Adult and Pediatric HIV/AIDS Confidential Case Reports for National HIV/AIDS Surveillance

Forms and Documents

Document Name	Status
Adult HIV/AIDS Confidential Case Report Form	Modified
Enhanced Perinatal Surveillance (EPS) Form	Modified
Case Report Updates Form	Modified
Form CDC 50.42B 0920-0573 - Pediatric Case Report: HIV Form	Removed
Pediatric HIV/AIDS Confidential Case Report Form	Modified
Form CDC 50.42A 0920-0573 - Adult Case Report: HIV Form	Removed
0920-0573_SS_PartBSurveillance_ver4.doc Supporting Statement B	2009-11-30
0920-0573_att_8b _HIV AIDS Confidentiality Security statement-Access packet.pdf Supplementary Document	2009-11-30
0920-0573_att_11b_HIV Incidence Consultation Attendee list.pdf Supplementary Document	2009-11-30
0920-0573_att 10_Non-Research Determ for HIV surv.pdf Supplementary Document	2009-11-30
0920-0573_att 9_ Sand_C_v3.pdf Supplementary Document	2009-11-30
0920-0573_att_11a _ HIV Incidence Estimation Consultation 2007 Agenda..pdf Supplementary Document	2009-11-30
0920-0573_att 8a_Assurance.pdf Supplementary Document	2009-11-30
0920-0573_att7b_ 2009 Workshop_Agenda.pdf Supplementary Document	2009-11-30
0920-0573_att7a_contact lists.pdf Supplementary Document	2009-11-30
0920-0573_att 6_ HIVAIDS Surveillance report 2007.pdf Supplementary Document	2009-11-30
0920-0573_att 5_publications list.doc Supplementary Document	2009-11-30
Attachment 2_60dayFRN.doc Supplementary Document	2009-11-30
0920-0573_att 1_ authorizing laws 42 USC 242b 242 k and 242m.pdf Supplementary Document	2009-11-30
0920-0573_att 4(d) EPS Sum of form changes_draft User Guide .pdf Supplementary Document	2009-11-30
0920-0573_att 4(c) VARHS Technical_Guidance.pdf Supplementary Document	2009-11-30
0920-0573_att 4(b)Technical_Guidance_HIV Incidence Surveillance.pdf Supplementary Document	2009-11-30
0920-0573_att 3(c)_eHARS Variables.doc Supplementary Document	2009-11-30
0920-0573_att 4(a) adult and ped instruct_Tech_Guidance_vol2.pdf Supplementary Document	2009-11-30
0920-0573_SS_SectAv6.doc Supporting Statement A	2009-11-30

IC Document Collections

IC ID	Document Title	Status
7028	Adult HIV/AIDS Confidential Case Report Form	Modified
46035	Enhanced Perinatal Surveillance (EPS) Form	Modified
46034	VARHS - Variant, Atypical, and Resistant HIV Surveillance Data Elements Other-Data Elements	Modified
46033	HIV Incidence Surveillance Data Elements Other-Incidence Data Elements	Modified
46032	Case Report Updates Form	Modified
46031	0920-0573 - Pediatric Case Report: HIV Form	Removed
46030	Pediatric HIV/AIDS Confidential Case Report Form	Modified
46029	0920-0573 - Adult Case Report: HIV Form	Removed

ICR Details

OMB Control No: 0920-0573	ICR Reference No: 200912-0920-003
Status: Historical Active	Previous ICR Reference No: 200611-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Adult and Pediatric HIV/AIDS Confidential Case Reports for National HIV/AIDS Surveillance
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: 01/14/2010
	Date Received in OIRA: 12/10/2009
Terms of Clearance: CDC is reminded that the Paperwork Reduction Act mandates that collection of new data elements or other changes to approved information collections be approved by OMB prior to implementation.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	36 Months From Approved	02/28/2010
Responses	200,335	0	271,337
Time Burden (Hours)	51,311	0	57,774
Cost Burden (Dollars)	0	0	0

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Abstract: The Division of HIV/AIDS Prevention in collaboration with health departments in states, DC and US dependent areas, conducts national surveillance for cases of HIV infection that includes critical data across the spectrum of HIV disease from HIV diagnosis, to AIDS, and death. In 2010, the enhanced electronic HIV/AIDS reporting system (eHARS) will be fully deployed, allowing for increased functionality and tracking of all documents related to cases reports in one system. CDC seeks to continue data collection of case reports with additional data elements. DHAP requests approval of a revised data form for Enhanced Perinatal Surveillance to include changes to improve the usability of the form.

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Authorizing Statute(s): US Code: 42 USC 242m Name of Law: General Provisions Respecting Effectiveness, Efficiency, and Quality of Health Services
   US Code: 42 USC 242b Name of Law: General Authority Respecting Research...
   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:
	74 FR 45640	09/03/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 62575	11/30/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
HIV Incidence Surveillance Data Elements
VARHS - Variant, Atypical, and Resistant HIV Surveillance Data Elements
Enhanced Perinatal Surveillance (EPS)	none	Enhanced Perinatal Surveillance
0920-0573 - Pediatric Case Report: HIV	CDC 50.42B	Pediatric HIV/AIDS Confidential Case Report
Adult HIV/AIDS Confidential Case Report	none	Adult HIV/AIDS Confidential Case Report
Pediatric HIV/AIDS Confidential Case Report	none	Pediatric HIV/AIDS Confidential Case Report
0920-0573 - Adult Case Report: HIV	CDC 50.42A	Att C_Adult HIV/AIDS Confidential Case Report
Case Report Updates	none, none	Adult HIV/AIDS Confidential Case Report ,   Pediatric HIV/AIDS Confidential Case Report

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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	200,335	271,337	0	-71,002	0	0
Annual Time Burden (Hours)	51,311	57,774	0	-6,463	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: The decrease in burden is due to estimated leveling of the number of cases reported over the next 3 years as surveillance systems mature in areas recently implementing name-based HIV reporting. The reduction in the number of areas conducting supplemental data collection for incidence and VARHS also decreased the burden hours.

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Annual Cost to Federal Government: $61,445,689

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)? 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: 12/10/2009

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