E8-25471. Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 8, 2008 (73 FR 51919). The final rule was published with an inadvertent error in the “Analysis of Impacts” section. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Diane Sullivan, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-11, Rockville, MD 20857, 301-827-7069, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

In FR Doc. E8-20709, appearing on page 51919 in the Federal Register of Monday, September 8, 2008, the following correction is made:

1. On page 51931, in the first column, under “IV. Analysis of Impacts,” in the first full paragraph, the sentence “The agency believes that this final rule is not a significant regulatory action as defined by the Executive order, because the rule either clarifies the agency's longstanding interpretation of, or increases latitude for manufacturers in complying with, existing CGMP requirements” is corrected to read “The agency certifies that this final rule is not a significant regulatory action as defined by the Executive order, because the rule either clarifies the agency's longstanding interpretation of, or increases latitude for manufacturers in complying with, existing CGMP requirements.”

Dated: October 16, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.