PRESOL | R | Development of a Quality Management System

FBO DAILY ISSUE OF MARCH 13, 2011 FBO #3396
SOLICITATION NOTICE

R -- Development of a Quality Management System

Notice Date: 3/11/2011
Notice Type: Combined Synopsis/Solicitation
NAICS: 541690 — Other Scientific and Technical Consulting 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: SOL11223SOL00031
Archive Date: 4/26/2011
Point of Contact: London L Johnson, Phone: 301-827-7041
E-Mail Address: london.johnson@fda.hhs.gov
(london.johnson@fda.hhs.gov)
Small Business Set-Aside: Total Small Business
Description: The United States Food and Drug Administration are seeking offers for the development of a quality management system for the Center of Drug Evaluation and Research's (CDER's) Pharmaceutical Quality Regulatory System. This is a combined synopsis/solicitation for commercial items (as defined by FAR 2.101) prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional included in this notice. This announcement constitutes the only solicitation. A written request for proposal will not be issued. This acquisition is subject to FAR part 15 (Contracting by Negotiation) and is fixed-price. This acquisition is issued as Request for Proposal number 11-223-SOL-00031. All responsible business sources may submit an offer that will be considered. The NAICS code is 541690. The small business size standard is $7 million. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 95-48. Offers in response to this request for proposal shall be submitted by 12:00 p.m. local prevailing time, April 12, 2011. I. BACKGROUND: Food and Drug Administration's Pharmaceutical Quality Initiative for the 21st Century was introduced in 2002 to enhance and modernize the regulation of pharmaceutical manufacturing and product quality - to bring a 21st century focus to this critical FDA responsibility. The initiative is intended to modernize FDA's regulation of pharmaceutical quality for veterinary and human drugs and select human biological products (e.g., vaccines). Two of the main tenets of the initiative were to ensure that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and to enhance the consistency and coordination of the overall FDA drug quality regulatory programs. As a result of the diligent work done under the Quality Initiative, the FDA has completed its assessment of the existing quality programs. We assessed current practices as well as available new tools of enhancing manufacturing science. Our assessment helped us create a new framework for the regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches. The three parts of the drug quality regulatory programs - review, compliance, and inspection have basically worked independent of each other over the years. However, to successfully implement all tenets of the Quality Initiative, it is necessary to develop more coordinated interactions between the three areas. The roles and responsibilities of each separate section must be defined and more specific processes must be implemented, most specifically to enhance communication between the sections. Currently CDER is engaged in an effort to reach organization-wide alignment on the vision and future for the pharmaceutical quality regulatory program. Through a series of facilitated retreats, workshops, and working groups, CDER leadership has articulated the vision for regulating pharmaceutical quality and will integrate the philosophy and vision in to the business processes of the Center. In summary, CDER intends to implement a "quality management system" for regulating pharmaceutical quality. It is important to clarify the reference to a "system". The purpose of this effort is not to develop an information system and does not involve information technology/systems development. Rather, "system" in this context refers to a philosophy and a method of management designed to provide evidence that a specified standard of quality has been met and is being continuously improved. To have a successful Pharmaceutical Quality Regulatory program at CDER, it is necessary for the Center to have a "systems approach" to management of the regulation of pharmaceutical quality. In other words, CDER will only be effective and efficient in achieving the objectives of its Pharmaceutical Quality program if it identifies, understands, and manages all of the interrelated processes involved as a system. II. PURPOSE AND OBJECTIVES: The purpose of this requirement is to develop a quality management approach for CDER's Pharmaceutical Quality Regulatory program. In the remainder of the SOW, we will refer to the desired approach as a "quality management system." The purpose of the procurement is to obtain subject matter expertise for developing a quality management system for regulating pharmaceutical quality. Specifically, the objectives for this effort include: 1) Evaluating the current progress toward developing a quality management system for the CDER pharmaceutical quality regulatory program and assess the current state, 2) Characterizing the desired state for a quality management system for CDER's pharmaceutical quality regulatory program; and 3) Providing recommendations and subject matter expertise to CDER leadership as the Center transitions to a quality management system. III. SCOPE OF WORK: The Contractor shall: 1) Evaluate and document the Center's current state in developing a quality management system for the CDER pharmaceutical regulatory program in light of the various process improvements underway, 2) Develop and document a concept of operations which characterizes how CDER's quality management system for regulating pharmaceutical quality should operate in the desired state, 3) Document recommendations for transitioning CDER to the desired state from its current state, and 4) Provide subject matter expertise and ongoing consulting support. IV. TASKS: TASK 1: Work Plan and Meeting(s) with Project Team: The work plan shall describe the activities planned for each task, the deliverable(s), and delivery dates for the deliverable(s). After submitting the work plan to CDER, the Project Team shall schedule a meeting(s) with the contractor to discuss the details of the work plan and any revisions for a final work plan. Deliverables: 1) Draft narrative Work Plan in MS Word with detailed descriptions of steps to be taken and expected outcomes at each step and 2) Final narrative Work Plan in MS Word that incorporates FDA input and feedback from reviewing the draft Work Plan. TASK 2: Evaluate and document the current state of CDER's system for regulating pharmaceutical quality and its progress toward developing a quality management system. Deliverables: 1) Report: Characterization of the current state: assessment of progress toward developing a quality management system for regulating pharmaceutical quality, including a progress report of efforts within the relevant business units responsible for regulating pharmaceutical quality and across those business units, documented in MS Word. TASK 3: Develop and document a concept of operations that characterizes the desired state for regulating pharmaceutical quality within a quality management system and that describes how the relevant business units should operate together within the quality management system. Deliverables: 1) Draft Report: Concept of Operations characterizing the desired state for regulating pharmaceutical quality within a quality management system and describing how the relevant business units should operate together within the quality management system, written in MS Word. 1) Final Report: Concept of Operations, written in MS Word including FDA input and feedback from reviewing the draft. TASK 4: Provide recommendations for bridging the gaps between the current state and desired state as assessed in Tasks 2 and 3 of this effort. Deliverables: 1) Report: Documented recommendations for bridging the gaps between the current state and the desired state, presented in an MS Word document. TASK 5: Provide subject matter expertise and technical advice to CDER Leadership for this effort, including on-going monitoring of CDER's progress toward establishing a quality management system. Deliverables: 1) Shall include summary presentations describing the progress, current status, challenges (internal and external), opportunities, or other issues associated with implementing a quality management system, and 2) Shall include summary narrative descriptions or characterizations of various aspects of implementing quality management systems in a regulatory environment. NOTE: All deliverables which require reports shall be delivered to the Contracting Officer's Technical Representative (COTR). The COTR shall review the document and provide comments to the Contractor within two weeks. The Contractor shall deliver the revised document to the COTR within two weeks of receipt. V. SITE VISITS: There shall be between 1-3 site visits per month to work with and interview staff in CDER's Office of Pharmceutical Science, Office of Compliance, the COTR, and the Office of the Center Director. VI. PLACE OF PERFORMANCE: The majority of the work under this contract shall be conducted at the contractor's site; however work can be conducted at FDA offices in Silver Spring, Maryland. VII. PERIOD OF PERFORMANCE: The period of performance shall be the date of award through one year with two one-year option periods, if exercised. VIII. CONTRACT ADMINISTRATION DATA: CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COTR): The following COTR will represent the Government for the purpose of this contract: (To be determined upon contract award) The COTR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The contact information for the Contracting Officer is: London Johnson/5630 Fishers Lane/Rockville, MD 20857/XI. INVOICE SUBMISSION: Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt payment) AND 52.232-33 (Payment by electronic funds transfer - Central Contractor Registration) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: The contractor shall submit invoices to the address designated in the purchase order (see block 21) to receive invoices. To constitute a proper invoice, the invoice must be submitted on company letterhead and include- (I) Name and Address of the Contractor. (II) Invoice date and invoice number. (III) Purchase order or contract number. (IV) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed. (V) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government Bill of Lading. (VI) Terms of any discount for prompt payment offered. (VII) Name and address of official to whom payment is to be sent (Must be the same as that in the purchase order or in a proper notice of an assignment). (VIII) Name, title, and phone number of person to notify in event of defective invoice. (IX) Taxpayer Identification Number (TIN). (X) Electronic Funds Transfer (EFT) banking information. (XI) Name and telephone number of the FDA project officer reference on the purchase order, and (XII) Any other information or documentation required by the purchase order. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. Questions relating to when payment will be received should be directed to the FDA Payment Office at (301) 827-3742 or FDAVENDORPAYMENTSTEAM@FDA.GOV. Invoice Payment: In consideration of satisfactory performance of the work as described throughout this order, the Government will pay the Contractor in accordance with the price sheet. This amount will be payable upon presentation of a proper invoice and upon receipt and acceptance by the government of the services specified in the Schedule. It is the requirement of the Government to obtain complete and satisfactory performance in accordance with the terms of the specifications and quality standards of this contract. Monthly invoices will be submitted for completed work during the past month. Upon approval of each monthly invoice, payment should be provided for services completed from 30 days of approved submission. X. FAR CLAUSES INCORPORATED BY REFERENCE: 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html. 52.202-1 Definitions (JUL 2004): 52.203-3 Gratuities (APR 1984), 52.203-5 Covenant Against Contingent Fees (APR 1984), 52.203-7 Anti-Kickback procedures (JUL 1995), 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (JAN 1997), 52.203-10 Price or Fee Adjustment for Illegal or Improper Activity (OCT 1997), 52.203-12 Limitation on Payments to Influence Certain Federal Transactions (SEP 2007), 52.204-4 Printed or Copied Double-Sided on Recycled Paper (AUG 2000), 52.207-7 Central Contractor Registration (APR 2008), 53.209-6 Protecting the Government's Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (SEP 2006), 52.212-4 Contract Terms and Conditions-Commercial Items. 52.215-2 Audit and Records-Negotiation (MAR 2009), 52.215-8 Order of Precedence- Uniform Contract Format (OCT 1997), 52.215-10 Price Reduction for Defective Cost or Pricing Data (OCT 1997), 52.215-15 Pension Adjustments and Asset Reversions (OCT 2004), 52.215-18 Reversion or Adjustment of Plans for Postretirement Benefits (PRB) Other than Pensions (JUL 2005), 52.216-24- Limitation of Government Liability (APR 1984), 52.219-1 Small Business Program Representations (MAY 2004), 52.219-6 Notice of Total Small Business Set-Aside (JUN 2003), 52.219-8 Utilization of Small Business Concerns (MAY 2004), 52.219-14 Limitations on Subcontracting (DEC 1996), 52.222-3 Convict Labor (June 2003), 52.222-21 Prohibition of Segregated Facilities (Feb 1999), 52.222-26 Equal Opportunity (Mar 2007), 52.222-35 Equal Opportunity for Special Disable Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (SEP 2006), 52.222-36 Affirmative Action for Workers with Disabilities, 52.222-37 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (SEP 2006), 52.222-50 Combating Trafflicking in Persons (FEB 2009), 52.222-54 Employment Eligibility Verification (JAN 2009), 52.223-6 Drug-Free Workplace (MAY 2001), 52.225-13 Restrictions on Certain Foreign Purchases (Jun 2008), 52.229-3 Federal, State and Local Taxes (APR 2003), 52.232-1 Payments (APR 1984), 52.232-8 Discounts for Prompt Payment (FEB 2002), 52.232-9 Limitation on withholding of Payments (APR 1984), 52.232-11 Extras (APR 1984), 52.232-17 Interest (OCT 2008), 52.232.23 Assignment of Claims (JAN 1986), 52.232-25 Prompt Payment (OCT 2008), 52.233-1 Disputes (JUL 2002), 52.233-3 Protest After Award (Aug 1996), 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004), 52.242-13 Bankruptcy (JUL 1995), 52.243-3 Changes- Time and Materials or Labor-Hours (SEP 2000), 52.246-25 Limitation of Liability (FEB 1997), 52.249-4 Termination for Convenience of the Government (APR 1984), 52.249-8 Default (APR 1984), 52.253-1 Computer Generated Forms (JAN 1991), XI. HHSAR CLAUSES INCORPORATED BY REFERENCE, 352.202-1 Definitions (Jan 2006), 352.232-9 Withholding of Contract Payments (APR 1984), 352.270-4 Pricing Adjustments (JAN 2001), 352.270-5 Key Personnel (JAN 2006), 352.270-6 Publications and Publicity (JUL 1991), 352.270-7 Paperwork Reduction Act (Jan 2001), 352.270-10 Anti-Lobbying (JAN 2006), XII. THE FOLLOWING CLAUSES ARE IN FULL TEXT, 52.215-19 Notification of Ownership Changes (OCT 1997), (a) The Contractor shall make the following notifications in writing: (1) When the Contractor becomes aware that a change in its ownership has occurred, or is certain to occur, that could result in changes in the valuation of its capitalized assets in the accounting records, the Contractor shall notify the Administrative Contracting Officer (ACO) within 30 days. (2) The Contractor shall also notify the ACO within 30 days whenever changes to asset valuations or any other cost changes have occurred or are certain to occur as a result of a change in ownership. (b) The Contractor shall- (1) Maintain current, accurate, and complete inventory records of assets and their costs; (2) Provide the ACO or designated representative ready access to the records upon request; (3) Ensure that all individual and grouped assets, their capitalized values, accumulated depreciation or amortization, and remaining useful lives are identified accurately before and after each of the Contractor's ownership changes; and (4) Retain and continue to maintain depreciation and amortization schedules based on the asset records maintained before each Contractor ownership change, (c) The Contractor shall include the substance of this clause in all subcontracts under this contract that meet the applicability requirement of FAR 15.408(k) (End of clause), 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (JAN 2011), (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)), (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553), (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78), (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: (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402), (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2010) (Pub. L. 109-282) (31 U.S.C. 6101 note), (6) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, suspended, or Proposed for Debarment (DEC 2010) (31 U.S.C. 6101 note),(10)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644), (12) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2), (20) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2), (21) 52.222-3, Convict Labor (June 2003) (E.O. 11755), (23) 52.222-21, Prohibition of Segregated Facilities (Feb 1999), (24) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246), (25) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212), (26) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793), (27) 52.222-37, Employment Reports on Veterans, (Sep 2010) (38 U.S.C. 4212), (28) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496), (29) 52.222-54, Employment Eligibility Verification (JAN 2009). (Executive Order 12989).(30)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) 42 U.S.C. 6962(c)(3)(A)(ii), (33) 52.223-18, Contractor Policy to Ban Text Messaging While Driving (SEP 2010) (E.O. 13513), (37) 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), (42) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332 52.217-8 Option to Extend Services, As prescribed in 17.208(f), insert a clause substantially the same as the following: Option to Extend Services (Nov 1999), The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 6 months. (End of clause), 52.217-9 Option to Extend the Term of the Contract (MAR 2000), (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years. 52.223-10 Waste Reduction Program (Aug 2000), (a) Definitions. As used in this clause-"Recycling" means the series of activities, including collection, separation, and processing, by which products or other materials are recovered from the solid waste stream for use in the form of raw materials in the manufacture of products other than fuel for producing heat or power by combustion. "Waste prevention" means any change in the design, manufacturing, purchase, or use of materials or products (including packaging) to reduce their amount or toxicity before they are discarded. Waste prevention also refers to the reuse of products or materials. "Waste reduction" means preventing or decreasing the amount of waste being generated through waste prevention, recycling, or purchasing recycled and environmentally preferable products. (b) Consistent with the requirements of Section 701 of Executive Order 13101, the Contractor shall establish a program to promote cost-effective waste reduction in all operations and facilities covered by this contract. The Contractor's programs shall comply with applicable Federal, State, and local requirements, specifically including Section 6002 of the Resource Conservation and Recovery Act (42 U.S.C. 6962, et seq.) and implementing regulations (40 CFR Part 247). 3352.224-70 Confidentiality of Information. The following clause covers the policy set forth in subpart 324.70 and is used in accordance with the instructions set forth in 324.7004: Confidentiality of Information (January 2006) (a) Confidential information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. (b) The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the ‘‘Disputes'' clause. (c) If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. (d) Confidential information, as defined in paragraph (a) of this clause, shall not be disclosed without the prior written consent of the individual, institution, or organization. (e) Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this clause, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. (f) Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials. (g) The provisions of paragraph (d) of this clause shall not apply to conflicting or overlapping provisions in other Federal, State, or local laws. 352.232-9 Withholding of contract payments. Insert the following clause in all solicitations and contracts other than awards made using simplified acquisition procedures: Withholding of Contract Payments (January 2006) Notwithstanding any other payment provisions of this contract, failure of the Contractor to submit required reports when due or failure to perform or deliver required work, supplies, or services, may result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of the Contractor as defined by the clause entitled ‘‘Excusable Delays'' or ‘‘Default'', as applicable. The government shall immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted. 352.270-6 Publications and Publicity. Insert the following clause in all solicitations and resultant contracts: Publications and Publicity (January 2006) (a) Unless otherwise specified in this contract and the Confidentiality of Information clause is included, the Contractor is encouraged to publish the results of its work under his contract. A copy of each article submitted by the Contractor for publication shall be promptly sent to the Project Officer. The Contractor shall also inform the Project Officer when the article or other publication is published, and furnish a copy of it as finally published. (b) The Contractor shall include in any publication resulting from work performed under this contract a disclaimer reading as follows: A. ‘‘The views expressed in written conference materials or publications and by speakers and moderators at HHS-sponsored conferences, do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.'' (c) Unless authorized by the Project Officer, the contractor shall not display the HHS logo on any conference materials or publications. XIII INSTRUCTIONS FOR SUBMITTING PROPOSALS- GENERAL INSTRUCTIONS- Your proposal must be prepared in accordance with the General Instructions, Technical Proposal Instructions, Business Proposal Instructions and Past Performance Instructions (See Subsections A through D of these instructions for details, as well as with the Statement of Work contained in Section C of this Request for Proposal (RFP). If you have a basic agreement with the Department, and it is applicable to the type of contract to be awarded, the resultant contract will incorporate the basic agreement by reference. These instructions establish the acceptable minimum requirements for the format and content of proposals. Special attention is directed to the requirements for the technical and business proposals, and the past performance information to be submitted in accordance with these instructions. The penalty for making false statements in offers is prescribed in 18 U.S.C. 1001.1) Submission of Proposals: The proposal shall be in two parts: TECHNICAL PROPOSAL and BUSINESS PROPOSAL. Each of the parts shall be separate and complete. All documents required for responding to this RFP should be placed in the following order when submitting proposals: a. COVER PAGE- with RFP title, RFP number and name of organization. Also, indicate on cover page either:(1) ORIGINAL PROPOSAL (signed), (2) COPY OF PROPOSAL. (a) BUSINESS PROPOSAL- The business proposal consists of cost and pricing data, administrative and management data. Please provide a cost breakdown of all tasks and hours. One (1) copy of the Representations and Certifications must be submitted with the original copy of the signed proposal only. Do not duplicate for every copy of the "Business Proposal" (See Subsection ‘B' of these instructions for details). (b) TECHNICAL PROPOSAL- The "Technical Proposal" shall not contain any reference to cost. However, resource information such as data concerning labor hours and categories, types of materials, subcontracts, travel, computer time, etc, must be included in the "Technical Proposal" so that the offerors' understanding of the scope ofwork may be evaluated. (See Subsection ‘C' of these instructions for details). (1) Your proposal must stipulate that it is predicated upon all terms and conditions of this RFP. (2) It is understood that your proposal shall be part of the official file. B. BUSINESS PROPOSAL INSTRUCTIONS- Your business proposal shall consist of three parts: Cost and Pricing Data, Other Administrative Data, and Representations and Certifications. The business proposal should be specific, complete in every detail and separate from your technical proposal. The following paragraphs provide guidance on your business proposal. (1) Cost or Pricing Data- Cost or pricing data refers to the portion of the offeror's submission which is factual. The requirement for cost or pricing data is satisfied when all facts reasonably available to the contractor up to the time of agreement on cost/price, and which might reasonably be expected to affect the price negotiations, are accurately disclosed to the Contracting Officer. Please submit, as a minimum, a cost proposal fully supported by cost or pricing data adequate to establish the reasonableness of the proposed amount. A detailed breakdown of estimated costs by phase, segment, or year must be submitted. For each separate cost estimate or line item, the offeror must furnish a breakdown by cost elements. (a) Subcontracted Effort Include parts, components, assemblies, and services that are to be produced or performed by others in accordance with offeror's design, specifications, or direction and that are applicable only to the prime contract. For each subcontract over $500,000.00, the support should provide a listing by source, item, quantity, price, type of subcontract, degree of competition, and basis for establishing source and reasonableness of price, as well as the results of review and evaluation of subcontract proposals when required by FAR 15.404-3. (a) Overhead, General and Administrative Expense- Unless your proposed burden rate(s) has recently been accepted by an agency of the U.S. Government, detailed projected estimates of the various items which are included in the total overhead pools are required. These projected estimates should be based upon past actuals as well as upon the planned mode and level of operation during the period in which effort is to be expended under the subject contract. These estimates should take into consideration all operating changes. Details of cost incurred in the previous fiscal year and current year to date should also be presented. If you have an approved indirect cost rate agreement, it is recommended that you attach a copy of the agreement to your proposal. (b) Special Testing- Include details of special testing (labor, material, and overhead), attaching a separate schedule, if necessary. Show the basis of the estimate. (c) Special Equipment-If special purpose equipment is being proposed, provide a description of the items, details of the proposed cost including competitive prices, and a justification as to why the Government should furnish the equipment or allow its purchase with contract funds. (See the paragraph below of this section for policy on equipment.)If fabrication by the prime contract is contemplated, include details of material, labor and overhead. (d) Travel Expense- Attach a schedule indicating the estimated number of person-trips required, destinations, mode and cost of transportation, and the number of days of subsistence per trip. Identify and support any other special transportation costs attributable to the performance of this project. (e) Consultant Service- Consultant service should be explained by indicating the specific area in which such service is to be used. Identify the contemplated consultants. State the number of days of each service estimated to be required and the consultant's quoted rate per day, and indicate the number of hours per day in which work will be performed. State whether the consultant has received the proposed rate in performing similar services for other contractors (f) Other Direct Costs Special direct taxes, such as Federal excise, state franchise or personal property taxes, directly applicable to this procurement should be identified, including basis or recovery. Taxes from which exemptions are available to the contractor directly, or afforded the Government when the procuring agency makes available a certificate of exemption, should not be included in the cost proposal. When the costs of materials for publication of reports required under the contract are included in your proposal, indicate the approximate total number of pages contemplated in the reports. The cost of computer time should be supported. Explain what is included in the rate. While the above are representative of other direct costs, they are not intended to be all-inclusive of the items which may be contained in your cost proposal. (g) Equipment- It is HHS policy that contractors shall provide all equipment and facilities necessary for performance of contracts. Exception may be granted to furnish government-owned property or to authorize purchase with contract funds, only when approved by the head of the procuring activity. If additional equipment must be acquired, the offeror shall include in your proposal the description, estimated cost of each item and whether you will furnish such items with your own funds. (h) Government-Owned Property- The offeror shall identify Government-owned property in their possession and/or property acquired from Federal funds, which you have title and that is proposed to use in the performance of the prospective contract. (i) Financial Capacity- The offeror shall indicate if it has the necessary financial capacity, working capital and other resources to perform the contract without assistance from any outside source. If not, indicate the amount required and the anticipated source (j) Other Administrative Data, Management Capability and Responsibility. In reviewing the proposal and other sources of information, the Contracting Officer must receive adequate information to evaluate each offeror's management capability and to determine whether the offeror is responsible. Therefore, under the Other Administrative Data section of your proposal, it is suggested that you provide adequate information in the following areas: (a) Capability to meet delivery or performance schedules, (b) Record of past performance, (c) Record of business integrity, (d) Possession of necessary organization, experience, and technical skills, or the ability to obtain them, (e) Possession of required facilities; and (f) Other special considerations involved in the instant acquisition. NOTE: If the information for any of the above areas has already been provided elsewhere in your proposal, please identify the section and/or page number of either your business or technical proposal where the information is located. XIV EVALUATION CRITERIA- Award will be made on a best value basis taking into account the following factors: (1) RELEVANT EXPERIENCE- a) Working knowledge of CDER Pharmaceutical Quality Initiative for the 21st Century, b) In-depth understanding of the roles and responsibilities of CDER's review, compliance, and inspection programs, c) Expertise in the pharmaceutical industry's manufacturing maturity. 2) PAST PERFORMANCE- (i) Past performance information is one indicator of an offeror's ability to perform the contract successfully. The currency and relevance of the information, source of the information, context of the data, and general trends in contractor's performance shall be considered. This comparative assessment of past performance information is separate from the responsibility determination required under Subpart 9.1. (ii) The solicitation shall describe the approach for evaluating past performance, including evaluating offerors with no relevant performance history, and shall provide offerors an opportunity to identify past or current contracts (including Federal, State, and local government and private) for efforts similar to the Government requirement. The solicitation shall also authorize offerors to provide information on problems encountered on the identified contracts and the offeror's corrective actions. The Government shall consider this information, as well as information obtained from any other sources, when evaluating the offeror's past performance. The source selection authority shall determine the relevance of similar past performance information. (iii) The evaluation should take into account past performance information regarding predecessor companies, key personnel who have relevant experience, or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. (iv) In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror may not be evaluated favorably or unfavorably on past performance. (v) The evaluation should include the past performance of offerors in complying with subcontracting plan goals for small disadvantaged business (SDB) concerns (see Subpart 19.7), monetary targets for SDB participation (see 19.1202), and notifications submitted under 19.1202-4(b) and 3)TECHNICAL AND MANAGEMENT APPROACH. XV. PRICE EVALUATION- The Price proposal shall represent the Offeror's response to the requirements of this RFP. The Government shall evaluate the total proposed price. In addition, this evaluation shall include an assessment of the Offeror's proposal for completeness, realism, reasonableness, and risk. At the Government's discretion, the Government may adjust the proposed cost to account for government-assessed cost risks. XVI. BASIS FOR AWARDS- This is a best value procurement. The Government intends to award to the responsible offeror whose offer, conforms to the Scope of Work. The Government may award this contract to other than the lowest priced technically acceptable proposal. Relevant Experience, Past Performance, and Technical and Management Approach are of equal weight and are significantly more important than Price. However, as the evaluation results of the offeror's technical and past performance areas become equivalent, price will gain greater importance in the "best value" decision. The Contracting Officer has the right to award without discussions.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/SOL11223SOL00031/listing.html)
Record: SN02399262-W 20110313/110311234635-9d22caecc7881f731412f918c4183b63 (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™

R -- Development of a Quality Management System