Sickle Cell Disease Program Evaluations

Forms and Documents

Document	Type	Status	Availability
Form 009_Sickle Cell_Cl Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Client Family Communication Form	Form	Modified	Available
Form 008_Sickle Cell_QI Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Quality Improvement Instrument	Form	Modified	Available
Form 007_Sickle Cell_Me Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Medical Home Family Index	Form	Removed	Available
Form 5 Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Health Survey	Form	Modified	Available
Form EDITED 8-29-11 Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Utilization Post	Form and Instruction	Modified	Available
Form 3 Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Utilization Questionnaire (pre-demonstration)	Form and Instruction	Modified	Available
Attachment_A_SCDTDP_legislation[1].docx	Supplementary Document	Uploaded 2012-05-04	Available
FINALss_Part B_sickle cell disease_3-22-2011 rl1 SUBMITTED to OMB-revised_10_24_11[1].docx	Supporting Statement B	Uploaded 2012-05-04	Available
Non-Sub Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2012-04-10	Available
Revised Supporting Statement A.docx	Supporting Statement A	Uploaded 2012-04-24	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
197496	Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Client Family Communication Form	Form	Modified
197495	Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Quality Improvement Instrument	Form	Modified
197494	Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Medical Home Family Index	Form	Removed
197493	Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - PedsQL for children & adolescents	Instruction	Modified
197492	Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - PedsQL for Parents	Instruction	Modified
197491	Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Health Survey	Form	Modified
197490	Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Utilization Post	Form and Instruction	Modified
197489	Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Utilization Questionnaire (pre-demonstration)	Form and Instruction	Modified
197488	Sickle Cell Disease and Newborn Screening Program (SCDNBSP) Evaluation - MDP SCT Questioniare	Instruction	Modified
197487	Sickle Cell Disease and Newborn Screening Program (SCDNBSP) Evaluation - MDP SCD Questioniare	Instruction	Modified

ICR Details

OMB Control No: 0915-0344	ICR Reference No: 201204-0915-001
Status: Historical Active	Previous ICR Reference No: 201104-0915-003
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Sickle Cell Disease Program Evaluations
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/04/2012
	Date Received in OIRA: 04/12/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2014	12/31/2014	12/31/2014
Responses	7,638	0	9,438
Time Burden (Hours)	2,787	0	3,476
Cost Burden (Dollars)	0	0	0

---

Abstract: This statement is a request for Office of Management and Budget approval for evaluation and quality improvement activities of the Sickle Cell Disease and Newborn Screening Program (SCDNBSP) and the Sickle Cell Disease Treatment and Demonstration Program (SCDTDP). The purpose of the evaluations and quality improvement activities is to assess the service delivery processes and outcomes resulting from the systems of care delivered by SCDNBSP and SCDTDP networks to individuals affected by Sickle Cell Disease (SCD) who present at their sites for care.

---

Authorizing Statute(s): PL: Pub.L. 108 - 357 712 Name of Law: The American Jobs Creation Act of 2004
   US Code: 42 USC 300b-1 Name of Law: Public Health Service Act
   US Code: 42 USC 701 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Sickle Cell Disease and Newborn Screening Program (SCDNBSP) Evaluation - MDP SCD Questioniare	1	SCD Questionnaire Form
Sickle Cell Disease and Newborn Screening Program (SCDNBSP) Evaluation - MDP SCT Questioniare	2	SCT Questionnaire Form
Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Utilization Questionnaire (pre-demonstration)	3	Utilization Data Form
Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Utilization Post	EDITED 8-29-11	Attach_E_Individual Utilization Data Form_Mar2010 - EDITED 8-29-111
Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Health Survey	5	Short Form 8 Health Survey (adult)
Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - PedsQL for Parents	PedsQL	Pediatric Quality of Life Inventory for parents of children and adolescents age 18 or younger
Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - PedsQL for children & adolescents	PedsQL	Pediatric Quality of Life Inventory for children and adolescents age 18 or younger
Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Quality Improvement Instrument	008_Sickle Cell_QI Instrument	008_Sickle Cell_QI Instrument
Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Client Family Communication Form	009_Sickle Cell_Client and Fam Comm Form	009_Sickle Cell_Client and Fam Comm Form
Sickle Cell Disease Treatment Demonstration Program (SCDTDP) Evaluation - Medical Home Family Index	007_Sickle Cell_Medical Home Index_Short, 007_Sickle Cell_Medical Home Index_Full	007_Sickle Cell_Medical Home Index_Short ,   007_Sickle Cell_Medical Home Index_Full

---

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	7,638	9,438	0	-1,800	0	0
Annual Time Burden (Hours)	2,787	3,476	0	-450	-239	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: Yes

Burden Reduction Due to: Cutting Redundancy

Short Statement: This is a request for a non-material or non-substantive change to streamline the process of data collection and reduce the burden on the public by making minor changes to our currently approved OMB package - OMB Number: 0915-0344, Expiration Date: 12/31/2014. The proposed changes are non-substantive; they will reduce the number of survey items that grantee teams will collect from individuals served through two programs, Sickle Cell Disease Treatment Demonstration Program (SCDTDP) and the Sickle Cell Disease Newborn Screening Program (SCDNBSP). These are achieved by eliminating duplicated demographic items across instruments, by using validated shorter versions of the same instruments, and by eliminating one instrument that collected information that will be gleaned from other sources (chart review).

---

Annual Cost to Federal Government: $1,671,000

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

---

Common Form ICR:  No

---

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: 04/12/2012

---