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

Forms and Documents

Document Name	Status
OMB_Memorandum_Conference_Call_issues_0920_0010.doc Supplementary Document	2009-03-03
Attachment_O_REVISED_Feb_09_WrittenConsentforCheekCells.doc Supplementary Document	2009-03-03
Dietary information collection_letter.doc Supplementary Document	2009-03-03
Attachment_O_REVISED_Feb_09_WrittenConsentforCheekCells.doc Supplementary Document	2009-03-03
SS_Part_B_ICRO Final.doc Supporting Statement B	2008-11-19
Att S_List of CATI Changes.doc Supplementary Document	2008-11-19
Att P_Thank You Letter.doc Supplementary Document	2008-11-19
Att M_Human Subjects Fact Sheet.doc Supplementary Document	2008-11-19
Att L_Intoductory Letter.doc Supplementary Document	2008-11-19
Att K_NBDPS Q&A Pamphlet.pdf Supplementary Document	2008-11-19
Att J_Confidentiality Oath.doc Supplementary Document	2008-11-19
Att I_Certificate of Confidentiality.pdf Supplementary Document	2008-11-19
Att H_CBDRP Collaborators List.doc Supplementary Document	2008-11-19
Att G_Birth Defects Prevention Act of 1998.pdf Supplementary Document	2008-11-19
Att F_List of Birth Defects.doc Supplementary Document	2008-11-19
Att D_List of Study Ctrs.doc Supplementary Document	2008-11-19
Att C_CDC IRB Appr Ltr.doc Supplementary Document	2008-11-19
Att B_ FRN 60d.pdf Supplementary Document	2008-11-19
Att A_GA DHR Ltr for MACDP.pdf Supplementary Document	2008-11-19
Att A.1_Birth Defects Prevention Act of 1998.pdf Supplementary Document	2008-11-19
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
SS_Part_A_Final.doc Supporting Statement A	2008-11-21

IC Document Collections

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

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 200812-0920-001
Status: Historical Active	Previous ICR Reference No: 200602-0920-007
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/16/2009
	Date Received in OIRA: 12/02/2008
Terms of Clearance: Approved consistent with Agency memo to OMB dated 02/26/2009 along with the revised informed consent form and the letter of support uploaded on 03/03/2009. OMB and the Agency recognize the substantial underestimation of burden in previous versions of this collection and have worked together to correct this oversight. The burden hours approved under this collection are an accurate representation of the scope (eight states: AR, CA, IA, MA, NC, NY, TX and UT, and Atlanta) of this collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2012	36 Months From Approved	05/31/2009
Responses	14,400	0	400
Time Burden (Hours)	5,400	0	600
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)
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	400	0	14,000	0	0
Annual Time Burden (Hours)	5,400	600	0	4,800	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 occurred due to data being collected from eight additional states.

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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)? Uncollected

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: 12/02/2008

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