Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women with Chronic Conditions

Forms and Documents

Document	Type	Status	Availability
Passback questions and responses.doc	Supplementary Document	Uploaded 2008-11-06	Available
pregnancy and nursing mm study LETTER AttachmentB.doc	Supplementary Document	Uploaded 2008-09-03	Available
SS Pregnancy MM study revised 10-29-08.doc	Supporting Statement A	Uploaded 2008-11-05	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
186597	Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women with Chronic Conditions	Other-Survey Protocol	New

ICR Details

OMB Control No: 0910-0631	ICR Reference No: 200809-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women with Chronic Conditions
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: 11/10/2008
	Date Received in OIRA: 09/17/2008
Terms of Clearance: This ICR is approved consistent with revised supporting statement and FDA memo of 10/29/08. FDA agrees that this is a formative research study, and that the qualitative data resulting from this research project will provide a preliminary framework and help FDA decide whether it would be useful to pursue quantitative studies to test the extent of any knowledge gaps. FDA agrees that such further research would be necessary before deciding whether changes to FDA communications, including prescription drug labeling, would are required and how best to change those communications.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2011	36 Months From Approved
Responses	60	0	0
Time Burden (Hours)	60	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The requested data collection and analysis will provide FDA with insight for evaluating and improving current procedures. It is designed to identify knowledge gaps that FDA could then address, which would ultimately improve decision making and hence the health outcomes of the affected patients. In addition to identifying specific opportunities to redress misperceptions or gaps in health care providers' knowledge regarding treating pregnant and nursing women, the data from this study may also help more generally to guide FDA's communications efforts to focus on areas of misinformation in health care providers' mental models regarding treatment decisions for all patients.

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Authorizing Statute(s): US Code: 21 USC 393 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:
	72 FR 70328	12/11/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 50030	08/25/2008
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Mental Models Study of Communicating with Health Care Providers about the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women with Chronic Conditions

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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	60	0	0	0	60	0
Annual Time Burden (Hours)	60	0	0	0	60	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $1,000

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)? Uncollected

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: 09/17/2008

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