SOLICITATION NOTICE
B -- study to to examine SEM-Raman experimental parameters for characterizing crystal formation in transdermal drug delivery systems and an option for using coupled SEM-Raman to characterize TDDS samples in order to detect and identify crystals
- Notice Date
- 8/22/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-1137761
- Archive Date
- 9/12/2014
- Point of Contact
- Carrie Strachan, Phone: 2404027620
- E-Mail Address
-
carrie.strachan@fda.hhs.gov
(carrie.strachan@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for a study to obtain knowledge regarding appropriate SEM-Raman experimental parameters for characterizing crystal formation in transdermal drug delivery systems (TDDS) and an option for using coupled SEM-Raman to characterize TDDS samples in order to detect crystals and determine the identity of those crystals. This is 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; quotes are being requested and a written solicitation will not be issued. a. Solicitation Number 1137761 is being issued as a Request for Quotation (RFQ). b. Provisions and clauses are those in effect through Federal Acquisition Circular 2005-76, effective 25 July 2014 c. The associated NAICS Code is 325412. d. Item Description: The Food and Drug Administration (FDA) requires a study to obtain knowledge regarding appropriate SEM-Raman experimental parameters for characterizing crystal formation in transdermal drug delivery systems (TDDS) and an option for using coupled SEM-Raman to characterize TDDS samples in order to detect crystals and determine the identity of those crystals. TDDS are dosage forms designed to deliver a therapeutically effective amount of drug across a patient’s skin. Recently, some of these products have been recalled because of crystal formation within the TDDS matrix. Failure to control crystal size and distribution could result in loss of aesthetic appeal, skin irritation, and loss of adhesion; suggesting a manufacturing process that is not under control. Also, presence of excess crystalized drug might result in reduced delivery relative to the expected amount of drug when used by patients. Scanning electron microscopies (SEM) coupled with Raman spectroscopy has been proposed as a technique to detect, measure, and determine crystallization in TDDS. SEM is used for inspecting topographies of materials with a magnification range that encompasses that of optical microscopy and extends it to the nanoscale; therefore, the start of crystallization would be visible with SEM. A coupled SEM-Raman instrument will allow morphological, elemental, chemical, physical, and electronic analysis without moving the sample between instruments. The purpose of this study is to determine the feasibility of coupled SEM-Raman to detect and confirm the identity of active pharmaceutical ingredient crystals in TDDS. For this preliminary study, SEM and Raman will be examined separately to determine the feasibility of coupled SEM-Raman. If feasibility is established via this study, the option for coupled SEM-Raman analyses will be exercised. For the preliminary study, the vendor shall examine seven (7) “as is” and seven (7) crystal containing (induced crystals) TDDS for crystals using reflected light microscopy. The vendor shall examine seven (7) “as is” and seven (7) crystal containing (induced crystals) TDDS for crystals using scanning electron microscopy (SEM). The SEM analyses shall include variation in instrument parameters/conditions (kV, detector selection, ESEM settings) to find optimum settings for observation of crystals on or in the TDDS. The SEM shall observe crystals at maximum depth achievable. The vendor shall examine seven (7) TDDS for crystals using Raman microspectroscopy and Raman microspectroscopy will be used for the four active pharmaceutical ingredients (Chlonidine, estradiol, levonorgestrel, and fentanyl.) A compact disk with the data files from SEM, light microscopy, and Raman tests will be required as well as an interpretive report. The interfaced SEM-Raman analyses shall be performed without moving the samples between instruments. For the optional services, the vendor shall examine twelve (12) “as is” and twelve (12) crystal induced TDDS for crystals using coupled SEM-Raman analysis without moving the samples between instruments. Raman microspectroscopy shall be used for the active pharmaceutical ingredients (Chlonidine, estradiol, levonorgestrel, and fentanyl) in the four TDDS. A compact disk with the data files will be required as well as an interpretive report. This optional service shall be listed as a separately priced line item. e. Instructions to Offerors The vendor shall have the following: · DEA registration for C-II, and submit current DEA Controlled Substance Registration Certificate. · Capable of performing SEM, Raman and light microscopy. Vendor shall submit brand, model, and date of last qualification for SEM, Raman, and light microscopy instruments. · Capable of performing coupled SEM-Raman experiments. · cGMP laboratory · capable of conducting LC-MS, LC-MS/MS, LC-MS/MS/MS, nuclear magnetic resonance (NMR), solution NMR spectroscopy, IR spectroscopy, single crystal structure determination, x-ray powder diffraction (XRPD), optical microscopy, differential scanning calorimetry (DSC), thermogravimetry (TGA), melting point determination, moisture sorption/desorption isotherms, infrared (IR) spectroscopy, Raman spectroscopy, solid-state NMR spectroscopy, ultraviolet (UV)spectrum, particle size distribution, surface area, scanning electron microscopy (SEM), Fourier Transform Infrared (FTIR) spectroscopy, Near infrared (NIR) spectroscopy, Energy Dispersive X-Ray (EDX) Spectroscopy, equilibrium solubility, and accelerated physical and chemical solid and solution stability. · Access to a multidisciplinary consulting and specialized analytical techniques. f. Period of Performance The preliminary study to determine instrument parameters for SEM and Raman, and to determine if it is possible to conduct coupled SEM-Raman measurements shall take 6 weeks from ARO. The option for using coupled SEM-Raman to characterize TDDS samples in order to detect crystals and determine the identity of those crystals shall take 5 months, if exercised. g. Deliverables: Compact disk with data files Interpretive report h. FAR Provision 52.212-1 (Instructions to Offerors - Commercial Items) (APR 2014) applies to this acquisition. Para (k) requires current registration in SAM at https://www.sam.gov. i. FAR Provision 52.212-2 Evaluation - Commercial Items (JAN 1999) applies to this acquisition. Award will be made to the Lowest Priced Technically Acceptable Offeror whose quote provides sufficient detail to evaluate compliance with the solicitation It is the responsibility of all interested offerors to review this site frequently for any updates/ amendments that may occur during the solicitation process. The posting of this requirement does not obligate the Government to award a contract nor does it obligate the Government to pay for any proposal preparation costs. The Government reserves the right to cancel this procurement/ solicitation either before or after the solicitation closing date, with no obligation to the offeror by the Government. The Government will issue a contract to the responsible, responsive offeror, with acceptable past performance, submitting the lowest price. All prospective contractors must be registered in the System for Award Management in order to be eligible for contract award. For registration, go to www.sam.gov and follow the instructions. j. Quotations must include a completed copy of FAR Provision 52.212-3 (Offeror Representations and Certifications - Commercial Items) (MAY 2014). Electronic submission is located at https://www.sam.gov. k. This order will include the following referenced clauses which may be accessed electronically at http://farsite.hill.af.mil. FAR 52.212-4 (Contract Terms and Conditions-Commercial Items) (MAY 2014) FAR 52.217-7 Option for Increased Quantity –Separately Priced Line Item. (MAR 1989) FAR 52.232-40 Providing Accelerated Payment to Small Business Subcontractors (DEC 2013) FAR 52.212-5 (Contract Terms and Conditions Required to Implement Statues Or Executive Orders-Commercial Items) (JULY 2014) FAR 52.219-8 (Utilization of Small Business Concerns and Small Disadvantage Business Concerns) (MAY 2014) FAR 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)) FAR 52.222-3, Convict Labor (June 2003) (E.O. 11755) FAR 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126) FAR 52.222-21, Prohibition of Segregated Facilities (Feb 1999) FAR 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246) FAR 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793) FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513) FAR 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) FAR 52.232-33 (Payment by Electronic Funds-System for Award Management (JUL 2013) FAR 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a) HHSAR 352.202-1 Definitions (JAN 2006) HHSAR 352.203-70 Anti-lobbying (JAN 2006) HHSAR 352.215-70 Late Proposals and Revisions (JAN 2006) HHSAR 352.233-71 Litigation and Claims (JAN 2006) HHSAR 352.242-73 Withholding of Contract Payments (JAN 2006) FAR 52.212-5 (Contract Terms and Conditions Required to Implement Statues Or Executive Orders-Commercial Items) (JULY 2014) FAR 52.219-8 (Utilization of Small Business Concerns and Small Disadvantage Business Concerns) (MAY 2014) FAR 52.232-33 (Payment by Electronic Funds-System for Award Management (JUL 2013) HHSAR 352.202-1 Definitions (JAN 2006) HHSAR 352.203-70 Anti-lobbying (JAN 2006) HHSAR 352.215-70 Late Proposals and Revisions (JAN 2006) HHSAR 352.233-71 Litigation and Claims (JAN 2006) HHSAR 352.242-73 Withholding of Contract Payments (JAN 2006) l. QUOTATIONS ARE DUE BY 2:00PM Eastern Standard Time on 28 AUGUST 2014 in order to be considered. Send quotation responses to Carrie Strachan @ Carrie.Strachan@fda.hhs.gov. Assistance or questions about this announcement may be sent to the above email.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-1137761/listing.html)
- Place of Performance
- Address: 645 S. Newstead Ave, St. Louis, Missouri, 63110, United States
- Zip Code: 63110
- Zip Code: 63110
- Record
- SN03476824-W 20140824/140822235052-1b5fa8de24722f9663731a2d18ded20c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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