Evaluating the Quality of Interview Data Collected by Teratology Information Services About Pregnancy Outcomes, Maternal and Infant Health, Following Medication Use During Pregnancy and Lactation

Forms and Documents

Document Name	Status
Follow-up Breastfeeding Interview Form	New
Initial Breastfeeding Interview Form	New
Follow-up Infant Interview Form	New
Initial Infant Interview Form	New
Follow-up Pregnancy Interview Form	New
Initial Pregnancy Interview Form	New
Enrollment Form Form	New
Script to Explain Project and Obtain Consent Form	New
Tracking Form Form	New
Telephone Script for Permission to be Contacted Form	New
Supp_StPART_B_rev0903091 omb_Rev121109.doc Supporting Statement B	2009-12-14
Attachment C3 090309.doc Supplementary Document	2009-09-30
Attachment_I_Research_Determination 090309.doc Supplementary Document	2009-09-30
Attachment H2 090309.pdf Supplementary Document	2009-09-30
Attachment H1 090309.pdf Supplementary Document	2009-09-30
Attachment F_Confidentiality Pledge 090309.doc Supplementary Document	2009-09-30
Attachment E_ScheduleofInterviews 090309.doc Supplementary Document	2009-09-30
Attachment B - 60 day FRN.pdf Supplementary Document	2009-09-30
Attachment A2.pdf Supplementary Document	2009-09-30
Attachment A1.pdf Supplementary Document	2009-09-30
Supp_StPART_A_rev0914091 OMB_Rev121109.doc Supporting Statement A	2009-12-14

IC Document Collections

IC ID	Document Title	Status
191066	Follow-up Breastfeeding Interview Form	New
191065	Initial Breastfeeding Interview Form	New
191064	Follow-up Infant Interview Form	New
191063	Initial Infant Interview Form	New
191062	Follow-up Pregnancy Interview Form	New
191061	Initial Pregnancy Interview Form	New
191060	Enrollment Form Form	New
191059	Script to Explain Project and Obtain Consent Form	New
191058	Tracking Form Form	New
191057	Telephone Script for Permission to be Contacted Form	New

ICR Details

OMB Control No: 0920-0838	ICR Reference No: 200910-0920-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Evaluating the Quality of Interview Data Collected by Teratology Information Services About Pregnancy Outcomes, Maternal and Infant Health, Following Medication Use During Pregnancy and Lactation
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 without change	Conclusion Date: 01/08/2010
	Date Received in OIRA: 10/21/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	36 Months From Approved
Responses	2,094	0	0
Time Burden (Hours)	516	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The US does not conduct comprehensive monitoring for pregnancy or infant outcomes related to medication exposures. The FDA collects adverse health event reports, but the time between pregnancy exposures and outcomes makes underreporting a limitation. Teratology Information Services (TIS)in the US and Canada use specialists to provide consultation and risk assessment about environmental exposures during pregnancy and breastfeeding, including medications, herbal preparations, and dietary supplements. They have direct contact with pregnant and breastfeeding women, and because women contact them for information about these exposures, they are in a unique position to monitor the effects of medication use during pregnancy and lactation. The goal of this project is to assess the quality of information on pregnancy outcomes and maternal and infant health following medication use during pregnancy and lactation that can be obtained from maternal interviews by typical TIS in the US.

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Authorizing Statute(s): US Code: 42 USC 247b-4 Name of Law: Children's Health Act of 2000
   US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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 65737	11/23/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 49381	09/28/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Initial Pregnancy Interview	none	Initial Pregnancy Interview
Follow-up Pregnancy Interview	none	Follow-up Pregnancy Interview
Initial Infant Interview	none	Initial Infant Interview
Follow-up Infant Interview	none	Follow-up Infant Interview
Initial Breastfeeding Interview	none	Initial Breastfeeding Interview
Follow-up Breastfeeding Interview	none	Follow-up Breastfeeding Interview
Telephone Script for Permission to be Contacted	none, none	Telephone Script for Permission to be Contacted - Counselor is Study Coordinator ,   Telephone Script for Permission to be Contacted - Counselor is not Study Coordinator
Tracking Form	none	Tracking Form
Script to Explain Project and Obtain Consent	none, none	Script to Explain Project and Obtain Consent - Pregnant Women ,   Script to Explain Project and Obtain Consent - Breastfeeding Women
Enrollment Form	none	Enrollment

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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	2,094	0	0	2,094	0	0
Annual Time Burden (Hours)	516	0	0	516	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 ICR. Please note that OMB waived the republication of the 60 day FRN after discussions and the retraction of a broader, yet similar project earlier this year.

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Annual Cost to Federal Government: $87,500

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? Yes

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: 10/21/2009

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