Laboratory Medicine Best Practices Project

Forms and Documents

Document Name	Status
IRB determination.pdf Supplementary Document	2009-11-20
Attachment F_2009 Laboratory Medicine Best Practices Workgroup.doc Supplementary Document	2009-11-20
Attachment E_Draft LMBP Quality Rating Guide_07272009.doc Supplementary Document	2009-11-20
Attachment G 60 day Public Comment and Response.pdf Supplementary Document	2009-11-20
Attachment A.pdf Supplementary Document	2009-11-20
Attachment D_Draft LMBP Evidence Summary Table Format .doc Supplementary Document	2009-11-20
OMB Supporting Statement LMBP.doc Supporting Statement A	2010-03-17

IC Document Collections

IC ID	Document Title	Status
192353	Laboratory Medicine Best Practices Project Data Submission Form Instruction	New

ICR Details

OMB Control No: 0920-0848	ICR Reference No: 201003-0920-013
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Laboratory Medicine Best Practices Project
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: 05/04/2010
	Date Received in OIRA: 03/26/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	36 Months From Approved
Responses	150	0	0
Time Burden (Hours)	100	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention (CDC) is requesting Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995 for a new collection of information from healthcare organizations about laboratory medicine unpublished studies or in house assessments that demonstrate practice effectiveness. CDC is requesting three year approval for this information collection request.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: USC
  

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:
	74 FR 3870	07/21/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 12754	03/17/2010
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
Laboratory Medicine Best Practices Project Data Submission Form

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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	150	0	0	150	0	0
Annual Time Burden (Hours)	100	0	0	100	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: The Centers for Disease Control and Prevention (CDC) is requesting Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995 for a new collection of information from healthcare organizations about laboratory medicine unpublished studies or in house assessments that demonstrate practice effectiveness. CDC is requesting three year approval for this information collection request.

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Annual Cost to Federal Government: $132,375

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? Yes

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)? 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: 03/26/2010

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