{"database": "openregs", "table": "crs_reports", "rows": [["IF13240", "Connecting Constituents with Federal Assistance for Health and Medical Businesses", "2026-06-02T04:00:00Z", "2026-06-06T05:53:06Z", "Active", "Resources", "Kate M. Costin, Michele L. Malloy", "Small Business Technology Transfer (STTR), Health & Medical R&D, Small Business, Technology & Innovation, Prescription Drugs, Health Care Delivery, SBA 8(a) Business Development Program, Small Business Innovation Research (SBIR), FDA Product Regulation & Medical Research", "Federal assistance for health- and medical-related groups primarily focuses on nonprofit organizations. For-profit health and medical businesses do not qualify for many of these opportunities. However, these businesses may qualify for other business-related federal assistance. Health and medical businesses include medical equipment companies, digital health companies, for-profit health care facilities, and medical device and pharmaceutical manufacturers, among others.\nFederal agencies assist businesses through a number of credit and technical assistance programs. With few exceptions, the federal government typically does not award grants for starting or expanding for-profit businesses. Exceptions include certain federal grants that may be available for businesses involved in research and development (R&D) activities (e.g., the Small Business Research Programs\u2014see CRS Report R43695, Small Business Research Programs: SBIR and STTR). Agencies may also contract with businesses.\nThis In Focus includes a summary of selected federal agencies and programs that provide business assistance such as loans, business counseling, and other forms of technical assistance to health and medical businesses. These programs vary in scope, funding levels, and availability, and their relevancy to meeting the needs of specific businesses also varies. This In Focus does not represent a comprehensive list of all potentially relevant federal assistance programs for health and medical businesses, nor does it cover federal contracting preferences and tax incentives.\nFor broader business assistance opportunities, including those from the Small Business Administration (SBA), see CRS In Focus IF12449, Connecting Constituents with Federal Assistance for Businesses.\nSpecific information about health care facilities is available in CRS Report R48081, Sources of Federal Funding for Health Care Facilities: Frequently Asked Questions.\nHealth and Human Services (HHS)\nOffice of Small and Disadvantaged Business Utilization (OSDBU)\nHHS partners with the SBA to support small business contractors. OSDBU, in conjunction with the SBA, supports several programs for small businesses:\nThe 8(a) Business Development Program supports small businesses owned by socially or economically disadvantaged people or entities competing for federal contracts. The SBA supports eligible entities through federal contracting opportunities, training, and technical assistance. Several CRS publications discuss the 8(a) Business Development Program, including CRS In Focus IF12458, The SBA\u2019s 8(a) Business Development Program. \nThe HUBZone program supports small businesses located in historically underutilized business areas. HUBZone-certified businesses are eligible for contract set-asides and sole-source awards. For more information, see CRS In Focus IF12428, The SBA\u2019s Historically Underutilized Business Zone (HUBZone) Program.\nAccording to the HHS website, \u201ceach year, the federal government aims to award at least 5% of all federal contracting dollars to Service-Disabled Veteran-Owned Small Businesses (SDVOSB).\u201d Businesses must be certified by the SBA under the SDVOSB program and may receive contract set-asides and sole-source awards.\nHHS sets aside certain federal contracts for eligible Women-Owned Small Businesses and Economically Disadvantaged Women-Owned Small Businesses. Entities must certify their eligibility through the SBA.\nOSDBU hosts the Small Business Customer Experience Portal, a database providing information on HHS programs\u2014including contracting opportunities and potential engagement opportunities with industry partners\u2014and a Small Business Directory.\nNational Institutes of Health (NIH)\nThe NIH Seed Fund is another SBA partnership that provides funding for small businesses through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs.\nSBIR contracts are funding opportunities available to small businesses that meet specific needs, as identified by NIH.\nSBIR and STTR grant funding opportunities are for small business entrepreneurs seeking non-dilutive funding (capital received that does not require giving up equity or ownership) for early-stage R&D. STTR grants require partnership with nonprofit research institutions.\nThe Small Business Transition Grant is awarded to  early-career scientists and professionals with research, technology development, and/or health care delivery skills and experience. Applicants must have limited entrepreneurial and independent (non-mentored) research leadership experience.\nThe Technical and Business Assistance Programs help small businesses identify and address certain product development needs. Funding can support assistance with product sales, intellectual property protections, market research, development of regulatory and manufacturing plans, and access to technical and business literature available through online databases.\nFood and Drug Administration (FDA)\nFDA research programs provide initiatives encouraging small businesses to meet federal research and development needs, increase private sector commercialization of innovations derived from federal R&D, and foster and encourage participation by minority and disadvantaged persons in technological innovation. \nInformation on small business assistance available through several FDA centers is available through the FDA\u2019s website. Examples of FDA funding avenues small businesses may qualify for include the following: \nThe FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science is an example of an agency-wide BAA established to support R&D in regulatory science and innovation.\nThe Center for Biologics Evaluation and Research Advanced Technologies Program supports development and adoption of advanced technologies to modernize biopharmaceutical manufacturing.\nThe Office of Regulatory and Emerging Science provides funding for extramural medical countermeasures (MCMs) regulatory science research to promote MCM safety, efficacy, quality, and performance.\nCenters for Medicare and Medicaid Services (CMS)\nCMS does not provide grant or loan funding directly to businesses. However, as the agency overseeing Medicare, Medicaid, the Children\u2019s Health Insurance Program, and the Health Insurance Marketplace, CMS has some initiatives that may involve health and medical businesses.\nIn order to bill Medicare for services provided, providers of medical care and suppliers of durable medical equipment, prosthetics/orthotics, and supplies can obtain national provider identifiers and complete the enrollment process. Businesses creating or supplying services or items they want Medicare to cover may seek details about the Medicare coverage determination processes. See CRS In Focus IF13031, Medicare Coverage: Background and Resources, for more information.\nThe CMS Innovation Center, also referred to as the Center for Medicare and Medicaid Innovation, develops and tests health care payment and service delivery options to improve patient care, lower costs, and align payment systems to promote patient-centered practices. Though participants in these pilot or demonstration programs are generally already Medicare providers, some opportunities (such as one current model to test healthy lifestyle interventions) more broadly include health care businesses, including technology companies. Businesses can search current models or sign up for updates.\nCMS also hosts initiatives that may seek participation or feedback from businesses. For example, their Health Technology Ecosystem initiative includes a Medicare App Library seeking developer applications.\nHealth care businesses seeking to become Medicaid providers may enroll with their state Medicaid agencies.\nBiomedical Advanced Research and Development Authority (BARDA)\nBARDA partners with industry to support the late state development of MCMs in order to respond to health security threats. Threats include chemical, biological, radiological, and nuclear accidents; incidents and attacks; pandemic influenza; and emerging infectious diseases.\nFunding to support industry partners specializing in developing MCMs may be available through the BARDA BAA.\nAdditional Resources\nCongressional offices and businesses may consult several additional potential sources of funding or training, including the following:\nState and local government agencies are often involved in administering grants and incentives for economic development purposes. Constituents can contact their state economic development organizations for additional assistance, incentives, or loan options. They can also contact their state health departments or view listed funding opportunities.\nThe resources at USA.gov broadly identify the government financing programs that may be available to help finance an existing business.\nThe Rural Health Information Hub provides state and topical guides that discuss funding opportunities. These guides are focused on rural areas and funding may or may not be available to for-profit organizations.\nThe SBA\u2019s Small Business Development Centers provide free counseling, training, and resources to small business owners and entrepreneurs. See CRS In Focus IF12402, The SBA\u2019s Small Business Development Centers Program.\nSCORE, an SBA partner organization, is a nonprofit association dedicated to helping nonprofits and small businesses achieve their goals through education and mentorship.", "https://www.congress.gov/crs_external_products/IF/PDF/IF13240/IF13240.1.pdf", "https://www.congress.gov/crs_external_products/IF/HTML/IF13240.html"]], "columns": ["id", "title", "publish_date", "update_date", "status", "content_type", "authors", "topics", "summary", "pdf_url", "html_url"], "primary_keys": ["id"], "primary_key_values": ["IF13240"], "units": {}, "query_ms": 0.188304009498097, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}