[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Notices]
[Page 47345]
[FR Doc No: 2018-20317]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3152]

Postapproval Changes to Drug Substances; Draft Guidance for
Industry; Availability; Correction

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entitled ``Postapproval Changes to Drug Substances; Draft Guidance for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 The document announced a draft guidance that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.

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,<PHONE_NUMBER>.

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''.

    Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20317 Filed 9-18-18; 8:45 am]
 BILLING CODE 4164-01-P