FDA FORM 2541A PDF

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.

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Learn more here. This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format. This guidance also provides general information about how to use FDA's systems for electronic submission of the applicable forms. In addition, this guidance describes administrative procedures for voluntary registration and voluntary submissions when a commercial processor has determined that its product is not an acidified food or a low-acid canned food, and is therefore not subject to our regulations for AF and LACF.

Further, this guidance describes a voluntary process whereby, upon request, we review data and other information that relate to a new processing method or new equipment. Submit either electronic or written comments on FDA guidances at any time. Electronic Submissions: Submit electronic comments in the following way:. Instructions: All submissions received must include the Docket No. Send two self-addressed adhesive labels to assist that office in processing your request. The guidance represents our 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. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. The process filing regulations in 21 CFR We intend to update these regulations to specify the new form numbers, and to provide information about how to access the online system for electronic submission of these forms, as soon as possible. This guidance describes: 1 Administrative procedures relating to the registration requirements of 21 CFR We received a few comments on the draft guidance, largely directed to the specific content of the forms discussed in the guidance rather than to the procedures described in the guidance, and have not made any modifications to the final guidance as a result of these comments.

We have, however, modified the content of the forms where appropriate. We have deleted information, which we had included in the draft guidance, explaining how the draft guidance would eventually supersede previous administrative guidance associated with previous editions of the forms, which are now obsolete.

We also have modified the Appendix of the final guidance to include additional resources— e. The guidance announced in this notice finalizes the draft guidance dated January This guidance refers to previously approved collections of information found in FDA regulations. The collections of information in parts , , and have been approved under OMB control number The collections of information related to 21 CFR 1. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

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