National Birth Defects Prevention Study

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
6607	National Birth Defects Prevention Study	Migrated

ICR Details

OMB Control No: 0920-0010	ICR Reference No: 200301-0920-002
Status: Historical Active	Previous ICR Reference No: 199909-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: National Birth Defects Prevention Study
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/27/2003
	Date Received in OIRA: 01/02/2003
Terms of Clearance: Approved. CDC is finalizing revisions to the survey instrument. Once finalized, CDC shall submit the revised instrument for OMB approval through a change worksheet. The response rate for the biologic sample collection portion of the study is only 50%. In compliance with the previous terms of clearace, CDC is conducting a pilot study to explore the use of additional incentive payments to boost the response rate. CDC will add an additional $20 incentive in two sites, that is linked to the return of the biologic sample kits. CDC will report the results of this pilot to OMB upon resubmission of this study and/or prior to applying the additional incentive to the full study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2006	05/31/2006	02/28/2003
Responses	400	0	1,600
Time Burden (Hours)	600	0	600
Cost Burden (Dollars)	0	0	0

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Abstract: NCBDDD has been monitoring the occurence of serious birth defects and genetic diseases in Atlanta since 1967. Its primary purpose is to describe the spatial and temporal patterns of birth defects occurence and serve as an early warning system for new teratogens Since 1997, the Division of Birth Defects and Developmental Disabilities has also been conducting the National Birth Defects Prevention Study (NBDPS), a case-control study of risk factors for selected birth defects. Infants with birth defects are identified and maternal interviews, and clinical/laboratory tests are conducted on approximately 300 cases and 100 controls .......

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
National Birth Defects Prevention Study

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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	400	1,600	0	-1,200	0	0
Annual Time Burden (Hours)	600	600	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: $0

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? No

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: 01/02/2003

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