Information Collection Request

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

ICR 200812-0920-001 · OMB 0920-0010 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
OMB_Memorandum_Conference_Call_issues_0920_0010.doc Supplementary Document Uploaded 2009-03-03 Available
Attachment_O_REVISED_Feb_09_WrittenConsentforCheekCells.doc Supplementary Document Uploaded 2009-03-03 Available
Dietary information collection_letter.doc Supplementary Document Uploaded 2009-03-03 Available
Attachment_O_REVISED_Feb_09_WrittenConsentforCheekCells.doc Supplementary Document Uploaded 2009-03-03 Repair queued
SS_Part_B_ICRO Final.doc Supporting Statement B Uploaded 2008-11-19 Available
Att S_List of CATI Changes.doc Supplementary Document Uploaded 2008-11-19 Repair queued
Att P_Thank You Letter.doc Supplementary Document Uploaded 2008-11-19 Repair queued
Att M_Human Subjects Fact Sheet.doc Supplementary Document Uploaded 2008-11-19 Available
Att L_Intoductory Letter.doc Supplementary Document Uploaded 2008-11-19 Repair queued
Att K_NBDPS Q&A Pamphlet.pdf Supplementary Document Uploaded 2008-11-19 Available
Att J_Confidentiality Oath.doc Supplementary Document Uploaded 2008-11-19 Repair queued
Att I_Certificate of Confidentiality.pdf Supplementary Document Uploaded 2008-11-19 Repair queued
Att H_CBDRP Collaborators List.doc Supplementary Document Uploaded 2008-11-19 Repair queued
Att G_Birth Defects Prevention Act of 1998.pdf Supplementary Document Uploaded 2008-11-19 Available
Att F_List of Birth Defects.doc Supplementary Document Uploaded 2008-11-19 Available
Att D_List of Study Ctrs.doc Supplementary Document Uploaded 2008-11-19 Repair queued
Att C_CDC IRB Appr Ltr.doc Supplementary Document Uploaded 2008-11-19 Repair queued
Att B_ FRN 60d.pdf Supplementary Document Uploaded 2008-11-19 Available
Att A_GA DHR Ltr for MACDP.pdf Supplementary Document Uploaded 2008-11-19 Repair queued
Att A.1_Birth Defects Prevention Act of 1998.pdf Supplementary Document Uploaded 2008-11-19 Repair queued
Att R_Cheek Cell Instructions.doc Supplementary Document Uploaded 2008-11-19 Available
Att O_Written Consent for Cheek Cells.doc Supplementary Document Uploaded 2008-11-19 Repair queued
Att N_Intro Phone Scripts.doc Supplementary Document Uploaded 2008-11-19 Available
SS_Part_A_Final.doc Supporting Statement A Uploaded 2008-11-21 Available
ICR Details
0920-0010 200812-0920-001
Historical Active 200602-0920-007
HHS/CDC
National Birth Defects Prevention Study (formerly titled: Metro Atlanta Birth Defects & Factor Surveillance Program)
Revision of a currently approved collection   No
Regular
Approved with change 03/16/2009
Retrieve Notice of Action (NOA) 12/02/2008
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
03/31/2012 36 Months From Approved 05/31/2009
14,400 0 400
5,400 0 600
0 0 0

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.

US Code: 42 USC 247b-4 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  73 FR 19853 04/11/2008
73 FR 70354 11/20/2008
No

  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
Yes
Miscellaneous Actions
No
Increase in burden occurred due to data being collected from eight additional states.

$2,582,590
Yes Part B of Supporting Statement
Yes
Uncollected
Uncollected
Uncollected
Uncollected
Thelma Sims 4046394771

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
12/02/2008