0920-1423 - Non-Substantive Change Request Memo 19SEP2025

Non-substantive Change Request

OMB Control Number 0920-1423

Expanding PrEP in Communities of Color (EPICC)

Summary of request: CDC/NCHHSTP requests changes to the data collection OMB Control Number 0920-1423 (exp 12/31/2026) to revise questions and content in alignment with EO 14168 Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.

Description of Changes Requested: This request updates sex questions and removes language related to gender diversity included in the Expanding PrEP in Communities of Color (EPICC) data collection instruments and study documents to be in accordance with EO 14168. Please check the boxes below if your request includes:

 Revision of an existing question(s)

 Deletion of an existing question(s)

There is no change in Burden Hours associated with the modifications made to comply with EO 14168.

The proposed changes affect the following attachments, and are included with this request:

• SSA (Tracked and Clean)

• SSB (Tracked and Clean)

• Att 3b_Aim2a Cohort Recruitment Plan (English and Spanish)

• Att 4f_Aim2a Cohort Screener (English and Spanish; Tracked and Clean)

• Att 4i_Aim2a Cohort Baseline Survey (English and Spanish; Tracked and Clean)

• Att 4k_Aim2a Cohort Follow Up Survey (English and Spanish; Tracked and Clean)

• Att 4j_Aim2a Cohort App Setup (Tracked and Clean)

• Att 4m_Aim2a Cohort Exit Interview (English and Spanish; Tracked and Clean)

• Att 4p_Aim2b Provider Pre-Focus Group Survey (Tracked and Clean)

• Att 4q_Aim2b Provider Focus Group Guide (Tracked and Clean)

• Att 5b_Aim2a Cohort Consent (English and Spanish; Tracked and Clean)

Table A: Description of Changes by Document	Type of Change	Question/Item	Requested Change
SSA	Removed references to gender identity in the document; study population is focused on Young Men that have Sex with Men (YMSM)	See tracked changes document for changes in text (i.e., removal of non-binary and other gender identities).	Remove references to gender identity in the document. YMSM are the focus of this study.
SSB	Removed references to gender identity in the document; study population is focused on Young Men that have Sex with Men (YMSM)	See tracked changes document for changes in text (i.e., removal of non-binary and other gender identities).	Remove references to gender identity in the document. YMSM are the focus of this study.
Att 3b_Aim2a Cohort Recruitment Plan (English and Spanish)	Removed images of gender diverse men to highlight men in general.	Removed of images of young men which depict gender diversity.	Use images included in this revised document.
Att 4f_Aim2a Cohort Screener (English and Spanish)	Question Change and Deletion (Pg. 6-7); Removed references to other gender identities on Pg. 2 (i.e., gender non-binary, etc.), the study population is focused on Young Men that have Sex with Men (YMSM).	Changed the wording on sex question on Pg. 7 from “What sex were you assigned at birth, on your original birth certificate?” to “What is your sex?” Removed question on Pg. 6-7: “How do you currently describe yourself?” See tracked changes in text on Pg. 2; study is focused on YMSM which does not specify other gender identities.	Change the wording on sex question to “What is your sex?” Response option: Male or Female. Remove question: “How do you currently describe yourself?” Remove references to other gender identities on Pg. 2.
Att 4i_Aim2a Cohort Baseline Survey (English and Spanish)	Replaced “Gender Identity” with “Sex” as a response option on Question R2 on Pg. 75.	What do you think are the main reasons for why you experienced this discrimination? (Choose all that apply) Replaced: Your gender identity With: Your sex	What do you think are the main reasons for why you experienced this discrimination? (Choose all that apply) Replace: Your gender identity With: Your sex
Att 4k_Aim2a Cohort Follow Up Survey (English and Spanish)	Removed demographic questions from the Cohort Aim2a Cohort Survey, including gender identity	Removed demographic questions from the Cohort Aim2a Cohort Follow-up Survey, including gender identity, on Pg. 4.	Remove demographic questions from the Cohort Aim2a Cohort Follow-up Survey, including gender identity
Att 4j_Aim2a Cohort App Setup	Removed gender-related terminology from content.	Removed reference to gender identities in text.	Remove reference to gender identities in text.
Att 4m_Aim2a Cohort Exit Interview (English and Spanish)	Removed use of pronouns in introduction script.	Deleted use of pronouns in introduction script on Pg. 2.	Do not include the use of pronouns in the Introduction Script does not incl
Att 4p_Aim2b Provider Pre-Focus Group Survey	Question Change and Deletion	Changed the wording on sex question on Pg. 4 from “What sex were you assigned at birth, on your original birth certificate?” to “What is your sex?” Removed question on Pg. 3-4: “How do you currently describe yourself?”	Change the wording on sex question to “What is your sex?” Response option: Male or Female. Remove question: “How do you currently describe yourself?”
Att 4q_Aim2b Provider Focus Group Guide	Removed use of pronouns in introduction script.	Deleted use of pronouns in introduction script on Pg. 2.	The Introduction Script does not include the use of pronouns.
Att 5b_Aim2a Cohort Consent (English and Spanish)	Removed references to other gender identities in the document.	See tracked changes document for changes in text on Pg. 3-4 (i.e., removal of non-binary and other gender identities).	Remove references to other gender identities in the document. YMSM are the focus of this study.