[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	New
Form 0920-22GA Aims 1&2 Clinic Assessment (Baseline & Final) Form and Instruction	New
Form 0920-22GA Aim 2b Provider Focus Group Guide Form and Instruction	New
Form 0920-22GA Aim 2b Provider Pre-Focus Group Survey Form and Instruction	New
Form 0920-22GA Aim 2b Provider Focus Group Contact Information Form and Instruction	New
Form 0920-22GA Aim 2b Provider Focus Group Screener Form and Instruction	New
Form 0920-22GA Aim 2a Cohort Exit Interview (English/Spanish) Form and Instruction	New
Form 0920-22GA Aim 2a Cohort Blood Collection Instructions (English/Spanish) Form and Instruction	New
Form 0920-22GA Aim 2a Cohort App Setup (English/Spanish) Form and Instruction	New
Form 0920-22GA Aim 2a Cohort Follow-up Survey (English/Spanish) Form and Instruction	New
Form 0920-22GA Aim 2a Cohort Baseline Survey (English/Spanish) Form and Instruction	New
Form 0920-22GA Aim 2a Cohort HIPAA Form (English & Spanish) Form and Instruction	New
Form 0920-22GA Aim 2a Cohort Contact Information (English/Spanish) Form and Instruction	New
Form 0920-22GA Aim 2a Cohort Screener (English/Spanish) Form and Instruction	New
Form 0920-22GA Aim 1 Provider Patient Interaction (Baseline and Final) Form and Instruction	New
Form 0920-22GA Aim 1 Provider Post-Training Survey Form and Instruction	New
Form 0920-22GA Aim 1 Provider Pre- Training Survey Form and Instruction	New
Form 0920-22GA Aim 1 Provider Training Contact Information Form and Instruction	New
Form 0920-22GA Aim 1 Provider Training Screener Form and Instruction	New
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[1].docx Supporting Statement B	2023-10-30
SSA.docx Supporting Statement A	2023-10-30

IC Document Collections

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

ICR Details

OMB Control No:	ICR Reference No: 202309-0920-011
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-22GA
Title: [NCHHSTP] Expanding PrEP in Communities of Color (EPICC)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/31/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	1,244	0
Time Burden (Hours)	759	0
Cost Burden (Dollars)	0	0

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Abstract: PrEP choices have been increasing with new drugs and formulations that will become available in the next few years, including the long-acting injectable PrEP drug CAB-LA. Educating healthcare providers about PrEP best practices, including recommended use of new PrEP drugs, will ensure the delivery of quality PrEP services in accordance with CDC guidelines, and increase the number of PrEP users. Evidence based tools are available to support PrEP initiation and use but have been underutilized. These tools will be implemented to help healthcare providers screen patients for PrEP indications; counsel them about PrEP choices and factors that are important in their choice of PrEP regimen; guide their selection of a PrEP regimen; and support their adherence to, and persistence with, PrEP. Implementation science methods will be used to evaluate the effectiveness of the education module and support tools.

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Authorizing Statute(s): None

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	0920-22GA	Att 4c_Aim1ProviderPreTrainingSurvey
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	Att 4l_Aim2a Cohort Blood Collection Instructions English
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)	0920-22GA, 0920-22GA	Att 4k_Aim2aCohortFollowUpSurveyEnglish ,   Att 4k_Aim2aCohortFollowUpSurveySpanish
Aim 2a Cohort HIPAA Form (English & Spanish)	0920-22GA, 0920-22GA	Att 4h_Aim2aCohortHIPAAFormEnglish ,   Att 4h_Aim2aCohortHIPAAFormSpanish
Aim 2a Cohort Screener (English/Spanish)	0920-22GA, 0920-22GA	Att 4f_Aim2aCohortScreenerEnglish ,   Att 4f_Aim2aCohortScreenerSpanish
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	Att 4p_Aim2b Provider Pre FocusGroup Survey
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	0	0	1,244	0	0
Annual Time Burden (Hours)	759	0	0	759	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 collection requesting a total of 3,535 burden hours across 36 months of data collection. The total estimated annualized burden hours are 759.

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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: 10/31/2023

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