Format and Content Requirements for Over-the-Counter Drug Product Labeling

ICR 201911-0910-009

OMB: 0910-0340

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-12-05
ICR Details
0910-0340 201911-0910-009
Historical Active 201612-0910-009
HHS/FDA CDER
Format and Content Requirements for Over-the-Counter Drug Product Labeling
Extension without change of a currently approved collection   No
Regular
Approved without change 12/31/2019
Retrieve Notice of Action (NOA) 12/05/2019
  Inventory as of this Action Requested Previously Approved
12/31/2022 36 Months From Approved 01/31/2020
7,859 0 961
94,320 0 11,523
1,950,000 0 0

The information collection supports agency regulations at 21 CFR 201.66. Respondents to the collection of information are producers or manufacturers of drug products requiring over-the-counter (OTC) labeling subject to these regulatory requirements.

US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  84 FR 28555 06/21/2019
84 FR 61064 11/12/2019
Yes

  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 7,859 961 0 0 6,898 0
Annual Time Burden (Hours) 94,320 11,523 0 0 82,797 0
Annual Cost Burden (Dollars) 1,950,000 0 0 0 1,950,000 0
No
No
The information collection reflects adjustments. We have adjusted our estimate to reflect an increase of 82,797 hours and a corresponding increase of 6,898 disclosures. The increase corresponds with agency data on the number of labeling reviews associated with new OTC drug product submissions. We discuss this more fully in our supporting statement at question 15.

$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
12/05/2019


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