"Cohort Study of HIV, STIs and Preventive Interventions among Young MSM in Thailand

Forms and Documents

Document Name	Status
Att 17 Mahidol University Approval Letter.pdf Supplementary Document	2016-10-31
Att 16 Thai EC Approval Letter.pdf Supplementary Document	2016-10-31
Att 15 CDC IRB Approval Letter.pdf Supplementary Document	2016-10-31
Att 2 60 Day FRN.pdf Supplementary Document	2016-10-31
Att 1_Sect 301 PHSA.pdf Supplementary Document	2016-10-31
Supporting Statement B.docx Supporting Statement B	2016-10-31
Supporting Statement A.docx Supporting Statement A	2016-10-31

IC Document Collections

IC ID	Document Title	Status
224251	HIV CASI Cohort Other-WORD/Screenshots	New
224250	YMSM Clinical Form Other-WORD	New
224249	Follow-up CASI Other-WORD/Screenshots	New
224248	Enrollment Consent Assent Other-WORD/Screenshots	New
224247	HIV CASI Other-WORD/Screenshots	New
224246	Screening CASI Other-WORD/Screenshots	New
224245	Screening Consent Assent Other-word	New
224244	Screening Checklist Other-WORD	New
224243	Key Iinformant Interview Other-WORD	New
224242	Key Informant Interview (KII) Consent Assent Other-WORD	New
224241	Focus Group Discussion Guide Other-WORD	New
224240	Focus Group Discussion (FGD) Consent Assent (English/Siamese) Other-WORD	New

ICR Details

OMB Control No: 0920-1191	ICR Reference No: 201610-0920-014
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-16JD
Title: "Cohort Study of HIV, STIs and Preventive Interventions among Young MSM in Thailand
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 without change	Conclusion Date: 07/14/2017
	Date Received in OIRA: 11/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved
Responses	2,675	0	0
Time Burden (Hours)	814	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of the Young MSM Study Thailand is to evaluate risk factors for HIV and sexually transmitted infections (STI), and describe incidence and prevalence in young men who have sex with men (MSM) and transgender women (TGW) in Thailand.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	81 FR 1952	01/14/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 76944	11/04/2016
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Focus Group Discussion (FGD) Consent Assent (English/Siamese)
Key Informant Interview (KII) Consent Assent
Screening Checklist
Focus Group Discussion Guide
Follow-up CASI
Key Iinformant Interview
Screening Consent Assent
HIV CASI
Screening CASI
Enrollment Consent Assent
YMSM Clinical Form
HIV CASI Cohort

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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	2,675	0	0	2,675	0	0
Annual Time Burden (Hours)	814	0	0	814	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: New collection request for a new OMB Control Number.

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Annual Cost to Federal Government: $2,350,000

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: 11/08/2016

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