National Birth Defects Prevention Study (formerly titled: Metro Atlanta Birth Defects & Factor Surveillance Program)

Forms and Documents

Document Name	Status
National Birth Defects Prevention Study (formerly titled: Metro Atlanta Birth Defects & Factor Surveillance Program) Form	Modified
OMB 0920-0010 Justification for Change4_7_10.doc Justification for No Material/Nonsubstantive Change	2010-04-08
Att R_Cheek Cell Instructions.doc Supplementary Document	2008-11-19
Att O_Written Consent for Cheek Cells.doc Supplementary Document	2008-11-19
Att N_Intro Phone Scripts.doc Supplementary Document	2008-11-19

IC Document Collections

IC ID	Document Title	Status
6608	National Birth Defects Prevention Study (formerly titled: Metro Atlanta Birth Defects & Factor Surveillance Program) Form	Modified
187391	Biologic Specimen Collection Kit Other-word	Modified

ICR Details

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
	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

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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.

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Authorizing Statute(s): US Code: 42 USC 247b-4 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
National Birth Defects Prevention Study (formerly titled: Metro Atlanta Birth Defects & Factor Surveillance Program)	none	NBDPS questionnaire
Biologic Specimen Collection Kit

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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.

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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

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Common Form ICR:  No

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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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