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Notice

Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability; Correction

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 June 30, 2015 (80 FR 37273). The document announced the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The document was published with an incorrect table title and contents. This document corrects those errors.

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FOR FURTHER INFORMATION CONTACT:

Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

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SUPPLEMENTARY INFORMATION:

In FR Doc. 2015-16013, appearing in the Federal Register of Tuesday, June 30, 2015, the following corrections are made:

1. On page 37274, in the first column, the title of table 2, “Table 2. Revised Draft Product-Specific BE Recommendations for Drug Products Cholestyramine” is corrected to read “Table 2. Revised Draft Product-Specific BE Recommendations for Drug Products”.

2. On page 37274, in the first column, in the first line of the table under table 2, “Cholestyramine” is added to precede “Doxycycline hyclate, Prasugrel hydrochloride, Tiagabine hydrochloride”.

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Dated: July 17, 2015.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2015-18024 Filed 7-22-15; 8:45 am]

BILLING CODE 4164-01-P