NIH awards $105M contract for regulatory support, with a 7-year duration and cost-plus-award-fee structure

Contract Overview

Contract Amount: $105,428,000 ($105.4M)

Contractor: Technical Resources International, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2017-04-15

End Date: 2024-04-14

Contract Duration: 2,556 days

Daily Burn Rate: $41.2K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 2

Pricing Type: COST PLUS AWARD FEE

Sector: R&D

Official Description: IGF::OT::IGF NIAID/DIVISION OF AIDS: REGULATORY SUPPORT CENTER

Place of Performance

Location: BETHESDA, MONTGOMERY County, MARYLAND, 20817

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $105.4 million to TECHNICAL RESOURCES INTERNATIONAL, INC. for work described as: IGF::OT::IGF NIAID/DIVISION OF AIDS: REGULATORY SUPPORT CENTER Key points: 1. Contract awarded for extensive regulatory support services, indicating a significant need for specialized expertise. 2. The cost-plus-award-fee structure incentivizes performance while managing costs, but requires careful oversight. 3. A long contract duration of over 7 years suggests a stable, ongoing requirement for these services. 4. The contract was competed, but with exclusions, warranting a closer look at the competitive landscape. 5. The North American Industry Classification System (NAICS) code 541712 points to research and development services. 6. The awardee, TECHNICAL RESOURCES INTERNATIONAL, INC., has secured a substantial portion of the contract value. 7. The contract is a definitive contract, suggesting a clear scope of work and delivery expectations.

Value Assessment

Rating: good

The contract's total award value is $105.4 million over approximately seven years. While specific benchmarks for 'regulatory support' are difficult to ascertain without more granular data, the cost-plus-award-fee (CPAF) structure is common for R&D and complex service contracts where performance is hard to define upfront. This structure allows for cost reimbursement plus a fee that is tied to performance objectives, aiming for value. However, it necessitates robust oversight to ensure costs remain reasonable and the award fee is justified by achieved outcomes. Without comparable contract data for similar regulatory support services at NIH or other agencies, a precise value-for-money assessment is challenging, but the long-term nature and significant funding suggest a critical and well-utilized service.

Cost Per Unit: N/A

Competition Analysis

Competition Level: limited

The contract was awarded under 'FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES.' This indicates that while the competition was intended to be broad, certain sources were excluded prior to the solicitation. The specific reasons for these exclusions are not detailed in the provided data. The presence of two bids suggests a limited but not entirely absent competitive environment. The exclusion of sources could potentially limit price discovery and innovation compared to a truly open competition, but may have been justified by specific technical requirements or past performance.

Taxpayer Impact: The exclusion of sources means taxpayers may not have benefited from the lowest possible price that a wider, unrestricted competition might have yielded. However, if the exclusions were based on essential qualifications, the resulting contract may better meet the government's specific needs, potentially leading to better outcomes and avoiding costs associated with underqualified bidders.

Public Impact

The primary beneficiaries are likely the National Institutes of Health (NIH) and its various divisions, such as the Division of AIDS, which rely on regulatory support for their research and development activities. Services delivered include crucial regulatory guidance, compliance assistance, and documentation support for scientific research projects. The geographic impact is primarily centered around the agency's operations, likely within Maryland where the contractor is located. Workforce implications include the employment of individuals with specialized expertise in regulatory affairs and scientific research support.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The 'exclusion of sources' in the competition raises questions about whether the most competitive pricing was achieved.
The Cost Plus Award Fee (CPAF) structure, while incentivizing, can lead to cost overruns if not rigorously managed.
The long contract duration (over 7 years) could indicate a lack of market dynamism or potential for vendor lock-in if not managed proactively.

Positive Signals

The contract was competed, indicating an effort to obtain services through a formal procurement process.
The CPAF structure aims to reward high performance, potentially leading to better service delivery.
The significant funding suggests the services provided are critical to the agency's mission.
The long duration implies a stable and reliable partnership for essential services.

Sector Analysis

This contract falls within the Research and Development sector, specifically NAICS code 541712, which covers R&D in the physical, engineering, and life sciences (except biotechnology). This is a critical sector for government innovation and scientific advancement. Spending in this area is often characterized by long-term investments, complex project management, and the need for highly specialized expertise. Comparable spending benchmarks are difficult to establish without knowing the exact nature of the regulatory support, but R&D contracts can range from millions to billions of dollars depending on the scope and duration. The NIH is a major funder of R&D, and contracts like this are essential for managing its vast portfolio of research initiatives.

Small Business Impact

The provided data indicates that small business participation (ss: false, sb: false) was not a specific set-aside criterion for this contract. Therefore, there are no direct subcontracting implications or specific impacts on the small business ecosystem stemming from a set-aside requirement. The primary contractor, TECHNICAL RESOURCES INTERNATIONAL, INC., is not identified as a small business in this context. Analysis of potential subcontracting opportunities for small businesses would require further investigation into the prime contractor's subcontracting plan, if one exists.

Oversight & Accountability

Oversight for this contract would primarily fall under the National Institutes of Health (NIH) contracting officers and program managers. The Cost Plus Award Fee (CPAF) structure necessitates close monitoring of costs and performance against defined objectives to justify the award fee. Inspector General jurisdiction would apply to investigations of fraud, waste, or abuse related to the contract. Transparency is generally facilitated through contract award databases like FPDS, but detailed performance metrics and cost breakdowns are often proprietary or sensitive.

Related Government Programs

NIH Research and Development Contracts
Biomedical Research Support Services
Regulatory Affairs Consulting
Life Sciences Research Support
Federal Contract Research Organizations

Risk Flags

Limited competition due to source exclusion
Potential for cost overruns with CPAF structure
Need for robust performance monitoring

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $105.4 million to TECHNICAL RESOURCES INTERNATIONAL, INC.. IGF::OT::IGF NIAID/DIVISION OF AIDS: REGULATORY SUPPORT CENTER

Who is the contractor on this award?

The obligated recipient is TECHNICAL RESOURCES INTERNATIONAL, INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $105.4 million.

What is the period of performance?

Start: 2017-04-15. End: 2024-04-14.

What is the historical spending pattern for regulatory support services at the NIH, and how does this contract compare?

Historical spending on regulatory support services at the NIH is not explicitly detailed in the provided data. However, the award of a $105.4 million contract over seven years suggests a significant and ongoing need for these services. To provide a comparative analysis, one would need to examine historical NIH contract databases (e.g., FPDS-NG) for similar NAICS codes (like 541712 or related professional, scientific, and technical services codes) and contract types (like CPAF) awarded over previous fiscal years. This would reveal trends in contract values, durations, and the number of competitors. Without this historical context, it's challenging to definitively state if this contract represents an increase, decrease, or stable level of spending for such services. The substantial value indicates it's a major investment in this area.

What are the specific performance objectives tied to the 'award fee' in this Cost Plus Award Fee (CPAF) contract?

The specific performance objectives that determine the 'award fee' for this contract are not detailed in the provided summary data. In a CPAF contract, these objectives are typically outlined in the contract's Performance Work Statement (PWS) or Statement of Objectives (SOO). They are designed to measure the contractor's success in meeting critical requirements, such as timely delivery of high-quality regulatory documentation, adherence to specific scientific or regulatory standards, successful navigation of complex regulatory pathways, effective communication with regulatory bodies, and overall contribution to research project milestones. The contracting officer assesses performance against these predefined metrics, and the awarded fee is a percentage of the allowable costs, up to a maximum specified in the contract, reflecting the degree to which these objectives were met or exceeded.

What were the reasons for excluding certain sources in this 'Full and Open Competition After Exclusion of Sources' award?

The provided data states the contract was awarded under 'FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES' but does not specify the reasons for these exclusions. Typically, such exclusions are justified based on specific technical requirements, unique capabilities, past performance on similar critical tasks, or national security considerations. For instance, if the regulatory support required highly specialized knowledge of a particular scientific domain or experience with a unique NIH process, only a limited number of contractors might possess those qualifications. The contracting agency would need to document the justification for these exclusions, often involving a determination that only specific sources could meet the government's needs. Without this documentation, it's difficult to assess if the exclusions were appropriate or potentially limited competition unnecessarily.

How does the contractor, TECHNICAL RESOURCES INTERNATIONAL, INC., perform on other federal contracts, particularly those with similar scope or agency?

Assessing the performance of TECHNICAL RESOURCES INTERNATIONAL, INC. on other federal contracts requires access to performance evaluation data, such as Contractor Performance Assessment Reporting System (CPARS) reports. The provided data does not include this information. Generally, federal agencies use CPARS to record past performance information on contractors for contracts exceeding certain dollar thresholds. A review of CPARS would reveal ratings on factors like technical quality, cost control, schedule adherence, management, and small business utilization for this contractor's previous awards. High ratings on similar contracts, especially those involving regulatory support or R&D services for agencies like NIH or HHS, would indicate a lower performance risk for this current $105.4 million contract. Conversely, poor past performance could be a significant risk indicator.

What is the typical market size and competitive landscape for regulatory support services within the life sciences R&D sector?

The market for regulatory support services within the life sciences R&D sector is substantial and growing, driven by the complexity of drug development, medical device approval, and scientific research compliance. This market includes a range of firms, from large, established government contractors to specialized boutique consulting firms. The competitive landscape can vary significantly depending on the specific niche. For broad regulatory affairs support, competition might be moderate to high. However, for highly specialized scientific or technical regulatory support, as potentially indicated by NAICS 541712, the number of qualified bidders may be smaller. The NIH, being a primary funder of biomedical research, represents a significant customer base, attracting numerous service providers. Market size estimates would require detailed industry reports, but the overall federal spending on R&D and related support services runs into the tens of billions annually.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: NIAIDDAIDSNIHAI2015049

Offers Received: 2

Pricing Type: COST PLUS AWARD FEE (R)

Evaluated Preference: NONE

Contractor Details

Address: 6500 ROCK SPRING DR, BETHESDA, MD, 20817

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Hispanic American Owned Business, Minority Owned Business, Small Business, Special Designations, U.S.-Owned Business, Woman Owned Business

Financial Breakdown

Contract Ceiling: $105,428,000

Exercised Options: $105,428,000

Current Obligation: $105,428,000

Actual Outlays: $47,240,964

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline