NIA-22-008504

Submitted by mahonkg on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Analyses of Relations of Plasma Neurofilament Light to MRI Markers of ADRD Risk and Brain Aging
Contracting Office
National Institute on Aging (NIA)

Contact Points

Primary Contract Specialist

Wiwa
Lui
wiwa.lui@nih.gov
NAICS Code Number
611310
Colleges, Universities and Professional Schools
Small Business Size Standard
$30.5M
FPDS Classification Code
R499
Estimated Period of Performance
8/1/22-7/31/2023
Set-Aside Status
Not Set Aside
Competition Status
Non-Competitive
Vendor Name
University of Maryland, Baltimore County (UMBC)
Vendor Address
1000 Hilltop Circle
Baltimore, MD 21250-0001
Single-Sole Source Determination
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1 ), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures and at a dollar value less than the simplified acquisition threshold are exempt from the requirements of FAR Part 6- Competition Requirements.

This notice of proposed acquisition is posted an intent to award to UMBC as this is the only entity that is capable of providing the required services. The University of Maryland at Baltimore County acquired the relevant MRI brain images from NIA Healthy Aging in Neighborhoods of Diversity study (HANDLS) participants via an ancillary study under NIA grant 2011-2015. Under this ancillary study, MRI data was collected to examine relationships of brain health with age, sex, race, and poverty status. Dr. Shari Waldstein was the principal investigator of that study and responsible for obtaining the MRI brain images now needed for this requirement.

UMBC has provided a sole source letter stating that Dr. Waldstein's lab at the University of Maryland is uniquely poised to directly address the objectives of this requirement for the reasons above and because she has recently examined relations of plasma NfL to select brain volumes and white matter integrity in our HANDLS neuroimaging sub-study. The letter also states that her data offers the only available source to determine whether NfL identifies disproportionate midlife MRI-assessed risk markers for Alzheimer’s dementia, vascular dementia, and accelerated brain aging among African Americans both independently of, and/or interactively as a function of poverty status, sex, and age cohort. Evidence of Dr. Waldstein’s lab as the sole source available to perform this work is derived from her prior use of HANDLS data, availability of the needed MRI data, and associated peer-reviewed publications


Background/Description of Requirement

This acquisition is being conducted under Federal Acquisition Regulations (FAR) Part 13 – Simplified Acquisition Procedures, and the resultant contract award will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-06 dated May 26, 2022.

As part of ongoing studies of health disparities in physical and psychological health, the National Institute on Aging (NIA) requires analyses of the utility of neurofilament light protein as a biomarker across levels of race and poverty status in relation to MRI markers of Alzheimer’s disease. These analyses will inform subsequent planned studies by NIA investigators on the changes in this assay, which is less time consuming and expensive than repeated MRIs on large samples of participants.

Background Information and Objective:

Health disparities in African Americans adults and adults with low socioeconomic status led to excess risk for poor brain health, especially for Alzheimer’s disease (AD) and AD-related dementias (ADRD). The excess risks experienced by these individuals is consistent with the notion that health disparities lead to earlier onset of more severe subclinical and clinical morbidity and mortality at younger ages. Alzheimer’s disease is 2-3 times more prevalent among African American than non-Hispanic, white adults. MRI images of the brain were obtained via an ancillary study during 2011-2015 and neurofilament light protein data are available on a subset of participants.

SCOPE OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

The Contractor shall provide the following services:

  • Use existing MRI data, collected by the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) study performed by the NIA Intramural Research Program and collected in an ancillary grant to the University of Maryland to examine relationships of brain health with age, sex, race, and poverty status. The existing MRI data collected on HANDLS participants shall be used as the bases for these analyses
  • Demonstrate previous analyses of MRI data from HANDLS participants combined with other sources of data from HANDLS.
  • Prepare the data, analyze the data, report, and interpret the results.

LEVEL OF EFFORT:

A senior researcher is required to perform these analyses and interpret the results.  The NIA estimates that the level of effort for this requirement shall be on 130 hours over one year. The contractor employee shall be considered key personnel.

GOVERNMENT RESPONSIBILITIES

The Government will supply demographic and NFL assay data on participants for whom the University of Maryland has previously acquired MRI images.

DELIVERY OR DELIVERABLES

Summaries of analyses and a draft manuscript interpreting results suitable for publication in a peer-reviewed journal.

REPORTING REQUIREMENTS

None required. The deliverable serves as the final project report.

Key Personnel:

The contractor employee providing service shall be considered key personnel.  The      contractor employee must meet the following key personnel requirements:

  • A senior researcher with backgrounds in neuroanatomy, brain imaging, and statistical analyses.
  • Proven publication experience in scientific literature.

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:

The key personnel specified in this contract are essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

CONTRACT TYPE: A Firm Fixed Price type order award not exceeding the Simplified Acquisition Threshold is anticipated to be awarded resulting from this requirement.

SUMMARY STATEMENT:

The Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), certification of country of ownership, and the certification of business size must be included in the response.
All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

Quoter Terms and Conditions (To be completed by the Offeror):

1. Period of Performance OR Delivery Date After Receipt of Order:

2. Shipping Point (F.O.B. OR Destination):

3. Payment Discount Terms:

4. Open Market; GSA FSS Contract Number; Other Government Agency (OGA) Contract Number, Government-wide Agency (GWAC) Contract Number; or National Institute of Health (NIH) Blanket Purchase Agreement (BPA) Number:

5. SAM Unique Entity Identifier (UEI) No:

6. Name of Company:

7. Street Address, City, State, Zip code:

8. Name of Person Authorized to Provide Quote:

9. Telephone Number and Email Address of Person Authorized to Provide Quote:

ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

The FAR Clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/

1. FAR Provision 52.212-1 Instructions to Offerors-Commercial Items (Sept 2021) is applicable to this solicitation.

2. FAR Provision 52.212.2 Evaluation-Commercial Items (Oct 2014) is applicable to this solicitation. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: Technical capability of the item offered to meet the Government requirement; Price; and Past performance [see FAR 13.106-2(b)(3)]

3. FAR Provision 52.212-3, Offeror Representations and Certifications-Commercial Items (Feb. 2021), is applicable to this solicitation 

4. FAR Clause 52.213-4, Terms and Conditions-Simplified Acquisitions (Other than Commercial Products and Commercial Services).  (Jan. 2022), is applicable to this solicitation.

In addition, the following FAR provisions and clauses are applicable to this solicitation and incorporated by reference: 

52.204-7 System for Award Management (Oct 2018), 

52.204-13 System for Award Management Maintenance (Oct 2018), 

52.204-16 Commercial and Government Entity Code Reporting (Aug 2020), 

52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020),

HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015).

The following provisions and clauses apply to this acquisition and are incorporated as an attachment.  Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their quotation.

  1. FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)
  2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2020)
  3. FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
  4. NIH Invoice and Payment Provisions

All responses must be received by July 29 , 2022, at 2pm EST and must reference announcement/ solicitation number NIA-22-008784. Responses may be submitted electronically to Wiwa Lui (wiwa.lui@nih.gov). Fax responses will not be accepted.

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.