HHS awards $22M for NIH Regulatory Affairs Support to Technical Resources International, Inc

Contract Overview

Contract Amount: $22,060,684 ($22.1M)

Contractor: Technical Resources International, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2015-06-26

End Date: 2023-07-28

Contract Duration: 2,954 days

Daily Burn Rate: $7.5K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 6

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: IGF::OT::IGF DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES: REGULATORY AFFAIRS SUPPORT

Place of Performance

Location: BETHESDA, MONTGOMERY County, MARYLAND, 20817

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $22.1 million to TECHNICAL RESOURCES INTERNATIONAL, INC. for work described as: IGF::OT::IGF DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES: REGULATORY AFFAIRS SUPPORT Key points: 1. Contract awarded to Technical Resources International, Inc. for $22.06M. 2. The contract supports the NIH Division of Microbiology and Infectious Diseases. 3. It falls under NAICS code 541711 (Biotechnology R&D). 4. The contract was awarded via full and open competition after exclusion of sources. 5. This is a definitive contract with a Cost Plus Fixed Fee pricing structure.

Value Assessment

Rating: good

The Cost Plus Fixed Fee structure can lead to cost overruns if not managed carefully. However, the contract duration and value suggest a potentially reasonable price for the services rendered, pending detailed cost analysis.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded through full and open competition after exclusion of sources, indicating an attempt to ensure fair pricing. However, the 'exclusion of sources' clause warrants further investigation into why specific sources were excluded and its potential impact on price discovery.

Taxpayer Impact: The competitive process aims to secure fair pricing, but the exclusion of sources could potentially limit optimal price discovery, impacting taxpayer value.

Public Impact

Supports critical research and development in infectious diseases. Ensures regulatory compliance for NIH-funded projects. Facilitates the advancement of biotechnology research. Impacts public health through support of disease research.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns with Cost Plus Fixed Fee.
Need to understand 'exclusion of sources' rationale.
Small business participation not indicated.

Positive Signals

Supports critical NIH mission.
Awarded through competitive process.
Long contract duration suggests stable support.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, specifically supporting regulatory affairs for the National Institutes of Health. Spending in this sector is driven by federal investment in scientific advancement and public health initiatives.

Small Business Impact

The data indicates that small business participation was not a factor in this award (ss: false, sb: false). Further analysis would be needed to determine if opportunities for small businesses were overlooked or if the nature of the requirement precluded their involvement.

Oversight & Accountability

The contract's long duration and cost-plus structure necessitate robust oversight from HHS and NIH to ensure cost control and adherence to regulatory requirements. Regular performance reviews and audits are crucial for accountability.

Related Government Programs

Research and Development in Biotechnology
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Cost Plus Fixed Fee pricing structure.
Potential for cost overruns.
Rationale for 'exclusion of sources' unclear.
No indication of small business participation.
Long contract duration requires sustained oversight.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $22.1 million to TECHNICAL RESOURCES INTERNATIONAL, INC.. IGF::OT::IGF DIVISION OF MICROBIOLOGY AND INFECTIOUS DISEASES: REGULATORY AFFAIRS SUPPORT

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 $22.1 million.

What is the period of performance?

Start: 2015-06-26. End: 2023-07-28.

What was the specific rationale for excluding certain sources in the 'full and open competition after exclusion of sources' award method, and did this exclusion impact the final contract price?

The rationale for excluding specific sources requires further investigation. Typically, such exclusions are based on unique capabilities, proprietary information, or specific national security concerns. Understanding this rationale is crucial to assess whether it legitimately enhanced competition or potentially limited price discovery, thereby impacting the final contract value and taxpayer investment.

How effectively has Technical Resources International, Inc. managed costs under the Cost Plus Fixed Fee structure throughout the contract's duration, and what mechanisms are in place to prevent cost o

Assessing cost management effectiveness requires reviewing performance reports, audit findings, and any incurred cost adjustments. The Cost Plus Fixed Fee structure inherently carries a risk of cost escalation. Robust oversight, clear performance metrics, and regular financial reviews by the contracting agency are essential to mitigate this risk and ensure the contractor operates efficiently within the agreed-upon fee.

What is the measurable impact of this regulatory affairs support on the efficiency and success rate of NIH's infectious disease research and development pipeline?

Measuring the direct impact involves analyzing key performance indicators related to the speed of regulatory approvals, the number of research protocols successfully navigated, and the overall contribution to advancing infectious disease research projects. Quantifying this impact could involve tracking timelines, success rates of submissions, and feedback from research teams benefiting from the support.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in 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: NIAIDDMIDNIHAI2014004

Offers Received: 6

Pricing Type: COST PLUS FIXED FEE (U)

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: $22,060,684

Exercised Options: $22,060,684

Current Obligation: $22,060,684

Actual Outlays: $2,790,628

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline