FDA FINAL RULE CORRECTION FOR HEPATITIS A VIRUS

The FDA is correcting a final rule that appeared in the Federal Register Feb. 9 that reclassified hepatitis A virus serological assays from class III into a class II.

On page 6679, under section VI "Analysis of Impacts,'' the second paragraph is corrected to read:

"The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of HAV serological assays from class III into class II will relieve manufacturers of the cost of complying with the premarket approval requirements in section 515 of the act. Because reclassification will reduce regulatory costs with respect to these devices, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities."