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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
6060	Attitudinal and Behavioral Effects of Direct-to-Consumer (DTC) Advertising of Prescription Drugs (Survey)	Migrated

ICR Details

OMB Control No: 0910-0399	ICR Reference No: 199901-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Attitudinal and Behavioral Effects of Direct-to-Consumer (DTC) Advertising of Prescription Drugs (Survey)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 01/29/1999
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/05/1999
	Date Received in OIRA: 01/25/1999
Terms of Clearance: 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
Expiration Date	03/31/1999	03/31/1999
Responses	1	0	0
Time Burden (Hours)	667	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: 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....

Emergency Justfication:

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

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

---

ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 01/25/1999

---