Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF MAY 12, 2023 SAM #7836
SOURCES SOUGHT

66 -- SOURCES SOUGHT: BUCHI Lyovapor L-200 Freeze Dryer with accessories, installation, and warranty (Brand-name or equal)

Notice Date

5/10/2023 11:22:23 AM
 

Notice Type

Sources Sought
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

75N95023Q00301-SS
 

Response Due

5/24/2023 6:00:00 AM
 

Point of Contact

Renato Gomes
 

E-Mail Address

renato.gomes@nih.gov
(renato.gomes@nih.gov)
 

Description

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 the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality.� 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. Small businesses are encouraged to respond. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). Background: Many programs within NCATS enable research collaborations to advance candidate therapeutics for both common and rare diseases into clinical testing.� One of the focuses of the DPI, TDB, is to partner with researchers to generate preclinical data and clinical-grade material for use in Investigational New Drug (IND) applications to a regulatory authority. To accomplish these goals, a brand-new formulation laboratory dedicated to preclinical research will be opened in the fall of 2023. In the new laboratory, scientists will research formulation and manufacturing processes to optimize products� composition, dosage form, and delivery system to ensure that they are safe, stable, and effective.� Specialized instruments essential for formulation development include equipment for formulation preparation, analytical assay, and stability studies. Moreover, the newly established formulation laboratory will be responsible for producing small-scale engineering batches of the studied drugs. The expertise and insights gained from these manufacturing processes and analytical tests will be shared with our collaborators to ensure the successful production of high-quality, GMP-compliant formulations suitable for human consumption in clinical trials. Furthermore, this system will be used to assist in the formulation development of lead APP candidates and other drug substances into phase I clinical trials. Thus, NCATS DPI TDB requires a freeze dryer (lyophilizer) to remove water or other solvents from a sample by sublimation, which is the process of converting a solid directly to a gas without passing through a liquid state. Purpose and Objectives: The Formulation Lab within Therapeutic Development Branch (TDB), under the Division of Preclinical Innovation (DPI), within the National Center for Advancing Translational Sciences (NCATS) seeks to purchase a BUCHI Lyovapor L-200 Freeze Dryer with accessories, installation, and warranty (brand-name or equal). Project Requirements: For reference purposes, the freeze dryer (lyophilizer) that meets the need of this requirement is the BUCHI Lyovapor L-200 Freeze Dryer with accessories, installation, and warranty (brand-name or equal), as provided in the DRAFT PURCHASE DESCRIPTION. The salient physical, functional, or performance characteristics that �equal� products must meet are provided in the attached DRAFT PURCHASE DESCRIPTION. Delivery Date: The NCATS DPI TDB Formulation Laboratory is under construction. Therefore, delivery is expected to be performed in September 2023. Delivery shall be FOB Destination to 9808 Medical Center Drive Building E, Rockville, MD, 20850 between the hours of 8:00 am and 5:00 pm, Eastern Standard Time, Monday through Friday (except on Federal Holidays). Installation: Installation shall be performed by personnel authorized by the manufacturer to perform installation activities. The installation shall occur at a date and time scheduled by NCATS, no later than sixty (60) days from delivery. Travel costs associated with installation, preventive maintenance and any warranty related services shall be covered by Contractor at no additional cost to the Government. Other important considerations: �In case domestic sources are available and capable of fulfilling the Government�s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products or 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. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies 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 notice number. 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. 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 Renato Gomes, Contract Specialist, at e-mail address renato.gomes@nih.gov. The response must be received on or before May 24, 2023, at 9:00 a.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 www.sam.gov. 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).�
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/0e2f68f77da84ed59154962df560f1f4/view)
 

Place of Performance

Address: Rockville, MD 20850, USA

Zip Code: 20850

Country: USA
 

Record

SN06678864-F 20230512/230510230118 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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