Assessment and Evaluation of the Role of Care Coordination (Case Management) in Improving Access and Care within the Spina Bifida Clinic System

Forms and Documents

Document Name	Status
Clinic Staff Interviews Form and Instruction	New
Clinic Staff - Telephone Interview Script Form and Instruction	New
Clinic Recruitment Form and Instruction	New
Caregivers - Telephone Recruitment and Screening Form and Instruction	New
Caregivers - Focus Group Form and Instruction	New
Caregivers - Focus Group Response Form Form and Instruction	New
Attachment D--IRB Approval Documents.doc Supplementary Document	2007-06-18
Attachment B-60 day FRN.doc Supplementary Document	2007-06-18
Attachment A--Applicable Laws.doc Supplementary Document	2007-06-18
0920-06BF SS A and B.doc Supporting Statement A	2007-06-20

IC Document Collections

IC ID	Document Title	Status
181193	Clinic Staff Interviews Form and Instruction	New
181192	Clinic Staff - Telephone Interview Script Form and Instruction	New
181191	Clinic Recruitment Form and Instruction	New
181190	Caregivers - Telephone Recruitment and Screening Form and Instruction	New
181189	Caregivers - Focus Group Form and Instruction	New
181188	Caregivers - Focus Group Response Form Form and Instruction	New

ICR Details

OMB Control No: 0920-0759	ICR Reference No: 200707-0920-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Assessment and Evaluation of the Role of Care Coordination (Case Management) in Improving Access and Care within the Spina Bifida Clinic System
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: 01/07/2008
	Date Received in OIRA: 07/13/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2009	12 Months From Approved
Responses	399	0	0
Time Burden (Hours)	244	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Spina bifida is one of the most common birth defects, affecting approximately 3 per 10,000 live births in the United States annually. Providing care for people who are born with spina bifida is complex and challenging. Multiple physicians and many other professionals and services are involved regularly in addressing the many medical and non-medical issues that these individuals and their families face. Care coordination has been utilized for individuals with complex health conditions such as cystic fibrosis and sickle cell anemia, and has been found to be beneficial for assisting patients and their families. However, a limited number of empirical studies have examined care coordination within the spina bifida clinic setting. The proposed data collection will use qualitative methods to 1) examine the extent to which care coordination in spina bifida clinics is perceived to be effective; 2) identify perceived barriers to providing care coordination in spina bifida clinics; and 3) identify potential best practices related to providing care coordination in spina bifida clinics.

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Authorizing Statute(s): US Code: 42 USC 317C Name of Law: Birth Defects and Developmental Disabilities Prevention Act of 2003
  

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 28703	05/17/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 34016	06/20/2007
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Caregivers - Focus Group Response Form	None	Focus Group Response Form
Caregivers - Focus Group	None	Focus Group Moderators Guide
Caregivers - Telephone Recruitment and Screening	None	Focus Group Telephone Script
Clinic Recruitment	None	Clinic Recruitment Script
Clinic Staff - Telephone Interview Script	None	Telephone Interview Script for Clinic Staff
Clinic Staff Interviews	None, None, None, None	Interview Guide for Clinic Director ,   Interview Guide for Clinician Provider ,   Interview Guide for Care Coordinator ,   Interview Guide for Clinic Staff

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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	399	0	0	399	0	0
Annual Time Burden (Hours)	244	0	0	244	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 data collection.

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Annual Cost to Federal Government: $165,111

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: 07/13/2007

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