documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
49 rows where docket_id = "FDA-2024-D-2604" sorted by posted_date descending
This data as json, CSV (advanced)
Suggested facets: subtype, posted_date, posted_month, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2024-D-2604-0059 | FDA | None FDA-2024-D-2604 | Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period | Proposed Rule | Reopening of Comment Period | 2025-05-29T00:00:00Z | 2025 | 5 | 2025-05-29T00:00:00Z | 2025-05-29T18:20:10Z | 2025-09653 | 0 | 0 | 09000064b8dc7731 | |
| FDA-2024-D-2604-0051 | FDA | None FDA-2024-D-2604 | Request for Extension from International Dairy Foods Association | Other | Request for Extension | 2025-05-02T04:00:00Z | 2025 | 5 | 2025-05-05T04:00:00Z | 2025-05-21T20:34:53Z | 0 | 0 | 09000064b8cf50da | ||
| FDA-2024-D-2604-0049 | FDA | None FDA-2024-D-2604 | Request for Extension from Consumer Brands Association | Other | Request for Extension | 2025-04-23T04:00:00Z | 2025 | 4 | 2025-04-23T04:00:00Z | 2025-04-23T15:59:18Z | 0 | 0 | 0900006486aa7993 | ||
| FDA-2024-D-2604-0048 | FDA | None FDA-2024-D-2604 | Request for Extension from Infant Nutrition Council of America (INCA) | Other | Request for Extension | 2025-03-26T04:00:00Z | 2025 | 3 | 2025-03-26T04:00:00Z | 2025-04-23T14:37:12Z | 0 | 0 | 0900006486a3dd76 | ||
| FDA-2024-D-2604-0011 | FDA | None FDA-2024-D-2604 | Reference 8 - CDC. 2010. 2010 Salmonella Outbreak Linked to Red and Black Pepper/Italian-Style Meats. May 4, 2010. Available at https://archive.cdc.gov/#/details?url=https://www.cdc.gov/salmonella/2010/montevideo-5-4-2010.html. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:29Z | 0 | 0 | 09000064868a73ea | |||
| FDA-2024-D-2604-0013 | FDA | None FDA-2024-D-2604 | Reference 10 - Strysko J, JR Cope, H Martin, C Tarr, K Hise, S Collier, et al. 2020. Food Safety and Invasive Cronobacter Infections during Early Infancy, 1961–2018. Emerg Infect Dis. 2020;26(5):857-865. Available at https://doi.org/10.3201/eid2605.190858. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:30Z | 0 | 0 | 09000064868a740d | |||
| FDA-2024-D-2604-0015 | FDA | None FDA-2024-D-2604 | Reference 12 - Lepuschitz S, W Ruppitsch, S Pekard-Amenitsch, SJ Forsythe, M Cormican, RL Mach, D Piérard, and F Allerberger. 2019. EUCRONI Study Group. Multicenter study of Cronobacter sakazakii infections in humans, Europe, 2017. Emerg. Infect. Dis. 25(3):515-522. Available at https://doi.org/10.3201/eid2503.181652. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:31Z | 0 | 0 | 09000064868a740f | |||
| FDA-2024-D-2604-0021 | FDA | None FDA-2024-D-2604 | Reference 18 - International Commission on Microbiological Specifications for Foods. 2018. “Establishment of Microbiological Criteria,” In: Microorganisms in Foods 7. Microbiological Testing in Food Safety Management, 2nd Edition, edited by RL Buchanan, W Anderson, L Anelich, J-L Cordier, R Dewanti-Hariyadi, and T Ross, Chapter 5, pp. 117-129, Springer International Publishing AG, Switzerland. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:35Z | 0 | 0 | 09000064868a7415 | |||
| FDA-2024-D-2604-0030 | FDA | None FDA-2024-D-2604 | Reference 27 - Codex Alimentarius. Code of Hygienic Practice for Powdered Formulae for Infants and Young Children CXC 66-2008. Available at https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:41Z | 0 | 0 | 09000064868a7449 | |||
| FDA-2024-D-2604-0033 | FDA | None FDA-2024-D-2604 | Reference 30 - International Commission on Microbiological Specifications for Foods. 2018. “Selection of cases and attributes plans.” In Microorganisms in Foods 7: Microbiological Testing in Food Safety Management, 2nd Edition, edited by RL Buchanan, W Anderson, L Anelich, J-L Cordier, R Dewanti-Hariyadi, and T Ross, Chapter 8, pp. 165-196, Springer International Publishing AG, Switzerland. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:42Z | 0 | 0 | 09000064868a745b | |||
| FDA-2024-D-2604-0040 | FDA | None FDA-2024-D-2604 | Reference 37 - Amezquita A, P Barretto, A Winkler, L Baert, B Jagadeesan, D Akins-Lewenthal, and A Klijn. 2020. The benefits and barriers of Whole-Genome Sequencing for pathogen source tracking: A food industry perspective. Food Safety Magazine. Available at https://www.food-safety.com/articles/6696-the-benefits-and-barriers-of-whole-genome-sequencing-for- | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:46Z | 0 | 0 | 09000064868a7462 | |||
| FDA-2024-D-2604-0009 | FDA | None FDA-2024-D-2604 | Reference 6 - Scallan, E, RM Hoekstra, FJ Angulo, RV Tauxe, MA Widdowson, SL Roy, JL Jones, and PM Griffin. 2011. Foodborne illness acquired in the United States--major pathogens. Emerg. Infect. Dis. 17 (1):7-15. Available at https://doi.org/10.3201/eid1701.p11101. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:28Z | 0 | 0 | 09000064868a73e8 | |||
| FDA-2024-D-2604-0026 | FDA | None FDA-2024-D-2604 | Reference 23 - UNITED STATES DISTRICT COURT WESTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION. United States of America (Plaintiff) v. Abbott Laboratories (Defendants). Complaint for Permanent Injunction. Case 1:22-cv-00441 ECF No. 1, Filed 05/16/22. Available at https://www.justice.gov/opa/press-release/file/1506081/download. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:38Z | 0 | 0 | 09000064868a7445 | |||
| FDA-2024-D-2604-0012 | FDA | None FDA-2024-D-2604 | Reference 9 - Patrick ME, BE Mahon, SA Greene, J Rounds, A Cronquist, K Wymore, E Boothe, S Lathrop, A Palmer, and A Bowen. 2014. Incidence of Cronobacter spp. infections, United States, 2003-2009. Emerg. Infect. Dis. 20(9):1520-1523. Available at https://doi.org/10.3201/eid2009.140545. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:30Z | 0 | 0 | 09000064868a73eb | |||
| FDA-2024-D-2604-0016 | FDA | None FDA-2024-D-2604 | Reference 13 - Pettengill JB, H Rand, SS Wang, D Kautter, A Pightling, and Y Wang. 2022 Transient and resident pathogens: Intra-facility genetic diversity of Listeria monocytogenes and Salmonella from food production environments. PLoS ONE 17(9):e0268470. Available at https://doi.org/10.1371/journal.pone.0268470. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:32Z | 0 | 0 | 09000064868a7410 | |||
| FDA-2024-D-2604-0020 | FDA | None FDA-2024-D-2604 | Reference 17 - Buchanan, RL. 2000. Acquisition of microbiological data to enhance food safety, J. Food Protect. 63:832–838. Available at https://doi.org/10.4315/0362-028x-63.6.832. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:34Z | 0 | 0 | 09000064868a7414 | |||
| FDA-2024-D-2604-0025 | FDA | None FDA-2024-D-2604 | Reference 22 - FDA. Warning letter to J.M. Smucker LLC. (January 23, 2023). Available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jm-smucker-llc-638042-01242023. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:38Z | 0 | 0 | 09000064868a7444 | |||
| FDA-2024-D-2604-0027 | FDA | None FDA-2024-D-2604 | Reference 24 - UNITED STATES DISTRICT COURT WESTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION. United States of America (Plaintiff) v. Abbott Laboratories (Defendants). CONSENT DECREE OF PERMANENT INJUNCTION. Available at https://dam.abbott.com/en-us/documents/pdfs/transparency/ECF-008-Consent-Decree.pdf. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:39Z | 0 | 0 | 09000064868a7446 | |||
| FDA-2024-D-2604-0028 | FDA | None FDA-2024-D-2604 | Reference 25 - CDC. 2022. 2022 Salmonella Outbreak Linked to Peanut Butter. July 2022. Available at https://archive.cdc.gov/#/details?url=https://www.cdc.gov/salmonella/senftenberg-05-22/index.html. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:40Z | 0 | 0 | 09000064868a7447 | |||
| FDA-2024-D-2604-0005 | FDA | None FDA-2024-D-2604 | Reference 2 - Scott, VN, Y Chen, TA Freier, J Kuehm, M Moorman, J Meyer, T Morille-Hinds, L Post, L Smoot, S Hood, J Shebuski, and J Banks. 2009. Control of Salmonella in low-moisture foods I: Minimizing entry of Salmonella into a processing facility. Food Protection Trends 29:342–353. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:26Z | 0 | 0 | 09000064868a73e4 | |||
| FDA-2024-D-2604-0029 | FDA | None FDA-2024-D-2604 | Reference 26 - Grocery Manufacturers Association. 2009. Control of Salmonella in Low-Moisture Foods.1 Available at https://graphics8.nytimes.com/packages/pdf/business/20090515_moss_ingredients/SalmonellaControlGuidance.pdf. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:40Z | 0 | 0 | 09000064868a7448 | |||
| FDA-2024-D-2604-0042 | FDA | None FDA-2024-D-2604 | Reference 39 - FDA. 2010. Compliance Policy Guide Sec. 527.300 Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-527300-dairy-products-microbial-contaminants-alkaline-phosphatase-activity. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:47Z | 0 | 0 | 09000064868a7464 | |||
| FDA-2024-D-2604-0004 | FDA | None FDA-2024-D-2604 | Reference 1 - Codex Alimentarius. Code of Hygienic Practice for Low-Moisture Foods, CXC 75-2015. Available at https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:25Z | 0 | 0 | 09000064868a73e3 | |||
| FDA-2024-D-2604-0008 | FDA | None FDA-2024-D-2604 | Reference 5 - Reich F, R Konig, W von Wiese, and G Klein. 2010. Prevalence of Cronobacter spp. in a powdered infant formula processing environment. Int. J. Food Micro. 140:214-217. Available at https://www.sciencedirect.com/science/article/pii/S0168160510001741. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:28Z | 0 | 0 | 09000064868a73e7 | |||
| FDA-2024-D-2604-0045 | FDA | None FDA-2024-D-2604 | Reference 42 - FDA. 2016. Guidance for Industry: Exempt Infant Formula Production. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-exempt-infant-formula-production. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:49Z | 0 | 0 | 09000064868a747a | |||
| FDA-2024-D-2604-0038 | FDA | None FDA-2024-D-2604 | Reference 35 - Lienau, EK, E Strain, C Wang, J Zheng, AR Ottesen, CE Keys, TS Hammack, SM Musser, EW Brown, MW Allard, G Cao, J Meng, and R Stones. 2011. Identification of a salmonellosis outbreak by means of molecular sequencing. New Engl. J. Med. 364(10): 981-982. Available at https://www.nejm.org/doi/full/10.1056/nejmc1100443 | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:45Z | 0 | 0 | 09000064868a7460 | |||
| FDA-2024-D-2604-0041 | FDA | None FDA-2024-D-2604 | Reference 38 - FDA. 2021. TechTalk Podcast Episode 2: Whole Genome Sequencing in the New Era of Smarter Food Safety. Available at https://www.fda.gov/food/new-era-smarter-food-safety-techtalk-podcast/techtalk-podcast-episode-2-whole-genome-sequencing-new-era-smarter-food-safety. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:47Z | 0 | 0 | 09000064868a7463 | |||
| FDA-2024-D-2604-0003 | FDA | None FDA-2024-D-2604 | List of References | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:04Z | 0 | 0 | 09000064868a7789 | |||
| FDA-2024-D-2604-0017 | FDA | None FDA-2024-D-2604 | Reference 14 - Grasso, EM, SF Grove, LA Halik, and SE Keller. 2015. Cleaning and sanitation of Salmonella-contaminated peanut butter processing equipment. Food Microbiology 46:100-106. Available at https://doi.org/10.1016/j.fm.2014.03.003. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:32Z | 0 | 0 | 09000064868a7411 | |||
| FDA-2024-D-2604-0022 | FDA | None FDA-2024-D-2604 | Reference 19 - FDA. Warning Letter to ByHeart, Inc. (August 30, 2023). Available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/byheart-inc-653854-08302023. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:35Z | 0 | 0 | 09000064868a7416 | |||
| FDA-2024-D-2604-0032 | FDA | None FDA-2024-D-2604 | Reference 29 - FDA. Letter to Infant Formula Manufacturers, Packers, Distributors, Exporters, Importers, and Retailers. (March 8, 2023). Available at https://www.fda.gov/media/166044/download. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:42Z | 0 | 0 | 09000064868a744b | |||
| FDA-2024-D-2604-0039 | FDA | None FDA-2024-D-2604 | Reference 36 - Allard MW, E Strain, D Melka, K Bunning, SM Musser, EW Brown, and R Timme. 2016. Practical value of food pathogen traceability through building a whole genome sequencing network and database. J. Clin. Microbiol. 54:1975–1983. Available at https://doi.org/10.1128/jcm.00081-16. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:45Z | 0 | 0 | 09000064868a7461 | |||
| FDA-2024-D-2604-0006 | FDA | None FDA-2024-D-2604 | Reference 3 - Chen, Y, VN Scott, TA Freier, J Kuehm, M Moorman, J Meyer, T Morille-Hinds, L Post, L Smoot, S Hood, J Shebuski, and J Banks. 2009. Control of Salmonella in low-moisture foods II: Hygiene practices to minimize Salmonella contamination and growth. Food Protection Trends 29:435–445. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:26Z | 0 | 0 | 09000064868a73e5 | |||
| FDA-2024-D-2604-0014 | FDA | None FDA-2024-D-2604 | Reference 11 - Council of State and Territorial Epidemiologists (CSTE). 2023. Public Health Reporting and National Notification for Invasive Cronobacter Infection Among Infants. Position Statement 23-ID-03. Available at https://www.cste.org/page/PositionStatements. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:31Z | 0 | 0 | 09000064868a740e | |||
| FDA-2024-D-2604-0023 | FDA | None FDA-2024-D-2604 | Reference 20 - FDA. Warning Letter to Perrigo Wisconsin, LLC. (August 30, 2023). Available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/perrigo-wisconsin-llc-659891-08302023. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:37Z | 0 | 0 | 09000064868a7442 | |||
| FDA-2024-D-2604-0034 | FDA | None FDA-2024-D-2604 | Reference 31 - Baert L, P McClure, A Winkler, J Karn, M Bouwknegt, and A Klijn. 2021. Guidance document on the use of whole genome sequencing (WGS) for source tracking from a food industry perspective. Food Control 130:108148. Available at https://doi.org/10.1016/j.foodcont.2021.108148. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:43Z | 0 | 0 | 09000064868a745c | |||
| FDA-2024-D-2604-0031 | FDA | None FDA-2024-D-2604 | Reference 28 - FDA. 2024. “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry (Draft Guidance).” Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:41Z | 0 | 0 | 09000064868a744a | |||
| FDA-2024-D-2604-0044 | FDA | None FDA-2024-D-2604 | Reference 41 - FDA. Food Code. Available at https://www.fda.gov/food/retail-food-protection/fda-food-code. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:49Z | 0 | 0 | 09000064868a7479 | |||
| FDA-2024-D-2604-0010 | FDA | None FDA-2024-D-2604 | Reference 7 - Centers for Disease Control and Prevention (CDC). 2007. 2007 Salmonella Outbreak Linked to Veggie Booty. July 18, 2007. Available at https://archive.cdc.gov/#/details?url=https://www.cdc.gov/salmonella/2007/veggie-booty-7-18-2007.html. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:29Z | 0 | 0 | 09000064868a73e9 | |||
| FDA-2024-D-2604-0018 | FDA | None FDA-2024-D-2604 | Reference 15 - Liu S, SE Keller, and NM Anderson. 2022. Transfer of Salmonella from inert food contact surfaces to wheat flour, cornmeal and NaCl. J. Food Prot. 85(2): 231-237. Available at https://doi.org/10.4315/JFP-21-225. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:33Z | 0 | 0 | 09000064868a7412 | |||
| FDA-2024-D-2604-0043 | FDA | None FDA-2024-D-2604 | Reference 40 - FDA. 1995. Compliance Policy Guide Sec. 555.300 Foods, Except Dairy Products - Adulteration with Salmonella. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-555300-foods-except-dairy-products-adulteration-salmonella. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:48Z | 0 | 0 | 09000064868a7478 | |||
| FDA-2024-D-2604-0007 | FDA | None FDA-2024-D-2604 | Reference 4 - Hayman, MM, SG Edelson-Mammel, PJ Carter, Y Chen, M Metz, JS Sheehan, BD Tall, CJ Thompson, and LA Smoot. 2020. Prevalence of Cronobacter spp. and Salmonella in milk powder manufacturing facilities in the United States. J. Food Prot. 83(10):1685–1692. Available at https://www.sciencedirect.com/science/article/pii/S0362028X22106228. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:27Z | 0 | 0 | 09000064868a73e6 | |||
| FDA-2024-D-2604-0019 | FDA | None FDA-2024-D-2604 | Reference 16 - Suehr, QJ, SE Keller, and NM Anderson. 2018. Effectiveness of dry purging for removing Salmonella from a contaminated lab scale auger conveyor system. International Association for Food Protection Annual Meeting, Salt Lake City, UT, July 8-11, 2018. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:34Z | 0 | 0 | 09000064868a7413 | |||
| FDA-2024-D-2604-0024 | FDA | None FDA-2024-D-2604 | Reference 21 - FDA. Warning letter to Reckitt/Mead Johnson Nutrition. (August 30, 2023). Available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reckittmead-johnson-nutrition-654775-08302023. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:37Z | 0 | 0 | 09000064868a7443 | |||
| FDA-2024-D-2604-0035 | FDA | None FDA-2024-D-2604 | Reference 32 - Tang S, RH Orsi, H Luo, C Ge, G Zhang, RC Baker, A Stevenson, and M Wiedmann. Assessment and Comparison of Molecular Subtyping and Characterization Methods for Salmonella. Front. Microbiol. 2019 Jul 12;10:1591. Available at https://doi.org/10.3389/fmicb.2019.01591. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:43Z | 0 | 0 | 09000064868a745d | |||
| FDA-2024-D-2604-0036 | FDA | None FDA-2024-D-2604 | Reference 33 - Deng, X, N Shariat, EM Driebe, CC Roe, B Tolar, E Trees, P Keim, W Zhang, EG Dudley, PI Fields, and DM Engelthale. 2015. Comparative Analysis of Subtyping Methods against a Whole-Genome-Sequencing Standard for Salmonella enterica Serotype Enteritidis. J Clin Microbiol 53(1). Available at https://doi.org/10.1128/jcm.02332-14. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:44Z | 0 | 0 | 09000064868a745e | |||
| FDA-2024-D-2604-0037 | FDA | None FDA-2024-D-2604 | Reference 34 - Neoh, H, XE Tan, HF Sapri, TL Tan. 2019. Pulsed-field gel electrophoresis (PFGE): A review of the “gold standard” for bacteria typing and current alternatives. Infection, Genetics and Evolution Volume 74, October 2019, 103935. Available at https://doi.org/10.1016/j.meegid.2019.103935. | Supporting & Related Material | Background Material | 2025-01-08T05:00:00Z | 2025 | 1 | 2025-01-08T16:38:44Z | 0 | 0 | 09000064868a745f | |||
| FDA-2024-D-2604-0002 | FDA | None FDA-2024-D-2604 | Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Guidance for Industry | Other | Guidance | 2025-01-07T05:00:00Z | 2025 | 1 | 2025-01-07T05:00:00Z | 2025-07-29T03:59:59Z | 2025-07-29T09:00:11Z | 1 | 0 | 09000064868a4c5c | |
| FDA-2024-D-2604-0001 | FDA | None FDA-2024-D-2604 | Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2025-01-07T00:00:00Z | 2025 | 1 | 2025-05-29T18:19:55Z | 2024-31528 | 0 | 0 | 09000064868a34d4 |
Advanced export
JSON shape: default, array, newline-delimited, object
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;