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Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” This draft guidance contains 15 sections of a multisection guidance intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 6, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2012-D-1002 for the draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition).” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the Office of Compliance, Division of Field Programs and Guidance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.
Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487.
We are announcing the availability of a draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.
On October 10, 2003, FDA issued an interim final rule (68 FR 58893) to implement amendments to the FD&C Act made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. Section 102 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended section 415 of the FD&C Act to, among other things, require facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States to submit additional registration information to FDA. Section 102 of FSMA also directed FDA to amend the definition of “retail food establishment” in 21 CFR 1.227. On July 14, 2016, FDA issued a final rule (Registration Final Rule) to amend and update FDA's registration regulation and implement the FSMA revisions (81 FR 45912; July 14, 2016).
This draft guidance was developed to answer frequently asked questions relating to the registration requirements of section 415 of the FD&C Act. The first edition of the guidance was issued as Level 2 guidance consistent with our good guidance practices regulation (21 CFR 10.115) and was made available on FDA's Web site on December 4, 2003. The second, third, fourth, and fifth editions of the guidance were issued as Level 1 guidance documents under 21 CFR 10.115 and were made available on FDA's Web site on January 12, 2004; February 17, 2004; August 6, 2004; and December 17, 2012, respectively. The sixth edition of the guidance was issued as Level 1 guidance and included one additional question and answer relating to a proposed amendment to the “farm” definition in 21 CFR 1.227 (see 79 FR 58523; September 29, 2014). Since publication of the sixth edition of the guidance, we have issued the Registration Final Rule. In addition, we have issued the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food final rule (Preventive Controls for Human Food Final Rule) (80 FR 55908; September 17, 2015) that, among other things, revised the definition of “farm” in 21 CFR 1.227. We have also issued the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule (Preventive Controls for Animal Food Final Rule) (80 FR 56169; September 17, 2015). We are issuing a seventh edition of the guidance to add information relating to the Registration Final Rule and the revised “farm” definition, as well as to address questions received from stakeholders since publication of the sixth edition. We are reserving two sections in the draft guidance and will issue a revised draft guidance at a later date that includes those reserved sections. The sections that we are announcing are as follows:
We intend to announce the availability for public comment of the remaining sections of the draft guidance in a revised draft guidance.
This edition of the draft guidance also revises information in existing questions and answers, removes some questions and answers, and makes editorial changes ( e.g., we reorganized existing questions and answers) to improve clarity. For the revised questions and answers, we are not adding a date indicating when the questions and answers were revised. As in the previous editions, the following indicators are used to help users identify revisions: (1) The guidance is identified as a revision of a previously issued document; (2) the revision date appears on the cover of the guidance; (3) the edition number of the guidance is included in its title; and (4) questions and answers that have been added are identified as such in the body of the guidance. In addition, we indicated certain sections in the draft guidance as “Reserved.”
Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of ( printed page 78528) Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 1.230 through 1.235 and 21 CFR 1.245 have been approved under OMB control number 0910-0502.
Dated: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26930 Filed 11-7-16; 8:45 am]
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