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withdrawn,object_id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-2016-D-1814-0037,FDA,FDA-2016-D-1814,Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Guidance for Industry; Availability,Notice,Notice of Availability,2019-05-09T04:00:00Z,2019,5,2019-05-09T04:00:00Z,,2019-05-09T13:38:57Z,2019-09530,0,0,0900006483c4ae17
FDA-2016-D-1814-0038,FDA,FDA-2016-D-1814,Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk: Guidance for Industry,Other,Guidance,2019-05-09T04:00:00Z,2019,5,2019-05-09T04:00:00Z,,2024-11-12T23:00:34Z,,1,0,0900006483c4cd7f
FDA-2016-D-1814-0029,FDA,FDA-2016-D-1814,Reference 26 - Guidlelines for Carcinogen Risk Assessment re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:17:42Z,,0,0,09000064823f82c6
FDA-2016-D-1814-0027,FDA,FDA-2016-D-1814,Reference 24 - A Review of the Reference Dose and Reference Concentration Processes re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:08:57Z,,0,0,09000064823f82c4
FDA-2016-D-1814-0030,FDA,FDA-2016-D-1814,Reference 27 - Supplemental Guidance for Assessing Susceptibility from Early-life Exposure to Carcinogens re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:21:20Z,,0,0,09000064823f9b7a
FDA-2016-D-1814-0025,FDA,FDA-2016-D-1814,Reference 22 - Differential Sensitivity of Children and Adults to Chemical Toxicity re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T12:58:09Z,,0,0,09000064823f82c2
FDA-2016-D-1814-0026,FDA,FDA-2016-D-1814,Reference 23 - Children as sensitive subgroup & their role in reg. toxicology re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:00:45Z,,0,0,09000064823f82c3
FDA-2016-D-1814-0034,FDA,FDA-2016-D-1814,Reference 31 - Species comparison of postnatal bone growth and development re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:36:01Z,,0,0,09000064823f9b7e
FDA-2016-D-1814-0028,FDA,FDA-2016-D-1814,Reference 25 - Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:14:47Z,,0,0,09000064823f82c5
FDA-2016-D-1814-0031,FDA,FDA-2016-D-1814,Reference 28 - Exposure Factors Handbook 2011 Edition re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:27:51Z,,0,0,09000064823f9b7b
FDA-2016-D-1814-0033,FDA,FDA-2016-D-1814,Reference 30 -  Species comparison of anatomical and functional renal development re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:33:05Z,,0,0,09000064823f9b7d
FDA-2016-D-1814-0032,FDA,FDA-2016-D-1814,Reference 29 - Postnatal growth and morphological development of the brain - a species comparison re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-12T05:00:00Z,2016,12,,,2016-12-12T13:30:53Z,,0,0,09000064823f9b7c
FDA-2016-D-1814-0014,FDA,FDA-2016-D-1814,Reference 11 - Incorporating pharmacokinetic differences between children and adults in assessing children’s risks to environmental toxicants re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:11:05Z,,0,0,09000064823f6e11
FDA-2016-D-1814-0015,FDA,FDA-2016-D-1814,Reference 13 - Developmental neurotoxicity of industrial chemicals  re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:24:52Z,,0,0,09000064823f6e13
FDA-2016-D-1814-0008,FDA,FDA-2016-D-1814,Reference 5 - Estimation of Toxic Hazard – A Decision Tree Approach re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:32:04Z,,0,0,09000064823f6198
FDA-2016-D-1814-0023,FDA,FDA-2016-D-1814,Reference 20 - Direct Dosing of Preweaning Rodents in Toxicity Testing and Research - Deliberations of an ILSI RSI Expert Working Group re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:46:18Z,,0,0,09000064823f6f32
FDA-2016-D-1814-0012,FDA,FDA-2016-D-1814,Reference 9 - Assessment of health risks resulting from early-life exposures - Are current chemical toxicity testing protocols and risk assessment methods adequate re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:47:01Z,,0,0,09000064823f619c
FDA-2016-D-1814-0021,FDA,FDA-2016-D-1814,Reference 18 -  Early life environment and developmental immunotoxicity in inflammatory dysfunction and disease re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:41:40Z,,0,0,09000064823f6f30
FDA-2016-D-1814-0002,FDA,FDA-2016-D-1814,Draft Guidance - Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and-or Human Milk,Other,Guidance,2016-12-09T05:00:00Z,2016,12,2016-12-09T05:00:00Z,,2024-11-12T06:17:07Z,,1,0,09000064823f5852
FDA-2016-D-1814-0001,FDA,FDA-2016-D-1814,Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Notice,Notice of Availability,2016-12-09T05:00:00Z,2016,12,2016-12-09T05:00:00Z,2017-02-08T04:59:59Z,2017-02-08T02:04:29Z,2016-29587,0,0,09000064823f44a8
FDA-2016-D-1814-0019,FDA,FDA-2016-D-1814,Reference 16 - Children's vulnerability to toxic chemicals - a challenge and opportunity to strengthen health and environmental policy re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:36:02Z,,0,0,09000064823f6f2e
FDA-2016-D-1814-0018,FDA,FDA-2016-D-1814,Reference 12 -Evaluation of child-adult pharmacokinetic differ. from a database derived from the therapeutic drug literature re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:31:42Z,,0,0,09000064823f6e12
FDA-2016-D-1814-0010,FDA,FDA-2016-D-1814,Reference 7 - Current status of developmental immunotoxicity - early-life patterns and testing re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:37:20Z,,0,0,09000064823f619a
FDA-2016-D-1814-0003,FDA,FDA-2016-D-1814,List of References re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:02:00Z,,0,0,09000064823f6542
FDA-2016-D-1814-0020,FDA,FDA-2016-D-1814,Reference 17 -Different dietary patterns in relation to age and the consequences for intake of food chemicals re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:39:08Z,,0,0,09000064823f6f2f
FDA-2016-D-1814-0016,FDA,FDA-2016-D-1814,Reference 14 - Detection Of Toxicity To Reproduction For Medicinal Products & Toxicity To Male Fertility S5(R2) re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:28:04Z,,0,0,09000064823f6e14
FDA-2016-D-1814-0009,FDA,FDA-2016-D-1814,Reference 6 - Toxicity Evaluation of Bisphenol A Administered by Gavage to Sprague Dawley Rats From Gestation Day 6 Through Postnatal Day 90 re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:34:30Z,,0,0,09000064823f6199
FDA-2016-D-1814-0011,FDA,FDA-2016-D-1814,Reference 8 - SCIENTIFIC REPORT submitted to EFSA re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:40:30Z,,0,0,09000064823f619b
FDA-2016-D-1814-0004,FDA,FDA-2016-D-1814,Reference 1 - Pharmacokinetics in the newborn re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:15:59Z,,0,0,09000064823f6543
FDA-2016-D-1814-0005,FDA,FDA-2016-D-1814,Reference 2 - Differences in sensitivity of children and adults to chemical toxicity - the NAS panel report re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:16:23Z,,0,0,09000064823f6544
FDA-2016-D-1814-0006,FDA,FDA-2016-D-1814,"Reference 3 - Juvenile Animal Toxicity Study Designs to Support
Pediatric Drug Development re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:21:34Z,,0,0,09000064823f6545
FDA-2016-D-1814-0022,FDA,FDA-2016-D-1814,Reference 19 - A lifestage-specific approach to hazard and dose-response characterization for children's health risk assessment re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:44:00Z,,0,0,09000064823f6f31
FDA-2016-D-1814-0024,FDA,FDA-2016-D-1814,Reference 21 - Infant Toxicology - State of the science and considerations in eval. of safety  re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:53:08Z,,0,0,09000064823f6cf7
FDA-2016-D-1814-0007,FDA,FDA-2016-D-1814,"Reference 4 - Comparison of Life-Stage-Dependent Internal Dosimetry for Bisphenol A, Ethinyl Estradiol, a Reference Estrogen, and Endogenous Estradiol to Test an Estrogenic Mode of Action in Sprague Dawley Rats re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:26:39Z,,0,0,09000064823f6197
FDA-2016-D-1814-0017,FDA,FDA-2016-D-1814,Reference 15 - National Vital Statistics Reports;  Deaths - Preliminary Data for 2009 re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T19:31:16Z,,0,0,09000064823f6e15
FDA-2016-D-1814-0013,FDA,FDA-2016-D-1814,Reference 10 - Pediatric pharmacokinetic data - implications for environmental risk assessment for children re Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2016-12-09T05:00:00Z,2016,12,,,2016-12-09T17:51:15Z,,0,0,09000064823f619d