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:
201004-0920-011
Status:
Historical Active
Previous ICR Reference No:
200812-0920-001
Agency/Subagency:
HHS/CDC
Agency Tracking No:
Title:
National Birth Defects Prevention Study (formerly titled: Metro Atlanta Birth Defects & Factor Surveillance Program)
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:
04/26/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/23/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2012
03/31/2012
03/31/2012
Responses
14,400
0
14,400
Time Burden (Hours)
5,640
0
5,400
Cost Burden (Dollars)
0
0
0
Abstract:
Birth defects and genetic diseases are associated with substantial morbidity and mortality in the United States. Birth defects are the leading cause of infant mortality. One in five infant deaths is due to birth defects. For the majority of the remaining birth defects, the causes are unknown. In the past, OMB approval was requested to only encompass the data collected from resuts within the state of Georgia. This current request will continue to include Georgia data and will also incorporate information from eight additional states.
Authorizing Statute(s):
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:
73 FR 19853
04/11/2008
30-day Notice:
Federal Register Citation:
Citation Date:
73 FR 70354
11/20/2008
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Biologic Specimen Collection Kit
National Birth Defects Prevention Study (formerly titled: Metro Atlanta Birth Defects & Factor Surveillance Program)
none
NBDPS 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
14,400
14,400
0
0
0
0
Annual Time Burden (Hours)
5,640
5,400
0
240
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:
Increase in burden due to addition of 7 questions.
Annual Cost to Federal Government:
$2,582,590
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
Agency Contact:
Maryam Daneshvar 4046394604
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:
04/23/2010
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