Attitudinal and Behavioral Effects of Direct-to-Consumer (DTC) Advertising of Prescription Drugs (Survey)

ICR 199901-0910-006

OMB: 0910-0399

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0399 199901-0910-006
Historical Active
HHS/FDA
Attitudinal and Behavioral Effects of Direct-to-Consumer (DTC) Advertising of Prescription Drugs (Survey)
New collection (Request for a new OMB Control Number)   No
Emergency 01/29/1999
Approved without change 03/05/1999
Retrieve Notice of Action (NOA) 01/25/1999
This collection is approved on the following condition: FDA must drop the following questions -- Q5, Q6, Q7, Q12, Q13, Q14, Q15, and Q16. FDA shall send a revised version of the survey consistent with these terms prior to implementing the survey in the field.
  Inventory as of this Action Requested Previously Approved
03/31/1999 03/31/1999
1 0 0
667 0 0
0 0 0

The FDA is required under the Food, Drug, and Cosmetic Act to assure that the advertising of prescription drugs is truthful and not misleading. Under an August 1997 guidance, manufacturers are now allowed to advertise prescription drugs directly to consumers and have been active in doing so. In order to develop timely policies concerning appropriate disclosure of risk and other information about the drugs, FDA needs to collect immediate information from the public about their understanding of and actions taken in response to seeking DTC advertising of prescription drugs. This information will be....

None
None


No

1
IC Title Form No. Form Name
Attitudinal and Behavioral Effects of Direct-to-Consumer (DTC) Advertising of Prescription Drugs (Survey)

  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 1 0 0 1 0 0
Annual Time Burden (Hours) 667 0 0 667 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
Yes Part B of Supporting Statement
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
01/25/1999


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