2018-20317. Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS

    ACTION:

    Notice; correction.

    SUMMARY:

    The Food and Drug Administration is correcting a notice entitled “Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability” that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and holders of drug master files and veterinary master files who may want to make a change to the drug substance manufacturing process during the drug product application postapproval period. The document was published with the incorrect docket number. This document corrects that error.

    Start Further Info

    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.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of Tuesday, September 11, 2018 (83 FR 45944), in FR Doc. 2018-19666, on page 45944, the following correction is made:

    On page 45944, in the first column, in the header of the document, and also in the third column under Instructions, “Docket No. FDA-2018-D-3151” is corrected to read “Docket No. FDA-2018-D-3152”.

    Start Signature

    Dated: September 12, 2018.

    Leslie Kux,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2018-20317 Filed 9-18-18; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
09/19/2018
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice; correction.
Document Number:
2018-20317
Pages:
47345-47345 (1 pages)
Docket Numbers:
Docket No. FDA-2018-D-3152
PDF File:
2018-20317.Pdf