{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-1995-N-0063\" sorted by posted_date descending", "rows": [["FDA-1995-N-0063-0147", "FDA", "FDA-1995-N-0063", "Reference 60 Infant Formula Act of 1980 Report by the Committee on Labor and Human Resources United States Senate", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T14:40:06Z", null, 0, 0, "090000648172d7c7"], ["FDA-1995-N-0063-0145", "FDA", "FDA-1995-N-0063", "Reference 57 Jensen and Jensen Invited Review Specialty Lipids for Infant Nutrition I. Milks and Formulas", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T14:36:38Z", null, 0, 0, "090000648172d7c4"], ["FDA-1995-N-0063-0169", "FDA", "FDA-1995-N-0063", "Reference 81 Minton et al Bone Mineral Content in Term and Preterm Appropriate-for-Gestational-Age Infants", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:06:53Z", null, 0, 0, "090000648174e748"], ["FDA-1995-N-0063-0159", "FDA", "FDA-1995-N-0063", "Reference 58 Ziegler et al Cow Milk Feeding in Infancy: Further Observations on Blood Loss from the Gastrointestinal Tract", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:54:21Z", null, 0, 0, "090000648172d7c5"], ["FDA-1995-N-0063-0140", "FDA", "FDA-1995-N-0063", "Reference 52 Summary of Findings", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T14:31:12Z", null, 0, 0, "090000648172d7b5"], ["FDA-1995-N-0063-0155", "FDA", "FDA-1995-N-0063", "Reference 69 Shenai et al Nutritional Balance Studies in Very Low-Birth- Weight Infants: Role of Soy Formula", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:47:32Z", null, 0, 0, "090000648172de15"], ["FDA-1995-N-0063-0156", "FDA", "FDA-1995-N-0063", "Reference 70 Lindroth et al Rickets in Very Low Birthweight Infants", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:48:27Z", null, 0, 0, "090000648172de16"], ["FDA-1995-N-0063-0176", "FDA", "FDA-1995-N-0063", "Reference 88 Memorandum of Telephone Conversation between Ed puro, FDA, and Mary Hudtloff Dated March 15, 1994", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:11:06Z", null, 0, 0, "090000648174e74f"], ["FDA-1995-N-0063-0160", "FDA", "FDA-1995-N-0063", "Reference 66 Koletzko et al Intestinal Milk - Bolus Obstruction in Formula-Fed Premature Infants Given High Doses of Calcium", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:54:29Z", null, 0, 0, "090000648172de12"], ["FDA-1995-N-0063-0158", "FDA", "FDA-1995-N-0063", "Reference 72 FDA Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:50:34Z", null, 0, 0, "090000648172de18"], ["FDA-1995-N-0063-0146", "FDA", "FDA-1995-N-0063", "Reference 59 Committee on Nutrition Commentary on Breast-Feeding and Infant Formulas, Including Proposed Standards for Formulas", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T14:38:37Z", null, 0, 0, "090000648172d7c6"], ["FDA-1995-N-0063-0168", "FDA", "FDA-1995-N-0063", "Reference 80 Ryan et al Phosphate, Alkaline Phosphatase and Bone Mineralization in Preterm Neonates", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:06:09Z", null, 0, 0, "090000648174e747"], ["FDA-1995-N-0063-0151", "FDA", "FDA-1995-N-0063", "Reference 64 Samuel J. Fomon, M.D. Nutrition of Normal Infants", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:36:36Z", null, 0, 0, "090000648172de10"], ["FDA-1995-N-0063-0166", "FDA", "FDA-1995-N-0063", "Reference 75 Moore and Roche Pediatric Anthropometry 2nd Edition", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:02:05Z", null, 0, 0, "090000648174e567"], ["FDA-1995-N-0063-0163", "FDA", "FDA-1995-N-0063", "Reference 77 Sarwar et al Difference in Protein Digestibility and Quality of Liquid Concentrate and Powder Forms of Milk-Baed Infant Formulas Fed to Rats", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:59:42Z", null, 0, 0, "090000648174e744"], ["FDA-1995-N-0063-0165", "FDA", "FDA-1995-N-0063", "Reference 79 Fomon and Nelson Calcium, Phoshorus, Magnesium, and Sulfur", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:01:39Z", null, 0, 0, "090000648174e746"], ["FDA-1995-N-0063-0177", "FDA", "FDA-1995-N-0063", "Reference 89 Memorandum of Telephone Conversation between Ed Puro, FDA, and Lorena, Hazleton Labs Dated March 17, 1993", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:11:35Z", null, 0, 0, "090000648174e750"], ["FDA-1995-N-0063-0144", "FDA", "FDA-1995-N-0063", "Reference 56 Jensen et al Lipids of Human Milk and Infant Formulas: A Review", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T14:35:40Z", null, 0, 0, "090000648172d7c3"], ["FDA-1995-N-0063-0141", "FDA", "FDA-1995-N-0063", "Reference 53 Internal FDA Memo dated May 12, 1994", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T14:32:07Z", null, 0, 0, "090000648172d7b6"], ["FDA-1995-N-0063-0149", "FDA", "FDA-1995-N-0063", "Reference 62 Hallberg et al Bioavailability in Man of Iro in Human Milk and Cow's Milk in Relation to Their Calcium Contents", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:35:08Z", null, 0, 0, "090000648172d3be"], ["FDA-1995-N-0063-0154", "FDA", "FDA-1995-N-0063", "Reference 68 Moya et al Short-Term polcose Substitution for Lactose Reduces Calcium Absorption in Healthy Term Babies", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:46:45Z", null, 0, 0, "090000648172de14"], ["FDA-1995-N-0063-0171", "FDA", "FDA-1995-N-0063", "Reference 83 Gary M. Chan Performance of Dual Energy X-Ray Absorptiometry in Evaluatiing Bone, Lean Body Mass, and Fat in Pediatric Subjects", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:07:57Z", null, 0, 0, "090000648174e74a"], ["FDA-1995-N-0063-0172", "FDA", "FDA-1995-N-0063", "Reference 84 Braillon et al Dual energy X-Ray Absorptiometry Measurements of bone mineral Content in Newborns: Validation of the Technique", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:08:29Z", null, 0, 0, "090000648174e74b"], ["FDA-1995-N-0063-0173", "FDA", "FDA-1995-N-0063", "Reference 85 Salle and Glorieux Assessment of Bone Mineral Content in Infants: The New Age", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:08:59Z", null, 0, 0, "090000648174e74c"], ["FDA-1995-N-0063-0174", "FDA", "FDA-1995-N-0063", "Reference 86 Samuel J. Fomon Nutrition of Normal Infants", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:09:38Z", null, 0, 0, "090000648174e74d"], ["FDA-1995-N-0063-0157", "FDA", "FDA-1995-N-0063", "Reference 71 Chan and Mileur Posthospitalization Growth and Bone Mineral Status of Normal Preterm Infants", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:49:19Z", null, 0, 0, "090000648172de17"], ["FDA-1995-N-0063-0142", "FDA", "FDA-1995-N-0063", "Reference 54 Tanner et al Analysis of Milk-Based Infant Formula", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T14:33:22Z", null, 0, 0, "090000648172d7c0"], ["FDA-1995-N-0063-0162", "FDA", "FDA-1995-N-0063", "Reference 74 Roche et al Weight and Recumbent Lenght from 1 to 12 Mo of Age: Refenece DAta for 1-mo Increments", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:56:14Z", null, 0, 0, "090000648174e566"], ["FDA-1995-N-0063-0167", "FDA", "FDA-1995-N-0063", "Reference 76 Behrman et al Nelson Textbook of Pediatrics 14th Edition", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:02:12Z", null, 0, 0, "090000648174e568"], ["FDA-1995-N-0063-0164", "FDA", "FDA-1995-N-0063", "Reference 78 Rudloff and Lonnerdal Solubility and Digestibility of Milk Proteins in Infant Formmulas Exposed to Different Heat Treatments", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:00:32Z", null, 0, 0, "090000648174e745"], ["FDA-1995-N-0063-0170", "FDA", "FDA-1995-N-0063", "Reference 82 Steichen et al  Bone Mineral Content Measurement in Small Infants by Single-Photon Absorptiometry: Cureent Methodologic Issues", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:07:24Z", null, 0, 0, "090000648174e749"], ["FDA-1995-N-0063-0148", "FDA", "FDA-1995-N-0063", "Reference 61 Saarinen et al Iron Absorption in Infants: High Bioavailability of Breast milk Iron as Indicated by the Extrinsic Tag Method of Iron Absorption and by the Concentration of Serum Ferritin", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:25:25Z", null, 0, 0, "090000648172d3bd"], ["FDA-1995-N-0063-0150", "FDA", "FDA-1995-N-0063", "Reference 63 Derman et al Factors Influencing the Absorption of Iron from Soya-Bean Protein Products", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:35:46Z", null, 0, 0, "090000648172de0f"], ["FDA-1995-N-0063-0161", "FDA", "FDA-1995-N-0063", "Reference 73 Lewis A. Barness Pediatric Nutrition Handbook 3rd Edition", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:55:22Z", null, 0, 0, "090000648174e565"], ["FDA-1995-N-0063-0152", "FDA", "FDA-1995-N-0063", "Reference 65 Steichen et al Osteopenia of Prematurity: The Cause and Possible Treatment", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:44:26Z", null, 0, 0, "090000648172de11"], ["FDA-1995-N-0063-0178", "FDA", "FDA-1995-N-0063", "Reference 90 Incorporated by Reference to Federal Register Notice Published July 9, 1996", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:12:36Z", null, 0, 0, "090000648174e751"], ["FDA-1995-N-0063-0153", "FDA", "FDA-1995-N-0063", "Reference 67 Ziegler and Fomon Lactose Enhances Mineral Absorption in Infancy", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T15:46:01Z", null, 0, 0, "090000648172de13"], ["FDA-1995-N-0063-0175", "FDA", "FDA-1995-N-0063", "Reference 87 Carlson et al First Year Growth of Preterm Infants Fed Standard Compared to Marine Oil n-3 Supplemented Formula", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T16:10:19Z", null, 0, 0, "090000648174e74e"], ["FDA-1995-N-0063-0143", "FDA", "FDA-1995-N-0063", "Reference 55 Southgate et al Nutrient Availability: Chemical and Biological Aspects", "Supporting & Related Material", "Background Material", "2014-07-17T04:00:00Z", 2014, 7, null, null, "2014-07-17T14:34:10Z", null, 0, 0, "090000648172d7c2"], ["FDA-1995-N-0063-0100", "FDA", "FDA-1995-N-0063", "Attachment C Industry Proposal on Infant Formula Powder Labeling Comment International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:08:04Z", null, 0, 0, "090000648056cb93"], ["FDA-1995-N-0063-0089", "FDA", "FDA-1995-N-0063", "Attachment A Suggested Language Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:04:32Z", null, 0, 0, "090000648056cb68"], ["FDA-1995-N-0063-0096", "FDA", "FDA-1995-N-0063", "Attachment on Basis and Context  of Sample Growth Trial Protocol Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:06:25Z", null, 0, 0, "090000648056cb75"], ["FDA-1995-N-0063-0114", "FDA", "FDA-1995-N-0063", "Reference 26 No Material Submitted", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:24:11Z", null, 0, 0, "090000648172d766"], ["FDA-1995-N-0063-0117", "FDA", "FDA-1995-N-0063", "Reference 29 Ronald F Tetzlaff GMP Documentation Requirements for Automated Systems Part 1", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:25:23Z", null, 0, 0, "090000648172d769"], ["FDA-1995-N-0063-0121", "FDA", "FDA-1995-N-0063", "Reference 33 Salmonella Ealing Inspections Associated with Consumption of Infant Dired Milk", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:27:41Z", null, 0, 0, "090000648172d770"], ["FDA-1995-N-0063-0133", "FDA", "FDA-1995-N-0063", "Reference 45 Jackson et al Control of Salmonellosis and Similar Foodborne Infections", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:38:31Z", null, 0, 0, "090000648172d7aa"], ["FDA-1995-N-0063-0115", "FDA", "FDA-1995-N-0063", "Reference 27 IEEE Standard Glossary of Software Engineering Terminology", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:24:39Z", null, 0, 0, "090000648172d767"], ["FDA-1995-N-0063-0125", "FDA", "FDA-1995-N-0063", "Reference 37 Farber and Peterkin Listeria Monocytogenes A Food Borne Pathogen", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:33:51Z", null, 0, 0, "090000648172d7a2"], ["FDA-1995-N-0063-0119", "FDA", "FDA-1995-N-0063", "Reference 31 Ronald F Tetzlaff GMP Documentation Requirements for Automated Systems Part 3, FDA Inspections of Computerized Laboratory Systems", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:26:09Z", null, 0, 0, "090000648172d76e"], ["FDA-1995-N-0063-0093", "FDA", "FDA-1995-N-0063", "Attachment E Letter from IFC to FDA CFSAN dated July 7 2003 Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:05:35Z", null, 0, 0, "090000648056cb6f"], ["FDA-1995-N-0063-0103", "FDA", "FDA-1995-N-0063", "Attachment F Letter from Douglas L Archer to International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:03:17Z", null, 0, 0, "090000648056cb8b"], ["FDA-1995-N-0063-0086", "FDA", "FDA-1995-N-0063", "Withdrawal of Comments from International Formula Council", "Other", "Withdrawal", "2014-07-16T04:00:00Z", 2014, 7, "2014-07-16T04:00:00Z", null, "2014-07-17T16:30:30Z", null, 0, 0, "090000648056cbd3"], ["FDA-1995-N-0063-0095", "FDA", "FDA-1995-N-0063", "Attachment G Guidelines Concerning Notification and Testing of  Infant Formulas Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:06:06Z", null, 0, 0, "090000648056cb73"], ["FDA-1995-N-0063-0107", "FDA", "FDA-1995-N-0063", "Appendix A3 Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:14:16Z", null, 0, 0, "090000648056cc22"], ["FDA-1995-N-0063-0136", "FDA", "FDA-1995-N-0063", "Reference 48 Harmon and Kautter Incidence and Growth Potential of Bacillus cerues in Ready-to Serve Foods", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:46:11Z", null, 0, 0, "090000648172d7af"], ["FDA-1995-N-0063-0124", "FDA", "FDA-1995-N-0063", "Reference 36 Paul G. Quie Antimicrobial Defenses in the Neonante", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:33:28Z", null, 0, 0, "090000648172d773"], ["FDA-1995-N-0063-0127", "FDA", "FDA-1995-N-0063", "Reference 39 Abram S. Benenson Control of Communicable Diseases in Man", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:34:37Z", null, 0, 0, "090000648172d7a4"], ["FDA-1995-N-0063-0135", "FDA", "FDA-1995-N-0063", "Reference 47 Robert T. Marshall Standard Methods for the Examination of Dairy Products", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:45:36Z", null, 0, 0, "090000648172d7ae"], ["FDA-1995-N-0063-0134", "FDA", "FDA-1995-N-0063", "Reference 46 FDA Bacteriological Analytical Manual 7th Edition 1992", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:45:18Z", null, 0, 0, "090000648172d7ad"], ["FDA-1995-N-0063-0091", "FDA", "FDA-1995-N-0063", "Attachment C Industry Proposal on Infant Formula Powder Labeling Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:05:02Z", null, 0, 0, "090000648056cb6c"], ["FDA-1995-N-0063-0098", "FDA", "FDA-1995-N-0063", "Attachment A International Formula Council Suggested Language Comment  International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:06:58Z", null, 0, 0, "090000648056cb97"], ["FDA-1995-N-0063-0094", "FDA", "FDA-1995-N-0063", "Attachment F Letter from Douglas L Archer to IFC Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:05:51Z", null, 0, 0, "090000648056cb71"], ["FDA-1995-N-0063-0109", "FDA", "FDA-1995-N-0063", "Reference 6 American Academy of Pediatrics Clinical Testing of Infant Formulas with Respect to Nutritional Suitability for Team Infants", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:20:33Z", null, 0, 0, "090000648172d722"], ["FDA-1995-N-0063-0120", "FDA", "FDA-1995-N-0063", "Reference 32 Letter from Infant Formula Council to FDA Dated March 31, 1993", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:26:48Z", null, 0, 0, "090000648172d76f"], ["FDA-1995-N-0063-0122", "FDA", "FDA-1995-N-0063", "Reference 34 Letter from Infant Formula Council to FDA Dated June 24, 1993", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:28:24Z", null, 0, 0, "090000648172d771"], ["FDA-1995-N-0063-0137", "FDA", "FDA-1995-N-0063", "Reference 49 FDA / CFSAN Draft of Microbiological Evaulation of Powdered Infant Formula Prepared by David A. Golden, Ph.D.", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:46:51Z", null, 0, 0, "090000648172d7b2"], ["FDA-1995-N-0063-0112", "FDA", "FDA-1995-N-0063", "Reference 9 Infant Formula Council Recommended Current Good Manufacturing Practice for Infant Formula", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:22:32Z", null, 0, 0, "090000648172d725"], ["FDA-1995-N-0063-0113", "FDA", "FDA-1995-N-0063", "Reference 25 Guidelines on Sterile Drug Products Produced by Aseptic Processing dated June 1987", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:23:30Z", null, 0, 0, "090000648172d765"], ["FDA-1995-N-0063-0123", "FDA", "FDA-1995-N-0063", "Reference 35 Michael P. Doyle Foodborne Bacterial Pathogens", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:33:04Z", null, 0, 0, "090000648172d772"], ["FDA-1995-N-0063-0126", "FDA", "FDA-1995-N-0063", "Reference 38 Listeria Monocytogenes Recommendations by the National Advisory Committee on Microbiological criteria for Foods", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:34:15Z", null, 0, 0, "090000648172d7a3"], ["FDA-1995-N-0063-0128", "FDA", "FDA-1995-N-0063", "Reference 40 Balows et al Laboratory Diagnosis of Infectious Diseases Principles and Pratice Volume 1", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:34:59Z", null, 0, 0, "090000648172d7a5"], ["FDA-1995-N-0063-0130", "FDA", "FDA-1995-N-0063", "Reference 42 Schwab et al Microbiological Quality of Dry-Milk Mixes and Milk Substitute Infant Formulas", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:37:26Z", null, 0, 0, "090000648172d7a7"], ["FDA-1995-N-0063-0092", "FDA", "FDA-1995-N-0063", "Attachment D Proposed Discussion Points on Powdered Infant Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:05:21Z", null, 0, 0, "090000648056cb6e"], ["FDA-1995-N-0063-0105", "FDA", "FDA-1995-N-0063", "Appendix A1 Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:12:53Z", null, 0, 0, "090000648056cc19"], ["FDA-1995-N-0063-0108", "FDA", "FDA-1995-N-0063", "Appendix B Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:15:56Z", null, 0, 0, "090000648056cc1c"], ["FDA-1995-N-0063-0085", "FDA", "FDA-1995-N-0063", "Correction from International Formula Council", "Other", "Correction(s)", "2014-07-16T04:00:00Z", 2014, 7, "2014-07-16T04:00:00Z", null, "2014-07-16T13:57:23Z", null, 0, 0, "090000648056cbcd"], ["FDA-1995-N-0063-0090", "FDA", "FDA-1995-N-0063", "Attachment B FDA Infant Formula GMP Regulation Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:04:48Z", null, 0, 0, "090000648056cb6a"], ["FDA-1995-N-0063-0102", "FDA", "FDA-1995-N-0063", "Attachment E Letter from IFC to FDA/CFSAN dated July 7 2003 Comment  from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:01:32Z", null, 0, 0, "090000648056cb90"], ["FDA-1995-N-0063-0097", "FDA", "FDA-1995-N-0063", "Attachment L Decision Tree Chart for Documentation of  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Microbiological Survey", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:37:47Z", null, 0, 0, "090000648172d7a8"], ["FDA-1995-N-0063-0104", "FDA", "FDA-1995-N-0063", "Attachment L Decision Tree Chart for Documentation of  Nutritional Adequacy of a New or Changed Infant Formula Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:03:51Z", null, 0, 0, "090000648056cb9d"], ["FDA-1995-N-0063-0110", "FDA", "FDA-1995-N-0063", "Reference 7 Congressional Record House Vol 126 Dated May 20, 1980", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:21:12Z", null, 0, 0, "090000648172d723"], ["FDA-1995-N-0063-0111", "FDA", "FDA-1995-N-0063", "Reference 8 Guidelines Concerning Notification and Testing of Infant Formulas", "Supporting & Related Material", 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"2014-07-16T16:08:23Z", null, 0, 0, "090000648056cb91"], ["FDA-1995-N-0063-0099", "FDA", "FDA-1995-N-0063", "Attachment B FDA Infant Formula GMP Regulation Comment from International Formula Council", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:07:48Z", null, 0, 0, "090000648056cb9f"], ["FDA-1995-N-0063-0132", "FDA", "FDA-1995-N-0063", "Reference 44 FDA Enforcement Report dated July, 14 1993", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:38:07Z", null, 0, 0, "090000648172d7a9"], ["FDA-1995-N-0063-0138", "FDA", "FDA-1995-N-0063", "Reference 50 FDA Consumer October 1988", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:47:21Z", null, 0, 0, "090000648172d7b3"], ["FDA-1995-N-0063-0139", "FDA", "FDA-1995-N-0063", "Reference 51 Memorandum of Record dated June 25, 1996", "Supporting & Related Material", "Background Material", "2014-07-16T04:00:00Z", 2014, 7, null, null, "2014-07-16T16:47:48Z", null, 0, 0, "090000648172d7b4"], ["FDA-1995-N-0063-0077", "FDA", "FDA-1995-N-0063", "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula; Correction", "Rule", "Correction", "2014-07-15T04:00:00Z", 2014, 7, "2014-07-15T04:00:00Z", null, "2014-07-15T14:43:19Z", "2014-16476", 0, 0, "09000064817ad884"], ["FDA-1995-N-0063-0061", "FDA", "FDA-1995-N-0063", "Comment from Jason and Jarvis Associates, LLC re FDA-1995-N-0063-0058", "Supporting & Related Material", "Background Material", "2014-07-09T04:00:00Z", 2014, 7, null, null, "2014-07-09T15:32:46Z", null, 0, 0, "090000648167063e"], ["FDA-1995-N-0063-0051", "FDA", "FDA-1995-N-0063", "Reference 1 - FDA. 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