Comment on FSMA

Dockets related to the FDA Food Safety Modernization Act (FSMA) open for public comment.

For more information on the rule making process please see the following resources:

• The Food Safety Law and the Rulemaking Process: Putting FSMA to Work

• Frequently Asked Questions on Dockets, Guidance, Laws, and Regulations

• View tutorials are also available:

  • FDA Food Safety Modernization Act: A Primer by FDA 

  • The Rulemaking Process: A Primer by FDA 

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Jump to:

• Dockets Open for Comments

• Closed Dockets 

     

Open Dockets

• Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm
  Draft Risk Assessment
  Docket Number: FDA-2012-N-1258; comments due by September 16, 2013 

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food 
  Proposed Rule
  Docket Number: FDA-2011-N-0920; comments due by September 16, 2013

• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  
  Proposed Rule
  Docket Number: FDA-2011-N-0921; comments due by September 16, 2013

• Improvement of Tracking and Tracing of Food; Establishment of Pilot Projects and Congressional Report
  Notice; Request for Comments
  Docket Number: FDA-2012-N-1153; comments due by July 3, 2013

• What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide
  Guidance for Industry
  Docket Number: FDA-2011-D-0643, comments can be submitted anytime  

• What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide  
  Guidance for Industry
  Docket Number: FDA-2012-D-1003, comments can be submitted anytime 

• Questions and Answers Regarding Food Facility Registration (Fifth Edition)
  Guidance for Industry
  Docket Number: FDA-2012-D-1002, comments can be submitted anytime 

• Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories
  Guidance for Industry
  Docket Number: FDA-2012-D-0585, comments can be submitted anytime  

• Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) 
  Guidance for Industry
  Docket Number: FDA-2011-D-0598, comments can be submitted anytime

• What You Need to Know About Administrative Detention of Foods
  Guidance for Industry
  Docket Number: FDA-2011-D-0643, comments can be submitted anytime

• Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act
  Guidance for Industry
  Docket Number: FDA-2011-D-0721, comments can be submitted anytime

• Fish and Fishery Products Hazards and Controls Guidance
  Guidance for Industry
  Docket Number: FDA- 2011-D-0287, comments can be submitted anytime

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Closed Dockets

• Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2013
  Notice; Request for Comments
  Docket Number: FDA-2012-N-0799

• Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories
  Draft Guidance for Industry
  Docket Number: FDA-2012-D-0585

• Improving Food Safety and Defense Capacity of State and Local Level, Review of State and Local Capacities
  Notice; Request for Comments
  Docket Number: FDA-2012-N-0145

• International Capacity Building With Respect to Food Safety; Public Meeting
  Notice of Public Meeting; Request for Comments
  Docket Number: FDA-2012-N-0437

• Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Submission of Food/Feed Facility Profile Information
  Notice; Request for Comments
  Docket Number: FDA-2012-N-0430

• Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements 
  Interim Final Rule 
  Docket Number: FDA-2002-N-0153

• FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
  Draft Guidance for Industry
  Docket Number: FDA-2011-D-0674 

• Agency Information Collection Activities; Proposals, Submissions, and Approvals: Improving Food Safety and Defense Capacity of State and Local Level: Review of State and Local Capacities
  Notice; Request for Comments
  Docket Number: FDA-2012-N-0145

• Preventive Controls for Registered Human Food and Animal Food/Feed Facilities
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0238 

• Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business
  Notice; Request For Comments
  Docket Number: FDA-2011-N-0529

• Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012
  Notice; Request For Comments
  Docket Number: FDA-2011-N-0528, Correction Notice 

• Draft Guidance: New Dietary Ingredient Notifications and Related Issues
  Draft Guidance for Industry
  Docket Number: FDA-2011-D-0376

• Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption
  Interim Final Rule; Request for Comments
  Docket Number: FDA-2011-N-0197

• Information Required in Prior Notice of Imported Food 
  Interim Final Rule; Request for Comments
  Docket Number: FDA-2011-N-0179

• FDA Food Safety Modernization Act, Focus on Inspections and Compliance; Public Meeting
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0366

• Food Safety Modernization Act, Focus on Preventive Controls for Facilities; Public Meeting
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0251

• FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting (Section 303. Accreditation of Third-Party Auditors)
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0146

• FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting (Section 303. Authority to Require Import Certifications for Food)
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0145

• FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting (Section 302. Voluntary Qualified Importer Program)
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0144

• FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting (Section 301. Foreign Supplier Verification Program)
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0143

• Ensuring the Safety of Imported Foods and Animal Feed; Comparability of Food Safety Systems and Import Practices of Foreign Countries; Public Hearing
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0135