SOLICITATION NOTICE
Q -- Genetics of Alzheimer�s Disease and related dementias in Latin America
- Notice Date
- 7/31/2023 10:58:23 AM
- Notice Type
- Combined Synopsis/Solicitation
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023Q00445
- Response Due
- 8/14/2023 8:00:00 AM
- Archive Date
- 08/29/2023
- Point of Contact
- Hashim Dasti, Phone: 3014028225, Karen Mahon, Phone: 3014357479
- E-Mail Address
-
hashim.dasti@nih.gov, karen.mahon@nih.gov
(hashim.dasti@nih.gov, karen.mahon@nih.gov)
- Description
- �(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. (ii)������� The solicitation number is 75N95023Q00445 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13�Simplified Acquisition Procedures; �and FAR Part 12�Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. (iii)������ The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-04, with effective date June 2, 2023. (iv)������ The associated NAICS code 541380 - Testing Laboratories and the small business size standard is $19 million.�� This requirement is full and open with no set-aside restrictions. (v)������� This requirement is for the following services: The Contractor shall assist in determining the genetic substructure and familial contributions to AD in Colombia by collecting patient samples from families with early onset neurodegenerative diseases. This will advance efforts to treat AD in patients with rare mutations. Second, the Contractor shall ship patient blood samples to CARD for sequencing and genotyping. (vi)������ Specific Requirements: ����������� To achieve NIA�s aim, the Contractor shall: Provide standardized protocols for study implementation, volunteer recruitment, eligibility criteria, informed consent, volunteer tracking, medical and neuropsychological testing, family history, phlebotomy, and specimen shipment. Coordinate collection of patient blood or DNA samples. Samples will be stored at the clinical sites after collection. The Contractor will then coordinate shipment of the stored patient samples from the sites to CARD. Monitor patient recruitment and provide patient recruitment numbers to the Government in annual reports. Identify case and control samples based on evidence of neurodegenerative diseases or lack thereof. A standardized diagnostic assessment shall be completed for each participant by the physician and entered directly into the REDCap database maintained by the Contractor. Provide the analyzed data in electronic form and associated summary reports as specified under �Reporting Requirements and Deliverables�, in order to support derived analyses and publications. Work To Be Performed: Independently, and not as an agent of the US Government, the Contractor shall provide all necessary personnel, facilities, supplies and services (except for those to be furnished by the US Government as specified elsewhere in this contract) to perform the work required by this contract. Recruitment of Subjects and Staff: The Contractor shall coordinate with the two sites in Colombia to develop a plan to recruit subjects for an established cohort, including subjects identified as patients warranting further investigation for dementia. Strategies for recruiting controls may include relatives of the index case or outreach to the community. The Contractor will also develop a staff plan for these efforts, including identifying staff to carry out the tasks outlined in this Statement of Work.� � Informed consent: The Contractor shall be responsible for coordinating with the sites in Colombia to ensure that each site obtains appropriate ethical approvals. The Contractor shall coordinate with the sites to identify, recruit, and obtain informed consent for eligible volunteers. The informed consent forms include language required for sharing of genomic data.� � Tasks: The Contractor shall coordinate and report on the below tasks, which will be carried out by the ten local sites: Site coordination: The Contractor shall provide standard operating procedures for the two clinical sites, as obtained through ethical approvals. The sites may not modify the protocols without first obtaining an ethical approval amendment, and it is necessary to protect the health and welfare of study participants. The Contractor shall also provide data and/or specimen disposition guidelines to the sites and obtain updated enrollment reports on activities on an annual basis. Recruitment: The Contractor shall identify and recruit up to 400 patients (cases and controls) through family recruitment, direct recruitment from primary care health workers at the local clinical sites, and outreach to persons in geographic proximity to clinical sites. The Contractor shall also provide inclusion and exclusion criteria for consistent patient recruitment efforts across the sites. Inclusion criteria will include patients with clinical diagnosis of mild/moderate AD using standard care approaches by the site principal investor. Genealogical history: The Contractor shall provide instruction and guidance to the sites to document the genealogical history of each participant in a standardized way that will be uploaded into the Progeny database at each site. Pedigrees shall be updated every time a patient is evaluated, or a family is visited in an extramural commission. These pedigrees will inform the selection of patient samples for long-read sequencing at CARD.� Phlebotomy and sample processing and archiving: The Contractor shall acquire, handle, and store biospecimens according to standardized protocols for sample collection and DNA extraction provided by the Contractor. Sites will be responsible for their own logistics, compliance, and training. Briefly, blood specimens will be drawn and collected in 2-4 K2 EDTA tubes and identified with the sample ID, site ID, and date of collection. Shipment: Patient samples shall be sent to CARD/NIA for genotyping and sequencing. On an annual basis, one aliquot of isolated DNA or blood per participant shall be delivered on dry ice to CARD for library preparation and sequencing. FedEx labels for these shipments will be provided by the coordinating site. A printed manifest should be included in the shipment and a copy should be emailed to the Government at the time of shipping. Monitoring and reporting: The Contractor shall provide a written report that includes the number of participants recruited, age and sex distribution by clinical site, and any barriers to successful recruitment. The report should also include the number of controls and diagnosed cases by age, sex, and location.� Computational analyses: NIA will return all raw sequencing and genotyping results to the Contractor via secure file transfer and upload of analyzed data to the Alzheimer�s Disease Data Initiative (ADDI) Workbench (whole genome sequencing and genotyping data) or Analysis Visualization and Informatics Lab-space (AnVIL) (long-read sequencing data). The Government will also advise on platform-based results communication, visualization, and dissemination, once sequencing and genotyping results have been analyzed and uploaded.� Deliverables: The Contractor shall provide up to 400 patient DNA or blood samples per year in a recruited cohort of AD and other neurodegenerative disease and neurologically healthy control cases across Colombia. The Contractor shall provide the Government with summary reports detailing the total number of patients recruited and samples collected on an annual basis. The Contractor shall also provide the above reports to the Government on a recurring basis. Reporting Requirements: The Contractor shall prepare and submit the following reports as specified below. All reports shall be submitted electronically either as a Word document or PDF file or Excel file, as appropriate. An annual report on patient recruitment, including recruitment efforts and sources of recruitment, number of cases and controls recruited, number of samples to be sent to NIH, and any factors impeding recruitment. Data Management System: The Contractor shall use the data management systems developed for the ReDLat study. This will include the use of a secure server for storage and the Alzheimer�s Disease AD Initiative (ADDI) Workbench to analyze all whole genome sequencing and genotyping data, as well as the National Human Genome Research Institute (NHGRI) Analysis Visualization and Informatics Lab-space (AnVIL) for storage and analysis of long-read sequencing data, which are secure centralized data storage analysis and access control platforms. In addition, the system shall provide a secure point of access for authorized users only. It shall store information for each participant, as obtained in accordance with Informed Consent from each participant, as approved by the local Ethics Committee in Colombia and entered in a standard database format. All information in the database shall be de-identified, associated only with an alphanumeric designation for each individual. A coded list relating database entries to particular individuals shall be stored securely and separately from the database, in order for the clinical site to contact participants for visits, accede to requests from participants who wish to withdraw from the study, and record deaths of participants (all in accordance with provisions of the Informed Consent for the study). Under no circumstances shall any information that can associate information with an identifiable individual be available to the NIA or any outside investigator. Database updates for de-identified participants shall be transmitted to the NIA. Section 508�Electronic and Information Technology Standards: The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. � 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.� (vii)����� The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 months. (viii)���� The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:� https://www.acquisition.gov/browse/index/far � https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html �� (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Mar 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022) �FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far ���� https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html � (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Dec 2022). Addendum to this FAR clause applies to this acquisition and is attached. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text.� Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (June 2023) NIH Invoice and Payment Provisions (ix)������ 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: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. �Technical and past performance, when combined, are significantly more important than cost or price A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer�s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (x)������� The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi)������ The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii)����� There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii)���� The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv)���� Responses to this solicitation must include clear and convincing evidence of the offeror�s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. The Unique Entity ID from SAM.gov, 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 quotations must be received by 11:00 A.M. Eastern, on August 14, 2023, and reference Solicitation Number 75N95023Q00445. Responses must be submitted electronically to Hashim Dasti, Contract Specialist, at hashim.dasti@nih.gov and Karen Mahon, Contracting Officer, at karen.mahon@nih.gov. Fax responses will not be accepted.
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- SN06769789-F 20230802/230731230045 (samdaily.us)
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