Performance Evaluation Program for Rapid HIV Testing

Forms and Documents

Document Name	Status
Form none assigned HIV Rapid Testing Performance Evaluation Sample and Laboratory Practices Questionnaire Surveys - HIV Rapid Testing Questionnaire Form	Modified
Form none assigned HIV Rapid Testing Performance Evaluation Sample and Laboratory Practices Questionnaire Surveys - HIV Rapid Testing Form EZ Form	New
WARNING for sample package.doc Supplementary Document	2007-03-29
Supporting Statement B 11-22-2006.doc Supporting Statement B	2006-11-22
Attachment #1- Authorizing Legislation.pdf Supplementary Document	2006-11-07
Supporting Statement A 11-22-2006.doc Supporting Statement A	2006-11-22

IC Document Collections

IC ID	Document Title	Status
7058	HIV Rapid Testing Performance Evaluation Sample and Laboratory Practices Questionnaire Surveys - HIV Rapid Testing Questionnaire Form	Modified
46421	HIV Rapid Testing Performance Evaluation Sample and Laboratory Practices Questionnaire Surveys - HIV Rapid Testing Form EZ Form	New

ICR Details

OMB Control No: 0920-0595	ICR Reference No: 200612-0920-004
Status: Historical Active	Previous ICR Reference No: 200305-0920-004
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: 03/29/2007
	Date Received in OIRA: 12/13/2006
Terms of Clearance: Approved consistent with CDC memo outlining changes to the collection. CDC will include a warning outlining potential hazards associated with test samples sent to labs under this collection of information.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2010	36 Months From Approved	03/31/2007
Responses	2,250	0	900
Time Burden (Hours)	625	0	175
Cost Burden (Dollars)	0	0	0

---

Abstract: To support our mission of improving public health and preventing disease through continuously improving laboratory practices, the Model Performance Evaluation Program (MPEP), Division of Laboratory Systems, Public Health Practice Program Office, Centers for Disease Control and Prevention intends to provide a new HIV rapid testing performance evaluation program (HIV Rapid Testing MPEP). This program will offer external performance evaluation (PE) for rapid tests such as the OraQuick Rapid HIV-1 Antibody Test, recently approved as a waived test by the U.S. Food and Drug Administration, and for other licensed tests such as the Abbott-Murex SUDS HIV-1 Test.

---

Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Research and investigations generally
  

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:
	71 FR 17103	04/05/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 66783	11/16/2006
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
HIV Rapid Testing Performance Evaluation Sample and Laboratory Practices Questionnaire Surveys - HIV Rapid Testing Questionnaire	none assigned	HIV Rapid Testing Questionnaire
HIV Rapid Testing Performance Evaluation Sample and Laboratory Practices Questionnaire Surveys - HIV Rapid Testing Form EZ	none assigned	HIV Rapid Testing Results Booklet

---

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	2,250	900	0	1,350	0	0
Annual Time Burden (Hours)	625	175	0	450	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: Revised instruments to include additional test kit manufactures coming to market.

---

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

---

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: 12/04/2006

---