National HIV Surveillance System (NHSS)

Forms and Documents

Document Name	Status
Adult HIV/AIDS Confidential Case Report Form and Instruction	Modified
Perinatal HIV Exposure Reporting (PHER) Form and Instruction	Modified
HIV Incidence Surveillance (HIS) Form and Instruction	Removed
Case Report Updates Form and Instruction	Modified
Pediatric HIV/AIDS Confidential Case Report Form and Instruction	Modified
Cluster Close-out Report Form and Instruction	New
Cluster Follow-up Report Form and Instruction	New
Initial Cluster Report Form and Instruction	New
Annual Reporting: Standards Evaluation Report (SER) Form and Instruction	Modified
Molecular HIV Surveillance (MHS) Form and Instruction	Removed
Laboratory Updates Form and Instruction	Modified
Case Report Evaluations Form and Instruction	Modified
Att 10_ Summary of Changes_18Jun19_clean.pdf Supplementary Document	2019-06-26
Att 9_Project Determination.pdf Supplementary Document	2019-06-26
SSB_3Jun19_clean.docx Supporting Statement B	2019-06-26
SSA_26Jun19_clean.docx Supporting Statement A	2019-06-26
Att 8_Data Security and Confidentiality Guidelines.pdf Supplementary Document	2019-06-26
Att 7b_HIV Surveillance Confidentiality Security Statement and Data Access Packet.pdf Supplementary Document	2019-06-26
Att 7a_Assurance of Confidentiality for HIV Surveillance.pdf Supplementary Document	2019-06-26
Att 6b_eHARS ATO_2019.pdf Supplementary Document	2019-06-26
Att 6a_eHARS PIA_2019.pdf Supplementary Document	2019-06-26
Att 5_cdc-hiv-surveillance-report-2017-vol-29.pdf Supplementary Document	2019-06-26
Att 2_ 60 Day FRN_0920-0573.pdf Supplementary Document	2019-06-26
Att 1_ Authorizing Legislation.pdf Supplementary Document	2019-06-26

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	Removed
46032	Case Report Updates Form and Instruction	Modified
46030	Pediatric HIV/AIDS Confidential Case Report Form and Instruction	Modified
236513	Data De-duplication Activities Other-Technical Guidance for Data Management: Duplicate Review	New
236512	Cluster Close-out Report Form and Instruction	New
236511	Cluster Follow-up Report Form and Instruction	New
236510	Initial Cluster Report Form and Instruction	New
236509	Investigation Reporting and Evaluation Other-Reporting Guidance: Data-to-Care	New
220109	Annual Reporting: Standards Evaluation Report (SER) Form and Instruction	Modified
205250	Molecular HIV Surveillance (MHS) Form and Instruction	Removed
205249	Laboratory Updates Form and Instruction	Modified
205248	Case Report Evaluations Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0573	ICR Reference No: 201906-0920-004
Status: Historical Active	Previous ICR Reference No: 201811-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0573
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 without change	Conclusion Date: 11/12/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance: OMB is approving this information collection request for a period of three years during which time CDC will request approval to extend or revise the collection if the agency seeks to continue the information collection activity beyond the period approved under this action.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	11/30/2019
Responses	968,334	0	639,254
Time Burden (Hours)	58,131	0	48,026
Cost Burden (Dollars)	1,569,524	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.

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Authorizing Statute(s): US Code: 42 USC 242b Name of Law: General Authority Respecting Research...
   US Code: 42 USC 247c Name of Law: Sexually Transmitted Diseases; Prevention and Control Projects and Programs
   US Code: 42 USC 247b Name of Law: Project Grants for Preventive 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:
	84 FR 16868	04/23/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 30118	06/26/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Case Report Updates	n/a, n/a	Adult HIV Case Report Form ,   Pediatric HIV Case Report Form
Perinatal HIV Exposure Reporting (PHER)	n/a	Perinatal HIV Exposure Reporting Form
Case Report Evaluations	n/a, n/a	Adult HIV Case Report Form ,   Pediatric HIV Case Report Form
Laboratory Updates	n/a, n/a	Adult HIV Case Report Form ,   Pediatric HIV Case Report Form
Investigation Reporting and Evaluation
Cluster Follow-up Report	n/a	Cluster Follow-up Form
Molecular HIV Surveillance (MHS)	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
Annual Reporting: Standards Evaluation Report (SER)	n/a	Standards Evaluation Report Form (Years 2-5)
Adult HIV/AIDS Confidential Case Report	n/a	Adult Case Report Form
Pediatric HIV/AIDS Confidential Case Report	n/a	Pediatric Case Report Form
Initial Cluster Report	n/a	Initial Cluster Report Form
Data De-duplication Activities
Cluster Close-out Report	n/a	Cluster Close-out Form

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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	968,334	639,254	0	329,080	0	0
Annual Time Burden (Hours)	58,131	48,026	0	10,105	0	0
Annual Cost Burden (Dollars)	1,569,524	0	0	1,569,524	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: See SS-A.15 for a complete description of changes to ICs, data collection content, and estimates. One IC (HIV incidence surveillance) was discontinued. One IC (Molecular HIV surveillance) was discontinued as a separate IC, and data elements were incorporated into modified content for other ICs. One new IC involves data management and de-duplication activities that affect estimates for case reporting. 4 new ICs are the result of new requirements under the cooperative agreement.

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Annual Cost to Federal Government: $66,870,415

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.     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: 06/26/2019

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