Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA; Affirmation

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of affirmation.

DATES:

August 23, 2017

FOR FURTHER INFORMATION CONTACT:

Joyce Strong, Office of Policy, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-9148.

SUPPLEMENTARY INFORMATION:

The Food and Drug Administration (FDA) is affirming the signature date for a notice that appeared in the Federal Register on August 21, 2017 (82 FR 39587). The document announced FDA's determination for the regulatory review period for RECUVYRA. The document published with an incorrect date for the signature. We affirm that the document was signed on August 15, 2017.