HHS Awards $9.7M for Pregnancy Safety Projects to Harvard Pilgrim Health Care

Contract Overview

Contract Amount: $9,714,571 ($9.7M)

Contractor: Harvard Pilgrim Health Care Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2024-03-29

End Date: 2027-09-29

Contract Duration: 1,279 days

Daily Burn Rate: $7.6K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: TIME AND MATERIALS

Sector: IT

Official Description: SENTINEL PDUFA VII COMMITMENT FOR PREGNANCY SAFETY DEMONSTRATION PROJECTS AND NEGATIVE CONTROL TOOL DEVELOPMENT

Place of Performance

Location: WELLESLEY HILLS, NORFOLK County, MASSACHUSETTS, 02481

State: Massachusetts Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $9.7 million to HARVARD PILGRIM HEALTH CARE INC for work described as: SENTINEL PDUFA VII COMMITMENT FOR PREGNANCY SAFETY DEMONSTRATION PROJECTS AND NEGATIVE CONTROL TOOL DEVELOPMENT Key points: 1. Contract awarded to Harvard Pilgrim Health Care Inc. for $9.7M. 2. Focus on pregnancy safety demonstration projects and negative control tool development. 3. Competition was full and open, suggesting potential for competitive pricing. 4. Sector is IT, specifically computing infrastructure and data processing.

Value Assessment

Rating: good

The award amount of $9.7M over approximately 3.5 years appears reasonable for specialized IT services related to health research. Benchmarking against similar large-scale data processing and hosting contracts would provide further context.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating multiple vendors had the opportunity to bid. This method generally promotes competitive pricing and ensures the government receives best value.

Taxpayer Impact: The use of competitive bidding is expected to result in fair pricing, maximizing the value of taxpayer funds allocated to this important health research initiative.

Public Impact

Enhances understanding of medication safety during pregnancy. Develops critical tools for future pharmaceutical research. Supports public health initiatives through improved data analysis. Potential for long-term improvements in maternal and infant health outcomes.

Waste & Efficiency Indicators

Waste Risk Score: 75 / 10

Positive Signals

Sector Analysis

This contract falls within the IT sector, specifically focusing on computing infrastructure, data processing, and web hosting. The value is moderate for a multi-year federal IT project, with benchmarks varying widely based on scope and complexity.

Small Business Impact

The data does not indicate any specific set-asides for small businesses. The prime contractor, Harvard Pilgrim Health Care Inc., is a large organization, suggesting limited direct opportunities for small businesses unless they are subcontractors.

Oversight & Accountability

The Food and Drug Administration (FDA) is the contracting agency, implying a level of oversight for health-related research. The contract duration and specific deliverables will be key to monitoring performance and accountability.

Related Government Programs

Risk Flags

Tags

computing-infrastructure-providers-data-, department-of-health-and-human-services, ma, delivery-order, 1m-plus

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $9.7 million to HARVARD PILGRIM HEALTH CARE INC. SENTINEL PDUFA VII COMMITMENT FOR PREGNANCY SAFETY DEMONSTRATION PROJECTS AND NEGATIVE CONTROL TOOL DEVELOPMENT

Who is the contractor on this award?

The obligated recipient is HARVARD PILGRIM HEALTH CARE INC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Food and Drug Administration).

What is the total obligated amount?

The obligated amount is $9.7 million.

What is the period of performance?

Start: 2024-03-29. End: 2027-09-29.

What is the specific methodology for developing the negative control tools and how will their effectiveness be validated?

The contract details should outline the specific scientific and technical methodologies to be employed in developing the negative control tools. Validation will likely involve rigorous testing against established benchmarks and expert review to ensure accuracy and reliability in identifying non-causal relationships, thereby strengthening the integrity of the pregnancy safety data.

How will the data generated from these projects be made accessible to the broader research community?

The accessibility of the generated data is crucial for maximizing its impact. The contract should specify protocols for data anonymization, standardization, and sharing mechanisms, such as secure data repositories or public-facing portals. This ensures that researchers can leverage the findings to advance maternal health knowledge.

What are the key performance indicators (KPIs) for measuring the success of the pregnancy safety demonstration projects?

Key performance indicators will likely focus on the successful completion of project milestones, the quality and completeness of the data collected, and the development of functional negative control tools. The FDA will monitor adherence to timelines, budget, and scientific rigor, with ultimate success measured by the contribution to improved understanding of drug safety in pregnancy.

Industry Classification

NAICS: InformationComputing Infrastructure Providers, Data Processing, Web Hosting, and Related ServicesComputing Infrastructure Providers, Data Processing, Web Hosting, and Related Services

Product/Service Code: SPECIAL STUDIES/ANALYSIS, NOT R&DSPECIAL STUDIES - NOT R and D

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: TIME AND MATERIALS (Y)

Evaluated Preference: NONE

Contractor Details

Address: 93 WORCESTER ST, WELLESLEY, MA, 02481

Business Categories: Category Business, Corporate Entity Tax Exempt, Nonprofit Organization, Not Designated a Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $9,714,571

Exercised Options: $9,714,571

Current Obligation: $9,714,571

Actual Outlays: $4,644,566

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75F40119D10037

IDV Type: IDC

Timeline

Start Date: 2024-03-29

Current End Date: 2027-09-29

Potential End Date: 2027-09-29 00:00:00

Last Modified: 2026-02-09

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