ON-SITE CLASSIFICATION SPECIALIST TO PERFORM PEER REVIEW

On-Site Classification Specialist to Perform Peer Review Functions This is a combined synopsis/solicitation for labor hour contract prepared in accordance with FAR 12.6 using Simplified Acquisition Procedures under the test program for commercial items found at FAR 13.5, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested. No other solicitation will be issued. The North American Industry Classification Code is 541612. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. STATEMENT OF WORK: 1.0 Introduction 1.1 Background The Office of Management Programs (OMP), FDA is responsible for administering the Food and Drug Administration (FDA) Peer Review Program. This program, unique to FDA and the National Institutes of Health, allows for promotions of FDA research scientists; pre- and post-market scientists, medical officers, engineers and related professionals, and consumer safety officers. The higher grade levels are peer reviewed according to the terms outlined in various peer review plans that have been agreed to by the Center Directors and the Commissioner of FDA. 1.2 Objective The purpose of this contract is to ensure the timely and accurate processing peer review packages for the Food and Drug Administration. This effort requires expertise to provide assistance to one federal employee to address a high volume of recurring peer review packages. 1.3 Project Scope This contract will provide support to the Office of Management Programs (OMP) in all phases of Peer Review Functions. 2.0 Description of Work The Contractor shall: a. Receive and review Peer Review Packages. b. Analyze proposed promotion packages prior to peer review meetings referring to reference materials such as the Classifiers Handbook; significant classification appeals decisions, Center peer review policy and procedures, etc. c. Provide advisory services to chair and committee members d. Participate in peer review committee meetings. e. Respond to appeals and grievances. f. Prepare final Peer Review reports and evaluations in proper format and acceptable to the OMP authorized approving official or his/her designee, and in conformance with the Office of Personnel Management (OPM) and PHS, FDA standards of adequacy, as specified in 5 USC Chapter 51; Federal Personnel Manual (FPM) HHS, PHS Chapter 511; applicable position Classification Standards; and OPM position Classification Standards Guidelines, Background and Introduction. g. Write job descriptions in the OPM factor evaluation system (FES) or narrative format to conform to the grade controlling standard format, with numbered paragraphs for major duties (with percentage of time) and an unnumbered topic or summary paragraph at the beginning on the mission of the organization. h. Prepare job descriptions and evaluation statements typed in final form on 8 " x 11 plain bond paper and ensure that an Optional Form 8 (OF-8) is attached to each job description with blocks 2-5, 7, 9-11, 15e, 18a-18e, and 22 are complete and accurate. i. Designate the units of work to be prepared in accordance with the list of jobs or positions provided for review by the Peer Review Coordinator. j. Advise employees of appeal rights and peer review procedures Coordinating Instructions a. In all cases, the job descriptions and OF-8 prepared by the contractor will be reviewed and signed by the responsible supervisor as representing an accurate description of the duties and responsibilities as certified by the supervisor's signature on Block 20a before being referred to the Peer Review Coordinator as the authorized approving official or his/her designee for technical review and acceptance. b. The contractor is not obligated to evaluate the positions at the requested grade level if the facts do not support such a determination. The program officials, not the contractor, will be responsible for the accuracy of all statements and documents submitted to OMP. 3.0 PERFORMANCE DELIVERABLES: a. DELIVERABLE: Final Job Descriptions with evaluation statements and completed OF-8's TASK: Prepare job descriptions and evaluation statements typed in final form on 8 " x 11 plain bond paper and ensure that an Optional Form 8 (OF-8) is attached to each job description with blocks 2-5, 7, 9-11, 15e, 18a-18e, and 22 are complete and accurate. DUE DATE: Within 10 business days from request for task to be completed b. DELIVERABLE: Attend peer review committee meetings. TASK: The Contractor shall participate in Peer Review meetings to provide expertise and identify any follow-up actions/informational research items required. DUE DATE: Quarterly c. DELIVERABLE: Receive and review Peer Review Packages. TASK: The Contractor shall complete the review of each Peer Review Package. DUE DATE: Within 10 business days from receipt d. DELIVERABLE: Formal response to appeals and grievances. TASK: Prepare responses to appeals and grievances for Government Project Officer Review. DUE DATE: First draft within 5 business days; final within 2 business days from receipt of Government changes e. DELIVERABLE: Job Descriptions. TASK: Write job descriptions in the OPM factor evaluation system (FES) or narrative format to conform to the grade controlling standard format, with numbered paragraphs for major duties (with percentage of time) and an unnumbered topic or summary paragraph at the beginning on the mission of the organization. DUE DATE: First draft within 5 business days; final within 2 business days from receipt of Government changes f. DELIVERABLE: Provide advice, expertise in person, via telephone, email, or hard copy. TASK: Advise employees of appeal rights and peer review procedures. DUE DATE: Within 3 business days from employee request Criteria for Acceptance: FDA will review contractor deliverables in accordance with specifications and standards stated in the criteria stated above and established during the 30 day period of customizing course materials and any directives issued during the life of this task. Meetings may be face-to-face or via conference calls or web conferencing; FDA to provide conference call and/or web conference connections. Only the Project Officer that initiated the tasking or designated manager has the authority to accept or reject deliverables. The acceptance of deliverables and satisfactory work performance required herein shall be based upon the timeliness, accuracy and suitability of the deliverable. The specific deliverables and schedule for delivery shall be as agreed upon and documented. All documents, plans, diagrams, presentations, etc., are to be submitted solely in electronic form and in the native file format of MS Word 2000, MS Excel 2000, or MS Power Point or later versions of those packages. Deliverables will be submitted to the Project Officer who initiated the request. 4.0 The contractor(s) shall work Monday through Friday on site at 5600 Parklawn Drive, Rockville, MD, 20857 from 8:30-5:00, excluding federal holidays, not to exceed a total of 1,664 hours for the performance period. FDA and the contractor will determine labor category(ies) based on specific task requirements. 5.0 Security and Privacy It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contract personnel will not divulge or release information or data developed or obtained in connection with performance of this contract, unless made public by FDA or upon written approval by the Project Officer. 6.0 Contractor Conformance with Applicable Laws, Regulations, Policies and Standards The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. HHS documents are found at: http://www.cdc.gov/irmo. PRICING SCHEDULE: Base Period: April 1, 2008 through March 31, 2009 CATEGORY HOURS FULLY LOADED HOURLY RATES TOTAL Classification specialist 1664* OPTION YEAR ONE (1): April 1, 2009 through March 31, 2010 CATEGORY HOURS FULLY LOADED HOURLY RATES TOTAL Classification specialist 1664* OPTION YEAR TWO (2): April 1, 2010 through March 31, 2011 CATEGORY HOURS FULLY LOADED HOURLY RATES TOTAL Classification specialist 1664* OPTION YEAR THREE (3): April 1, 2011 through March 31, 2012 CATEGORY HOURS FULLY LOADED HOURLY RATES TOTAL Classification specialist 1664* OPTION YEAR FOUR (4): April 1, 2012 through March 31, 2013 CATEGORY HOURS FULLY LOADED HOURLY RATES TOTAL Classification specialist 1664* GRAND TOTAL (Base + Option Years) *The quantities of person-hours are estimates; however, the Government may require any amount more or less than the quantity specified for any individual item, as long as the Total Not-to-Exceed Price is not exceeded. Contractor exceeding the ceiling price does so at own risk. PERIOD OF PERFORMANCE: One base and four option years. QUESTION DEADLINE: All questions must be submitted via email to kimberly.davila@fda.hhs.gov by 2:00pm, Eastern Time, Monday, January 7, 2008. No phone calls will be accepted. PROPOSALS ARE DUE: 2:00pm, Eastern Time, Monday, January 28, 2008. AWARD DATE: The anticipated award date is March 1, 2008; however, all dates in this announcement are subject to change. PLEASE NOTE: In order to receive an award, contractor must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun and Bradstreet number and banking information. CONFLICT OF INTERESET: FDA 1338 Individual Conflict of Interest As a regulatory agency charged with protection of public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has policies and procedures that safeguard against actual and apparent conflict of interest on the part of its employees. In contracting for review and evaluation of scientific data and information submitted to the agency, it is critical that the FDA be assured that there is no actual or apparent conflict of interest on the part of the individual contractor. Offers performing work under this contract must assure the protection of information and data they receive under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of the contractor. DEFINITION of Conflict of Interest Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501). CONTRACTOR'S CONFLICT OF INTEREST RESPONSIBILITIES The individual contractor must be free of interest prior to performing under this contract. Anytime prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the project officer. The project officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the project officer. CONFLICT OF INTERSET SCREENING An individual offeror /contractor submitting a proposal in response to this solicitation must submit the following information (if no relevant information exists, please provide a statement to that effect). 1. A list of any stock holdings and investments for you, your spouse and minor children. 2. Any positions, either compensated or not, that you currently hold (or have under negotiation). 3. Any contracts, grants, or cooperative research and development assignments that you are working on or have under negotiation; 4. Any other sources of income (not mentioned above) 5. Any other relevant information concerning any past, present, or planned interests that may have a bearing on the responsibilities described in the Statement of Work. The project officer shall conduct a review if the information submitted and determine if a conflict of interest exists prior to forwarding any documents to the contractor. Prior to submitting new work assignments, the project officer will follow-up with the contractor to determine if any changes to his/her financial interest have occurred. CONFLICT OF INTEREST AGREEMENT In executing this contract, the individual contractor agrees: 1. To report to the proper authority within the FDA (the Project Officer), any situation or event that may constitute a conflict of interest, whether actual or potential. 2. To act impartially and not give preferential treatment to any individual or organization which has submitted applications, information, and or data. 3. Not to solicit any gift or other item, nor accept any gift or other item, of monetary value exceeding $20.00 from any person or entity seeking official action from, doing business with or conducting activities related to the evaluations and work performed under this contract. Aggregate market value of individual gifts should not exceed $50.00 in a calendar year. 4. Not to disclose any information and/or data within his or her purview, or to which he/she has access as a result of performing work under this contract. 5. Not to participate in any matter involving specific parties who are likely to or can directly affect the financial interest of a member of his household or a relative with whom they have a close personal relationship; and 6. To disqualify himself from participating in particular matters involving former employees or their representatives, with whom they have worked within the past one (1) year and who might represent a conflict of interest. EVALUATION: The major evaluation factors for this solicitation include technical, which encompasses experience and past performance factors, and cost/price factors. Although technical factors are of paramount consideration in the award of the contract, cost/price is also important to the overall decision. All evaluation factors, other than cost/price, when combined, are significantly more important than cost or price. Offerors are advised that award will be made to that offeror whose proposal provides the combination of features that offers the best or greatest overall value to the Government. The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate determining factor for award of a contract as proposals become more equal based on the other factors. The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the Request For Quote (RFQ). The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFQ. Offeror must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. POTENTIAL AWARD WITHOUT DISCUSSIONS The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. TECHNICAL EVALUATION CRITERIA The evaluation criteria are used by the technical evaluation committee when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. Area 1 Past Performance/Experience (55 points) The contractor shall describe their past performance, identifying other organizations with which they have participated in similar efforts including the degree of their involvement, the size and complexity of the organization and other information describing their experience. Contractors shall submit a list of three (3) contracts. Contracts listed may include those entered into by the Federal Government, agencies of State and local governments and commercial customers. Contractors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. The reference list of the three (3) contracts shall include the following information for each contract and subcontract: 1. Name of contracting activity 2. Contract number 3. Contract type 4. Total contract value 5. Contract work 6. contracting officer and telephone 7. Program manager and telephone 8. Administrative contracting officer, if different from #6, and telephone Each contractor will be evaluated on their performance under existing and prior contracts for similar products or services. Performance information will be used as an evaluation factor against which contractors? relative rankings will be compared to assure best value to the government. The government will focus on information that demonstrates quality of performance relative to the size and complexity of the procurement under consideration. The Contractor will be evaluated on its specific experience in providing on site Peer Review support as follows: a. The Contractor's proposed on site staff must demonstrate at least two (2) year experience writing job descriptions in the OPM factor evaluation system (FES) or narrative format to conform to the grade controlling standard format, with numbered paragraphs for major duties (with percentage of time) and an unnumbered topic or summary paragraph at the beginning on the mission of the organization. b. The Contractor's proposed on site staff must demonstrate obvious experience in preparing job descriptions and evaluation statements and ensuring that an Optional Form 8 (OF-8) is attached to each job description with blocks 2-5, 7, 9-11, 15e, 18a-18e, and 22 are complete and accurate. c. The Contractor's proposed on site staff must demonstrate at least two (2) years experience in preparing final Peer Review reports and evaluations in acceptable to the OMP authorized approving official or his/her designee, and in conformance with the Office of Personnel Management (OPM) and PHS, FDA standards of adequacy, as specified in 5 USC Chapter 51; Federal Personnel Manual (FPM) HHS, PHS Chapter 511; applicable position Classification Standards; and OPM position Classification Standards Guidelines, Background and Introduction. Area 2 Personnel (20 Points) Factors to be considered: a. The skills and experience of contractor staff with respect to the tasks delineated in the Statement Of Work (SOW), b. Skills and qualifications of contractor staff as compared to the proposed labor categories, c. Contractor personnel available to commit to the contract and d. Contractor labor resources available locally to FDA?s Rockville offices. Area 3 Technical Understanding and Approach (25 Points) Objectives: This effort seeks to ensure the timely completion of FDA Peer Review packages and requires specific expertise to provide responses to appeals and grievances. Approach: The Contractor shall describe the proposed approach for: a. Receiving and reviewing Peer Review Packages. b. Analyzing proposed promotion packages prior to peer review meetings referring to reference materials such as the Classifiers Handbook; significant classification appeals decisions, Center peer review policy and procedures, etc. c. Providing advisory services to chair and committee members d. Responding to appeals and grievances. e. Designating the units of work to be prepared in accordance with the list of jobs or positions provided for review by the Peer Review Coordinator. f. Advising employees of appeal rights and peer review procedures Methods: Describe in detail the methodologies that would be used for the project, indicating level of experience with each. Schedule: The FDA anticipates on site support will be required 32 hours/week but reserves the right to adjust this schedule as workload requirements dictate, not to exceed 1,664 hours/calendar year. PROVISIONS and CLAUSES: 52.252-2 clauses incorporated by reference 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 this/these address(es): http://www.AGENCY.gov, http://www.AGENCY.gov/offices/cpo/AGENCYar.cfm, http://www.arnet.gov/far/loadmainre.html. The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-5, FAR 52.217-8, FAR 52.219-6, FAR 52.219-8, FAR 52.219-28, FAR 52.222-3, FAR 52.222-19, FAR 52.222-21, FAR 52.222-26, FAR52.222-35, FAR 52.222-36, FAR 52.222-39, FAR 52.225-3, FAR 52.225-13, FAR 52.232-29, FAR 52.232-33, FAR 52.239-1, FAR 52.222-41, FAR 52.222-42, FAR 52.222-43. Responses to this notice must be sent via email to kimberly.davila@fda.hhs.gov. No phone calls will be accepted.