HRSA-25-039 Final V2.pdf

Notice of Funding Opportunity

Application due February 11, 2025

Federal Office of Rural Health Policy Community-Based Division

Black Lung Data and Resource Center Opportunity number: HRSA-25-039

Contents Before you begin 4

Step 1: Review the Opportunity 5

Basic information 6

Eligibility 7

Program description 9

Award information 11

Step 2: Get Ready to Apply 15

Get registered 16

Find the application package 16

Application writing help 16

Step 3: Write Your Application 18

Application contents and format 19

Step 4: Learn About Review and Award 27

Application review 28

Selection process 33

Award notices 34

Step 5: Submit Your Application 35

Application submission and deadlines 36

Application checklist 38

Step 6: Learn What Happens After Award 40

Post-award requirements and administration 41

Reporting 43

Contents 2

Contacts and Support 44

Contents 3

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on February 11, 2025.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 4 https://sam.gov/ https://grants.gov/

Jump to a step

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 6

Eligibility 7

Program description 9

Award information 11

Basic information Health Resources and Services Administration (HRSA)

Federal Office of Rural Health Policy

Community-Based Division

Supporting data collection, analysis, and operational improvements for recipients of funding through the Black Lung Clinics Program.

Have questions?

Go to Contacts and Support.

Key facts

Opportunity name: Black Lung Data and Resource Center

Opportunity number:

HRSA-25-039

Announcement version:

New

Federal assistance listing:

93.965

Statutory authority :

Social Security Act, §711(b) (42 U.S.C. 912(b))

Key dates

NOFO issue date:

December 12, 2024

Informational webinar:

December 18, 2024, 1pm

ET

Application deadline:

February 11, 2025

Expected award date is by: June 1, 2025

Expected start date: July 1, 2025

See other submissions for other time frames that may apply to this NOFO.

Summary This program funds the Black Lung Data Resource Center (BLDRC). The BLDRC provides technical assistance to clinics funded through the Black Lung Clinics Program (BLCP).

Products of the BLDRC will improve health care for people who suffer from black lung.

The BLDRC provides support and improvements related to:

• Patient-level data collection and analysis.

• Clinic operations.

• Quality and breadth of clinic services.

Funding details Application type: New

Expected total available funding in FY 2025: $135,000

Expected number and type of awards: Up to one cooperative agreement.

Funding range per award: Up to $135,000 each budget period.

We plan to fund awards in five 12-month budget periods for a total five-year period of performance from July 1, 2025, to June 30, 2030.

The program and awards depend on the appropriation of funds and are subject to change based on the availability and amount of appropriations.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 6 https://www.govinfo.gov/content/pkg/USCODE-2022-title42/pdf/USCODE-2022-title42-chap7-subchapVII-sec912.pdf https://www.govinfo.gov/content/pkg/USCODE-2022-title42/pdf/USCODE-2022-title42-chap7-subchapVII-sec912.pdf https://hrsa-gov.zoomgov.com/j/1607382562?pwd=e4JSowahvKpbcvsnvBTpr5OALaRZOA.1 https://www.hrsa.gov/rural-health/grants/black-lung

Eligibility Who can apply You can apply if you are a domestic public or private organization.

Types of eligible organizations These types of domestic* organizations may apply:

• Public institutions of higher education

• Private institutions of higher education

• Nonprofits with or without a 501(c)(3) IRS status

• For-profit organizations, including small businesses

• State, county, city, township, and special district governments, including the District of Columbia, domestic territories, and the freely associated states

• Independent school districts

• Rural Emergency Hospitals

• Native American tribal governments

• Native American tribal organizations

* “Domestic” means the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

Individuals are not eligible applicants under this NOFO.

Other eligibility criteria Completeness and responsiveness criteria We will review your application to make sure it meets these basic requirements to move forward in the competition.

We will not consider an application that:

• Is from an organization that does not meet all eligibility criteria.

• Requests funding above the award ceiling shown in the funding range.

• Is submitted after the deadline.

Step 1: Review the Opportunity 7

Application limits You may not submit more than one application. If you submit more than one application, we will only accept the last on-time submission.

Cost sharing This program has no cost-sharing requirement. If you choose to share in the costs of the project, we will not consider it during merit review. We will hold you accountable for any funds you add, including through reporting.

Step 1: Review the Opportunity 8

Program description Purpose The purpose of the Black Lung Data and Resource Center (BLDRC) program is to improve health care in rural areas by supporting patient-level data collection and analysis, clinic operations, and the quality and breadth of services provided by recipients of Black Lung Clinics Program (BLCP) funding. For the purposes of this Notice of Funding Opportunity, BLCP award recipients are referred to as BLCP recipients.

Additional details about the program requirements and expectations for BLCP recipients can be found in HRSA-25-040.

Our goal is to strengthen BLCP recipients’ ability to examine and treat respiratory diseases and pulmonary impairments in active and inactive U.S. coal miners. To that end, the BLDRC provides programmatic assistance and resources to help BLCP recipients use data analysis to better understand the health status and needs of U.S.

coal miners. BLDRC support and data analysis contributes to advancing evidence-based models of health care for rural health care providers, including BLCP recipients and other health care providers serving rural populations.

The BLDRC will work with BLCP recipients and stakeholders to address long-standing challenges and barriers to medical, outreach, educational, and benefits counseling services for U.S. coal miners. The BLDRC will also help collect and analyze information on the demographics and clinical status of coal miners with Coal Mine Dust Lung Diseases (CMDLD), or black lung diseases, especially Coal Workers Pneumoconiosis (CWP) and its most severe form, Progressive Massive Fibrosis (PMF). The BLDRC supports BLCP recipients, including rural health providers, in discerning effective methods to address challenges, analyzing best practices, and informing lessons learned that translate across rural and non-rural health care settings. These methods also expand and further enhance support for health care delivery in rural areas.

Background Section 711(b) of the Social Security Act (42 U.S.C. 912(b)) authorizes the Black Lung Data and Resource Center. This program strengthens the operations and quality of the BLCP through the use of data and technical assistance and is intended to promote improvements in health care and development of best practices in affected communities and rural populations. By working with various Black Lung clinics and other federal entities, the BLDRC can synthesize the most effective approaches to operating clinics, collecting and analyzing data, and improving the breadth and quality of clinic services. The BLDRC uses data analysis and public dissemination of best

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 9 https://grants.gov/search-results-detail/355370 practices to improve BLCP operations, which are of particular interest to rural areas impacted by black lung diseases. This public dissemination creates new opportunities for rural communities to implement evidence-based models of health care based on relevant BLDRC data analysis recommendations.

Currently, there is no single comprehensive, national dataset that contains information on active, inactive, retired, and disabled U.S. coal miners who have worked in surface and underground mines. As a result, it is difficult to know how many active, inactive, retired, and disabled U.S. coal miners there are, as well as their complete health and wellness profile. This program aims to fill that gap.

Program requirements and expectations If you are funded, we will expect you to enhance the operations of BLCP recipients. Your activities must include:

• Programmatic assistance to BLCP recipients to improve operations and improve data collection.

• Support to BLCP recipients with collecting and analyzing data about the demographics and clinical status of U.S. coal miners.

The BLDRC will collaborate with HRSA, BLCP recipients, and other federal stakeholders to focus on strengthening the operational efficiencies of BLCP recipients, improving the quality and breadth of services BLCP recipients provide, and increasing the number of U.S. coal miners served.

This program aims to improve health care in rural areas through technical support for BLCP recipients. For the purposes of this NOFO, there are two ways to determine if a county or census tract is located in a HRSA-designated rural area:

• Rural Health Grants Eligibility Analyzer

◦ The Rural Health Grants Eligibility Analyzer identifies all counties and census tracts that are considered a HRSA-designated rural area as of Fiscal Year (FY) 2025.

• List of formerly HRSA-designated rural counties

◦ There are 17 counties that were considered fully within HRSA-designed rural areas in FY 2024 that are no longer fully rural due to updates from the Office of Management and Budget (OMB).

◦ While either some or all areas in these 17 counties will not appear as rural in the Rural Health Grants Eligibility Analyzer, reference to these counties in your application will qualify as HRSA-designated rural areas for the purposes of this NOFO.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 10 https://www.hrsa.gov/rural-health/about-us/what-is-rural https://data.hrsa.gov/tools/rural-health https://www.hrsa.gov/sites/default/files/hrsa/rural-health/about/counties-no-longer-fully-rural-fy25.pdf

Award information Cooperative agreement terms Our responsibilities Aside from monitoring and technical assistance, we also get involved in these ways:

• Working with you to synthesize feedback from BLCP recipients on their current operational processes, such as:

◦ Funding and reimbursement programs.

◦ Department of Labor (DOL) timeliness and National Institute of Occupational Safety and Health (NIOSH) certifications.

◦ Staff recruitment and retention.

◦ Telehealth or telemedicine.

◦ Medical, outreach, educational, and benefits counseling services provided to U.S. coal miners.

◦ Patient-level data collection systems.

• Determining areas of programmatic assistance needed.

• Facilitating communication with BLCP recipients to implement programmatic assistance to enhance operations, improve the quality and breadth of services BLCP recipients provide, and increase the number of U.S. coal miners served.

• Facilitating collaboration with key federal stakeholders, including DOL and NIOSH, to determine how BLCP recipients can better capture clinical issues and emerging trends related to black lung disease through data collection and analysis.

• Reviewing areas of data recommendations for incorporation of relevant data to support and inform BLCP and other rural programs.

• Reviewing and providing guidance on deliverables prior to completion.

• Disseminating deliverables to key stakeholders within and outside the black lung community.

Your responsibilities You must follow all relevant laws and policies. Your other responsibilities will include:

• Collecting, synthesizing, and analyzing HRSA and other federal entities’ data sources to understand the burden of black lung disease nationwide. Other federal entities might include the Department of Energy, Mine Safety and Health Administration, DOL, and NIOSH.

Step 1: Review the Opportunity 11

• Maintaining HRSA’s current database of black lung-related data, including patient-level data submitted by BLCP recipients.

• Supporting federal connections and building collaboration among stakeholders.

• Soliciting and synthesizing feedback from BLCP recipients on their current operational processes, such as:

◦ Funding and reimbursement programs.

◦ DOL timeliness and National Institute of Occupational Safety and Health (NIOSH) certifications.

◦ Staff recruitment and retention.

◦ Telehealth or telemedicine.

◦ Medical, outreach, educational, and benefits counseling services provided to U.S. coal miners.

◦ Patient-level data collection systems and HRSA’s current database of black lung-related data, including patient-level data submitted by BLCP recipients.

• Determining areas of programmatic assistance needed.

• Collaborating with HRSA to determine how BLCP award recipients can better capture clinical issues and emerging trends related to black lung disease through their patient-level data collection and analysis.

• Providing programmatic assistance, onsite and virtually as appropriate, for BLCP recipients to enhance operations, improve the quality and breadth of services BLCP recipients provide, and increase the number of U.S. coal miners served. This may include, but is not limited to:

◦ Hosting regular webinars or podcasts that provide guidance on compliance with regulations, certifications updates, emergent disease trends, and other topics.

• Hosting regular conference calls with individual and small groups of BLCP recipients, as needed, to resolve chronic BLCP challenges.

◦ Creating data sheets, including executive summaries and infographics or other print materials to be used in outreach activities.

◦ Creating and maintaining a digital reference library for programmatic assistance materials.

• Facilitating presentations, onsite and virtually, during program meetings and assisting with public dissemination of programmatic information.

• Developing data privacy and sharing agreements, and analyzing and disseminating patient-level and aggregate data collected by black lung clinics.

• Responding in a timely manner to HRSA requests for project updates related to data analysis and programmatic assistance provided.

Step 1: Review the Opportunity 12

• Adhering to HRSA guidelines about acknowledgement and disclaimer on all products produced by HRSA award funds.

• Other activities that have the potential to enhance BLCP recipients’ operations.

Funding policies and limitations Policies

• We will only make awards if this program receives funding. If Congress appropriates funds for this purpose, we will move forward with the review and award process.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting the project’s objectives.

◦ A decision that continued funding is in the government’s best interest.

• If we receive more funding for this program, we may:

◦ Fund more applicants from the rank order list

◦ Extend the period of performance

◦ Award supplemental funding

General limitations

• For guidance on some types of costs we do not allow or restrict, see Project

Budget Information in Section 3.1.4 of the Application Guide. You can also see 45 CFR part 75, or any superseding regulation, General Provisions for Selected Items of Cost.

• You cannot earn profit from the federal award. See 45 CFR 75.400(g).

• Congress’s current appropriations act includes a salary limitation, which applies to this program. As of January 2024, the salary rate limitation is $221,900. This limitation may be updated.

Indirect costs Indirect costs are costs you charge across more than one project that cannot be easily separated by project. For example, this could include utilities for a building that supports multiple projects.

To charge indirect costs you can select one of two methods:

Method 1 – Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency at time of award.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=19 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75#75.400

Method 2 – De minimis rate. Per 45 CFR 75.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is 15% of modified total direct costs (MTDC). See 2 CFR 200.1 for the definition of MTDC. You can use this rate indefinitely.

Program income Program income is money earned as a result of your award-supported project activities. You must use any program income you generate from awarded funds for approved project-related activities. Find more about program income at 45 CFR 75.307.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 14 https://www.ecfr.gov/current/title-45/part-75#p-75.414(f) https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC)) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.307

Step 2:

Get Ready to Apply

In this step

Get registered 16

Find the application package 16

Application writing help 16

Get registered SAM.gov You must have an active account with SAM.gov to apply. This includes having a Unique Entity Identifier (UEI). SAM.gov registration can take several weeks. Begin that process today.

To register, go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist to find out what you’ll need to register.

When you register or update your SAM.gov registration, you must agree to the financial assistance general certifications and representations. You must agree to those for grants specifically, as opposed to contracts, because the two sets of agreements are different. You will have to maintain your registration throughout the life of any award.

Grants.gov You must also have an active account with Grants.gov. You can see step-by-step instructions at the Grants.gov Quick Start Guide for Applicants.

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov and search for opportunity number HRSA-25-039.

After you select the opportunity, we recommend that you click the Subscribe button to get updates.

Application writing help Visit HHS Tips for Preparing Grant Proposals.

Visit HRSA’s How to Prepare Your Application page for more guidance.

See Apply for a Grant for other help and resources.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 16 https://sam.gov/content/entity-registration https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/search-grants https://www.hhs.gov/grants-contracts/grants/get-ready-for-grants-management/tips-for-preparing-grant-proposals/index.html https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application https://www.hrsa.gov/grants/apply-for-a-grant

Join the webinar For more information about this opportunity, join the webinar on Wednesday, December 18, 2024, at 1pm ET.

If you are not able to join through your computer, you can call in:

• Phone number: 833-568-8864

• Meeting ID: 160 738 2562

• Passcode: 76265912

We will record the webinar. If you are not able to join live, please contact Anna Feins at blacklung@hrsa.gov to obtain the playback link.

Have questions? Go to Contacts and Support.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 17 https://hrsa-gov.zoomgov.com/j/1607382562?pwd=e4JSowahvKpbcvsnvBTpr5OALaRZOA.1 mailto:blacklung@hrsa.gov

Step 3:

Write Your Application

In this step

Application contents and format 19

Application contents and format Applications include five main components. This section includes guidance on each.

Application page limit: 40 pages

Submit your information in English and express whole number budget figures using U.S. dollars.

Make sure you include each of these:

Components Submission format

Project abstract Use the Project Abstract Summary form.

Project narrative Use the Project Narrative Attachment form.

Budget narrative Use the Budget Narrative Attachment form.

Attachments Insert each in the Attachments form.

Other required forms Upload using each required form.

Required format You must format your narratives and attachments using our required formats for fonts, size, color, format, and margins. See the formatting guidelines in Section 3.2 of the Application Guide.

Project abstract Complete the Project Abstract Summary form. Include a short description of your proposed project. Include the needs you plan to address, the proposed services, and the population groups you plan to serve. For more information, see Section 3.1.2. of the Application Guide. Please include the following information:

• Organization name and full address.

• Entity type/type of facility.

• Website URL if you have one.

• Dollar amount being requested for your project.

• Your organization’s proposed project goals and objectives.

• Expected outcomes of the proposed project.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 3: Write Your Application 19 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=24 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=35

Project narrative In this section, you will describe all aspects of your project. Project activities must comply with the non-discrimination requirements.

Use the section headers and the order listed.

Introduction See merit review criterion 1: Need

Need Briefly describe the project goals, objectives, and expected outcomes, including how the proposed project will:

• Enhance understanding of the scope and the needs of the U.S. coal miner population.

• Enhance BLCP operations, specifically related to patient-level data collection and analysis.

• Improve the quality and breadth of services BLCP recipients provide.

• Increase the number of U.S. coal miners served.

Needs assessment Briefly describe existing available data on:

• The U.S. coal worker population.

• The current incidence and prevalence of CMDLDs, including CWP and PMF.

• Challenges and barriers black lung clinics face, including but not limited to:

◦ Funding and reimbursement.

◦ DOL timeliness and NIOSH certifications.

◦ Staff recruitment and retention.

◦ Telehealth or telemedicine.

◦ Issues related to the provision of medical, outreach, educational, and benefits counseling services.

◦ Patient-level data collection and analysis efforts.

◦ HRSA’s current database of black lung-related data, including patient-level data submitted by BLCP recipients.

Include how demographic information and clinical status of coal miners is collected and how that data could be used to enhance operations, improve the quality and breadth of services BLCP recipients provide, and increase the number of U.S. coal miners served.

Step 3: Write Your Application 20

Approach See merit review criterion 2: Response

Methodology Propose methods that you will use to provide programmatic assistance, specifically surrounding patient-level and aggregate data collection and analysis, in order to strengthen the operational efficiencies of BLCP recipients. The aim of this approach is to improve the quality and breadth of services BLCP recipients provide and increase the number of U.S. coal miners served.

As appropriate, include how you will develop effective tools and strategies for:

• Ongoing programmatic assistance.

• Collaboration across BLCP recipients and with other stakeholders.

• Clear communication.

• Patient-level data collection and analysis.

• Maintaining and improving HRSA’s current database of black lung-related data, including patient-level data submitted by BLCP recipients.

• Information sharing and dissemination involving BLCP recipients, federal agencies, and other stakeholders. Include a plan to disseminate reports, products, or project outputs so key target audiences receive the project information.

Include a description of any innovative methods that you will use in your approach.

Work plan See merit review criteria 2: Response and 4: Impact

• Describe how you’ll achieve each of the objectives during the period of performance.

• Provide a timeline that includes each activity and identifies who is responsible for each. As needed, identify how key stakeholders will help plan, design, and carry out all activities, including the application.

• You will also include a more detailed work plan in your attachments.

Resolving challenges See merit review criterion 2: Response

Discuss challenges that you are likely to encounter in designing and implementing the activities described in the work plan, and approaches that you will use to resolve such challenges.

Step 3: Write Your Application 21

Performance reporting and assessment See merit review criteria 3: Performance reporting and assessment, 4: Impact, and 5: Resources and capabilities

Describe your plan for measuring performance of your project. See reporting for more information.

Data collection, analysis, and dissemination

• Describe your organization’s expertise and experience in patient-level and aggregate data collection, analysis, and dissemination. This should include:

◦ A plan to safeguard data privacy and sharing.

◦ Data-sharing agreements.

◦ Methods of analysis.

◦ Prior experience using data collection tools to collect and analyze patient-level data.

◦ Examples of previous dissemination techniques and materials published.

◦ A description of any potential obstacles to data collection and your plan to address those obstacles.

Input and feedback

• Describe your organization’s capacity to solicit, analyze, and disseminate programmatic feedback and to provide programmatic assistance. This should include a description of the methods used to:

◦ Build trust and collaboration.

◦ Collect feedback and information about program challenges.

◦ Synthesize results.

◦ Determine priority.

◦ Implement assistance.

Impact and evaluation

• Describe a plan for program performance evaluation that will contribute to continuous quality improvement. The program performance evaluation should monitor ongoing processes and your progress towards the goals and objectives of the project. Include descriptions of the inputs (for example, organizational profile, collaborative partners, key personnel, budget, and other resources), key processes, and expected outcomes of the funded activities.

• Describe how the proposed project will impact BLCP recipients, including but not limited to strengthening the operational efficiencies of BLCP recipients, improving

Step 3: Write Your Application 22 the quality and breadth of services BLCP recipients provide, and increasing the number of U.S. coal miners served as well as the broader public health community.

• Describe the systems and processes that will support your organization’s performance management requirements and your methods for ensuring the project is effective through tracking and analysis of performance outcomes.

Describe:

◦ How your organization will collect and manage data (for example, assigned skilled staff and data management software) in a way that allows for accurate and timely reporting of performance outcomes.

◦ Current experience, skills, and knowledge related to performance evaluation, including individuals on staff, materials published, and previous work of a similar nature.

◦ Any potential obstacles for assessing effectiveness of program performance and plans to address those obstacles.

Organizational information See merit review criterion 5: Resources and capabilities

• Briefly describe your organization’s current mission and structure, the scope of your current activities, and how these elements all contribute to the organization’s ability to conduct required activities and meet program expectations.

• Describe your organization’s expertise in and experience with CMDLDs, including CWP and PMF. This should include a description of the current experience, skills, and knowledge of the organization, including:

◦ Individuals on staff.

◦ Materials published.

◦ Previous work related to the study and publication of CMDLD incidence and prevalence as well as primary, secondary, and tertiary prevention.

◦ The current experience, skills, and knowledge of staff and the implementation of previous work of a similar nature.

• Discuss how you will follow the approved plan, as outlined in the application, to properly account for federal funds and document all costs to avoid audit findings.

• Describe how you will routinely assess the unique programmatic assistance and data collection and analysis needs of BLCP recipients and the medical, outreach, educational, and benefits counseling services needs of U.S. coal miners to improve program performance.

Step 3: Write Your Application 23

Budget and budget narrative See merit review criterion 6: Support requested

Your budget should follow the instructions in Section 3.1.4. Project Budget Information

- Non-Construction Programs (SF-424A) of the Application Guide and the instructions listed in this section. Your budget should show a well-organized plan.

HHS now uses the definitions for equipment and supply in 2 CFR 200.1. The new definitions change the threshold for equipment to the lesser of the recipient’s capitalization level or $10,000 and the threshold for supplies to below that amount.

The total project or program costs are all allowable (direct and indirect) costs incurred for the HRSA award activity or project. This includes costs charged to the award and non-federal funds used to satisfy a matching or cost-sharing requirement (which may include maintenance of effort, if applicable).

The budget narrative supports the information you provide in Standard Form 424-A.

See other required forms. It includes an itemized breakdown and a clear justification of the requested costs. The merit review committee reviews both.

As you develop your budget, consider:

• If the costs are reasonable and consistent with your project’s purpose and activities.

• The restrictions on spending funds. See funding policies and limitations.

• You cannot use program funds to pay for membership dues and fees for the National Coalition of Black Lung and Respiratory Disease Clinics, Inc.

• You cannot use program funds for any activities associated with lobbying or advocacy efforts, including planning or conducting lobbying or advocacy events.

• You must clearly account for funds and attest to their use in accordance with these restrictions

To create your budget narrative, see detailed instructions in Section 3.1.5 of the Application Guide.

See Manage Your Grant for other information on costs and financial management.

Attachments Place your attachments in order in the Attachments form. See the application checklist to determine if they count toward the page limit.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 3: Write Your Application 24 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=19 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Equipment) https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200#p-200.1(Supply) https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=30 https://www.hrsa.gov/grants/manage-your-grant

Attachment 1: Work plan Attach the project’s work plan. Make sure it includes everything required in the corresponding project narrative section.

This attachment is required in addition to the description provided in the project narrative work plan section.

We recommend that you format your work plan as a table and use these headings:

• Goals and objectives.

• Key action steps (including target population where applicable).

• Activities.

• Outputs, data sources, and program assessment methods. These might include the direct products or deliverables of program activities and how you will assess them.

• Outcomes and measurements. These might include the result of a program, typically describing a change in people or systems.

• Person and service area responsible.

• Performance period and completion date.

Attachment 2: Staffing plan and job descriptions See Section 4.1.vi of the Application Guide.

Attach a staffing plan that includes:

• Each staff member’s name, title, affiliation, and full-time equivalents (FTEs).

• Descriptions of the positions that will be funded with BLDRC funds. Limit each job description to one page.

• Qualifications, roles, and responsibilities of each staff member, including those who currently work at your organization and those who will be filling any unfilled positions.

• A description of your organization’s timekeeping process to ensure that you will comply with the federal standards related to documenting personnel costs.

Attachment 3: Biographical sketches Include biographical sketches for people who will hold the key positions described in Attachment 2. Each biographical sketch should be no more than two pages. Do not include non-public, personally identifiable information. If you include a biographical sketch for someone you have not yet hired, include a letter of commitment from that person with the biographical sketch.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 3: Write Your Application 25 https://www.hrsa.gov/sites/default/files/hrsa/grants/sf424-application-guide.pdf#page=33 https://grants.gov/learn-grants/grant-terminology#p

Attachment 4: Agreements with other entities Provide any documents that describe working relationships between your organization and others you cite in your application. Documents that confirm actual or pending contractual or other agreements should clearly describe the roles of the contractors and any deliverables. Make sure any letters of agreement are signed and dated.

Attachment 5: For multi-year budgets — fifth-year budget For the fifth budget year, submit a copy of Section B of the SF-424A as an attachment.

We do not count this in the page limit however, any related budget narrative does count. See Section 4 of the Application Guide.

Attachment 6: Project organizational chart Provide a one-page diagram that shows the project’s organizational structure.

Attachments 7-15: Other relevant documents (optional) You may use attachments 7 through 15 to add other relevant documents.

Other required forms You will need to complete some other forms. Upload the following forms at Grants.gov.

You can find them in the NOFO application package or review them and any available instructions at Grants.gov Forms.

Forms Submission Requirement

Application for Federal Assistance (SF-424) With application.

Budget Information for Non-Construction Programs (SF-424A)

With application.

Disclosure of Lobbying Activities (SF-LLL) If applicable, with the application or before award.

Budget Narrative Attachment Form With application

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 3: Write Your Application 26 https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=13 https://www.grants.gov/forms

Step 4:

Learn About Review and Award

In this step

Application review 28

Selection process 33

Award notices 34

Application review Initial review We review each application to make sure it meets eligibility criteria, including the completeness and responsiveness criteria. If your application does not meet these criteria, it will not be funded.

We will not review any pages that exceed the page limit.

Merit review A panel reviews all applications that pass the initial review. The members use these criteria.

Criterion Total number of points = 100

1. Need 25 points

2. Response 25 points

3. Performance reporting and evaluation 15 points

4. Impact 10 points

5. Resources and capabilities 15 points

6. Support requested 10 points

Criterion 1: Need 25 points.

See Project Narrative Introduction section.

The panel will review your application for how well it demonstrates:

• The current incidence and prevalence of CMDLDs, including CWP and PMF.

• The current status and issues related to data collection efforts and the provision of medical, outreach, educational, and benefits counseling services for U.S. coal miners. These issues may include but are not limited to:

◦ Funding and reimbursement.

◦ DOL timeliness and NIOSH certifications.

◦ Staff recruitment and retention.

◦ Telehealth or telemedicine.

Step 4: Learn About Review and Award 28

◦ How demographic information and clinical status of coal miners is collected and reported.

• The purpose of the proposed project, including the project goals, objectives, and expected outcomes.

• How the proposed project will enhance understanding of the U.S. coal miner population.

• How the proposed project will maintain and/or improve upon HRSA’s current database of black lung-related data, including patient-level data submitted by BLCP recipients.

• How the proposed project will strengthen the operational efficiencies of BLCP recipients, improve the quality and breadth of services BLCP recipients provide, and increase the number of U.S. coal miners served.

Criterion 2: Response 25 points.

See Project Narrative Approach, Work plan, and Resolving challenges sections.

The panel will review your application for:

• How well the work plan can accomplish the project’s goals and objectives for programmatic assistance.

• The work plan should explain how these goals and objectives will strengthen the operational efficiencies of BLCP recipients, improve the quality and breadth of services BLCP recipients provide, and increase the number of U.S. coal miners served within the given time period.

• How well the work plan can accomplish the project’s goals and objectives for patient-level and aggregate data collection, analysis, and dissemination.

◦ The work plan should explain how these goals and objectives will maintain current data collection practices, strengthen the operational efficiencies of BLCP recipients, improve the quality and breadth of services BLCP recipients provide, and increase the number of U.S. coal miners served within the given time period.

• How the applicant will improve the ability of BLCP award recipients to collect and report meaningful patient-level data on U.S. coal miners and identify a consistent and unified approach to collect and report data within the BLCP.

• What methods the applicant will use to disseminate reports, products, and project outputs to the project’s target audiences.

Step 4: Learn About Review and Award 29

• Effectiveness of methods to address the stated needs of the project, including demonstrable previous experience using these methods in a setting related to black lung.

• Meaningful support and collaboration with key stakeholders in planning, designing, and implementing all program activities as well as any collaborative activities.

• Challenges that the applicant is likely to encounter in designing and implementing the activities described in the work plan, and approaches that they will use to resolve such challenges.

• Strategies to address current barriers and challenges related to medical, outreach, educational, and benefits counseling services and patient-level data collection efforts.

• Key personnel have adequate time devoted to the project to achieve project objectives.

Criterion 3: Performance reporting and assessment 15 points.

See Project Narrative performance reporting and assessment section.

The panel will review your application for how well the application demonstrates the strength and effectiveness of:

• The plan to improve program performance by routinely assessing the data collection and analysis needs of BLCP recipients.

• The methods proposed for data collection, analysis, and dissemination, including methods that are proven to be effective from prior experience.

• The methods for program performance evaluation that will contribute to continuous quality improvement.

• The methods to monitor and evaluate ongoing processes and the progress of the project toward the goals.

• Systems and processes that support the organization’s performance management requirements by effectively tracking performance outcomes, including how data will be collected and managed to ensure accurate and timely reporting.

• Solutions for overcoming potential obstacles for implementing program performance evaluation.

• Evidence that the evaluative measures will be able to assess project results, including:

◦ How well the program objectives have been met.

Step 4: Learn About Review and Award 30

◦ How much these improvements can be attributed to the project.

◦ Continuous quality improvement.

Criterion 4: Impact 10 points.

See Project Narrative Work plan and Performance reporting and assessment sections.

The panel will review your application for:

• The effectiveness of the proposed project on meeting the goals and objectives of the program.

• The strength of the public health impact evidenced in proposed project activities.

• The effectiveness of the applicant’s plans for sharing project results.

• The strength of the likely impact resulting from the proposed project.

• The strength of the proposed project’s ability to continue beyond the federal funding.

Criterion 5: Resources and capabilities 15 points

See Project Narrative Organizational information and performance reporting and assessment sections.

The panel will review your application to determine how well the application demonstrates:

• Organizational expertise in and experience with CMDLDs, including CWP and PMF.

• How the staffing plan directly links to the activities proposed in the work plan.

• The organizational capacity to solicit, analyze, and disseminate programmatic feedback and provide programmatic assistance, including a description of the methods used to:

◦ Build trust and collaboration.

◦ Collect feedback and information about program challenges.

◦ Synthesize results.

◦ Determine priority.

◦ Implement assistance.

• Organizational expertise and experience in patient-level and aggregate data collection, analysis, and dissemination, including:

◦ A plan to safeguard data privacy and sharing.

◦ Data-sharing agreements.

Step 4: Learn About Review and Award 31

◦ Methods of analysis.

◦ Prior experience using data collection tools to collect and analyze patient-level data.

• Examples of previous dissemination techniques and materials published, including materials related to black lung.

◦ Any potential obstacles to data collection and methods to address those obstacles.

• How the proposed staffing plan contributes to the ability of the organization to meet program expectations and fulfill the cooperative agreement recipient’s responsibilities outlined in the cooperative agreement requirements section.

• The organization’s current mission and structure, and scope of current activities.

• If the application is from an entity that plans to work with a consortium to implement the proposed project:

◦ Consortium member responsibilities and involvement relative to program goals.

◦ The process for soliciting and incorporating feedback from consortium members.

◦ Potential challenges for the consortium and approaches to avoid or address such challenges.

◦ Letters of commitment or memoranda of understanding provided from all consortium members.

Criterion 6: Support requested 10 points.

See Budget and budget narrative section.

The panel will review your application to determine:

• How well the proposed plan properly accounts for federal funds and documents all costs to avoid audit findings.

• The reasonableness of the proposed budget for each year of the period of performance in relation to the objectives, the complexity of the research activities, and the anticipated results.

• The reasonableness of the costs, as outlined in the budget and required resources sections, given the scope of work.

We do not consider voluntary cost sharing during merit review.

Step 4: Learn About Review and Award 32

Risk review Before making an award, we review your award history to assess risk. We need to ensure all prior awards were managed well and demonstrated sound business practices. We:

• Review any applicable past performance.

• Review audit reports and findings.

• Analyze the budget.

• Assess your management systems.

• Ensure you continue to be eligible.

• Make sure you comply with any public policies.

We may ask you to submit additional information.

As part of this review, we use SAM.gov Entity Information Responsibility / Qualification to check your history for all awards likely to be more than $250,000 over the period of performance. You can comment on your organization’s information in SAM.gov. We’ll consider your comments before making a decision about your level of risk.

If we find a significant risk, we may choose not to fund your application or to place specific conditions on the award.

For more details, see 45 CFR 75.205.

Selection process When making funding decisions, we consider:

• The amount of available funds.

• Assessed risk.

• Merit review results. These are key in making decisions but are not the only factor.

• The larger portfolio of HRSA-funded projects, including the diversity of project types and geographic distribution.

We may:

• Fund out of rank order.

• Fund applications in whole or in part.

• Fund applications at a lower amount than requested.

• Decide not to allow a recipient to subaward if they may not be able to monitor and manage subrecipients properly.

• Choose to fund no applications under this NOFO.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 4: Learn About Review and Award 33 https://sam.gov/content/entity-information https://www.ecfr.gov/current/title-45/section-75.205

Award notices We issue Notices of Award (NOA) on or around the start date listed in the NOFO. See Section 4 of the Application Guide for more information.

By drawing down funds, you accept the terms and conditions of the award.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 4: Learn About Review and Award 34 https://www.hrsa.gov/sites/default/files/hrsa/grants/sf424-application-guide.pdf#page=46

Step 5:

Submit Your Application

In this step

Application submission and deadlines 36

Application checklist 38

Application submission and deadlines Your organization’s authorized official must certify your application. See the section on finding the application package to make sure you have everything you need.

Make sure you are current with SAM.gov and UEI requirements. When you register or update your SAM.gov registration, you must agree to the financial assistance general certifications and representations, and specifically with regard to grants.

Make sure that your SAM.gov registration is accurate for both contracts and grants, as these registrations differ. See information on getting registered. You will have to maintain your registration throughout the life of any award.

Deadlines You must submit your application by February 11, 2025, at 11:59 p.m. ET.

Grants.gov creates a date and time record when it receives the application.

Submission method Grants.gov You must submit your application through Grants.gov. You may do so using Grants.gov Workspace. This is the preferred method. For alternative online methods, see Applicant System-to-System.

For instructions on how to submit in Grants.gov, see the Quick Start Guide for Applicants. Make sure that your application passes the Grants.gov validation checks, or we may not get it. Do not encrypt, zip, or password protect any files.

Have questions? Go to Contacts and Support.

Other submissions Intergovernmental review If your state has a process, you will need to submit application information for intergovernmental review under Executive Order 12372, Intergovernmental Review of Federal Programs. Under this order, states may design their own processes for obtaining, reviewing, and commenting on some applications. Some states have this process and others do not.

1. Review 2. Get Ready 3. Write 4. Learn 5. Submit 6. Award Contacts

Step 5: Submit Your Application 36 https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application/assurances-non-construction-programs https://www.grants.gov/system-to-system/applicant-system-to-system/ https://www.grants.gov/system-to-system/applicant-system-to-system/…