Determination

PD Guide Updated 5/23/2022 Page 43 of 29

STUDY TRACKING AND REPORTING SYSTEM (STARS)

PROJECT DETERMINATION

Template

Step 1: Project Description

Step 2: Regulation and Policy

Step 3: Funding Information

Step 5: Project Staff

Step 6: DMP/Data/Spatiality Information

Step 7: Confirm Routing

Step 8: Supporting Information and Comments

STEP 1: PROJECT DESCRIPTION

Project Description Information

Project Title [150 characters max]:

Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex With Men in a Transformational Era (aka MIC-DROP study)

• Anticipated Start and Completion Dates: 10/01/2022–09/30/2026

• Select the Priority of the project.

☒ Standard

☐ Urgent

• If ‘Urgent,’ Date Needed? _____________________________________________

• Justification for “Urgent” priority: ______________________________________

• Provide Description of Project:

[3500 characters max. A short, clear description with sufficient detail to enable a reader to quickly understand whether the project or data set is of interest to them.]

This project determination is for a CDC-sponsored research investigation that will result in data collection, management, and deidentification by the funded recipient. CDC will not be engaged in these activities or receive any personally identifiable identifying information (PII). In this study, HIV-negative gay, bisexual, and other men who have sex with men (MSM) will be recruited in the community to complete quarterly online surveys over 2 years, with a subset of men to participate in focus groups and individual interviews to better understand HIV pre-exposure prophylaxis (PrEP) and condom use, adherence, persistence, and transitioning among products over time. HIV prevention messaging will be developed and tested among the cohort to help close HIV prevention gaps in protection.

To conduct this study, the Division of HIV Prevention (DHP) is funding a multisite cooperative agreement with research sites in Atlanta, Detroit, and San Diego that are located in phase 1 Ending the HIV Epidemic in the U.S. (EHE) jurisdictions. The NOFO recipient is Emory University who is in turn contracting with San Diego State University and University of Michigan. This study is anticipated to undergo IRB review at Emory University and to require OMB-PRA review. This PD submission has been pre-cleared by HRB and DHP ACS.

Identifying a Project Associated with an IMS Activation and Type of Response

Note: COVID-19 related Projects and Funding should select 2019 Novel Coronavirus Response.

• Is this submission associated with an IMS activation, Center, Institute or Office (CIO) Emergency Response, Epi-Aid (may or may not be associated with an IMS or CIO Emergency Response), or Assessment of Chemical Exposure (ACE).

☐ Yes

☒ No

• If ‘Yes’, provide type(s) of response and name(s): _____________________________________

Name of CIO Emergency Response: ­­­­­­­­­­­­­­­­_________________________________________________

Name of the Epi-Aid: _____________________________________________________________

Name of Assessment of Chemical Exposure: __________________________________________

Primary Priority Related to the Project or Funding

• Select only one from the list below:

☐ Transmission of SARS-CoV-2

☐ Protection of healthcare personnel and patients

☐ Natural history of SARS-CoV-2 infection

☐ COVID-19 disease detection, burden, and impact

☐ Prevention, mitigation, and intervention strategies

☒ Social, behavioral, and communication science

☐ Other Scientific Topic (If selected, the system requires a value for other)

________________________________________________________________________

☐ Not Associated with a Scientific Topic

• Indicate secondary priorities selections if appropriate.

If appropriate, select all that apply from the list below:

☐ Transmission of SARS-CoV-2

☐ Protection of healthcare personnel and patients

☐ Natural history of SARS-CoV-2 infection

☐ COVID-19 disease detection, burden, and impact

☒ Prevention, mitigation, and intervention strategies

☐ Social, behavioral, and communication science

☐ Other Scientific Topic

• Task Forces Associated with Project

If appropriate, indicate Task Forces associated with the project.

☐ Chief Medical Officer Unit

☐ Community Interventions and Critical Populations

☐ Data, Analytics, and Modeling

☐ Epidemiology and Surveillance

☐ Global Migration

☐ Health Systems and Worker Safety

☐ International

☐ Joint Information Center (JIC)

☐ Laboratory and Testing

☐ STLT

☐ Vaccine Task Force

☒ Not Applicable

Goals/Purposes

• Briefly describe the purpose of the project and how it addresses needs or priorities.

[3500 characters max]

The goal of this study is to understand the use of preexposure prophylaxis (PrEP) and other HIV and sexually transmitted infections (STI) prevention interventions over time among MSM. The study will also identify the most effective brief PrEP and other HIV and STI prevention messaging to increase protective behaviors among MSM. All MSM will be tested for HIV and STIs quarterly with referral to prevention and treatment services. The funded recipient will generate rapid reports following each wave of data collection to identify community trends and implications for prevention messaging.

Objective(s)

• Describe the specific objectives of the project and indicate if/how they relate to a public health emergency, or vaccines and immunization activities.

[3500 characters max]

1. To assess patterns in the use of available HIV prevention interventions (e.g., PrEP, condoms, prevention messaging) over time in a racially/ethnically community-based sample of MSM three U.S. cities.

2. To assess HIV and STI infection and the association with type of prevention intervention among HIV-negative MSM during a transformational era with the availability of biomedical HIV prevention interventions.

3. To develop and test HIV and STI prevention messages during a transformational era with the availability of biomedical HIV prevention interventions.

4. To generate rapid reports following each wave of quantitative and qualitative assessment that include key study findings, HIV prevention trends, and recommendations for public health messaging and behavioral interventions that can be used to guide HIV prevention interventions.

Health Equity Questions

• Does this project include interventions, services, or policy change work aimed at improving the health of groups who have been excluded or marginalized and/or decreasing disparities?

☒ Yes

☐ No

Elements of Health Equity Science

• In what ways does this project incorporate elements of health equity science?

[Select all that apply. A Minimum of one selection is required.]

☐ Project does not incorporate elements of health equity science. [Note: If this item is selected, the system will not allow any other health equity selection as they do not apply.]

☐ Measuring Disparities: Measuring or documenting one or more health disparities (in absolute and/or relative terms) or their change over time.

☒ Studying Social Determinants of Health (SDOH): Studying, measuring, or evaluating social determinants of health or their change over time (check all that apply)

☒ Assessing impact: Assessing the effectiveness or impact interventions, policies, programs, system or environment changes have on the health of groups that have been excluded or marginalized, or on social determinants of health (other than process evaluation)

☐ Methods to improve health equity research and practice: For example, developing methods, instruments, or other innovations to advance progress towards health equity or improve measurement of social determinants of health

☐ Other (Please summarize, e.g., economic analysis, ethical analysis, formative research)

Studying Social Determinants of Health (SDOH)

• In what ways does this project incorporate elements of health equity science?

[Check all that apply. Minimum of one selection is required.]

☒ Economic Stability (e.g., Employment, Income, Wealth, Food Security, Housing Stability and Homelessness, Poverty).

☒ Education (All levels of education including Early Childhood Education and Development, also Language and Literacy)

☒ Health Care Access (e.g., Access to Health Care (including Insurance), Access to Primary Care, Health Literacy)

☒ Neighborhood and Environment (e.g., Access to Healthy Foods, Crime and Violence, Environmental and Climate Conditions, Housing Quality, Access to Broadband)

☒ Social and Community Context (Other characteristics of contexts within which people live, learn, work, and play. Examples include Discrimination (including Racism), Civic Participation, Incarceration, Social Cohesion, Workplace Conditions).

☐ Indices of SDOH (Measures that attempt to aggregate and quantify multiple social determinants of health). Specify determinants addressed [3500 characters max]:

☐ Other SDOH topics (SDOH-related areas that do not neatly in the above categories [3500 characters max]:

☐ Assessing Impact: Assessing the effectiveness or impact interventions, policies, programs, system or environment changes have on health of groups that have been excluded or marginalized, or on social determinants of health (other than process evaluation).

☐ Methods to improve health equity research and practice: For example, developing methods, instruments, or other innovations to advance progress towards health equity or improve measurement of social determinants of health.

☐ Other (Please summarize. E.g., economic analysis, ethical analysis, formative research):

Working with Outside Institutions

• Will you be working with an outside Organization or Institution?

☒ Yes

☐ No

Submitting to the IRB Office

• Do you anticipate this project will be submitted to the IRB Office?

☐ Yes [If “Yes”, Step 2-Policy & Regulation will follow after Step 1 is completed.]

☒ No [If “No”, then Step-2-Policy & Regulation is not required.]

Data

• Will the project be collecting, generating, obtaining, or transferring data?

☒ Yes

☐ No

Activities or Tasks

• Select all activities or tasks applicable to this project.

☒ New collection of information, data, or biospecimens

☐ Secondary data or specimen analysis

☐ Purchase, use, or transfer of information, data biospecimens or materials

☒ Research with humans

☐ Activity involving live vertebrate animals

☐ All work onsite at CDC facilities

☐ Programmatic work

Target Populations (Required)

• Select all target population(s) included/represented. Use the Population Guidance link (Population (cdc.gov) to view the population(s), definition(s), and source(s) for the population categories

X	Check all that apply
X	Adult 18-64 years		Impaired hearing or deaf
X	American Indian or Alaska Native		Impaired mental
X	Asian		Impaired physical
X	Black or African American		International
	Businesses	X	Male
	Children		Native Hawaiian or Other Pacific Islander
	Older adults >64 years		Neonates
	Emancipated Minor		No human population
	Farmers		Other
	Females		Patient
	Fetuses		Pregnant women
	General US Population		Prisoners
	Healthcare providers		Transgender
X	Hispanic or Latino	X	White
X	Immigrants or Refugees		Other (Describe):

Tags/Key Words

• Provide tags/keywords under which the project could be indexed, cataloged, or searched under in biomedical and health-related databases such as MEDLINE/PubMed, NLM Catalog, etc. Examples might include population surveillance, communicable diseases, behavioral symptoms, sleep disturbances.

HIV; HIV prevention; preexposure prophylaxis; PrEP; sexually transmitted infection; STI; `prevention messaging; MSM; gay men

CDC’s Role

• Describe the nature of CDC's involvement to include funding, technical assistance, development of concept, protocol, information collection instruments, data management, etc. Indicate whether the CDC has final decision authority over the project.

☒ Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design and data collection

☒ CDC employees will provide substantial technical assistance or oversight

☐ Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design and data collection as a condition of any funding provided.

☐ Activity originated and designed by non-CDC staff (awardee or external collaborator)

☐ CDC employees or agents will obtain data by intervening or interacting with participants

☒ CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens

☐ CDC employees or agents will obtain or use identifiable (including coded) private data or biological specimens

☒ CDC employees will participate as co-authors in presentation(s) or publications.

☐ OTHER (Describe):

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

Method Categories

• Select the Method Categories. This is the approach and plan to meet the objectives such as interventions, procedures, screening, etc. Multiple selections can be made.

☐ Discussion Group

☐ Exposure Investigation

☒ Focus Group

☐ Genetic Sequencing

☐ Health Consultation

☐ Health Education

☐ Hybrid Study Design

☒ Individual Interviews (Qualitative)

☒ Other: Analytic Services (can be data/specimen TA for non-research, research, investigations): Participant surveys

Methods

• Describe the approach and plan to meet the objectives such as interventions, procedures, target population and respondent recruitment, screening and enrollment.

• Provide information to describe steps taken to ensure the quality of the project and if applicable, whether a review of the proposed statistical methods has been completed.

• 3500 characters maximum

1. Our primary recruitment strategy will be through online advertisement (i.e., social media and dating apps). Each site will also work with local organizations to provide recruitment materials to attract participants to the online eligibility screener.

2. Enroll at least 1,275 HIV-negative MSM across 3 sites (n=425 per site) with 765 PrEP users (255 per site) and 510 non-PrEP users (170 per site) at baseline. . Eight quantitative assessments will be conducted quarterly over the 2-year cohort study, including items on:

1. PrEP use, PrEP adherence, condom use, and sexual and substance use behavior

2. Awareness, knowledge, beliefs, and perceptions of various HIV and STI prevention products

3. Development and testing of prevention messages

3. Complete at least three qualitative assessments (focus groups and interviews) with a sample of participants. Assessments will be conducted every six months during the study period (interviews: n=90 total interviews with same n=30 men each of 3 assessments; focus groups: n=90-150 with n=30-50 men each of 3 assessments) to study:

1. PrEP initiation and adherence, condom use, and sexual and substance use behavior

2. Awareness, knowledge, beliefs, and perceptions of various HIV prevention products

3. Testing of brief HIV prevention messages for prevention interventions

4. Enroll a minimum of 380 (~30%) Black/African American and 380 (~30%) Hispanic/Latino MSM. All study materials and assessments will be offered in both English and Spanish with bilingual staff support. Quarterly HIV and STI testing of participants will be provided. Persons with HIV or an STI diagnosed will be linked to care.

Information, Data, or Bio-specimens collection

• Explain how information, data, or bio-specimens will be collected. Information refers to facts, statistics, opinions, observations and biological or genetic material provided or learned about human persons.

• Identify each collection activity for this project.

• Describe who the information will be collected from and what personally identifiable information will be used for the related activities.

• Provide information on the estimated burden (in hours) to respondents for each data collection activity proposed.

• 3,500 characters max

The recipient and its contractors will conduct online surveys of MSM every 3 months. The surveys will query respondents about participating in focus groups and interview to recruit a sample of respondents. If the respondent agrees to participate, they will be asked for their contact information although this information will be collected and maintained separately from their survey data. After completion of each wave of surveys, focus groups, and interviews, all PII will be destroyed. Collected data without PII will be sent to Emory University for analyses. These data will also be sent to CDC.

HIV and STI testing will be conducted remotely among study participants every 6 months, and results coordination will be managed centrally by Emory University. The data will not include PII. At the completion of the study, deidentified aggregate HIV and STI testing data will be sent to CDC for analyses.

Expected Use of Findings/Results and their Impact

• Enter the expected use of findings/results and their impact.

• Describe how the information will be used and the results disseminated, including plans for peer- reviewed publication, conference presentations and/or web postings.

• 3,500 characters max

Rapid reports of survey waves will be generated every three months and sent to CDC to identify HIV prevention gaps and messaging opportunities and recommendations for MSM. Analyses of survey, focus group, and interview data will be analyzed by recipients and CDC to disseminate findings in peer-reviewed journals and at conferences and meetings. Effective prevention messaging will be implemented in CDC messaging and community programs (e.g., mobile apps, social marketing campaigns, website information sources, other written prevention materials) to improve HIV prevention for communities of MSM.

CDC/ATSDR HRPO/IRB Protocol Number & OMB Control #

• If available, provide the CDC/ATSDR HRPO/IRB Protocol # if this has a Protocol #: ____________

• If available, provide the OMB Control # if this has a Control #: ____________________________

Personally, Identifiable Information (PII)

• Could individuals potentially be identified based on Information collected?

☒ Yes

☐ No

If “Yes”, Will PII be captured (including coded data)? Will the project collect, store, or transmit Personal Identifying information (PII) that can be used on its own or with other information to identify, contact, or locate a single person, or to identify an individual in context? This includes information in control of outside CDC partners and contractors.

☒ Yes

☐ No

Does CDC have access to the identifiers (including coded data)?

☐ Yes

☒ No

Assurance of Confidentiality & Certificate of Confidentiality

• Is the project covered by an Assurance of Confidentiality? See the following link for guidance: Assurances of Confidentiality (cdc.gov).

☐ Yes

☒ No

• Does this activity meet the criteria for a Certificate of Confidentiality (CoC)? See the following link for guidance: Certificates of Confidentiality (cdc.gov).

☒ Yes

☐ No

Formal Written Agreement

• Is there a formal written agreement prohibiting the release of identifiers?

Is an agreement in place to prevent information from being disclosed to others which serves as a non-disclosure of identifiers (e.g., Key Agreement, Material Transfer Agreement, Technical Assistance Letter, Memorandum of Understanding, Data Use Agreement, Form 0.1375A, Form 0.1375B, etc.)?

☐ Yes (If ‘Yes’, provide/upload the formal written agreement)

☒ No

STEP 2: REGULATION AND POLICY – PROTOCOL INFORMATION

Regulation and Policy - IRB Office

• Do you anticipate this project will be submitted to the IRB Office? [This item was previously addressed in Step 1.]

☐ Yes [If “Yes”, then Step 2-Policy & Regulation is required.]

☒ No [If “No”, then Step-2-Policy & Regulation is not required. Skip to Section 3-Funding Information.]

Number of Study Participants, Populations Included

• Estimated # of study participants: 1,275

Report estimated counts rather than percentages.

Include study subjects at domestic and foreign sites.

• Select (“x”) the extent to which the following population(s) will be included, and the page # in the protocol if applicable.

Children: ☐ Targeted, ☐ Allowed, ☐ Excluded, or ☐ N/A, Protocol Page # _______

Minors: ☐ Targeted, ☐ Allowed, ☐ Excluded, or ☐ N/A, Protocol Page # _______

Prisoners: ☐ Targeted, ☐ Allowed, ☐ Excluded, or ☐ N/A, Protocol Page # _______

Pregnant Women: ☐ Targeted, ☐ Allowed, ☐ Excluded, or ☐ N/A, Protocol Page # _______

Emancipated Minors: ☐ Targeted, ☐ Allowed, ☐ Excluded, or ☐ N/A, Protocol Page # _______

Suggested Level of Risk to Subjects

• Suggest level of risk to subjects:

☐ Minimal

☐ Greater than minimal

NOTE: Select “Minimal” when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The definition varies slightly for research involving prisoners.

NOTE: Select “Greater than Minimal” when the probability and magnitude of harm or discomfort anticipated in the proposed research are greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Any disclosure of illegal activities, sexual attitudes, genetics, religious beliefs, mental health that could place participants at risk of criminal or civil liability, be damaging to the participants financial standing, employability, insurability, reputation, or be stigmatizing.

Exempt or Non-Exempt Research

• Do you anticipate this project will be exempt research or non-exempt research?

☐ Exempt

☐ Non-Exempt

• Select each category and the applicable options for all that apply to the protocol.

Each option is also presented further below with details and information that appear in STARS.

☐ Educational Practices

☐ Educational Tests, Surveys, Interviews, or Observation of Public Behavior

☐ Benign Behavioral Interventions and Collection of Information

☐ Secondary Research for which Consent is not Required

☐ Research and Demonstration Projects

☐ Taste and Food Quality Evaluation and Consumer Acceptance Studies

☐ Storage or Maintenance for Secondary Use for which Broad Consent is Required

☐ Secondary Research for Which Broad Consent is Required

NOTE:

• Studies may be exempt from review when human participants conform to one of the categories from section 46.101(b) of 45 CFR 46.

• Research may qualify for Exempt status if it involves very minimal or no risk.

• Projects will not be given Exempt status if they include any degree of deception, involve more than very minimal risk to participants, involve sensitive information, or include protected classes or vulnerable populations.

• Please note that researchers must always engage in practices that ensure privacy and that minimize the risks to participants, regardless of the level of review.

Exempt Research Category 1: Educational Practices

• If “Exempt” was selected above, check if the following applies:

☐ Category 1: Educational Practices:

• Normal educational practices in commonly accepted education settings.

NOTE: Category 1: Educational Practices 45 CRF 46.104(d)(1) Research in Established or Commonly Accepted Education Settings that Involves Normal Educational Practices and Not likely to Adversely Impact Students' Opportunity to Learn or Assessment of Educator

Exempt Research Category 2: Educational Tests, Surveys, Interviews, or Observation of Public Behavior

• If “Exempt” was selected above, check if the following applies:

☐ Educational tests, surveys, interviews, or observation of public behavior

• At least one of the criteria below must be met:

☐ Recorded in such a manner that identity cannot readily be ascertained

☐ Disclosure outside the research would not reasonably place subjects at risk of liability or be damaging

☐ Adults only, identity can readily be ascertained

NOTE:

Category 2: Educational tests, surveys, interviews, or observation of public behavior 45 CFR 46.104(d)(2) Research only includes Educational Tests, Surveys, Interviews, Public Observation and Not Likely to Adversely Impact Students’ Opportunity to Learn or Assessment of Educators if at least ONE of the following criteria met: (i) Recorded information cannot readily identify the subject (directly or indirectly/linked); Surveys & Interviews: No Children; Educational Tests or Observation of Public Behavior: Can Only include Children when Investigators Do Not participate in activities being observed OR (ii) Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation); Surveys & Interviews: No Children; Educational Tests or Observation of Public Behavior: Can Only include Children When Investigators Do Not Participate in Activities being Observed OR (iii) Information is recorded with identifiers & IRB conducts Limited Review; NO Children

Exempt Research Category 3: Benign Behavioral Interventions and Collection of Information

• If “Exempt” was selected above, check if the following applies:

☐ Benign Behavioral Interventions and Collection of Information

• Category 3: Benign Behavioral Interventions and Collection of Information:

☐ Information obtained is recorded by the investigator in such a manner that the identity of human subjects cannot be readily ascertained directly or through identifiers linked to subjects.

☐ Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement or reputation

☐ Information obtained is recorded by the investigator in such a manner that the identity of human subjects can readily be ascertained directly or through identifiers linked to the subjects; Research involves deceiving the subjects regarding the nature or purposes of the research; Subject authorizes the deception through prospective agreement.

NOTE:

Category 3: Benign Behavioral Interventions and Collection of Information - 45 CRF 46.104(d)(3) Research involving Benign Behavioral Interventions through verbal, written responses, (including data entry or audiovisual recording) from adult subject who prospectively agrees and ONE of following met: May Not include Medical Interventions; Subject prospectively agrees (ii) Benign Behavioral Interventions must be: Brief in Duration, Painless/Harmless, Not Physically Invasive, Not Likely to Have a Significant Adverse Lasting Impact on Subjects, Unlikely that Subjects Will Find Interventions Offensive or Embarrassing (iii)No deception unless participant prospectively agrees. Recorded information cannot readily identify the subject (directly or indirectly/linked); ORB. Any disclosure of responses outside of the research would NOT reasonably place subject at risk (criminal, civil liability, financial, employability, educational advancement, reputation); ORC. Information is recorded with identifiers & IRB conducts Limited Review

Exempt Research Category 4: Secondary Research for which consent is not Required

• If “Exempt” was selected above, check if the following applies:

☐ Secondary Research for Which Consent is Not Required

• Category 4: Secondary Research for Which Consent is Not Required

☐ Identifiable private information or identifiable biospecimens are publicly available

☐ Information, which may include information about biospecimens, recorded by investigator such that the identity of human subjects cannot readily be ascertained; Investigator does not contact subjects, and investigator will not re-identify subjects

☐ Research use of identifiable health information which that use is regulated by HIPAA as health care operations, research or public health activities and purposes as those terms are defined in HIPAA

☐ The research is conducted b, or on behalf of, a federal department or agency using government generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with applicable with applicable federal privacy standards found in the E-Government act, Privacy Act and the Paperwork Reduction Act.

NOTE:

Category 4, Secondary Research for which Consent is not Required - 45 CFR 46.104(d)(8) Secondary Research for Which Consent is Not Required: Use of Identifiable Information or Identifiable Biospecimen that have been or will be collected for some other 'primary' or 'initial' activity, if ONE of following criteria met: No Primary Collection from subjects for the research; Allows Both Retrospective and Prospective Secondary Use.(i) Biospecimens or Information is Publicly Available; OR(ii) Information recorded so subject cannot readily be identified (directly or indirectly/linked); Investigator does not contact subjects and will not re-identify the subjects; OR(iii) Collection and Analysis involving Investigators Use of Identifiable Health Information when use is regulated by HIPAA "health care operations" or "research" or "public health activities and purposes"; OR(iv) Research information collected by or on behalf of federal government using government generated or collected information obtained for non-research activities.

Exempt Research Category 5: Research and Demonstration Projects

• If “Exempt” was selected above, check if the following applies:

☐ Research and Demonstration Projects

• Check if applicable:

☐ Conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads designed to study, evaluate, improve or otherwise examine public benefit or service program

NOTE:

Category 5, Research and Demonstration Projects - 45 CFR 46.104(d)(5) Research and demonstration projects supported by a Federal Agency/Dept. AND Designed to study, public benefit or service programs. Must be posted on a Federal Web Site. Federal website that will satisfy the consent form posting requirement: ClinicalTrials.gov

Exempt Research Category 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies

• If “Exempt” was selected above, check if the following applies:

☐ Taste and Food Quality Evaluation and Consumer Acceptance Studies

• Check if applicable:

☐ Foods that are wholesome without additives

☐ If a food is consumed that contains food ingredient at or below the level and for use found to be safe, or agricultural chemical or environmental contaminant at or below level food to be safe, by FDA or approved by EPA or Food Safety and Inspection Service of USDA.

Exempt Research Category 7: Storage or Maintenance for Secondary Use for which Broad Consent is Required

• If “Exempt” was selected above, check if the following applies:

☐ Storage or Maintenance for Secondary Use for which Broad Consent is Required

• Check if applicable:

☐ Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use

NOTE:

Category 7: 45 CFR 46.104(d)(7) Storage or Maintenance of Identifiable Private Information or Identifiable Biospecimens for Secondary Research which Broad Consent is required. Limited IRB review required under S46.111(a)(8).

Exempt Research Category 8: Secondary Research for Which Broad Consent is Required

• If “Exempt” was selected above, check if the following applies:

☐ Secondary Research for Which Broad Consent is Required

• Check if applicable:

☐ Broad consent for storage, maintenance and secondary research use of identifiable private information or identifiable biospecimens was obtained.

NOTE:

Category 8: 45 CFR 46.104(d)(8) Secondary research involving use of Identifiable Private Information or Identifiable Biospecimens for which Broad Consent was Required Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens was obtained in accordance with S46.116(a)(1) through (4), (a)(6) and (d)[S46.104(8) (i)]. Limited IRB review required under S46.111(a)(8). Note 1: [S46.104(8)(ii)] Documentation of informed consent or waiver of documentation of consent was obtained in accordance with S46.117 Note 2: [S46.104(8) (iv)] Investigator does not include returning individual research results to subjects as part of the study plan

Non-Exempt Research*

• Do you anticipate this project will be exempt research or non-exempt research? This item was also addressed above.

☐ Exempt

☐ Non-Exempt

NOTE:

Select Non-Exempt for any proposed research not qualifying for Exempt Research status requires IRB members review and vote on the proposal. These typically involve projects that place human subjects at more than minimal risk, or that involve sensitive topics or vulnerable populations such as prisoners, terminally ill patients, children, veterans, or cognitively impaired persons.

A proposal that does not fulfill the criteria for Exempt status may undergo an Expedited review if it involves no more than minimal risk to the participants and meets other standards, such as not including protected classes or vulnerable populations, and not using intentional deception.

If Non-exempt Research was selected, address the following as they pertain to Informed Consent, Clinical Trial and Other Considerations.

Non-Exempt Research/Informed Consent

• Check all that apply. Characterize requested changes to required features of the informed consent process. If a waiver is requested, enter the page number of the protocol where the waiver is justified:

☐ Waiver or alteration of elements of informed consent for adults: Page # ____

☐ Waiver of assent for children capable of providing assent: Page # ____

☐ Waiver of parental permission: Page # ____

☐ Waiver or alteration or authorization under HIPAA Privacy Rule: Page # ____

NOTE:

Which waivers to the consent process are requested: IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(d), provided all the following four conditions are met: 1. research involves no more than minimal risk, 2. not adversely affect the rights and welfare, 3. research could not practicably be carried out without the waiver or alteration, and 4. subjects are provided with additional pertinent information after participation. Public benefit or service programs: 45 CFR 46.116(c). Research in emergency settings: 45 CFR 46.101(i). If a waiver is requested, enter the page number of the protocol where the waiver is justified. Check all that apply.

Non-Exempt Research/Informed Consent

• Which waivers to documentation of informed consent are requested?

☐ Waiver of documentation of informed consent for adults: Page # ____

☐ Waiver of documentation of assent for children capable of providing assent: Page # ____

☐ Waiver of documentation of parental permission: Page # ____

NOTE:

Which waivers to documentation of informed consent are requested? Potential participants, or the parents of children who are potential participants, are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB. The FDA has not adopted this category so it cannot be used if the research is subject to the FDA regulations 21 CFR 50. If a waiver is requested, enter the page number of the protocol where the waiver is justified. Check all that apply.

Non-Exempt Research/Informed Consent

• How is it shown that the consent process is in understandable language?

☐ Reading level has been estimated: Page # ____

☐ Comprehension tool is provided: Page # ____

☐ Short form is provided: Page # ____

☐ Translation planned or performed: Page # ____

☐ Certified translation/translator: Page # ____

☐ Translation and back-translation to/from target language(s): Page # ____

☐ Other Method: Page # ____

Describe “Other Method”: _______________________________________________

_____________________________________________________________________

_____________________________________________________________________

NOTE: How is it shown that the consent process is in understandable language? Consent process in understandable language regulations are 45 CFR 46.116 and 45 CFR 46.117 and/or FDA regulations 21 CFR 50.25 and 21 CFR 50.27 apply. Subjects must be provided with both 1. A written consent document in a language understandable to them AND 2. An interpreter fluent in both English and the participant's spoken language to aid in the consent process. If a waiver is requested, enter the page number of the protocol where the waiver is justified. Check all that apply.

Regulation and Policy – Non-Exempt Research/Clinical Trial

• Clinical Trial - Check all that apply.

☐ Does the study involve human participants?

☐ Are the participants prospectively assigned to an intervention?

☐ Is the study designed to evaluate the effect of the intervention on the participant?

☐ Is the effect being evaluated a health-related biomedical or behavioral outcome?

☐ This study is a registrable clinical trial. NOTE: If the study is a registrable clinical trial, enter the ID and/or select the ClinicalTrials.gov link to the route to the U.S. National Library of Medicine ClinicalTrials.gov for additional information.

NOTE:

1) 45 CFR 46.102(b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. 2) 45 CFR 46.102(e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 3) 45 CFR 46.102(2) Intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. If the answer to any one of these questions is yes, then a Certificate of Confidentiality will apply to the research per subsection 301(d) of the Public Health Service Act. If you check all, then the study meets the definition of a clinical trial.

Non-Exempt Research/Other Considerations

• Other Considerations - Check all that apply.

☐ Exception is requested to PHS, informing those tested about HIV serostatus:

Protocol Page # _____

☐ Human genetic testing is planned now or in the future.

☐ This study involves long-term storage of identifiable biological specimens.

☐ This study involves a drug, biologic, or device.

☐ This study will be conducted under an Investigational New Drug (IND) exemption or Investigational Device Exemption (IDE).

IND/IDE #: ____________

NOTE:

1) 45 CFR 46.102(b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. 2) 45 CFR 46.102(e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 3) 45 CFR 46.102(2) Intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. If the answer to any one of these questions is yes, then a Certificate of Confidentiality will apply to the research per subsection 301(d) of the Public Health Service Act. If you check all, then the study meets the definition of a clinical trial.

STEP 3: FUNDING INFORMATION

Step 3: Funding

• This step is designed to capture funding details associated with this project. If the project does not have any associated funding, select next to advance to Step 4.

• Items will include the following: Funding Type, Funding Title, Funding Number, Original Fiscal Year, Number of Years of Award, and Budget Amount

• NOTE: This step is designed to capture funding details associated with this project. If the project does not have any associated funding, select next to advance to Step 4.

Funding – Funding Type and Title

• Select the Funding Type (Select one):

☐ CDC Contract

☒ CDC Cooperative Agreement

☐ CDC Funding Intramural

☐ CDC Grant

☐ Cooperative Research and Development Agreement

☐ FDA Funding

☐ Funding from Another CIO

☐ Gift

☐ IMS Response

☐ Other Federal Funding

☐ Technical Assist-CDC Not Reimbursed

☐ Technical Assist-CDC Reimbursed

☐ Other (Specify):

Funding Title (255 Characters): Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex With Men in a Transformational Era

Funding #: RFA-PS-22-004

[This is the award number assigned to the project (i.e., the NOFO number for a cooperative agreement, the contract number for a contract, or the spend plan unique ID for the IMS Response.]

• Original Fiscal Year: 2022

• Number of Years of Award: 4

• Budget Amount: $5.9 million

STEP 4: EXTERNAL INSTITUTION(S)

Step 4: Adding Outside Organizations & Institutions

This section should be completed if “Yes” was the response for the following:

• Will you be working with an outside Organization or Institution?

☒ Yes

☐ No

If applicable, provide the following information for each awardee or collaborating institution involved in the project in any capacity.

Institution #1:

• Institution’s Name: Emory University

[E.g., University of Tennessee-Chattanooga]

• Federal Wide Assurance Number (FWA #): Will auto-populate in STARS

[STARS will auto-populate this # with Institution's name. The FWA is assigned to an institution for the Protection of Human Subjects.]

• FWA Expiration Date: ___Will auto-populate in STARS______________________________________

[STARS will auto-populate this date with Institution's name.]

• IRB Title:

[This is the Internal Review Board for the Institution (if applicable and available). It will be provided in drop-down menu. For example, “U Tennessee Chattanooga IRB #1”]

• IRB Expiration Date: _________________________________________________________________

[This is the Institution’s Internal Review Board Expiration Date. STARS will auto-populate this date with IRB Title.]

• Funding #:

[This is the unique identifier assigned to the funding vehicle.]

Institution #2:

• Institution’s Name: San Diego State University

[E.g., University of Tennessee-Chattanooga]

• Federal Wide Assurance Number (FWA #): Will auto-populate in STARS

[STARS will auto-populate this # with Institution's name. The FWA is assigned to an institution for the Protection of Human Subjects.]

• FWA Expiration Date: ___Will auto-populate in STARS______________________________________

[STARS will auto-populate this date with Institution's name.]

• IRB Title:

[This is the Internal Review Board for the Institution (if applicable and available). It will be provided in drop-down menu. For example, “U Tennessee Chattanooga IRB #1”]

• IRB Expiration Date: _________________________________________________________________

[This is the Institution’s Internal Review Board Expiration Date. STARS will auto-populate this date with IRB Title.]

• Funding #:

[This is the unique identifier assigned to the funding vehicle.]

Institution #3:

• Institution’s Name: University of Michigan

[E.g., University of Tennessee-Chattanooga]

• Federal Wide Assurance Number (FWA #): Will auto-populate in STARS

[STARS will auto-populate this # with Institution's name. The FWA is assigned to an institution for the Protection of Human Subjects.]

• FWA Expiration Date: ___Will auto-populate in STARS______________________________________

[STARS will auto-populate this date with Institution's name.]

• IRB Title:

[This is the Internal Review Board for the Institution (if applicable and available). It will be provided in drop-down menu. For example, “U Tennessee Chattanooga IRB #1”]

• IRB Expiration Date: _________________________________________________________________

[This is the Institution’s Internal Review Board Expiration Date. STARS will auto-populate this date with IRB Title.]

• Funding #:

[This is the unique identifier assigned to the funding vehicle.]

STEP 5: PROJECT STAFF INFORMATION

Step 5: Project Staff information

Project Contact: Gordon Mansergh (gcm2)

CDC Staff (including contractors) and non-CDC staff involved in the project in any scientific capacity should be added as staff. This includes the person submitting the project by default will be added as the project contact.

By default, the person submitting the project is assigned the role of Project Contact. The project contact supervises the administrative aspects of the clearance process. For example, they are responsible for initiating the clearance process and refining/updating the project based on reviewer feedback.

SIQT AND CITI TRAINING: After entering a staff’s name or User ID in STARS, the system will auto-populate the person’s SIQT and CITI training expiration dates. If the field remains blank after entering the staff’s name or user ID into the system, the individual must complete the training or do a refresher as appropriate. All CDC/ATSDR staff must be compliant before the PD can be submitted.

Non-CDC staff are not required to be compliant with SIQT or CITI trainings.

CDC/ATSDR Staff Members:

1.
CDC Staff Member's Name or User ID: Gordon Mansergh	Staff’s Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☒ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address: gcm2@cdc.gov
Phone Number: 404-639-6135
Organization/Institution: CDC/DDID/NCHHSTP/DHP/HRB
2.
CDC Staff Member's Name or User ID:	Staff’s Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address:
Phone Number:
Organization/Institution:
3.
CDC Staff Member's Name or User ID:	Staff’s Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address:
Phone Number:
Organization/Institution: CDC
4.
CDC Staff Member's Name or User ID:	Staff’s Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address:
Phone Number:
Organization/Institution:
5.
CDC Staff Member's Name or User ID:	Staff’s Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address:
Phone Number:
Organization/Institution:

Non-CDC/ATSDR Staff Members:

1.
Non-CDC/ATSDR Staff Member's Name: Patrick Sullivan	Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☒ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address: pssulli@emory.edu
Phone Number: 404-210-6039
Organization/Institution: University of California-San Francisco
2.
Non-CDC/ATSDR Staff Member's Name: Keith Horvath	Role on Project: ☒ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address: khorvath@sdsu.edu
Phone Number: 619-594-3346
Organization/Institution: San Diego State University

3.
Non-CDC/ATSDR Staff Member's Name: Rob Stephenson	Role on Project: ☒ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address: rbsteph@umich.edu
Phone Number: 734-615-0149
Organization/Institution: University of Michigan
4.
Non-CDC/ATSDR Staff Member's Name: Emily Dove-Medows, PhD	Role on Project: ☒ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address: dovemed@umich.edu
Phone Number: 917-697-962440
Organization/Institution: University of Michigan
5.
Non-CDC/ATSDR Staff Member's Name: Travis Sanchez, DVM	Role on Project: ☒ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address: Travis.sanchez@emory.edu
Phone Number: 404-727-8403
Organization/Institution: Emory University

5.
Non-CDC/ATSDR Staff Member's Name:	Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address:
Phone Number:
Organization/Institution:
6.
Non-CDC/ATSDR Staff Member's Name:	Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address:
Phone Number:
Organization/Institution:
7.
Non-CDC/ATSDR Staff Member's Name:	Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address:
Phone Number:
Organization/Institution:
8.
Non-CDC/ATSDR Staff Member's Name:	Role on Project: ☐ Co-Investigator ☐ Contract Officer Representative ☐ Contract Official ☐ Data Owner ☐ Principal Investigator ☐ Program Lead ☐ Program Official ☐ Program Coordinator ☐ Project Officer ☐ Statistician ☐ Technical Monitor
Email Address:
Phone Number:
Organization/Institution:

STEP 6: DATA INFORMATON

Step 6: Data Management Plan

Proposed Data collection START Date: 10/01/2023

Proposed Data collection END Date: 09/30/2026

Select the Proposed Public Access Level (can choose multiple options):

☐ Public

☐ Non-public

☒ Restricted

*Complete sections below according to how the above question was answered.

Non-Public Details

• If “Non-Public” was selected, explain reason for not releasing the data.

(This may include information regarding access or restrictions based on privacy, security, or other policies of the owner of the data. As other examples: Removal of identifiers renders the remaining data of no value; Not sharable due to protection of intellectual property or trade secrets.)

Restricted Details

• If “Restricted” was selected, indicate the “Data Use Type”:

NOTE: For a CDC Restricted dataset, this is the type of data use agreement that must be in place in order to receive this dataset (e.g., Data Sharing Agreement, Joint Statement of Understanding).

A data sharing agreement will be required

• If “Restricted” was selected, provide the “Data Use Type URL”:

NOTE: For a CDC Restricted dataset, this is the website where the process for requesting access to the dataset can be found.

To be determined

• If “Restricted” was selected, indicate the “Data Use Contact”:

NOTE: Indicate the staff to contact about the data use understanding. If no contact is identified, go back to add New Staff Member and define that new staff member as a “Data Use Contact.”)

Patrick Sullivan for Emory dataset(s)
Gordon Mansergh for CDC dataset(s)

Details for All Public Access Types, Regardless of Above Selection

• Provide Public Access Justification: [3,500 characters max]

Please provide justification comment for your public access selection.

Collected data will be made publicly available upon request after analyses and dissemination of aggregate data are completed. Restricted access based upon request is the status because of ongoing analyses of these data by the study team after the study is completed. Request approval will be provided to ensure coordination and nonduplication of ongoing and planned analyses by the team.

• Explain how access will be provided to the data: [3,500 characters max]

In explanation, also include provisions for protection of privacy, confidentiality, security, intellectual property, proprietary, or other rights (e.g., suppression of person identifiers, etc.)

Access will provided to the public based on request and in coordination of ongoing and planned analyses of the data following study completion. Data requests by email to Emory or CDC will be reviewed by the data management group and access will be awarded through secure cloud source access to be managed by Emory. The dataset will have been deidentified and lists/files of ID links will have been destroyed by Emory prior, at the completion of the study. CDC-received external requests will be referred to Emory for secure and central management of data access.

• Describe plans for archival and long-term preservation of the data: [3,500 characters max]

(Please include justification for lack of storage or where storage will be and for how long. Also, the final DMP should include a link to the archived data with a description of when, how and by whom the data can be accessed. Please indicate that all laws, regulations, and rights regarding data have been complied.)

To be developed

Geographic Spatiality information:

NOTE: If the project takes place across the entire United States/Country, then the selection is United States only. In this case, you would not select State/Province or County/Region. Otherwise, further specify the project location.

Country	United States
State/Province
County/Region

STEP 7: CONFIRMING ROUTING

STEP 7: Confirming Routing

Reviewers:

• Indicate Reviewers or their Roles (e.g., Team Lead, Branch Chief, Technical Lead, PRA Contact, Division ADS):

• Prevention Research Team Lead

• HIV Research Branch ACS

• DHP PRA Contact

• DHP ADS

• NCHHSTP PRA Contact

• NCHHSTP ADS

Ad Hoc Reviewers:

Ad Hoc Reviewer(s) for Mandatory or Informational Review Only

• Select the type of review:

☐ Mandatory Review

☐ Informational Only

Mandatory Review

• Provide the reviewer’s name: _____________________________________________________

• Enter the number of business days allowed to complete the review:_____________________

• Indicate where in the clearance process the reviewer should be inserted to receive the project for review (e.g., First, Second, etc.):________________________________________________

• Should the reviewer receive an email alert when the project is submitted and after it clears?

☐ Yes

☐ No

Informational Review:

• Provide the reviewer’s name: _____________________________________________________

STEP 8: SUPPORTING INFORMATION AND COMMENTS

Step 8: Supporting Information and Comments

• The following CDC Forms are required as appropriate:

☐ If you require reliance on research partners, upload CDC form 0.1370 CDC Research.

☒ If your project relies on non-CDC IRB, upload 0.1371 Request to Allow CDC to Rely on a Non-CDC IRB.

☐ If your project has an institution that relies on a CDC IRB please upload 0.1372 - Request to Allow an Outside Institution to Rely on a CDC IRB.

• Please indicate if you will:

☒ Add Supporting Files

☐ Add Supporting Comments

If Adding Supporting files, please Complete the Table Below -

NOTE: The system allows for multiple uploads and zip files for supporting documents. The maximum File Size is 100 MB

File Name	Description/Text of File
MIC-DROP_protocol 10-28-2022	Study protocol

Adding Supporting Comments -

If needed, please provide comments below for the reviewers:

Provide any additional information that will assist the reviewers in their review of your project.

This comment will be displayed at the beginning of each email that is sent during the clearance process and on the project’s details page - “Initiator Comment”.

[2,000 characters max]

PD Form, Blank Template 03-16-2022