Mental Models Study of Recruitment and Retention of Pregnant Women Into a Pregnancy Registry

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
part b.doc	Supporting Statement B	Uploaded 2010-03-03	Repair queued
Attachment B Flyer for PR Participants (Final).doc	Supplementary Document	Uploaded 2010-03-03	Repair queued
Attachment C Invitation Letter for HCPs (Final) (2).doc	Supplementary Document	Uploaded 2010-03-03	Repair queued
Attachment B Flyer for Women with Asthma (Final).doc	Supplementary Document	Uploaded 2010-03-03	Repair queued
Final DP PAR-SupportingStatement-InfoCollection Revision 03122010.doc	Supporting Statement A	Uploaded 2010-03-12	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
192427	Mental Models Study of Recruitment and Retention of Pregnant Women Into a Pregnancy Registry	Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201004-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Mental Models Study of Recruitment and Retention of Pregnant Women Into a Pregnancy Registry
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 06/15/2010
	Date Received in OIRA: 04/05/2010
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		24 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This data collection will provide FDA with insight for evaluating and guiding industry design of pregnancy exposure registry recruitment and retention methods to improve the quality and quantity of study outcomes data that can inform labeling for use of drugs during pregnancy.

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Authorizing Statute(s): US Code: 21 USC 901 Name of Law: FDAAA
   US Code: 21 USC 905 Name of Law: FDAAA
  

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:
	74 FR 42901	08/25/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 8957	02/26/2010
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Mental Models Study of Recruitment and Retention of Pregnant Women Into a Pregnancy Registry

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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

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Annual Cost to Federal Government: $5,551

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]? No

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: 04/05/2010

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