DOCUMENTATION FOR THE GENERIC CLEARANCE

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Request for genIC Approval 
Performance Measures Project
OMB Control Number 0920-1282
CIO:  NCHHSTP/Division of STD Prevention
PROJECT TITLE:  Performance Measurement for STD PCHD (2026-2028)
PURPOSE AND USE OF COLLECTION:  The goal of this project is to guide performance measurement efforts among the 59 health departments that receive funding from CDC to conduct STD surveillance, prevention and control through cooperative agreement PS19-1901. The purpose is to assess recipients’ individual and collective progress towards the larger aims of 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 rapidly generate reports that compare and contrast recipients’ progress. Findings will be disseminated to all STD PCHD recipients and key CDC staff working to support these recipients, in order to stimulate discussion of areas for program improvement and technical assistance.
The Congenital Syphilis (CS) Supplement Addendum applies only to the subset of STD PCHD recipients that receive the CS supplement funded under CDC-RFA-PS19-1901. The addendum collects aggregate, programmatic data on point-of-care testing (POCT) procurement and utilization, clinical outcomes, and data quality for the supplement budget period of July 1, 2026 – February 28, 2027. No personally identifiable information (PII) is collected or submitted to CDC; all data are reported in the aggregate.
NUMBER AND TITLE OF NOFO:  PS19-1901 Sexually Transmitted Diseases Prevention and Control for Health Departments (STD PCHD)
NUMBER OF PARTICIPATING RECIPIENTS:  50 state, 7 local, and 2 territorial health departments

DESCRIPTION OF NOFO (check all that apply):
_X_	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 PS19-1901 STD PCHD, the Division of STD Prevention awards nearly $100,000,000 annually for comprehensive STD surveillance, prevention, and control to 59 state, local, and territorial entities. As DSTDP’s flagship cooperative agreement, many stakeholders inside and outside of DSTDP are invested and interested in the program and its outcomes. The time-limited Congenital Syphilis (CS) Supplement to PS19-1901 provides up to $3,250,000 to eligible recipients to purchase and deploy syphilis point-of-care tests (POCTs) and treatment medications in high-burden community settings. Congenital syphilis cases have increased markedly over the last decade, with nearly 4,000 cases reported in 2024, driven by surging syphilis rates among women of childbearing age and inadequate testing and treatment during pregnancy. The CS supplement represents a targeted, one-time investment directed by HHS leadership to address this public health emergency. Performance measurement for the supplement is a critical accountability mechanism and will inform future CS-related funding decisions.
PERFORMANCE METRICS USED & JUSTIFICATIONS:
Health departments play a critical role in addressing sexually transmitted disease (STD) prevention and control and are well-positioned to monitor local trends in STDs through case-based surveillance and to respond to emerging threats and outbreaks. Health department STD programs also have the authority and skills to conduct disease investigation activities including partner services, an effective intervention to prevent STD transmission in some populations. Given that most STDs are diagnosed outside of public STD clinics, health departments must also work with primary care and other health care providers and organizations to promote the delivery of recommended, evidence-based STD screening, timely treatment, and other prevention services.  
Federal support for state, local, and territorial health departments to carry out these functions has been in place for decades and remains a critical source of funding to monitor and fight STDs across the US. The STD PCHD cooperative agreement is the latest iteration of this support, covering the 7-year period 2019-2025. In 2019, approximately $92.5 million dollars were awarded by CDC to 59 state, local, and territorial health departments to carry out a focused scope of work that reflects the core public health functions of assessment, assurance, and policy and aligns with STD epidemiology and best practices. CDC supports these health department recipients to:
    • Conduct STD surveillance
    • Respond to STD-related outbreak
    • Identify persons with STDs and link them and their partners to care and to treatment through targeted disease investigation and intervention
    • Promote CDC-recommended screening, diagnosis, and treatment practices among relevant providers
    • Disseminate local data and information to the health care community and public; monitor and develop STD-related policy
    • Develop and strengthen multi-sector partnerships to support STD prevention and control
    • Support HIV prevention goals and collaborate with health department HIV programs; and 
    • Analyze and use data for increased program insights and program improvement.
STD PCHD explicitly emphasizes three Strategy Areas: Surveillance (Strategy Area I), Disease investigation and intervention (Strategy Area II), and the Promotion of CDC-Recommended Screening, Diagnosis, and Treatment (Strategy Area III).
CDC requests OMB approval to collect aggregate data from the recipients of cooperative agreement PS19-1901 STD PCHD. Recipients will report progress on a select set of performance measures on an annual basis. Information will be transmitted electronically to a designated contact person at CDC and through the federal system (GrantSolutions) that houses official communication between CDC and cooperative agreement recipients. 
It is important to collect performance measures now because recipients are currently implementing strategies under the cooperative agreement. The information can only be used to direct program improvement if it is collected concurrently with implementation.  CDC developed a Microsoft Excel-based Data Collection Tool (Attachment 1) to document progress toward the intended outcomes of the STD PCHD cooperative agreement in line with the strategies, activities, and outputs encompassed under STD PCHD. CDC’s performance measurements include both process and outcome measures and are consistent with the logic model and approach specified in the STD PCHD cooperative agreement. 
Each worksheet supplies performance measure data related to STD PCHD’s overarching goals for improved 1) surveillance, 2) disease intervention and investigation, and 3) uptake of CDC-recommendations for screening, diagnosis, and treatment for STD prevention. Relevant expected outcomes include improved completion and timeliness of public health surveillance data on reportable STDs, increased treatment of reported syphilis cases and their partners, increased identification of persons living with HIV, increased screening and diagnosis of STDs, and increased use of recommended, timely treatment for syphilis and for gonorrhea. 
Specifically, the Data Collection Tool (Attachment 1) is comprised of a cover page and 7 data entry worksheets:
    • Pregnancy Ascertainment.  Items in this worksheet are used to obtain information on the timeliness of pregnancy ascertainment for female syphilis cases, which is essential to timely public health follow-up to prevent congenital syphilis.
    • Congenital Syphilis.  Items in this worksheet are used to estimate the number of potential cases averted through interventions in mother-to-child transmission. Congenital syphilis has been increasing markedly, and this information provides additional context on prevention efforts not obtained through congenital syphilis surveillance.
    • Outbreak Response. Items in this worksheet record activations of the STD outbreak response plan and estimate the personnel contributions that STD programs make towards STD and other (non-STD) outbreaks that these health departments respond to. Outbreak response is a high priority for all health departments, and STD program staff often are asked to assist with non-STD outbreaks.  These measures help capture this work and service. 
    • Early Syphilis Cases: Disease Investigation and Intervention. Items in this worksheet record standard disease investigation and intervention metrics for four key subpopulations: pregnant women, other women of reproductive age, men who have sex with women, and men who have sex with men (or men and women).  Disease investigation and intervention is a core prevention and control strategy for syphilis, and significant resources are devoted to it in most health departments. These measures capture key outcomes associated with that work, including how priority medical practices in each jurisdiction offer DoxyPEP and their successes and challenges in patient uptake. 
    • STD-related HIV prevention in Disease Investigation. Items in this worksheet record select, high priority HIV-related outcomes that are routinely addressed in the course of syphilis disease investigation:  new HIV diagnoses, linkage to care for people with HIV, and referral to PrEP (pre-exposure prophylaxis for HIV), for the four subpopulations outlined above.  These items are intended to assess key aspects of STD programs’ contributions to HIV prevention, a national priority.
    • Treatment. Items in this worksheet record the extent of timely, recommended treatment of reported cases for syphilis and gonorrhea. Assurance of appropriate treatment is a core function of health departments.
    • Dashboard. This worksheet auto populates with data visuals from the data entered on the previous worksheets. Recipients are not asked to enter any additional information. The purpose of this worksheet is to provide each recipient an instant visual on each of their performance measures that they can use in their own reporting and documentation. 
    • Feedback. These questions request feedback on the data collection tool and dashboard. Recipients can voluntarily provide this information and share their input on whether the data quality checks were helpful and if the dashboard was useful. 
The CS Supplement Addendum is applicable only to recipients awarded the CS supplement and covers the supplement budget period of July 1, 2026 – February 28, 2027, with data to be reported to CDC no later than May 31, 2027. CDC developed a standalone CS Supplement Performance Measure Data Collection Tool (Attachment 4) to document progress toward the intended outcomes of the supplement.
The CS Supplement Addendum is organized into five sections:
    1. Procurement — Number of POCT syphilis tests purchased (cs_1), number of other syphilis tests purchased (cs_2), amount and type of syphilis treatment medications purchased (cs_3, cs_3a).
    2. Test Utilization — Number of supplement-purchased syphilis tests used during the reporting period, disaggregated by population (total clients, women of reproductive age 15–44, pregnant women) and by venue type (cs_4, cs_4a), including emergency departments, labor and delivery/OB-GYN settings, STD specialty clinics, family planning/reproductive health clinics, FQHCs, community-based organizations, correctional facilities, mobile or field-based testing sites, and other.
    3. POCT Results and Confirmatory Testing — Number of positive/reactive POCT results; number for whom confirmatory serologic testing was initiated; confirmatory results (positive, negative); number with no confirmatory testing documented; and calculated concordance rate (cs_5 through cs_5e).
    4. Clinical Outcomes — Number of women newly diagnosed with syphilis via supplement-funded POCT, disaggregated by pregnancy status; number completely and correctly treated; treatment type (BPG, Doxycycline); and timeliness of treatment (within 14 days of specimen collection) (cs_7 through cs_8c).
    5. Data Quality and Limitations — Overall data quality rating; description of data limitations (attribution gaps, missing confirmatory results, venue data gaps, linkage failures, period-alignment issues); subgrantee/contracted partner use; supplement period dates; and months during which POCT activities were actively underway (cs_9 through cs_14).
All data submitted to CDC under the CS Supplement Addendum are reported exclusively in the aggregate. No PII is submitted to or accepted by CDC. Individually identifiable testing and treatment records are retained solely by the recipient jurisdiction in accordance with applicable federal, state, and local confidentiality requirements.
It is important to collect these performance measures concurrently with implementation so that data can be used to direct program improvement, assess supplement reach and effectiveness, and inform future CS-related investment and policy decisions. 
CDC minimized the scope of this data collection by identifying other ways to obtain desired data. For example, the current information collection includes relatively few measures related to surveillance, because CDC will use the STD surveillance data already submitted by recipients to assess surveillance data quality and completeness (see OMB No. 0920-0728 National Notifiable Disease Surveillance System). CDC also reviewed other information collections that affect many STD PCHD recipients to determine the need for new data collection (see OMB No. 0920-1072 Enhanced STD Surveillance Network; OMB No. 0920-0573 National HIV Surveillance System; OMB No. 0920-0696 National HIV Prevention Program Monitoring and Evaluation). Further, CDC minimized the scope of this data collection by limiting the CS Supplement Addendum to aggregate programmatic and expenditure data directly tied to supplement activities and outcomes. No new individually identifiable data are collected by or submitted to CDC.
Finally, this PPEO Generic IC matches the intent of this ICR by being directly related to performance measurement for a CDC cooperative agreement, to cover regular (in this case, annual) submission of select, aggregate data points from recipients to CDC for performance measurement purposes.  The data collection template for this STD submission – while different in some ways from the template provided in the PPEO Generic IC – is also fully in alignment with this Generic IC, in terms of the format, type, and level of data to be collected.  The STD program and PPEO had prior discussions about the potential fit of the STD program’s proposed performance measurement template and the ICR in general and concluded that it seemed appropriate for this mechanism.
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: _____Lindsey Evans (6/15/2026)

To assist review, please answer the following questions:
BURDEN HOURS 
Type of Respondents
Form Name
No. of Respondents
No. Responses per Respondent
Average Burden per Response (in hours)
Total Burden
Hours
State health departments
STD PCHD Performance Measures Data Collection Tool (Attachment 1) 
50
1
30
1500
Local health departments
STD PCHD Performance Measures Data Collection Tool (Attachment 1)
7
1
30
210
Territorial health departments
STD PCHD Performance Measures Data Collection Tool (Attachment 1)
2
1
30
60
State health departments
CS Supplement Performance Measures Data Collection Tool (Attachment 4) 
50
1
3
150
Local health departments
CS Supplement  Performance Measures Data Collection Tool (Attachment 4)
7
1
3
21
Territorial health departments
CS Supplement Performance Measures Data Collection Tool (Attachment 4)
2
1
3
6
Total




1,947

RESPONDENT COST BURDEN
The STD Program Manager at each site will complete the Data Collection Tool. The average hourly wage for an STD Program Manager is based on the US Bureau of Labor Statistics job category for Epidemiologist (code 19-1041), with a mean hourly wage of $44.47 as of May 2024. A wage rate multiplier has been applied to ensure the value represents a fully loaded respondent cost burden that accounts for all applicable costs, such as benefits, overheads, and fringes.  


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
2026, 2027, 2028
3
1,947
5,841

FEDERAL COST:  The estimated annual cost to the Federal government is   ___$216,516.56__
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 three personnel: one GS-13, Step 5 staff at 37.5% time effort (annual salary: $126,302); one GS-13, Step 4 staff at 37.5% time effort staff (annual salary: $122,587); and one GS-14, Step 5 staff at 10% (annual salary: $149,249) Pay & Leave : Salaries & Wages - OPM.gov. A wage rate multiplier has been applied to ensure the value represents a fully loaded federal cost that accounts for all applicable costs, such as benefits, overheads, and fringes. 
Total: [$47,363.25  2] + [$45,970.13  2] + [$14,924.90  2] = $216,516.56

Administration of the Instrument
    1. How will you collect the information? (Check all that apply)
[X] Web-based 
[X] Email
[  ] Postal Mail 
[  ] Other, Explain

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