Document ID: FDA-2013-E-0264-0007
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent
Extension; RECUVYRA; Affirmation
Posted Date: 2017-08-23T04:00Z

[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17961]

[[Page 40008]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0264; FDA-2013-E-0263; and FDA-2013-E-0218]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of affirmation.

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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.

    Dated: August 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17961 Filed 8-21-17; 4:15 pm]
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