Editor's Note: FDA issued draft guidance for the administrative procedures used by commercial processors that manufacture, process, or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods or LACF). Interested parties have 60 days to submit comments on the draft guidance.

Food and Drug Administration

 Draft Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format

Contains Nonbinding Recommendations

Draft-Not for Implementation

Also available in PDF (112KB).

This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2411.  

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition
January 2014

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction
A. Why FDA Is Issuing This Draft Guidance
FDA ("we") is issuing this draft guidance to alert stakeholders to changes we are planning for the administrative procedures currently used by commercial processors that manufacture, process, or pack acidified foods (AF) and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as "low-acid canned foods" or "LACF")[2]. The Notice of Availability for this draft guidance (Ref. 1) includes instructions on how stakeholders can comment on those planned changes. The planned changes include:

• Providing the following separate process filing forms and assigning each form a unique form number: ◦Food Process Filing for Low-Acid Retorted Method (Form FDA 2541d) (Appendix 1);
• Food Process Filing for Acidified Method (Form FDA 2541e) (Appendix 2);
• Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f) (Appendix 3); and
• Food Process Filing for Low-Acid Aseptic Systems (Form FDA 2541g) (Appendix 4).
• Establishing a new "smart form" system for electronic submission of Forms FDA 2541d, 2541e, 2541f, and 2541g. After you begin entering data on the "smart form," this new electronic system will prompt you for required and optional information based on the information you already entered.
• Providing instructions for paper submission of Forms FDA 2541d, 2541e, 2541f, and 2541g (Appendices 5 through 8).
• Providing instructions for electronic submission of Forms FDA 2541d, 2541e, 2541f, and 2541g.

As of the date of this draft guidance we do not have screen shots available for the electronic versions of the new process filing forms, or instructions for submitting the new process filing forms electronically. However, the electronic versions of the new forms will request the same information as the paper forms, which are available for your reference in the Appendix. The instructions for the electronic forms will be very similar to the instructions for the paper forms, which are available for your reference in the Appendix.

If you have submitted process filing forms to FDA in the past, or if you submit such forms in the near future before the new system becomes operational, some of the changes we are making might impact the Submission Identifiers (SIDs) assigned to those submissions. We plan to send you a letter to alert you if there is this type of administrative change to your submission(s) (see Appendix 9 for our current draft of such a letter).

We will consider comments we receive, and may modify the procedures as a result of comments, before we establish the new procedures in the final version of this guidance.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in our guidances means that something is suggested or recommended, but not required.

In the remainder of this guidance, "you" refers to:

• Commercial processors who manufacture, process, or pack AF or LACF;
• Commercial processors who manufacture, process, or pack products that they have determined are not AF, but who wish to voluntarily submit information about such products to FDA; and
• Persons who are authorized to act on behalf of such commercial processors. 

B. What Commercial Processors Should Do Until FDA Issues the Final Version of this Guidance
Many of the procedural details we describe in this draft guidance are not currently operational. This draft guidance is being issued so that you can provide us with your comments; it is not being issued to give you information about the system that is currently active. You therefore should not refer to this draft guidance for information about submitting your process filing or registration forms to us. Instead, you should refer to our guidance dated July 2012 (Ref. 2). Once we have considered any comments and the new procedures are ready to be implemented, we will prepare the final version of this guidance and announce in the Federal Register that it is available. When we do so, the final version of this guidance will supersede the guidance dated July 2012, and the July 2012 guidance will be obsolete. At that point in time, the new forms and systems will become operational, and you will be able to refer to the final version of this guidance when submitting your forms to FDA.

C. What this Guidance Will Do
This guidance is intended for:

• Commercial processors who manufacture, process, or pack AF and/or LACF;
• Commercial processors who manufacture, process, or pack products that they have determined are not AF, but who wish to voluntarily submit information about such products to FDA; and
• Persons who are authorized to act on behalf of such commercial processors.  

This guidance describes:

• Administrative procedures relating to the registration and process filing requirements of 21 CFR 108.25(c) (for AF) and 21 CFR 108.35(c) (for LACF);
• Administrative procedures for voluntary registration and process filing submissions for certain products manufactured, processed, or packed by a commercial processor who has determined that the products are not subject to the registration and process filing requirements of 21 CFR 108.25(c) (for AF) or 21 CFR 108.35(c) (for LACF); and
• A voluntary process whereby, upon request, we review data and other information that relate to a new processing method or new equipment.

This guidance addresses two basic types of submissions that are required for AF and LACF:

• Food Canning Establishment Registration using Form FDA 2541 (see Appendix 10); and
• Process filings using Forms FDA 2541d, FDA 2541e, FDA 2541f, or FDA 2541g (see Appendices 1 through 4, respectively).[3]

D. What this Guidance Does Not Do
This guidance does not provide detailed instructions on how to complete electronic or paper submissions of Forms FDA 2541, 2541d, 2541e, 2541f, and 2541g. Such instructions are available elsewhere (See Appendix 11 for instructions for electronic submission of Form FDA 2541, Appendix 12 for instructions for paper submission of Form FDA 2541, and Appendices 5 through 8 for instructions for paper submission of Forms FDA 2541d, 2541e, 2541f, and 2541g).