Sickle Cell Disease Treatment Demonstration Program - Quality Improvement Data Collection

Forms and Documents

Document Name	Status
Form D Sickle Cell Disease Treatment Demonstration Program - Quality Improvement Data Collection Form and Instruction	New
Appendix J-_Justification for Annual Estimate of Burden - 9-16-16.docx Supplementary Document	2016-09-29
Appendix J_Justification for Annual Estimate of Burden.docx Supplementary Document	2016-06-28
Appendix I_SCDTDP_OMB 60-day FRN PUBLISHED.pdf Supplementary Document	2016-06-28
Appendix C_SCDTDP Oversight Steering Committee Members.docx Supplementary Document	2016-06-28
Appendix B_SCDTDP Data Summit Participants.docx Supplementary Document	2016-06-28
Appendix A PLAW-108publ357_ACA2004_Section712.pdf Supplementary Document	2016-06-28
SCDTDP Supporting Statement PASSBACK -Donnell edits (Clean 9-19-16 DS.docx Supporting Statement A	2016-09-29

IC Document Collections

IC ID	Document Title	Status
222219	Sickle Cell Disease Treatment Demonstration Program - Quality Improvement Data Collection Form and Instruction	New

ICR Details

OMB Control No: 0906-0019	ICR Reference No: 201606-0906-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HRSA	Agency Tracking No:
Title: Sickle Cell Disease Treatment Demonstration Program - Quality Improvement Data Collection
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	Conclusion Date: 10/05/2016
	Date Received in OIRA: 10/01/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2019	36 Months From Approved
Responses	320	0	0
Time Burden (Hours)	1,920	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In response to the growing need for resources devoted to sickle cell disease and other hemoglobinopathies, the United States Congress, under Section 712 of the American Jobs Creation Act of 2004 (Pub. L. 108–357) (42 U.S.C. 300b–1 note), authorized a demonstration program for the prevention and treatment of sickle cell disease (SCD) to be administered by the Maternal and Child Health Bureau (MCHB) of the Health Resources and Services Administration (HRSA) in the U.S. Department of Health and Human Services. The program is known as the Sickle Cell Disease Treatment Demonstration Program (SCDTDP). The SCDTDP is designed to improve access to services for individuals with sickle cell disease, improve and expand patient and provider education, and improve and expand the continuity and coordination of service delivery for individuals with sickle cell disease and sickle cell trait. The specific aims for the program are threefold: (1) Increase the number of providers treating persons with sickle cell disease, (2) increase the number of providers prescribing hydroxyurea, and (3) increase the number of providers knowledgeable about treating sickle cell disease as well as increase the number of sickle cell patients that are seen by providers knowledgeable about sickle cell disease. To achieve the goals and objectives of the program, the SCDTDP uses quality improvement (QI) methods in a collective impact model which supports cross-sector collaboration for achieving measurable effects on major social issues. The collective impact model requires shared measurement which facilitates tracking progress in a standardized method in order to promote learning and enhance continuous improvement.

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Authorizing Statute(s): PL: Pub.L. 108 - 357 712 Name of Law: American Jobs Creation Act of 2004
  

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:
	80 FR 248	12/28/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 123	06/27/2016
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
Sickle Cell Disease Treatment Demonstration Program - Quality Improvement Data Collection	D, E, F, H, G	Appendix D_ SCDTDP Data Collection Form ,   Appendix E_SCDTDP Measure Specifications ,   Appendix F_SCDTDP_Data Request Form ,   Appendix G Tracking Project Performance Measures Template ,   Appendix H_Project Performance-Outcome Measure Detail Sheet Template

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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	320	0	0	320	0	0
Annual Time Burden (Hours)	1,920	0	0	1,920	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 ICR, so an increase in burden from zero.

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Annual Cost to Federal Government: $871,738

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]? 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: 06/29/2016

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