View Information Collection Request (ICR) Package
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Burden
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Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
201505-0920-009
Status:
Historical Active
Previous ICR Reference No:
201312-0920-002
Agency/Subagency:
HHS/CDC
Agency Tracking No:
Title:
Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
12/03/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/16/2015
Terms of Clearance:
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
12/31/2018
36 Months From Approved
01/31/2017
Responses
4,712
0
7,700
Time Burden (Hours)
2,291
0
2,888
Cost Burden (Dollars)
0
0
0
Abstract:
BD-STEPS is a multi-site case control study of a select number of major birth defects. The purpose of the Birth Defects Case Control Collaborative is to identify causes of birth defects using epidemiologic and genetic research methods and provide information that will be translated into public health prevention messages and to promote health and quality of life by preventing and controlling disease, injury and disability.
Authorizing Statute(s):
US Code:
42 USC 247b-4
Name of Law: Public Health Service Act
PL:
Pub.L. 105 - 168 1
Name of Law: Birth Defects Prevention 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:
80 FR 8655
02/18/2015
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 31380
06/02/2015
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
none, none, none, none
Consent for Bloodspot Release
,
Consent for Bloodspot Retrieval - Spanish
,
Consent for Bloodspot Retrieval - Multiples
,
Consent for Bloodspot Retrieval - Multiples - Spanish
Medical Record Request
none, none
Medical Record Release Authorization
,
Medical Record Release Authorization
Medical Record Review
Mother's Questionnaire
none, none
BD-STEPS Questionnaire
,
BD-STEPS Questionnaire - Spanish
Occupational Questionnaires
none, none, none, none, none, none, none, none
Agriculture Questionnaire
,
Electronic Equipment Operator Questionnaire
,
Cosmetology Questionnaire
,
Healthcare Questionnaire
,
Housekeeping Questionnaire
,
Office Work Questionnaire
,
Restaurant Work Questionnaire
,
Teacher Questionnaire
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
4,712
7,700
0
-2,988
0
0
Annual Time Burden (Hours)
2,291
2,888
0
-597
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:
This revision removes saliva collection from the protocol, adds bloodspot collection, and implements new on-line questionnaires. There is a total reduction in burden.
Annual Cost to Federal Government:
$1,880,110
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?
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:
Shari Steinberg 404 639-4942 sxw2@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:
06/16/2015
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