FDA DOC - repeat.doc

FDA-SOL-08-00653

Addendum to FAR Clause 52-212-1 Part E - INSTRUCTIONS TO OFFERORS COMMERCIALS ITEMS E.1 52.215-1 Instructions to Offerors-Competitive Acquisition (JAN 2004)

(a) Definitions. As used in this provision--

“Discussions” are negotiations that occur after establishment of the competitive range that may, at the Contracting Officer's discretion, result in the offeror being allowed to revise its proposal.

In writing, writing, or written means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information.

“Proposal modification” is a change made to a proposal before the solicitation's closing date and time, or made in response to an, or made to correct a mistake at any time before award.

“Proposal revision” is a change to a proposal made after the solicitation closing date, at the request of or as allowed by a Contracting Officer as the result of negotiations.

“Time,” if stated as a number of days, is calculated using calendar days otherwise specified, and will include Saturdays, Sundays, and legal holidays. However, if the last day falls on a Saturday, Sunday, or legal holiday, then the period shall be the next working day.

(b) Amendments to solicitations. If this solicitation is amended, all terms and conditions that are not amended remain unchanged. Offerors shall acknowledge receipt of any amendment to this solicitation by the date and time specified in the amendment(s).

(c) Submission, modification, revision, and withdrawal of proposals.

(1) Unless other methods (e.g., electronic commerce or facsimile) are permitted in the solicitation, proposals and modifications to proposals shall be submitted in paper media in sealed envelopes or packages (i) addressed to the office specified in the solicitation, and (ii) showing the time and date specified for receipt, the solicitation number, and the name and address of the offeror. Offerors using commercial carriers should ensure that the proposal is marked on the outermost wrapper with the information in paragraphs (c)(1)(i) and (c)(1)(ii) of this provision.

(2) The first page of the proposal must show—

(i) The solicitation number;

(ii) The name, address, and telephone and fax numbers of the offeror (and electronic address if available);

(iii) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and agreement to furnish any or all items upon which prices are offered at the price set opposite each item;

(iv) Names, titles, and telephone and facsimile numbers (and electronic addresses if available) of persons authorized to negotiate on the offeror's behalf with the Government in connection with this solicitation; and

(v) Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent's authority, unless that evidence has been previously furnished to the issuing office.

(3) Submission, modification, revision, and withdrawal of proposals.

(i) Offerors are responsible for submitting proposals, and any modifications or revisions so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that proposal or revision is due.

(ii)

(A) Any proposal, modification or revision received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(1) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of proposals; or

(2) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(3) It is the only proposal received.

(B) However, a late modification of an otherwise successful proposal that makes its terms more favorable to the Government will be considered at any time it is received and may be accepted.

(iii) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(iv) If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(v) Proposals may be withdrawn by written notice received at any time before award. Oral proposals in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile proposals, proposals may be withdrawn via facsimile received at any time before award, subject to the conditions specified in the provision at 52.215-5, Facsimile Proposals. Proposals may be withdrawn in person by an offeror or an authorized representative, if the identity of the person requesting withdrawal is established and the person signs a receipt for the proposal before award.

(4) Unless otherwise specified in the solicitation, the offeror may propose to provide any item or combination of items.

(5) Offerors shall submit proposals in response to this solicitation in English, unless otherwise permitted by the solicitation, and in U.S. dollars, unless the provision at FAR 52.225-17, Evaluation of Foreign Currency Offers, is included in the solicitation.

(6) Offerors may submit modifications to their proposals at any time before the solicitation closing date and time, and may submit modifications in response to an amendment, or to correct a mistake at any time before award.

(7) Offerors may submit revised proposals only if requested or allowed by the Contracting Officer.

(8) Proposals may be withdrawn at any time before award. Withdrawals are effective upon receipt of notice by the Contracting Officer.

(d) Offer expiration date. Proposals in response to this solicitation will be valid for the number of days specified on the solicitation cover sheet (unless a different period is proposed by the offeror).

(e) Restriction on disclosure and use of data. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall--

(1) Mark the title page with the following legend: This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed--in whole or in part—for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this offeror as a result of--or in connection with--the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government's right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in sheets [insert numbers or other identification of sheets]; and

(2) Mark each sheet of data it wishes to restrict with the following legend: Use or disclosure of data contained on this sheet is subject to the restriction on the title page of this proposal.

(f) Contract award.

(1) The Government intends to award a contract resulting from this solicitation to the responsible offeror(s) whose proposal(s) represents the best value after evaluation in accordance with the factors and sub factors in the solicitation.

(2) The Government may reject any or all proposals if such action is in the Government's interest.

(3) The Government may waive informalities and minor irregularities in proposals received,

(4) The Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). Therefore, the offeror's initial proposal should contain the offeror's best terms from a cost or price and technical standpoint. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals.

(5) The Government reserves the right to make an award for a services less than the services offered, at the cost or prices offered, unless the offeror specifies otherwise in the proposal.

(6) The Government reserves the right to make a single award if, after considering the additional administrative costs, it is in the Government's best interest to do so.

(7) Exchanges with offerors after receipt of a proposal do not constitute a rejection or counteroffer by the Government.

(8) The Government may determine that a proposal is unacceptable if the prices proposed are materially unbalanced between line items or subline items. Unbalanced pricing exists when, despite an acceptable total evaluated price, the price of one or more contract line items is significantly overstated or understated as indicated by the application of cost or price analysis techniques. A proposal may be rejected if the Contracting officer determines that the lack of balance poses an unacceptable risk to the Government.

(9) If a cost realism analysis is performed, cost realism may be considered by the source selection authority in evaluating performance or schedule risk.

(10) A written award or acceptance of proposal mailed or otherwise furnished to the successful offeror within the time specified in the proposal shall result in a binding contract without further action by either party.

(11) If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(i) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(ii) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(iii) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(iv) A summary of the rationale for award.

(v) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

E.2 52.216-1 Type of Contract (APR 1984)

The Government anticipates the award of a single contract, ID/IQ contract with one base and five (5) year option periods.

At the discretion of the Contracting Officer, the Government may use a variety of contract types under this contract, including: Firm Fixed Price (FFP); Time and Materials (T&M), or a combination thereof.

Each individual Task Order Proposal (ITO) issued under this contract will identify the Government’s determination of contract type.

E.3 52.233-2 Service of Protest (SEP 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Glenda Barfell

Director, Office of Acquisitions & Grants Services

Food and Drug Administration

5630 Fishers Lane, HFA-500

Rockville, MD 20857

FAX: 301-827-7039

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

E.4 52.215-20 Requirements for Cost or Pricing Date or Information Other than Cost or Pricing Data – Alternate IV (OCT 1997)

(a) Submission of cost or pricing date is not required.

(b) Provide information other than cost or pricing data described below in Part E.12.

E.5 Solicitation Amendments

Any amendments or other informational material issued by the Government prior to the due date for proposals will be made available only on FedBizOpps (http://www.fedbizopps.gov/). The Government reserves the right to amend or cancel the solicitation as necessary to meet FDA requirements.

E.6 Incurring Cost Prior to Contract Execution

Issuance of this solicitation does not constitute an award commitment on the part of the Government. This request does not commit the Government to pay for costs incurred prior to the execution of a formal contract unless specifically authorized in writing by the Contracting Officer. The Contracting Officer is the only individual who can legally obligate the Government to the expenditure of public funds should a contract result by reason of a response to this Request for Proposals.

E.7 General Instructions to Offerors

(a) Single Award. The U.S. Government anticipates awarding approximately one (1) contract as a result of this Solicitation.

(b) Total 8(a) Small Business Set-aside. The Contracting Officer has determined that this entire acquisition be set-aside for small 8(a) business, pursuant to the requirements of FAR 19.8.

(c) RFP Instructions. If an Offeror does not follow the instructions set forth herein, the Offeror's proposal may be eliminated from further consideration or the proposal may be down-graded and not receive full or partial credit under the applicable evaluation criteria.

(d) Accurate and Complete Information. Offerors must set forth full, accurate and complete information as required by this RFP. The penalty for making false statements to the Government is prescribed in 18 U.S.C. 1001.

(e) Pre-award Survey. FDA reserves the right to perform a pre-award survey which may include, but is not limited to: (1) interviews with individuals to establish their ability to perform contract duties under the project conditions; (2) a review of the prime contractor's financial condition, business and personnel procedures, etc.; and (3) site visits to the prime contractor's institution.

(f) Offer Acceptability. The Government may determine an offer to be unacceptable if the offer does not comply with all of the terms and conditions of the RFP and prospective contract:

(1) Completion of Standard Form 1449, Blocks 17a;

(2) Submission of proposed costs/prices and indirect cost information as required by pricing schedule of this RFP;

(3) Submission of proposed percentage for ceiling on indirect cost rates as required by pricing schedule of this RFP;

(4) Completion of the "Representations, Certifications, and Other Statements of Offerors" in Part G;

(5) Submission of information required by Part L or any other section of this RFP. The submission of these items in accordance with these instructions will, if the Government accepts the offer, contractually bind the Government and the successful Offeror to the terms and conditions of the prospective contract. Offerors shall follow the instructions contained in this RFP and supply all information and signature/certifications, as required.

(6) Offerors should not assume that the Contracting Officer will independently obtain information necessary to evaluate the offeror’s proposal, and should therefore supply all information required by this RFP for the evaluation of its proposal. The offeror’s failure to provide the information required could result in rejection of the proposal.

(g) The Government reserves the right to amend or cancel the Solicitation, as necessary, to meet FDA requirements.

(h) Proposal Preparation Costs. The U.S. Government will not pay for any proposal preparation costs.

(i) Proposals must be submitted in the English language and prices must be in U.S. dollars.

E.8 Delivery Instructions

(a) Proposals submitted in response to this RFP will be received the following manner:

(i) via regular mail - sending two (2) originals, eight (8) copies, and two (2) duplicate CDs of a Technical Proposal (Volume 1) and two (2) originals, three (3) copies and two (2) duplicate CDs of a Business Proposal (Volume 2):

Food and Drug Administration

Office of Acquisitions & Grants Services

5630 Fishers Lane, HFA-500

Rockville, MD 20857

Attn: Patricia Pemberton

(ii) Hand delivery (including commercial courier) of two (2) originals, eight (8) copies, and two (2) duplicate CDs of a Technical Proposal (Volume 1) and two (2) originals, three (3) copies and two (2) duplicate CDs of a Business Proposal (Volume 2).

Food and Drug Administration

Office of Acquisitions & Grants Services

5630 Fishers Lane

Rockville, MD 20857

Attn: Patricia Pemberton

(b) Questions in response to this solicitation must be received in writing via e-mail to Sharon McCauley at sharon macauley@fda.hhs.gov AND Patricia Pemberton at patricia.pemberton@fda.hhs.gov by June 9, 2008 at 2:00 pm (ET) for consideration at the pre-proposal conference.

Final questions shall be received by not later than 10:00am (local time), Friday, 06/13/2008. No questions will be accepted after this date. No phone calls, please.

(c) Closing Date and Time. All proposals in response to this RFP shall be due at the address specified in (a), not later than 3:30 pm (local time) on 07/02/2008. *No proposals shall be accepted via email.*

(d) The information requested below must be placed in sealed envelopes clearly marked on the outside with the following information:

RFP No.: FDA-SOL-08-00653 Technical (Volume 1) and Cost/Business (Volume 2) Proposals must be kept separate from each other. Technical Proposals must not make reference to pricing data in order that the technical evaluation may be made strictly on the basis of technical merit.

E.9 Instructions for the Preparation of the Technical Proposal

(a) Offerors must organize the technical proposal to follow the technical evaluation criteria listed in Section M.

(b) Text color shall be black. Color may be used in graphics or charts for greater clarity at the offeror’s option. Text in graphics and charts shall be no smaller than 9-point Arial Narrow; text in tables shall be no smaller than 9-point Arial. No fonts may be condensed.

(c) The written Technical Proposal is not limited. Offerors shall use only 8.5 inch by 11 inch (210mm by 297mm) paper, single-spaced pages with margins no less than one inch on each border. Number each page consecutively. Do not use a type smaller than 12 point.

Note: Technical proposal may contain a table, chart, graph, etc., not otherwise excluded below.

Not included in this page limitation are the following:

- Table of Contents;

- Dividers-

- Appendix attachments which contain biographical information (i.e., resumes and other documentation provided by the Offeror) for proposed candidates; RESUMES ARE LIMITED TO 2 PAGES EACH.

- Contractor Past Performance Listing;

All critical information from appendices should be summarized in the technical proposal.

Responses to Requests for Base Order Proposals (See Instructions for Volume 1)

(d) CD Format: Each CD submitted with the technical and business proposals shall contain copies of the proposal in two formats: pdf (Adobe Acrobat 7.0 or older) and in the original format, for example: word (2003), excel (2003), or in other applicable formats. If there is a discrepancy between the CD and the hard copy, the hard copy takes precedence. Offerors shall certify that each CD-ROM has been checked using the latest version of virus detection software and is virus free. The certification shall identify the virus detection software and version used.

(e) The Technical Proposal (Volume 1) shall be submitted in three-ring binders and include the information set forth below.

E.10 Volume 1 – Technical Proposal

E.10.1 Technical- The Offeror shall address the following items:

Offerors are encouraged to submit proposals for both the base contract, pricing schedule for the individual task orders however, for purposes of evaluation, only the base contract task order proposal shall be factored into the evaluation of the overall firm fixed price contract and the ITO pricing schedule will be evaluated for the ID/IQ portion of the contract. (See Part F for additional information).

E.10.1.1 Technical Understanding

The Offeror shall describe the level of knowledge and understanding of the scope of work, detailed in Part D.1, to provide the required mission-critical services to meet FDA’s objectives.

E.10.1.2 Base Contract Task Proposal

Offerors are REQUIRED to submit a Base Contract Task Proposals as the first task utilizing attachment 9 of the pricing schedule. Offerors that fail to submit a proposal for the Base Contract Task will be excluded from the competition without further consideration.

Technical Proposals submitted in response to base contract task shall be prepared in accordance with the instructions therein and shall be included in a separate binder “Volume #2 Base Contract Task Order Proposals”. Business Proposals submitted in response to base contract task proposal shall also be prepared in accordance with the instructions for the overall ID/IQ contract and shall be included in Volume 2 “Business Proposal”.

The Base contract Business Proposals shall be separately tabbed and submitted as part of Volume 2, Business Proposal.

E.10.2 Management- The Offeror shall address the following:

The Offeror shall describe 1) the strategy for the overall management of this contract and demonstrate how to provide the maximum breadth and depth of capabilities to provide services which fall within the scope of The FDA Document Control Room project as defined in Part D.1) how the offeror will ensure a unified, integrated management approach for this program, irrespective of the mix of labor categories.

E.10.2.1 Management Approach

The Offeror shall describe its management approach for FDA Document Control Room Program and discuss how its management approach will ensure the accomplishment of Document Control Room objectives.

The offeror shall describe its plan for FDA Document Control Room project operations, including, at a minimum:

1. Base contract management processes, including schedule management, cost estimating, program/project control, subcontractor management and program/project reporting.

2. Risk management at the FDA Document Control Room Firm fixed price (base Contract) and ID/IQ contract level. The offeror shall describe the major challenges to success on the FDA Document Control Room Program and the offeror’s plan for mitigating those risks.

3. Performance management, including a discussion of maintaining quality assurance and control, and the development and tracking of quality and quantitative performance measures through the use of Critical Processing Time Constraint (included in Amendment 000005)in collaboration with the Document Control Room.

4. Resource management (staffing and physical assets), including the Offeror’s plan to retain adequate, qualified staffing for the FDA Document Control Room, processes for resolution of priority and resource conflicts, the approach to collaboration, flexibility, creativeness, responsiveness, willingness to change, and innovative solutions.

5. Subcontractor Management, (if necessary), including an approach to monitoring, evaluating, and correcting/rewarding subcontractor performance, and managing information flow across a program organization that may consist of multiple subcontractors.

6. Approach to collaboration, flexibility, creativeness, responsiveness, willingness to change, innovative solutions, thought leadership, and progressive approach to resource management.

E.10.2.2 Organizational Structure The Offeror shall describe its organization and organizational structure, including a description of 1) where the FDA Document Control Room contract will sit within the Offeror’s corporate structure, 2) the interrelationships of the organizational elements, 3) communications channels, 4) levels of approval and authority, 5) roles and responsibilities of the organization and Key Personnel (for Base Contract task and the ID/IQ portion), including the level of executive management to which the Program Manager for the overall Base firm fixed price portion and ID/IQ contract reports, and 6) applicable corporate policies that may impact contract/task order performance and administration. The Offeror shall propose Key Personnel to oversee the performance of the base contract along with the ID/IQ portion of the contract. At a minimum, the offeror shall propose a Program Manager who has been employed continuously with the offeror for at least one (1) year prior to the date of submission of the proposal. The offeror shall provide a letter of commitment, resume, and at least three references for any proposed Program Manager. The letter of commitment shall indicate the date of availability of the proposed Key Personnel and how long the individual candidate’s commitment is binding. Letters of commitment, resumes, and references shall not count shall be included in an appendix to the Technical Proposal. If, after submission of the offeror’s proposal, but prior to award, an individual designated as Key Personnel becomes unavailable, the offeror shall promptly notify the Contracting Officer and update the proposal accordingly. In such a situation, the offeror may be allowed to offer a substitute at the Contracting Officer’s discretion.

The Offeror shall describe its plan for the location of its program office.

E.10.3 Relevant Experience- The Offeror shall address the following:

The offeror shall provide information about 3 projects that are most similar to this effort in terms of type, scope, complexity and size. The offeror shall describe their current and past experience, identifying other organizations in which they have performed similar tasks including the degree of their involvement (prime or subcontractor), the size of the client’s organization, and other information to describe their expertise and performance in the subject areas, highlighting the organization’s demonstrated successes. Projects listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers.

For each project identified above, the offeror shall submit the following information:

1. Name of contracting activity (Federal Government agency, local government, commercial customer)

2. Contract number

3. Contract type

4. Total contract value, and subcontract value (if applicable)

5. Contracting Officer contact information (phone, fax, email)

6. Project Officer/Contracting Officer’s Technical Representative contact information (phone, fax, email)

7. Administrative Contracting Officer contact information – if different from item 5 (phone, fax, email)

8. Description of work

9. Narrative highlighting the relevance of the work performed in terms of type, scope, complexity, and size.

In addition, the offeror should provide one example (with reference contact information) of corporate experience that demonstrates how the corporation responded when a project went off track, either over budget, behind schedule, below quality standards or some other difficulty.

E.10.4 Past Performance- The Offeror shall address the following:

For the purposes of this solicitation, past performance shall be defined as the offeror’s record of conforming to specifications and to standards of quality service. Evaluation of past performance will be based on performance documentation or any other pertinent information available. It will not be based solely on information provided by the offeror. 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. 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.

a) In an appendix to Volume #1 Technical Proposal, the Offeror must provide past performance information for itself as follows:

· Submit completed Past Performance Questionnaires (Attachment) for each of the projects listed under Relevant Experience. Submit the entire Past Performance Questionnaire electronically or fax to Patricia Pemberton at Patricia.Pemberton@fda.hhs.gov.

· Submit completed Past Performance Questionnaires for up to three (3) additional most recent contracts, according to the procedures described in the previous paragraph.

· If extraordinary problems impacted any of the referenced contracts, provide a short explanation and the corrective action taken (this is required by FAR 15.305(a)(2)).

· Describe any quality awards or certifications that indicate exceptional capacity to provide the service or product described in the statement of work.

E.11 Volume 2 – Business Proposal E.11.1 Organization of Business Proposal

Offerors’ business proposals shall be clear and concise. Proposals shall consist of a Table of Contents and be organized with the following elements:

(a) Part 1 - Standard Form (SF) 1449 The Offeror must submit the cover page (Part A) of this Solicitation [Standard Form (SF) 1449, "Commercial Solicitation, Offer, and Award", with blocks 17a, with an original signature of a person authorized on behalf of the Offeror to sign the offer.

(b) Part 2 - Proposed Costs/Prices

(1) The offeror must submit a proposal that complies with the instructions set forth herein. The price/cost proposal will be used for the purpose of evaluating price/cost for the award of the Base Contract and the ID/IQ portion, page 6. Offerors shall provide the following:

A. A completed Pricing Table, page 6 and Attachment 9.

B.

Offerors must identify all necessary labor categories for the ID/IQ portion. The rates will be in accordance with the pricing table completed from above on page 6. In addition, offerors will estimate any materials that are necessary as well as the anticipated other direct costs for each task order. Material handling fees will be included in the other direct costs.

Note: For further clarification, the following budget line items include the costs as listed:

(1) Other Direct Costs - bank fees, courier services, phone and fax, Internet services, office rental, equipment and supplies, office utilities, office cleaning and maintenance, etc.

(2) Offerors shall explain how they intend to budget for costs associated with ID/IQ oversight and reporting requirements.

(3) Offerors shall submit a detailed salary history, exclusive of bonuses, additional benefits or compensation packages for all proposed staff and consultants, identified by name in the proposal, including key personnel.

(4) Offerors shall provide additional supporting budget documentation (as necessary), including profit/fee policy, etc. to substantiate all proposed costs.

(c) Part 4 - Representations, Certifications, and Other Statements of Offerors

The Offeror and each proposed subcontractor shall complete Part G, "Representations, Certifications, and Other Statements of Offeror", and sign and date on the last page in the space provided.

(d) Part 5 - Policies and Procedures

If the offeror does not have prior Federal contracting experience submit a copy of its personnel policies, especially regarding salary and wage scales, fringe benefits, merit increases, promotions, leave, differentials, travel and per diem regulations, etc. The Contracting Officer may determine that a Pre-Award Survey is necessary. (See FAR 9.106).

(e) Part 6 - Evidence of Responsibility

The offeror shall submit sufficient evidence of responsibility for the contracting officer to make an affirmative determination of responsibility pursuant to the requirements of FAR Subsection 9.104-1. If the offeror fails to submit sufficient evidence for the contracting officer to make an affirmative determination of responsibility, then the contracting officer may make a determination of non-responsibility and will contact the Small Business Administration (SBA) to make a final determination before awarding a contract to that offeror. To be determined responsible, a prospective contractor must:

(1) Have adequate financial resources to perform the contract, or the ability to obtain them (see FAR 9.104-3(a));

(2) Be able to comply with the required or proposed delivery or performance schedule, taking into consideration all existing commercial and governmental commitments;

(3) Have a satisfactory performance record (See FAR 9.104-3(b) and Subpart 42.15). A prospective contractor shall not be determined responsible or non-responsible solely on the basis of a lack of relevant performance history, except as provided in FAR 9.104-2;

(4) Have a satisfactory record of integrity and business ethics;

(5) Have the necessary organization, experience, accounting and operational controls, and technical skills, or the ability to obtain them (including, as appropriate, such elements as production control procedures, property control systems, quality assurance measures, and safety programs applicable to materials to be produced or services to be performed by the prospective contractor.). (See FAR 9.104-3(a));

(6) Have the necessary production, construction, and technical equipment and facilities, or the ability to obtain them (See FAR 9.104-3(a)); and

(7) Be otherwise qualified and eligible to receive an award under applicable laws and regulations (e.g., Equal Opportunity, Clean Air and Water, Small Business Subcontracting, etc.).

(f) Part 8 - Information Concerning Work-Day, Work-Week, and Paid Absences

(1) The offeror shall indicate the number of hours and days in its normal work-day and its normal work-week, both domestically and overseas, for employees and consultants. In addition, the offeror and each proposed major subcontractor shall- indicate how paid absences (US holidays, local holidays, vacation and sick) shall be covered.

(2) A normal, work-year, including paid absences (holidays, vacations, and sick leave) is 2,080 hours (260 days x 8 hours per day). However, some organizations do not have an 8-hour workday, and some accounting systems normally provide for direct recovery of paid absences by using a work-year of less than 2,080 hours to compute individuals' unburdened daily rates. The offeror shall describe their work day and work week policies.

(3) The work day and work week policies and the method of accounting for paid absences for the offeror will be incorporated into the contract as an attachment.

(g) Part 9 – Conflict of Interest The offeror shall provide a Conflict of Interest (COI) certificate that demonstrates the offeror’s compliance with the requirements specified in RFP Part B.29, and confirms that, at the time of submission of the offer, the offeror and its teaming partners/major subcontractors and/or subcontractors are not in violation of the Conflict of Interest provisions.

E.12.1 Instructions for Preparation of Pricing Labor Table At its discretion, the offeror may include additional labor categories needed for the performance of the work required under this contract. Per FAR 15.406-2, the Government reserves the right to request that the offeror or its subcontractors certify their cost or pricing data. To ensure that the Government is able to perform a fair assessment of the proposed cost/price, the offeror is required to submit, at a minimum, the information identified in this section. Each business proposal shall include supporting information that is cross-referenced to facilitate clear traceability/reconciliation for all work proposed to be done by the offeror.

The Government reserves the right to conduct comprehensive audits of proposals. Field pricing assistance other than audits may be used.

E.12.2 Assumptions

The offeror shall include all assumptions supporting the development of the offeror’s business proposal, not otherwise discussed in the budget narratives.

E.12.3 Site Visits The offeror shall make available for inspection by the Government the offeror’s premises or facilities used for, off-site storage facilities, or the like. The Government and its authorized evaluation support teams may conduct site visits to any of the aforesaid facilities during the course of the source selection process. The Government shall have access to the site for observation of security, telecommunications, data processing, data storage, and administrative functions.

The offeror shall identify a responsible point of contact (and his/her alternative) with the requisite authority to arrange and conduct the site visit as described, and shall provide this information to the Government as part of the documentation for Volume 3 – Business Proposal. The Government will provide the offeror’s point of contact at least five (5) business days’ notice of the intended visit.

FAR Clause 52.212-2 Evaluation Commercial Items or Other Description of Evaluation Factors for Award F.1 General Information

(a) The Government may award a contract without discussions with offerors in accordance with FAR 52.215-1.

(b) The Government intends to evaluate offerors in accordance with Part F of this RFP and make contract award to the responsible offeror whose proposal(s) represents the best value to the U.S. Government.

(c) The submitted technical information will be evaluated by a technical evaluation committee using the technical criteria shown below. When evaluating the competing offerors, the Government will consider the written information provided by the offerors and any other information obtained by the Government through its own research.

(d) For overall evaluation purposes, technical factors are considered significantly more important than price/cost factors.

F.2 Technical Evaluation The criteria listed below are presented by major category, so that offerors will know which areas require emphasis in the preparation of information. Offerors should note that these criteria serve as the standard against which all technical information will be evaluated, and serve to identify the significant matters which offerors should address. The technical evaluation criteria (a), (b), (c) and (d) as listed below will be evaluated in descending order of importance. Sub-criteria are of equal importance, unless otherwise stated.

a) Technical Approach

b) Project Management and Operation

c) Relevant Experience

d) Past Performance

F.3 Determination of Competitive Range

(a) The competitive range of offerors with whom negotiations will be conducted (if necessary) will be determined by the Contracting Officer pursuant to FAR 15.306(c). A competitive range determination (if necessary) may take place at any point in the evaluation process.

(b) Offerors are advised that, in accordance with FAR 52.215-1, if the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals.

F.4 Price/Cost Analysis Price analysis shall be conducted in accordance with FAR 404-1(b).

If applicable, proposed costs shall be evaluated for reasonableness, allowability and allocability. This analysis is intended to determine the degree to which the costs included in the cost proposal are fair and reasonable and the reasonableness of proposed daily labor rates, fee, and ceilings on indirect cost rates and fee.

F.5 Source Selections

(a) The overall evaluation methodology set forth above will be used by the contracting officer as a guide in determining which proposal(s) offer the best value to the U.S. Government. In accordance with FAR 52.215-1, and as set forth in Part E of this solicitation, award will be made by the Contracting Officer to the responsible offeror(s) whose proposal(s) represents the best value to the U.S. Government after evaluation in accordance with all factors and sub-factors in this solicitation.

(b) This procurement utilizes the tradeoff process set forth in FAR 15.101-1. If the Contracting Officer determines that competing technical proposals are essentially equal, cost/price factors may become the determining factor in source selection. Further, the Contracting Officer may award to a higher priced offeror if a determination is made that the higher technical evaluation of that offeror merits the additional cost/price.

F.6 Technical Evaluation Criteria

F.6.1 Technical Approach

The Government will evaluate the offeror’s technical approach for the FDA Document Control Room project and all other work described in Part D.1 while: complying with the legislative and executive mandates, regulatory and departmental requirements and prescribed technical standards applicable to the FDA Document Control Room Program. The Government will also evaluate the offeror’s technical understanding of the requirements for the IDIQ contract and the base contract tasks. The purpose of this evaluation is to determine the consistency and practical application of the offeror’s overall technical approach.

F.6.1.1 Subfactor 1: Technical Understanding of the overall IDIQ The Government will evaluate how well the offeror demonstrates the level of knowledge and understanding of FDA program requirements to perform the work and meet the program’s mission needs and objectives as shown by the offeror’s Technical Volume.

F.6.1.2 Subfactor 2: Technical Understanding of the Base Contract task

The Base Contract task shall be evaluated in accordance with the evaluation criteria contained in the RFP. As a result, an overall rating will be assigned to this Base Contract and factored into the evaluation of the technical proposal for the base contract firm fixed price portion.

F.6.2 Project Management and Operations

The Government will evaluate the clarity and effectiveness of the offeror’s comprehensive approach to managing all aspects of contract performance and administration. Evaluation Criterion #2 Project and Management and Operation consists of three (3) subfactors, which shall are listed in descending order of importance.

F.6.2.1 Subfactor 1: Depth and Breadth of offerors Proposed Team

The Offeror’s proposal shall demonstrate: 1)capabilities to provide the services within the scope of FDA Document Control Room; 2) a successful approach is to ensure a unified integrated management team, irrespective of the mix of labor categories.

F.6.2.2 Subfactor 2: Management Approach

The Offeror’s proposal shall demonstrate a comprehensive and effective management plan for the overall ID/IQ contract, which specifically addresses the offeror’s approach to the areas of specified in Section E.14 F.6.2.3 Subfactor 3: Organizational Structure The Offeror’s proposal shall demonstrate; 1) an appropriate, efficient and effective organizational structure and 2) the commitment of a Program Manager that meets the requirements set for in Part E.

F.6.3 Relevant Experience

The Offeror’s proposal shall demonstrate the success of efforts on current and previous contracts, which are relevant to the FDA Document Control Room Program in terms of type, scope, complexity, and size. A highly scored proposal will provide relevant experiences from the areas required and will demonstrate a similarity to work to be performed under this effort. The highly scored proposal will also demonstrate the offerors ability to overcome difficulties encountered during performance with minimum impact to the program.

F.6.4 Past Performance

Past performance information will be used for both the responsibility determination and best value decision. FDA may use performance information obtained from other than the sources identified by the offeror. FDA may utilize existing databases of contractor performance information and solicit additional information from the references provided in response to the RFP and from other sources.

If the performance information contains negative information on which the offeror has not previously been given an opportunity to comment, FDA will provide the offeror an opportunity to comment on it priority to its consideration in the evaluation, and any offeror comment will be considered with the negative performance information.

FDA will initially determine the relevance of similar performance information as a predictor of probable performance under the subject requirement. FDA may give more weight to performance information that is considered more relevant and/or more current.

The contractor performance information shall demonstrate a successful record of past performance and shall be evaluated in terms of:

· Quality of service, including consistency in meeting goals and targets;

· Cost control, including forecasting costs as well as accuracy in financial reporting;

· Timeliness of performance, including adherence to contract schedules and other time-sensitive project conditions and effectiveness of management to make prompt decisions and ensure efficient completion of tasks;

· Business relations, addressing the history of professional behavior and overall business-like concern for the interests of the customer, including coordination, cooperative attitude in remedying problems and timely completion of all administrative requirements;

· Customer satisfaction with performance, including end user wherever possible;

· Effectiveness of key personnel, including appropriateness of personnel for the job and prompt and satisfactory changes in personnel when problems with clients where identified;

Ratings of score will be given. A rating of Good past performance will take precedence over neutral or poor past performance ratings. Neutral past performance will take precedence over a poor rating.

In cases where:

(i) an offeror lacks relevant performance history;

(ii) information on performance is not available; or

(iii) an offeror is a member of a class of offerors where there is provision not to rate the class against a subfactor; then the offeror will not be evaluated favorably or unfavorably on performance and shall receive a neutral rating.

Overall, 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.

F.9 Risk The Government will assess the relative risks associated with each offeror’s proposal and potential performance. Risk is defined as the likelihood that the Government will be negatively impacted by the offeror’s failure to meet the negotiated business, technical, management and schedule performance and cost. The Government’s assessment will recognize the distinction between proposal risk and performance risk:

1) Proposal risks are those associated with an offeror’s proposed approach in meeting the Government’s needs and requirements. The evaluation team will assess proposal risk and integrate their assessments into the rating of each evaluation factor and appropriate subfactor.

2) Performance risks are those associated with an offeror’s likelihood of success in performing the solicitation’s requirements as indicated by that offeror’s record of past performance.

Assessment of risk is an integral component of the evaluation. It will serve to inform the evaluators regarding the likelihood that the offeror’s proposed solutions would successfully meet the requirements of this RFP, within reasonable time frames and funding profiles and without placing unreasonable risk on the Government. In analyzing the risk of the offeror’s proposed solutions, the Government will also consider the offeror’s willingness to share in this risk.

Proposals that require substantial revisions because of significant omissions of information required by the solicitation (to include all stated terms, conditions, representations, certifications and all other information required by RFP Section E) may not be considered among the most highly rated proposals within the competitive range in accordance with FAR 15.305. Offeror proposals that restate the requirements from the RFP or simply state that the offeror’s proposal is compliant with the RFP without providing a description of the approaches, techniques or solutions may be considered non-responsive or may receive a very low rating for those items. Proposals that do not conform to all requirements in the RFP may be rejected without further evaluation, deliberation or discussion. The Government may reject any proposal that is evaluated to be unrealistically low or high when compared to Government estimates, such that the proposal is deemed to reflect an inherent lack of competence or an inherent failure to understand/comprehend the complexity and risks of the program.

If at any point during the evaluation process the Government concludes that the offeror is not likely to receive an award, the Government may eliminate the offeror from further consideration for award. Any offeror eliminated from further consideration will be officially notified in writing.

The Government reserves the right to waive minor irregularities and discrepancies in offers received.

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