NASA Solicitation: A Dose Escalation Study of Scopolamine Administered as a Nasal Gel

General Information

Document Type: Combine Solicitation
Solicitation Number: NNJ05111221Q
Posted Date: Jun 13, 2005
Original Response Date: Jun 20, 2005
Current Response Date: Jun 20, 2005
Original Archive Date: Jun 13, 2006
Current Archive Date: Jun 13, 2006
Classification Code: A — Research & Development
Naics Code: 541710 — Research and Development in the Physical, Engineering, and Life Sciences

Contracting Office Address

NASA/Lyndon B. Johnson Space Center, Houston Texas, 77058-3696, Mail Code: BH

Description

This notice 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; offers are being requested and a written solicitation will not be issued. This notice is being issued as a Request for Quote (RFQ) for the implementation in a Food and Drug Administration (FDA) compliant Contract Research Organization (CRO) facility, a Phase I clinical study designed to evaluate the pharmacokinetics and pharmacodynamics of a range of intranasal doses of scopolamine (IN SCOP).

This study is a randomized, double blind, placebo-controlled, dose ranging study of IN SCOP at three dose levels compared to placebo. Subject participation must be randomized to receive four treatments in a four-way crossover design with treatment periods separated by a seven-day washout period. Twelve healthy male and female subjects will be required to complete all 4 treatments and pertinent data collection.

Vital signs, blood, saliva and urine samples must be collected in a 24 hour period after treatment. These samples should be processed and shipped according to industry standard biological sample processing and shipping procedures on dry ice along with pertinent documentation and Case Report Forms (CRFs). NASA will provide a Personal Data Assistant (PDA) for sleep and performance data collection. This sleep and performance data must be completed, results compiled and delivered to NASA at the end of each treatment. Any adverse events must be recorded and reported immediately to NASA. NASA specific requirements for subject selection, in addition to standard History and Physical screening, include drug screening, HIV and Hepatitis A&B screening, Electrocardiogram (EKG), creatinine clearance for all subjects, and pregnancy test for female subjects. Scheduled delivery of all samples, data and products should be no later than September 30, 2005. The provisions and clauses in the RFQ are those in effect through FAC 05-03. The NAICS Code and the small business size standard for this procurement are 541710 and 500 employees respectively.

The offeror shall state in their offer their size status for this procurement. All responsible sources may submit an offer which shall be considered by the agency. Delivery to NASA/Johnson Space Center, Houston, TX is required on or before September 30, 2005. The DPAS rating for this procurement is DO-C9. Offers for the items(s) described above are due by June 20, 2005 to NASA Johnson Space Center, Projects Procurement Office Attn: BH4 Tasha Davis, 2101 NASA Parkway, Houston, TX 77058 and must include, solicitation number, FOB destination to this Center, proposed delivery schedule, discount/payment terms, warranty duration (if applicable), taxpayer identification number (TIN), identification of any special commercial terms, and be signed by an authorized company representative.

Offerors are encouraged to use the Standard Form 1449, Solicitation/Contract/Order for Commercial Items form found at URL: http://server-mpo.arc.nasa.gov/Services/NEFS/NEFSHome.tml

Offerors shall provide the information required by FAR 52.212-1 (JAN 2005), Instructions to Offerors-Commercial, which is incorporated by reference.   FAR 52.212-4 (OCT 2003), Contract Terms and Conditions-Commercial Items is applicable.  

FAR 52.212-5 (JAN 2005), Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items is applicable and the following identified clauses are incorporated by reference: 52.203-6, Restrictions on Subcontractor Sales to the Government (Jul 1995), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 1999) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)). 52.222-3, Convict Labor (June 2003) (E.O. 11755). 52.222-21, Prohibition of Segregated Facilities (Feb 1999). 52.222-26, Equal Opportunity (Apr 2002) (E.O. 11246). 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4214). 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (U.S.C. 793) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4214). 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201). 52.225-13, Restrictions on Certain Foreign Purchases (Dec 2003) (E.o.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332). 52.245-4 Government Furnished Property (Short Form) Apr 84 The FAR may be obtained via the Internet at URL: http://www.arnet.gov/far/   The NFS may be obtained via the Internet at URL: http://www.hq.nasa.gov/office/procurement/regs/nfstoc.htm

All contractual and technical questions must be in writing (e-mail or fax) to Tasha Davis not later than June 15, 2005. Telephone questions will not be accepted. Selection and award will be made to the lowest priced, technically acceptable offeror, Technical acceptability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the product offered meets the Government’s requirement. Offerors must include completed copies of the provision at 52.212-3, Offeror Representations and Certifications – Commercial Items with their offer. These may be obtained via the internet at URL: http://prod.nais.nasa.gov/eps/Templates/Commercial_Greater_Than_25K.doc    .

These representations and certifications will be incorporated by reference in any resultant contract. An ombudsman has been appointed — See NASA Specific Note “B”. Prospective offerors shall notify this office of their intent to submit an offer.

It is the offeror’s responsibility to monitor the following Internet site for the release of solicitation amendments (if any): http://prod.nais.nasa.gov/cgi-bin/eps/bizops.cgi?gr=D&pin=73            . Potential offerors will be responsible for downloading their own copy of this combination synopsis/solicitation and amendments (if any). Any referenced notes may be viewed at the following URLs linked below.

Point of Contact

Tasha Davis, Contract Specialist, Phone (281) 483-4214, Fax (281) 483-4066, Email tasha.davis-1@nasa.gov – Cynthia W. Maclean, Contract Officer, Phone (281) 244-5903, Fax (281) 483-4173, Email cynthia.w.maclean@nasa.gov

Email your questions to Tasha Davis at tasha.davis-1@nasa.gov