Evaluation of TransLife Center (TLC): A Locally-Developed Combination Prevention Intervention for Transgender Women at High Risk of HIV Infection

Forms and Documents

Document Name	Status
Staff Interview Form	Unchanged
Participant Interview Form	Unchanged
Follow-up Assessment Form	Modified
Baseline Assessment Form	Modified
Contact Information Form	Unchanged
Eligibility Screening Form	Modified
Summary of Proposed Changes in the ICR for TLC 0920-1246.docx Justification for No Material/Nonsubstantive Change	2020-10-15
CDC-Research-Protocol_Form Approved09-21-20_clean.docx Supplementary Document	2020-10-15
SSB_08Oct20_clean.docx Supporting Statement B	2020-10-15
SSA_08Oct20_clean.docx Supporting Statement A	2020-10-15
Att 9_Certificate of Confidentiality.pdf Supplementary Document	2018-09-07
Att 8 PIA 18CI Final.pdf Supplementary Document	2018-09-07
TG Data Use Plan3Apr2017.docx Supplementary Document	2020-10-15
Att 6c_UIC IRB Determination.pdf Supplementary Document	2018-09-07
2017-767_Initial IRB approval.pdf Supplementary Document	2020-10-15
2017-767_Mod Approval Letter.pdf Supplementary Document	2020-10-15
Att 5b_Consent to Interview.pdf Supplementary Document	2018-09-07
Appendix D_Adult-consent-COVID_ v10-05-20_clean.docx Supplementary Document	2020-10-15
Att 3_Recruitment Materials.doc Supplementary Document	2018-09-07
Att 2_60-Day FRN.pdf Supplementary Document	2018-09-07
Att 1_Auth Legislation.docx Supplementary Document	2018-09-07

IC Document Collections

IC ID	Document Title	Status
232941	Staff Interview Form	Unchanged
232939	Participant Interview Form	Unchanged
232936	Follow-up Assessment Form	Modified
232934	Baseline Assessment Form	Modified
232931	Contact Information Form	Unchanged
232928	Eligibility Screening Form	Modified

ICR Details

OMB Control No: 0920-1246	ICR Reference No: 202010-0920-005
Status: Active	Previous ICR Reference No: 201809-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1246-21AK
Title: Evaluation of TransLife Center (TLC): A Locally-Developed Combination Prevention Intervention for Transgender Women at High Risk of HIV Infection
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/18/2020
	Date Received in OIRA: 10/15/2020
Terms of Clearance: Previous terms continue: Approved with the understanding that this is an exploratory study and incentive amounts, although more that typically offered, may be necessary to determine if a more rigorous study is possible.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2021	10/31/2021	10/31/2021
Responses	465	0	465
Time Burden (Hours)	255	0	255
Cost Burden (Dollars)	6,207	0	6,207

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Abstract: The purpose of this data collection is to evaluate the Translife Center (TLC), which provides combination HIV prevention services to adult transgender women at high risk for HIV infection. Data will be used to compare pre-intervention levels of HIV risk to those at 4 and 8 months post-baseline. Data will be gathered by the cooperative agreement awardee, Chicago House & Social Service Agency, and partner organizations, the Ann & Robert H. Lurie Children’s Hospital of Chicago and the University of Illinois at Chicago. Information will be collected through interviewer and self-administered instruments. This change request is due to COVID-19 and changes some collections from in-person to online or phone.

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Authorizing Statute(s): US Code: 42 USC 301 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:
	83 FR 4207	01/30/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 45451	09/07/2018
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Eligibility Screening	n/a	TLC Eligibility Screener
Participant Interview	n/a	TLC Interview
Contact Information	n/a	TLC Contact Information
Baseline Assessment	n/a	TLC Baseline Assessment
Follow-up Assessment	n/a	TLC Follow Up Assessment
Staff Interview	n/a	TLC Interview

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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	465	465	0	0	0	0
Annual Time Burden (Hours)	255	255	0	0	0	0
Annual Cost Burden (Dollars)	6,207	6,207	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $695,535

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? No

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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: 10/15/2020

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