Anonymous Pre and Post Influenza Vaccine Sera Panels
Added: Apr 03, 2014 2:20 pm This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.Solicitation 2014-N-15807 is issued as a Request for Proposal [RFP]. The solicitation document and incorporated provision and clauses are those in effect tough Federal Acquisition Circular (FAC) 2005-72. This procurement is totally set-aside for small businesses providing services under NAICS code 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) for which the size standard is 500 employees.SUPPLIES/SERVICES - COST/PRICE: The Government intends to award a firm-fixed price award with a base period of 12 months with 4 optional 12-month performance periods, place of contract performance will be determined by the successful vendor. The Government is seeking pricing for the following requirement performed IAW the standards outlined in this document.Base Award Period of Performance (PoP): Date of Award - 12 months after date of awardCONTRACT LINE ITEM NUMBER (CLIN): 0001 DESCRIPTION: Pre and Post Influenza Vaccine Sear Panels [anonymous Pediatric, Adult & Elderly samples IAW with the SOWQTY/UNIT: 1 Job UNIT PRICE: EXTENDED PRICE:Option 1, Year Two [PoP: 13 months after date of award - 24 months after date of award]CONTRACT LINE ITEM NUMBER (CLIN): 1001 DESCRIPTION: Pre and Post Influenza Vaccine Sera Panels [anonymous Pediatric, Adult and Elderly samples IAW the SOW] QTY/UNIT: 1 Job UNIT PRICE: EXTENDED PRICE:Option 2, Year Tee [PoP: 25 months after date of award - 36 months after date of award]CONTRACT LINE ITEM NUMBER (CLIN): 2001 DESCRIPTION: Pre and Post Influenza Vaccine Sera Panels [anonymous Pediatric, Adult and Elderly samples IAW the SOW]QTY /UNIT: 1 Job UNIT PRICE: EXTENDED PRICE:Option 3, Year Four [PoP: 37 months after date of award - 48 months after date of award]CONTRACT LINE ITEM NUMBER (CLIN): 3001 DESCRIPTION: Pre and Post Influenza Vaccine Sera Panels [anonymous Pediatric, Adult & Elderly samples IAW the SOWQTY / UNIT: 1 Job UNIT PRICE: EXTENDED PRICE:Option 4, Year Five [PoP: 49 months after date of award - 60 months after date of award]CONTRACT LINE ITEM NUMBER (CLIN): 4001 DESCRIPTION: Pre and Post Influenza Vaccine Sera Panels [anonymous Pediatric, Adullt and Elderly samples IAW the SOWQTY / UNIT: 1 Job UNIT PRICE: EXTENDED PRICE:BACKGROUND OF NEEDThe Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD), Influenza Division (ID) has a requirement for anonymous, pre and post influenza sera panel from pediatric, adult, and elderly U.S populations; and anonymous large volume post-influenza vaccination sera from adult U.S. donors. The sera panels are required to determine if antibodies induced by the current influenza vaccine effectively inhibit currently circulating influenza viruses. Large volume post-influenza immunization sera from adult donors will be used in hemagglutination inhibition assays during antigenic characterization of virus isolates submitted to CDC for surveillance. SCOPE OF WORKThe successful vendor will provide pre- and post- immunization serum samples from eligible pediatric (N=60), adult (N=60), and elderly (N=60) participants with the current, seasonal, trivalent, killed virus influenza vaccine. The pediatric participants must be healthy and between the ages of 6 months tough 35 months who are eligible to receive the influenza vaccine for the first time. Infants and children with a prior history of vaccination or a prior history of laboratory confirmed influenza are excluded from participating. The adults participants must be between the ages of 18 years tough 49 years and healthy. The elderly participants must be community dwelling, aged 65 or older and healthy. Anyone taking immune suppressing drugs or with a history of an immune compromising disease is excluded from the study.SPECIFIC REQUIREMENTSThe contractor will arrange for pre-immunization serum samples (S1) to be collected at the first visit, followed by administration of the influenza vaccine. For adult and elderly participants, the contractor will arrange for a post-immunization serum sample (S2) to be collected 3-4 weeks after the administration of the influenza vaccine.For pediatric participants, the contractor will arrange for a second influenza vaccine to be given 4 weeks after the first vaccine, according to recommendations of the Advisory Committee on Immunization Practices (ACIP), and a post-immunization serum sample (S2) to be collected 3-4 weeks after administration of the second influenza vaccine dose. For elderly participants, the contractor shall arrange for the collection of approximately 20 ml of blood at each visit so that a minimum of 10 ml of serum is obtained. For pediatric participants, the contractor shall arrange for the collection of approximately 5 ml of blood at each visit so that a minimum of 2.5 ml of serum is obtained.For adult participants, the contractor shall arrange for the collection of approximately 100 ml of blood from the post-immunization sample (S2) from a total of 30 participants. This will allow for the collection of a minimum of 50 ml of serum. For the remaining 30 adult participants, the contractor shall arrange for the collection of approximately 20 ml of blood so that a minimum of 10 ml of serum is obtained.The minimum acceptable sera volume criterion by age category is as follows:Pediatric = 2.5 ml of pre vaccination sera and 2.5 ml of post vaccination seraAdult = 10 ml of pre vaccination sera and 10 ml of post vaccination sera from 30 of the participants and 50 ml of post vaccination sera from the remaining 30 participantsElderly = 10 ml of pre vaccination sera and 10 ml of post vaccination seraThe contractor will be responsible for ordering sufficient influenza vaccine, enrolling participants, collecting blood, administering the vaccine, processing of samples, record keeping, and shipment of serum samples to the CDC. Ordering of Vaccine: The contractor shall order sufficient trivalent, seasonal, inactivated, influenza vaccine for the immunization of 60 pediatric participants, 60 adult participants, and 60 elderly participants. The contractor will place an early order for the vaccine so that delivery of the vaccine is expected in September 2014.Enrollment of Participants: The contractor shall randomly recruit participants eligible to receive the influenza vaccine. Pediatric participants must be between the ages of 6 tough 35 months, health, and eligible to receive influenza vaccine for the first time. Infants and children with a prior history of influenza vaccination or a prior history of laboratory confirmed influenza are excluded from participating. Adult participants must be between the ages of 18 years tough 49 years and healthy. Elderly participants must be 645 years of age or older and community dwelling. Anyone taking immune suppressing drugs or with a history of immune compromising disease is excluded from this study. Recruits are to be anonymous. Adult participants donating 100 ml of S2 blood will be recruited as early in the study as possible.Collection of Blood and Administration of Vaccine: Pediatric participants: The contractor shall confirm eligibility for the study at the first visit to the clinic. Prior to administration of the vaccine, approximately 5 ml of blood will be collected. Blood will be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1 to this document). The first dose of vaccine shall be administered after the blood is collected. An appointment will be made for the infant/child to return in 4 weeks. At the second visit, the second dose of vaccine will be administered and an appointment will be made for the infant/child to return in 3 to 4 weeks. At the third visit, approximately 5 ml of blood will be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1).Adult and elderly participants: The contractor shall confirm eligibility for the study at the first visit to the clinic. Prior to the administration of the vaccine, approximately 20 ml of blood will be collected. Blood will be collected from each participant in aw collection tube designed for the collection of serum (refer to Attachment 1). The first dose of vaccine will be administered after the blood is collected. An appointment will be made for the participant to return in 3 to 4 weeks. At the second visit, for 30 adult participants, the contractor shall collect a total of 100 ml of blood. For the remaining 30 adult participants as well as elderly participants, the contractor shall collect 20 ml of blood during their second visit.Processing of blood samples: After collection, the tubes of blood will be stored at 4° C for up to 18 hours. Sometime between 1 hour and 18 hours after collection, the blood collection tube shall be centrifuged to separate the clotted blood from the serum and the serum shall be moved to a clean tube. The serum shall be aliquoted as described in the paragraph below. The clotted blood may be discarded.Aliquoting of serum: All tubes containing serum shall be kept on ice during the process of aliquoting. Serum shall be aliquoted into Sarstedt tubes, catalog #72.694.007 [or an equivalent tube agreed to by the agency's Project Officer/Contracting Officer's Representative (PO/COR)]. Each tube shall contain approximately 1.0 ml of serum. The S1 and S2 aliquots shall be labeled with separate unique identification numbers with labels provided by the CDC. Multiple labels of each unique identification number will be provided so that aliquots originating from the same collection time are labeled with the same identification number.Serum from pediatric participants: For each collection time, there should be a minimum of 2.5 ml of serum obtained from the 5 ml of blood collected. Tee (3) aliquots shall be prepared. Two (2) tubes containing 1 ml of sera and one tube containing a minimum of 0.5 ml of sera.Serum from 30 adult participants from whom 20 ml of blood were collected during the second visit: For each collection time, there should be a minimum of 10 ml of serum obtained from the 20 ml of blood collected. Ten (10) aliquots shall be prepared. Each tube will contain 1 ml of sera.Serum from 30 adult participants from whom 100 ml of blood were collected during the second visit: A minimum of 50 ml of serum should be obtained from the 100 ml of S2 blood collected. The serum shall be aliquoted into ten (10) 1.0 ml aliquots, and the remaining serum for each donor shall be divided equally between two (2) 50 ml conical tubes, Falcon catalog #352098 [or an equivalent tube agreed to by the Project Officer/ Contracting Officer's Representative (PO/COR)].Serum from elderly participants: For each collection time, there should be a minimum of 10 ml of serum obtained from the 20 ml of blood collected. Ten (10) 1.0 ml aliquots shall be prepared.Serum samples shall be immediately stored at -20° C after aliquoting. A recapitulation of the contents of each shipment is provided as Attachment 3 to this document.Record keeping: Information for each serum sample shall be recorded on an Excel spreadsheet provided by the CDC (refer to Attachment 2 to this document).Shipment of serum samples to CDC: The contractor shall arrange for four (4) shipments of serum samples to CDC. The dates and contents of each shipment are defined in the Schedule of Deliverables. All shipments shall be sent via overnight carrier, to ensure delivery and receipt by the CDC PO/COR within 24 hours of shipment. All serum shipments shall be packed with sufficient dry ice to ensure that samples remain frozen for a minimum of 72 hours after shipment. For each shipment, the PO/COR and the designated laboratory contact shall be notified of the planned shipment date and shall be sent the tracking information as soon as it is available. A hardcopy of the excel spreadsheet shall be included with each shipment and an electronic copy shall be emailed to the PO/COR and the designated laboratory contact at the time of each shipment. Prior to shipment all identifying linkage must be stripped from the study spreadsheet. The contractor is required to ensure the anonymity of each participant's serum samples. Serum samples are to be sent to:ATTENTION: Ms. Heather Tatum / Wendy SessionsCenters for Disease Control and PreventionFlu SerologyBuilding 23, Room #84511600 Clifton Road, NEAtlanta, GA 30333Phone: (404) 639-4130 or (404) 639-3211Email: htatum@cdc.gov and wsessions@cdc.govFirst Shipment: The first shipment shall be sent as soon as the 30 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain (1) two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples and (2) one of the two S2 aliquots in the 50 ml tube from the high volume donor samples.Second Shipment: The second shipment shall be sent within five (5) business days after agency receipt of the first shipment. The second shipment shall contain (1) the remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample and (2) the remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples.Third Shipment: The third shipment shall contain (1) one 1.0 ml of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric samples, (2) two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 elderly samples, and (3) two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from adult participants donating 20 ml of blood.Fourth Shipment: The fourth shipment shall be sent within five (5) business days after agency receipt of the third shipment.Successful completion of this project requires that the contractor meets or exceeds the following performance/delivery milestones:SCHEDULE OF DELIVERABLES / PERFORMANCE MILESTONES[PoP: Date of Award - 12 months after Date of Award]ITEM #: 0001 DECRIPTION: Progress Report (see Note 1 for details of report)QTY/MODE: 1 electronic copy each DATE DUE:NLT 7th of each monthDELIVER TO: PO or COR and COITEM #: 0002 DESCRIPTION: Annual Report - Draft (see Note 2) for details of report QTY/MODE: 1 electronic copy DUE DATE: NLT 1 March each year DELIVER TO: PO or CORITEM #:0003DESCRIPTION: Spreadsheet (Excel) - information for each serum sample QTY/MODE: 1 hard copy, 1 electronic copy DATE DUE: with each shipmentDELIVER TO: hardcopy included in each shipment; electronic copy to PO/CORITEM #: 0004 DESCRIPTION: Recruitment of pediatric participants completed QTY/MODE: NADATE DUE: NLT 15 Oct 2014 DELIVER TO:NAITEM #: 0005 DESCRIPTION:Recruitment of 30 adult high volume donors completed QTY/MODE:NA DATE DUE:NLT 21 Oct 2014 DELIVER TO: NAITEM #: 0006 DESCRIPTION: First shipment of high volume adult (S1 and S2) sera aliquots QTY/MODE: IAW SOWDATE DUE: NLT 18 Nov 2014 DELIVER TO: PO/CORITEM #0007:DESCRIPTION: Second shipment of remaining high volume (S1 and S2) sera aliquots QTY/MODE: IAW SOWDATE DUE: NLT 25 Nov 2014 DELIVER TO:PO/CORITEM #: 0008DESCRIPTION: All recruitment, other than pediatric participants and adult high volume donors completed QTY/MODE: NA DATE DUE:NLT 28 Oct 2014 DELIVER TO:NAITEM #: 0009 DESCRIPTION: Third shipment to include pediatric, elderly and adult sera aliquots QTY/MODE: IAW SOW DATE DUE: NLT 02 Dec 2014 DELIVER TO: PO/CORITEM #: 0010 DECRIPTION: Fourth Shipment of remaining pediatric, elderly, and adult sera aliquots QTY/MODE: IAW SOW DATE DUE: NLT 09 Dec 2014 DELIVER TO: PO/CORNOTE 1: Form, format and content of the monthly progress report shall be coordinated with the PO/COR. It is anticipated that the progress reports for September, October, and November, and December shall give a full accounting of the recruitment and sample collection to date. The reports shall be cumulative for the current influenza season. Each report shall list the number of participants, based on age category, for the current influenza vaccine season. The age categories shall be subdivided to indicate the number of individuals who have provided S1 and S2 serum samples.NOTE 2: The annual report shall document work performed during each performance period. Within 15 days of receipt, the PO/COR will provide review comments to the contractor to be addressed and/or incorporated into the contractor's final annual report. Form, format, and content of reports shall be coordinated with the PO/COR. In addition, the contractor is invited to include a narrative discussion of any changes that they recommend to enhance performance of any follow-up project for similar services.The Federal Acquisition Regulation (FAR) provision found at 52.212-1, Instructions to Offerors - Commercial Items (Jul 2013) applies to this acquisition. The provision is supplemented by the following Centers for Disease Control and Prevention (CDC) addenda:CDCAG001 - Invoice Submission (Mar 2006)(a) The Contractor shall submit the original contract invoice/voucher to the entity shown below:The Centers for Disease Control and PreventionOffice of the Chief Financial Officer (OCFO)P.O. Box 15580Atlanta, GA 30333Or - The Contractor may submit the original invoice/voucher via facsimile or email:Fax: 404-638-5324 Email: FMOAPINV@CDC.GOVNOTE: Submit to only one (1) of the above locations.(b) The contractor shall submit 2 copies of the invoice/voucher to the cognizant contracting office previously identified in this contract. These invoices/voucher copies shall be addressed to the attention of the Contracting Officer.(c) The Contractor is 0, is not 0 required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer.(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.(e) The Contractor shall include (as a minimum) the following information on each invoice:(1) Contractor's Name & Address(2) Contractor's Tax Identification Number (TIN)(3) Purchase Order/Contract Number and Task Order Number, if Appropriate(4) Invoice Number(5) Invoice Date(6) Contract Line Item Number and Description of Item(7) Quantity(8) Unit Price & Extended Amount for each line item(9) Shipping and Payment Terms(10) Total Amount of Invoice(11) Name, title and telephone number of person to be notified in the event of a defective invoice(12) Payment Address, if different from the information in (c)(1).(13) DUNS + 4 Number(End of Clause)FAR provision 52.212-2, Evaluation - Commercial Items (Jan 1999) applies to this acquisition and is supplemented by the following addenda:The following factors shall be used to evaluate written proposals received:1. Technical Requirements, Approach and Management Plan (maximum of 40 points of 100 possible points may be awarded) - offeror must fully, but concisely, describe their approach to accomplishing the technical and performance requirements of the project as presented herein. Offerors should identify the tasks required to be accomplished and performance milestones to be met. Detailed information should be provided that includes the offeror's plans and procedures to ensure adequate supply of influenza vaccine, timely enrollment of participants, administration of vaccine, collection of specified volume of blood, processing and aliquoting of sera, and shipment of human sera specimens to the agency. The offeror's technical approach must evidence their ability to appropriately manage operations to meet the time requirements of the Statement of Work (SOW). Offeror should discuss their plan for controlling the quality of the information and samples collected. This criterion will be evaluated based upon the soundness, practicality and feasibility of the approach to the successful completion of the performance and delivery requirements of this project.2. Institutional Capabilities / Infrastructure (maximum of 30 points of 100 possible points may be awarded) - offeror must demonstrate they possess the required resources (i.e. personnel, equipment, materials, data) and ability to reach the desired study populations, as well as obtain Institutional Review Board (IRB) clearance(s) for the study. The offeror's proposal should identify specific sites of vaccine administration and collection of blood specimens and the IRB clearance processes for each site. The offeror must demonstrate prior experience in clinical research of a similar scope. This criterion will be evaluated based upon the quantity and quality of available resources; the offeror ‘s demonstrated ability to identify and recruit the required study population within the timeframes mandated; and the soundness and feasibility of plans supporting the IRB clearance process.3. Staffing / Personnel Qualifications (maximum of 30 points of 100 possible points may be awarded) -Offeror should provide a staffing plan which demonstrates an understanding of the labor requirements of this solicitation. Offeror will identify key personnel that will be involved in performance of the project; providing appropriate background, education, experience and credentials (including laboratory and research experience and expertise).Past Performance information is one indicator of an offeror's ability to perform a contract successfully. A comparative assessment of a contractor's past performance will be made. Offerors shall identify past or current contracts (including Federal, State, and local government and private) for efforts similar to the requirements outlined in this solicitation. Additionally, offerors are invited to provide information on problems encountered on the identified contracts and the offeror's corrective actions. A determination, in accordance with the ratings shown below, will be made as to the relevancy of an offeror's past performance information:Rating - Very Relevant Definition - Present/past performance effort involved essentially the same scope and magnitude of effort and complexities this solicitation requires.Rating - Relevant Definition - Present/past performance effort involved similar scope and magnitude of effort and complexities this solicitation requires.Rating - Somewhat Relevant Definition - Present/past performance effort involved some of the scope and magnitude of effort and complexities this solicitation requires.Rating - Not RelevantDefinition - Present/past performance effort involved little or none of the scope and magnitude of effort and complexities this solicitation requires.Past performance information shall be obtained from any sources available to the Government, to include, but not limited to, the Past Performance Information Retrieval System (PPIRS), Federal Awardee Performance and Integrity Information System (FAPIIS), Contractor Performance Assessment Reporting System (CPARS), System for Award Management (SAM) or other databases; interviews with Program Manager(s) and Contracting Officer(s).The currency and relevance of the information, source of the information, context of the data, and general trends in a contractor's performance will be considered. Based upon the information obtained, a determination will be made as to the Government's level of confidence in the offeror's ability to successfully perform the requirements of this solicitation utilizing the ratings shown below:Rating - Substantial Confidence Definition - Based on the offeror's recent/relevant performance record, the Government has a high expectation that the offeror will successfully perform the required effort.Rating - Satisfactory Confidence Definition - Based on the offeror's recent/relevant performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effortRating - Limited ConfidenceDefinition - Based on the offeror's recent/relevant performance record, the Government has a low expectation that the offeror will successfully perform the required effort.Rating - No Confidence Definition - Based on the offeror's recent/relevant performance record, the Government has no expectation that the offeror will be able to successfully perform the required effort.Rating - Unknown Confidence (Neutral)Definition - No recent/relevant performance record is available or the offeror's performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned.Technical and past performance when combined, are significantly more important than cost or price.Offerors are advised to include a completed copy of the FAR provision found at 52.212-3 Offeror Representations and Certifications - Commercial Items (Nov 2013) with their offer. FAR provision 52.212-3 is supplemented by the following addenda:Representation By Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction Under Any Federal LawThe Consolidated Appropriations Act, 2012 Pub. L 112-74 and the Consolidated and Further Continuing Appropriations Act, Pub. L 112-55 prohibit covered agencies from using funds to enter into contracts with corporations with have unpaid federal tax delinquencies or certain felony convictions unless certain conditions are met.(a) The Offeror represents that -(1) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal or State law within the preceding 24 months.(2) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability.(End of provision)FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items (Sep 2013) applies to this acquisition.FAR Clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders - Commercial Items (Jan 2014) applies to acquisition. The following FAR clauses cited in 52.212-5 are applicable to this acquisition: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).52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (31 U.S.C. 6101 note).52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 013) (41 U.S.C. 2313).52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).52.219-8, Utilization of Small Business Concerns (Jul 2013) (15 U.S.C. 637(d)(2) and (3)).52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637(d)(4)).52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).52.222-3, Convict Labor (June 2003) (E.O. 11755).52.222-21, Prohibition of Segregated Facilities (Feb 1999).52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).52.222-37, Employment Reports on Veterans (SEP 2010) (38 U.S.C. 4212).52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) E.O. 13496).52.222-54, Employment Eligibility Verification (AUG 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513).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).52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013)(31 U.S.C. 3332).52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989)(29 U.S.C. 206 and 41 U.S.C. 351, et seq.).52.222-43, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).The following Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses are applicable to this acquisition:352.203-70, Anti - Lobbying (Jan 2006)352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Jan 2010)352.223-70, Safety and Health (Jan 2006)352.231-71, Pricing of Adjustments (Jan 2001)The following HHSAR provision is applicable to this acquisition and is provided in full text.352.270-4, Notice to Offerors of Requirements of 45 CFR Part 46, Protection of Human Subjects (Jan 2006)(a) Copies of the Department of Health and Human Services (HHS) regulations for the protection of human subjects, 45 CFR Part 46, are available from the Office for Human Research Protections (OHRP), Bethesda, Maryland 20892. The regulations provide a systematic means, based on established ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by HHS.(b) The regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data tough intervention or interaction with the individual, or identifiable private information. The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects.The use of autopsy materials is governed by applicable State and local law and is not directly regulated by 45 CFR Part 46.(c) Activities in which the only involvement of human subjects will be in one or more of the categories set forth in 45 CFR 46.101(b)(1-6) are exempt from coverage.(d) Inappropriate designations of the noninvolvement of human subjects or of exempt categories of research in a project may result in delays in the review of a proposal. The Government's Project Officer will make a final determination of whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the proposal. In doubtful cases, the Project Officer will consult with OHRP.(e) In accordance with 45 CFR Part 46, offerors being considered for award shall file with OHRP an acceptable Assurance of Compliance with the regulations, specifying review procedures and assigning responsibilities for the protection of human subjects. The initial and continuing review of a research project by an institutional review board shall ensure that: the rights and welfare of the human subjects involved are adequately protected; the risks to the subjects are reasonable in relation to both the potential benefits, if any, to the subjects and the importance of the knowledge to be gained; and informed consent will be obtained by methods that are adequate and appropriate. HHS regulations for the protection of human subjects (45 CFR Part 46), information regarding OHRP registration and assurance requirements/processes, and OHRP contact information can be accessed at the OHRP website (at http://www.hhs.gov/op/assurances/assurances_index.html).(f) Offerors may consult with OHRP for advice or guidance concerning either regulatory requirements or ethical issues pertaining to research involving human subjects.(End of provision)The following Centers for Disease Control and Prevention (CDC) agency clause is applicable to this acquisition:CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (April 2013)In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations. The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor's responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations. [End of Clause]Questions concerning this requirement should be submitted to the Contracting activity no later than noon, on Tuesday 08 April 2014. Answers to submitted questions will be electronically published within 48 hours of the receipt of questions.Proposals in response to this solicitation must arrive in the Contracting Activity no later than 5:00 PM EDT, on Monday, 21 April 2014. Questions and proposals submitted in response to this solicitation should be sent to the following:Centers for Disease Control and Prevention (CDC)Procurement and Grants Office2920 Brandywine RoadAtlanta, GA 30341ATTN: Donna J Myler, Contracting Officeror by electronic mail to: dmyler@cdc.govATTACHMENTS:1 - Human Sera Collection Guidelines2 - Sample Submission Spreadsheet3 - Summary of Shipment and Contents
2014-N-15807 Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services
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