Inactive

COMBINED SYNOPSIS / SOLICITATION COMPETITIVE Title: Early Markers of Alzheimer’s Disease: PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA) (i) This is a combined synopsis/solicitation f... COMBINED SYNOPSIS / SOLICITATION COMPETITIVE Title: Early Markers of Alzheimer’s Disease: PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA) (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is conducted under the authority of 42 U.S.C. 287(a). (ii) The solicitation number is 75N95023Q00065 and the solicitation is issued as a request for quote (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-01 dated December 30, 2022. (iv) The associated NAICS code is 621512 – Diagnostic Imaging Centers, and the small business size standard is $16.5 million. This requirement utilizes full and open competition. (v) Project Background: Advances in molecular imaging with positron emission tomography (PET) have allowed a window into the hallmark pathologies of AD in living humans. The ability to image amyloid plaques and tau tangles in vivo is impacting the conduct of clinical trials, including verifying target engagement, informing patient selection, and advancing therapeutic monitoring and outcomes. Importantly, PET molecular imaging tools also are now widely applied in research studies of individuals without cognitive impairment to identify the earliest stages of AD and elucidate the temporal sequence of events leading to cognitive impairment and AD. Information on biomarker status also provides the opportunity to study age-related cognitive changes in individuals without (as well as with) AD pathology. The National Institute on Aging (NIA) initiated amyloid PET imaging with Pittsburgh compound B (PiB) in the Baltimore Longitudinal Study of Aging (BLSA) in 2005 and tau PET imaging with AV-1451 (T-807) in 2016. Consistent with autopsy data from BLSA and other studies, approximately 30% of cognitively normal individuals have detectable amyloid deposition in the brain on amyloid PET imaging. Individuals with higher levels of ?-amyloid are older, more likely to carry the Apolipoprotein E ?4 allele, have greater longitudinal decline in memory and other cognitive functions, and are more likely to accumulate amyloid and show tau progression over time. In addition, through the BLSA autopsy program, we have shown the correspondence between in vivo imaging and post-mortem values of amyloid burden. Work by our group has been central to defining the relationship between amyloid burden and memory change, to characterizing the magnitude and spatial pattern of progression of amyloid burden and its relation to tau progression, to highlighting the importance of individuals with intermediate amyloid levels that would be considered PiB negative in many binary classification schemes, and to identifying modifiers of amyloid burden. The NIA has also developed an approach for estimating age at onset of amyloid accumulation, providing an individualized index that can be used as a dependent outcome to assess factors that may modify age at onset of amyloid accumulation. This approach was applied to demonstrate that Apolipoprotein E ?4 genotype is associated with earlier age of onset of amyloid accumulation in the BLSA sample. The BLSA was initiated in 1958 and is a multi-disciplinary study of physiologic and psychologic aspects of normal aging in community-dwelling men and women. Since 1994, the NIA has been conducting a longitudinal brain imaging study of selected older adults in the BLSA to characterize individual differences in longitudinal brain changes, to investigate the extent to which these brain changes underlie individual differences in cognitive aging, to identify brain changes that may be predictors of cognitive decline and Alzheimer’s disease (AD), and to assess the impact of potential modulators of brain and cognitive aging. More recently, the NIA has been using PET scanning to acquire in vivo measures of brain amyloid and tau, the hallmark pathologies of AD. (vi) Project Requirements: This is anticipated to be an indefinite delivery/indefinite quantity contract using primarily fixed-price delivery orders. The contractor shall perform amyloid and tau PET scans and CT scans and shall transfer in a timely manner all images and associated data, as specified by the NIA. As NIA cannot predict with absolute accuracy how many scans will be needed, a range will be provided. Quotes should provide pricing per dose. The IDIQ minimum is 45 tau scans and 45 amyloid scans, and the maximum is 500 amyloid doses and 500 tau doses. The estimated amount that NIA plans to order per year are below: • Base Year: Estimated MINIMUM: 45 tau scans and 45 amyloid scans. Estimated MAXIMUM: 75 tau scans and 75 amyloid scans. • Year 1: Estimated MINIMUM: 45 tau scans and 45 amyloid scans. Estimated MAXIMUM: 75 tau scans and 75 amyloid scans. • Year 2: Estimated MINIMUM: 60 tau scans and 60 amyloid scans. Estimated MAXIMUM: 95 tau scans and 95 amyloid scans. • Year 3: Estimated MINIMUM: 60 tau scans and 60 amyloid scans. Estimated MAXIMUM: 95 tau scans and 95 amyloid scans. • Year 4: Estimated MINIMUM: 60 tau scans and 60 amyloid scans. Estimated MAXIMUM: 95 tau scans and 95 amyloid scans. The Contractor must have the capability to perform ALL the requirements listed on the Statement of Work at an imaging facility within 15 miles of the NIA Clinical Research Program at Harbor Hospital, Baltimore, MD. The Contractor must also provide all information and assistance required for regulatory documents, including materials to meet Institutional Review Board, FDA, and radiation safety regulatory requirements. (vii) Requirements must be met at an imaging facility within 15 miles of the NIA Clinical Research Program at Harbor Hospital, Baltimore, MD. The estimated ordering period will be from March 20, 2023 through March 19, 2028, if all options are exercised. (viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. (ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Products and Commercial Services, applies to this acquisition. (a) The award resulting from this solicitation will be made to the responsible offeror whose proposal is most advantageous to the Government, Technical Capability, Past Performance and other factors considered. (x) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with offers. (xi) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The following FAR provisions or clauses are 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 Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Entity Code Maintenance (Aug 2020) 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services of Equipment (Nov 2021) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015). 52.212-4(g), Invoice, is supplemented by the NIH Invoice and Payment Instructions. (xii) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement. (xiii) The offeror must complete and return FAR 52.204-24 and FAR 52.204-26 with its offer. (xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. The Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), 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. All responses must be received by March 15, 2023, 9:00 am, Eastern Standard Time and reference number 75N95023Q00065. Responses shall be submitted electronically to Michelle Cecilia, Contracting Officer, michelle.cecilia@nih.gov. Quotes must be submitted in the English language and in US Dollars. Fax responses will not be accepted. Attachments: 1. 52.216-18 - Ordering 2. 52.216-19 – Order Limitations 3. 52.216-22 – Indefinite Quantity 4. 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items 5. NIH Invoice and Payment Instructions 6. Additional terms and Conditions 7. Statement of Work

Inactive Total Small Business Set-Aside (FAR 19.5)

SMALL BUSINESS SOURCES SOUGHT NOTICE 1. Solicitation Number: 75N95023Q00065 2. Title: Early Markers of Alzheimer’s Disease: PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA) 3. Classific... SMALL BUSINESS SOURCES SOUGHT NOTICE 1. Solicitation Number: 75N95023Q00065 2. Title: Early Markers of Alzheimer’s Disease: PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA) 3. Classification Code: Q522 – Medical-Radiology 4. NAICS Code: 621512 – Diagnostic Imaging Centers 5. Size Standard: $16.5 million 6. Description: PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA) This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Institute on Aging (NIA) initiated amyloid PET imaging with Pittsburgh compound B (PiB) in the Baltimore Longitudinal Study of Aging (BLSA) in 2005 and tau PET imaging with AV-1451 (T-807) in 2016. Consistent with autopsy data from BLSA and other studies, approximately 30% of cognitively normal individuals have detectable amyloid deposition in the brain on amyloid PET imaging. Individuals with higher levels of ?-amyloid are older, more likely to carry the Apolipoprotein E ?4 allele, have greater longitudinal decline in memory and other cognitive functions, and are more likely to accumulate amyloid and show tau progression over time. In addition, through the BLSA autopsy program, we have shown the correspondence between in vivo imaging and post-mortem values of amyloid burden. Work by our group has been central to defining the relationship between amyloid burden and memory change, to characterizing the magnitude and spatial pattern of progression of amyloid burden and its relation to tau progression, to highlighting the importance of individuals with intermediate amyloid levels that would be considered PiB negative in many binary classification schemes, and to identifying modifiers of amyloid burden. The NIA has also developed an approach for estimating age at onset of amyloid accumulation, providing an individualized index that can be used as a dependent outcome to assess factors that may modify age at onset of amyloid accumulation. This approach was applied to demonstrate that Apolipoprotein E ?4 genotype is associated with earlier age of onset of amyloid accumulation in the BLSA sample. The BLSA was initiated in 1958 and is a multi-disciplinary study of physiologic and psychologic aspects of normal aging in community-dwelling men and women. Since 1994, the NIA has been conducting a longitudinal brain imaging study of selected older adults in the BLSA to characterize individual differences in longitudinal brain changes, to investigate the extent to which these brain changes underlie individual differences in cognitive aging, to identify brain changes that may be predictors of cognitive decline and Alzheimer’s disease (AD), and to assess the impact of potential modulators of brain and cognitive aging. More recently, the NIA has been using PET scanning to acquire in vivo measures of brain amyloid and tau, the hallmark pathologies of AD. Purpose and Objectives: The purpose of this procurement is to acquire services to perform in vivo Positron Emission Tomography (PET) scans to measure brain amyloid and tau neuropathology in BLSA participants on a combined PET/computed tomography (CT) scanner. Studies of amyloid deposition will be conducted using PET and an FDA-approved amyloid imaging agent and studies of tau pathology will be conducted using PET and a second generation tau PET imaging compound. Project requirements: Independently, 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 work required. The Contractor shall perform amyloid and tau PET scans and CT scans and shall transfer in a timely manner all images and associated data, as specified by the Government. A minimum of 45 amyloid and 45 tau scans, and a maximum of 75 amyloid and 75 tau scans in the Base and first option year of performance, and a minimum of 60 amyloid and 60 tau scans, and a maximum of 95 amyloid and 95 tau scans for option years 3, 4, and 5 are anticipated. Specific requirements: Have experience in conducting and transferring PET images and related data (such as amount of radioactivity injected, time of study, any deviations from expected acquisition protocol, scanner and reconstruction parameters) in clinical research studies. Be located within 15 miles of the NIA Clinical Research Facility at Harbor Hospital, in Baltimore, MD. Coordinate with NIA staff in scheduling the PET scan studies. Perform in vivo brain amyloid and tau PET scans, including receipt of radiotracer doses from outside vendors, injection of radiotracers into human subjects, and acquisition of PET scans. Scanner requirements: 5 mm FWHM or better PET spatial resolution, with potential of improved resolution using AI reconstruction methods. State of the art digital silicon photomultipliers (SiPM) Time of flight Acquisition requirements: Amyloid PET scans: Ability to collect at least 20 minutes of scan data, binned as four 5-minute timeframes Tau PET scans: Ability to collect at least 60 minute dynamic scans from time of injection in list mode Image reconstruction requirements: At a minimum, a state of the art statistical reconstruction (such as ordered subsets expectation maximization) should be available for PET scans. Ability to reconstruct dynamic tau PET scans using various options for binning the time frames. Provide medical monitoring of participants during PET scan procedures. Provide secure electronic transfer of imaging and related data to the NIA. Provide all information required for regulatory documents, including materials to meet Institutional Review Board, FDA, and radiation safety regulatory requirements. Anticipated period of performance with minimum and maximum scans: • Base Year: 12 months: a minimum of 45 amyloid and 45 tau scans. A maximum of 75 amyloid and 75 tau scans • Option Year 1: 12 months: a minimum of 45 amyloid and 45 tau scans. A maximum of 75 amyloid and 75 tau scans • Option Year 2: 12 months: a minimum of 60 amyloid and 60 tau scans. A maximum of 95 amyloid and 95 tau scans • Option Year 3: 12 months: a minimum of 60 amyloid and 60 tau scans. A maximum of 95 amyloid and 95 tau scans • Option Year 4: 12 months: a minimum of 60 amyloid and 60 tau scans. A maximum of 95 amyloid and 95 tau scans Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. Capability statement /information sought: Small business concerns that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Small businesses must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested small businesses are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Michelle Cecilia, Contracting officer, at e-mail address michelle.cecilia@nih.gov. The response must be received on or before January 19, 2023 at 3:00 p.m. Eastern Time. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”