National Birth Defects Prevention Study

Forms and Documents

Document Name	Status
Mother Questionnaire Form	Modified
supp st B.docx Supporting Statement B	2012-04-23
Attachment R_Thank You Letter.doc Supplementary Document	2012-04-23
Attachment O_NBDPS Publications 2_7_year.docx Supplementary Document	2012-04-23
Attachment N_NBDPS_Factsheet.pdf Supplementary Document	2012-04-23
Attachment M_Introductory Letter.doc Supplementary Document	2012-04-23
Attachment L_QABrochure(21).pdf Supplementary Document	2012-04-23
Attachment K_Blank_Confidentiality Oath Pledges 9-10 rev.doc Supplementary Document	2012-04-23
Attachment H CDC (NCBDDD) Certificate Document.pdf Supplementary Document	2012-04-23
Attachment G_Revised Collaborators List_FINAL2012.docx Supplementary Document	2012-04-23
Attachment F_List of Birth Defects.doc Supplementary Document	2012-04-23
Attachment D2 List of Study Centers.doc Supplementary Document	2012-04-23
Attachment D_CDC IRB Approval_Exp 1-29-13.docx Supplementary Document	2012-04-23
Attachment C_Letter of Authorization DCH2012-13.pdf Supplementary Document	2012-04-23
Attachment B_60-Day Federal Register Notice.pdf Supplementary Document	2012-04-23
Attachment A_Birth Defects Prevention Act of 1998.pdf Supplementary Document	2012-04-23
Attachment Q_Cheek Cell Instruction.pdf Supplementary Document	2012-04-23
Attachment J_Att10 Buccal CF MF 10-11.doc Supplementary Document	2012-04-23
Attachment I_Att23 Intro Phone Scripts_10-11.doc Supplementary Document	2012-04-23
SuppStatement_A_FINAL_SC_2.docx Supporting Statement A	2012-04-30

IC Document Collections

IC ID	Document Title	Status
6608	Mother Questionnaire Form	Modified
187391	Biologic Specimen Collection Kit Other-Word	Modified

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 201204-0920-007
Status: Historical Active	Previous ICR Reference No: 201004-0920-011
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: National Birth Defects Prevention Study
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/30/2012
	Date Received in OIRA: 04/30/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2015	36 Months From Approved	07/31/2012
Responses	14,400	0	14,400
Time Burden (Hours)	5,640	0	5,640
Cost Burden (Dollars)	0	0	0

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Abstract: Infants with birth defects are identified through the surveillance system in each participating state; control infants are randomly selected from electronic birth certificates or birth hospitals in the same population, and mothers of case and control infants are interviewed by phone about medical history, pregnancies, environmental exposures and lifestyle. DNA genetic samples are obtained from cheek cells from the mother, father, and infant, and sent to the lab by mail.

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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:
	77 FR 10751	02/23/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 24960	04/26/2012
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
Mother Questionnaire	none	Mother 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	5,640	0	0	0	0
Annual Cost Burden (Dollars)	0	0	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:

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Annual Cost to Federal Government: $2,429,100

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]? 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

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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: 04/30/2012

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