Qualitative Assessment of Mothers' Attitudes Toward Collecting Biological Specimens to Study Risk Factors for Birth Defects and Preterm Delivery in the National Birth Defects Prevention Study

Forms and Documents

Document Name	Status
Form None assigned Qualitative Assessment of Mothers' Attitudes ... National Birth Defects Prevention Study - Focus Group Moderator's Guide Form and Instruction	New
0920-06AW Supplement Supporting Statement rev 3-15-07.doc Supporting Statement B	2007-03-22
Public Comment 03.19.06.pdf Supplementary Document	2006-11-28
Appendix L CDC IRB Approval for Focus Groups 11-5-06.pdf Supplementary Document	2006-11-20
Appendix O BLS Atlanta Wage Table.pdf Supplementary Document	2006-11-20
Appendix N BLS Atlanta Wage Table Childcare.pdf Supplementary Document	2006-11-20
Appendix M NBDPS Confidentiality Oath.doc Supplementary Document	2006-11-20
Appendix K 60-day Federal Register Notice.pdf Supplementary Document	2006-11-20
Appendix A4 NBDPS Certificate of Confidentiality Exp 8-09.pdf Supplementary Document	2006-11-20
Appendix A3 Birth Defects Prevention Act of 1998.pdf Supplementary Document	2006-11-20
Appendix A1 Sec. 317C 42 USC 247B-4 NCBDDD.pdf Supplementary Document	2006-11-20
Appendix A2 Sec. 301 42 USC 241.pdf Supplementary Document	2006-11-20
0920-06AW Supplement Supporting Statement rev 11-20-06.doc Supporting Statement A	2006-11-20

IC Document Collections

IC ID	Document Title	Status
46391	Qualitative Assessment of Mothers' Attitudes ... National Birth Defects Prevention Study - Focus Group Moderator's Guide Form and Instruction	New

ICR Details

OMB Control No: 0920-0737	ICR Reference No: 200612-0920-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Qualitative Assessment of Mothers' Attitudes Toward Collecting Biological Specimens to Study Risk Factors for Birth Defects and Preterm Delivery in the National Birth Defects Prevention Study
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/22/2007
	Date Received in OIRA: 12/12/2006
Terms of Clearance: Approved consistent with CDC revisions to the supporting statement included in the public docket.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2010	36 Months From Approved
Responses	72	0	0
Time Burden (Hours)	180	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Since 1997, the NCBDDD has 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 per year. Controls are selected among normal births in the same population. These proposed focus groups (which are a supplement to the National Birth Defects Prevention Study) will use qualitative research to provide data on the barriers to participation in the collection of biological specimens by mothers on themselves, their infants, and young children.

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Authorizing Statute(s): US Code: 42 USC 247b-4 Name of Law: Collection of data on birth defects
   US Code: 42 USC 241 Name of Law: Research and Investigations Generally
  

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:
	71 FR 13852	03/17/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 66331	11/14/2006
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Qualitative Assessment of Mothers' Attitudes ... National Birth Defects Prevention Study - Focus Group Moderator's Guide	None assigned, None assigned	Appendix I Moderators Guide_Participator rev 10-27-06 ,   Appendix J Moderators Guide_Nonparticpator rev10-27-06

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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	72	0	0	72	0	0
Annual Time Burden (Hours)	180	0	0	180	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: These proposed focus groups will increase the burden of OMB#0920-0100. This increase is necessary to understand why some respondents chose to participate and some chose not to participate in the OMB approved collection.

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Annual Cost to Federal Government: $106,679

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 11/29/2006

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