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

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Follow-up Breastfeeding Interview	Form	New	Available
Initial Breastfeeding Interview	Form	New	Available
Follow-up Infant Interview	Form	New	Available
Initial Infant Interview	Form	New	Available
Follow-up Pregnancy Interview	Form	New	Available
Initial Pregnancy Interview	Form	New	Available
Enrollment	Form	New	Available
Script to Explain Project and Obtain Consent - Breastfeeding Women	Form	New	Available
Script to Explain Project and Obtain Consent - Pregnant Women	Form	New	Available
Tracking Form	Form	New	Available
Telephone Script for Permission to be Contacted - Counselor is not Study Coordinator	Form	New	Available
Telephone Script for Permission to be Contacted - Counselor is Study Coordinator	Form	New	Available
Supp_StPART_B_rev0903091 omb_Rev121109.doc	Supporting Statement B	Uploaded 2009-12-14	Available
Attachment C3 090309.doc	Supplementary Document	Uploaded 2009-09-30	Available
Attachment_I_Research_Determination 090309.doc	Supplementary Document	Uploaded 2009-09-30	Available
Attachment H2 090309.pdf	Supplementary Document	Uploaded 2009-09-30	Available
Attachment H1 090309.pdf	Supplementary Document	Uploaded 2009-09-30	Available
Attachment F_Confidentiality Pledge 090309.doc	Supplementary Document	Uploaded 2009-09-30	Available
Attachment E_ScheduleofInterviews 090309.doc	Supplementary Document	Uploaded 2009-09-30	Available
Attachment B - 60 day FRN.pdf	Supplementary Document	Uploaded 2009-09-30	Available
Attachment A2.pdf	Supplementary Document	Uploaded 2009-09-30	Available
Attachment A1.pdf	Supplementary Document	Uploaded 2009-09-30	Available
Supp_StPART_A_rev0914091 OMB_Rev121109.doc	Supporting Statement A	Uploaded 2009-12-14	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
191066	Follow-up Breastfeeding Interview	Form	New	Follow-up Breastfeeding Interview
191065	Initial Breastfeeding Interview	Form	New	Initial Breastfeeding Interview
191064	Follow-up Infant Interview	Form	New	Follow-up Infant Interview
191063	Initial Infant Interview	Form	New	Initial Infant Interview
191062	Follow-up Pregnancy Interview	Form	New	Follow-up Pregnancy Interview
191061	Initial Pregnancy Interview	Form	New	Initial Pregnancy Interview
191060	Enrollment Form	Form	New	Enrollment
191059	Script to Explain Project and Obtain Consent	Form	New	Script to Explain Project and Obtain Consent - Breastfeeding Women
191059	Script to Explain Project and Obtain Consent	Form	New	Script to Explain Project and Obtain Consent - Pregnant Women
191058	Tracking Form	Form	New	Tracking Form
191057	Telephone Script for Permission to be Contacted	Form	New	Telephone Script for Permission to be Contacted - Counselor is not Study Coordinator
191057	Telephone Script for Permission to be Contacted	Form	New	Telephone Script for Permission to be Contacted - Counselor is Study Coordinator

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
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/21/2009
Terms of Clearance:

table that charts list comparision

	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

table that charts list of burden

IC Title	Form No.	Form Name
Enrollment Form	none	Enrollment
Follow-up Breastfeeding Interview	none	Follow-up Breastfeeding Interview
Follow-up Infant Interview	none	Follow-up Infant Interview
Follow-up Pregnancy Interview	none	Follow-up Pregnancy Interview
Initial Breastfeeding Interview	none	Initial Breastfeeding Interview
Initial Infant Interview	none	Initial Infant Interview
Initial Pregnancy Interview	none	Initial Pregnancy Interview
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
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

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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	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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