Supporting Statement FINAL-Revised w TC 2-26-20_

Health Resources and Services Administration

SUPPORTING STATEMENT

The Health Center Program Forms

A. Justification

1. Circumstances of Information Collection

The Health Resources and Services Administration (HRSA) is requesting a revision of OMB approval for forms that are used by several Bureau of Primary Health Care (BPHC) programs providing grant funding to serve medically underserved and vulnerable populations. The forms are currently approved under OMB number 0915-0285, Health Center Program Application Forms with an expiration of January 31, 2020.

The Health Center Program, administered by HRSA, is authorized under section 330 of the Public Health Service (PHS) Act, most recently amended by section 50901(b) of the Bipartisan Budget Act of 2018, P.L. 115-123. Health centers are community-based and patient-directed organizations that deliver affordable, accessible, quality, and cost-effective primary health care services to patients regardless of their ability to pay. Nearly 1,400 health centers operate approximately 12,000 service delivery sites that provide primary health care to more than 28 million people in every U.S. state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin.  HRSA utilizes forms for new and existing health centers and other entities to apply for various grant and non-grant opportunities, renew grant and non-grant designations, report progress, and change their scopes of project.

Health Center Program-specific forms are necessary for Health Center Program award processes and oversight. These forms provide HRSA staff and objective review committee panels with information essential for application evaluation, funding recommendation and approval, designation, and monitoring. These forms also provide HRSA staff with information essential for evaluating compliance with Health Center Program legislative and regulatory requirements.

2. Purpose and Use of the Information

The purpose of these forms is to provide information to HRSA staff and objective review committee panels to support application evaluation; funding recommendation and approval; designation; and monitoring. Health centers use a combination of the application forms to apply for one or more of the following opportunities:

• Advancing Precision Medicine (APM) is a supplemental funding opportunity to support health center participation in the National Institutes of Health’s All of Us Research Program (AoU) and to advance health centers’ interoperability functionality, preparedness to use and share patient data, and capacity to participate in future research opportunities. 

• Budget Period Progress Report (BPR) is an application that provides an update on the progress for Health Center Program award recipients.

• Capital Development funding opportunities provide funding for construction, renovation, repair and/or improvement of health center service delivery sites.

• Change in Scope (CIS) requests are submitted by existing health centers to change the current approved scope of project as they relate to services offered, sites, and other scope activities that require prior approval by HRSA.

• Enhancing Behavioral Health Workforce (EBHW) is a supplemental funding opportunity to increase access to quality opioid use disorder (OUD) and other substance use disorder (SUD) treatment by increasing the number of professionals and paraprofessionals trained to deliver behavioral health and primary care services as part of integrated, interprofessional teams in HRSA-supported health centers.

• Expanding Access to Quality Substance Use Disorder and Mental Health Services (SUD-MH) is a supplemental funding opportunity for existing Health Center Program (H80) health centers to implement and advance evidence-based strategies to expand access to integrated substance use disorder (SUD) and mental health services.

• Health Center Controlled Networks (HCCNs) are networks of health centers working together to use health information technology (HIT) to improve operational and clinical practices.

• Integrated Behavioral Health Services (IBHS) is a supplemental funding opportunity for existing Health Center Program (H80) award recipients to increase access to high quality integrated behavioral health services, including prevention or treatment of mental health conditions and/or substance use disorders, including opioid use disorder.

• Loan Guarantee Program (LGP) supports loans to eligible Health Center Program award recipients for the construction/expansion, alteration/renovation, and modernization of health center medical facilities.

• Look-Alike (LAL) applications support organizations seeking initial designation, renewal of designation, or annual certification as a look-alike. Look-Alikes must meet all eligibility requirements of a section 330 grant, but they do not receive section 330 grant funds.

• National Health Center Training and Technical Assistance Partners (NTTAPs) provide national training and technical assistance (T/TA) to potential and existing section 330-funded health centers with the goal of assisting them to address HHS and HRSA priorities, improve performance, and support program development and analysis activities.

• Native Hawaiian Health Care Improvement Act (NHHCIA) is a congressional special initiative with the purpose of improving the provision of comprehensive disease prevention, health promotion, and primary care services to Native Hawaiians.

• New Access Points (NAP) is a competitive funding opportunity that provides operational support for new service delivery sites for the provision of comprehensive primary health care services (i.e., new access points). Applicants must propose at least one full-time, permanent new access point site that has primary medical care as its main purpose.

• Oral Health Infrastructure (OHI) is a competitive supplemental funding application to support one-time investments that enhance new or existing high quality, integrated oral health services in health centers.

• Primary Care Associations (PCAs) are cooperative agreements with state and regional organizations that provide T/TA to potential and existing health centers with the goal of assisting them to address HHS and HRSA priorities, improve performance, and support program development and analysis activities.

• Primary Care HIV Prevention (PCHP) is supplemental funding to expand HIV prevention services that decrease the risk of HIV transmission in geographic locations identified by Ending the HIV Epidemic: A Plan for America, focusing on identifying individuals for whom pre-exposure prophylaxis (PrEP) is clinically indicated, and supporting their access to and use of PrEP.

• Quality Improvement Awards (QIAs) provide supplemental funding to recognize the highest performing health centers nationwide as well as those health centers that have made significant quality improvement gains from the previous year to improve quality, efficiency, and the value of health care delivery in the communities they serve.

• Service Area Competition (SAC) is a competitive funding opportunity for existing and new health center organizations to receive federal financial assistance to support affordable, quality primary health care services for a community and its vulnerable population(s) in a service area already served by the Health Center Program.

The forms provide information that is required by HRSA for reviewing applications, award recommendations, monitoring, and ensuring compliance with conditions of award for the programs mentioned above. The following forms are used to collect the required information:

• Checklist for Adding a New Service: Combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the population by the addition of the service(s).

• Checklist for Adding a New Service Delivery Site: Combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the population by the addition of the service site.

• Checklist for Adding a New Target Population: Combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the existing target population by the addition of the new target population.

• Checklist for Deleting Existing Service: Combination of a checklist and narrative. It provides program with an understanding of the impact to the community and population by the deletion of the service(s).

• Checklist for Deleting Existing Service Delivery Site: Combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the population by the deletion of the service site.

• Clinical Performance Measures: Collects information on specific clinical performance measures to be accomplished during the project period, including goals; baselines; methodology; key contributing and restricting factors; and major planned actions.

• Equipment List: Used by applicants to provide a detailed equipment list to identify the equipment to be purchased with Capital Development funding. Equipment type will be categorized as clinical or non-clinical.

• Expanded Services: Collects the project narrative for projects proposed in an Expanded Services supplemental application.

• Federal Object Class Categories: A standard form that is used to obtain budget information from the SF-424A.

• Financial Performance Measures: Collects information on specific financial performance measures to be accomplished during the project period, including goals; baselines; methodology; key contributing and restricting factors; and major planned actions.

• Form 1A: General Information Worksheet: Collects summary information on the applicant organization and the proposed project including specific applicant information, the proposed service area, target population, service providers, and patient and visit projections.

• Form 1B: BPHC Funding Request Summary: Collects program specific project budget estimates.

• Form 1C: Documents on File: Collects the date of the last review or revision of key documents used by the health center governing board and staff for ensuring compliance with Health Center Program requirements.

• Form 2: Staffing Profile: Identifies the total personnel and number of full-time equivalents (FTEs) for the proposed project.

• Form 3: Income Analysis: Identifies the estimated non-Federal revenues (all other sources of income aside from the section 330 grant funds) for the requested budget.

• Form 3A: FQHC Look-Alike Budget Information: Collects projected expenses and revenues.

• Form 4: Community Characteristics: Identifies service area and target population data.

• Form 5A: Services Provided: Identifies the mode of service provision for all clinical and non-clinical services.

• Form 5B: Service Sites: Collects information on the site location including address, contact information, and site characteristics (e.g., zip codes from which the majority of the patients will come to the site, hours of operation).

• Form 5C: Other Activities/Locations: Collects information on activities provided at a location other than a service site.

• Form 6A: Current Board Member Characteristics: Collects information on board members, including areas of expertise, years of service on the board, and demographics.

• Form 6B: Request for Waiver of Board Member Requirements: Used to request a waiver of governing board requirements. Only organizations seeking support for Migrant Health Centers, Health Care for the Homeless, and Public Housing Primary Care may request a waiver.

• Form 8: Health Center Agreements: Identifies when the applicant organization has an agreement with another organization to carry out a substantial portion of the proposed scope of project and ensures compliance with governance requirements.

• Form 12: Organization Contacts: Collects contact information for the Chief Executive Officer, Contact Person, Medical Director, and Dental Director of the organization.

• Funding Sources: Identifies other sources of funding that will be necessary to fund the overall project proposal.

• HCCN Progress Report Table: Provides consistent, quantifiable, and up-to-date information on award recipients’ progress towards the funding goals and the funded projects’ impact on each participating health center.

• Health Center Program Progress Report (previously Substance Abuse Progress Report): This form is used to monitor activities approved in expanded services grants.

• Health Center Program: Supplemental Information (previously Outreach and Enrollment Supplemental form): Collects information from applicants regarding how funding will be used to increase the number of individuals assisted, enrollees and FTEs. Applicants also describe the strategies to implement funding activities.

• Operational Plan: Outlines reasonable, time-framed goals and action steps necessary to become operational and compliant with the Health Center Program requirements within 120 days of the Notice of Award.

• Other Requirements for Sites: Collects information on the proposed site(s) regarding ownership, site control, and historic preservation issues.

• Program Specific Forms Instructions: Provides instructions for SAC related forms.

• Project Narrative Update (previously Program Narrative Update): Requires approved 330 award recipients to provide an update on progress and changes that have impacted the community/target population and award recipient organization, from the beginning of the budget period until the date of the submission; the expected progress for the remainder of the budget period; and projected plans for the entire budget period.

• Project Qualification Criteria: Requires applicants to specifically address eligibility criteria identified in the funding opportunity.

• Project Work Plan: Collects information from PCAs, NTTAPs, and HCCNs about the T/TA activities they plan to conduct for a given period of time.

• Proposal Cover Page: Collects information from applicants that address how all projects together will address the needs of the community as well as the long-term impact of all projects.  The form also requires applicants to explain how they plan to maintain improved access/services that will result from the project(s) within their existing operational budget/grant support.

• Summary Page: Collects prepopulated key application data and components to enable SAC and NAP applicants to easily review and verify.

The following section below describes the revisions from the last clearance package:

1. The addition of new structured and non-structured forms:

The following forms are new forms for this clearance package.

• Capital Semi-Annual Progress Report: Used to report progress by award recipients of capital-related funding on a bi-annual basis.

• Diabetes Action Plan—Quarterly Report Template: Used to monitor three performance improvement actions related to strengthening the health center’s performance on the Uniform Data System (UDS) diabetes measure.

• FY2018 Expanding Access to Quality Substance Use Disorder and Mental Health Services (SUD-MH)/Integrated Behavioral Health Services (IBHS) Progress Reporting: Used to report progress, by award recipients that receive SUD-MH or IBHS supplemental funding on a tri-annual basis.

• FY2020 Ending the HIV Epidemic—Primary Care HIV Prevention (PCHP) Progress Reporting: Used to report progress by award recipients of PCHP supplemental awards on an annual basis.

• HRSA EHBs Action Plan: Utilized to monitor health centers’ performance improvement activities reviewed during HRSA health center site visits.

• HRSA Loan Guarantee Program Application: Application to support loans to eligible 330 Health Center Program award recipients for construction/expansion, alteration/renovation, and modernization of health center medical facilities.

• Participating Health Center List: Collects names of unique health centers (Health Center Program award recipients and look-alikes) that are committed to participating in the HCCN project.

• Patient Target and Calculations: Enables award recipients to review and confirm their patient target annually.

• Project Overview: Collects estimates of the number of new and existing patients to receive each service as a result of PCHP-supported activities.

• Project Plan: Collects project plan activities and outputs for each objective of PCHP supported activities.

2. This section identifies the specific changes to previously cleared Health Center Program forms.

• Checklist for Adding a New Service: Text changes to update instructions and hyperlinks.

• Checklist for Adding a New Service Delivery Site: Text changes to update instructions and hyperlinks.

• Checklist for Adding a New Target Population: Text changes to update instructions and hyperlinks.

• Checklist for Deleting Existing Service: Text changes to update instructions and hyperlinks.

• Checklist for Deleting Existing Service Delivery Site: Text changes to update instructions and hyperlinks.

• Clinical Performance Measures: Updated to reflect most recent list of Clinical Performance Measures, Focus Area, Performance Measures, Numerator Description, and Denominator Description.

• Equipment List: No changes.

• Expanded Services: Updated to reflect new name and to include new sections (Existing Patient Impact, New Patient Impact, and New Patient by Population Type).

• Federal Object Class Categories: No changes.

• Financial Performance Measures: Updated to reflect most recent list of Financial Performance Measures, Focus Area, Performance Measures, Numerator Description, and Denominator Description.

• Form 1A: Text changes to update instructions for sections, project period dates, and section titles.

• Form 1B: Updated to add One-Time Funding Request.

• Form 1C: Text changes and revised the list of required documents.

• Form 2: Updated instructions and added staff titles and number of burden estimate.

• Form 3: Revised to update Note section.

• Form 3A: Revised to remove instructions.

• Form 4: Revised to update Note section and add new section.

• Form 5A: Revised to update Note section and update Substance User Disorder title.

• Form 5B: Revised Note section, form field, and burden estimate.

• Form 5C: Revised to add maximum characters for the Activity section

• Form 6A: Text changes to update Note section and burden estimate.

• Form 8: Changed to clarify questions and updated Note section.

• Form 12: Updated to add additional staff and update burden estimate.

• Funding Sources: No changes.

• HCCN Progress Report Table: Updated to include sections for “Enhanced the Patient and Provider Experience” and “Advance Interoperability.”

• Health Center Program Progress Report (previously Substance Abuse Progress Report): Updated to change title so that the form can be used across multiple opportunities.

• Health Center Program Supplemental Information (previously Outreach and Enrollment Supplemental Form): Updated to include new sections for optimal usage.

• Operational Plan: Updated to include additional instructions and revise Focus areas.

• Other Requirements for Sites: No changes.

• Program Specific Forms Instructions: Provides instructions for SAC related forms.

• Project Narrative Update (previously Program Narrative Update): Revised to update title (formerly Program Narrative Update) and to reflect updated/streamlined instructions.

• Project Qualification Criteria: No changes.

• Project Work Plan: Updated to combine the details for training and technical assistance activities to be conducted by PCAs, NTTAPs, and HCCNs.

• Proposal Cover Page: No changes.

• Summary Page: Updated to combine both SAC and NAP summary pages into one document.

3. Use of Improved Information Technology

The data collection forms are completed by applicants or award recipients using a web-based data collection system that is completely integrated with the HRSA EHBs. The HRSA EHBs provides authentication and authorization services to all applicants.

Application data can be submitted using standard web browsers through a Section 508 compliant user interface. The system presents users with electronic forms that clearly communicate what is required and provide assistance in completing their applications. Usability features such as those that pre-populate data from prior year applications based on business rules prevent redundant data entry. Users are able to work on the forms in part, save them online, and return to complete them later. Business rules are also in place in the system to ensure the data submitted meets the legislative and programmatic requirements. The users are provided with a summary of items that are complete, as well as incomplete, along with links to jump to the appropriate sections to complete the identified incomplete parts.

4. Efforts to Avoid Duplication

The applicant information requested in these forms is unique to these programs and is not captured elsewhere.

5. Involvement of Small Entities

This activity does not have a substantial impact on small entities or small businesses.

6. Consequences if Information Collected Less Frequently

If the information is not collected annually HRSA would be unable to make grant awards. The information is also required in order to monitor the progress of Health Center Program awardees to ensure that they are in compliance with section 330 of the PHS Act and Health Center Program policies, as well as to provide information required in reports to Congress.

7. Consistency with the Guidelines in 5 CFR 1320.5(d)(2)

The data are collected in a manner consistent with guidelines contained in 5 CFR 1320.5(d)(2).

8. Consultation Outside the Agency

The notice required by 5 CFR 1320.8(d) was published in the Federal Register on April 8, 2019 (Vol. 84, No. 67, page 13937). No comments were received.

The guidance and applications were provided to the National Association of Community Health Centers (NACHC) for review of the materials regarding clarity and the estimate of annualized burden. The NACHC members consulted were:

Ted Henson, Director, Health Center Performance & Innovation

Gervean Williams, Director, Health Center Financial Trainings

Jennifer Notly, Director, Innovative Primary Care

Emily Heard, Health Center Governance Training

Cindy Thomas, Director, Leadership Training and Cooperative Agreement Management

National Association of Community Health Centers

301-347-0400

The feedback from the external stakeholders indicates that the forms are clear and the allocation of time for most forms is reasonable. Based on comments received, burden estimates were increased for several forms.

9. Remuneration of Respondents

Respondents will not receive any payments or gifts.

10. Assurance of Confidentiality

No assurance of confidentiality is made to the applicants. These applications specify the reporting of aggregate data on users and the services they receive, in addition to descriptive information about each award recipient and its operations and financial systems. Award recipient-level data are covered under the Freedom of Information Act.

11. Questions of a Sensitive Nature

There are no questions of a sensitive nature.

12. Estimates of Annualized Hour Burden

Estimates of annualized reporting burden are as follows:

Form Name	Number of Respondents	Number of Responses per Respondent	Total Responses	Average Burden per Response (in hours)	Total Burden Hours
Capital Semi-Annual Progress Report (new)	996	2	1,992	1	1,992
Checklist for Adding a New Service	450	1	450	2	900
Checklist for Adding a New Service Delivery Site	1,480	1	1,480	2	2,960
Checklist for Adding a New Target Population	100	1	100	2	200
Checklist for Deleting Existing Service	500	1	500	2	1,000
Checklist for Deleting Existing Service Delivery Site	750	1	750	2	1,500
Clinical Performance Measures	1,058	1	1,058	3.5	3,703
Diabetes Action Plan - Quarterly Report Template (new)	1,058	4	4,232	2	8,464
Equipment List	1,375	1	1,375	1	1,375
Expanded Services	996	1	996	1	996
Federal Object Class Categories	735	1	735	0.25	184
Financial Performance Measures	1,058	1	1,058	1.5	1,587
Form 1A: General Information Worksheet	1,058	1	1,058	1	1,058
Form 1B: BPHC Funding Request Summary	1,000	1	1,000	0.75	750
Form 1C: Documents on File	1,058	1	1,058	0.5	529
Form 2: Staffing Profile	1,058	1	1,058	1	1,058
Form 3: Income Analysis	1,058	1	1,058	1	1,058
Form 3A: FQHC Look-Alike Budget Information	50	1	50	1	50
Form 4: Community Characteristics	1,058	1	1,058	1	1,058
Form 5A: Services Provided	1,058	1	1,058	1	1,058
Form 5B: Service Sites	1,508	1	1,508	1	1,508
Form 5C: Other Activities/Locations	1,058	1	1,058	0.5	529
Form 6A: Current Board Member Characteristics	1,058	1	1,058	1	1,058
Form 6B: Request for Waiver of Board Member Requirements	1,058	1	1,058	1	1,058
Form 8: Health Center Agreements	1,058	1	1,058	1	1,058
Form 12: Organization Contacts	1,058	1	1,058	0.5	529
Funding Sources	735	1	735	0.5	368
FY2018 Expanding Access to Quality SUD-MH/IBHS Progress Reporting (new)	1,375	3	4,125	1	4,125
FY2020 Ending the HIV Epidemic—Primary Care HIV Prevention (PCHP) Progress Reporting (new)	182	1	182	1	182
HCCN Progress Report Table	90	1	90	1	90
Health Center Program Progress Report (previously Substance Abuse Progress Report)	735	1	735	1	735
Health Center Program: Supplemental Information (previously Outreach and Enrollment Supplemental Form)	500	1	500	1	500
HRSA EHBs Action Plan (new)	1,058	4	4,232	1	4,232
HRSA Loan Guarantee Program Application (new)	20	1	20	1	20
Operational Plan	500	1	500	3	1,500
Other Requirements for Sites	600	1	600	0.5	300
Participating Health Center List (new)	90	1	90	1	90
Patient Target and Calculations (new)	1,058	1	1,058	1	1,058
Program Specific Forms Instructions	1,500	1	1,500	1	1,500
Project Narrative Update (previously Program Narrative Update)	883	1	883	4	3,532
Project Overview (new)	182	1	182	1	182
Project Plan (new)	182	3	546	1.5	819
Project Qualification Criteria	735	1	735	1	735
Project Work Plan	135	1	135	4	540
Proposal Cover Page	735	1	735	1	735
Summary Page	1,558	1	1,558	0.5	779
Total Hours	37,605		48,063		59,242

The burden estimates for the applications and forms were based on previous experience with these forms and input from award recipients using the HRSA EHBs system and application forms.

Type of Respondent	Total Burden Hours	Hourly Wage Rate1	Total Respondent Costs
Medical and Health Services Managers	59,242	$95.90	$5,681,307.80
Total	59,242	$95.90	$5,681,307.80

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

The costs to respondents is comprised of their time, recordkeeping, reporting, data management, and auditing, as well as employer overhead and fringe benefits.

14. Estimates of Annualized Cost to the Government

The estimated annual cost to the government is approximately $154,046 (1 GS-11, 2 GS-13, 1 GS-14 FTEs – 40% time of work) for reviewing the forms, and for processing and providing notification to applicants.

15. Change in Burden

For this clearance request, each form is being submitted separately to accurately reflect the number of respondents per form. The OMB Inventory currently contains 44,608 burden hours for this activity. This request is for 59,242 total burden hours, for an increase of 14,634 hours. The increase in hours is due to program adjustments resulting from an increase in the number of health center organizations, as well as an increase in the number of new funding opportunities that required new data to be submitted by the applicants. The data needed for new funding opportunities could not be captured in forms previously approved.

16. Plans for Analysis and Timetable of Key Activities

There will be no statistical analysis done on the information received nor will there be any publication of the information reported on the applications.

17. Exemption for Display of Expiration Date

The expiration date will be displayed.

18. Certifications

This project fully complies with CFR 1320.9. The certifications are included in this package.

1 Wages for Medical and Health Services Managers are based on Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, Medical and Health Services Managers, on the Internet at http://www.bls.gov/ooh/management/medical-and-health-services-managers.htm (visited November 4, 2019), as well as employer overhead and fringe benefits..

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