunteer Clinical Professor of Dermatology, Indiana University, School of Medicine to FDA/CDRH - Letter Other Letter(s) 2013-08-01T04:00:00Z 2013 8 2013-08-01T04:00:00Z   2013-08-23T06:42:18Z   0 0 0900006481389384
FDA-2013-N-0461-0001 FDA None FDA-2013-N-0461 General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-05-09T04:00:00Z 2013 5 2013-05-09T04:00:00Z 2013-08-08T03:59:59Z 2014-05-21T01:08:27Z 2013-10982 0 0 09000064812d1aaa

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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;