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

ICR 202011-0910-003

OMB: 0910-0340

Federal Form Document

Forms and Documents
Document
Name
Status
Form
New
Justification for No Material/Nonsubstantive Change
2020-12-01
Supporting Statement A
2019-12-05
ICR Details
0910-0340 202011-0910-003
Active 201911-0910-009
HHS/FDA CDER
Format and Content Requirements for Over-the-Counter Drug Product Labeling
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/08/2020
Retrieve Notice of Action (NOA) 12/01/2020
  Inventory as of this Action Requested Previously Approved
12/31/2022 12/31/2022 12/31/2022
7,860 0 7,859
94,895 0 94,320
1,950,000 0 1,950,000

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
  
PL: Pub.L. 116 - 136 3851 Name of Law: CARES

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 7,860 7,859 1 0 0 0
Annual Time Burden (Hours) 94,895 94,320 575 0 0 0
Annual Cost Burden (Dollars) 1,950,000 1,950,000 0 0 0 0
No
No
We estimate an additional 575 burden hours to the information collection resulting from provisions under CARES pertaining to OTC drug user fees. Upon implementation of the program we intend to offer a more definitive estimate of the anticipated number of respondents.

$0
No
    No
    No
No
No
No
Yes
Domini Bean 301 796-5733 domini.bean@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.
12/01/2020


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