Document ID: FDA-2010-D-0529-0033
Agency: fda
Document Type: Notice
Title: Qualification Process for Drug Development Tools; Guidance for Industry; Availability; Correction
Posted Date: 2020-12-11T05:00Z

[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80119-80120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27288]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]

Qualification Process for Drug Development Tools; 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) is correcting a notice 
entitled ``Qualification Process

[[Page 80120]]

for Drug Development Tools; Guidance for Industry; Availability'' that 
appeared in the Federal Register of November 25, 2020. The document 
announced the availability of a final guidance for industry and FDA 
staff that met the 21st Century Cures Act's requirement to issue 
guidance on this qualification process and elaborated on the new 
qualification process and transparency requirements and discusses the 
taxonomy for biomarkers and other drug development tools. The document 
was published with incorrect information in the Paperwork Reduction Act 
of 1995 section. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Chris Leptak, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-
796-0017; or Stephen Ripley, Center for Biologics Evaluation and 
Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, 
MD 20993-0002; 240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 25, 2020 
(85 FR 75334), in FR Doc. 2020-26051, the following correction is made:
    On page 75336, in the first 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 (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 pertaining to submissions of investigational new drug 
applications have been approved under OMB control number 0910-0014; the 
collections of information pertaining to submissions of new drug 
applications and abbreviated new drug applications have been approved 
under OMB control number 0910-0001; and the collections of information 
pertaining to submissions of biologics license applications in 21 CFR 
part 601 have been approved under OMB control number 0910-0338.''

    Dated: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27288 Filed 12-10-20; 8:45 am]
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