Laboratory Medicine Best Practices Project

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Laboratory Medicine Best Practices Project Data Submission Form	Form and Instruction	Modified	Available
Attachment G Public Comments.docx	Supplementary Document	Uploaded 2013-02-07	Available
Attachment F Final AoC LMBP Document.11-20-12.pdf	Supplementary Document	Uploaded 2013-02-07	Available
Attachment E_2009 Laboratory Medicine Best Practices Workgroup.doc	Supplementary Document	Uploaded 2013-02-07	Available
Attachment D_ LMBP Evidence Summary Table .doc	Supplementary Document	Uploaded 2013-02-07	Available
Attachment B 60 D FRN 0920-0848 Dec 4 2012.pdf	Supplementary Document	Uploaded 2013-02-07	Available
Attachment A Public Health Service Act.pdf	Supplementary Document	Uploaded 2013-02-07	Available
OMB Supporting Statement Part A and B 0920 0848.doc	Supporting Statement A	Uploaded 2013-02-07	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
192353	Laboratory Medicine Best Practices Project Data Submission Form	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0848	ICR Reference No: 201302-0920-013
Status: Historical Active	Previous ICR Reference No: 201204-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No: 18777
Title: Laboratory Medicine Best Practices Project
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/13/2013
	Date Received in OIRA: 02/15/2013
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2016	36 Months From Approved	05/31/2013
Responses	150	0	150
Time Burden (Hours)	100	0	100
Cost Burden (Dollars)	0	0	0

---

Abstract: CDC requests OMB approval for an extension of information collection from healthcare organizations about laboratory medicine unpublished studies or in house assessments that demonstrate practice effectiveness.

---

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

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
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 71796	12/04/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 9698	02/11/2013
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Laboratory Medicine Best Practices Project Data Submission Form	none	LMBP Project Summary

---

ICR Summary of Burden

table that charts list 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	150	0	0	0	0
Annual Time Burden (Hours)	100	100	0	0	0	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: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $116,000

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

---

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: 02/15/2013

---