GENIC Request Template: PS20-2010 and PS20-2004 (carryover 2023-2025)

Request for genIC Approval

Performance Measures Project

0920-1282

CIO: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

PROJECT TITLE: Centers for Disease Control and Prevention Ending the HIV Epidemic in the United States: Performance Measures (continuation 2023-2025)

PURPOSE AND USE OF COLLECTION: CDC has provided funding through two Notices of Funding Opportunity (NOFO) to support the development and implementation of programs tailored to ending the HIV epidemic in America.

PS20-2010: Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States provides funding to 32 state, local, and territorial health departments that have a current direct funding relationship with CDC and have jurisdictions identified in the national Ending the HIV Epidemic (EHE) Initiative, Phase 1 (see page 6). PS20-2010 Component A is the core component and jurisdictions are required to implement comprehensive HIV programs to diagnose HIV, provide HIV treatment to achieve viral suppression, prevent new HIV transmissions, and rapidly respond to potential HIV outbreaks. Component B funding is provided to a subset of the Component A jurisdictions to estimate HIV incidence using a recency-based assay. Component C funding is provided to a subset of the Component A jurisdictions to scale-up HIV prevention services in STD specialty clinics.

PS20-2004: National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers (NNPTC) provides funding to 8 recipients to enhance training and technical assistance efforts. Part A1 is funded by CDC through the HHS Minority HIV/AIDS Program (MHAH), under the larger EHE initiative, to help STD specialty clinics strengthen their HIV prevention services.

This request for genIC approval is applicable to closely related performance measures reported for all recipients of PS20-2010 Component A, PS20-2010 Component C and PS20-2004 Part A1. While funded through two cooperative agreements, all three of these components are closely related in their intent, share an original funding source (Department of Health and Human Services for Ending the HIV Epidemic), and overlap significantly in their proposed performance measures. For these reasons, we propose to package these together for a single submission.

The purpose of the collection is to assess recipients’ individual and collective progress towards implementing the strategies and achieving the outcomes outlined in the cooperative agreement, direct technical assistance to recipients, and obtain information needed to help assess the cooperative agreement’s public health impact. The resulting data will be used to generate rapid feedback reports and other products that summarize and compare recipients’ progress. Findings will be disseminated to all funded recipients and key CDC staff working to support these recipients, to stimulate discussion of areas for program improvement and technical assistance.

NUMBER AND TITLE OF NOFOs: PS20-2010: Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States & PS20-2004: National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers

NUMBER OF PARTICIPATING RECIPIENTS: 40

• For PS20:2010, 32 health departments are funded for core HIV prevention work, of which 7 of those 32 health departments are also currently funded for STD specialty clinic work. Up to 14 additional recipients may also be funded for the STD specialty clinic work in 2021, depending on funding availability. The burden described below reflects this upper bound of 21 recipients for the STD specialty clinic work.

• PS20-2004: 8 STD prevention training centers are funded for additional STD specialty clinic work.

DESCRIPTION OF NOFO (check all that apply):

__ Funds all 50 states

_X_ Has budget higher than $10 million per year

_X_ Has significant stakeholder interest (e.g. partners, Congress)

Please elaborate:

Through PS20-2010 and PS20-2004, CDC’s awarded $113 million for the implementation of programs tailored to ending the HIV epidemic in America by 32 state, local, and territorial health departments and 8 STD prevention training centers across the United States supporting the federal initiative Ending the HIV Epidemic: A Plan for America (EHE). As this represents new funding to support EHE, many stakeholders inside and outside of CDC are invested and interested in the programs and their outcomes.

PERFORMANCE METRICS USED & JUSTIFICATIONS:

Based on information provided in their applications and additional consultation with recipients, CDC developed a set of novel cross-jurisdiction and jurisdiction-specific performance measures to monitor progress in achieving the stated goals. Some measures are shared across all three funding streams, and some are unique to each (see measures below).

All measures would be reported in aggregate to CDC by the recipients, twice a year, on a similar time frame. Twice a year data reporting is needed for CDC to identify program performance issues that might result in costly program inefficiencies and provide timely assistance to recipients being funded to end the HIV epidemic. Additionally, because these are high profile EHE NOFOs, more frequent reporting is expected to an expanded set of stakeholders within CDC and outside of CDC who are interested in monitoring progress.

PS20-2010 Component A proposes a set of strategies to achieve four overarching goals (1) Diagnose all people with HIV as early as possible after infection, (2) Treat the infection rapidly and effectively to achieve sustained viral suppression, (3) Prevent new HIV transmissions by using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs), and (4) Respond quickly to potential HIV outbreaks to get needed prevention and treatment services to people who need them.

PS20-2010 Component C and PS20-2004 Part A1 also propose a set of strategies to achieve two goals that are in line with and support the goals of PS20-2010 Component A: (1) Increase the capacity of STD specialty clinics to provide culturally sensitive HIV preventive clinical services and linkage to care, and (2) Increase the number of STD specialty clinics providing PrEP.

Although all three programs require a set of strategies to successfully achieve the stated goals, it is with an understanding that local public health must be responsive to local circumstances. Thus, in response to each strategy, CDC strongly encourages applicants to propose disruptively innovative activities unique to their jurisdiction's local context.

PS20-2010 Component A Measures

There are a total of 24 PS20-2010 Component A performance measures for health departments, of which 20 are required and 4 optional. These measures have been developed with input from PS20-2010 recipients through a series of webinars. Data collection approval for both required and optional is being requested in this GenIC (See attachment 1)

Of these 24 measures, 20 are required and measure recipient progress for prevention activities not currently collected by existing OMB approvals in the following domains 1) HIV Testing (conducting routine, opt-out HIV testing in prioritized health care facilities and in prioritized jails and correctional facilities, conducting HIV testing in prioritized non-traditional venues (e.g., retail locations, pharmacies), and HIV testing through the distribution of HIV self-test kits); 2) Pre-exposure Prophylaxis or PrEP (screened, eligible, referred, linked and prescribed PrEP); 3) Syringe Services Program or SSP (screened, referred, linked to a SSP, number of SSPs, number of SSP encounters, and referral to key SSP services).

The remaining 4 measures are optional, as they are only reported by recipients who elect to implement the following activities 1) Integrated Services (screening for HIV with viral hepatitis/TB/STD screening); 2) Linkage to a TelePreP provider; 3) Navigator Assistance (receipt of navigator assistance for HIV/STD Screenings/PrEP/SSP); and 4) Social Marketing Campaigns (impressions overall and by priority group).

Where appropriate, the aggregated data will be reported stratified by the variables age, gender, race and Hispanic origin, population group, and test setting. Although the respondents (i.e., health departments and prevention training centers) are collecting data at a client level for these variables, they will be reporting to CDC on a smaller number of categories that reduces the potential for small cell sizes that could identify an individual client. Race and ethnicity are to be collected at the local level in accordance with OMB standards (https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf). Hispanic or Latino persons can be of any race. (See Attachment 2)

PS20-2010 Component C and PS20-2004 Part A1 Measures

There are a total of 13 required PS20-2010 Component C and PS20-2004 Part A1 performance measures for STD clinics funded by Health Departments and Prevention training Centers. (See Attachment 2).

Of the 13 measures, 7 are a direct subset of the performance measures from PS20-2010 Component A. Specifically, these include the measures related to 1) HIV Testing in prioritized health care settings and 2) PrEP. Although the measures are identical, the data source or agency is different. Component A will potentially include many health care settings and other STD specialty care clinics not included in Component C or PS20-2004 Part A1. Through these performance measures, CDC would receive information about the specific STD clinics receiving support through those STD clinic-focused initiatives.

The remaining 6 measures focus of the STD specialty care clinic initiatives on increasing clinic capacity. Of these 6 measures, 2 are additional patient outcome measures and 4 are about clinic capacity.

Where appropriate, the aggregated data will be reported stratified by the variables age, gender, race and Hispanic origin, population group, and test setting. Although the respondents (i.e., health departments and prevention training centers) are collecting data at a client level for these variables, they will be reporting to CDC on a smaller number of categories that reduces the potential for small cell sizes that could identify an individual client. Race and ethnicity are to be collected at the local level in accordance with OMB standards (https://www.govinfo.gov/content/pkg/FR-1997-10-30/pdf/97-28653.pdf). Hispanic or Latino persons can be of any race. (See Attachment 2)

Related work

The performance measures to be reported under this GenIC were developed to assess the outcomes of innovative activities not currently approved under an existing OMB. These measures are unique to PS20-2010 and PS20-2004 funding in that they measure aggregate HIV prevention activities and services for all persons at a facility (not just those receiving a CDC-funded service), thus allowing for a broader assessment of jurisdictional EHE processes and outcomes.

Minimizing the burden of this data request was an active consideration throughout the process of identifying performance measures for this cooperative agreement. To minimize recipient data collection and reporting burden, DHAP and DSTDP collaborated on the technical specifications and reporting for these measures.

CDC also minimized the scope of this data collection by identifying other ways to obtain data to monitor program performance. Whenever possible, CDC will use program data covered under existing OMB approved collections. However, modification of these systems to report this information request would be costly and would result in delayed performance monitoring.

Current OMB approved collections

National HIV Surveillance System (NHSS) (OMB 0920-0573, expiration date 11/30/2022)

NHSS data are used to measure intermediate and long-term HIV outcomes (e.g., increased viral suppression, reduced new HIV diagnoses) at the county, state, and national level. Data are reported to CDC by health departments through the Enhanced HIV/AIDS Reporting System (eHARS), which is a browser-based, CDC-developed application to report data on persons with diagnosed HIV.

1. National Notifiable Disease Surveillance System (NNDSS) (OMB No. 0920-0728, expiration date 4/30/2023)

The National Notifiable Disease Surveillance System (NNDSS) is used at the state, territorial, federal, and international to share health information to monitor, control, and prevent the occurrence and spread of state-reportable and nationally notifiable infectious and some noninfectious diseases and conditions. NNDSS data are used to measure STD outcomes on four nationally notifiable STDs (i.e., chlamydia, gonorrhea, syphilis, and chancroid).

2. National HIV Prevention Program Monitoring and Evaluation (NHM&E) (OMB 0920-0696, expiration date 10/31/2021)

NHM&E data are used to measure CDC-funded HIV testing activity and HIV partner services program performance by CDC-funded health departments and community-based organizations. Data are reported at the test- or client-level to CDC using a contracted web-based data collection and reporting system.

3. 4) Enhanced STD Surveillance Network or SSuN (OMB 0920-1072, expiration date 10/31/2023).

SSuN data contain medical record data to measure STD care and treatment outcomes among STD clinic populations. For a subset of recipients, SSuN can be used as a mechanism to report some of the indicators covered in this GenIC. However, we are requesting separate reporting due to differences in the purpose and type of data being collected through SSun and this GenIC.

This PPEO Generic IC matches the intent of this ICR by being directly related to performance measurement for CDC cooperative agreements, to cover twice yearly submission of select, aggregate data points from recipients to CDC for performance measurement purposes. In this way, the data collection templates are fully in alignment with this Generic IC, in terms of the intent, format, type, and level of data to be collected.

CERTIFICATION:

I certify the following to be true:

1. The collection is non-controversial and does not raise issues of concern to other federal agencies.

2. Information gathered is meant primarily for program improvement and accountability; it is not intended to be used as the principal basis for policy decisions

Name: ________________________________________________

To assist review, please answer the following questions:

ANNUALIZED BURDEN HOURS

This table calculates the total estimated burden per year for all recipients.

Type of Respondents	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Health Departments	HIV EHE Performance Measures Data Collection Tool: Component A sections	32	2	30	1,920
Health Departments	EHE Performance Measures Data Collection Tool: STD specialty clinics sections	21	2	10	420
Prevention Training Centers	EHE Performance Measures Data Collection Tool: STD specialty clinics sections	8	2	20	320
Totals		Total Annualized Responses	122	Total Burden Hours	2,660

TOTAL BURDEN HOURS FOR THIS GENIC

This table specifies the calendar years in which information will be collected and calculates the total burden hours requested over the approved timeframe of the generic.

Data Collection Timeframe (List up to 3 Years)	No. Years Requested	Annualized Burden Hours	Total Burden Hours for this GENIC
2023, 2024, 2025	3	2,660	7,980

See examples provided with this template.

The Health Department HIV or STD Program Staff will complete the respective Data Collection Tools. The average hourly wage for an HIV or STD Program Staff is based on the US Bureau of Labor Statistics job category for Epidemiologist (code 19-1041), with a mean hourly wage of $37.64 as of November 2020 (website last checked on 11/30/2020 https://www.bls.gov/oes/current/oes_nat.htm#19-0000). The total estimated annualized burden cost is $100,122.40.

FEDERAL COST: The estimated annual cost to the Federal government is $192,234.00

The cost is based on providing technical assistance to jurisdictions on the Data Collection Tools and review, analysis, and reporting of the submitted data by four (4) GS-13, Step 1 staff (Division of HIV/AIDS Prevention (2); Division of STD Prevention (2)) at .50 FTE. GS-13, Step 1 annual salary is $96,117 (https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2020/ATL.pdf). $96,117 x 0.50 = $48,058.50 x 4 = $192,234.00

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based

[ X ] Email

[ ] Postal Mail

[ ] Other, Explain

Please make sure all instruments, instructions, and scripts are submitted with the request.

List of Recipients

PS20-2010 Recipients (*indicates currently funded for Component C (n=7))

1. Alabama Department of Health*

2. Arizona Department of Health*

3. Arkansas Department of Health

4. Baltimore City Health Department

5. California Department of Public Health

6. Chicago Department of Health

7. District of Columbia Department of Health*

8. Florida Department of Health

9. Georgia Department of Public Health

10. Houston Dept of Health and Human Services

11. Indiana State Department of Health

12. Kentucky State Cabinet for Health

13. Los Angeles County Department of Public Health

14. Louisiana Department of Health

15. Massachusetts Department of Public Health

16. Maryland Department of Health*

17. Michigan Dept. of Health and Human Services

18. Mississippi State Department of Health

19. Missouri Department of Health*

20. Nevada Department of Health

21. New Jersey Department of Health

22. New York City Dept. of Health & Mental Hygiene

23. North Carolina Department of Health

24. Ohio Department of Health

25. Oklahoma State Department of Health

26. Philadelphia Department of Health*

27. Puerto Rico Department of Health

28. San Francisco Department of Public Health*

29. South Carolina Department of Health and Environmental Control

30. Tennessee Department of Health

31. Texas Department of State Health Services

32. Washington State Department of Health

PS20-2004 Recipient Training Centers

1. Columbia University

2. Johns Hopkins University

3. University of Alabama

4. University of California, San Francisco

5. University of Washington

6. Washington University, St. Louis

7. Denver Public Health

8. Massachusetts Department of Public Health

Instructions for completing genIC Request for Approval for

Performance Measurements Project

Project Title: Provide the name of the collection that is requested.

PURPOSE AND USE OF COLLECTION: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

NUMBER AND TITLE OF NOFO: Provide federal grant or other identifying number and title

NUMBER OF PARTICIPATING RECIPIENTS: Enter number of recipient organizations

DESCRIPTION OF NOFO: Briefly describe the key programmatic activities and the targeted group/groups for this collection.

PERFORMANCE METRICS USED & JUSTIFICATIONS: Describe the changes to the sample forms and justifications for metrics selected

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

COMPLETING THE TABLE: ANNUALIZED RESPONSES AND BURDEN HOURS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households; (2) Private Sector; (3) State, local, or tribal governments; (4) Federal Government or Non-Governmental Organizations. Only one type of respondent can be selected.

Form Name: Provide the title of the information collection form.

No. of Respondents: Provide an estimate of the Number of respondents i.e., the number of recipients that will complete the form.

Burden per Response: Provide an estimate of the amount of time required for a respondent to complete the form one time. If burden can be expressed in whole hours, enter an integer value. If burden can not be expressed in whole hours, express as minutes using the following notation: “[xx] / 60”.

Example: Enter “10” to signify “10 hours”.

Enter “320/60” to signify “320 minutes” which is equivalent to “5 hours and 20 minutes.”

Number of Responses per Respondent: The number of times a respondent will complete the form in one year (1= annual; 2=semi-annual; 4=quarterly; 12-monthly).

Total (Annualized) Burden Hours: Multiply straight across the row and round to the nearest integer.

COMPLETING THE TABLE: TOTAL BURDEN FOR THIS GENIC

Data Collection Timeframe: List (specify) the years in which data will be collected.

Number of Years: Enter the number of years (1, 2, or 3).

Annualized Burden Hours: Enter the Total Annualized Burden Hours from the preceding table.

Total Burden Hours for this GENIC: Multiply the Number of Years times the Annualized Burden Hours.

FEDERAL COST: Estimate the annual cost to the Federal government for this collection.

Administration of the Instrument: Identify how the information will be collected. More than one box may be checked.

*Note to applicants- please delete the instructions page upon completion of this template

EXAMPLE 1

ANNUALIZED BURDEN HOURS

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Avg. Burden Per Response	Total Burden (in Hours)
States	Standard Annual Reporting Form for CAT A and CAT B	50	1	30	1,500
States	Supplemental Form for CAT B Recipients	10	1	2	20
Totals					1,520

TOTAL BURDEN HOURS FOR THIS GENIC

Data Collection Timeframe (List up to 3 Years)	No. Years Requested	Annualized Burden Hours	Total Burden Hours for this GENIC
2023, 2024, 2025	3	1,520	4,560

EXAMPLE 2

ANNUALIZED BURDEN HOURS

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Avg. Burden Per Response	Total Burden (in Hours)
States	Standard Annual Reporting Form	50	1	25	1,250
States	Quarterly Report	50	4	1	200
Totals					1,450

TOTAL BURDEN HOURS FOR THIS GENIC

Data Collection Timeframe (List up to 3 Years)	No. Years Requested	Annualized Burden Hours	Total Burden Hours for this GENIC
2024, 2025	2	1,450	2,900

EXAMPLE 3

ANNUALIZED BURDEN HOURS

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Avg. Burden Per Response	Total Burden (in Hours)
States	Performance Monitoring Report	30	1	615/60	308
Totals					308

TOTAL BURDEN HOURS FOR THIS GENIC

Data Collection Timeframe (List up to 3 Years)	No. Years Requested	Annualized Burden Hours	Total Burden Hours for this GENIC
2025	1	308	308

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