National HIV Surveillance System (NHSS)

Forms and Documents

Document Name	Status
Form 0920-0573 Adult HIV/AIDS Confidential Case Report Form and Instruction	Modified
Form 0920-0573 Perinatal HIV Exposure Reporting (PHER) Form and Instruction	Modified
Form 0920-0573 HIV Incidence Surveillance (HIS) Form and Instruction	Modified
Case Report Updates Form	Modified
Form 0920-0573 Pediatric HIV/AIDS Confidential Case Report Form	Modified
Form 0920-0573 Molecular HIV Surveillance (MHS) Form and Instruction	New
Form 0920-0573 Laboratory Updates Form and Instruction	New
Final SS-B.doc Supporting Statement B	2012-12-19
Final Att-8a Assurance of Conf.pdf Supplementary Document	2012-12-19
Final Att 10b_ Statistical Consult Part List.pdf Supplementary Document	2012-12-19
Final Att 10a_Statistical Consult Agenda.pdf Supplementary Document	2012-12-19
Final Att 9_ 2011 HIV Sec Conf Guidlines.pdf Supplementary Document	2012-12-19
Final Att 8b_ Security Statement.pdf Supplementary Document	2012-12-19
Final Att 7c_2012 CSTE Pre Conf Mtg Agenda.pdf Supplementary Document	2012-12-19
Final Att 7b_2011 HIV Workshop Agenda.pdf Supplementary Document	2012-12-19
Final Att 3c_eHARS Variables (2).pdf Supplementary Document	2012-12-19
Final Att 3f_CRF Changes.docx Supplementary Document	2012-12-19
Final Att-4d MHS Tech Guidance (2).pdf Supplementary Document	2012-12-19
Final Att 6_ 2010 HIV Surv Report.pdf Supplementary Document	2012-12-19
0920-0573_att 4(b)Technical_Guidance_HIV Incidence Surveillance.pdf Supplementary Document	2009-11-30
Final Att-4b Peds Tech Guidance Vol 2 (2).pdf Supplementary Document	2012-12-19
Final Att-4a Adult Tech Guidance Vol 2 (2).pdf Supplementary Document	2012-12-19
Final Att 3c_eHARS Variables (2).pdf Supplementary Document	2012-12-19
Final Rev corr SS A.docx Supporting Statement A	2013-02-11

IC Document Collections

IC ID	Document Title	Status
7028	Adult HIV/AIDS Confidential Case Report Form and Instruction	Modified
46035	Perinatal HIV Exposure Reporting (PHER) Form and Instruction	Modified
46034	HIV Incidence Surveillance (HIS) Form and Instruction	Modified
46033	HIV Incidence Surveillance Data Elements Other-Incidence Data Elements	Removed
46032	Case Report Updates Form	Modified
46030	Pediatric HIV/AIDS Confidential Case Report Form	Modified
205250	Molecular HIV Surveillance (MHS) Form and Instruction	New
205249	Laboratory Updates Form and Instruction	New
205248	Case Report Evaluation Instruction	New

ICR Details

OMB Control No: 0920-0573	ICR Reference No: 201301-0920-001
Status: Historical Active	Previous ICR Reference No: 201106-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: National HIV Surveillance System (NHSS)
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: 02/13/2013
	Date Received in OIRA: 01/02/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved	02/28/2013
Responses	639,008	0	200,335
Time Burden (Hours)	53,700	0	51,311
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention (CDC) requests approval for revisions to a previously approved project 0920-0573 expiration 01/31/2013 called "National HIV Surveillance System (NHSS)" for a period of 3 years. The Division of HIV/AIDS Prevention (DHAP), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC in collaboration with health departments in the states, the D.C., and U.S. dependent areas, conducts national surveillance for cases of human immunodeficiency virus (HIV) infection that includes critical data across the spectrum of HIV disease from HIV diagnosis, to acquired immunodeficiency syndrome (AIDS), the end-stage disease caused by infection with HIV, and death. The revisions requested in this extension include modifications to currently collected data elements and forms to align with anticipated changes in the case definitions for HIV surveillance to be published in 2012 and continuation of HIV surveillance activities funded under the new funding opportunity announcement CDC-RFA-PS13-1302 NATIONAL HIV SURVEILLANCE SYSTEM (NHSS). These include minor modifications of testing categories to accommodate new testing algorithms and modifications to staging criteria and non-substantial editorial changes aimed at improving the format and usability of the forms such as improved wording of terms and changes in the format of some response options. In addition, elements from the former enhanced perinatal surveillance (EPS) were reduced and the form is modified for continuation in 2013 as Perinatal HIV Exposure Reporting (PHER). Surveillance data collection on variant and atypical strains (formerly variant, atypical and resistant HIV surveillance (VARHS)) will also be continued as Molecular HIV Surveillance (MHS) with a reduced number of data elements previously approved under VARHS.

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Authorizing Statute(s): US Code: 42 USC 242b Name of Law: General Authority Respecting Research...
   US Code: 42 USC 242m Name of Law: General Provisions Respecting Effectiveness, Efficiency, and Quality of Health Services
   US Code: 42 USC 242k Name of Law: National Center for Health Statistics
  

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:
	77 FR 47848	08/10/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 76045	12/26/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Adult HIV/AIDS Confidential Case Report	0920-0573	Adult HIV Confidential Case Report Form
Pediatric HIV/AIDS Confidential Case Report	0920-0573	Pediatric HIV Confidential Case Report Form
Case Report Updates	none, 0920-0573	Pediatric HIV/AIDS Confidential Case Report ,   Final Att-3a Adult CRF (2)
HIV Incidence Surveillance (HIS)	0920-0573	Final Att 4c_Incidence TG append (2)
Perinatal HIV Exposure Reporting (PHER)	0920-0573	Final Att-3e PHER Form (2)
Case Report Evaluation
Laboratory Updates	0920-0573	Final Att 5_2009-2012 Publications
Molecular HIV Surveillance (MHS)	0920-0573	Final Att 3d_MHS data elements (2)
HIV Incidence Surveillance Data Elements

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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	639,008	200,335	0	-60,925	499,598	0
Annual Time Burden (Hours)	53,700	51,311	0	-10,154	12,543	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 requested burden for this project is 53,700 hours. The previous burden associated with this information collection was 51,311 hours. The requested total burden represents an approximate 5% increase. This small increase reflects reductions in some activities and increases in others and refinements in some of our calculations. Our estimate now reflects the stabilization of case reporting due to having mature reporting systems in all areas. Burden calculations in this revision were based on reported cases without any additional adjustments for areas without mature reporting systems. This resulted in a decrease in burden for adult and pediatric case reports and evaluations based on those reports. We anticipate increased reporting activities related to laboratory and other updates to cases reports. We refined our estimates for these updates to more accurately reflect the number of updates and considered the burden required for each method of update separately (primarily electronic or other methods). Burden estimates for incidence data collection increased due to a small refinement in our estimate. Additionally, burden associated with MHS activities (formerly VARHS) increased primarily due to expansion in the number of sites participating (from 11 to 53). There was an overall decrease in burden attributed to perinatal exposure reporting (PHER) (formerly EPS) which is primarily due to the reduction in data elements and burden time per response from 60 minutes to 30 minutes.

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Annual Cost to Federal Government: $68,792,000

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? Yes

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

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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: 01/02/2013

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