85 FR 239 pgs. 80119-80120 - Qualification Process for Drug Development Tools; Guidance for Industry; Availability; Correction
Type: NOTICEVolume: 85Number: 239Pages: 80119 - 80120
Pages: 80119, 80120Docket number: [Docket No. FDA-2010-D-0529]
FR document: [FR Doc. 2020-27288 Filed 12-10-20; 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-2010-D-0529]
Qualification Process for Drug Development Tools; Guidance for Industry; Availability; Correction
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of availability.
SUMMARY:
[top] The Food and Drug Administration (FDA) is correcting a notice entitled "Qualification Process
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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