NIH Awards $230M for PCCA/MMAB Gene Therapy Regulatory Support Over 3 Years

Contract Overview

Contract Amount: $230,617 ($230.6K)

Contractor: CCS Associates, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2025-05-21

End Date: 2028-05-20

Contract Duration: 1,095 days

Daily Burn Rate: $211/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 3

Pricing Type: LABOR HOURS

Sector: Healthcare

Official Description: NEW SOW FOR REGULATORY ACTIVITIES FOR PCCA AND MMAB GENE THERAPY PRODUCTS

Place of Performance

Location: SAN JOSE, SANTA CLARA County, CALIFORNIA, 95131

State: California Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $230,616.68 to CCS ASSOCIATES, INC. for work described as: NEW SOW FOR REGULATORY ACTIVITIES FOR PCCA AND MMAB GENE THERAPY PRODUCTS Key points: 1. Significant investment in gene therapy regulation highlights growing sector importance. 2. CCS Associates, Inc. secures a substantial contract for specialized consulting. 3. The contract's duration and value suggest a critical, ongoing need for these services. 4. Focus on PCCA and MMAB gene therapy products indicates specific regulatory priorities. 5. Potential for future contract growth exists if initial performance is strong.

Value Assessment

Rating: fair

The contract value of $230.6 million over three years for consulting services appears high. Benchmarking against similar scientific and technical consulting contracts is difficult without more specific service details, but the per-year cost is substantial.

Cost Per Unit: N/A

Competition Analysis

Competition Level: limited

The contract was awarded under 'FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES,' indicating a limited competition approach. This method may have restricted the pool of potential bidders, potentially impacting price discovery and overall cost-effectiveness.

Taxpayer Impact: Taxpayers are funding a significant contract for specialized regulatory consulting. The effectiveness of the chosen competition method in securing the best value for taxpayer money warrants scrutiny.

Public Impact

Ensures continued regulatory oversight for critical gene therapy products. Supports the development and approval pathways for innovative medical treatments. Contributes to public safety by ensuring compliance with health regulations. Potentially accelerates the availability of new gene therapies to patients. Funds specialized expertise within the scientific and technical consulting sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Limited competition may lead to higher costs.
Contract duration is long, increasing risk of scope creep or changing needs.
Lack of small business participation noted.

Positive Signals

Addresses a critical and growing area of healthcare innovation.
Secures essential regulatory support for advanced therapies.
Contract awarded to a single entity suggests specialized capabilities.

Sector Analysis

This contract falls within the Scientific and Technical Consulting Services sector, specifically related to healthcare and biotechnology. Spending in this area has been increasing due to advancements in areas like gene therapy, requiring specialized regulatory expertise.

Small Business Impact

The data indicates that small businesses were not involved in this contract award (sb: false). This suggests the contract was awarded to a larger entity, and there may be missed opportunities for small business participation in this significant federal spending area.

Oversight & Accountability

The contract's 'limited' competition and 'delivery order' nature warrant oversight to ensure adherence to the Statement of Work and prevent cost overruns. Regular performance reviews will be crucial for accountability.

Related Government Programs

Other Scientific and Technical Consulting Services
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Limited competition raises concerns about potential lack of cost-effectiveness.
Long contract duration (3 years) increases risk of evolving needs and scope creep.
No indication of small business participation.
Specific details on regulatory activities are absent, hindering full assessment.
High contract value requires robust oversight to ensure taxpayer value.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $230,616.68 to CCS ASSOCIATES, INC.. NEW SOW FOR REGULATORY ACTIVITIES FOR PCCA AND MMAB GENE THERAPY PRODUCTS

Who is the contractor on this award?

The obligated recipient is CCS ASSOCIATES, 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 $230,616.68.

What is the period of performance?

Start: 2025-05-21. End: 2028-05-20.

What specific regulatory activities will CCS Associates, Inc. be performing for PCCA and MMAB gene therapy products, and how do these align with NIH's strategic goals?

The specific regulatory activities are not detailed in the provided data. However, they likely encompass pre-clinical and clinical trial support, data review, compliance monitoring, and preparation for regulatory submissions. These activities directly align with NIH's mission to support biomedical research and accelerate the translation of scientific discoveries into new therapies, ensuring these advanced treatments meet safety and efficacy standards before reaching patients.

Given the limited competition, what measures are in place to ensure CCS Associates, Inc. is providing cost-effective services and avoiding potential price gouging?

While the data indicates limited competition, the contract type 'FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES' suggests some form of competitive process occurred, albeit restricted. Oversight mechanisms such as performance metrics, regular progress reports, and potentially independent cost reviews would be essential to ensure cost-effectiveness. The agency should actively monitor the contractor's adherence to the labor hour pricing structure and the overall value delivered.

How will the effectiveness of CCS Associates, Inc.'s regulatory support be measured, and what are the key performance indicators for this contract?

The effectiveness will likely be measured by the timely and accurate completion of assigned regulatory tasks, adherence to deadlines for submissions and reviews, and the quality of guidance provided to NIH and the product developers. Key performance indicators could include the number of regulatory milestones achieved, the success rate of submissions supported, and feedback from internal NIH stakeholders on the contractor's responsiveness and expertise.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Management, Scientific, and Technical Consulting Services › Other Scientific and Technical Consulting Services

Product/Service Code: SUPPORT SVCS (PROF, ADMIN, MGMT) › PROFESSIONAL SERVICES

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: 75N95025R00023

Offers Received: 3

Pricing Type: LABOR HOURS (Z)

Evaluated Preference: NONE

Contractor Details

Address: 2107 N 1ST ST STE 640, SAN JOSE, CA, 95131

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

Financial Breakdown

Contract Ceiling: $545,690

Exercised Options: $230,617

Current Obligation: $230,617

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75N95022D00013

IDV Type: IDC

Timeline