Change Request

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Change Request Memo

Performance Measurement for STD PCHD (2026-2028)
(OMB No. 0920-1282; Exp. 06/30/2026)

Request Type: Change Request

Requested Change: Addition of a Congenital Syphilis (CS) Supplement Addendum to the previously approved Performance Measurement for STD PCHD data collection, applicable only to recipients of CS supplement funding, resulting in an increase in estimated burden for supplement recipients of no more than 3 hours per respondent totaling an additional 177 annualized burden hours.

Summary: NCHHSTP/Division of STD Prevention requests a Revision of the above-named data collection to add a CS Supplement Addendum comprised of a CS Supplement Performance Measure Data Collection Tool (Attachment 4) and CS Supplement Performance Measure Technical Specifications and Reporting Reference Guide (Attachment 5). The CS Addendum will be completed only by the subset of existing STD PCHD cooperative agreement recipients funded by the CS Supplement under CDC-RFA-PS19-1901. The CS Supplement Addendum collects aggregate programmatic data across five domains: (1) POCT and medication procurement, (2) test utilization by population and venue, (3) POCT results and confirmatory testing, (4) clinical outcomes, and (5) data quality and limitations. Data will be collected once and at the end of the supplement budget period (July 31, 2026 – February 28, 2027), with finalized data reported to CDC no later than May 31, 2027.

This Revision increases the burden estimate for supplement recipients only. All other aspects of the previously approved STD PCHD data collection — including respondent population, data collection methodology, frequency, privacy and confidentiality protections, and data security — remain unchanged for non-supplement recipients.

Attachments
    • Attachment 4: CS Supplement Performance Measure Data Collection Tool
    • Attachment 5: CS Supplement Performance Measure Technical Specifications and Reporting Reference Guide 
    • PPEO GenIC Template_PS19-1901 STD PCHD _TrackedRevision
    • PPEO GenIC Template_PS19-1901 STD PCHD_CleanRevision

Background and Justification
Congenital syphilis (CS) cases have increased markedly over the last decade, with nearly 4,000 cases reported in 2024. This increase is driven by surging syphilis rates among women of childbearing age and by inadequate or absent testing and treatment during pregnancy. When untreated, syphilis causes serious adult sequelae and tragic pregnancy outcomes including stillbirth, infant death, and severe lifelong medical conditions.

In response, current HHS senior leadership directed CDC to promptly supplement PS19-1901 with up to $3,250,000 to provide eligible STD PCHD recipients with resources to purchase and deploy syphilis point-of-care tests (POCTs) and treatment medications in high-burden community settings. The supplement budget period is July 1, 2026 – February 28, 2027. Funded activities are organized across three allowable domains: (1) Testing — purchase of POCT kits and ancillary supplies; (2) Treatment — purchase of syphilis treatment medications; and (3) Programmatic activities — support for partners to implement testing and treatment in non-clinical community venues such as emergency departments, shelters, correctional settings, substance use programs, community health centers, and mobile health units.

The addition of the CS Supplement Addendum to the existing STD PCHD data collection is necessary to ensure adequate performance monitoring, accountability, and program evaluation for this HHS-directed investment. The addendum enhances CDC's ability to assess the reach and effectiveness of supplement-funded activities, monitor progress toward CS prevention objectives, and generate aggregate findings to inform future CS-related funding and policy decisions. The type and level of data collected remain consistent with the existing scope and intent of the PPEO Generic IC and the approved STD PCHD data collection: aggregate, programmatic data at the recipient level, with no PII submitted to or accepted by CDC.

Effect of Proposed Changes on Currently Approved Instruments
    • Addition of CS Supplement Addendum instruments applicable only to CS supplement recipients 
        ◦ Attachment 4: CS Supplement Performance Measure Data Collection Tool
        ◦ Attachment 5: CS Supplement Performance Measure Technical Specification and Reporting Reference Guide
    • Increase in reporting burden for CS Supplement Addendum respondents only 
    • No change to data collection methodology, frequency, or systems for non-supplement recipients 
    • No change to respondent population for the base STD PCHD data collection 
    • No change to privacy, confidentiality, or data security protections 
    • No changes to the structure, purpose, or currently approved instruments of the existing STD PCHD performance measures data collection

Form
Current Question/Item
Requested Change
CS Supplement Addendum
N/A – new procurement section for supplement recipients only
cs_1 Number of POCT syphilis tests purchased; cs_2 Number of other (non-POCT) syphilis tests purchased; cs_3 Amount of syphilis treatment medications purchased; cs_3a (Text) Describe unit of measure for cs_3 (e.g., # BPG injections, # Doxycycline treatment packs)
CS Supplement Addendum
N/A – new test utilization section for supplement recipients only
cs_4: 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 POCT vs. other syphilis tests used. cs_4a: POCT used, by venue type: Emergency department/urgent care; Labor & delivery/OB-GYN setting; STD specialty clinic; Family planning/reproductive health clinic; FQHC; Community-based organization (CBO); Correctional facility; Mobile or field-based testing site; Other (describe in cs_10).
CS Supplement Addendum
N/A – new POCT results and confirmatory testing section for supplement recipients only
cs_5 Number of positive/reactive results from supplement-funded POCT; cs_5a Of those: number for whom confirmatory serologic testing was initiated; cs_5b Of those: number with confirmatory result also positive/reactive; cs_5c Of those: number with confirmatory result negative/non-reactive; cs_5d Of those: number with no confirmatory testing documented; cs_5e (Calculated) Concordance rate: cs_5b ÷ cs_5a
CS Supplement Addendum
N/A – new clinical outcomes section for supplement recipients only
cs_7 Number of women newly diagnosed with syphilis via supplement-funded POCT; cs_7a Of those: number pregnant at time of diagnosis; cs_7b Of those: number of reproductive age (15–44), not known to be pregnant; cs_8 Of those (cs_7): number completely and correctly treated for syphilis; cs_8a Of those: number treated with BPG; cs_8b Of those: number treated with Doxycycline; cs_8c Of those: number treated within 14 days of specimen collection
CS Supplement Addendum
N/A – new data quality and limitations section for supplement recipients only
cs_9 Overall data quality (Excellent / Good / Fair / Poor); cs_10 Data limitations, including attribution gaps, missing confirmatory results, venue data gaps, linkage failures between POCT positives and surveillance records, period-alignment issues (text); cs_11 Did the project area use a subgrantee or contracted partner for supplement-funded POCT? (Yes / No); cs_12 If yes (cs_11): subgrantee name(s) and venue(s) (text); cs_13 Supplement period (start – end date); cs_14 Months during which POCT activities were actively underway (whole number)


Effect on Burden Estimate

Form
Approved Burden
Requested Burden
STD PCHD Performance Measures Data Collection Tool 
(Att 1 original submission)
30 hours per respondent
Total: 1,770 annualized burden hours
No change
CS Supplement Performance Measures Data Collection Tool (Attachment 4)
N/A
3 hours per respondent
Total: 177 annualized burden hours
TOTAL
1,770 hours
1,947 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 (Att 1 original submission) 
50
1
30
1500
Local health departments
STD PCHD Performance Measures Data Collection Tool (Att 1 Original Submission)
7
1
30
210
Territorial health departments
STD PCHD Performance Measures Data Collection Tool (Att 1 Original Submission)
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. 


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