Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

ICR 201601-0910-002

OMB: 0910-0734

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0734 201601-0910-002
Historical Active 201211-0910-007
Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection   No
Approved without change 06/20/2016
Retrieve Notice of Action (NOA) 01/12/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved 06/30/2016
449 0 203
1,880 0 824
0 0 0

The final guidance provides information on the implementation of the new statutory provisions described in #1 in the Supporting Statement and in the final guidance, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation; how the Food and Drug Administration plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changed.

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

Not associated with rulemaking

  80 FR 53161 09/02/2015
80 FR 78740 12/17/2015

  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 449 203 0 0 246 0
Annual Time Burden (Hours) 1,880 824 0 0 1,056 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
The adjustments to the currently approved burden hours of 824 are based on the latest data. The new burden hours are 1,880 total hours. This is a renewal of information collection without any program changes.

Ila Mizrachi 301 796-7726 [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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