OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 200910-0920-007 · OMB 0920-0838 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Follow-up Breastfeeding Interview Form New Repair queued
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 Repair queued
Enrollment Form Form New Repair queued
Script to Explain Project and Obtain Consent Form New Available
Tracking Form Form New Available
Telephone Script for Permission to be Contacted Form New Repair queued
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 Repair queued
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 Repair queued
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 Repair queued
Supp_StPART_A_rev0914091 OMB_Rev121109.doc Supporting Statement A Uploaded 2009-12-14 Available
IC Document Collections
IC IDCollectionTypeStatusForm
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
0920-0838 200910-0920-007
Historical Active
HHS/CDC
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
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/08/2010
Retrieve Notice of Action (NOA) 10/21/2009
  Inventory as of this Action Requested Previously Approved
01/31/2013 36 Months From Approved
2,094 0 0
516 0 0
0 0 0
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.
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
  
None
Not associated with rulemaking
  72 FR 65737 11/23/2007
74 FR 49381 09/28/2009
Yes
  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
Yes
Miscellaneous Actions
No
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.
$87,500
Yes Part B of Supporting Statement
Yes
Uncollected
Uncollected
No
Uncollected
Maryam Daneshvar 4046394604
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/21/2009