85 FR 234 pgs. 78336-78337 - Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability; Correction
Type: NOTICEVolume: 85Number: 234Pages: 78336 - 78337
Pages: 78336, 78337Docket number: [Docket No. FDA-2017-D-5739]
FR document: [FR Doc. 2020-26691 Filed 12-3-20; 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-2017-D-5739]
Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability; Correction
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of availability.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is correcting a notice entitled "Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability" that appeared in the Federal Register of November 25, 2020. The document announced the availability for a guidance for industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930, elizabeth.giaquinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In the Federal Register of November 25, 2020 (85 FR 75336), in FR Doc. 2020-26050, the following correction is made:
On page 75337, in the third column, under the heading, "II. Paperwork Reduction Act of 1995", the paragraph is corrected to read:
[top] "While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget
Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26691 Filed 12-3-20; 8:45 am]
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