FDA_SSN_1251377.pdf

U.S. FDA SOURCES SOUGHT NOTICE (SSN)

Cryogenically-cooled 13C direct-detect probe and preventive maintenance

SSN #: FDA_SSN_1251377

Posted Date: January 25, 2022 Response Date: February 07, 2022 Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing

MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION

This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the cryoprobe instrument and preventive maintenance described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible.

The appropriate NAICS code for the acquisition is 334516 – Analytical Laboratory Instrument Manufacturing, Small Business Size Standards – 1,000 employees.

Requirement and Background The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), Office of Vaccine Research and Review (OVRR) requires a cryogenically-cooled 13C direct detect probe for its existing Bruker AV-III-HD console/700 MHz Nuclear Magnetic Resonance (NMR) spectrometry system.

NMR spectroscopy is used to delineate structure-function relationships in biomolecules such as glycans, proteins and nucleic acids. Structures are determined using state-of-the-art NMR experiments including, but not limited to, triple resonance 1H-15N-13C, three and four-dimensional NMR. The instruments are also used to detect other compositional elements such as impurities and contaminants, and must be able to detect quantities as minute as one part per billion of such impurities. Although ongoing research been successful to date, the spectral overlap present in PS NMR spectra limits our ability to interpret them. Spectral overlap occurs in the 1H and 13C dimensions, but direct detection of the 13C portion of the spectrum provides improved resolution. This improvement in resolution is crucial for PSs.

Recent advances in resolution methods made by CBER structural biology research groups has improved the resolution and our ability to measure and interpret PS spectra; however, employing these methods results in a concurrent reduction in sensitivity. State-of-the-art NMR accessories are now available which can dramatically restore this loss in sensitivity, improving up to three-fold what is possible with the current instrumentation. Thus, integration of a cryogenically-cooled 13C probe will allow us to optimize and enhance NMR resolution and productivity in the characterizations of oligosaccharides, PSs and PS conjugate vaccines. In addition to the cryoprobe instrument itself, this requirement also includes three (3) post-warranty option years of preventive maintenance.

Minimum Technical Requirements are as follows for a cryogenically-cooled 13C direct detect probe for an existing Bruker AV-III-HD console/700 MHz Nuclear Magnetic Resonance (NMR) spectrometry system, S/N: 10180058:

1. Shall be a new, cryogenically-cooled probe capable of seamless integration with existing

Bruker AV-III-HD console/700 MHz Nuclear Magnetic Resonance (NMR) spectrometry system, S/N: 10180058, and existing Bruker cryoplatform;

2. Shall be capable of performing concurrently with the NMR console and magnet to produce 1H and 13C magnetic resonance spectra with higher sensitivity than an existing 1H direct detect TCI cryogenically cooled probe;

3. Shall be capable of locking on deuterium;

4. Shall be capable of being tuned to the 13C resonance frequency, 176 MHz, with no more than

1% reflected power on a 200 mM sucrose dissolved in water;

5. Capable of 13C pulse width ≤ 10 ms and 1H pulse width ≤ 10 ms;

6. Shall be capable of signal to noise ratio (S/N) in 13C ≥ 3500:1 for ASTM (noise range 1400 Hz) and 3000:1 for ASTM (noise range 40 ppm);

7. Shall be capable of signal to noise ratio (S/N) in 1H ≥ 500:1 for 2 mM sucrose in H2O;

8. Shall have a Gradient pulse power of 50 G/cm, and Gradient recovery time of ≤ 100 ms;

9. Shall have the capability to conduct variable temperature experiments over the range of -40 to 150 °C in normal operation; capable of operating in variable temperature mode using dried air (with a dew point < -80°C and pressure of 80 psi) and meet all the above listed performance specifications. The sample temperature shall be adjustable in 0.1°C increments;

10. For a cryogenically cooled probe, a significant increase in signal-to-noise ratio is expected compared to a room temperature probe. In the case of the required cryogenically-cooled probe, the increases shall be demonstrated in the 13C NMR dimension of a multi-dimensional NMR experiment. The signal-to-noise ratio increase seen in the one-dimensional spectra shall be demonstrated to be realized in two-dimensional spectra. The following experiments shall be run to show that the increase in signal-to-noise ratio seen in a 1D 13C NMR spectrum for a 200 mM sucrose sample is also realized in 1H – 13C 2D spectra:

a. Two dimensional 1H – 13C HETCOR with INEPT type magnetization transfer (hxinepph Bruker pulse program), and 13C direct detection (7 or 14 hour) spectra that also show the same signal-to-noise ratio increase on the same sucrose sample for the new cryoprobe; and

b. Two dimensional 1H detected 1H – 13C HCCH-TOCSY (~3 hr) experiment, using a 35 ms spinlock in 13C showing no arcing, increased noise or carbon artifacts on a 13C labeled sample of sucrose in 150 mM sodium chloride. Acquisition parameters shall be set as follows: 13C sw = 200 ppm, digital resolution = 2 Hz/pt and AQ = 600 ms).

11. Shall include a minimum 1-yr. manufacturer’s full warranty;

12. Shall include all shipping/freight charges FOB Destination;

13. Shall include installation, staff familiarization/training, and initial calibration and qualification.

Minimum Technical Requirements are as follows for the three (3) option years of preventive maintenance service for the cryogenically-cooled 13C direct detect probe described herein:

*”10K-hours” service plan shall include at least one (1) planned on-site preventive maintenance visit for routine certification and/or calibration per contract year; service shall include exchange of Sumitomo coldhead with a refurbished coldhead along with cryoplatform cleaning and adjustment as required;

*Access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument;

*Priority access to technical support (e-mail and telephone) Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern (Prevailing) Time;

*All maintenance activities shall be performed by formally trained and certified technicians and/or engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.;

*All preventive maintenance service pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Service Records and Reports *The Contractor shall, commensurate with the completion of each preventive maintenance or repair service visit (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the service, and for information purposes, the on-site hours expended, and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Point of Contact (TPOC) and Contract Specialist, summarizing all maintenance activities (including warranty work) each time service is performed.

Preventive maintenance shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year’s Day Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day

Thanksgiving Day Christmas Day

Delivery Terms Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and stated need as described herein. The system(s) shall be delivered with all necessary supplies and accessories required for installation and start-up.

Contract Type: Commercial Item-Firm Fixed Price

Period(s) of Performance (Estimated) Initial Warranty: 12 consecutive months from date of system delivery and acceptance Option Year 1: 12 consecutive months commencing from expiration of warranty period;

Option Year 2: 12 consecutive months from expiration of Option Year 1;

Option Year 3: 12 consecutive months from expiration of Option Year 2.

Delivery Address U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72, Room G434 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the cryogenically-cooled 13C direct detect probe and preventive maintenance services described herein and meeting all technical requirements set forth above.

Although the target audience for this Notice are small businesses or small businesses capable of providing these stocks from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following:

1. Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding with the capability of providing virus stocks offered by another firm;

2. Descriptive literature, brochures, marketing material, etc. detailing the multi-parameter spectral analyzing cell sorter instrument system and preventive-corrective maintenance services which the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements and delivery time identified above can be met;

3. Provide recent (within the last three (3) years) and relevant past performance information for the manufacture and/or sale in which the offeror has provided same or substantially similar cell sorter instrument systems and preventive-corrective maintenance services. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent;

4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested;

5. If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns;

6. Though this is not a request for quote, informational pricing is encouraged;

7. The Government is not responsible for locating or securing any information, not identified in the response.

Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on February 7, 2022, to Tim Walbert, Contract Specialist, at the following address:

timothy.walbert@fda.hhs.gov.

Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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 pre-solicitation synopsis and/or combined synopsis-solicitation may be published on Federal Contract Opportunities (formerly FBO) at https://beta.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information 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).

mailto:timothy.walbert@fda.hhs.gov https://beta.sam.gov/