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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
6725	CDC Model Performance Evaluation Program (MPEP) for Retroviral and AIDS-Related Testing	Migrated

ICR Details

OMB Control No: 0920-0274	ICR Reference No: 200408-0920-002
Status: Historical Active	Previous ICR Reference No: 200302-0920-009
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 with change	Conclusion Date: 10/14/2004
	Date Received in OIRA: 08/03/2004
Terms of Clearance: Approved consistent with CDC memo submitted to OMB 10/01/04. CDC will track the total number of calls received from laboratories which failed to produce accurate results, and the total number of inaccurate results. CDC will report on these numbers to OMB in the next submission of this collection. CDC will also provide an evaluation of the utility of directly contacting laboratories that generate inaccurate results in the next submission of this package. OMB has reviewed CDC's rationale for not moving toward a blind proficiency testing model,that is a model in which laboratories would not be aware the samples being tested were sent by CDC, at this time OMB is satisfied that process constraints make such a format impracticable.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2007	10/31/2007	10/31/2004
Responses	2,835	0	4,548
Time Burden (Hours)	1,057	0	852
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
CDC Model Performance Evaluation Program (MPEP) for Retroviral and AIDS-Related Testing

---

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	2,835	4,548	0	-1,713	0	0
Annual Time Burden (Hours)	1,057	852	0	205	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:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $0

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]? 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

---

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: 08/03/2004

---