Combined_Synopsis_Solicitation.doc

COMBINED SYNOPSIS/SOLICITATION

FOR COMMERCIAL ITEMS

General Information

Contracting Office Address

5630 Fishers Lane Room 2131

Rockville, MD 20857 Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a Request for Quotations. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular Fac 2005-74.

The associated North American Industrial Classification System (NAICS) code for this procurement is 519190, with a small business size standard of $7.0.

The Food and Drug Administration is seeking to purchase access to an existing database in order to review Market Share Reports for Medical Devices. This requirement is being solicited under full and open competition using the procedures in FAR part 13.5.

All interested companies shall provide quotations for the following:

Supplies

Unit Total

Line Item Description Units of Issue Price Price

Access to Database 1 yr. subscription Option Year 1 1 yr. subscription Option Year 2 1 yr. subscription Option Year 3 1 yr. subscription Option Year 4 1 yr. subscription PURPOSE: The FDA is seeking sources to provide access to an existing database holding market share reports. The database must meet the requirements of this statement of work.

Market Share Reports shall provide information on all types of medical devices (cardiovascular, dental, orthopedic, radiologic, in vitro diagnostic, ophthalmic, ENT, plastic surgery, general surgery, urology, ob/gyn, gastroenterology, renal, neurological, general hospital, physical medicine, anesthesia and respiratory devices.)

The information shall include manufacturers and brand names, brand specific market share information trended over time, description of devices, analysis of disease prevalence, upcoming innovation, current development status, device risks and benefits, information on related clinical trials, and company profiles.

Each report shall include a comprehensive analysis of the specific market and shall be approximately 300-400 pages with textual analysis, exhibits and charts, patient populations, procedure forecasts, analysis of competitive landscape, share-by-supplier data, company and product profiles, and outlook for the future. The data contained in the market share reports should be current (less than 2 yrs old) and comprehensive. The research should be extensive and include data from clinicians, researchers and industry insiders.

FDA anticipates 200 reports per year. The reports should be available on line and available to anyone in CDRH who wants to access them. They shall be digitally available whether going through the FDA library or a hosted website.

The data should be provided in databases or text/table reports.

Period of Performance: One year base with four (4) one-year option periods.

Place of Performance

Electronically

Provisions The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

· FAR 52.212-1, “Instructions to Offerors–Commercial Items” (April 2014)

· Addendum: The offeror needs to submit a list of potential reports that they could run along with 1 example of a previously run report and an outline of what database is to be used to provide these reports.

· Offers must show: A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary

· All quotations shall be sent to the contract specialist, Daniel Weingarten electronically via e-mail to Daniel.Weingarten@fda.hhs.gov.

· Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the contract specialist Daniel Weingarten.

· Submission shall be received not later than Friday, August 22, 2014 at 12 p.m. Eastern Time. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

· FAR 52.212-2, “Evaluation – Commercial Items” (Jan 1999)

· Addendum: The award shall be made to the quoter whose quotation is the lowest priced technically acceptable. The offeror’s quotes shall be evaluated on thoroughness of previous reports along with the range of topics future reports could be run using.

· FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” (May 2014)

Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

52.212-4 Contract Terms and Conditions—Commercial Items. (May 2014) - is hereby incorporated by reference.

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items.

As prescribed in 12.301(b)(4), insert the following clause:

Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jul 2014)

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

_X__ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

_X__ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note).

_X__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

_X__ (16) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)).

_X__ (25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

_X__ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X__ (29) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

_X__ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X__ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X__ (32) 52.222-35, Equal Opportunity for Veteran (Jul 2014) (38 U.S.C. 4212).

_X__ (33) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

_X__ (34) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

_X__ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X__ (36) 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

_X__ (43) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

_X__ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

_X__ (45) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X__ (46) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

_X__ (52) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

52.217-8 -- Option to Extend Services (Nov 1999)

52.217-9 -- Option to Extend the Term of the Contract (Mar 2000) Point of Contact

Daniel Weingarten, Contract Specialist, Food and Drug Administration Office of Acquisition and Grants Services

240-402-7625 Daniel.Weingarten@fda.hhs.gov 5630 Fishers Lane

Room 2131

Rockville, MD 20857