83 FR 182 pg. 47345 - Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction
Type: NOTICEVolume: 83Number: 182Page: 47345
Page: 47345Docket number: [Docket No. FDA-2018-D-3152]
FR document: [FR Doc. 2018-20317 Filed 9-18-18; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability; Correction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.
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The Food and Drug Administration is correcting a notice entitled "Postapproval Changes to Drug Substances; Draft Guidance for Industry; Availability" that appeared in the Federal Register of September 11, 2018. The document announced a draft guidance that provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new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]
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