SOLICITATION NOTICE
Q -- Early Markers of Alzheimer�s Disease: PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
- Notice Date
- 3/8/2023 8:16:23 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 621512
— Diagnostic Imaging Centers
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023Q00065
- Response Due
- 3/22/2023 6:00:00 AM
- Archive Date
- 04/06/2023
- Point of Contact
- Michelle Cecilia, Phone: 3018277199
- E-Mail Address
-
michelle.cecilia@nih.gov
(michelle.cecilia@nih.gov)
- Description
- 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 �
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/ad5cec128feb4646bb287a31bd8959eb/view)
- Place of Performance
- Address: MD 21225, USA
- Zip Code: 21225
- Country: USA
- Zip Code: 21225
- Record
- SN06611936-F 20230310/230309211940 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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