Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
mental models justification 9 2009.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2009-09-23	Available
Supporting Statement - 9-24- 2009.pdf	Supporting Statement A	Uploaded 2009-09-24	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
188794	Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effecti		New
188793	Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effecti		New

ICR Details

OMB Control No: 0910-0649	ICR Reference No: 200904-0910-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/25/2009
	Date Received in OIRA: 04/14/2009
Terms of Clearance: The approval is based on the understanding that this formative Mental Models study is the first part of a larger study and that results of this exploratory, qualitative study will not be used to inform policy decisions without further investigation. Specifically, the results from this qualitative study will be used to inform the development of later quantitative studies, with the ultimate goal of better understanding consumer and physician conceptualizations of drug product efficacy. Should FDA publish or otherwise disclose the results of this study, FDA will disclose all study limitations. The approved incentive amount per physician or specialist participant is $100, with the option to come back to OMB and request a higher amount if response rates are not adequate given the nature and use of information from this study even after attempting to increase participation through non-monetary means. Should FDA request higher incentive amounts, FDA should provide adequate justification as part of that request in the Supporting Statement.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved
Responses	44	0	0
Time Burden (Hours)	33	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Federal Food, Drug, and Cosmetic Act (the Act) requires that manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product's uses and risks. By its nature, the presentation of this risk information is likely to evoke active trade-offs by consumers, i.e., comparisons with the perceived risks of not taking a treatment, and comparisons with the perceived benefits of taking a treatment. The FDA has an interest in fostering safe and proper use of prescription drugs, which is an activity that necessitates understanding of both risks and benefits. Thus, an in-depth understanding of physicians' processing of this information, their thinking on relevant topics, and their informational needs are central to this regulatory task. Under the Act, FDA engages in a variety of communication activities to ensure that patients and health care providers have the information they need to make informed decisions about treatment options, including the use of prescription drugs. FDA regulations (21 CFR ? 201.57) describe the content of required product labeling, and FDA reviewers ensure that labeling contains accurate and complete information about the known risks and benefits of each drug.

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Authorizing Statute(s): US Code: 21 USC 201.57 Name of Law: FFDCA
   US Code: 21 USC 201(e)(5)(ii) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 71006	11/24/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 15293	04/03/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effecti
Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effecti

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ICR Summary of Burden

table that charts list 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	44	0	0	44	0	0
Annual Time Burden (Hours)	33	0	0	33	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new collection of information where under the Act, FDA engages in a variety of communication activities to ensure that patients and health care providers have the information they need to make informed decisions about treatment options, including the use of prescription drugs.

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Annual Cost to Federal Government: $125,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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: 04/14/2009

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