Custom Radiosynthesis of PET Ligands and Use of PET Facility
DESCRIPTION:
The National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) and National Institutes of Health (NIH) is seeking Capability Statements from BOTH Other than Small Business and Small Business organizations with the demonstrated capability of providing service to support the NIDA-IRP Biobehavioral Imaging and Molecular Neuropsychopharmacology Unit with Positron Emission Tomography compound radiosynthesis, the required instruments, supply of animals and housing of animals.
This is a 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 business sources; (2) the availability of capable 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. The established NAICS code is 541690, Other Scientific and Technical Consulting Services. The U.S. Small Business Administration establishes a size standard for 541690 as $16.5 million in annual sales or less.
BACKGROUND:
The NIDA IRP Neuroimaging Research Branch (NRB) neuroscientists’ research requires in vivo imaging of the brain and its molecular processes in a way that parallels human imaging research. The purpose of this acquisition is to acquire a service contract to support the NIDA-IRP Biobehavioral Imaging and Molecular Neuropsychopharmacology Unit.
PURPOSE AND OBJECTIVES:
Positron Emission Tomography (PET) is a non-invasive imaging technique that enables picomolar detection (i.e. the highest sensitivity among all non-invasive imaging modalities available) of molecular processes in a living animal. PET compound radiosynthesis requires dedicated instrumentation and skillset which the NIDA-IRP does not have.
The objective of this contract is to: 1) prepare custom radiosynthesis of specific derivatives either with F18 or C11 on a weekly basis, 2) obtain an estimated 300 rats and/or mice (per contract year), 3) house said animals for the duration of the studies and 4) allow NIDA researchers to have access (approximately 50 hours total per year) to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain. The custom radiotracers will be utilized in ongoing experiments of NRB’s Molecular Neuropsychopharmacology Unit. The objective is to synthesize several radiotracer derivatives, labeled with either F18, C11 or another radioisotope that will bind various targets. There is a specific need to have these PET tracers synthesized in close vicinity to NIDA-IRP so that we can have them available for immediate use in PET imaging experiments. Due to their half-life (most commonly used radiotracers: 110 minutes for F18- and 20 min for C11-labeled PET tracers) NIDA needs a facility to be within 2 miles of the NIDA-IRP so that the PET tracers can be quickly transported for immediate use. The NIDA-IRP address is 251 Bayview Blvd, Baltimore, MD 21224.
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:
Task 1: The Contractor shall prepare radiosynthesis, including custom radiosynthesis, of specific derivatives using either C11 or F18 or other radioisotopes, as requested by the Government.
Task 2: The Contractor shall supply animals (e.g. mice or rats) to NIDA Researchers to use in the experiments.
Task 3: The Contractor shall provide food and housing of the small animals for the duration of each experiment. It is estimated that animals will need housing for up to approximately 3 weeks.
Task 4: The Contractor shall provide NIDA researchers with access to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain.
SPECIFIC REQUIREMENTS:
Specifically, the Contractor shall:
For Task 1:
Prepare routine and custom radiosynthesis compounds in accordance with the type, amount and required date of delivery of radiochemical specified in the Government’s request. The Government will give a lead time of at least 2-3 weeks estimated per request.
Notify the Government when the synthesized ligands are available for use within five minutes of completing synthesis.
For Task 2:
Provide the Government with rats or mice as specified by the Government (an estimated 300 animals per contract year) for use in experiments.
For Task 3:
Provide housing to each animal for approximately up to 3 weeks. Animals will be requested by the Government by the amount, which will vary by experiment, and will be specified at the time of the request.
For Task 4:
Provide NIDA researchers with access to a small animal PET scanner during the period of performance (an estimated 50 hours required per contract year).
Provide all electronic data files produced from the PET scans to the Government within twenty-four hours after scanning is complete.
KEY PERSONNEL:
A radiochemist is required for the synthesis of radiotracers.
INSTRUCTIONS:
Respondents must provide clear and convincing documentation of their capability and experience with providing the personnel and services as specified in the tasks above. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) current capability to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and other management capability; and (e) examples of prior completed Government contracts, references, and other related information.
Each capability statement must include the respondent’s DUNS number, organization name, and address. Each response should include the technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses. The capability statement should clearly identify the size and type of business (e.g., 8(a), HubZone, Non-Profit, Other Than Small Business, 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 an outline format that addresses each of the elements of the project requirement and in the capability statement paragraphs stated herein. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, resumes, or references, if requested.
Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Shaun Rostad at Shaun.Rostad@nih.gov, NO LATER THAN 1:00 p.m. EST on July 22, 2021. The Subject line for the submission should include this Sources Sought Number and organization name. NIDA will not accept paper or faxed capability statements.
THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. 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 pre-solicitation 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).
75N95021Q00289 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
7/8/21, 2:35 PM Custom Radiosynthesis of PET Ligands and Use of PET Facility
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 separate written solicitation will not be issued.
ii. The solicitation number is 75N95021Q00289 and the solicitation is issued as a Request for Quotation (RFQ) on an unrestricted basis, as a full and open requirement.
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; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. A time and materials type of purchase order is contemplated for this requirement.
iii. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-06, dated 06-10-2021.
iv. The North American Industry Classification System (NAICS) code for this procurement is 541690 - Other Scientific and Technical Consulting Services with associated small business size standard of $16.5 million.
v. Line Items: NIDA anticipates the use of a Time and Materials / Labor Hour (T&M/LH) type contract as a result of this solicitation. If an award is made as a result of this solicitation, NIDA shall establish a ceiling price for the contract that the Contractor shall not exceed.
NIDA also anticipates the use of Options and Options Quantities in accordance with the Federal Acquisition Regulation (FAR) 52.217-7 Option for Increased Quantity – Separately Priced Line Items (Mar 1989); 52.217-8 Option to Extend Services (Nov 1999); and 52.217- 9 Option to Extend the Term of the Contract (Mar 2000).
It is anticipated that this contract will consist of a 12-month Base Period, with two (2) additional 12-month Option Periods. The contract will also include additional option quantities. This period of performance will allow for the greatest flexibility given the program needs and funding availability.
Below is a table that contains the line item number and description of the requirement for the anticipated award of the Base Period.
Line No. Description
1 FY21. Base Period. Custom Radiosynthesis of PET Ligands and Use of PET Facility. 9/20/21 – 9/19/22.
vi. Description of Requirement: The objective of this contract is to: 1) prepare custom radiosynthesis of specific derivatives either with F18 or C11 on a weekly basis, 2) obtain an estimated 300 rats and/or mice (per contract year), 3) house said animals for the duration of the studies and 4) allow NIDA researchers to have access (approximately 10-50 hours total per year) to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain. The custom radiotracers will be utilized in ongoing experiments of NRB’s Molecular Neuropsychopharmacology Unit. The objective is to synthesize several radiotracer derivatives, labeled with either F18, C11 or another radioisotope that will bind various targets. There is a specific need to have these PET tracers synthesized in close vicinity to NIDA-IRP so that we can have them available for immediate use in PET imaging experiments.
Due to their half-life (most commonly used radiotracers: 110 minutes for F18- and 20 min for C11-labeled PET tracers) NIDA needs a facility to be within 2 miles of the NIDA-IRP so that the PET tracers can be quickly transported for immediate use.
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:
Task 1: The Contractor shall prepare radiosynthesis, including custom radiosynthesis, of specific derivatives using either C11 or F18 or other radioisotopes, as requested by the Government.
Task 2: The Contractor shall supply animals (e.g. mice or rats) to NIDA Researchers to use in the experiments.
Task 3: The Contractor shall provide food and housing of the small animals for the duration of each experiment. It is estimated that animals will need housing for up to approximately 3 weeks.
Task 4: The Contractor shall provide NIDA researchers with access to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain.
Refer to Attachment 1 - Statement of Work for additional details.
vii. Period of Performance:
The required period of performance is one year with two one-year option periods.
Base Year: September 20, 2021 through September 19, 2022
Option Year 1: September 20, 2022 through September 19, 2023
Option Year 2: September 20, 2023 through September 19, 2024
viii. The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Items (Oct 2015) is applicable to this solicitation.
ix. The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition. The following is provided as an addendum to clause 52.212-2:
The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, i.e. this RFQ will be evaluated and award made on the basis of best value to the Government. Offeror’s submitting a response must provide a completed Price Quote to be evaluated and considered for award. Price quotes must indicate fixed unit pricing and total cost, including shipping cost and estimated time of delivery after receipt of order, and warranty and training considerations.
Technical evaluation shall be based on the following:
Mandatory Criteria:
The Offeror’s facility shall be within a 2-mile radius of the NIDA IRP Facility located at:
251 Bayview Blvd., Suite 200,
Baltimore, MD 21224
Animal Welfare: The Offeror must demonstrate its understanding and compliance with the NIH Guide for Care and Use of Laboratory Animals. The Offeror shall submit evidence that its proposal was reviewed and approved by the Institution’s Animal Care and Use Committee (IACUC).
2. Technical Approach (70 points)
NIDA shall evaluate:
a. The Offeror’s proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the efforts to be performed and the skill level required to perform them.
b. The Offeror shall be able to prepare custom radiosynthesis of specific derivatives using either C11, F18 or another radioisotope within 2-3 weeks of submitted requests.
c. The Offeror shall be able to supply animals to NIDA Researchers to use in the experiments and house them for the duration of each experiment (length of time to be determined by NIDA researchers).
d. Provide NIDA researchers with access to a small animal PET scanner to perform imaging of radiotracer distribution and occupancy in the rodent brain.
3. Past Performance (30 points)
a. NIDA will evaluate the Offeror’s demonstrated capabilities and past performance on a contract with similar requirements in the areas covered by the Statement of Work.
The award will be made on a competitive best value basis, using “tradeoff” among cost/price and non-cost/price factors. The Government may elect to award to other than the lowest priced Offeror, or other than the Offeror with the highest rated non-cost/price proposal. In either case, a tradeoff will be conducted. The government reserves such right of flexibility in conducting the evaluation as necessary to assure an award with the Contractor providing the best value to the government.
The major evaluation factors for this solicitation include technical and cost/price factors. Interrelationships of these elements will be assessed consistent with the regulations concerning the considerations of cost and other factors in determining contract award. Technical factors are of paramount consideration in the award of the contract, however cost/price is also important to the overall contract award decision. Therefore, Offerors are reminded that award will be made to the Offeror whose proposal provides the combination of features that offers the best or greatest overall value to the Government.
The Government may request clarifying information from the schedule contractor, as it relates to its quote.
(b) Options. Options and Option Quantities should be priced separately from the Base Requirement. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).
(c) 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 Offeror is to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer. Offerors must include the representation at 52.204-24 if it is not in in their completed FAR Representations and Certifications. A copy of that representation is attached as Attachment 2 - Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.
xi. The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition and is supplemented by Attachment 4 - 52.212-4 Addendum and Supplemental Clauses.
xii. The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. See attachment.
xiii. The following additional contract requirement(s) or terms and conditions as determined by the Contracting Officer are necessary for this acquisition and consistent with customary commercial practices. Additional contract requirement(s) or terms and conditions determined by the Contracting Officer to be necessary for this acquisition are supplemented by the following attachments:
Attachment 1 – Statement of Work
Attachment 2 - 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment
Attachment 3 - Invoicing Instructions
Attachment 4 - 52.212-4 Contract Terms and Conditions – Commercial Items (October 2018)
Attachment 5 - 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items.
Attachment 6 – HHS Subcontracting Plan Template
xiv. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
xv. Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation. The Offeror's technical approach shall indicate compliance with the Scope of Work, and describe an essential understanding of the requirements involved in accomplishing the work. Please also include with your technical proposal sufficient information (including contract numbers, if applicable) to demonstrate performance of a contract with similar requirements to those outlined in the Scope of Work.
A detailed work plan may be submitted indicating how each aspect of the statement of work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical plan should reflect a clear understanding of the nature of the work being undertaken. The technical approach should include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate your understanding and management of important events or tasks.
The technical plan shall include:
Technical Approach of how the work will be performed.
A milestone schedule and timelines for the project, indicating the estimated period of performance for each task.
Facilities and /or resources used.
The business quote 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 ceiling price, as a Time and Materials type of purchase order is contemplated for this requirement. The proposal should include unit pricing for access to the small animal PET scanner, animals and their housing, and fully loaded labor hours for the production of radiotracers, along with any other required materials costs.
Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services (see section x. above).
Offerors must also submit a completed Small Business Subcontracting Plan with its Business Quote. The Small Business Subcontracting Template is incorporated as Attachment 6 of this CSS.
Offerors MUST include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, OR provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet.
In addition the Dun & Bradstreet Number (DUNS), 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.
Questions may be submitted to Shaun Rostad and Josh Lazarus at shaun.rostad@nih.gov and josh.lazarus@nih.gov up to August 11th, 2021 at 2:00 p.m. Eastern Standard Time.
All responses must be received no later than August 20, 2021, 2:00 PM EST. Late responses may not be accepted. All responses must reference solicitation number 75N95021Q00289. Responses must be submitted electronically to shaun.rostad@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, please contact Shaun Rostad by email at shaun.rostad@nih.gov or by phone at 301-443-6677.
75N95021Q00289 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
8/6/21, 3:21 PM