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

Forms and Documents

Document Name	Status
Form CDC 50.42A 0920-0573 - Adult Case Report: AIDS Form	Modified
Form None assigned 0920-0573 - Enhance Perinatal Surveillance (EPS) Data Collection Form and Instruction	New
Form CDC 50.42A 0920-0573 - VARHS -variant, atypical, and resistant HIV Surveillance Data Elements Form	New
Form CDC 50.42A 0920-0573 - Case Report Updates Form	New
Form CDC 50.42B 0920-0573 - Pediatric Case Report: HIV Form	New
Form CDC 50.42B 0920-0573 - Pediatric Case Report: AIDS Form	New
Form CDC 50.42A 0920-0573 - Adult Case Report: HIV Form	New
Attachment E CRF instructions.pdf Supplementary Document	2006-11-15
0920-0573 30-Day FRN published.htm Supplementary Document	2006-11-15
Attachment M statistical consultation summary.pdf Supplementary Document	2006-11-14
Attachment L Assurance.pdf Supplementary Document	2006-11-14
Attachment J Surv Coord and Consultants.pdf Supplementary Document	2006-11-14
Attachment I HASR.pdf Supplementary Document	2006-11-14
Attachment K Seccon.pdf Supplementary Document	2006-11-14
Attachment B.pdf Supplementary Document	2006-11-14
Attachment A Public Health Laws 42 USC 242b 242 k and 242m.pdf Supplementary Document	2006-11-14
0920-0573 - Abstract for Part I.doc Supplementary Document	2006-11-14
0920-0573 Supporting Statement final 111306.doc Supporting Statement A	2007-02-02

IC Document Collections

IC ID	Document Title	Status
7028	0920-0573 - Adult Case Report: AIDS Form	Modified
46035	0920-0573 - Enhance Perinatal Surveillance (EPS) Data Collection Form and Instruction	New
46034	0920-0573 - VARHS -variant, atypical, and resistant HIV Surveillance Data Elements Form	New
46033	0920-0573 - HIV Incidence Surveillance Data Elements and Procedures Instruction	New
46032	0920-0573 - Case Report Updates Form	New
46031	0920-0573 - Pediatric Case Report: HIV Form	New
46030	0920-0573 - Pediatric Case Report: AIDS Form	New
46029	0920-0573 - Adult Case Report: HIV Form	New

ICR Details

OMB Control No: 0920-0573	ICR Reference No: 200611-0920-001
Status: Historical Active	Previous ICR Reference No: 200210-0920-004
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 with change	Conclusion Date: 02/02/2007
	Date Received in OIRA: 11/15/2006
Terms of Clearance: Approved consistent with revised supporting statement submitted to OMB 1/30/06. 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	02/28/2010	36 Months From Approved	02/28/2007
Responses	271,337	0	79,981
Time Burden (Hours)	57,774	0	13,191
Cost Burden (Dollars)	0	0	0

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Abstract: [See attachment]

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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...
  

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:
	70 FR 48551	08/18/2005
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 66530	11/15/2006
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
0920-0573 - VARHS -variant, atypical, and resistant HIV Surveillance Data Elements	CDC 50.42A	Adult HIV/AIDS Confidential Case Report
0920-0573 - Case Report Updates	CDC 50.42A, CDC 50.42B	Adult HIV/AIDS Confidential Case Report ,   Pediatric HIV/AIDS Confidential Case Report
0920-0573 - Enhance Perinatal Surveillance (EPS) Data Collection	None assigned	Enhanced HIV/AIDS Surveillance to Maximally Reduce Perinatal HIV Transmission
0920-0573 - Adult Case Report: AIDS	CDC 50.42A	Att C_Adult HIV/AIDS Confidential Case Report
0920-0573 - Adult Case Report: HIV	CDC 50.42A	Att C_Adult HIV/AIDS Confidential Case Report
0920-0573 - Pediatric Case Report: AIDS	CDC 50.42B	Pediatric HIV/AIDS Confidential Case Report
0920-0573 - Pediatric Case Report: HIV	CDC 50.42B	Pediatric HIV/AIDS Confidential Case Report
0920-0573 - HIV Incidence Surveillance Data Elements and Procedures	CDC 50.42A	Adult 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	271,337	79,981	0	191,356	0	0
Annual Time Burden (Hours)	57,774	13,191	0	44,583	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: Changing Forms

Short Statement: The increase in burden is due to several factors. First we have refined the methods used to calculate burden to better reflect the variety of follow-up activities respondents (health departments) conduct to compile and complete case reports We have also incorporated estimated burden activities for evaluations and case updates. Finally, we have included estimated burden for collection of additional data elements for incidence surveillance, variant, atypical and resistant HIV surveillance, and enhanced perinatal surveillance.

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Annual Cost to Federal Government: $58,000,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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)? Uncollected

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: 11/15/2006

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