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Contract Opportunity

1. Contracting Office Address: 10903 New Hampshire Avenue, WO Building 75, Room 4734, Silver Spring, MD, 20903

2. Solicitation Number: 75F401-24-Q-1274006

3. Subject: Construction of a Database Bio-Pharmaceutics Classification System

4. Classification Code: DC10

5. NAICS Code: 541711

6. Response Date: 11:59pm ET on 3/3/2024 due via email to the Primary Point of Contact listed in the sam.gov webpage for this combined synopsis-solicitation.

7. Description:

(i) Disclaimer: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 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. The Government intends to negotiate and solicit with only one source: Drexel University, Office of Research & Innovation 3250 Chestnut St., Suite 3010, Philadelphia, PA., 19104.

Drexel University will provide full standard access to a BCS Class Database that contains the BCS class information (especially class IV) of over 80% of the currently approved NDA drug products.

Under the authority of FAR (13.106(b)(1)(i). This is not a request for competitive proposals; however, any responsible offeror may submit a quote which will be given due consideration by the agency.

(ii) This acquisition is issued as a Request for Quote (RFQ).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-02 dated December 22nd.

(iv) For purposes of this acquisition, the associated NAICS code is 541711. The small business size standard is 1000 employee(s). This action is being solicited as a Sole Source.

(v) Line-Item Structure: The following is a list of line-item number(s) and items, quantities, and units of measure, (including option(s), if applicable) and should be reflected in the Offeror’s quote/proposal:

0001: BCS Class Database Construction

Period of Performance

The period of performance shall be twelve (12) months from the date of contract award.

(vi) Specifications/Requirement: See attached Requirements Document.

Drexel University shall construct a user-friendly database that contains the BCS class information of drug substances found in most of the currently approved NDA drug products. The constructed database will facilitate the selection of the appropriate regulatory pathway for drug products reformulated by adding nitrosamine reducing excipients.

Only FDA-approved NDA drug products will be included to construct the database. BCS IV class drug substances must be identified while other BCS classes (I, II, or III) may not need to be specified. The delivered BCS class database shall be accurate and can be executed and maintained inside the FDA computer/firewall system.

Government Furnished Equipment

FDA will provide a government owned laptop to the contractor with the prerequisite that the contractor passes the background investigation.

(vii) Delivery: Offsite at the contractor’s place of business. The contractor shall electronically deliver the BCS class database, the code, and the instruction manual/materials to the COR at least two weeks prior to the end of the contract. The delivered BCS class database must be executed and maintained inside the FDA computer/firewall system.

Drexel University,

Office of Research & Innovation

3250 Chestnut St., Suite 3010

Philadelphia, PA., 19104

Acceptance shall be performed at the Destination.

The COR/designee will inspect and verify that the delivered BCS class database is complete, accurate, and user-friendly and that the code is operational, functional, and compatible with FDA hardware and software environment.

The COR/designee will provide written notification of acceptance or rejection within 10 days of receipt to the contractor via email. The contractor shall correct any deficiencies within thirty (30) calendar notice.

If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR/designee of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

(viii) The provision at 52.212-1, Instructions to Offerors – Commercial DEVIATION 2018-O0018, applies to this acquisition. The following addenda have been attached to this provision:

In addition to the requirements set for the in FAR 52.212-1, all offers responding to this solicitation must provide their business size in relation to the NAICS code contained in this solicitation and shall identify any socioeconomic categories to which they belong.

(ix) Evaluation Criteria – Sole Source

(x) Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer.

(xi) The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to this clause: N/A

(xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable:

52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer)

52.219-28, Post Award Small Business Program Representation (OCT 2022)

52.222-3, Convict Labor (JUN 2003)

52.222-19, Child Labor-Cooperation with Authorities and Remedies (DEC 2022)

52.222-21, Prohibition of Segregated Facilities (APR 2015)

52.222-26, Equal Opportunity (SEP 2016)

52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020)

52.222-50, Combating Trafficking in Persons (NOV 2021)

52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020)

52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021)

52.232-33 Payment By Electronic Funds Transfer System (OCT 2018)

(xiii) The following additional contract requirement(s) or terms and conditions apply:

52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019)

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013)

352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS (DEC 2015)

352.232-71 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

352.239-73 ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE (DEC 2015)

(xiv) This acquisition is rated under the Defense Priorities and Allocations System (DPAS) as N/A

(xv) Date, Time, and Place offers are due: 11:59pm ET on 3/3/2024 due via email to Carole Edwards at carole.edwards@fda.hhs.gov

(xvi) Name and Telephone Number of the Individual to Contact for Information Regarding the Solicitation: Carole Edwards, (301) 838-7586

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