Foreign Supplier Verification Program

 
Docket ID: FDA-2011-N-0143
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:

This rule describes what a food importer must do to verify that its foreign suppliers produce food that is as safe as food produced in the United States. FDA is taking this action to improve the safety of food that is imported into the United States.

RIN: 0910-AG64
Impacts and Effects: International
CFR Citation: 21 CFR 11,21 CFR 111,21 CFR 1
Priority: Economically Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Spring 2016
Agenda Stage of Rulemaking: Completed Action
Major Rule: Yes
Legal Authorities: 21 U.S.C. 384a, title III, sec 301 of FDA Food Safety Modernization Act, Pub. L. 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: Private Sector
Requires Regulatory Flexibility Analysis: Business
Small Entities Affected: No
International Impacts: Yes
Energy Effects: No
Included in Regulatory Plan: No
Legal Deadline
ActionSourceDescriptionDate
JudicialOtherTo the Office of the Federal Register for publication.10/31/2015
Timetable
ActionDateFR Citation
NPRM07/29/201378 FR 45729
NPRM Comment Period Extended11/20/201378 FR 69602
NPRM Comment Period End11/26/2013
NPRM Comment Period Extended End01/27/2014
Supplemental NPRM09/29/201479 FR 58573
Supplemental NPRM Comment Period End12/15/2014
Final Rule11/27/201580 FR 74225
Final Rule Effective01/27/2016
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: FDA-2011-N-0146
Short Title: Foreign Supplier Verification Program
Keyword(s): cfsan20119, cfsan, section 301, OP, 2012-60, 2016-256
Type: Rulemaking
Docket Status: OPEN
Center: CFSAN
Docket Item Code: N
 

Primary Documents

View All  (26)
Comment Period Closed
Dec 15, 2014 11:59 PM ET
Proposed Rule
Posted: 09/29/2014
ID: FDA-2011-N-0143-0247
Comment Period Closed
Jan 27, 2014 11:59 PM ET
Proposed Rule
Posted: 11/20/2013
ID: FDA-2011-N-0143-0037
Comment Period Closed
Jan 27, 2014 11:59 PM ET
Proposed Rule
Posted: 08/16/2013
ID: FDA-2011-N-0143-0025
Comment Period Closed
Nov 26, 2013 11:59 PM ET
Other
Posted: 10/17/2013
ID: FDA-2011-N-0143-0035
Comment Period Closed
Nov 26, 2013 11:59 PM ET
Other
Posted: 10/17/2013
ID: FDA-2011-N-0143-0029

Supporting Documents

View All  (43)
Comments Not Accepted
Supporting & Related Material
Posted: 12/02/2015
ID: FDA-2011-N-0143-0373
Comments Not Accepted
Supporting & Related Material
Posted: 12/02/2015
ID: FDA-2011-N-0143-0379
Comments Not Accepted
Supporting & Related Material
Posted: 12/02/2015
ID: FDA-2011-N-0143-0371

Comments

View All  (336)

450
Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Completed
Current Stage
Agency Contact
Brian L. Pendleton
Senior Policy Advisor
FDA/HHS
brian.pendleton@fda.hhs.gov
301 796-4614
301 847-8616 (Fax)
Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
*This count refers to the total comment/submissions received on this docket, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.