ICR Documents

Supporting Statement A Document Date Uploaded SSA_GAIN.docx 12/22/2025 Supporting Statement B Document Date Uploaded SSB_GAIN.docx 12/22/2025 Supplementary Documents Title Document Document Type Date Uploaded Authorizing Legislation Att 1_Auth Legislation.docx Supplementary Document 06/16/2021 60-day Federal Register Notice Att 2_60-Day FRN Published 12-21-2020.pdf Supplementary Document 06/16/2021 GAIN Study Activities and Visul Overview Att 3_GAIN study activities and visual overview.pdf Supplementary Document 06/16/2021 GAIN Data Sources and Variables Att 4_GAIN data sources and variables.docx Supplementary Document 06/16/2021 IRB Approval Letter Att 6_GAIN IRB approval letter.pdf Supplementary Document 06/16/2021 Privacy Impact Assessment Att 7_Privacy impact assessment (PIA).pdf Supplementary Document 06/16/2021 Consent Form: Testing, PEP, and PrEP Group Att 8_Consent form GAIN study_Testing PEP PrEP Group.pdf Supplementary Document 06/16/2021 Consent Form: Gay City HIV+ Group Att 9_Consent form GAIN study_Gay City HIV+ Group.pdf Supplementary Document 06/16/2021 Consent Form: Randomized Controlled Trial Group Att 10_Consent Form_RCT Group.pdf Supplementary Document 06/16/2021 Consent form GAIN study_Testing PEP PrEP Group 09SEP2022 Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docx Supplementary Document 09/09/2022 Consent form GAIN study_HIV+ Group 09SEP2022 Att 9_Consent form GAIN study_HIV+ Group_clean_082922.docx Supplementary Document 09/09/2022 Information Sheet - University of Washington Att 16_GAIN patient information sheet_changes accepted_082922.docx Supplementary Document 09/13/2022 Summary of Changes Att 1_Summary of Proposed Changes.docx Supplementary Document 11/02/2023 Summary of Burden Hours Att 2_Estimate of Annualized Burden Hours.docx Supplementary Document 11/02/2023 Consent Form GAIN Consent Form_clean.docx Supplementary Document 11/17/2024 Burden Table Burden Table_Gain 0920-1357.docx Supplementary Document 11/17/2024 30 Day FRN 30 Day FRN GAIN.docx Supplementary Document 12/22/2025 Authorizing Legislation Att 1 Auth Legislation.docx Supplementary Document 12/22/2025 IRB Att 6a UW IRB Approval Initial.pdf Supplementary Document 12/22/2025 IRB Continued Att 6b UW IRB Approval Continuing.pdf Supplementary Document 12/22/2025 Consent Att 5 Consent Form.docx Supplementary Document 01/13/2026 GAIN Study - Change Request Memo 13SEP2022 Nonsubstantiative change request justification_GAIN_0920-1357.docx Justification for No Material/Nonsubstantive Change 09/13/2022 Change Request Justification Justification for Nonmaterial Non-substantive Change _rev 110223.docx Justification for No Material/Nonsubstantive Change 11/02/2023 Change Request Justification Memo for Nonsubstantive Change Request_0920-1357_GAIN.docx Justification for No Material/Nonsubstantive Change 11/17/2024 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received