CDC Model Performance Evaluation Program (MPEP) for Retroviral and AIDS-Related Testing

Forms and Documents

Document Name	Status
Supporting Statement Part B_091407 (Revised).doc Supporting Statement B	2007-09-19
Attachment 12 Final Report.doc Supplementary Document	2007-08-03
Attachment 11 Report Cover Ltr.doc Supplementary Document	2007-08-03
Attachment 9 Result Form Cover Ltr.doc Supplementary Document	2007-08-03
Attachment 8 HIICF_earlyShip.doc Supplementary Document	2007-08-03
Attachment 8 HIICF_domestic.doc Supplementary Document	2007-08-03
Attachment 7 Password Letter_earlyship.doc Supplementary Document	2007-08-03
Attachment 6 PreShpmntLtr_domestic.doc Supplementary Document	2007-08-03
Attachment 5 Wel_Add.doc Supplementary Document	2007-08-03
Attachment 4 Wel_New.doc Supplementary Document	2007-08-03
Attachment 3 Enrollment Form.doc Supplementary Document	2007-08-03
Attachment 10 Result Form.doc Supplementary Document	2007-08-03
Attachment 8 HIICF_earlyShip.doc Supplementary Document	2007-08-07
Supporting Statement A 0920-0274_102407(Revised).doc Supporting Statement A	2007-10-24

IC Document Collections

IC ID	Document Title	Status
37750	CDC Model Performance Evaluation Program (MPEP) Enrollment Form Other-Enrollment Form	Modified
182465	CDC Model Performance Evaluation Program (MPEP) Results Form Other-Test Result Form	New
182464	CDCModel Performance Evaluation Program (MPEP) Laboratory Change Form Other-Laboratory Change Form	New

ICR Details

OMB Control No: 0920-0274	ICR Reference No: 200710-0920-010
Status: Historical Active	Previous ICR Reference No: 200411-0920-008
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: CDC Model Performance Evaluation Program (MPEP) for Retroviral and AIDS-Related Testing
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/21/2008
	Date Received in OIRA: 10/25/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	02/29/2008
Responses	1,628	0	4,245
Time Burden (Hours)	257	0	1,057
Cost Burden (Dollars)	0	0	0

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Abstract: The CDC Model Performance Evaluation Program (MPEP) assesses the performance of laboratories that test for recognized diseases of public health significance (namely HIV infection). Testing includes HIV antibody, Rapid HIV-1 antibody, HIV-1 RNA determinations, and CD4 T-cell determinations. The basis for the MPEP is to establish methods for identifying and defining problems in the testing process, to evaluate strategies for improving or maintaining high quality testing, and to allow laboratories to improve or maintain the quality of their testing by providing them the opportunity for self assessment.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: THE PUBLIC HEALTH AND WELFARE
  

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:
	72 FR 8385	02/26/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 38599	07/13/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
CDC Model Performance Evaluation Program (MPEP) Enrollment Form
CDCModel Performance Evaluation Program (MPEP) Laboratory Change Form
CDC Model Performance Evaluation Program (MPEP) Results 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	1,628	4,245	0	-2,617	0	0
Annual Time Burden (Hours)	257	1,057	0	-800	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: System request

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Annual Cost to Federal Government: $37,500

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]? 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: 10/25/2007

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