Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner

ICR 201004-0910-004

OMB: 0910-0835

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-04-06
ICR Details
0910-0835 201004-0910-004
Historical Inactive
HHS/FDA
Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 08/29/2010
Retrieve Notice of Action (NOA) 04/19/2010
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency must submit to OMB a summary of all comments on the information collection burden associated with the new disclosure requirements and any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

The proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA is also proposing, as directed by FDAAA, standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDAAA.

PL: Pub.L. 110 - 85 901 Name of Law: FDAAA
  
PL: Pub.L. 85 - 110 901 Name of Law: FDAAA

0910-AG27 Proposed rulemaking 75 FR 15376 03/29/2010

Yes

No
No
The proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act (the act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner.

$0
No
No
No
Uncollected
No
Uncollected
Eliazabeth Berbakos 3018271482

  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.
04/19/2010


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