How to Get HHS Contracts: Complete Guide to Department of Health & Human Services Contracting

The Department of Health and Human Services (HHS) is the second-largest federal agency by budget, with over $30 billion in annual contract spending across healthcare, biomedical research, public health, and social services. HHS operates critical agencies including the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS).

Why Pursue HHS Contracts:

HHS offers unique opportunities for businesses across multiple sectors - far beyond just healthcare providers. The department needs:

Research and Development
NIH alone spends over $20 billion annually on biomedical research contracts, including lab services, clinical trials management, data analysis, scientific equipment, and specialized consulting. Small businesses with scientific expertise can compete for multi-million dollar research contracts.

Healthcare IT and Data Analytics
CMS and FDA require massive IT infrastructure to manage healthcare data, claims processing, electronic health records integration, and data security. The healthcare IT contracting market within HHS exceeds $5 billion annually.

Public Health Services
CDC contracts for disease surveillance, laboratory testing, vaccine distribution logistics, emergency response, and public health education campaigns. The COVID-19 pandemic expanded this market significantly.

Facilities and Support Services
With research campuses, laboratories, and administrative offices nationwide, HHS needs facilities maintenance, laboratory support, security services, administrative support, and professional services.

Annual Contract Spending by HHS Operating Division:

• NIH: $20-22 billion (biomedical research, clinical trials, lab services)
• CMS: $3-4 billion (IT systems, data analytics, program integrity)
• CDC: $2-3 billion (lab services, public health programs, emergency response)
• FDA: $1-2 billion (lab testing, IT systems, regulatory support)
• ACF/HRSA/Other: $2-3 billion (social services, healthcare programs, grants management)

Who Should Pursue HHS Contracts:

HHS is ideal for contractors in:

• Biomedical and clinical research firms


• Healthcare IT and software development companies


• Laboratory and scientific services providers


• Data analytics and consulting firms


• Healthcare administration and program management


• Facilities management for research and medical facilities


• Medical device and pharmaceutical testing services

To compete for HHS contracts, you must complete several registration steps:

1. SAM.gov Registration (Required)

Register at sam.gov with:

• DUNS/UEI number


• TIN (Tax Identification Number)


• NAICS codes for your services (541714 for research, 541512 for IT, 621999 for healthcare services)


• Banking information for payment


• Representations and certifications

Processing time: 2-3 weeks. Free to register (beware of third-party scam sites charging fees).

2. ORCA Small Business Certifications (Recommended)

If you qualify, obtain certifications for:

• Small Business (SB)


• Women-Owned Small Business (WOSB) - HHS has 5% WOSB goal


• 8(a) Business Development - access to sole-source opportunities up to $4M


• Service-Disabled Veteran-Owned (SDVOSB)


• HUBZone

HHS awards billions in set-aside contracts - certification reduces competition by 80-90%.

3. NIH NITAAC Registration (For IT Contracts)

NIH Information Technology Acquisition and Assessment Center (NITAAC) operates three major IT contract vehicles:

• CIO-SP4: Small business IT contracts ($20B ceiling)


• CIO-CS: Commodity IT products and services


• CIO-SP3: Large business IT contracts

Register at nitaac.nih.gov if you provide IT services to compete for NIH and other HHS IT work.

4. HHS Small Business Office Registration

Register with the HHS Office of Small and Disadvantaged Business Utilization (OSDBU):

• Create profile at hhs.gov/grants/contracts/get-ready-to-do-business-with-hhs


• Receive notifications of upcoming opportunities


• Access mentor-protege matching services

Additional Requirements for Research Contracts:

If competing for NIH or CDC research contracts, you may need:

• CLIA Certification (Clinical Laboratory Improvement Amendments) - required for clinical lab testing


• AAALAC Accreditation - for animal research facilities


• IRB Approval - Institutional Review Board for human subjects research


• Facility Security Clearance - for select agent research or classified programs

HHS contracts span diverse categories. Here are the highest-value opportunities:

1. Biomedical Research and Clinical Trials ($15B+ annually)

NIH contracts for research support services:

• Clinical trial site management and patient recruitment


• Laboratory services (histology, genomics, proteomics, imaging)


• Bioinformatics and data analysis


• Preclinical research (animal studies, toxicology)


• Scientific consulting and subject matter expertise

Typical contract values: $500K-$10M per contract, 1-5 year base periods with options

Entry strategy: Subcontract to established NIH contractors first, build relationships with Principal Investigators (PIs), target smaller NIH institutes with less competition.

2. Healthcare IT and Data Analytics ($5B+ annually)

CMS, FDA, and NIH need technology solutions:

• Electronic health records (EHR) integration and interoperability


• Healthcare data analytics and reporting platforms


• Medicare/Medicaid claims processing systems


• Clinical decision support software


• Cybersecurity and data protection for health information


• Cloud migration and IT modernization

Typical contract values: $1M-$50M per contract, multi-year IDIQs common

Entry strategy: Get on NITAAC CIO-SP4 contract vehicle, partner with healthcare IT specialists, target FDA and smaller HHS divisions before competing for large CMS contracts.

3. Laboratory and Testing Services ($3B+ annually)

CDC and FDA contract for lab capabilities:

• Diagnostic testing and assay development


• Pathogen sequencing and genetic analysis


• Environmental and water testing


• Food and drug safety testing


• Vaccine potency and stability testing


• Biosafety level 2/3 laboratory operations

Typical contract values: $250K-$5M per contract, often with multi-year options

Entry strategy: CLIA certification is critical, start with state/local public health labs to build past performance, then target CDC regional labs.

4. Public Health Program Support ($2B+ annually)

CDC and HRSA contract for program management:

• Disease surveillance and epidemiology support


• Vaccine distribution and logistics


• Public health education and outreach campaigns


• Community health program implementation


• Healthcare workforce training and development


• Grants management support for HHS grant programs

Typical contract values: $500K-$10M per contract

Entry strategy: Partner with public health experts, target specific disease programs (HIV, diabetes, maternal health), start with smaller HRSA or ACF opportunities.

5. Facilities and Administrative Support ($2B+ annually)

HHS campuses need ongoing services:

• Facilities maintenance and janitorial services for NIH campus, CDC facilities, FDA labs


• Laboratory equipment maintenance and calibration


• Security services for research facilities


• Administrative support (HR, finance, program management)


• Conference and event planning for scientific meetings

Typical contract values: $250K-$5M per contract, recurring annual opportunities

Entry strategy: These are most accessible for new contractors - less specialized than research or IT, local presence matters, competitive pricing wins.

HHS has robust small business programs and goals:

Small Business Contracting Goals:

HHS must award at least:

• 23% to small businesses overall


• 5% to Women-Owned Small Businesses (WOSB)


• 5% to Service-Disabled Veteran-Owned Small Businesses (SDVOSB)


• 3% to HUBZone businesses


• 5% to 8(a) businesses

These goals create $7+ billion in set-aside opportunities annually.

HHS Office of Small and Disadvantaged Business Utilization (OSDBU)

Free resources for small businesses:

• One-on-one counseling: Schedule sessions with HHS OSDBU specialists who review your capabilities and identify opportunities


• Matchmaking events: Quarterly events connecting small businesses with HHS program offices


• Training webinars: Monthly training on HHS acquisition process, proposal writing, past performance


• Mentor-Protege Program: Matches small businesses with established HHS contractors for teaming and subcontracting

Contact: hhs.gov/grants/contracts/get-ready-to-do-business-with-hhs or email osdbu@hhs.gov

Forecast of HHS Contracting Opportunities

HHS publishes its acquisition forecast showing upcoming opportunities by quarter:

• Contract type and estimated value


• Expected solicitation release date


• Set-aside status (unrestricted vs. small business)


• Contracting office and point of contact

Access at: hhs.gov/grants/contracts/contract-opportunities

8(a) Sole-Source at HHS

If you are 8(a) certified, HHS can award you sole-source contracts without competition:

• Up to $4 million for services


• Up to $7 million for manufacturing

HHS awards hundreds of 8(a) sole-source contracts annually. Build relationships with HHS program offices to position for direct awards.

Mentor-Protege Program Benefits

HHS operates a mentor-protege program where large contractors mentor small businesses:

• Joint venture opportunities on HHS contracts


• Training on HHS acquisition process


• Teaming agreements that meet small business subcontracting goals


• Introduction to HHS program offices

Apply through HHS OSDBU if you are a small business seeking guidance.

HHS contracts are competitive, but these strategies improve your odds:

Step 1: Choose Your Target Operating Division

Do not try to pursue all of HHS - focus on one:

• NIH: Best for research, clinical, laboratory, scientific services


• CDC: Best for public health, laboratory testing, disease surveillance, emergency response


• FDA: Best for regulatory support, lab testing, IT systems for food/drug safety


• CMS: Best for healthcare IT, data analytics, Medicare/Medicaid program support

Each division has different acquisition offices, timelines, and evaluation criteria.

Step 2: Build Relationships Before Bidding

HHS program offices want to know you before you bid:

• Attend industry days and pre-solicitation conferences


• Schedule one-on-one meetings with HHS OSDBU to discuss your capabilities


• Join professional associations (Society for Clinical Research Associates, Healthcare Information Management Systems Society)


• Connect with Principal Investigators (PIs) at NIH who may request your services in future contracts

Step 3: Start as a Subcontractor

Your first HHS contract will likely be as a subcontractor to a prime:

• Monitor sam.gov for newly awarded HHS contracts, then contact the prime to offer subcontracting services


• Register on NITAAC and respond to subcontracting opportunities posted by primes


• Reach out to established HHS contractors in your industry and offer teaming

One year of subcontracting experience builds past performance that makes you competitive as a prime.

Step 4: Target Smaller Opportunities First

Start with contracts under $1M where competition is less intense:

• Facilities services at individual NIH institutes or CDC labs


• Short-term professional services or consulting engagements


• Delivery orders under existing HHS IDIQs (if you can get on the IDIQ contract vehicle)


• 8(a) set-asides (if you are certified)

Step 5: Differentiate Your Technical Approach

HHS evaluations heavily weigh technical approach and past performance:

• Demonstrate understanding of HHS mission and specific program goals


• Provide detailed technical solution with clear methodologies


• Include resumes of key personnel with relevant healthcare/research experience


• Show past performance in similar healthcare or research environments (commercial counts)

Generic proposals lose to those that demonstrate deep understanding of HHS priorities.

Common Mistakes to Avoid:

❌ Bidding without past performance: Build subcontracting experience first
❌ Targeting large CMS or NIH contracts as first opportunity: Start smaller
❌ Generic technical approaches: HHS values specialized expertise
❌ Ignoring small business programs: Certification dramatically improves odds
❌ Not attending industry days: Missing critical information shared verbally

HHS-Specific Resources:

HHS Acquisition Resources:

• HHS Forecast: hhs.gov/grants/contracts/contract-opportunities


• HHS OSDBU: hhs.gov/grants/contracts/get-ready-to-do-business-with-hhs


• NIH NITAAC: nitaac.nih.gov (IT contract vehicles)


• NIH Office of Acquisitions: oma.od.nih.gov

Training and Events:

• HHS Small Business Events: Quarterly matchmaking and training events


• NIH Small Business Forum: Annual conference connecting small businesses with NIH acquisition community


• CDC Small Business Program: cdc.gov/contracts/small-business

Key HHS Contracting Offices:

• NIH Office of Acquisition (OA): Manages all NIH research and administrative contracts


• CDC Acquisition and Assistance Field Services Office: Manages CDC contracts


• FDA Office of Acquisitions and Grants Services: Manages FDA contracts


• CMS Office of Acquisition and Grants Management: Manages CMS IT and program support contracts

External Resources:

• GovContractScout: Get matched to upcoming HHS opportunities based on your NAICS codes and capabilities


• Healthcare Information and Management Systems Society (HIMSS): Networking for healthcare IT contractors


• National Grants Management Association: Training for HHS grants and contracts administration