General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

ICR 202310-0910-006

OMB: 0910-0340

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Unchanged
Supporting Statement A
2023-10-25
ICR Details
0910-0340 202310-0910-006
Received in OIRA 202212-0910-002
HHS/FDA CDER
General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions
Revision of a currently approved collection   No
Regular 10/27/2023
  Requested Previously Approved
36 Months From Approved 02/28/2026
29,130 29,118
134,268 134,124
0 0

Drugs and drug products not labeled in compliance with applicable statutory and regulatory requirements may be misbranded and subject to enforcement action under the Federal Food, Drug, and Cosmetic Act. This information collection sets forth labeling required by the applicable authorities and supports FDA implementation of the attendant reporting, recordkeeping, and disclosure activities.

PL: Pub.L. 109 - 462 760 Name of Law: Dietary Supplement and Nonprescription Drug Consumer Protection Act
   US Code: 21 USC 321; 352 Name of Law: FD&C Act; Prohibited acts; misbranded drugs
  
PL: Pub.L. 116 - 136 Subpart F, Part I Name of Law: CARES Act; OTC Drug Review

0910-AH62 Proposed rulemaking 87 FR 38313 06/28/2022

No

  Total Request 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 29,130 29,118 0 0 12 0
Annual Time Burden (Hours) 134,268 134,124 0 0 144 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The proposed information collection will expand the scope to provide for new regulatory provisions. Estimated burden from the corresponding information collection will result in an adjustment by 144 hours and 12 disclosures annually.

$1,001,407
No
    No
    No
No
No
No
Yes
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  No

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.
10/27/2023


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