FBO_Combined_synopsis-solicitation_FBO-SOL-1182707-R.pdf

FDA-SOL-1182707-R

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition

Circular (FAC) 2005-95.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION

WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA-SOL-1182707 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 and this is a full and open competition. This will be awarded as Firm-Fixed Price. Prospective

Offerors are responsible for downloading the solicitation and any amendments from

FedBizOpps (FBO). The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing best value and discussions are not necessary.

The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA) has a need for development of a bio-relevant dissolution system for in-vitro dissolution testing of drug products.

A. BACKGROUND AND OVERVIEW:

The FDA’s Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

Physiologically relevant dissolution testing that is predictive of in vivo performance can greatly support regulatory decision-making and minimize the need for in vivo bioequivalence studies. A vast majority of new molecular entities that are seeking FDA approval are poorly soluble. For poorly soluble Biopharmaceutics Classification System (BCS) class II compounds drug absorption in the gastrointestinal tract is most likely dissolution rate limited. To create a basis for a better in vitro and in vivo correlation IVIVC, FDA supports the development of biorelevant dissolution models that render the dissolution test closer to the in vivo situation. One aspect of this goal is to support the fast and rational development of biorelevant dissolution testing conditions that mimic the properties of human gastrointestinal environments.

B. OBJECTIVES/PURPOSE

The objective of this requirement is to acquire a system (a mechanical property tester with torsion and medium bath options that will be used to develop a biorelevant dissolution testing system. This system shall be capable to study dissolution of drug formulations under biorelevant test conditions to better support CDER’s NDA/ANDA review process. The requested instrument can also be used to test mechanical properties (bending, shear, fatigue, creep and stress relaxation) of drug products and medical devices. The acquisition of such an instrument will greatly enhance the agency’s ability to evaluate biopredictive dissolution models for oral solid dosage formulations and provide recommendations for meaningful dissolution testing parameters.

C. STATEMENT OF WORK (SOW) -- SCOPE OF WORK

The Contractor shall perform and/or provide the following tasks/deliverables:

1. The Contractor shall provide an instrument as required to provide both compress and torsion applied on the test samples in bio-relevant medium. The instrument shall be used for dissolution testing of solid oral dosage formulations under simulated Gastro

Intestinal (GI) contractile condition.

Instrument shall have the following salient characteristics:

A. Proprietary linear motor operates without friction for high resolution, low-force testing.

B. The instrument shall provide mechanical testing (tension/compression) with torsion and medium bath options.

C. The instrument shall be capable of controlling with the force and torque capacity of 0 - 225N and 0 - 5.64N-m, respectively.

D. A small volume chamber for testing (300-500mL)

E. Real-time test parameter control (stress, strain and torsion) through software program.

F. Intuitive software design to simplify test setup and a flexible hardware platform for changing test needs.

G. Compatible computer system with software that calculates results from data and provides reports.

2. The Contractor shall provide Installation Qualification (IQ), Operational Qualification

(OQ) and Performance Qualification (PQ) during installation of the instrument.

3. The Contractor shall include training in the quote which shall include three (3) days (8 hour), on-site familiarization training for multiple users (the FDA estimates 4 users will attend this training session). This training session shall take place at the place of performance. This training session will be arranged by the technical point of contact

(TPOC) or TPOC designated project coordinator. Training session shall take place within

30 days after installation and acceptance by the FDA. This training session should include the following training objectives:

A. Provide guidance to end users on the proper use of the instrument B. Any routine maintenance required by the users

C. Any safety and related safeguards as deemed appropriate D. Information on what the users should do if the unit is not functioning properly E. Other topics deemed necessary by the vendor F. Training and/or service manuals shall be made available to the FDA one week in advance of the delivery and installation by either electronic and/or printed material.

D. PLACE OF PERFORMANCE :

Food & Drug Administration

Division of Pharmaceutical Analysis

645 S. Newstead Avenue

St. Louis, MO 63110

FOB Inspection and acceptance: Destination

E. PERIOD OF PERFORMANCE:

The period of performance for this order shall be within 90 days of award:

F. LINE ITEM AND PRICES:

Period of Performance Unit of

Measure Fixed-Price

Total

Line Item 0001 Dissolution Testing Instrument 1 each $

Line Item 0002 Installation including OQ, PQ and IQ 1 each $

Line Item 0003 Training 1 each $

Total: $

Provide a fixed price quote in accordance with the Statement of Work identified.

G. GENERAL INFORMATION

For all on-site maintenance, the Contractor’s personnel are required to report to the security guards at the White Oak Building 75, 10903 New Hampshire Ave, Silver Spring, MD 20903, who will contact the Technical Point of Contact (TPOC) or his or her designated FDA employee.

The Contractor’s personnel must be escorted by the TPOC or his or her designated FDA employee at all times while working on-site under this order.

The Contractor shall perform all on-site maintenance service during the hours of 9:00 am to 5:00 pm ET, Monday through Friday, unless otherwise indicated by the TPOC.

H. GOVERNMENT HOLIDAYS

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day

(3) President’s Day (8) Veterans' Day

(4) Memorial Day (9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

I. EVALUATION AND AWARD:

Lowest Priced, Technically Acceptable (LPTA)

FDA will first evaluate all Offerors’ prices, then, evaluate the apparent lowest-priced quote/proposal for acceptability under the technical and past performance factors (if applicable). If the lowest-price Offeror was evaluated as unacceptable, FDA would then consider the acceptability of the next lowest-price Offeror, continuing this process as necessary.

J. INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (JAN 2017)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.***

The total number of pages for the technical quote shall not exceed fifteen (15) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to sarah.hussain@fda.hhs.gov no later than July 7, 2017, 10:00 a.m. Eastern Standard Time.

Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

PROPOSAL DUE: All proposals are due, electronically through GSA e-buy for the RFQ no later than July 14, 10:00 a.m. Eastern Standard Time.

PROVISIONS and CLAUSES:

The Full text of the Federal Acquisition Regulation (FAR) can be accessed on the internet at https://www.acquisition.gov/far/

The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial Items; FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--Commercial Items; FAR 52.217-8, Option to Extend Services; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity;; FAR 52.222- 36, Affirmative Action for Workers with Disabilities; FAR 52.232-18 Availability of Funds; FAR 52.232-33 Payment by Electronic Funds Transfer—System for Award Management.

Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the mailto:sarah.hussain@fda.hhs.gov mailto:Monifa.Coleman@fda.hhs.gov https://www.acquisition.gov/far/ following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov.