National HIV Surveillance System (NHSS)

Forms and Documents

Document Name	Status
Adult HIV/AIDS Confidential Case Report Form and Instruction	Unchanged
Perinatal HIV Exposure Reporting (PHER) Form and Instruction	Unchanged
HIV Incidence Surveillance (HIS) Form and Instruction	Unchanged
Case Report Updates Form and Instruction	Unchanged
Pediatric HIV/AIDS Confidential Case Report Form and Instruction	Unchanged
Annual Reporting: Standards Evaluation Report (SER) Form and Instruction	Unchanged
Molecular HIV Surveillance (MHS) Form and Instruction	Unchanged
Laboratory Updates Form and Instruction	Unchanged
Case Report Evaluations Form and Instruction	Unchanged
Proposed Changes_APR_Jun2016.docx Justification for No Material/Nonsubstantive Change	2016-06-29
CDC-RFA-PS13-130205CONT17-(Cleaned).docx Supplementary Document	2016-06-24
SSA_17FEB16.docx Supporting Statement A	2016-02-19
Att 11_Summary of Changes 13Nov2015.pdf Supplementary Document	2016-02-16
Att 10_NHSS Project Determination.pdf Supplementary Document	2016-02-16
Att 9_Data Security and Confidentiality Guidelines.pdf Supplementary Document	2016-02-16
Att 8b_HIV Surveillance Confidentiality Security Statement and Data Access Packet.pdf Supplementary Document	2016-02-16
Att 8a_Assurance of Confidentiality for HIV Surveillance.pdf Supplementary Document	2016-02-16
Att 7b. 2015 ATO.pdf Supplementary Document	2016-02-16
Att 7a. 2015 PIA.pdf Supplementary Document	2016-02-16
Att 6_HIV Surveillance Coordinators & Data Managers List.pdf Supplementary Document	2016-02-16
Att 5_HIVsurveillanceReport.pdf Supplementary Document	2016-02-16
Att 4c_Suppl Surv Act 1 HIV Incidence TG.pdf Supplementary Document	2016-02-16
Att 4b_Technical Guidance PCRF_PHER_20151030_v4_OMB.pdf Supplementary Document	2016-02-16
Att 4a_Technical Guidance ACRF v11_OMB.pdf Supplementary Document	2016-02-16
Att 1_ Authorizing Legislation.pdf Supplementary Document	2016-02-16
Att 2_60 Day FRN.pdf Supplementary Document	2016-02-16
Supporting Statement B.docx Supporting Statement B	2016-02-16

IC Document Collections

IC ID	Document Title	Status
7028	Adult HIV/AIDS Confidential Case Report Form and Instruction	Unchanged
46035	Perinatal HIV Exposure Reporting (PHER) Form and Instruction	Unchanged
46034	HIV Incidence Surveillance (HIS) Form and Instruction	Unchanged
46032	Case Report Updates Form and Instruction	Unchanged
46030	Pediatric HIV/AIDS Confidential Case Report Form and Instruction	Unchanged
220110	Annual Reporting: Annual Performance Report (APR) Instruction	Modified
220109	Annual Reporting: Standards Evaluation Report (SER) Form and Instruction	Unchanged
205250	Molecular HIV Surveillance (MHS) Form and Instruction	Unchanged
205249	Laboratory Updates Form and Instruction	Unchanged
205248	Case Report Evaluations Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-0573	ICR Reference No: 201606-0920-017
Status: Historical Active	Previous ICR Reference No: 201602-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0573-16ASN
Title: National HIV Surveillance System (NHSS)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/30/2016
	Date Received in OIRA: 06/30/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	06/30/2019	06/30/2019
Responses	639,313	0	639,313
Time Burden (Hours)	50,504	0	50,504
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention (CDC) requests approval for revisions to the National HIV Surveillance System (NHSS) expiring on 02/29/2016. The HIV Incidence and Case Surveillance Branch, partners with health departments in the states, D.C., and U.S. dependent areas to report cases of human immunodeficiency virus (HIV) infection, inclusive of data across the spectrum of disease from diagnosis to death. Revisions to this ICR include the addition of annual reporting hours for completing a Standards Evaluation Report (SER) and an Annual Performance Report (APR). In addition, modifications to currently collected data elements and forms including the Adult Case Report Form (ACRF), Pediatric Case Report Form (PCRF) and the Perinatal HIV Exposure Reporting (PHER) Form are also requested.

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Authorizing Statute(s): US Code: 42 USC 242k Name of Law: National Center for Health Statistics
   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
  

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:
	80 FR 40067	07/13/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 7801	02/16/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Annual Reporting: Standards Evaluation Report (SER)	NA	NHSS Standards Evaluation Report Form
Adult HIV/AIDS Confidential Case Report	NA	Adult HIV Confidential Case Report Form 2015
Pediatric HIV/AIDS Confidential Case Report	NA	Pediatric HIV Confidential Case Report Form 2015
Case Report Updates	NA, NA	Adult HIV Confidential Case Report Form 2015 ,   Pediatric HIV Confidential Case Report Form 2015
HIV Incidence Surveillance (HIS)	NA	Adult HIV Confidential Case Report Form 2015
Perinatal HIV Exposure Reporting (PHER)	NA	Perinatal HIV Exposure Reporting (PHER) Form
Case Report Evaluations	NA, NA	Adult HIV Confidential Case Report Form 2015 ,   Pediatric HIV Confidential Case Report Form
Laboratory Updates	NA, NA	Adult HIV Confidential Case Report Form 2015 ,   Pediatric HIV Confidential Case Report Form
Molecular HIV Surveillance (MHS)	NA, NA	Adult HIV Confidential Case Report Form 2015 ,   Pediatric HIV Confidential Case Report Form 2015
Annual Reporting: Annual Performance Report (APR)

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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	639,313	639,313	0	0	0	0
Annual Time Burden (Hours)	50,504	50,504	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $72,116,505

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: 06/30/2016

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