PRESOL | D | Pharmacoviligence Analytical Tool

FBO DAILY ISSUE OF AUGUST 06, 2008 FBO #2445
SOLICITATION NOTICE

D -- Pharmacoviligence Analytical Tool

Notice Date: 8/4/2008
Notice Type: Combined Synopsis/Solicitation
NAICS: 541511 — Custom Computer Programming Services
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-SOL-08-1045418
Archive Date: 8/28/2008
Point of Contact: Jody L. O'Kash,, Phone: 301-827-5094, Ted L Weitzman,, Phone: 301-827-7178
E-Mail Address: Jody.O'Kash@fda.hhs.gov, ted.weitzman@fda.hhs.gov
Small Business Set-Aside: N/A
Description: (i) This is a combined/synopsis solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. (ii) This is solicitation number FDA-SOL-08-1045418 and this solicitation is being issued as a Request for Quote (RFQ). This is the only solicitation that will be issued for this requirement. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-12. (iv) The applicable NAICS code is 541511. (v) The following are Brand Name descriptions of items and units of measure: 1) Assured Information System’s Standard 12 month Perpetual Vet (PV) Works Veterinary Adverse Event Reporting Software License without workflow for 12 primary users and 6 secondary read only users (to include a 180 day warranty). The software includes all functional specifications, database definition, help/user guides, and Evidence of Acceptance Test Plan execution. 2) Annual Maintenance that covers product upgrades, help-desk support from 8am to 5pm EST, remote access support by telephone and email, and software bug fixes providing fix or workaround. 3) Separate Administration Program to include code-list maintenance, user maintenance and form security, company product maintenance, delete/undelete/purge case, and system options. NOTE: We do not anticipate purchasing training or hardware components for the software. (vi) DESCRIPTION OF REQUIREMENTS / STATEMENT OF NEED: The Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) / Center of Veterinary Medicine (CVM) is seeking a veterinary drug safety software that provides comprehensive data entry and reporting, full audit trail links to Microsoft Office and image and document management. As part of the application, Document Management functionality allows source documents and images of regulatory reports to be stored and retrieved with the case itself. This is a BRAND NAME OR EQUAL TO request for quote (RFQ). In order to be considered for award a vendor offering an EQUAL TO product must submit with their quote supporting documentation that their product meets the following salient characteristics: 1) Process Driven Pharmacovigilance: User defined graphical process maps; 'To do' list drives process execution; 'To do' list prioritized by lateness; seriousness; Fully integrated with safety functionality / data handling; Uses established third-party workflow engine; Auto-completion of tasks; Web-based; Escalation procedures; Process health check / performance reports; and Management functions including workload balancing. 2) Pharmacovigilance Functionality: Collects and reports data to meet all common international regulations including FDA, Fedesa / CVMP, EMEA, European states, Australian, Coding of cases against user dictionaries; Extensive data validation; cross-field checks and use of pick lists; Handles animal reactions, human exposures, lack of efficacy and product complaints; Duplicate check function; Integrated spell-checker; FDA 21 CFR Part 11 compliance; Case data export; Notes may be added to any field; Full audit trail; Letter generation using Microsoft Word; Open database for use of third-party query and reporting tools; Extensive use of reference dictionaries, e.g. contacts, laboratory tests, Integrated document management; Built-in query tool, Handles user time zones in a global implementation. 3) Technical: Scalable from single PC to corporate client / server network; Internet access; Oracle database; UNIX / Windows NT / 2000 server; Windows 98 / NT / 2000/ XP clients; Citrix Metaframe compatible; RAD development technology; Interface with Microsoft Office; and Interface with Crystal Reports. 4) License: Software License as described above for 12 primary users and 6 secondary (read only) users for a continuing twelve month period. 5) Includes Annual Maintenance and Support: Covering: Product upgrades, Help Desk support Monday thru Friday from 8 a.m. to 5 p.m. Eastern Time, Remote access support by telephone and Email, and Software bug fixing, includes providing fix or workaround. 6) System Administration: Include a separate administration module in which CVM may amend the contents of dropdown lists to reflect local business procedures as well as maintain user security and a product dictionary. (vii) Delivery of the product will be FOB destination. The contractor shall deliver the product to FDA/Center for Veterinary Medicine, 7529 Standish Place, Rockville, MD 20852 no later than seven days after receipt of a an award. (viii) The provision at 52.212-1, Instructions to Offerors (APR 2008) -- Commercial, applies to this acquisition and is available at website: http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P257_45709. (ix) The provision at 52.212-1, Evaluation -- Commercial Items (Jan 1999) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will offer the best value to the Government, technical factors, price, and past performance considered. To determine technical merit, each quotation will be evaluated against the technical evaluation factors. The following factors shall be used to evaluate offers and are listed in descending order of importance. 1) Technical Understanding and Approach. The proposed technology will be evaluated on its ability to meet all of the requirements listed in part (vi) of this solicitation. Contractors shall furnish as part of their quotation all descriptive material necessary for the government to determine whether their service meets the technical requirements. The technical proposals will be graded subjectively with final scores of, “Minimally Acceptable”, “Acceptable”, or “Exceptional”. A score of “Minimally Acceptable” would mean that the proposed technology minimally met the requirements and demonstrated to be difficult to implement. A score of “Acceptable” would mean that the proposed technology fully met the requirements and demonstrated its ability to be implemented. A score of “Exceptional” would mean that the proposed technology exceeded the requirements and would be easy to implement. 2) Price. The Government will evaluate proposed prices for a base period plus four options. FAR Provision 52.217-5, Evaluation of Options (Jul 1990) applies to this procurement. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s). The vendor may submit a rent versus purchase price quote if renting the software is a standard commercial practice offered by the vendor. Price is of less importance than technical capabilities and past performance combined. Award will not be automatically made on the basis of the highest technical merit. However price may become an important factor as the degree of equality between technical proposals becomes closer. 3) Past Performance: Vendors should provide two references of similar efforts performed during the last three years. This will include a description of the project, project title, contract number, contract amount, client identification including agency or company name, contracting and technical reviewing official name(s), address and telephone number. The government is seeking to determine whether an offeror has consistently demonstrated a strong commitment to customer satisfaction and high performance of services. This is a matter of judgment. The government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror’s likelihood of success in performing the acquisition requirements as indicated by that offeror’s past performance record. Rating of positive, neutral, and poor will be given. A positive past performance will take precedence over neutral or poor past performance. Neutral past performance takes precedence over poor past performance. A contractor with no past performance will be given a score of neutral, which will neither be used to the advantage nor disadvantage of the offeror. The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror’s likelihood of success in performing the acquisition requirements as indicated by that offeror’s record of past performance. 4) English Language and U.S. Currency: FAR provisions 52.214-34 -- Submission of Offers in the English Language (Apr 1991) and 52.214-35 -- Submission of Offers in U.S. Currency (Apr 1991) applies to this acquisition. Offers received in other than in the English language or U.S. dollars shall be rejected. The Government intends to issue one firm fixed award for this requirement. The Government reserves the right to make award without discussions. (x) Vendors shall complete FAR 52.212-3, Offerors Representations and Certifications - Commercial Items (JUN 2003). This can be done electronically at http://orca.bpn.gov. The contracting officer will review the vendor’s online certifications at http://orca.bpn.gov to ensure that they are accurate and complete. If the vendor does not have active representations and certifications registered online they will be disqualified from being considered for award. (xi) The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (FEB 2007), applies to this acquisition. (xii) The clause at FAR 52.217-9 -- Option to Extend the Term of the Contract (MAR 2000) and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JUNE 2007), applies to this acquisition as well as the following clauses cited therein: 52.219-6, Notice of Total Small Business Set-Aside (JUN 2003) (Alternate I OCT 1995), 52.222-3, Convict Labor (JUN 2003)(EO 11755); 52.222-19, Child Labor - Cooperation with Authorities and Remedies (JAN 2006)(EO13126); 52.222-21, Prohibition of Segregated Facilities (FEB 1999); 52.222-26, Equal Opportunity (MAR 2007)(EO11246); 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era and other Eligible Veterans (SEP 2006)(38 USC 4212); 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998)(29 USC 793); 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era and other Eligible Veterans (SEP 2006)(38 USC 4212), 52.232-1 Payments (APR 1984); 52.232-33 Payment by Electronic Funds Transfer –Central Contractor Registration (OCT 2003); 52.225-1 Buy American Act---Supplies (JUN 2003), 52.225-13 Restriction on Certain Foreign Purchases (FEB 2006), 52.239-1 Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a), Payment by Electronic Funds Transfer - Other than Central Contractor Registration (MAY 1999). Full text of clauses and provisions can be accessed at www.arnet.gov/far. (xiii) In order to comply with Section 508 of the Rehabilitation Act, the Government asks vendors to complete a Voluntary Product Accessibility Template (VPAT) and submit it with their quote. The technical standards applicable to this requirement are: 1194.21 Software Applications and Operating Systems (a,b,c,d,e,f,g,h,i,j,l ), 1194.31 Functional Performance Criteria (a,b,c,d,e,f), and 1194.41 Information, Documentation, and Support (a,b,c). The 508 technical standards are available at http://www.section508.gov/. All questions must be submitted in writing to Jody.O’Kash@fda.hhs.gov no later than Friday, August 8, 2008 at 5pm EST. Answers to all questions will be posted as an amendment to the solicitation. Price Proposals, Technical proposals, and VPAT may be submitted electronically at Jody.O'Kash@fda.hhs.gov no later than Wednesday, August 13, 2008 at 5pm EST.
Web Link: FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=2d76b51da35a513ff10375d895b588b1&tab=core&_cview=1)
Place of Performance: Address: FDA / Center for Veterinary Medicine, 7529 Standish Place, Rockville, Maryland, 20852, United States; Zip Code: 20852
Record: SN01630460-W 20080806/080804222511-2d76b51da35a513ff10375d895b588b1 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

| FSG Index | This Issue's Index | Today's FBO Daily Index Page |

Loren Data's SAM Daily™

D -- Pharmacoviligence Analytical Tool