Formative Research, Messages and Materials Development for NCBDDD

Forms and Documents

Document Name	Status
Safer Use of Medications During Pregnancy Form and Instruction	New
SptngStmnt B_rev.docx Supporting Statement B	2013-06-12
Att F_ExampleSurvey_rev.docx Supplementary Document	2013-06-12
Att E_ Example Focus Group Moderators Guide_rev.docx Supplementary Document	2013-06-12
Att D_Sample Consent Form_rev.doc Supplementary Document	2013-06-12
Att C_Sample Screener_rev.docx Supplementary Document	2013-06-12
Att B_60dy_FRN.pdf Supplementary Document	2013-06-12
Att A_ Applicable Laws or Regulations.docx Supplementary Document	2013-06-12
SptngStmnt A_rev.doc Supporting Statement A	2013-06-12

IC Document Collections

IC ID	Document Title	Status
214220	Safer Use of Medications During Pregnancy Form and Instruction	New

ICR Details

OMB Control No: 0920-0990	ICR Reference No: 201306-0920-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 19777
Title: Formative Research, Messages and Materials Development for NCBDDD
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 without change	Conclusion Date: 09/26/2013
	Date Received in OIRA: 06/21/2013
Terms of Clearance: Approved consistent with the understanding that individual memos explaining the exact methods for information collection along with the relevant data collection instruments will be submitted for each study under this clearance as GenICs and data collection will not begin until approval is received for the individual GenIC.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	36 Months From Approved
Responses	155,400	0	0
Time Burden (Hours)	49,650	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: NCBDDD will collect data from the public and health care providers to support formative research, messages and materials development in birth defects and developmental disabilities, human development and disabilities, and blood disorders.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: PHSA
  

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:
	78 FR 14553	03/06/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 35272	06/12/2013
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
Safer Use of Medications During Pregnancy	None, None, None, None, None, None, None, None, None, None, None, None, None, None	Initial Screener for Focus Group Participants ,   Focus Group Consent Form ,   Focus Group Screenshot Moderator Guide - Pain ,   Focus GroupScreenshot Moderator Guide - Depression ,   Focus Group Screenshot Moderator Guide - Asthma ,   Focus Group Screenshot Moderator Guide - Previous Pregnancy Acute Meds ,   Focus Group Moderator Guide - Previous Pregnancy Depression ,   Focus Group Screenshot Moderator Guide - Previous Pregnancy Asthma ,   Follow-Up Interview Moderator Guide - Pain ,   Follow-Up Interview Moderator Guide - Depression ,   Follow-Up Interview Moderator Guide - Asthma ,   Follow-Up Interview Moderator Guide - Previous Pregnancy Acute Meds ,   Follow-Up Interview Moderator Guide - PreviousPregnancy Depression ,   Follow-Up Interview Moderator Guide - Previous Pregnancy Asthma

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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	155,400	0	0	155,400	0	0
Annual Time Burden (Hours)	49,650	0	0	49,650	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: This is a new generic clearance request.

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Annual Cost to Federal Government: $193,500

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

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: 06/21/2013

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