NIA 23-009160

Post Date/ Solicitation Issue Date

July 28, 2023 12:00 pm

Closing Response Date

August 7, 2023 12:00 pm

Proposed Award Date

August 10, 2023 12:00 pm

Project Title

Services to Conduct Brain Autopsies and Post-mortem MRI in BLSA Autopsy Donors

Contracting Office

National Institute on Aging (NIA)

Small Business Size Standard

$19M

FPDS Classification Code

Q301

Estimated Period of Performance

September 27, 2023 - September 26, 2024

Delivery of Goods

N/A

Competition Status

Non-Competitive

Single-Sole Source Determination

Statutory Authority: This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand name or industrial mobilization).

The purpose of this acquisition is to procure services to Conduct Brain Autopsies and Post-mortem MRI in BLSA Autopsy Donors for the National Institute on Aging (NIA.

This notice of proposed acquisition is posted as an intent to award to John Hopkins Medical Institutions as no source other than the JHMI Division of Neuropathology can meet the requirements of this contract. The brain autopsies must be performed in the JHMI Division of Neuropathology for consistency with prior autopsies, because participants have made arrangements for their bodies to be delivered to JHMI upon their death, and due to the fact that the BLSA brain repository is maintained by JHMI Division of Neuropathology as part of the Johns Hopkins Alzheimer’s Disease Research Center (ADRC). The postmortem MRI scans must be performed at JHMI because the body will be at the facility and postmortem interval, i.e., time between death and performance of the autopsy, must be minimized.

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 2023-04 dated June 2, 2023.

The purpose of this requirement is for the Laboratory of Behavioral Neuroscience (LBN) at the National Institute on Aging (NIA) to obtain brain autopsies for post-mortem assessment of brain pathology and post-mortem MRI scans of BLSA participants coming to autopsy.  The Contractor will perform autopsies and histological analysis of prior autopsy specimens for BLSA autopsy participants, regardless of clinical diagnosis, and will acquire MRI scans where feasible.   A specific focus will be the relation of in vivo brain amyloid-beta amyloid and tau deposition, as demonstrated by PET scanning, with amyloid-beta and tau deposition in postmortem tissues. 

Project Background:  

The purpose of this research program by the Laboratory of Behavioral Neuroscience (LBN) is to enhance understanding of age-associated physical and biological changes in health and disease. LBN investigates structural and functional brain changes and how they relate to age-associated changes in cognition, including the development of Alzheimer’s disease (AD), and factors that modify cognitive and brain aging. The BLSA autopsy program involves a long-standing arrangement with the Johns Hopkins Alzheimer’s Disease Research Center (ADRC), whereby brain autopsies are conducted in the Division of Neuropathology of Johns Hopkins Hospital. 

The overall goal is to understand the biological substrates of age-related cognitive decline and cognitive resilience. To this end, there is a continued need for autopsy studies and post-mortem MRI’s to allow investigation of the relationship between antemortem cognitive and brain changes, including in vivo amyloid and potentially tau imaging studies with brain pathology at autopsy.  Continuation of postmortem MRI studies will provide new imaging data on participants for whom imaging data were not acquired antemortem and will provide postmortem imaging data for imaging-pathology correlations for individuals with prior imaging studies, especially to examine the associations between in vivo amyloid and tau imaging and post-mortem immunohistochemistry.  A second focus will be to examine the relation between tau deposits and cognitive and affective status of BLSA participants who have come to autopsy.

SCOPE OF WORK

GENERAL REQUIREMENTS:  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:

SPECIFIC REQUIREMENTS:  

Specifically, the Contractor will provide the following services:

• Prepare tissues from the BLSA brain bank for research studies and perform immunohistochemistry.
• Perform postmortem MRI studies for two (2) individuals as some BLSA participants coming to autopsy are local and thus eligible for MRI scans.
• Investigate the relation of in vivo brain amyloid and tau deposition, measured by PET scanning, with amyloid and tau deposits in postmortem tissues.
• Investigate the relation between amyloid and tau deposits and antemortem cognition and affect.
• Participate in writing initial drafts of the findings and analyses and in editing manuscripts to obtain the final submitted version.

The brain autopsies must be performed in the JHMI Division of Neuropathology for consistency with prior autopsies, because participants have made arrangements for their bodies to be delivered to JHMI upon their death, and due to the fact that the BLSA brain repository is maintained by JHMI Division of Neuropathology as part of the Johns Hopkins Alzheimer’s Disease Research Center (ADRC).

GOVERNMENT RESPONSIBILITIES

The Government will provide the contractor with MRI and PET images and other necessary information for analysis of autopsy data in relation to imaging, cognition and affect.

DELIVERY OR DELIVERABLES

Description of Tasks and Associated Deliverables:

• Prepare additional tissues from the BLSA brain bank for research studies and perform and quantify immunohistochemistry.
• Perform postmortem MRI studies for 2 individuals since some BLSA participants coming to autopsy are local and thus eligible for MRI scans.

• Provide results of analysis of in vivo brain amyloid and tau deposition in relation to postmortem findings, including use of whole hemisphere brain sections where possible.

REPORTING REQUIREMENTS

Electronic project report in the form of an excel spreadsheet describing:

1. List of autopsies performed, including BLSA ID, date of death, cause of death and post-mortem interval;
2. Pathological diagnoses, including CERAD and Braak scores, information on infarcts, vascular disease, and Lewy-Body disease;
3. Results of immunohistochemical analyses;
4. List of postmortem MRI scans performed, including BLSA ID and date of scan.

OTHER CONSIDERATIONS

TRAVEL:  No travel is required. However, contractor should interact with the key NIA scientist involved in these studies via phone and Email, as necessary.

KEY PERSONNEL:  Senior Researcher

DATA RIGHTS:  The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer.  In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” is hereby incorporated by reference and made a part of this contract/order.

PUBLICATIONS AND PUBLICITY:  The Contractor is not required to write or publish articles of data in relation to the SOW.  The Contractor may not include the results of this contract in any publication or public materials. NIA may publish the results of the study, and if so, the contractor may be cited in this publication.

CONFIDENTIALITY OF INFORMATION:  N/A 

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. NIH Blanket Purchase Agreement (BPA) Number:
5. SAM 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 (Nov 2021) is applicable to this solicitation.
2. FAR Provision 52.212.2 Evaluation-Commercial Items (Nov 2021) 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 (DEC 2022) is applicable to this solicitation. 
4. FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (DEC  2022) is applicable to this solicitation.
5. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services (June 2023) is applicable to this solicitation.
6.  FAR Clause 52.227-14, Rights in Data-General

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

1. 52.204-7 System for Award Management (Oct 2018),
2. 52.204-13 System for Award Management Maintenance (Oct 2018),
3. 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020),
4. 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020)
5. HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)
6. FAR 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023)

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 (Nov 2021)
2. FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
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 August 7, 2023 at 12 pm EST and must reference announcement/ solicitation number NIA-23-009160. Responses may be submitted electronically to Carla Blalock (Carla.blalock@nih.gov). Fax responses will not be accepted.