Prescription Drug Advertisements

ICR 201808-0910-010

OMB: 0910-0686

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0686 201808-0910-010
Active 201706-0910-014
HHS/FDA CDER
Prescription Drug Advertisements
Revision of a currently approved collection   No
Regular
Approved without change 08/29/2018
Retrieve Notice of Action (NOA) 08/21/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved 11/30/2020
126,159 0 21,804
18,475,780 0 18,162,706
0 0 0

This information collection supports FDA regulations regarding prescription drug advertising. Under authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that advertisements published in journals, magazines, newspapers, or other periodicals, as well as advertisements broadcast through media such as radio, television, and telephone communication systems comply with the public health protection provisions therein. Respondents to the information collection are sponsors of prescription drug product promotional material. The information collection also includes agency guidance clarifying the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human and animal prescription drugs and prescription biological products.

US Code: 21 USC 301 et seq. Name of Law: FFDCA
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  78 FR 69691 11/20/2013
82 FR 58423 12/12/2017
No

  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 126,159 21,804 0 104,355 0 0
Annual Time Burden (Hours) 18,475,780 18,162,706 0 313,074 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
The information collection is being revised to include agency guidance on third-party disclosure. This is discussed in the supporting statement.

$0
No
    No
    No
No
No
No
Uncollected
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.
08/21/2018


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