2017-17961. Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA; Affirmation  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of affirmation.

    DATES:

    August 23, 2017

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    FOR FURTHER INFORMATION CONTACT:

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

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    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.

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    Dated: August 21, 2017.

    Leslie Kux,

    Associate Commissioner for Policy.

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    [FR Doc. 2017-17961 Filed 8-21-17; 4:15 pm]

    BILLING CODE 4164-01-P

Document Information

Published:
08/23/2017
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notification of affirmation.
Document Number:
2017-17961
Dates:
August 23, 2017
Pages:
40008-40008 (1 pages)
Docket Numbers:
Docket Nos. FDA-2013-E-0264, FDA-2013-E-0263, and FDA-2013-E-0218
PDF File:
2017-17961.pdf