Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

ICR 201903-0910-022

OMB: 0910-0734

Federal Form Document

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ICR Details
0910-0734 201903-0910-022
Active 201601-0910-002
Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection   No
Approved without change 07/18/2019
Retrieve Notice of Action (NOA) 06/26/2019
  Inventory as of this Action Requested Previously Approved
07/31/2022 36 Months From Approved 07/31/2019
387 0 449
1,620 0 1,880
121,500 0 0

The subject guidance document was developed to assist drug and biological product application holders in making safety-related labeling changes as required by statute. Specifically, section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)), added by section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to require certain safety-related labeling changes based on information that becomes available after approval of the drug or biological product. While these requirements are codified in agency regulations (21 CFR part 314 – drugs; 21 CFR part 601 – biologics), the guidance provides background and procedural information regarding agency implementation.

US Code: 21 USC 355(o)(4)(B) Name of Law: Federal Food, Drug, and Cosmetic Act

Not associated with rulemaking
Other Documents for OIRA Review

  84 FR 3461 02/12/2019
84 FR 26880 06/10/2019

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 387 449 0 0 -62 0
Annual Time Burden (Hours) 1,620 1,880 0 0 -260 0
Annual Cost Burden (Dollars) 121,500 0 0 0 121,500 0
Based on a review of safety labeling notifications that were issued during calendar years 2016 and 2017 we have reduced the number of respondents to reflect fewer submissions. We attribute the adjustment to expected variability and note that it results in 62 fewer annual responses and 260 fewer annual burden hours. We have also uploaded costs that were previously reported, but not reflected at

Domini Bean 301 796-5733 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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