MODIFICATION
R -- Pharmaceutical Review, Compliance and Inspection of Regulatory Programs
- Notice Date
- 7/17/2009
- Notice Type
- Modification/Amendment
- 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
- FDA1058842
- Archive Date
- 8/6/2009
- Point of Contact
- David - Kordel,
- E-Mail Address
-
david.kordel@fda.hhs.gov
(david.kordel@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Solicitation Number: FDA1058842 Response Date: 22 July 2009 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-33. The associated North American Industrial Classification System (NAICS) code for this procurement is 541690 for a 100% small business set-aside. The FDA intends to issue a firm fixed-price purchase order for the following technical assistance. 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. Our findings have put the Agency on a path to restructure its oversight of pharmaceutical quality regulation, thereby developing the product quality regulatory system of the future. The three parts of the drug quality regulatory programs - review, compliance, and inspection have basically worked independent of each other over the years. However, in order to successfully implement all of the tenets of the Quality Initiative, it is necessary to develop more coordinated interactions between the three areas. In order to do this, 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. Recently an evaluation was performed to determine roles and responsibilities of review, compliance, and inspection under the new regulatory paradigm and to recommend appropriate processes to ensure effective interaction and communication. That recent assessment of the product quality review process among the relevant FDA business units found a lack of clear roles and responsibilities and lack of clear and cohesive process steps for ensuring product quality. The work conducted under this contract will be a continuation of the previous assessment task and will focus on following up on the recommendations to develop a seamless process between the various business units involved in product quality review, compliance, and inspections with a focus on documenting roles and responsibilities at each stage of the process. II. Purpose and Objective The purpose of this effort will be to develop a quality management system for drug product quality review and will involve: 1) Characterizing the Desired State for Review, Compliance & Inspection in the 21st century 2) Developing Multiple Examples (at least 3) to Clarify Desired State Relative to Current State 3) Assessing Capabilities & Skills of Existing Staff and Identify Opportunities for Development 4) Providing SME Consulting to FDA Leadership to Enable Desired State 5) Providing On-Going Monitoring Support to Process Consulting and SOP Development Effort During Course of Pilot III. Description of Deliverables The deliverables for this project include: 1) Documenting a characterization of the desired state for the FDA's product quality review business process; 2) Assessing the capabilities and skill sets of the existing staff who conduct compliance reviews; 3) Developing example scenarios to be used during a pilot to test the new standard operating procedures; and 4) Providing subject matter expertise and ongoing consulting support. IV. Period of Performance Vendor shall provide monthly status reports of progress and shall provide a final recommendation to Center management within 12-months of initiation of contract. V. Release of Information by Contractor The contractor shall not release any data generated by the study conducted under this project without the approval of the Project Officer. VI. Site Visits Visits may be required to interview staff in FDA's Office of Pharmaceutical Science and Office of Compliance and to give presentations to Center leadership. VII. Statement of Work 1. Tasks and Activities Task 1: Work Plan and Meeting(s) with Project Team The work plan shall describe the activities planed for each task, the deliverable(s), and delivery dates for the deliverable(s). After submitting the work plan to CDER, the Project Team will 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 Work Plan 2) Final Work Plan Task 2: Identify the desired state for the product quality review, compliance & inspection process to form the foundation for 21st Century Deliverables: 1)Documented characterization of the desired state for product quality review Task 3: Develop scenarios of product quality issues that shall be managed during a pilot of the new business process associated with the Desired State. Deliverables: 1) Three documented scenarios of product quality issues: one example each for an early, mid, and end-of-life-cycle issue to be managed during a pilot of the new business process associated with the Desired State Task 4: Define and evaluate capabilities and skill sets of existing staff involved in Compliance review: Deliverables: 1) Draft report on staff assessment; 2) Final report on staff assessment. Task 5: Provide subject matter expertise and technical guidance to CDER Leadership for this effort. Task 6: Provide On-Going Monitoring Support to Process Consulting and new Standard Operating Procedure Development Effort during the Course of Pilot VIII. Personnel Employee Development and Staffing The contractor shall provide a stable, competent work force to perform each task order. The contractor shall promote among its personnel the importance of gaining insight and appreciation about the organizational structures of CDERIOPS and its mission, policies, and organizational preferences. The contractor shall institute procedures to refresh and enhance this knowledge and understanding. Employees shall remain technically current in their fields of expertise. Key Personnel Continuity is critical to successful contract execution. The contractor shall not divert key personnel without the prior written consent of the Project Officer. In the event substitution becomes necessary (e.g., an employee's departure from the company or medical disability), the FDA may require that the contractor provide replacement personnel. The contractor shall demonstrate that the prospective substitute personnel possess qualifications commensurate with those of the personnel being replaced. The FDA reserves the right to disapprove the proposed substitutes. Specialized Expertise In the performance of this SOW, the contractor may require access to highly specialized management or training skills or industry knowledge that the contractor may not have among its available employee base. Under these circumstances, the contractor may acquire these temporary short-term resources through other means. This contract requires that the contractor have quick and expedient access to these types of specialized business management consulting capabilities. Necessary Qualifications of Personnel To successfully fulfill the objectives of this contract, OPS has determined that the following skills or knowledge are essential: 1) Knowledge ofFDA regulatory authority 2) Knowledge of OPS, OC, and CDER missions and business practices 3) Knowledge ofFDA Plain Language guidelines 4) Knowledge of CDER drug review process 5) Federal and Agency Standards and Policy The contractor shall abide by all FDA and federal regulations, policies, and procedures in effect during the contract period of performance. This includes all changes in laws, regulations, policies, and procedures as they evolve during the contract period of performance. A resume is required for the position which measures the qualifications and experience of the proposed contractor detailed in the requirement. A "man year" equates to 720 hours. One resume is to be provided for the combined labor category as follows: Medical Scientists (Occupation Code 19-1042), Pharmacists (Occupation Code 29-1051) Resumes shall be included with your proposal for evaluation. Resumes shall not be submitted for the labor categories containing zero hours. Personnel proposed by the offeror will be evaluated for their formal education/training, technical skills and years of experience against the desired qualifications set forth in Attachment A. All resumes shall be weighted equally for evaluation purposes. Resumes that meet the desired qualifications will be scored in the acceptable range, while those that exceed the desired requirements of education and/or experience will be scored higher." For instance, if the requirement is for a Bachelor's degree and the proposed person has a Masters degree they would receive extra credit (i.e. Acceptable versus Exceptional). The resumes will be scored against the following criteria: 1. Formal Education and/or training. 2. General Experience. 3. Specialized Experience. 4. Previous work experience clearly indicates skill and ability to perform in the labor category for which he/she is being proposed. A price breakdown should be submitted in the following format for evaluation: Base Year: I. Fully Burdened Hourly Rate Item description: a. Technical Assistance: ___ hours at a rate of $___ per hour = $____ or $_____/month or __ hours/month Total Fully Burdened Hourly labor costs = $______ ($______/month or ____ hours/month) IX. Place of Performance The majority of work under this contract is expected to be conducted at the contractor's site. Work may also be conducted at FDA offices in Silver Spring, Maryland. X. Organizational Conflict of Interest The contractor and all of its present and future affiliates and subsidiaries shall agree to: 1) Neither compete, nor assist others in competing, for any procurement of the supplies or services that are described in the documents delivered by the contractor under this delivery order; and 2) Not furnish, either as a prime or subcontractor, the supplies or services that are described in any procurement that is based upon the documents delivered by the contractor under this delivery order. The above prohibitions shall also apply to the contractor's employees, subcontractors, consultants, or any other person who participates in the performance of this delivery order. The contractor shall require such persons to sign a statement agreeing to the above restrictions. The original of the above statement shall be provided to the Contracting Officer prior to the person beginning work under the delivery order. The contractor shall sign an agreement to protect proprietary information prior to receiving the proposals, and the companies proposing on this requirement shall agree to the contractor's review as a condition of submitting their proposals. XI. Reporting Requirements The contractor shall send an invoice at the completion of each task to the Contracting Officer's Technical Representative. Attached to the invoice will be the following detailed information: 1) Written reports identified under "Deliverables" 2) Monthly Status Report of task deliverables QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 4:30 pm (1630) EST on 14 July 2009. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," 2) Past Performance, and 3) Price. Technical Capability and Past Performance is significantly more important than price. Evaluation of Technical Capability shall be based on the information provided in the quotation. Quoters shall include their understanding of the requirement and any past performance that can support your quote or other literature which CLEARLY DOCUMENTS that the offered service meets or exceeds the specifications stated herein. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.217-8, Option to Extend Services 52.217-9, Option to Extend the Term of the Contract 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. 52.243-3 Changes—Time-and-Materials or Labor Hours This is a Combined Synopsis/Solicitation for technical assistance as defined herein. The Government intends to award a Firm Fixed-Price Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541690; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA, Silver Spring, MD 20993. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on 22 July 2009 to the attention of David Kordel, david.kordel@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED. Attachment A The following factors will be considered in the award of this requirement. -Extent of experience working with and/or knowledge of CDER Pharmaceutical Quality Initiative for the 21st Century and an in-depth understanding of the roles and responsibilities of CDER's review, compliance and inspection programs. -Reasonableness of cost.
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