Performance Evaluation Program for Rapid HIV Testing

Forms and Documents

Document Name	Status
Form 1 Model Performance Evaluation Program (MPEP) For HIV Rapid Testing (HIV-RT) ENROLLMENT FORM Form and Instruction	Modified
Form 2 HIV Rapid Testing Form EZ WORKSHEET Form and Instruction	Modified
Form 4 Laboratory Practices Questionnaire (LPQ) Form and Instruction	New
Form 3 Information Change Form Form and Instruction	New
Attachment 2_60 day FRN.pdf Supplementary Document	2009-12-17
30dyFRN_E9-29967.pdf Supplementary Document	2009-12-17
Attachment 4c_LPQ Report.pdf Supplementary Document	2009-12-18
Attachment 4b_LPQRT Cover letter-pswrdltr.doc Supplementary Document	2009-12-18
Attachment 6b_ICF cover email.doc Supplementary Document	2009-12-18
Attachment 3l_ Sample HIV RT EZ Report.pdf Supplementary Document	2009-12-17
Attachment 3k_ Nonresponder letter-email.doc Supplementary Document	2009-12-17
Attachment 3j_Reminder email.doc Supplementary Document	2009-12-17
Attachment 3i_Password notify ltr.doc Supplementary Document	2009-12-17
Attachment 3h_Donor Report Cover Letter.doc Supplementary Document	2009-12-17
Attachment 3g_Donor Report.doc Supplementary Document	2009-12-17
Attachment 3f_WARNING HIV RT EZ 0909.doc Supplementary Document	2009-12-17
Attachment 3e_HIV RT EZ Entry Instructions.doc Supplementary Document	2009-12-17
Attachment 3d_MPEP General Information.doc Supplementary Document	2009-12-17
Attachment 3c_HIV RT EZ cover letter.doc Supplementary Document	2009-12-17
Attachment 3b_Preshipment letter.doc Supplementary Document	2009-12-17
Attachment 5b_Welcome letter.doc Supplementary Document	2009-12-17
Supporting Statement_ 11 10 2009 (5).doc Supporting Statement A	2009-12-17

IC Document Collections

IC ID	Document Title	Status
7058	Model Performance Evaluation Program (MPEP) For HIV Rapid Testing (HIV-RT) ENROLLMENT FORM Form and Instruction	Modified
46421	HIV Rapid Testing Form EZ WORKSHEET Form and Instruction	Modified
191810	Laboratory Practices Questionnaire (LPQ) Form and Instruction	New
191809	Information Change Form Form and Instruction	New

ICR Details

OMB Control No: 0920-0595	ICR Reference No: 201001-0920-002
Status: Historical Active	Previous ICR Reference No: 200612-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Performance Evaluation Program for Rapid HIV 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: 02/03/2010
	Date Received in OIRA: 01/20/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	36 Months From Approved	03/31/2010
Responses	1,680	0	2,250
Time Burden (Hours)	387	0	625
Cost Burden (Dollars)	0	0	0

---

Abstract: CDC is requesting OMB approval to continue its HIV rapid testing performance evaluation program (HIV Rapid Testing MPEP). This program collects data on laboratories' performance of rapid HIV tests. Laboratories use this program as an external quality assurance assessment of their performance. Laboratories receive two testing challenges per year and also participate in a laboratory practices questionnaire to compare their testing practices with aggregate results from all HIV-RT MPEP participants.

---

Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act (42USC 241)
  

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:
	74 FR 28938	06/18/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 66968	12/17/2009
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Model Performance Evaluation Program (MPEP) For HIV Rapid Testing (HIV-RT) ENROLLMENT FORM	1	Model Performance Evaluation Program (MPEP) For HIV Rapid Testing (HIV-RT) ENROLLMENT FORM
HIV Rapid Testing Form EZ WORKSHEET	2	HIV Rapid Testing Form EZ WORKSHEET
Information Change Form	3	Information Change Form
Laboratory Practices Questionnaire (LPQ)	4	Laboratory Practices Questionnaire (LPQ)

---

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	1,680	2,250	0	-570	0	0
Annual Time Burden (Hours)	387	625	0	-238	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: The net decrease in burden is due to the elimination of foreign laboratories from the program.

---

Annual Cost to Federal Government: $397,490

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)? 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: 01/20/2010

---