Non material change request

Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified

Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers

OMB Control No. 0910-0037

JUSTIFICATION MEMORANDUM FOR 83-C CHANGE REQUEST

The Food and Drug Administration (we) is submitting this nonmaterial/non-substantive change request (83-C) in order to make minor technical edits to forms related to this collection of information. The edits will help respondents submitting Food Process Filings. We do not expect a change in the hour or cost burden estimates. We propose to edit the following forms (attached): Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g.

For Forms FDA 2541d, FDA 2541e, and FDA 2541f, on page 7 of each of these forms, we propose to remove the parts of the tables’ headings as indicated in the attached. The parts of the headings we want to remove offer brief instructions on how and when to complete that particular section. However, we have found that these brief instructions do not cover all situations and ultimately may confuse the user. We are confident that users are going to run into circumstances where these headings do not accurately communicate when a processor must put information in these columns, and that it is better to just let the full instructions guide the user.

For Forms FDA 2541d and FDA 2541g, as indicated in the attached, we propose to increase the number of available spaces after a decimal point to allow for situations where industry needs to expand up to three digits after the decimal point. When this occurs, industry has been forced to submit a paper form (rather than electronic submission) as a means to provide accurate information. Conversely, we also propose for the 2541g form to decrease the number of available spaces after a decimal point to avoid sending a signal that the expectation is for a number that exceeds three decimal places.

For Form FDA 2541d, for question H.2., on page 5, we propose to correct the description of added ingredients to change “dry ingredients” to “the hydrated dry ingredients.” The words “the hydrated” was unintentionally omitted.