82 FR 162 pg. 40008 - Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA; Affirmation

Type: NOTICEVolume: 82Number: 162Page: 40008
Docket number: [Docket Nos. FDA-2013-E-0264; FDA-2013-E-0263; and FDA-2013-E-0218]
FR document: [FR Doc. 2017-17961 Filed 8-21-17; 4:15 pm]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
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.

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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