Black Lung Supporting Statement A

Supporting Statement A

Black Lung Clinics Program Performance Measures

OMB Control No. 0915-0292

Revision

Terms of Clearance: None

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Health Resources and Services Administration (HRSA)’s Federal Office of Rural Health Policy (FORHP) is requesting continued OMB approval to collect information on recipient activities and performance measures electronically through the Performance Improvement and Measurement System (PIMS). This activity collects information for the Black Lung Clinics Program (BLCP) to provide HRSA with information on grant activities funded under this program, as well as information to meet requirements under the Government Performance and Results Act of 1993 (GPRA). These measures first received OMB review and approval in September 2004, under OMB Number 0915-0292, and has a current expiration date of August 31, 2022.

In its authorizing language (SEC. 711. [42 U.S.C. 912]), Congress charged FORHP with “administering grants, cooperative agreements, and contracts to provide technical assistance and other activities as necessary to support activities related to improving health care in rural areas.” FORHP’s mission is to sustain and improve access to quality health care services for rural communities.

The BLCP is authorized by Sec. 427(a) of the Federal Mine Safety and Health Act of 1977, as amended, (30 U.S.C. 937). The Black Lung PIMS is the reporting system for the BLCP recipients. The BLCP supports projects that demonstrate a clear target population, community need, and provision of the following services, in consultation with a physician who has training/experience in the diagnosis and treatment of pulmonary and respiratory diseases: primary care, patient and family education and benefits counseling; outreach; U.S. Department of Labor disability exams in accordance with the authorizing legislation; patient care coordination (including individual care plans for patients); and smoking cessation and other treatments that may relieve symptoms of the pulmonary and respiratory diseases. A total of 15 recipients provide services across 15 states. These 15 recipients have met the needs of over 7,000 miners in FY 2019.

Although the number of active coal miners has decreased due to mechanization, there has been an increase in the number of coal miners with the disease. The BLCP remains a vital program, and PIMS is the tool that allows FORHP to measure the impact of the grant funding.

The proposed revisions to the BLCP measures are a result of the accumulation of grantee and stakeholder feedback, and information gathered from the previously approved BLCP measures. The proposed changes include revisions of current measures for better usability and additional questions about screening program participation, smoking, pulmonary function testing, referral for services, and Coronavirus (COVID-19) vaccination. Please see attached BLCP Form for revisions in red text.

2. Purpose and Use of Information Collection

FORHP conducts an annual data collection of user information for the BLCP. The purpose of this data collection is to provide HRSA with information on how well each recipient is meeting the needs of active and retired miners in their communities.

Data from the annual report provides quantitative information about the programs, specifically: (a) the characteristics of the patients they serve (age, diagnoses, occupation type); (b) the characteristics of services provided (clinical services and benefits counseling); and (c) the number of patients served. These are clinical measures collected at a de-identified level. HRSA has created this system as a result of the lack of resources allocated to the clinics to track miner patients across grant recipients.

HRSA provides Comma-Separated Value (CSV) spreadsheets for clinics to export data from their Electronic Medical Record (EMR) into the appropriate format. The spreadsheets are converted into a JavaScript Object Notation (JSON) file using the Rural Health Data Tool (RHDT), software developed and provided for free by HRSA. This software installed on the network of the clinics not HRSA, de-identifies the data that the clinics then upload into the Electronic Handbooks (EHB), a HRSA-wide platform that offers grants management services to grantees and HRSA staff (more information on EHB below). The de-identified data is then accessed by HRSA staff for programmatic review in EHB.

This assessment will provide useful information on the BLCP and will enable HRSA to provide data required by Congress under the Government Performance and Results Act of 1993. It will also ensure that funded organizations have demonstrated a need for services in their communities and that federal funds are being effectively used to provide services to meet those needs.

The type of information requested in the Black Lung PIMS enables FORHP to assess the following characteristics about its programs:

• The total number of coal miners served by FORHP-funded black lung clinics;

• The types of services the coal miners use and the BLCP clinics provide; and

• The characteristics of the coal miners the BLCP clinics serve.

As required by the Government Performance and Results Act (GPRA), FORHP has developed an annual program goal related to performance indicators. The Black Lung PIMS provides data for this performance indicator.

The measures support HRSA’s Strategic Plan goal to improve access to quality health care and services by strengthening health systems to support the delivery of quality health services to care and expanding the capacity of the health care safety net. The indicators for this program goal are:

• Total number of miners served each year; and

• Total number of miners screened each year

The database is capable of identifying and responding to the needs of the Black Lung community. The database:

• Yields trends on patient characteristics in an area that lacks sufficient national and state data; and

• Facilitates the electronic transmission of data by the recipients, through use of standard formats and definitions.

The database collects data in order to address long-term performance goals of the program and respond to GPRA requirements.

3. Use of Improved Information Technology and Burden Reduction

This activity is fully electronic. Data are collected through and maintained in a database in HRSA’s Electronic Handbook (EHB). The EHB is a website that all HRSA recipients, including those for the program covered in this approval request, are required to use when applying electronically for grants using OMB approved Standard Forms. The EHB has a helpdesk feature that includes a toll-free number and e-mail address for any technical questions from recipients. As this database is fully electronic and recipients submit the data electronically via a HRSA managed website, burden is reduced for the recipient and program staff. The time burden is minimal, since there is no data entry element for program staff due to the electronic transmission from recipient systems to the PIMS; additionally, there is less chance of error in translating data and analysis of the data.

4. Efforts to Identify Duplication and Use of Similar Information

There is no other data source available that tracks the number of patients served by the BLCP. Due to the lack of an EMR system that links to HRSA, there is no other way to track the number of miners served, the types of services miners receive, and the characteristics of miner patients across grant recipients. This software and method is provided free of charge to grantees, and should help alleviate the financial burden it would take for clinics to implement this on their own. The Department of Labor’s (DOL) Division of Coal Mine Workers’ Compensation collects data on the number of applicants and benefit recipients; however, the BLCP serves many more clients than would be eligible under the definitions for DOL. The Mine Safety and Health Administration (MSHA) collects information on the number of mines, the number of active miners, and injuries/deaths related to mining. The National Institute of Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC) provides medical testing and surveillance for active coal miners. The BLCP recipients serve active, inactive, retired, and disabled coal miners.

5. Impact on Small Businesses or Other Small Entities

Every effort has been made to ensure the data requested are the minimum necessary to answer basic questions useful in determining whether recipient awarded goals and objectives are being met. Data requested are currently being collected by the projects or can be easily incorporated into normal project procedures. The data collection activities will not have a significant impact on small entities.

6. Consequences of Collecting the Information Less Frequently

Data in response to these performance measures are collected on an annual basis. Grant dollars for these programs are awarded annually. This information is needed by the program, FORHP, and HRSA in order to measure effective use of grant dollars to report on progress toward strategic goals and objectives. There are no legal obstacles to reduce the burden

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

The request fully complies with the regulation.

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

Section 8A:

A 60-day Federal Register Notice was published in the Federal Register on May 13, 2021, vol. 86, No. 91, pp. 26225-26226. There were no public comments.

Section 8B:

The following recipients were consulted in 2021 while finalizing the performance measures:

Dr. Leonard Go

Project Director

Northwestern Medicine

Phone: 312.996.9270

Email: lgo2@uic.edu

Dr. Kirsten Almberg

Co-Principal Investigator

University of Illinois – Chicago

Phone: 312.996.9477

Email: almberg@uic.edu

Lauren Zell-Baran, MPH

Epidemiologist, Database Manager

National Jewish Health

Phone: 303-398-1187

Email: zellbaranl@njhealth.org

There were no major problems that could not be solved during consultation.

9. Explanation of any Payment/Gift to Respondents

Respondents will not receive any payments or gifts.

10. Assurance of Confidentiality Provided to Respondents

The data system does not involve the reporting of information about identifiable individuals; therefore, the Privacy Act is not applicable to this activity. The proposed performance measures will only be used in aggregate form for reporting program activities.

11. Justification for Sensitive Questions

There are no sensitive questions.

12. Estimates of Annualized Hour and Cost Burden

12A. Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Total Responses	Average Burden per Response (in hours)	Total Burden Hours
Black Lung Clinic Personnel (project directors, health practitioners, technical workers etc.)	Black Lung Clinics Program Measures	15	1	15	10	150
Total		15		15		150

These estimates were determined by consultations with three (3) recipients from the program. These recipients piloted the new measures and were asked to estimate 1) how much time it would take and 2) how much it would cost to report program activities.

It should also be noted that the burden is expected to vary across the recipients. This variation is tied primarily to the type of program activities specific to the recipient’s project and current data collection system.

12B. Estimated Annualized Burden Costs

Type of Respondent	Total Burden Hours	Hourly Wage Rate	Total Respondent Cost
Project Directors, Health Practitioners, Technical Workers, etc.	150	$57.12	$8,568
Total	150		$8,568

Source: https://www.bls.gov/oes/current/oes119111.htm

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

There is no capital or start-up cost component for this collection. Other than their time, there is no cost to respondents

14. Annualized Cost to Federal Government

Staff at FORHP monitor the contracts and provide guidance to recipient project staff at a cost of $1,595.52 per year (72 hours per year at $22.16 per hour at a GS-09 Step 1 base salary level).

15. Explanation for Program Changes or Adjustments

The estimated burden is the same as the currently approved burden estimate. The proposed extension of the performance measures includes patient-level data collection. Examples of measures include type and severity of pulmonary diagnosis and rate of disease progression.

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

There are currently no plans to publish the data. The data may be used in aggregate at the recipient or program level to document the success of the program. This information might be used in the FORHP Annual Report produced internally for the agency.

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

The OMB number and Expiration date will be displayed on every page of every form/instrument.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.

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