Document ID: FDA-2017-D-5739-0009
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2020-12-04T05:00Z

[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78336-78337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26691]

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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.

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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:
    ``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

[[Page 78337]]

(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved 
collections of information are subject to review by OMB under the PRA. 
The collections of information for meetings related to generic drug 
development have been approved under OMB control number 0910-0797.''

    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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