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:
0920-0010
ICR Reference No:
202101-0920-008
Status:
Historical Active
Previous ICR Reference No:
202003-0920-021
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-0010-21CJ
Title:
Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/04/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/21/2021
Terms of Clearance:
Previous terms continue: Approved consistent with the understanding that CDC will continue to work with SAMHSA on questions related to illicit drug use. The Agency will include the OMB control number and expiration date (as well as the burden statement) on all questionnaires and forms administered to participants in this collection.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2023
02/28/2023
02/28/2023
Responses
8,940
0
8,940
Time Burden (Hours)
4,433
0
4,433
Cost Burden (Dollars)
44,307
0
44,307
Abstract:
The purpose of BD-STEPS is to evaluate factors associated with the occurrence of birth defects and stillbirths and ultimately to work to prevent major birth defects and stillbirths associated with maternal risk factors. We propose to make two non-substantive changes to the currently-approved protocol for the Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). 1. To streamline the process by which women who are eligible are notified of and administered the stillbirth portion of BD-STEPS. 2. To add questions to the BD-STEPS interview to ask women about receipt of a COVID-19 vaccine.
Authorizing Statute(s):
PL:
Pub.L. 105 - 168 1
Name of Law: Birth Defects Prevention Act
US Code:
42 USC 247b-4
Name of Law: Public Health Service Act
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:
84 FR 7374
03/04/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 44314
08/23/2019
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Consent for Bloodspot Retrieval
n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a
Bloodspot Consent (English)
,
Bloodspot Verbal Consent (English)
,
Bloodspot Consent for Multiples (English)
,
Bloodspot Verbal Consent for Multiples (English)
,
Bloodspot Consent (Spanish)
,
Bloodspot Verbal Consent (Spanish)
,
Bloodspot Consent for Multiples (Spanish)
,
Bloodspot Verbal Consent for Multiples (Spanish)
Consent for Linkage to Reportable Infectious Diseases Results
n/a, n/a, n/a, n/a
Written Consent for Release of Reportable Infectious Diseases (English)
,
Written Consent for Release of Reportable Infectious Diseases (Spanish)
,
Verbal Consent for Release of Reportable Infectious Diseases (English)
,
Verbal Consent for Release of Reportable Infectious Diseases (Spanish)
Mother's Consent Script and Computer Assisted Telephone Interview
n/a, n/a, n/a, n/a
Introductory Phone Script (English)
,
Introductory Phone Script (Spansih)
,
BDSTEPS_CATI_V8.0
,
BDSTEPS_CATI_V8.0_SPAN
Occupational Questionnaires
n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a, n/a
Agriculture_Screenshots_English
,
Agriculture_Screenshots_Spanish
,
Cosmetology_Screenshots_English
,
Cosmetology_Screenshots_Spanish
,
Electronic Equipment Operators_Screenshots_English
,
Electronic Equipment Operators_Screenshots_Spanish
,
Healthcare_Screenshots_English
,
Healthcare_Screenshots_Spansih
,
Janitorial_Screenshots_English
,
Janitorial_Screenshots_Spanish
,
Office Worker_Screenshots_English
,
Office Worker_Screenshots_Spanish
,
Restaurant Worker_Screenshots_English
,
Restaurant Worker_Screenshots_Spanish
,
Teaching_Screenshots_English
,
Teaching_Screenshots_Spanish
Supplemental CATI about Stillbirth
n/a, n/a, n/a, n/a
Introductory Phone Script for the Interview about Stillborth (English)
,
Introductory Phone Script for the Interview about Stillborth (Spanish)
,
Computer Assisted Phone Interview about Stillbirth (English)
,
Computer Assisted Phone Interview about Stillbirth (Spanish)
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
8,940
8,940
0
0
0
0
Annual Time Burden (Hours)
4,433
4,433
0
0
0
0
Annual Cost Burden (Dollars)
44,307
44,307
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$2,783,726
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.
Yes
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?
No
Agency Contact:
Kevin Joyce 404 639-1944 kdj7@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:
01/21/2021
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