Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer (DTC) Promotion of Prescription Drugs

ICR 200110-0910-001

OMB: 0910-0479

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0479 200110-0910-001
Historical Active
HHS/FDA
Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer (DTC) Promotion of Prescription Drugs
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/04/2001
Retrieve Notice of Action (NOA) 10/04/2001
Approved consistent with changes described in FDA memos of 11-21- 01, 11-28-01 and 12-3-01. FDA shall conduct a study of nonres- pondents to the patient survey to assess the representativeness of the sample in this survey. Approval is for 18 months which will give FDA sufficient time to complete this collection.
  Inventory as of this Action Requested Previously Approved
06/30/2003 06/30/2003
1 0 0
637 0 0
0 0 0

The FDA is required under Food, Drug, and Cosmetic Drug, and Cosmetic Act to assure that the advertising of prescription drugs is truthful and not misleading. Under a final August 1999 guidance, manufacturers were instructed how to construct television and radio ads that were consistent with the regulations by disclosing both the benefits and the major risks of the prescription drug being advertised. At the time, FDA stated it would assess the effects of the guidance, and of the agency's DTC policies in general, within the subsequent two years. A number of DTC promotion increase the studies,........

None
None


No

1
IC Title Form No. Form Name
Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer (DTC) Promotion of Prescription Drugs

  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) 637 0 0 637 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.
10/04/2001


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