PRESOL | B | Part 11 Regulation Consulting Services

FBO DAILY ISSUE OF JUNE 07, 2008 FBO #2385
SOLICITATION NOTICE

B -- Part 11 Regulation Consulting Services

Notice Date: 6/5/2008
Notice Type: Modification/Amendment
NAICS: 541990 — All Other Professional, Scientific, and Technical Services
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
ZIP Code: 72079-9502
Solicitation Number: FDA-SOL-08-00622
Response Due: 6/17/2008 5:00:00 AM
Archive Date: 7/2/2008
Point of Contact: Karen L Conroy,, Phone: 781-596-7715, Priscella,, Phone: 214-253-5274
E-Mail Address: kconroy@ora.fda.gov, priscella.sullivan@fda.hhs.gov
Small Business Set-Aside: Total Small Business
Description: ________________________________________ Solicitation Number: FDA-SOL-08-00622 Notice Type: Combined Synopsis/Solicitation Synopsis: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2005-25, effective April 22, 2008. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541990, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. This is a total small business set-aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. 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. This solicitation is issued as a Request for Quote (RFQ) The Government’s period of performance is one year from effective date of award with one option year period. The Food and Drug Administration (FDA) intends to award a purchase order for consulting services to help support the amendment of 21 CFR 11 ( Part 11, Electronic Records and Electronic Signatures). The Statement of Work is as follows: Objective: This contract seeks to expand those efforts and provide the necessary written material in support of the generation of a proposed amended regulation, a finalized regulation, preparation and publication of industry guidance (including writing and editing regulation language),reviewing comments from industry and making revisions to various Agency documents, as necessary. Background Information: In August 2002, the FDA embarked on an initiative to enhance the regulation of pharmaceutical manufacturing. This was entitled ‘Pharmaceutical camps for the 21st century: A Risk-based Approach,” and included a number of goals for the Agency to complete. One objective was completed when the Agency published new draft and final Part 11 GMP Guidance for notice and comment. The draft guidance was published February 23, 2003, and the final guidance was published August 2003. Scope of Work Independently, and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials and services and otherwise do all things necessary for, or incident to the performance of the work as described below. FDA’s Center for Drug Evaluation and Research (CDER), Office of Compliance, seeks a contractor that has the depth and breath of understanding of the issues of the Part 11 “Electronic Records, Electronic Signatures – Scope and Application.” This contract will continue the efforts initiated in 2005-2006 and expand these to include the preparation of a revised Part 11 Regulation. This contract will include preparing, editing and reviewing pharmaceutical industry comments in preparation for a finalized and revised 21 CFR Part 11. Further, since additional Guidance for Industry may be required, in that the Regulation will be changed, the contractor will also assist with material necessary for the preparation and publication of draft and final industry guidance. At the discretion of the government, the contractor will also provide technical assistance in writing and editing regulation language, preparing documentation for a Federal Register notice, and making revisions to various Agency documents as necessary in support of the Part 11 initiative. Deliverables: The Contractor shall submit the following reports/deliverables: 1. Prepare a proposed work plan with timeline and milestones for accomplishing tasks 2. Prepare and review material necessary for the publication and preparation of a revised Part 11 Regulation 3. Provide support in writing and finalizing the revised Part 11 Regulation 4. Provide support in writing draft and final guidance in support of the revised Part 11 regulation DESCRIPTION OF DELIVERABLES The Contractor shall submit a copy of a proposed work plan, with a timeline and milestones for completing the objectives as stated in the solicitation. Following approval of the plan by the government, the Contractor shall submit a progress report every 3 month(s) to the Project Officer. The progress report shall be narrative in form and shall include a summary of progress toward completion of tasks and problems encountered to date, including contractor’s assessment of specific impact of such problems and on scheduled date of completion. The Draft Final Technical Report shall be due one month before the end of the contract. The Contractor shall be required to make revisions deemed necessary by the Project Officer. Acceptance of the Final Technical Report by the Project Officer will complete the contract. DELIVERY SCHEDULE (Base Year) *assumes award will be made by July 14, 2008. ItemDescriptionQuantityDue Date 1.Project Outline and Approval2August 1, 2008 2.Progress reports2September 1, 2008 December 1, 2008 March 1, 2009 June 1, 2009 3.Draft Final Technical Report2*June 14, 2009 4.Final Technical Report2*July 14, 2009 *One copy of the Progress Report and the Final Technical Report shall be sent to the Contracting Officer. The base year contract will cover 12 months with the period of performance from XXXX, 2008 to XXXX, 2009. The optional year, to be exercised at the discretion of the government, will be from XXXX, 2009 to XXXX, 2010. Each reporting period (November, February, May, June, and July upon a satisfactory final technical report) will receive a 20% disbursement of the total funds allotted upon satisfactory progress and/or completion of the respective component of the project. Payment of work performed will be based on compliance with the progress reporting schedule and the quality and timeliness of the technical reports used to determine whether the performance is satisfactory. EVALUATION FOR AWARD Basis for Award: a. Proposals received will first be evaluated from a technical standpoint without regard to proposed cost. Those proposals considered to be technically acceptable will then be evaluated from a financial and management standpoint. b. Technical factors are significantly more important than cost or price. It is pointed out, however, that should technical competence between offerors be considered approximately the same, then cost or price could become primary. c. FDA will base its award decision using a best value analysis that results in the most advantageous acquisition for the government. FDA’s acquisition strategy used to obtain best value may result in an award to other than the lowest priced, technically rated offeror. Best value analysis spans a continuum from the lowest priced, technically acceptable proposal to those proposals in which tradeoffs between price, past performance, and each offeror’s technical solution is evaluated. This tradeoff process (see FAR 15.101-1) depends on the government’s assessment of quality factors, including but not limited to past performance, compliance with solicitation requirements, technical excellence, management capability, personnel qualifications and prior experience, and price. TECHNICAL EVALUATION CRITERIA: Area Details Percentage Personnel Experience and Capability40% Offeror’s proposal should demonstrate contractor’s knowledge and experience working with regulatory organizations and stakeholders within the last five years. Specifically, the proposal should demonstrate the offeror’s ability to draft, quality control and edit guidance and Regulation documents. Technical Approach 30% Offeror’s proposal should demonstrate knowledge and experience with the policies and procedures for dealing with computer, electronic and automated systems in FDA and the regulated industry. Strong computer science and writing skills a must. Past Performance20% Offerors shall demonstrate experience with federal regulatory agencies, programs and regulatory and review policies. Proposal shall also demonstrate offeror’s ability, training and knowledge with writing, editing and re-commenting on proposed regulation documents, guidances and standard operating procedures. Relevant experience shall be within the last three to five years. Feasibility of Completion10% Offeror’s experience in successful implementation, execution, and publication of regulatory documents. Security Notice: Contractor staff and management will have access to information that may be privileged and confidential materials of the United States Government. These printed and electronic documents are for internal use only, are not to be copied or released without permission, and remain the sole property of the United States Government. Some of these materials are protected by the Privacy Act of 1974 (revised PubLaw 93-5791) and Title 38. Unauthorized disclosure of Privacy Act or Title 38 covered materials is a criminal offense. [NOTE: Reference Attachment 1 to this RFQ] PAYMENT SCHEDULE: Payment will be made based upon satisfactory progress and/or completion of the respective component of the project. Each reporting period (November, February, May, June, and July upon a satisfactory final technical report) contractor will receive a 20% disbursement of the total funds allotted. Payment of work performed will be based on compliance with the progress reporting schedule and the quality and timeliness of the technical reports used to determine whether the performance is satisfactory. FACILITIES: Contractor provided facility. CCR: Vendors 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 & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Karen.conroy@fda.hhs.gov no later than June 10, 2008, 2:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: Karen.conroy@fda.hhs.gov, no later than 2:00pm, EST on _June17, 2008. PROVISIONS and CLAUSES: 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 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Karen.conroy@fda.hhs.gov. No phone calls will be accepted. ALL OTHER SOLICITATION REQUIREMENTS REMAIN UNCHANGED. ***************************************************************************************************************** Contracting Office Address: Food & Drug Administration One Montvale Ave. Stoneham, MA 02180 Place of Performance: 5100 Paint Branch Parkway College Park, Maryland 20740 United States Primary Point of Contact.: Karen Conroy, Contract Specialist karen.conroy@fda.hhs.gov Phone: 781-596-7715 Fax: 781-596-7896 ________________________________________ ATTACHMENT I FDA 1335 Personnel Security Clearance Requirements 1. BACKGROUND The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type. Contractor employees who will be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all time while in DHHS-owned or leased space. 2. GENERAL The contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract: a.Certification that all required security form packets (See Charts A and/or B incorporated in this clause) and a list of contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff. b. "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in paragraph a. above. With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor. Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times. All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required vary with the position risk levels for the contract. The position risk levels for this contract are Level 1. There are two (2) potential position risk levels, which are: a.Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 5 below. b.Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6). Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation. In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Project Officer for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor. A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed. 3. BADGING PROCESS The FDA Project Officer will sponsor Contractor employees on the FDA Form 3391 for the purpose of obtaining an FDA Security Access Card. In order to obtain one, a contractor employee must receive a “favorable” fingerprint return. Fingerprints must be submitted to the Personnel Security Office at least ten (10) days prior to the commencement of work. Fingerprints will be submitted in one of two ways, depending on where the contract will be performed: a. Contractor employees who will work in the Washington D.C. metro area will, at the direction of the FDA Project Officer or his/her designee, contact the Personnel Security Branch to schedule a fingerprinting appointment, or b. Contractor employees who will work in a field office will submit fingerprints to: Food and Drug Administration Personnel Security Staff, OSO 5600 Fishers Lane PKLN 15A-22, HFA-640 Rockville, MD 20857 Upon the receipt of a “favorable” fingerprint return, each Contractor employee must present two forms of identification in order to receive his or her badge. One form of identification must be a government-issued photo identification document. Acceptable forms of photo identification are referenced on the FDA Form 3391. Acceptable forms of secondary identification are listed on the back of the I-9 Form. This form can be obtained at http://uscis.gov/graphics/formsfee/forms/files/i-9.pdf An individual who receives an unfavorable report may appeal that finding by submitting a written request to the Personnel Security Staff. 4. BACKGROUND INVESTIGATIONS The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under this contract. Required background investigations may include, but not be limited to: •Review of prior Government/military personnel records; •Review of FBI records and fingerprint files; •Searches of credit bureaus; •Personal interviews; and •Written inquiries covering the subject's background. Background investigations will be conducted by the Office of Personnel Management (OPM). The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees. The Contractor shall submit the information required for eQIP access and other requisite forms for the risk level(s) specified. In addition, the contractor shall provide a cover letter which includes: the Contractor's name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees' for whom a background check is required and those employees’ social security numbers, dates of birth, and former names. This cover letter and all completed forms shall be transmitted, in a separate sealed envelope marked, "TO BE OPENED BY ADDRESSEE ONLY," to: Food and Drug Administration OSO/Office of Security Operations Attn: Personnel Security Staff 5600 Fishers Lane, PKLN 15A-22, HFA-640 Rockville, MD 20857 The contractor shall send a separate letter to the Contracting Officer that includes the contract number and employee names. The contractor shall advise its prospective employees that all standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations. Personnel Security Staff will resolve with the contract employee any issues arising out of inaccurate or incomplete forms. Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position. At any time, if a contractor employee for whom security forms have been submitted is terminated or otherwise ceases work under the contract, the contractor shall immediately notify Personnel Security Staff, in writing, with copies to the respective FDA Project and Contracting Officers. The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract. Those who are not cleared must cease work on the contract immediately. If a Contractor employee changes job responsibilities under this contract, the contractor shall notify the Contracting Officer, and the Government will make a determination whether an additional security clearance is required. In the event that a cleared individual is replaced, the contractor shall notify the Contracting Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual. The Contractor shall be responsible for the return of any Government issued security badges to the Project Officer. 6. NON-PUBLIC DATA PROTECTION The contractor shall protect the privacy of all information reported by or about contract employees and shall protect against unauthorized disclosure. CHARTS A & B ARE APPENDED TO THIS CLAUSE For clarification purposes and to facilitate the flow of all required security forms, the following matrix is provided: CHART A Mandatory for all on-site contract employees NON-SENSITIVE POSITIONS - LEVEL 1 FORM NAMEOBTAIN FROMWHEN REQUIREDSUBMIT TODATE REQUIRED FDA Form 3391 - FDA Security Card Access RequestProject Officer. Sponsorship must be provided by FDA Project Officer.All positions on DHHS property or leased spaceFood and Drug Administration OC/OCM/OSOPP Office of Security Operations, Policy & Planning Attn: Personnel Security Branch 5600 Fishers Lane PKLN 15A-22, HFA-640 Rockville, MD 20857 **Form must be submitted by Security Rep.Form must be received prior to making fingerprint appointment. Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement formContracting OfficerAll positions with access to non-public privileged, proprietary, or trade secret informationContracting Officer for retention in contract fileTen (10) calendar days prior to commencement of work Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act ReleaseContractor generatedAll positions, including intermittent, per diem or temporary*Food and Drug Administration OC/OCM/OSOPP Office of Security Operations, Policy & Planning Attn: Personnel Security Branch 5600 Fishers Lane PKLN 15A-22, HFA-640 Rockville, MD 20857 (301) 827-5502, -5521, -5507, -5508Ten (10) calendar days prior to commencement of work SF 85 - Questionnaire for Non-Sensitive PositionsOnline via OPM’s e-QIP systemNon-Sensitive Positions - Level 1 Clearance*Submit to OPM online via the e-QIP systemTen (10) calendar days upon request of the Contracting Officer FD 258 - Fingerprint Chart (2 Charts Required) Fingerprinting services available by appointment only. Call (301) 827-9527Contracting OfficerNon-Sensitive Positions - Level 1 Clearance*Food and Drug Administration OC/OCM/OSOPP Office of Security Operations, Policy & Planning Attn: Personnel Security Branch 5600 Fishers Lane PKLN 15A-22, HFA-640 Rockville, MD 20857 (301) 827-5502, -5521, -5507, -5508Ten (10) calendar days prior to commencement of work *In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer. *Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass. Personnel Security Branch 5600 Fishers Lane PKLN 12A-43, HFA 630 Rockville, MD 20857 Hours 8:00 a.m. -11: a.m. and 1:00 p.m.-3:00 p.m. Mon-Fri No appointment necessary (301) 827-9615 CHART B Public Trust Positions - Levels 5 or 6 FORM NAMEOBTAIN FROMWHEN REQUIREDSUBMIT TODATE REQUIRED SF 85P - Questionnaire for Public Trust Positions Online via OPM’s e-QIP system Public Trust Positions - Level 5 or 6 Clearance*Submit to OPM online via the e-QIP system Ten (10) calendar days prior to commencement of work FD 258 - Fingerprint Chart (2 Charts Required) Fingerprinting services available by appointment only. Call (301) 827-9527Contracting OfficerPublic Trust Positions - Level 5 or 6 Clearance*Food and Drug Administration OC/OCM/OSOPP Office of Security Operations, Policy & Planning Attn: Personnel Security Branch 5600 Fishers Lane PKLN 15A-22, HFA-640 Rockville, MD 20857 (301) 827-5502, -5521, -5507, -5508Ten (10) calendar days prior to commencement of work FDA Form 3391 - FDA Security Card Access RequestProject Officer. Sponsorship must be provided by FDA Project Officer.All positions on DHHS property or leased spaceFood and Drug Administration OC/OCM/OSOPP Office of Security Operations, Policy & Planning Attn: Personnel Security Branch 5600 Fishers Lane PKLN 15A-22, HFA-640 Rockville, MD 20857 **Form must be submitted by Security Rep. Form must be received prior to making fingerprinting appointment. Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement formContracting OfficerAll positions with access to non-public privileged, proprietary, or trade secret informationContracting Officer for retention in contract fileTen (10) calendar days prior to commencement of work Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act ReleaseContractor generatedAll positions, including intermittent, per diem or temporary*Food and Drug Administration OC/OCM/OSOPP Office of Security Operations, Policy & Planning Attn: Personnel Security Branch 5600 Fishers Lane PKLN 15A-22, HFA-640 Rockville, MD 20857 (301) 827-5502, -5521, -5507, -5508Ten (10) calendar days prior to commencement of work *In addition to the submission of these forms, the contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer. *Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass. Personnel Security Branch 5600 Fishers Lane PKLN 12A-43, HFA 630 Rockville, MD 20857 Hours 8:00 a.m. -11:00 a. m. and 1:00 p.m. -3:00 p.m. Mon-Fri. No appointment necessary (301) 827-9615
Web Link: FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=693877096ab7107f1f6999ec9041e91d&tab=core&_cview=1)
Place of Performance: Address: 5100 Paint Branch Parkway College Park Maryland 20740, College Park, Maryland, 20740, United States; Zip Code: 20740
Record: SN01587451-W 20080607/080605215916-fbb34673a83a9a66e54d3635caaf6ab8 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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B -- Part 11 Regulation Consulting Services