83 FR 47345 - Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 182 (September 19, 2018)

The Food and Drug Administration is correcting a notice entitled ``Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new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.

[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Notices]
[Page 47345]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20317]


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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Postapproval Changes to Drug Substances; Draft Guidance for 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.

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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entitled ``Postapproval Changes to Drug Substances; Draft Guidance for 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 The document announced a draft guidance that 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, 301-796-9115.

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