[NCHHSTP] Expanding PrEP in Communities of Color (EPICC)

Forms and Documents

Document Name	Status
Form 0920-22GA Aims 1&2 Clinic Assessment (every 6 months) Form and Instruction	Unchanged
Form 0920-22GA Aims 1&2 Clinic Assessment (Baseline & Final) Form and Instruction	Unchanged
Form 0920-22GA Aim 2b Provider Focus Group Guide Form and Instruction	Unchanged
Form 0920-22GA Aim 2b Provider Pre-Focus Group Survey Form and Instruction	Modified
Form 0920-22GA Aim 2b Provider Focus Group Contact Information Form and Instruction	Unchanged
Form 0920-22GA Aim 2b Provider Focus Group Screener Form and Instruction	Unchanged
Form 0920-22GA Aim 2a Cohort Exit Interview (English/Spanish) Form and Instruction	Unchanged
Form 0920-22GA Aim 2a Cohort Blood Collection Instructions (English/Spanish) Form and Instruction	Modified
Form 0920-22GA Aim 2a Cohort App Setup (English/Spanish) Form and Instruction	Unchanged
Form MOD00003217 Aim 2a Cohort Follow Up Survey (English/Spanish) Form and Instruction	Unchanged
Form 0920-22GA Aim 2a Cohort Baseline Survey (English/Spanish) Form and Instruction	Unchanged
Form 0920-22GA Aim 2a Cohort HIPAA Form (English & Spanish) Form and Instruction	Unchanged
Form 0920-22GA Aim 2a Cohort Contact Information (English/Spanish) Form and Instruction	Unchanged
Form MOD00003217 Aim 2a Cohort Screener (English/Spanish) Form and Instruction	Modified
Form 0920-22GA Aim 1 Provider Patient Interaction (Baseline and Final) Form and Instruction	Unchanged
Form 0920-22GA Aim 1 Provider Post-Training Survey Form and Instruction	Unchanged
Form MOD00003217 Aim 1 Provider Pre- Training Survey Form and Instruction	Unchanged
Form 0920-22GA Aim 1 Provider Training Contact Information Form and Instruction	Unchanged
Form 0920-22GA Aim 1 Provider Training Screener Form and Instruction	Unchanged
Justification and Summary of Changes.docx Justification for No Material/Nonsubstantive Change	2024-12-23
Att 5b_Aim2aCohortConsentSpanish_clean.docx Supplementary Document	2024-12-23
Att 5b_Aim2aCohortConsentEnglish_clean.docx Supplementary Document	2024-12-23
Justification for Nonmaterial Nonsubstantive Change to an OMB Approved Information Collection.docx Justification for No Material/Nonsubstantive Change	2024-01-05
Att 10_Summary of Changes Table (24BY).docx Supplementary Document	2024-01-05
Att_6l_Wake_County_Health_Department_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6k_Baylor_Harris_Health_PrEP_Clinic_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6j_Bliss_Healthcare_Services_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6i_USF_Ybor_Youth_Clinic_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6h_Five_Horizons_Health_Services_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6g_Amity_Medical_Group_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6f_Childrens_Hospital_of_Philadelphia_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6e_Childrens_Hospital_Montefiore_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6d_Cook_County_HHS_IRB_agreement[1].pdf Supplementary Document	2023-10-31
Att_6b_University_of_North_Carolina_Chapel_Hill_IRB_agreement[1].pdf Supplementary Document	2023-10-30
Att_6a_Florida_State_University_IRB_Letter_of_Approval[1].pdf Supplementary Document	2023-10-30
Att_9_Provider_Training_Summary[1].docx Supplementary Document	2023-10-30
Att_7_Data_Use_Plan_EPICC[1].docx Supplementary Document	2023-10-30
Att_1_Auth_Legislation[1].docx Supplementary Document	2023-10-30
30_Day_FRN_EPICC[1].docx Supplementary Document	2023-10-30
SSB_Clean_23DEC2023.docx Supporting Statement B	2024-12-23
SSA_Clean_23DEC2023.docx Supporting Statement A	2024-12-23

IC Document Collections

IC ID	Document Title	Status
263138	Aims 1&2 Clinic Assessment (every 6 months) Form and Instruction	Unchanged
263136	Aims 1&2 Clinic Assessment (Baseline & Final) Form and Instruction	Unchanged
263135	Aim 2b Provider Focus Group Guide Form and Instruction	Unchanged
263134	Aim 2b Provider Pre-Focus Group Survey Form and Instruction	Modified
263133	Aim 2b Provider Focus Group Contact Information Form and Instruction	Unchanged
263132	Aim 2b Provider Focus Group Screener Form and Instruction	Unchanged
263131	Aim 2a Cohort Exit Interview (English/Spanish) Form and Instruction	Unchanged
263130	Aim 2a Cohort Blood Collection Instructions (English/Spanish) Form and Instruction	Modified
263129	Aim 2a Cohort App Setup (English/Spanish) Form and Instruction	Unchanged
263128	Aim 2a Cohort Follow Up Survey (English/Spanish) Form and Instruction	Unchanged
263127	Aim 2a Cohort Baseline Survey (English/Spanish) Form and Instruction	Unchanged
263122	Aim 2a Cohort HIPAA Form (English & Spanish) Form and Instruction	Unchanged
263121	Aim 2a Cohort Contact Information (English/Spanish) Form and Instruction	Unchanged
263120	Aim 2a Cohort Screener (English/Spanish) Form and Instruction	Modified
263118	Aim 1 Provider Patient Interaction (Baseline and Final) Form and Instruction	Unchanged
263117	Aim 1 Provider Post-Training Survey Form and Instruction	Unchanged
263116	Aim 1 Provider Pre- Training Survey Form and Instruction	Unchanged
263115	Aim 1 Provider Training Contact Information Form and Instruction	Unchanged
263114	Aim 1 Provider Training Screener Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1423	ICR Reference No: 202412-0920-015
Status: Received in OIRA	Previous ICR Reference No: 202401-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1423-25CJ
Title: [NCHHSTP] Expanding PrEP in Communities of Color (EPICC)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/23/2024

	Requested	Previously Approved
Expiration Date	12/31/2026	12/31/2026
Responses	1,244	1,244
Time Burden (Hours)	759	759
Cost Burden (Dollars)	0	0

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Abstract: The purpose of this study is to implement and evaluate the effectiveness of a clinic-based intervention that utilizes evidence-based education and support tools to 1) increase provider knowledge of and comfort with HIV preexposure prophylaxis (PrEP) modalities in clinical practice and 2) improve PrEP adherence among young men and non-binary persons who have sex with men (YMSM). This Change Request is responsive to input from community stakeholders and aligns with the goals and plans of this project. Requested changes do not impact the approved burden and do not result in an overall change in the scope of data collection. Changes are being made to bolster study enrollment and strengthen data collection efforts which are critical to the final analyses and study outcomes. Changes will also further harmonize this study with the mChoice Study (OMB 0920-1428) as both are funded through PS-21-003, PrEP Choice. Finally, CDC would plans on updating the race and ethnicity questions to reflect the new standards announced by the Office of Management and Budget (OMB) on 03/29/2024.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. 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:
	88 FR 41623	06/27/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 62793	09/13/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 19

IC Title	Form No.	Form Name
Aim 1 Provider Patient Interaction (Baseline and Final)	0920-22GA	Att 4e_Aim1ProviderPatientInteraction
Aim 1 Provider Post-Training Survey	0920-22GA	Att 4d_Aim1ProviderPostTrainingSurvey
Aim 1 Provider Pre- Training Survey	MOD00003217	Aim 1 Provider Pre-Training Survey
Aim 1 Provider Training Contact Information	0920-22GA	Att 4b_Aim1ProviderTrainingContactInformation
Aim 1 Provider Training Screener	0920-22GA	Att 4a_Aim1ProviderTrainingScreener
Aim 2a Cohort App Setup (English/Spanish)	0920-22GA	Att 4j_Aim2aCohortAppSetupEnglishSpanish
Aim 2a Cohort Baseline Survey (English/Spanish)	0920-22GA, 0920-22GA	Att 4i_Aim2aCohortBaselineSurveyEnglish ,   Att 4i_Aim2aCohortBaselineSurveySpanish
Aim 2a Cohort Blood Collection Instructions (English/Spanish)	0920-22GA, 0920-1423, 0920-1423	Att 4l_Aim2a Cohort Blood Collection Instructions English ,   Aim 2a Cohort Blood Collection Instructions_English ,   Aim 2a Cohort Blood Collection Instructions_Spanish
Aim 2a Cohort Contact Information (English/Spanish)	0920-22GA	Att 4b_Aim1ProviderTrainingContactInformation
Aim 2a Cohort Exit Interview (English/Spanish)	0920-22GA, 0920-22GA	Att 4m_Aim2a Cohort Exit Interview English ,   Att 4m_Aim2aCohortExitInterviewSpanish
Aim 2a Cohort Follow Up Survey (English/Spanish)	0920-1423-24BY, MOD00003217	Aim 2a Cohort Follow Up Survey English ,   Encuesta de seguimiento de cohortes (Aim2aCohortFollowUpSurveySpanish)
Aim 2a Cohort HIPAA Form (English & Spanish)	0920-22GA, 0920-22GA	Att 4h_Aim2aCohortHIPAAFormEnglish ,   Att 4h_Aim2aCohortHIPAAFormSpanish
Aim 2a Cohort Screener (English/Spanish)	MOD00003217, V2023-1102, 0920-1423, 0920-1423	Aim 2a Cohort Screener English ,   Elegibilidad de cohorte (Aim2aCohortScreener_Spanish) ,   Aim 2a - Cohort Screeeer_English ,   Aim 2a - Cohort Screeeer_Spanish
Aim 2b Provider Focus Group Contact Information	0920-22GA	Att 4o_Aim2b Provider FocusGroup Contact Information
Aim 2b Provider Focus Group Guide	0920-22GA	Att 4o_Aim2b Provider FocusGroup Contact Information
Aim 2b Provider Focus Group Screener	0920-22GA	Att_4n_Aim2bProvider FocusGroup Screener
Aim 2b Provider Pre-Focus Group Survey	0920-22GA, 0920-1423	Att 4p_Aim2b Provider Pre FocusGroup Survey ,   Aim 2b Provider Pre-Focus Group Survey_23DEC2024
Aims 1&2 Clinic Assessment (Baseline & Final)	0920-22GA	Att 4r_Aim1&2ClinicAssessmentBaselineAndFinal
Aims 1&2 Clinic Assessment (every 6 months)	0920-22GA	Aims 1&2 Clinic Assessment (every 6 months)

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ICR Summary of Burden

	Total Request	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	1,244	1,244	0	0	0	0
Annual Time Burden (Hours)	759	759	0	0	0	0
Annual Cost Burden (Dollars)	0	0	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:

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Annual Cost to Federal Government: $1,112,799

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

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.     No

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.     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? 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: 12/23/2024

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