Prevent Hepatitis Transmission among Persons who Inject Drugs

Forms and Documents

Document Name	Status
Follow-up Survey Form	New
Initial Survey Form	New
Screener Form	New
Supporting Statement A1.docx Supporting Statement A	2016-06-09
CDC ProjectDetermination.pdf Supplementary Document	2016-01-11
Att 6B UNM ConsentForm.pdf Supplementary Document	2016-01-11
Att 6A UC ConsentForm.docx Supplementary Document	2016-01-11
Att 5E CoC UNM.pdf Supplementary Document	2016-01-11
Att 5D CoC UC.pdf Supplementary Document	2016-01-11
Att 5B UNM IRB.pdf Supplementary Document	2016-01-11
Att 5A UC IRB.pdf Supplementary Document	2016-01-11
Att 4B UNM Protocol.doc Supplementary Document	2016-01-11
Att 4A UC Protocol.docx Supplementary Document	2016-01-11
Att 2B.docx Supplementary Document	2016-01-11
Att 2A.pdf Supplementary Document	2016-01-11
Att 2 60-Day FRN.pdf Supplementary Document	2016-01-11
Att 1 AuthLegislation.doc Supplementary Document	2016-01-11
Supporting Statement B.doc Supporting Statement B	2016-06-09

IC Document Collections

IC ID	Document Title	Status
219539	Follow-up Survey Form	New
219538	Initial Survey Form	New
219537	Screener Form	New

ICR Details

OMB Control No: 0920-1116	ICR Reference No: 201601-0920-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15ARG
Title: Prevent Hepatitis Transmission among Persons who Inject Drugs
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/09/2016
	Date Received in OIRA: 01/19/2016
Terms of Clearance: Approved consistent with the understanding that respondents are selected using convenience sampling and will not be representative of the national population of persons who inject drugs (PWID). Any reporting or publication of outcomes will be accompanied by a discussion of any limitations posed by the recruitment and sampling methodologies.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	1,822	0	0
Time Burden (Hours)	949	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This study addresses the high prevalence of HCV infection by developing an integrated approach for detection, prevention, care and treatment of infection among persons aged 18-30 years who reside in non-urban counties. In addition to providing HCV testing, participants will be offered testing for the presence of co-infections with hepatitis B virus (HBV) and HIV. Adherence to prevention services and retention in care will be assessed through follow up interviews. HCV re-infection will be determined through follow-up blood tests.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

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 37264	06/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 1951	01/14/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Initial Survey	none	Initial Survey
Screener	none	Screener
Follow-up Survey	none	Follow-up Survey

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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	1,822	0	0	1,822	0	0
Annual Time Burden (Hours)	949	0	0	949	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: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

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Annual Cost to Federal Government: $447,000

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]? 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: 01/19/2016

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