00-9580. Pediatric Parenteral Multivitamin Products; Drug Efficacy Study Implementation; Announcement of Marketing Conditions; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of January 26, 2000 (65 FR 4253). The document announced the conditions for marketing pediatric parenteral multivitamin drug products for the indications for which they are now regarded as effective. The document was published with an inadvertent error. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

In FR Doc. 00-1787 appearing on page 4253 in the Federal Register of Wednesday, January 26, 2000, the following correction is made:

On page 4255, in the first column, in paragraph B.2.(a), beginning in the second line, the sentence “Caution: Federal law prohibits dispensing without prescription” is corrected to read “Rx only.”

This change is made in accordance with section 126(a) of the Food and Drug Modernization Act of 1997. Section 126(a) modified section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(4)).

Dated: April 7, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.