Supporting Statement A FPAR 2.0_revised_clean 2.28.25

Supporting Statement
Family Planning Annual Report 2.0

Submitted to

Office of Management and Budget
Office of Information and Regulatory Affairs

Submitted by

Department of Health and Human Services
Office of the Assistant Secretary for Health
Office of Population Affairs
POC: Jamie Kim

Jamie.Kim@hhs.gov

01/06/2025

Supporting Statement
Family Planning Annual Report 2.0

Contents

A. JUSTIFICATION 1

1. Circumstances Making the Collection of Information Necessary 1

2. Purpose and Use of Information Collection 2

3. Use of Improved Information Technology (IT) and Burden Reduction 8

4. Efforts to Identify Duplication and Use of Similar Information 9

5. Impact on Small Businesses or Other Small Entities 10

6. Consequences of Not Collecting the Information or Less Frequent Collection 10

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 10

8. Comments in Response to the Federal Register Notice/Outside Consultation 10

9. Explanation of Any Payment/Gift to Respondents 11

10. Assurance of Confidentiality Provided to Respondents 11

11. Justification for Sensitive Questions 11

12. Estimates of Annualized Burden Hours (Total Hours and Wages) 12

13. Estimates of other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs 14

14. Annualized Cost to Federal Government 14

15. Explanation for Program Changes or Adjustments 15

16. Plans for Tabulation and Publication and Project Time Schedule 15

17. Reason(s) Display of OMB Expiration Date Is Inappropriate 16

18. Exceptions to Certification for Paperwork Reduction Act Submissions 17

B. DATA COLLECTION PROCEDURES: FPAR Data System 17

C. REFERENCES 18

EXHIBITS

Exhibit 1–Goals for the Title X Family Planning Program 3

Exhibit 2–List of Individuals who Provided Extensive Review and Feedback on FPAR 2.0 10

Exhibit 3–Estimated Hour Burden 13

Exhibit 4–Estimated Annualized Cost to Respondents for Information Collection 14

Exhibit 5–Annualized Cost of FPAR Reporting to Federal Government 14

Exhibit 6–Timetable for Data Collection, Analysis, and Publication 16

ATTACHMENTS

A. Authorizing Title X Program Regulations A–1

B. 2024 FPAR 2.0 Data Elements with Valid Values B–1

C. 60–Day Federal Register Notice C–1

Supporting Statement
Family Planning Annual Report 2.0

1. JUSTIFICATION

This is a request for Office of Management and Budget (OMB) approval to renew the encounter level data collection for the Family Planning Annual Report (FPAR). This was previously approved by OMB under OMB No. 0990-0479, expiration February 28, 2025. This annual reporting requirement is for family planning services delivery projects authorized and funded by the Title X Family Planning Program [“Population Research and Voluntary Family Planning Programs” (Public Law 91-572)], which was enacted in 1970 as Title X of the Public Health Service Act of Title X of the Public Health Service Act, 42 United States Code [USC] 300).¹ A renewal for three years is requested.

The HHS Office of Population Affairs’ Title X Family Planning Program is the only federal grant program dedicated solely to providing individuals with comprehensive family planning and related preventive health services. Family planning services delivered by Title X recipients include a broad range of medically approved services, which includes all Food and Drug Administration (FDA)-approved contraceptive products and natural family planning methods for clients who want to prevent pregnancy and space births; pregnancy testing and counseling; assistance to achieve pregnancy; basic infertility services; sexually transmitted infection (STI) services; and other preconception health services. The program is designed to provide access to contraceptive services, supplies, and information to all who want and need them. Title X services are voluntary, confidential, and provided regardless of one’s ability to pay. By law, priority is given to persons from low-income families (42 USC 300a-4).²

In fiscal year 2023, the Title X program received approximately $286.5 million in federal Title X funding. In accordance with the statute and regulations (42 Code of Federal Regulations [CFR] Part 59), at least 90% of the appropriation is used for clinical family planning services.^2,3 In 2023, Title X-funded providers served approximately 2.8 million family planning users (i.e. clients) through 4.3 million family planning encounters. Of the 2.8 million unique users served in 2023, most (60 percent; 1.7 million) clients were under 100% of Federal Poverty Level (FPL) and received free services. An additional 23 percent of users (644,123) reported a family income between 101 to 250 percent of FPL and received discounted services on a sliding fee scale. In 2023, Title X grantees operated in all 50 states, the District of Columbia, and eight U.S territories and freely associated states.⁴

Attachment A to this statement contains a copy of the authorizing Title X program regulations that necessitate the collection of the information; Attachment B is a copy of the current version of the FPAR 2.0 Data Elements with Valid Values (2024 Valid Values) – Jan. 2025. Attachment C is a copy of the 60-Day Federal Register Notice.

1. Circumstances Making the Collection of Information Necessary

Annual submission of the FPAR is required of all Title X Family Planning Services grantees for purposes of monitoring, improving and reporting program performance (45 CFR Part 74 and 45 CFR Part 92).^5-8 In 2022, OPA began transitioning to a new data collection and reporting system for the Title X program, called FPAR 2.0. The FPAR 2.0 data collection built on data already reported in FPAR 1.0 and added additional detail that allows OPA to report to HHS leadership and Congress more completely on the services provided by Title X grantees in their communities. Several of the data elements are related to clinical quality measures developed by OPA and used in CMS mandatory reporting and OPA developed Quality Family Planning guidelines (first released in 2014 and updated with a major revision in 2024).^9,10 Under FPAR 2.0, grantees report fine-grained information on individual encounters between a client and a Title X provider. This detailed information enables OPA to accurately monitor grantees’ performance, service provision, and compliance with legislative mandates.

2. Purpose and Use of Information Collection

The FPAR is the only source of annual, uniform reporting by all grantees (“Title X services grantees”) funded under Section 300 of the Public Health Service Act.¹ The FPAR 2.0 system provides consistent, national-level data on the Title X Family Planning program and its users. OPA assembles and analyzes comparable and relevant program data to answer questions about the characteristics of the population served, the provision and use of services, and the impact of the program on certain family planning outcomes. FPAR 2.0 collects a standard set of data elements pertaining to users and encounters, such as user demographics, service delivery, family planning intentions and methods.

Encounter level data collected through FPAR 2.0 improves the quality of data reported to OPA and reduces reporting burden for grantees. The system automates procedures previously done manually, such as tabulating and checking basic counts of clients served and types of services provided. Additionally, the more granular data collected with FPAR 2.0 contributes to a learning healthcare environment by greatly expanding the options for data analysis and reporting—for example, through interactive data dashboards and visualizations, customized tabulations and reports, and application of analytics and statistical analyses on the encounter-level data files.

Information from FPAR 2.0 is important to OPA for several reasons. First, OPA uses FPAR 2.0 data to monitor program compliance with statutory requirements, regulations, and operational guidance set forth in the Title X Family Planning Guidelines, consisting of the Program Requirements for Title X Funded Family Planning Projects (Title X Requirements) and clinical recommendations as outlined in Providing Quality Family Planning Services (QFP),^7,10which include the following:

• Monitoring compliance with legislative mandates, such as giving priority in the provision of services to low-income persons (42 USC 300a-4)²

• Ensuring that Title X services grantees and their subcontractors provide a broad range of family planning methods and services (42 USC 300)¹

Second, OPA uses FPAR 2.0 data to meet accountability and federal performance requirements for Title X family planning funds as required by the 1993 Government Performance and Results Act. Performance goals for the Title X Family Planning program (see Exhibit 1) include giving priority in the provision of family planning services to low-income individuals, reducing invasive cervical cancer through Pap testing, reducing infertility through chlamydia screening, and increasing program efficiency by monitoring the cost of care.

Exhibit 1–Goals for the Title X Family Planning Program

Measure Number	Measure Title
8000.01	Total number of unduplicated clients served in Title X service sites.
8000.02	Maintain the proportion of clients served who are at or below 250% of the Federal poverty level at 90% of total unduplicated family planning users.
8000.05	Increase the proportion of females ages 15 - 24 attending Title X family planning clinics screened for Chlamydia infection.
8000.07	Percentage of Title X clinic female clients who adopted or who reported using a contraceptive method at their last visit
8000.08	Increase the percentage of Title X clinic clients who are screened for cervical cancer
8000.09	Percentage of clients attending a Title X clinic who are uninsured
8000.11	Increase the proportion of Title X female clients age 15-24 who are screened for gonorrhea
8000.12	Increase the proportion of Title X clients who are screened for syphilis
8000.13	Increase the proportion of Title X clients who are screened for HIV
8000.10	Percentage of Title X sites with telehealth capabilities

Third, OPA relies on FPAR 2.0 data to guide strategic and financial planning, respond to inquiries from policymakers and Congress about the program, and estimate program impact. FPAR 2.0 data provides needed context for objective grant reviews, comprehensive program reviews and evaluation, and assessment of program technical needs. Finally, the data is used for continuous quality improvement at both the program and grantee level to ensure the best quality care is delivered to clients.

FPAR Structure and Content

FPAR 2.0 data include: 1) encounter data, 2) a grantee profile cover sheet, 3) a project revenue report, and 4) utilization of family planning clinical services providers report. These data provide OPA with information on the characteristics of the Title X service network and the individuals (family planning “users” or “clients”) who receive Title X services, including information on clients’ contraceptive use and receipt of related preventive health services. Below, we describe each FPAR 2.0 component and present OPA’s justification for collecting the data. In addition, we explain how OPA will use the data and present illustrative questions, which OPA can help answer with the data.

Encounter-level Data

In this section, we describe the data elements reflected in the user encounter data (Attachment B).

• User demographic data, including age, sex, ethnicity, and race, allows OPA to monitor access to and use of Title X services among the diverse populations these projects serve.

These data permit OPA to answer such questions as:

• How does the age composition of users compare across regions, states, and grantees?

• What is the ethnic or racial composition of female and male clients served by Title X-funded service sites?

• What is the ethnic or racial composition of Title X clients who do not self-identify with one or more of the five minimum OMB race categories?

• How do user ethnic and racial composition compare across regions, states, and grantees?

• Are we providing client-centered care?

User economic and social data allow OPA to monitor the Title X program’s role in supporting the health care safety net for vulnerable individuals who confront financial, social, or cultural barriers to care due to low income, lack of health insurance, or limited English proficiency (LEP). The data collected to monitor these barriers are detailed below.

User Income reported by grantees allow OPA to monitor use of services by low-income individuals, assess compliance with the statutory requirements and regulations regarding priority in the provision of care to low-income persons, and guide funding allocation across regions and grantees. By federal statute 42 USC 300a-4,² programs that receive Title X funding are required to give priority to persons from low-income families, defined as individuals with family incomes of 100% or less of the HHS poverty guidelines (“poverty level”). Program regulations (42 CFR Part 59)³ further specify that persons from low-income families must receive services at no charge, unless a third-party source (e.g., Medicaid, other public or private health insurance) is authorized or obligated to pay the charge, and that Title X service providers must develop and apply a schedule of discounts based on ability to pay for persons with family incomes between 101% and 250% of the poverty level. In 2023, 83% (2.3 million) of users had family incomes that qualified them for either subsidized or no-charge services. The data collected permit OPA to answer such questions as:

• What percentage of Title X clients has family incomes at or below 100% the poverty level, thereby qualifying them for services at no charge?

• What percentage of Title X clients has family incomes between 101% and 250% of the poverty level, thereby qualifying them for services on a sliding fee scale?

User’s Principal Health Insurance Coverage Status is a key indicator of health care access. Insured individuals are more likely than those without insurance to have a usual source of medical care and to receive timely, recommended, and needed health care.^12,13 In 2023, 58% (1.8 million) of family planning users had either public (67%, 2.0 million) or private (23%, 629,969) insurance covering broad primary medical care benefits; 27% (752,034 million) were uninsured. Health insurance coverage status was unknown or not reported for 4% (101,467) of users. In addition to serving as an indicator of health care access, health insurance status has important implications for project financing and sustainability. Identifying clients with health insurance allows providers to seek third-party payment for the full cost of care in accordance with program regulations. Family Planning Title X service providers collect data for OPA to assess patterns and trends in clients’ health insurance status, and identify opportunities and technical assistance needs among grantees and subrecipients. The data collected permit OPA to answer such questions as:

• What percentage of family planning users is insured (i.e., has public or private health insurance covering broad primary medical care)?

• What percentage of family planning users is uninsured (i.e., has no public or private health insurance covering broad primary medical care)?

Limited English Proficiency (LEP) of the client is reported by grantees in compliance with Title VI of the 1964 Civil Rights Act and Title VI regulations¹⁴ that require Title X service providers to ensure meaningful access to LEP clients who seek Title X-funded services. In the Title X setting, LEP users are those clients who do not speak English as their primary language and who have a limited ability to read, write, speak, or understand English. Because of their limited English proficiency, LEP users derive little benefit from Title X family planning services and information provided in English. The federal guidance¹⁴ in addressing the needs of LEP individuals who seek HHS-funded services lists four factors that are the basis for evaluating compliance: (1) the number or proportion of LEP persons eligible to be served or likely to be encountered by the program or grantee, (2) the frequency with which LEP individuals come in contact with the program, (3) the nature and importance of the recipient program activity or service, and (4) the resources available to the recipient and the cost of implementing language assistance measures. The LEP reporting requirement requires that Title X–funded agencies establish mechanisms for identifying and counting LEP individuals, thereby generating the data needed to assess language assistance needs and the adequacy of language assistance plans. OPA uses LEP data to assess the program’s compliance with regulations related to ensuring meaningful access to clients who have limited English proficiency and identify grantee technical assistance needs in the area of language assistance. The data collected permit OPA to answer the question:

• What percentage of Title X users report LEP and are best served in a language other than English?

Family planning method use (by sex and age) reported by grantees allow OPA to assess patterns and trends in female and male contraceptive method use over time, monitor the availability and use of newer FDA–approved contraceptive technologies, and compare the program’s contraceptive method-mix with nationally representative data sources (e.g., National Survey of Family Growth).¹⁵ The types of contraceptive methods (i.e., most effective) that providers offer may vary in terms of supply costs and service delivery requirements, thereby affecting overall project costs. Title X projects are required to provide a broad range of acceptable and effective, medically approved family planning methods (42 USC 300 and 42 CFR 59).^1,3 The data collected permit OPA to monitor project financial concerns that may result from contraceptive supply issues and permit OPA to answer questions such as:

• What are the patterns of contraceptive use (i.e., “method mix”) by method type or age group for female and male users?

• What percentage of female clients use contraception? What percentage of female clients rely on most, moderately and less effective forms of family planning methods?

• What percentage of female clients are pregnant or seeking pregnancy?

Use of related preventive health services data are reported by grantees as required by Title X regulation (42 CFR 59).³ This includes the number of cervical cancer screenings, and referrals (female users only), tests for STDs—for example, chlamydia, gonorrhea, syphilis, and HIV. OPA monitors these data for the program’s implementation of early detection and prevention of cancers, efforts to reduce infertility through chlamydia screening, adoption and adherence to changing screening guidelines, as well as delivery of the number of positive STD tests. The data collected permit OPA to answer such questions as:

• Of the total number of Pap tests performed, what percentage were abnormal and requires further follow-up?

• How many gonorrhea and syphilis tests were performed?

• How many anonymous HIV tests were performed?

• How many confidential HIV tests were positive?

Number of family planning encounters by provider type (i.e., physicians, physician assistants, nurse practitioners, certified nurse midwives, and registered nurses with an expanded scope of practice) are reported by grantees to help OPA monitor patterns and trends in service utilization and to respond to frequently asked questions about the types of clinical services providers (CSPs) that deliver Title X-funded care. The data collected permit OPA to answer such questions as:

• What percentage of family planning encounters do CSPs deliver? What percentage of encounters do other service providers deliver?

Grantee Profile Cover Sheet

The Grantee Profile Cover Sheet identifies the grantee organization, person(s) responsible for overseeing the Title X grant and preparation of the report, and the time period covered by the report. The cover sheet also collects information on the number of Title X subrecipients and service delivery sites supported by the grant. This information will be automatically populated in the Grantee Profile Cover Sheet based on previous information provided by the grantee to OPA. If there is an error in the pre-populated fields, the grantee may enter the corrected information in the Grantee Profile Cover Sheet “Note” field and notify the program officer (PO) that key grant information has changed.

Project Revenue

Project revenue (i.e., actual cash receipts or drawdown amounts) is reported by grantees during the reporting period from each funding source to support activities within the scope of the grantee’s approved Title X services grant, even if the funds are not expended during the reporting period. Title X Family Planning Services grantees are required to maintain a financial management system that meets the standards for administering grants, as specified in 45 CFR Part 74⁵ and 45 CFR Part 92,⁶ as well as document and keep records of all income and expenditures. OPA uses the revenue data to monitor patterns and trends in the amount of Title X project revenue from all sources and at all program levels. The data collected permit OPA to answer such questions as the following:

• What is the composition of revenue, by source, reported by Title X family planning projects (e.g., Title X, Medicaid, private third-party, state or local government, state block grants, or patient payments)?

• What percentage of total project revenue is from public or private third-party sources?

Utilization of Family Planning Clinical Services Providers

Grantees report data on the composition (full-time equivalents [FTEs]) of clinical provider staffing (i.e., physicians, physician assistants, nurse practitioners, certified nurse midwives, and registered nurses with an expanded scope of practice). In conjunction with information about family planning encounters by provider type collected in the encounter data, OPA monitors patterns and trends in the number and composition of clinical services provider staffing and provider efficiency. The data collected permits OPA to answer such questions as:

• What is the composition of CSP staff?

• What is the ratio of mid-level CSP FTEs to physician FTEs?

• How many family planning encounters with a CSP are there per CSP FTE?

3. Use of Improved Information Technology (IT) and Burden Reduction

To minimize reporting burden, OPA collects only the minimum information needed to monitor compliance with statutory and regulatory requirements and to manage the Title X program. In addition, OPA encourages and supports several efforts to improve the efficiency and ease with which grantees compile, tabulate, and report FPAR data.

OPA developed a standalone website to replace the existing FPAR reporting module website. The new FPAR 2.0 Data System (https://fpar.opa.hhs.gov) opened in January 2023 to HHS/OPA staff and grantees for submission of 2022 FPAR data. The FPAR system is up-to-date with the Revision 5 Authority to Operate (ATO), including cybersecurity and privacy review, before the HHS mandated 9/30/2024 deadline. The Revision 5 ATO does not expire until 8/9/2027.

Built with input from users such grantees and OPA staff, the website has a user-friendly interface with improved login and multi-factor authentication methods, streamlined navigation and approval processes; forms that pre-populate with grant identifying information to reduce data input and increase accuracy; a Helpdesk accessed by toll-free phone or e-mail; online reference materials for grantees; and extensive technical assistance to help grantees transition to the new system (e.g., training webinars, frequently asked questions [FAQ], briefs, and video-based trainings).

Using a standards-based, encounter-level data reporting reduces administrative burden on OPA and Title X grantees and enables previously manual procedures to be automated, such as tabulating and checking basic counts of clients served and types of services provided. It also expands the options for data analysis and reporting—for example, through interactive data dashboards and visualizations, customized tabulations and reports, and application of analytics and statistical analyses on the encounter-level data files.

Furthermore, the FPAR 2.0 Data System allows grantees to validate their encounter-level data using a range of automated validation checks. The FPAR 2.0 Data System also prevents grantees from submitting a final report that includes tables with unresolved validation issues. The electronic validation feature and the system’s rules regarding submission of a final FPAR reduce the time burden for grantees, HHS/OPA staff, and the FPAR contractor associated with identifying and resolving inconsistencies in the reported data.

For HHS/OPA staff that review and approve each FPAR, the FPAR 2.0 Data System offers automated features to streamline FPAR review and approval, including automated e-mails to inform the grantee or OPA about specific actions taken on an FPAR (e.g., submission, acceptance/approval, request for revision) and an FPAR Submission Status Report that shows total and region-specific information on the submission status of all FPARs on any selected day. In addition, the FPAR 2.0 Data System provides a user administration page where HHS/OPA staff manage (i.e., register, approve, and disable) all system user accounts. At the end of every reporting period, OPA and the vendor discuss issues that arose during the previous year and work on system improvements based on user feedback from OPA staff to grantees.

4. Efforts to Identify Duplication and Use of Similar Information

As noted in Section A.2, FPAR 2.0 is the only source of annual, uniform reporting by all Title X Family Planning Services grantees. The information requested in FPAR 2.0 is unique to the Title X Family Planning program and is unavailable from other sources. Furthermore, FPAR 2.0 does not duplicate items from other OPA data collection efforts for this program. In the absence of FPAR 2.0 data, there is no other source or mechanism for collecting timely and uniform data that OPA relies on to guide program policies, priorities, decisions, and strategies.

While the federally funded National Survey of Family Growth (NSFG) is an important source of detailed information about family planning and reproductive health knowledge, attitudes, and behaviors among reproductive-aged individuals in the United States, the survey is designed to be representative of the reproductive-aged population (15 to 44 years) nationally and is not representative of services provided specifically to Title X clients. Due to the survey’s design, the NSFG is an inappropriate data source for monitoring and managing the Title X Family Planning program because NSFG data cannot be used to generate reliable estimates of Title X service utilization patterns, client demographic characteristics, or client contraceptive behaviors.

5. Impact on Small Businesses or Other Small Entities

No small business will be impacted in this study.

6. Consequences of Not Collecting the Information or Less Frequent Collection

Title X services grantees are required to complete and submit the FPAR on an annual basis. OPA uses FPAR data for key management tasks such as monitoring compliance with statutory requirements, allocating funds among grantees, determining grantee eligibility for continued funding, and strategic program and financial planning. Less frequent collection of FPAR data would severely hamper OPA’s ability to manage the Title X Family Planning grant program and adjust changes in funding or other factors in a timely manner.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The Information Collection Request fully complies with regulation 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice/Outside Consultation

A 60-day Federal Register Notice was published in the Federal Register on October 31, 2024, Vol. 89, No. 211; pp. 86826 - 7 (see attachment C). There were no public comments.

Outside Consultation. Outside consultation was conducted over the last three years with inputs from experts at the FPAR contractor, Mathematica, and from OPA’s technical assistance grantees at the Reproductive Health National Training Center and Clinical Training Center for Sexual and Reproductive Health. Additionally, HHS OPA Title X program staff have provided expertise. User feedback has been analyzed and incorporated annually into iterative changes to the data system and elements to improve ease of data collection and reporting. Regarding the elements, this primarily relates to the inclusion or exclusion of more standardized response/reporting codes without changing the actual elements.

Exhibit 2–List of Individuals who Provided Extensive Review and Feedback on FPAR 2.0

Year	Name/Title/Affiliation
2012 - 2025	HHS Office of Population Affairs
2020 - 2025	Mathematica – contracted to OPA
2020 - 2025	Reproductive Health National Training Center (formerly, Family Planning National Training Center) administered by JSI, INC, an OPA technical assistance grantee
2020-2025	Clinical Training Center for Sexual and Reproductive Health (CTC-SRH) – administered by the University of Missouri – Kansas City School of Nursing & Health Sciences, an OPA technical assistance grantee

In addition, OPA asked HHS staff that oversees grantee Title X projects and interacts with grantees on FPAR reporting issues, to share any known problems and issues with the current forms and instructions, as well as suggest ways to resolve any unclear wording that might reduce data quality or add burden. Mathematica conducts annual and ad hoc reviews and solutions to reporting issues.

9. Explanation of Any Payment/Gift to Respondents

No payments or gifts will be provided to respondents.

10. Assurance of Confidentiality Provided to Respondents

Data will be kept private to the extent allowed by law. Per 42 CFR Part 593, while personally identifiable information (PII) will be collected about clients, the PII will not include client names or other direct personal identifiers; consequently, the data will not constitute Privacy Act records. FPAR 2.0 will not be used to attempt to identify particular clients, but only to study clients’ characteristics at an aggregate level. The PII about a particular client will include a unique identifying number for data integrity purposes to ensure the system does not double-count individuals when compiling aggregate data covering more than one encounter. The unique identifying number will not be a direct personal identifier and cannot be used to retrieve data for study. Currently data is reported annually in 15 aggregate tables, and that will continue. Additional analyses will not include small cell sizes.

The FPAR 2.0 data system is hosted in the contractor’s Mathematica Cloud Support System (MCSS), a FedRAMP authorized cloud environment. The FPAR 2.0 data system is up-to-date with HHS ATO requirements and was awarded a new Revision 5 ATO that expires 8/9/2027. It passed all cybersecurity, privacy, and accessibility checks.

11. Justification for Sensitive Questions

While FPAR 2.0 collects several items of a sensitive nature in the encounter data (e.g., user income and insurance status, user race and ethnicity, type of contraceptive method used or adopted, STD tests performed, and Pap and HIV test results) none of these records are connected to a direct personal identifier and cannot be connected to an individual with the existing data set. These sensitive data are required to monitor compliance with statutory requirements, program regulations and guidelines, performance reporting, and ongoing program management.

Regarding the updated 2024 SPD-15 standards,¹⁵ OPA requests approval to continue to collect previously approved race/ethnicity items and not update to the 2024 revised SPD-15 standards at this renewal OPA is aware of the timeline to implement the revision in a future clearance request. OPA anticipates being able to implement the revised race and ethnicity items by the next renewal for FPAR 2.0 (estimated to be Feb 2028).

There are several logistical reasons why adopting the 2024 revised race/ethnicity standards is not possible during this renewal:

1. FPAR 2.0 data elements are based on standards promulgated in the United States Core Data for Interoperability (USCDI) and maintained by the HHS Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP).¹⁶ This is part of the baseline standardization of electronic health records and includes standard terminology and codes for collecting and reporting data. USCDI is analogous to a dictionary that updated annually with new or revised elements. Currently, no published version of USCDI supports SPD-15. USCDI v5 was published July 2024 which started the cycle to collect recommendations for USCDI v6. It is anticipated that USCDI v6 will not be published until July 2025.

2. ASTP recently published a proposed rule: Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) Proposed Rule.¹⁷ HTI-2 was published 8/5/24 and was open for its 60 day comment-period until 10/4/24. Among the many provisions in HTI-2, it proposed including SPD-15 in a future version of USCDI, i.e., in a future USCDI v6 or v7, or later.¹⁸ Additionally, HTI-2 proposes requiring the adoption of USCDI v4 by 1/1/28.¹⁷

3. Without published standards from USCDI, it would be burdensome and potentially at odds with future published standards for OPA to require grantees to modify their data systems to report this new data to OPA. In summary:

   1. SPD-15 is not included in any currently published version of USCDI.

   2. USCDI v4 (which does not include the 2024 revision to SPD-15), was published in July 2023 and is not expected to be fully adopted until 1/1/28. This date is dependent on any comments to proposed rule HTI-2 which still has to go through a 30D comment period after review and response to the 60D comments, i.e., this date is still currently in question and may change.

   3. If HTI-2 is published with SPD-15 to be incorporated into a future version of USCDI (which seems likely), USCDI v6 would still not be published until July 2025 at the earliest.

   4. At which point, ASTP would have to release another proposed rule to require the adoption of USCDI v6.

4. OPA assumes that the revised SPD-15 will be included in either USCDI v6 or v7, but without published standards, OPA cannot begin to assess or plan for implementation.

5. OPA assumes that by the next renewal for FPAR 2.0 (estimated to be Feb 2028), standards will be finalized and there will be enough time for EHR vendors, grantees, and OPA to adequately plan for and perform the necessary workflow updates.

12. Estimates of Annualized Burden Hours (Total Hours and Wages)

12A. Estimated Annualized Burden Hours

OPA revised burden estimates based on comments received by the National Family Planning and Reproductive Health Association (NFPRHA) during the original 60-day comment period in 2021. According to a member survey of 40 members, NFPRHA reported an average one-time implementation burden of 183 hours per grantee. That member survey was based on outdated information, specifically the number of data elements, several of which had been deleted or made optional. OPA utilized this number in its burden estimate in 2021.

Recognizing the challenges in implementing FPAR 2.0, OPA offered a three-year optional reporting pathway for those grantees who could not meet the FPAR 2.0 implementation timeline. As of September 2024, the last year of the transition, over 2/3 of grantees have transitioned to FPAR 2.0 and by January 2025, all grantees are expected to have completed their transition. Therefore, the one-time implementation burden is no longer included in burden estimates. OPA assumes twice as much hourly burden as FPAR 1.0, for 72 hours per grantee per year.

The estimated annualized hour burden of responding to this information collection is 6,336 hours (see Exhibit 3). The hour-burden estimates include the time spent by grantee staff to retrieve, compile, verify, and report the FPAR data using the FPAR 2.0 Data System, and exclude any hour burden associated with customary and usual practices that the grantee would carry out in the absence of the FPAR reporting requirement.

Exhibit 3–Estimated Hour Burden

Type of Respondent	Form Name	Number of Respondents	Number of Responses per Respondent	Average Annualized Burden per Response (Hours)	Annualized Total Burden (Hours)
Grantees	FPAR	88	1	72	6,336

The majority of Title X service grantees have some type of electronic reporting system, although not all. The annual reporting burden will vary greatly depending on available technology and available resources.

12. B. Estimated Annualized Respondent Cost Burden

The estimated total annualized labor cost to respond to the FPAR is $325,290 or an average of $3,696 per respondent (see Exhibit 4). The estimated hourly wage rate ($51.34) is a weighted average based on the distribution of the hour burden across four different categories of grantee labor (i.e., clerical/unskilled, skilled/technical, managerial or professional, and executive). This hour burden across labor categories is based on a burden estimate done by the American College of Gynecologists and Obstetricians in May of 2021. The average wage rate for each labor category was obtained from the U.S. Bureau of Labor Statistics 2023 wage rates for the health care and social assistance sector.¹⁹

Exhibit 4–Estimated Annualized Cost to Respondents for Information Collection

Type of Respondent	Total Burden Hours	Average (Weighted) Hourly Wage Rate	Total Respondent Cost
Grantees	6,336	$51.34	$325,290

13. Estimates of other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs

14. Annualized Cost to Federal Government

The estimated annualized cost to the federal government for collecting FPAR data is $929,183. Exhibit 5 presents a breakdown of this total. This number is based on the last CLIN of the contract and represent system costs needed to maintain a hybrid data system to accommodate grantees who are transitioning to FPAR 2.0 and those who have already transitioned. It is anticipated that costs will be lower in future years. The estimate includes costs by federal staff and by the FPAR contractor for the following activities:

• OPA Staff and FPAR Data Coordinator–To review, correct, and approve FPAR submissions, oversee and coordinate the work of the FPAR data contractor, review and approve validation procedures performed by contractor and addressed by the FPAR Review Checklist, and review contractor prepared reports about data quality and data submission; and

• FPAR 2.0 Contractor–To validate FPAR data, including review and update SAS programs, preparation and dissemination of the validation results report, and work with the FPAR Data Coordinator and regional staff to resolve issues; develop/update FPAR Review Checklist for use by OPA staff in their review of FPARs; prepare of initial tabulations of national and regional data; prepare the FPAR Data Validation/Quality/Transition Report and the FPAR Submission Reports; operate and maintain the FPAR Data System website, staff Helpdesk, resolve system issues/bugs, prepare and deliver grantee and OPA training webinars, review and update system documentation, and update system security documents and interact with HHS/OIT and ASPA on issues related to website compliance with HHS requirements.

Exhibit 5–Annualized Cost of FPAR Reporting to Federal Government

Source	Amount ($)
FPAR review/approval and validation resolution, seed data review by OPA Office Staff (400 hours x $52.80/hour)	$21,120
FPAR review/approval, validation resolution, seed data request, FPAR contractor oversight/management (350 hours x $52.80/hour)	$19,530
FPAR 2.0 project management	$107,710
System development and maintenance	$350,506
Technical assistance to grantees and electronic health record vendors	$430,317
Total Annualized Cost	$929,183

15. Explanation for Program Changes or Adjustments

Estimated Annualized Burden Hours. The requested annualized burden of 6,336 hours is approximately 11% less than the previous estimate of 7,140 hours. This reflects a reduction in the number of burden hours per response from 102 hours to 72 hours. FPAR 2.0 implementation burden, included in the 2021 estimate, should now be completed so that portion of the previous estimate is no longer included.

The previous 2021 estimate utilized a smaller number of respondents. Since then, more grantees have re-entered the Title X program taking the number of funded organizations back to the historic average. Implementation burden is assumed to be completed at this point as all grantees should have fully transitioned to FPAR 2.0 by January 1, 2025.

Estimated Annualized Labor and Non-labor Costs. As a result of the inflation and more current wage estimates, the annualized labor cost and non-labor costs have also increased.

16. Plans for Tabulation and Publication and Project Time Schedule

Annually, the FPAR 2.0 contractor will validate, tabulate, analyze, and disseminate the FPAR data in the form of a national summary. If possible, with the more granular data, OPA will produce more summaries based on geographic data. For the reporting period (calendar year), the national summary presents national (aggregate) data for each of the components described in the FPAR 2.0 encounter data and project revenues, user income level and age group by state, and trend data (from 1999 to the current reporting year) for selected FPAR data items. The national summary also presents a description of the procedures used to compile and validate the data, as well as definitions of all key FPAR 2.0 terms and definitions. The appendix to the national summary contains detailed, table-specific notes on any discrepancies between OPA-requested data and what individual grantees were able to provide, how those data inconsistencies were resolved, and the effect, if any, on the data presented in the report. OPA posts a 508-compliant PDF version of the national summary on the OPA website, where the public has full access.

By February 28 of each year, the grantees compile and submit data for the recently completed calendar year. Exhibit 6 presents the timetable for key activities following OMB approval. The timetable assumes an OMB approval date of 3/1/25.

Exhibit 6–Timetable for Data Collection, Analysis, and Publication

Activity	Expected Date of Completion
Data collection	1/7/2025 through 2/28/25 (for 2024 FPAR data) January-February 2026 (for 2025 FPAR data) January-February 2027 (for 2026 FPAR data)
Resolve validation issues	April 2025 (for 2024 FPAR data) April 2026 (for 2025 FPAR data) April 2027 (for 2026 FPAR data)
Export FPAR data file to contractor for validation and tabulation	May 2025 (for 2024 FPAR data) May 2026 (for 2025 FPAR data) May 2027 (for 2026 FPAR data)
Prepare draft national summary for OPA review	July 2025 (for 2024 FPAR data) July 2026 (for 2025 FPAR data) July 2027 (for 2026 FPAR data)
Post 508-compliant version of national summary to OPA Web site	September 2025 (for 2024 FPAR data) September 2026 (for 2025 FPAR data) September 2027 (for 2026 FPAR data)

17. Reason(s) Display of OMB Expiration Date Is Inappropriate

The 3-year expiration date for OMB approval will be displayed on all versions of the form (i.e., electronic, Web-based).

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

2. DATA COLLECTION PROCEDURES: FPAR Data System

The FPAR reporting requirement does not use statistical methods. In accordance with federal regulations, annual FPAR submission is required of all Title X Family Planning Services grantees for purposes of monitoring and reporting program performance (45 CFR Part 74 and 45 CFR Part 92).^5,6 The Family Planning Annual Report 2.0 (FPAR 2.0) Data System is dedicated to collecting and managing Title X FPAR data. The System’s purpose is to facilitate user-friendly submission of annual FPAR data by Title X service grantees and to provide a central location for review, approval, storage, and management of FPAR data by HHS/OPA staff. The website’s target audiences include authorized staff of Title X service grantees and HHS/OPA staff responsible for administering grants and monitoring performance. The general public is not an intended audience.

3. REFERENCES

1. 42 United States Code (USC) 300, Project Grants and Contracts for Family Planning Services. Retrieved October 09, 2024, from https://uscode.house.gov/view.xhtml?req=(title:42%20section:300%20edition:prelim)

2. 42 USC 300a-4, Grants and contracts. Retrieved January 2, 2025, from https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&req=granuleid%3AUSC-prelim-title42-section300a-4

3. 42 Code of Federal Regulations (CFR) Part 59, Grants for Family Planning Services (September 10, 2024). Retrieved September 10 2024, from https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-59

4. Killewald, P., Leith, W., Paxton, N., Rosenthal, I., Troxel, J., Wong, M., & Zief, S. (2024, September). Family planning annual report: 2023 national summary. Office of Population Affairs, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services. Retrieved December 30, 2024, from https://opa.hhs.gov/sites/default/files/2024-10/2023-FPAR-National-Summary-Report.pdf

5. 45 CFR Part 74, Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Nonprofit Organizations, and Certain Grants and Agreements with States, Local Governments and Indian Tribal Governments. Retrieved October 26, 2020, from https://www.govinfo.gov/content/pkg/CFR-2000-title45-vol1/pdf/CFR-2000-title45-vol1-part74.pdf

6. 45 CFR Part 92, Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments. Retrieved October 26, 2020, from https://www.govinfo.gov/content/pkg/CFR-2011-title45-vol1/pdf/CFR-2011-title45-vol1-part92.pdf

7. HHS Office of Population Affairs. Title X Program Expectations. https://opa.hhs.gov/grant-programs/title-x-service-grants/about-title-x-service-grants/title-x-program-expectations

8. HHS Office of Population Affairs. (2022, July) Title X Program Handbook. https://opa.hhs.gov/sites/default/files/2022-08/title-x-program-handbook-july-2022-508-updated.pdf

9. Gavin L, Pazol K, Ahrens K. Update: Providing Quality Family Planning Services Recommendations of CDC and the U.S. Office of Population Affairs, 2017 Morbidity and Mortality Weekly Report, 66, 1381-1385. http://dx.doi.org/10.15585/mmwr.mm6650a4

10. Romer, Sarah E, et al. Providing Quality Family Planning Services in the United States: Recommendations of the U.S. Office of Population Affairs (Revised 2024). American Journal of Preventive Medicine, 67(6) S41-S86. https://doi.org/10.1016/j.amepre.2024.09.007

11. HHS Heath Resources and Services Administration. (2025). Health Center Program Uniform Data System (UDS) Data Overview. https://data.hrsa.gov/tools/data-reporting/program-data

12. Bernstein J, Chollet D, Peterson S. (2010, April 30). How Does Insurance Coverage Improve Health Outcomes? Mathematica Policy Research, Inc. https://www.mathematica.org/publications/how-does-insurance-coverage-improve-health-outcomes

13. KFF. (2024, December 12). Women's Health Insurance Coverage. https://www.kff.org/womens-health-policy/fact-sheet/womens-health-insurance-coverage-fact-sheet/

14. HHS. (2024, December 6). Limited English Proficiency. https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html

15. Office of Management and Budget. (2024, October 17). OMB Statistical Policy Directive No. 15 on Race and Ethnicity Data Standards. https://spd15revision.gov/

16. HealthIT.gov. United States Core Data for Interoperability (USCDI). Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT. https://www.healthit.gov/isp/united-states-core-data-interoperability-uscdi

17. Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability, 89 F.R., 63498 (proposed August 5, 2024) (to be codified at 45 CFR pts. 170, 171, and 172). https://www.federalregister.gov/documents/2024/08/05/2024-14975/health-data-technology-and-interoperability-patient-engagement-information-sharing-and-public-health#agency

18. HealthIT.gov. (2024 July) ONC Standards Bulletin – July 2024. Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT. https://www.healthit.gov/topic/standardsbulletin_24-2

19. Bureau of Labor Statistics. May 2023 National Industry-Specific Occupational Employment and Wage Estimates: Sector 62-Health Care and Social Assistance; April 2024. https://www.bls.gov/oes/2023/may/naics2_62.htm