[NCHHSTP] National HIV Surveillance System (NHSS)

Forms and Documents

Document Name	Status
Adult HIV/AIDS Confidential Case Report Form and Instruction	Unchanged
Case Report Updates Form and Instruction	Unchanged
Form 0920-0573 Pediatric HIV Confidential Case Report Form (with Perinatal HIV Exposure information) Form and Instruction	Unchanged
Cluster Close-out Report Form and Instruction	Modified
Cluster Follow-up Report Form and Instruction	Modified
Initial Cluster Report Form and Instruction	Modified
Form 0920-0573 Annual Reporting: Standards Evaluation Report (SER) Form and Instruction	Unchanged
Laboratory Updates Form and Instruction	Unchanged
Case Report Evaluations Form and Instruction	Unchanged
Justification Memo 2.docx Justification for No Material/Nonsubstantive Change	2024-12-30
Summary of Proposed Changes Table.docx Supplementary Document	2024-12-30
NHSS Justification Memo.docx Justification for No Material/Nonsubstantive Change	2024-12-17
Justification Memo for Nonsubstantive Change Request_0920-0573_NHSS.docx Justification for No Material/Nonsubstantive Change	2024-08-05
Att 1_ Table 1_Summary of Proposed Changes.docx Supplementary Document	2023-10-17
Justification for Nonmaterial.docx Justification for No Material/Nonsubstantive Change	2023-10-17
Att_10 Summary of Changes FINAL_08Feb22_SERv3_PWID _update_clean.pdf Supplementary Document	2022-09-08
Att_9_Project Determination.pdf Supplementary Document	2022-09-08
Att_8_Data Security and Confidentiality Guidelines.pdf Supplementary Document	2022-09-08
Att_7(b) NHSS_ Complete AoC_Final updated 102621 per amendment_CSpacket.pdf Supplementary Document	2022-09-08
Att_7(a) NHSS_ AoC Statement_FinalOct2019.pdf Supplementary Document	2022-09-08
Att_6(b) ATO.pdf Supplementary Document	2022-09-08
Att_6(a) PIA.pdf Supplementary Document	2022-09-08
Att_5 cdc-hiv-surveillance-report-2020-updated-vol-33.pdf Supplementary Document	2022-09-08
Att_4(f) Cluster Report Form Instructions updated 11052021_share.pdf Supplementary Document	2022-09-08
Att_4(e) DETECTING HIV TRANSMISSION CLUSTERS 2022 v1 (1).pdf Supplementary Document	2022-09-08
Att_4(d) D2C-Monitoring-and-Evaluation-Guidance _Jun21fin_508C_8.30.pdf Supplementary Document	2022-09-08
Att_4(c) DUPLICATE REVIEW 2022 v1.pdf Supplementary Document	2022-09-08
Att_4(b) PEDIATRIC HIV CASE REPORT FORM 2023 v2_PWID edit_clean.pdf Supplementary Document	2022-09-08
Att_4(a) ADULT HIV CONFIDENTIAL CASE REPORT FORM 2023 v2.pdf Supplementary Document	2022-09-08
Att_3(c) NHSS_dataelements_OMB_BG_KB_Clean_PWID edit_clean.pdf Supplementary Document	2022-09-08
Att_2(a) 60 Day FRN pub 4 -1-2022.pdf Supplementary Document	2022-09-07
Att_1_ Authorizing Legislation.pdf Supplementary Document	2022-09-07
SSB_08Aug22_clean.docx Supporting Statement B	2022-09-07
SSA_NHSS_31AUG22_clean.docx Supporting Statement A	2022-09-07

IC Document Collections

IC ID	Document Title	Status
7028	Adult HIV/AIDS Confidential Case Report Form and Instruction	Unchanged
46032	Case Report Updates Form and Instruction	Unchanged
46030	Pediatric HIV Confidential Case Report Form (with Perinatal HIV Exposure information) Form and Instruction	Unchanged
236513	Data De-duplication Activities Other-Technical Guidance for HIV Surveillance Programs: Duplicat	Unchanged
236512	Cluster Close-out Report Form and Instruction	Modified
236511	Cluster Follow-up Report Form and Instruction	Modified
236510	Initial Cluster Report Form and Instruction	Modified
236509	Investigation Reporting and Evaluation Other-Data to Care Reporting Guidance for PS18-1802 and PS20-201	Unchanged
220109	Annual Reporting: Standards Evaluation Report (SER) 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: 202412-0920-021
Status: Received in OIRA	Previous ICR Reference No: 202412-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0573-25CM
Title: [NCHHSTP] 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	Date Submitted to OIRA: 01/06/2025

	Requested	Previously Approved
Expiration Date	02/28/2026	02/28/2026
Responses	1,035,569	1,035,569
Time Burden (Hours)	60,731	60,731
Cost Burden (Dollars)	0	0

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Abstract: CDC in collaboration with state and local health departments in the 50 states, the District of Columbia, and U.S. dependent areas, conducts national surveillance for cases of HIV infection that provides critical data across the spectrum of HIV disease from HIV diagnosis, to AIDS, the end-stage disease caused by infection with HIV, and death. HIV surveillance data are used to monitor the extent and characteristics of the HIV burden in the United States. In addition, this national system provides essential data to estimate HIV incidence and monitor patterns in HIV drug resistance and genetic diversity, detect HIV clusters, and perinatal exposures. In this nonsubstantive change request, we are requesting modifications to the initial, follow-up, and annual/closeout cluster report forms (CRFs), which are submitted to CDC by health departments.

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Authorizing Statute(s): US Code: 42 USC 247b Name of Law: Project Grants for Preventive Health Services
   US Code: 42 USC 247c Name of Law: Sexually Transmitted Diseases; Prevention and Control Projects and Programs
   US Code: 42 USC 242b Name of Law: General Authority Respecting Research...
  

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:
	87 FR 19097	04/01/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 55812	09/12/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Adult HIV/AIDS Confidential Case Report	None	Adult HIV Confidential Case Report Form
Annual Reporting: Standards Evaluation Report (SER)	0920-0573, 0920-0573-24HX	2024 Standards Evaluation Report (SER) Surveillance Program Performance ,   Standards Evaluation Report (SER) " Surveillance Program Performance"
Case Report Evaluations	None, None	Adult HIV Confidential Case Report Form ,   Pediatric HIV Confidential Case Report Form
Case Report Updates	None, None	Adult HIV Confidential Case Report Form ,   Pediatric HIV Confidential Case Report Form
Cluster Close-out Report	None	Cluster Close-out Form
Cluster Follow-up Report	None	Cluster Follow-up Form
Data De-duplication Activities
Initial Cluster Report	None	Initial Cluster Report Form
Investigation Reporting and Evaluation
Laboratory Updates	None, None	Adult HIV Confidential Case Report Form ,   Pediatric HIV Confidential Case Report Form
Pediatric HIV Confidential Case Report Form (with Perinatal HIV Exposure information)	0920-0573	Pediatric HIV Confidential Case Report Form

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ICR Summary of Burden

	Total Request	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	1,035,569	1,035,569	0	0	0	0
Annual Time Burden (Hours)	60,731	60,731	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: $66,043,503

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

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? No

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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: 01/06/2025

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