View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-1190
ICR Reference No:
201710-0920-013
Status:
Historical Active
Previous ICR Reference No:
201710-0920-001
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-1190
Title:
ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/02/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/30/2017
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2021
36 Months From Approved
07/31/2019
Responses
71,450
0
106,625
Time Burden (Hours)
14,211
0
20,541
Cost Burden (Dollars)
0
0
0
Abstract:
Multiple projects have been jointly developed between INS and CDC, including enhanced surveillance of pregnant women with symptomatic Zika virus disease. CDC seeks to implement a prospective cohort study in which we will follow women enrolled in the first trimester of pregnancy, their male partners, and their children in several cities in Colombia in which ZIKV transmission is currently ongoing. This is a continuation study to collect data on the OMB-approved Emergency Clearance package 0920-1142, and the Standard ICR 0920-1190, which covered collection of infants out to six months old. This Revision ICR will collect information on infants from 6 months out to two years after birth.
Authorizing Statute(s):
US Code:
42 USC 241
Name of Law: U.S. PHSA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
82 FR 41265
08/30/2017
30-day Notice:
Federal Register Citation:
Citation Date:
82 FR 56028
11/27/2017
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
19
IC Title
Form No.
Form Name
Bayley Scales of Infant and Toddler Development
NA
Standardized Infant Assessments
Center for Epidemiologic Studies Depression Scale
NA
Center for Epidemiologic Studiesd Depression Scale
Male Partners - Adult Symptoms Questionnaire
NA, none
ZEN Columbia - Adult Symptoms Questionnaire - English
,
ZEN Colombia: Adult Symptoms - Spanish
Male Partners - Male Enrollment Questionnaire
NA, NA
ZEN Columbia - Male Partner Enrollment Questionnaire - English 26MAY2017
,
ZEN Columbia: Male Partner Enrollment Questionnaire - Spanish 08SEP2017
Male Partners - Male Partner Eligibility Questionnaire
none, NA
ZEN Columbia - Male Partner Eligibility - English 26MAY2017
,
ZEN Colombia : Male Partner Eligibility - Spanish
Parent-Child Eligibility Questionnaire
NA, NA
Parent-Child Follow-Up Eligibility Screening Form - English
,
Parent-Child Follow-Up Eligibility Screening Form - Spanish
Parent-Child Enrollment Questionnaire
NA, NA
Parent-Child Follow-Up Enrollment Form - English
,
Parent-Child Follow-Up Enrollment Form - Spanish
Parent-Child Follow-Up Questionnaire
NA, NA
Parent-Child Follow-Up Questionnaire - English
,
Parent-Child Follow-Up Questionnaire - Spanish
Parenting Stress Index IV
NA
Standardized Infant Assessments
Peabody Developmental Motor Scales
NA
Standardized Infant Assessments
Pregnant Women - Adult Symptoms Questionnaire
none, NA
ZEN Columbia - Adult Symptoms Questionnaire - English
,
ZEN Colombia: Adult Symptoms - Spanish
Pregnant Women - Ages and Stages 2 and 24 Month Questionnaire
NA, NA, NA, NA
Ages and Stages Questionnaire - 2 month English
,
Ages and Stages Questionnaire - 2 month Spanish
,
Ages and Stages Questionnaire - 24 month English
,
Ages and Stages Questionnaire - 24 month Spanish
Pregnant Women - Ages and Stages 6 Month Questionnaire
NA, NA, NA, NA
Ages and Stages Questionnaire - 6 month English
,
Ages and Stages Questionnaire - 6 month Spanish
,
Ages and Stages Questionnaire - 4 month English
,
Ages and Stages Questionnaire - 4 month Spanish
Pregnant Women - Ages and Stages: 12 and 24 Month Questionnaire
NA, NA, NA, NA
Ages and Stages Questionnaire - 12 month English
,
Ages and Stages Questionnaire - 12 month Spanish
,
Ages and Stages Questionnaire - 24 month English
,
Ages and Stages Questionnaire - 24 month Spanish
Pregnant Women - Infant Symptoms Questionnaire
NA, none
ZEN Colombia: Infant Symptoms - English
,
ZEN Columbia: Infant Symptoms - Spanish 08SEP2017
Pregnant Women - Pregnant Women Eligibility Questionnaire
NA, NA
ZEN Columbia: Pregnant Women Eligibility - English 08SEP2017
,
ZEN Columbia: Pregnant Women Eligibility - Spanish 08SEP2017
Pregnant Women - Pregnant Women Enrollment Questionnaire
NA, NA
ZEN Columbia - Pregnant Woman Enrollment Questionnaire - English 26MAY2017
,
ZEN Columbia: Pregnant Women Enrollment Questionnaire - Spanish 08SEP2017
Pregnant Women - Pregnant Women Follow-Up Questionnaire
NA, NA
ZEN Columbia: Pregnant Women Follow-Up Questionnaire - English 08SEP2017
,
ZEN Columbia: Pregnant Women Follow-Up Questionnaire - Spanish 08SEP2017
Strengths and Difficulties Questionnaire
NA, NA
Strengths and Difficulties Assessment - ENGLISH
,
Strengths and Difficulties Assessment - SPANISH
Test of Nonverbal Intelligence
NA
Standardized Infant Assessments
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
71,450
106,625
0
-35,175
0
0
Annual Time Burden (Hours)
14,211
20,541
0
-6,330
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
Submission of this Revision for 0920-1190 ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia reflects 1) decrease in burden hours because of lowering number of remaining respondents to 500 pregnant women and 125 male partners during the pregnancy follow-up, as enrollment is progressing, and 2) increase in burden hours with the addition of data collection to follow 900 children from 6 months to 2 years of age
Annual Cost to Federal Government:
$4,105,479
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Jeffrey Zirger 404 639-7118 wtj5@cdc.gov
Common Form ICR:
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:
(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:
11/30/2017
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