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withdrawn,object_id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-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,,,2014-07-17T14:40:06Z,,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,,,2014-07-17T14:36:38Z,,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,,,2014-07-17T16:06:53Z,,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,,,2014-07-17T15:54:21Z,,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,,,2014-07-17T14:31:12Z,,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,,,2014-07-17T15:47:32Z,,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,,,2014-07-17T15:48:27Z,,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,,,2014-07-17T16:11:06Z,,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,,,2014-07-17T15:54:29Z,,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,,,2014-07-17T15:50:34Z,,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,,,2014-07-17T14:38:37Z,,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,,,2014-07-17T16:06:09Z,,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,,,2014-07-17T15:36:36Z,,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,,,2014-07-17T16:02:05Z,,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,,,2014-07-17T15:59:42Z,,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,,,2014-07-17T16:01:39Z,,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,,,2014-07-17T16:11:35Z,,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,,,2014-07-17T14:35:40Z,,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,,,2014-07-17T14:32:07Z,,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,,,2014-07-17T15:35:08Z,,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,,,2014-07-17T15:46:45Z,,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,,,2014-07-17T16:07:57Z,,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,,,2014-07-17T16:08:29Z,,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,,,2014-07-17T16:08:59Z,,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,,,2014-07-17T16:09:38Z,,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,,,2014-07-17T15:49:19Z,,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,,,2014-07-17T14:33:22Z,,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,,,2014-07-17T15:56:14Z,,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,,,2014-07-17T16:02:12Z,,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,,,2014-07-17T16:00:32Z,,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,,,2014-07-17T16:07:24Z,,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,,,2014-07-17T15:25:25Z,,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,,,2014-07-17T15:35:46Z,,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,,,2014-07-17T15:55:22Z,,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,,,2014-07-17T15:44:26Z,,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,,,2014-07-17T16:12:36Z,,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,,,2014-07-17T15:46:01Z,,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,,,2014-07-17T16:10:19Z,,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,,,2014-07-17T14:34:10Z,,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,,,2014-07-16T16:08:04Z,,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,,,2014-07-16T16:04:32Z,,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,,,2014-07-16T16:06:25Z,,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,,,2014-07-16T16:24:11Z,,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,,,2014-07-16T16:25:23Z,,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,,,2014-07-16T16:27:41Z,,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,,,2014-07-16T16:38:31Z,,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,,,2014-07-16T16:24:39Z,,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,,,2014-07-16T16:33:51Z,,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,,,2014-07-16T16:26:09Z,,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,,,2014-07-16T16:05:35Z,,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,,,2014-07-16T16:03:17Z,,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,,2014-07-17T16:30:30Z,,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,,,2014-07-16T16:06:06Z,,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,,,2014-07-16T16:14:16Z,,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,,,2014-07-16T16:46:11Z,,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,,,2014-07-16T16:33:28Z,,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,,,2014-07-16T16:34:37Z,,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,,,2014-07-16T16:45:36Z,,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,,,2014-07-16T16:45:18Z,,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,,,2014-07-16T16:05:02Z,,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,,,2014-07-16T16:06:58Z,,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,,,2014-07-16T16:05:51Z,,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,,,2014-07-16T16:20:33Z,,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,,,2014-07-16T16:26:48Z,,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,,,2014-07-16T16:28:24Z,,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,,,2014-07-16T16:46:51Z,,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,,,2014-07-16T16:22:32Z,,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,,,2014-07-16T16:23:30Z,,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,,,2014-07-16T16:33:04Z,,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,,,2014-07-16T16:34:15Z,,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,,,2014-07-16T16:34:59Z,,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,,,2014-07-16T16:37:26Z,,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,,,2014-07-16T16:05:21Z,,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,,,2014-07-16T16:12:53Z,,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,,,2014-07-16T16:15:56Z,,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,,2014-07-16T13:57:23Z,,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,,,2014-07-16T16:04:48Z,,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,,,2014-07-16T16:01:32Z,,0,0,090000648056cb90
FDA-1995-N-0063-0097,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,,,2014-07-16T16:06:39Z,,0,0,090000648056cb79
FDA-1995-N-0063-0106,FDA,FDA-1995-N-0063,Appendix A2 Comment from International Formula Council,Supporting & Related Material,Background Material,2014-07-16T04:00:00Z,2014,7,,,2014-07-16T16:12:14Z,,0,0,090000648056cc1b
FDA-1995-N-0063-0129,FDA,FDA-1995-N-0063,Reference 41 Chapter 2 Microorganisms in Foods,Supporting & Related Material,Background Material,2014-07-16T04:00:00Z,2014,7,,,2014-07-16T16:35:21Z,,0,0,090000648172d7a6
FDA-1995-N-0063-0131,FDA,FDA-1995-N-0063,Reference 43 Collins-Thompson et al Microbiological Guidelines and Sampling Plans for Dried Infant Cereals and Powdered Infant Formula from a Canadian National Microbiological Survey,Supporting & Related Material,Background Material,2014-07-16T04:00:00Z,2014,7,,,2014-07-16T16:37:47Z,,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,,,2014-07-16T16:03:51Z,,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,,,2014-07-16T16:21:12Z,,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,Background Material,2014-07-16T04:00:00Z,2014,7,,,2014-07-16T16:21:54Z,,0,0,090000648172d724
FDA-1995-N-0063-0116,FDA,FDA-1995-N-0063,Reference 28 FDA Glossary of Computerized System and Software Development Terminology August 1995,Supporting & Related Material,Background Material,2014-07-16T04:00:00Z,2014,7,,,2014-07-16T16:25:05Z,,0,0,090000648172d768
FDA-1995-N-0063-0118,FDA,FDA-1995-N-0063,Reference 30 Ronald F Tetzlaff GMP Documentation Requirements for Automated Systems Part 2,Supporting & Related Material,Background Material,2014-07-16T04:00:00Z,2014,7,,,2014-07-16T16:25:47Z,,0,0,090000648172d76a
FDA-1995-N-0063-0101,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,,,2014-07-16T16:08:23Z,,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,,,2014-07-16T16:07:48Z,,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,,,2014-07-16T16:38:07Z,,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,,,2014-07-16T16:47:21Z,,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,,,2014-07-16T16:47:48Z,,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,,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,,,2014-07-09T15:32:46Z,,0,0,090000648167063e
FDA-1995-N-0063-0051,FDA,FDA-1995-N-0063,"Reference 1 - FDA. Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula. Regulatory Impact Analysis for Final Rule - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula",Supporting & Related Material,Background Material,2014-06-10T04:00:00Z,2014,6,,,2014-06-10T20:26:38Z,,0,0,09000064817368eb
FDA-1995-N-0063-0052,FDA,FDA-1995-N-0063,"Reference - 1-1 Zink, Don. Statement of Donald L. Zink, Ph. D.: Infant Formula Manufacturing Practices, 2013 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula",Supporting & Related Material,Background Material,2014-06-10T04:00:00Z,2014,6,,,2014-06-10T20:26:49Z,,0,0,09000064817368ed
FDA-1995-N-0063-0050,FDA,FDA-1995-N-0063,List of References,Supporting & Related Material,Background Material,2014-06-10T04:00:00Z,2014,6,,,2014-06-10T19:00:18Z,,0,0,09000064817368ec
FDA-1995-N-0063-0053,FDA,FDA-1995-N-0063,"Reference 1-2 - Silverman, B. Statement of Benson M. Silverman, M.D. ""Industry Efforts to Meet Quality Factor Requirements,"" 2013 - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula",Supporting & Related Material,Background Material,2014-06-10T04:00:00Z,2014,6,,,2014-06-10T20:27:04Z,,0,0,09000064817368ee
FDA-1995-N-0063-0054,FDA,FDA-1995-N-0063,"Reference 1-3 - Dickinson, D.L. and R.L. Verbeek. ""Wage Differentials Between College Graduates With and Without Learning Disabilities - Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula",Supporting & Related Material,Background Material,2014-06-10T04:00:00Z,2014,6,,,2014-06-10T20:27:20Z,,0,0,09000064817368ef
FDA-1995-N-0063-0049,FDA,FDA-1995-N-0063,"Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula",Rule,Final Rule,2014-06-10T04:00:00Z,2014,6,2014-06-10T04:00:00Z,2014-07-11T03:59:59Z,2014-07-03T01:01:55Z,2014-13384,0,0,0900006481734cd4