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
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.