An official website of the United States government.
The objectives of this project were to develop a set of criteria to be used when developing and validating a computerized Low-Acid Canned Food (LACF) filing form generator, for submission electronically or in printed format.
<p>
The Food and Drug Administration (FDA) issued a final rule (CFR Title 21 part 11) concerning electronic records, that went into effect in August, 1997. This rule allows any Title 21 required signature (i.e, low-acid canned foods (LACF) filing forms) to be made using an electronic procedure. Part 11 also notes that for the FDA to receive documents with electronic signatures there needs to be a phase-in period. </P>
<P>
This project was intended to minimize this phase-in period for LACF filings. A computerized filing procedure will eliminate transcription errors by the FDA, improve the ability to determine if the FDA has received a filing, improve ease of filing, increase the speed of processing a filing,and improve the accuracy of a filing. A report describing the data file format and Asmart@ checking rules for all forms (2541, 2541a, and 2541c) were completed. </p>
<P>
These rules can now be incorporated into computerized form filling programs. The long time to develop the Asmart@ checking rules,the inability to identify an individual to work on the development of a draft electronic filing system, and the decision that an electronic filing system should be completed by the FDA forced the project to eliminate any work on the development of an electronic filing system. Any future work on an electronic LACF filing system will be conducted by the FDA. </p>
<P>
The recent (Sept. 1998) passage of the Paperwork Elimination Act, has added an urgency to this technology. The Paperwork Elimination Act requires Federal Agency=s to have by the end of 2003 a procedure whereby any required paperwork can be filed with the government electronically.</P>