FBODaily.com | FedBizOpps: PRESOL | A | NIMH POSTMORTEM HUMAN BRAIN COLLECTION - Request for Proposal

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 10, 2017 FBO #5678
SOLICITATION NOTICE

A -- NIMH POSTMORTEM HUMAN BRAIN COLLECTION - Request for Proposal

Notice Date: 6/8/2017
Notice Type: Combined Synopsis/Solicitation
NAICS: 541990 — All Other Professional, Scientific, and Technical Services
Contracting Office: Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
ZIP Code: 20892-9559
Solicitation Number: HHS-NIHNIDA(SSSA)RFP-17-384
Archive Date: 7/22/2017
Point of Contact: Zenab A. Chowdhry, Phone: 3018276909, Nancy Lamon-Kritikos,
E-Mail Address: zenab.chowdhry@nih.gov, nancy.lamon-kritikos@nih.gov
(zenab.chowdhry@nih.gov, nancy.lamon-kritikos@nih.gov)
Small Business Set-Aside: N/A
Description: Request for Proposal - 1 - SOLICITATION SECTION A - SOLICITATION/CONTRACT FORM 1. Requisition or other Purchase Authority: Public Law 92.218 as amended 2. Request for Proposal (RFP) Number: HHS-NIHNIDA(SSSA)RFP-17-384 3. Issue Date: June 8, 2017 4. Set Aside: [X] No [ ] Yes See Part IV Section L 5. Title : NIMH POSTMORTEM HUMAN BRAIN COLLECTION 6. ISSUED BY:Station Support/Simplified AcquisitionsOffice of Acquisitions - NIDA Neuroscience COACNational Institutes of Health6001 Executive Blvd.Room 3172Bethesda, MD 20892 7. SUBMIT OFFERS TO:See Part III, Section J,"Packaging and Delivery of theProposal," ATTACHMENT 1 ofthis Solicitation. 8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specifiedin, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 5:00PM local time on Thursday, July 7, 2017. Offers will be valid for 120 days unless a different period is specifiedby the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043. 9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERYOF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINTOF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS. IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THEPLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDEREDLATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions toOfferors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION. 10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerorsmust access the CCR through The System for Award Management (SAM) at http://www.sam.gov 11. FOR INFORMATION CALL: Zenab ChowdhryPHONE: 301-827-6909e-MAIL: zenab.chowdhry@nih.govCOLLECT CALLS WILL NOT BE ACCEPTED. Written questions about the RFP may be submitted via E-mail to:zenab.chowdhry@nih.gov Nancy Lamon-KritikosContracting OfficerOffice of Acquisitions RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 2 - RFP TABLE OF CONTENTS PART I - THE SCHEDULE.............................................................................. 4 SECTION A - SOLICITATION/CONTRACT FORM....................................................... 1 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS.......................................... 4 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT.................................... 6 SECTION D - PACKAGING, MARKING AND SHIPPING................................................. 8 SECTION E - INSPECTION AND ACCEPTANCE....................................................... 9 SECTION F - DELIVERIES OR PERFORMANCE...................................................... 10 SECTION G - CONTRACT ADMINISTRATION DATA................................................... 11 SECTION H - SPECIAL CONTRACT REQUIREMENTS................................................. 14 PART II - CONTRACT CLAUSES....................................................................... 17 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS................................ 21 SECTION J - LIST OF ATTACHMENTS............................................................... 21 SOLICITATION ATTACHMENTS................................................................... 21 BUSINESS PROPOSAL ATTACHMENTS........................................................... 21 INFORMATIONAL ATTACHMENTS................................................................ 21 PART IV - REPRESENTATIONS AND INSTRUCTIONS................................................... 22 SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS....... 22 SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS............................ 23 1. GENERAL INFORMATION...................................................................... 23 a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION................................. 23 b. NAICS CODE AND SIZE STANDARD......................................................... 27 c. TYPE OF CONTRACT AND NUMBER OF AWARDS............................................ 27 d. COMMITMENT OF PUBLIC FUNDS.......................................................... 27 e. COMMUNICATIONS PRIOR TO CONTRACT AWARD.......................................... 27 f. RELEASE OF INFORMATION................................................................ 27 g. PREPARATION COSTS..................................................................... 27 h. SERVICE OF PROTEST..................................................................... 27 2. INSTRUCTIONS TO OFFERORS................................................................ 28 a. GENERAL INSTRUCTIONS.................................................................. 28 1. Contract Type and General Clauses........................................................ 28 2. Authorized Official and Submission of Proposal.............................................. 28 3. Proposal Summary and Data Record (NIH-2043)............................................. 28 4. Separation of Technical and Business Proposals............................................. 29 5. Alternate Proposals....................................................................... 29 6. Evaluation of Proposals................................................................... 29 7. Potential Award Without Discussions....................................................... 29 8. Use of the Metric System of Measurement.................................................. 29 9. Selection of Offerors...................................................................... 29 10. Information and Physical Access Security.................................................. 30 11. Solicitation Provisions Incorporated by Reference........................................... 31 b. TECHNICAL PROPOSAL INSTRUCTIONS.................................................... 32 1. Technical Discussions.................................................................... 32 RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 3 - 2. Other Considerations..................................................................... 34 3. Technical Evaluation...................................................................... 34 c. BUSINESS PROPOSAL INSTRUCTIONS...................................................... 34 1. Basic Cost/Price Information............................................................... 34 2. Proposal Cover Sheet.................................................................... 34 3. Information Other than Cost or Pricing Data................................................. 35 4. Salary Rate Limitation.................................................................... 35 5. Other Administrative Data................................................................. 36 6. Qualifications of the Offeror............................................................... 36 SECTION M - EVALUATION FACTORS FOR AWARD................................................. 38 1. GENERAL.................................................................................... 38 2. COST/PRICE EVALUATION.................................................................... 38 3. EVALUATION OF OPTIONS.................................................................... 38 4. TECHNICAL EVALUATION FACTORS........................................................... 38 5. PAST PERFORMANCE FACTOR................................................................ 39 RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 4 - PART I - THE SCHEDULE THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION. ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE CONTRACT AWARD. THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE TERMS AND CONDITIONS OF THE RESULTANT CONTRACT. SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES The purpose of this contract is to provide services to assist NIMH in acquiring donor brain specimens for research purposes. The Contractor shall seek to identify and refer all appropriate specimens to the NIMH for potential consent, and perform extractions and shipments when approved. The donated postmortem human brain specimens will be used for research by the HBCC into the neurobiology of complex mental disorders, and also distributed to approved/ qualified outside investigators for research. ARTICLE B.2. PRICES/COSTS The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. ARTICLE B.3. PRICES a. The total fixed price of this contract is $. b. Upon delivery and acceptance of the services described in SECTION C of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below: c. SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD Description of Service Price ($) Unit Quantity Total ($) Basic services as described in the Statement of Work, Contract Attachment 3 Per Month 12 ARTICLE B.4. OPTION PRICES a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 5 - b. Pursuant to FAR Clause 52.217-9 set forth in ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The fixed price of this contract will be increased as set forth in paragraph c., below. c. Upon the delivery and acceptance of the Option Servicesdescribed in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below: Option Period Description of Option Service(s) Price Units Quantity Total Price of Option 1 Basic services as described in the Statement of Work, Contract Attachment 3. Per Month 12 2 Same as above 3 Same as above 4 Same as above ARTICLE B.5. ADVANCE UNDERSTANDINGS Specific items (e.g., elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost) (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award. 1. Data Rights The Contractor shall have the right to use the data collected at the NIMH during neuropathological examination of the brain, as part of the autopsy report. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 6 - SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT ARTICLE C.1. STATEMENT OF WORK a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated June 2, 2017, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments). ARTICLE C.2. REPORTING REQUIREMENTS All reports required herein shall be submitted in electronic format. a. Technical Progress Reports 1. In addition to the required reports set forth elsewhere in this Schedule (as applicable), the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.] For proposal preparation purposes only, it is estimated that the required electronic version(s) of these reports will be required as follows [ Note: reports are brief summaries of the number of cases accepted for donations] : [ ] Monthly [ ] Quarterly [X] Semi-Annually [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report) b. Other Reports/Deliverables 1. Information Security and Physical Access Reporting Requirements The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article. a. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 7 - may have access to non-public Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf. (Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.) RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 8 - SECTION D - PACKAGING, MARKING AND SHIPPING All donor specimens shall be packaged and shipped in accordance with all federal, state and local regulations. See also specific information in the Statement of Work regarding communications with NIMH, and coordination of shipments and deliveries. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 9 - SECTION E - INSPECTION AND ACCEPTANCE a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided. b. For the purpose of this SECTION, is the authorized representative of the Contracting Officer. c. Inspection and acceptance will be performed at: Human Brain Collection Core, NIMH 10 Center Drive, Bethesda, MD 20892-1385 Acceptance of technical reports and services may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt. d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996). RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 10 - SECTION F - DELIVERIES OR PERFORMANCE ARTICLE F.1. PERIOD OF PERFORMANCE a. The period of performance of this contract shall be from August 2017 through August 2018. b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below: Option Option Periods (Estimated) 1 August 2018 - August 2019 2 August 2019 - August 2020 3 August 2020 - August 2021 4 August 2021 - August 2022 ARTICLE F.2. DELIVERIES a. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the Services and reports specified in the Delivery Schedule which are described in SECTION C of this contract. b. Specimen Delivery Address Human Brain Collection Core, NIMH Bldg. 10, Rm. 4N312 10 Center Drive, Bethesda, MD 20892-1385 c. Prior to shipping, the NIMH shall be contacted with shipping details, including the overnight courier tracking number (as applicable). ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998) This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar. FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE: 52.242-15, Stop Work Order (August 1989) Alternate I (April 1984) is not applicable to this contract. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 11 - SECTION G - CONTRACT ADMINISTRATION DATA ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR) The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract: [To be specified prior to award.] The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract The Government may unilaterally change its COR designation. ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. (End of Clause) The following individual(s) is/are considered to be essential to the work being performed hereunder: Name Title To be specified prior to award ARTICLE G.3. INVOICE SUBMISSION a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 12 - 1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer. a. The original invoice shall be submitted to the following designated billing office: National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500 b. One copy of the invoice shall be submitted to the following approving official: Contracting Officer Office of Acquisitions, NIDA Station Support/Simplified Acquisitions National Institutes of Health Room 3172 6001 Executive Blvd. MSC Bethesda, MD- 2089 E-mail: zenab.chowdhry@nih.gov The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number. [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."] 2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests: a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIDA Invoices SSSA (NIH/NIDA). b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer. c. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer. d. Invoice Matching Option. This contract requires a three-way match. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 13 - e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization. f. The Contract Title is: NIMH Postmortem Human Brain Collection g. Contract Line Items as follows: Prism Line Item # Line Item Description 1 Base Year Services 2 Option Year 1 Services 3 Option Year 2 Services 4 Option Year 3 Services 5 Option Year 4 Services b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088. ARTICLE G.4. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE a. Contractor Performance Evaluations Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on To be determined [Insert Dates]. Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final. Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions. b. Electronic Access to Contractor Performance Evaluations Contractors may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 14 - SECTION H - SPECIAL CONTRACT REQUIREMENTS ARTICLE H.1. HUMAN SUBJECTS It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer. ARTICLE H.2. HUMAN MATERIALS The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. ARTICLE H.3. ACKNOWLEDGEMENT OF FEDERAL FUNDING The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources. ARTICLE H.4. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography. ARTICLE H.5. GUN CONTROL The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control. ARTICLE H.6. OPTION PROVISION Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the price of the contract will be increased as set forth in the OPTION PRICES Article in SECTION B of this contract. ARTICLE H.7. INFORMATION AND PHYSICAL ACCESS SECURITY A. Standard for Encryption language a. The Contractor shall use Federal Information processing Standard (FIPS) 140-2-compliant encryption (Security) Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 15 - under this contract is considered "sensitive" in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems, dated February 2004). b. The Contractor shall verify that the selected encryption product has been validated under the Cryptographic Module Validation Program (see http://csrc.nist.gov/groups/STM/cmvp/) to confirm compliance with FIPS 140-2 (as amended). The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative. c. The Contractor shall use the Key Management Key (see FIPS 201, Chapter 4, as amended) on the HHS personal identification verification (PIV) card; or alternatively,the Contractor shall establish and use a key recovery mechanism to ensure the ability for authorized personnel to decrypt and recover all encrypted information (see http://csrc.nist.gov/drivers/documents/ombencryption-guidance.pdf). The Contractor shall notify the Contracting Officer and the Contracting Officer's Technical Representative of personnel authorized to decrypt and recover all encrypted information. d. The Contractor shall securely generate and manage encryption keys to prevent unauthorized decryption of information in accordance with FIPS 140-2 (as amended). e. The Contractor shall ensure that this standard is incorporated into the Contractor's property management/ control system or establish a separate procedure to account for all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive HHS information. f. The Contractor shall ensure that its subcontractors (all tiers) which perform work under this contract comply with the requirements contained in this clause. B. Additional NIH Requirements 1. LOSS AND/OR DISCLOSURE OF PERSONALLY IDENTIFIABLE INFORMATION (PII) - NOTIFICATION OF DATA BREACH The Contractor shall report all suspected or confirmed incidents involving the loss and/or disclosure of PII in electronic or physical form. Notification shall be made to the NIH Incident Response Team (IRT) via email ( IRT@mail.nih.gov) within one hour of discovering the incident. The Contractor shall follow up with IRT by completing and submitting one of the applicable two forms below within three (3) work days of incident discovery: NIH PII Spillage Report at: https://ocio.nih.gov/InfoSecurity/Policy/Documents/ NIH_PII_Spillage_Proced.doc NIH Lost or Stolen Assets Report at: https://ocio.nih.gov/InfoSecurity/Policy/Documents/ ISSO_Stolen_Device-Media_Handling_Procedures.doc ARTICLE H.8. CONFIDENTIALITY OF INFORMATION a. Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 16 - c. If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization. e. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. f. Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials. g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws. The following information is covered by this article: The personal identities of decedent referrals and cases accepted for donation to NIMH. ARTICLE H.9. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is: US Department of Health and Human Services Office of Inspector General ATTN: OIG HOTLINE OPERATIONS P.O. Box 23489 Washington, D.C. 20026 RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 17 - PART II - CONTRACT CLAUSES SECTION I - CONTRACT CLAUSES THE FOLLOWING ARTICLE I.1. GENERAL CLAUSE LISTING(S) WILL BE APPLICABLE TO MOST CONTRACTS RESULTING FROM THIS RFP. HOWEVER, THE ORGANIZATIONAL STRUCTURE OF THE SUCCESSFUL OFFEROR(S) WILL DETERMINE THE SPECIFIC GENERAL CLAUSE LISTING TO BE CONTAINED IN THE CONTRACT(S) AWARDED FROM THIS RFP: The complete listing of these clauses may be accessed at: https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors ARTICLE I.1. GENERAL CLAUSES FOR A NEGOTIATED FIXED-PRICE SERVICE CONTRACT RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 18 - ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES Any authorized substitutions and/or modifications other than the General Clauses which will be based on the type of contract/Contractor will be determined during negotiations. It is expected that the following substitution(s) will be made part of the resultant contract: a. Alternate IV (October 2010) of FAR Clause 52.215-21, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data--Modifications (October 2010) is added. b. Alternate I (April 1984), of FAR Clause 52.227-1, Authorization and Consent (December 2007) is deleted in its entirety. FAR Clause 52.227-11, Patent Rights--Ownership by the Contractor (May 2014) is deleted in its entirety. Alternate IV (December 2007), of FAR Clause 52.227-14, Rights In Data--General (May 2014) is deleted in its entirety. Alternate II (April 2012), of FAR Clause 52.245-1, Government Property (April 2012) is deleted in its entirety. c. FAR Clause 52.232-17, Interest (May 2014) is applicable to this contract. d. Alternate I (February 2002), of FAR Clause 52.232-25, Prompt Payment (July 2013) is deleted. e. Alternate II, (September 1996), of FAR Clause 52.249-2, Termination for Convenience of the Government (Fixed-Price) (April 2012) is added. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 19 - ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following: This contract incorporates the following clauses by reference, (unless otherwise noted), 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. a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES 1. FAR Clause 52.217-8, Option to Extend Services (November 1999). "..The Contracting Officer may exercise the option by written notice to the Contractor within 30 days 2. FAR Clause 52.222-26, Equal Opportunity (September 2016) 3. FAR Clause 52.227-14, Rights in Data - General (May 2014). b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES: 1. HHSAR Clause 352.223-70, Safety and Health (December 2015) RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 20 - ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT Additional clauses other than those listed below which are based on the type of contract/Contractor shall be determined during negotiations. Any contract awarded from this solicitation will contain the following: This contract incorporates the following clauses in full text. a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES 1. FAR Clause 52.217-9, Option to Extend the Term of the Contract (March 2000). a. The Government may extend the term of this contract by written notice to the Contractor within 15 days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30days before the contract expires. The preliminary notice does not commit the Government to an extension. b. If the Government exercises this option, the extended contract shall be considered to include this option clause. c. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 21 - PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS SECTION J - LIST OF ATTACHMENTS The following documents are incorporated into this RFP: SOLICITATION ATTACHMENTS Attachment No. Title Location Attachment 1: Packaging and Delivery of Proposal (Non R & D) See attached Attachment 2: Proposal Intent Response Sheet See attached. Attachment 3: Statement of Work See attached. Attachment 4: Additional Proposal Instructions See attached. Attachment 5: Section K - Representations, Certifications, and Other Statements of Offerors See attached Attachment 6: Information Technology Systems Security - Prospective Offeror Non-Disclosure Agreement http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/Nondisclosure.pdf BUSINESS PROPOSAL ATTACHMENTS Attachment No. Title Location Attachment 7: Proposal Summary and Data Record, NIH-2043 http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/NIH2043.pdf Attachment 8: Contract Pricing Chart See attached INFORMATIONAL ATTACHMENTS Attachment No. Title Location Attachment 9: Invoice Instructions for NIH Fixed Price Contracts NIH(RC)-2 http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/rc2_508.pdf Attachment 10: Safety and Health, HHSAR Clause 352.223-70 https://oamp.od.nih.gov/sites/ default/files/DGS/FORMS/ hhsar_352.223-70_safety_and_health_508.pdf Attachment 11: Commitment to Protect Non-Public Information Contractor Agreement https://ocio.nih.gov/aboutus/ publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 22 - PART IV - REPRESENTATIONS AND INSTRUCTIONS SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS IF YOU INTEND TO SUBMIT A PROPOSAL, YOU MUST : 1. Go to the System for Award Management (SAM) and complete the Representations and Certifications. The SAM website may be accessed at: http://www.sam.gov ; and 2. Complete, and INCLUDE as part of your BUSINESS PROPOSAL: SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS which is included as an Attachment in Section J-LIST OF ATTACHMENTS, SOLICITATION ATTACHMENTS of this solicitation. If you are unable to access this SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS electronically, you may request a copy from the Contracting Officer identified on the cover page of this solicitation. 3. FAR Clause 52.204-19 Incorporation by Reference of Representations and Certifications (December 2014). The Contractor's representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract. (End of Clause) RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 23 - SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS 1. GENERAL INFORMATION a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION [FAR Provision 52.215-1 (January 2006)] a. Definitions. As used in this provision-- "Discussions" are negotiations that occur after establishment of the competitive range that may, at the Contracting Officer's discretion, result in the offeror being allowed to revise its proposal. "In writing", "writing", or "written" means any worded or numbered expression that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information. "Proposal modification" is a change made to a proposal before the solicitation's closing date and time, or made in response to an amendment, or made to correct a mistake at any time before award. "Proposal revision" is a change to a proposal made after the solicitation closing date, at the request of or as allowed by a Contracting Officer as the result of negotiations. "Time," if stated as a number of days, is calculated using calendar days, unless otherwise specified, and will include Saturdays, Sundays, and legal holidays. However, if the last day falls on a Saturday, Sunday, or legal holiday, then the period shall include the next working day. b. Amendments to solicitations. If this solicitation is amended, all terms and conditions that are not amended remain unchanged. Offerors shall acknowledge receipt of any amendment to this solicitation by the date and time specified in the amendment(s). c. Submission, modification, revision, and withdrawal of proposals. 1. Unless other methods (e.g., electronic commerce or facsimile) are permitted in the solicitation, proposals and modifications to proposals shall be submitted in paper media in sealed envelopes or packages (i) addressed to the office specified in the solicitation, and (ii) showing the time and date specified for receipt, the solicitation number, and the name and address of the offeror. Offerors using commercial carriers should ensure that the proposal is marked on the outermost wrapper with the information in paragraphs (c)(1)(i) and (c)(1)(ii) of this provision. 2. The first page of the proposal must show-- i. The solicitation number; ii. The name, address, and telephone and facsimile numbers of the offeror (and electronic address if available); iii. A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation and agreement to furnish any or all items upon which prices are offered at the price set opposite each item; iv. Names, titles, and telephone and facsimile numbers (and electronic addresses if available) of persons authorized to negotiate on the offeror's behalf with the Government in connection with this solicitation; and v. Name, title, and signature of person authorized to sign the proposal. Proposals signed by an agent shall be accompanied by evidence of that agent's authority, unless that evidence has been previously furnished to the issuing office. 3. Submission, modification, revision, and withdrawal of proposals. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 24 - (i)Offerors are responsible for submitting proposals, and any modifications or revisions, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that proposal or revision is due. (ii) (A) Any proposal, modification, or revision received at the Government office designated in the solicitation after the exact time specified for receipt of offers is "late" and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and-- (1) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of proposals; or (2) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or (3) It is the only proposal received. (B) However, a late modification of an otherwise successful proposal that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted. (iii) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the proposal wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel. (iv) If an emergency or unanticipated event interrupts normal Government processes so that proposals cannot be received at the office designated for receipt of proposals by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation, the time specified for receipt of proposals will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume. (v) Proposals may be withdrawn by written notice received at any time before award. Oral proposals in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile proposals, proposals may be withdrawn via facsimile received at any time before award, subject to the conditions specified in the provision at 52.215-5, Facsimile Proposals. Proposals may be withdrawn in person by an offeror or an authorized representative, if the identity of the person requesting withdrawal is established and the person signs a receipt for the proposal before award. (4) Unless otherwise specified in the solicitation, the offeror may propose to provide any item or combination of items. (5) Offerors shall submit proposals in response to this solicitation in English, unless otherwise permitted by the solicitation, and in U.S. dollars, unless the provision at FAR 52.225-17, Evaluation of Foreign Currency Offers, is included in the solicitation. (6) Offerors may submit modifications to their proposals at any time before the solicitation closing date and time, and may submit modifications in response to an amendment, or to correct a mistake at any time before award. (7) Offerors may submit revised proposals only if requested or allowed by the Contracting Officer. (8) Proposals may be withdrawn at any time before award. Withdrawals are effective upon receipt of notice by the Contracting Officer. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 25 - (d) Offer expiration date. Proposals in response to this solicitation will be valid for the number of days specified on the solicitation cover sheet (unless a different period is proposed by the offeror). (e) Restriction on disclosure and use of data. (1) The proposal submitted in response to this request may contain data (trade secrets; business data (e.g., commercial information, financial information, cost and pricing data); and technical data) which the offeror, including its prospective subcontractor(s), does not want used or disclosed for any purpose other than for evaluation of the proposal. The use and disclosure of any data may be so restricted; provided, that the Government determines that the data is not required to be disclosed under the Freedom of Information Act, 5 U.S.C. 552, as amended, and the offeror marks the cover sheet of the proposal with the following statements, specifying the particular portions of the proposal which are to be restricted: "Unless disclosure is required by the Freedom of Information Act, 5 U.S.C. 552, as amended, (the Act) as determined by Freedom of Information (FOI) officials of the Department of Health and Human Services (HHS), data contained in the portions of this proposal which the offeror has specifically identified by page number, paragraph, etc. as containing restricted information shall not be used or disclosed except for evaluation purposes. The offeror acknowledges that HHS may not be able to withhold a record (e.g. data, document, etc.) nor deny access to a record requested pursuant to the Act and that the HHS's FOI officials must make that determination. The offeror hereby agrees that the Government is not liable for disclosure if HHS has determined that disclosure is required by the Act. If a contract is awarded to the offeror as a result of, or in connection with, the submission of this proposal, the Government shall have right to use or disclose the data to the extent provided in the contract. Proposals not resulting in a contract remain subject to the Act. The offeror also agrees that the Government is not liable for disclosure or use of unmarked data and may use or disclose the data for any purpose, including the release of the information pursuant to requests under the Act. The data subject to this restriction are contained in pages ( insert page numbers, paragraph designations, etc. or other identification)." (2) In addition, the offeror must mark each page of data it wishes to restrict with the following statement: "Use or disclosure of data contained on this page is subject to the restriction on the cover sheet of this proposal or quotation." (3) Offerors are cautioned that proposals submitted with restrictive statements or statements differing in substance from those cited above may not be considered for award. The Government reserves the right to reject any proposal submitted with a nonconforming statement(s). (f) Contract award. (1) The Government intends to award a contract or contracts resulting from this solicitation to the responsible offeror(s) whose proposal(s) represents the best value after evaluation in accordance with the factors and subfactors in the solicitation. (2) The Government may reject any or all proposals if such action is in the Government's interest. (3) The Government may waive informalities and minor irregularities in proposals received. (4) The Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). Therefore, the offeror's initial proposal should contain the offeror's best terms from a cost or price and technical standpoint. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 26 - limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals. (5) The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit cost or prices offered, unless the offeror specifies otherwise in the proposal. (6) The Government reserves the right to make multiple awards if, after considering the additional administrative costs, it is in the Government's best interest to do so. (7) Exchanges with offerors after receipt of a proposal do not constitute a rejection or counteroffer by the Government. (8) The Government may determine that a proposal is unacceptable if the prices proposed are materially unbalanced between line items or subline items. Unbalanced pricing exists when, despite an acceptable total evaluated price, the price of one or more contract line items is significantly overstated or understated as indicated by the application of cost or price analysis techniques. A proposal may be rejected if the Contracting Officer determines that the lack of balance poses an unacceptable risk to the Government. (9) If a cost realism analysis is performed, cost realism may be considered by the source selection authority in evaluating performance or schedule risk. (10) A written award or acceptance of proposal mailed or otherwise furnished to the successful offeror within the time specified in the proposal shall result in a binding contract without further action by either party. (11) If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable: (i) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer. (ii) The overall evaluated cost or price and technical rating of the successful and debriefed offeror and past performance information on the debriefed offeror. (iii) The overall ranking of all offerors, when any ranking was developed by the agency during source selection; (iv) A summary of the rationale for award. (v) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror. (vi) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency. (End of Provision) Alternate I (October 1997).As prescribed in 15.209(a)(1), substitute the following paragraph (f)(4) for paragraph (f)(4) of the basic provision: (f) (4) The Government intends to evaluate proposals and award a contract after conducting discussions with offerors whose proposals have been determined to be within the competitive range. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals. Therefore, the offeror's initial proposal should contain the offeror's best terms from a price and technical standpoint. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 27 - b. NAICS CODE AND SIZE STANDARD Note: The following information is to be used by the offeror in preparing its Representations and Certifications (See Section K of this RFP), specifically in completing the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATION, FAR Clause 52.219-1. 1. The North American Industry Classification System (NAICS) code for this acquisition is 541990. 2. The small business size standard is $15M. THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the Federal Acquisition Regulation (FAR) requires in every solicitation, (except for foreign acquisitions) the inclusion of the North American Industry Classification System (NAICS) Code and corresponding size standard which best describes the nature of the requirement in the solicitation. c. TYPE OF CONTRACT AND NUMBER OF AWARDS 1. It is anticipated that one or more award(s) will be made from this solicitation and that the award(s) will be made on/about August 2017. 2. It is anticipated that the award(s) from this solicitation will be a multiple-year Fixed-Price type Completion contract with a Period of Performance of: Base year with 4 yearly options. d. COMMITMENT OF PUBLIC FUNDS The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed procurement. Any other commitment, either explicit or implied, is invalid. e. COMMUNICATIONS PRIOR TO CONTRACT AWARD Offerors shall direct all communications to the attention of the Contract Specialist or Contracting Officer cited on the face page of this SOLICITATIONS. Communications with other officials may compromise the competitiveness of this acquisition and result in cancellation of the requirement. f. RELEASE OF INFORMATION Contract selection and award information will be disclosed to offerors in accordance with regulations applicable to negotiated acquisition. Prompt written notice will be given to unsuccessful offerors as they are eliminated from the competition, and to all offerors following award. g. PREPARATION COSTS This RFP does not commit the Government to pay for the preparation and submission of a proposal. h. SERVICE OF PROTEST (SEPTEMBER 2006) - FAR 52.233-2 (a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from: Contracting Officer Office of Acquisitions, NIDA Station Support/Simplified Acquisitions National Institutes of Health Room 3172 RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 28 - 6001 Executive Blvd. MSC Bethesda, MD 20892- (b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. (End of Provision) 2. INSTRUCTIONS TO OFFERORS a. GENERAL INSTRUCTIONS INTRODUCTION The following instructions will establish the acceptable minimum requirements for the format and contents of proposals. Special attention is directed to the requirements for technical and business proposals to be submitted in accordance with these instructions. 1. Contract Type and General Clauses It is contemplated that one or more completion/fixed price type contract(s) will be awarded. (See General Information) Any resultant contract(s) shall include the clauses applicable to the selected offeror's organization and type of contract awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed contract. 2. Authorized Official and Submission of Proposal The proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this RFP. Your proposal shall be submitted in the number of copies, to the addressees, and marked as indicated in the Attachment entitled, PACKAGING AND DELIVERY OF PROPOSAL, Part III, Section J hereof. Proposals will be typewritten, paginated, reproduced on letter size paper, printed/copied double-sided, on at least 30 percent post consumer fiber paper, as required by FAR 4.302(b), and will be legible in all required copies. To expedite the proposal evaluation, all documents required for responding to the SOLICITATION should be placed in the following order: I. COVER PAGE Include RFP title, number, name of organization, DUNS No., identification of the proposal part, and indicate whether the proposal is an original or a copy. II. TECHNICAL PROPOSAL It is recommended that the technical proposal consist of a cover page, a table of contents, and the information requested in the Technical Proposal Instructions and as specified in SECTION J, List of Attachments. III. BUSINESS PROPOSAL It is recommended that the business proposal consist of a cover page, a table of contents, and the information requested in the Business Proposal Instructions and as specified in SECTION J, List of Attachments. 3. Proposal Summary and Data Record (NIH-2043) RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 29 - The Offeror must complete the Form NIH-2043, attached, with particular attention to the length of time the proposal is firm and the designation of those personnel authorized to conduct negotiations. (See SECTION J, Attachment entitled, PROPOSAL SUMMARY AND DATA RECORD). 4. Separation of Technical and Business Proposals The proposal must be prepared in two parts: a "Technical Proposal" and a "Business Proposal." Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other. The technical proposal should disclose your technical approach in as much detail as possible, including, but not limited to, the requirements of the technical proposal instructions. 5. Alternate Proposals You may, at your discretion, submit alternate proposals, or proposals which deviate from the requirements; provided, that you also submit a proposal for performance of the work as specified in the statement of work. Such proposals may be considered if overall performance would be improved or not compromised and if they are in the best interests of the Government. Alternative proposals, or deviations from any requirements of this RFP, shall be clearly identified. 6. Evaluation of Proposals The Government will evaluate proposals in accordance with the factors set forth in PART IV, SECTION M of this RFP. 7. Potential Award Without Discussions The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial prices are fair and reasonable and that discussions are not necessary. 8. Use of the Metric System of Measurement It is the policy of the Department of Health and Human Services to support the Federal transition to the metric system and to use the metric system of measurement in all procurements, grants, and other business related activities unless such use is impracticable or is likely to cause significant inefficiencies. The offeror is encouraged to prepare their proposal using either "Hard Metric," "Soft Metric," or "Dual Systems" of measurement. The following definitions are provided for your information: Hard Metric - - The replacement of a standard inch-pound size with an accepted metric size for a particular purpose. An example of size substitution might be: selling or packaging liquids by the liter instead of by the pint or quart (as for soft drinks), or instead of by the gallon (as for gasoline). Soft Metric - The result of a mathematical conversion of inch-pound measurements to metric equivalents for a particular purpose. The physical characteristics are not changed. Dual Systems - The use of both inch-pound and metric systems. For example, an item is designed, produced, and described in inch-pound values with soft metric values also shown for information or comparison purposes. 9. Selection of Offerors a. The acceptability of the technical portion of each contract proposal will be evaluated by a technical review committee. The committee will evaluate each proposal in strict conformity with RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 30 - the evaluation factors of the RFP, utilizing point scores and written critiques. The committee may suggest that the Contracting Officer request clarifying information from an offeror. b. The business portion of each contract proposal found to be technical acceptable will be subjected to a cost and price analysis, management analysis, etc. c. The Contracting Officer will, in concert with program staff, decide which proposals are in the competitive range. The competitive range will be comprised of all of the most highly rated proposals. Oral or written discussions will be conducted with all offerors in the competitive range. While it is NIDA's policy to conduct discussions with all offerors in the competitive range, NIDA reserves the right, in special circumstances, to limit the number of proposals included in the competitive range to the greatest number that will permit an efficient competition. All aspects of the proposals are subject to discussions, including cost, technical approach, past performance, and contractual terms and conditions. At the conclusion of discussions, each offeror still in the competitive range shall be given an opportunity to submit a written Final Proposal Revision (FPR) with the reservation of the right to conduct finalization of details with the selected source in accordance with HHSAR Part 315. d. The process described in FAR 15.101-1 will be employed, which permits the Government to make tradeoffs among cost or price and non-cost factors and to consider award to other than the lowest price offeror or other than the highest technically rated offeror. e. The NIDA reserves the right to make a single award, multiple awards, or no award at all to the SOLICITATION. In addition, the SOLICITATION may be amended or canceled as necessary to meet NIDA's requirements. Synopses of awards exceeding $25,000 will be published in FedBizOpps. 10. Information and Physical Access Security is applicable to this solicitation and the following information is provided to assist in proposal preparation. IMPORTANT NOTE TO OFFERORS: The following information shall be addressed in a separate section of the Technical Proposal entitled "Information Security." The Homeland Security Presidential Directive (HSPD)-12 and the Federal Information Security Management Act of 2002 (P.L. 107-347) (FISMA) requires each agency to develop, document, and implement an agency-wide information security program to safeguard information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor (including subcontractor), or other source. A. Standard for Encryption language a. The Contractor shall use Federal Information processing Standard (FIPS) 140-2- compliant encryption (Security) Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information under this contract is considered "sensitive" in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems, dated February 2004). b. The Contractor shall verify that the selected encryption product has been validated under the Cryptographic Module Validation Program (see http://csrc.nist.gov/groups/ STM/cmvp/) to confirm compliance with FIPS 140-2 (as amended). The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 31 - c. The Contractor shall use the Key Management Key (see FIPS 201, Chapter 4, as amended) on the HHS personal identification verification (PIV) card; or alternatively, the Contractor shall establish and use a key recovery mechanism to ensure the ability for authorized personnel to decrypt and recover all encrypted information (see http:// csrc.nist.gov/drivers/documents/ombencryption-guidance.pdf). The Contractor shall notify the Contracting Officer and the Contracting Officer's Technical Representative of personnel authorized to decrypt and recover all encrypted information. d. The Contractor shall securely generate and manage encryption keys to prevent unauthorized decryption of information in accordance with FIPS 140-2 (as amended). e. The Contractor shall ensure that this standard is incorporated into the Contractor's property management/control system or establish a separate procedure to account for all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive HHS information. f. The Contractor shall ensure that its subcontractors (all tiers) which perform work under this contract comply with the requirements contained in this clause. B. Additional NIH Requirements 1. LOSS AND/OR DISCLOSURE OF PERSONALLY IDENTIFIABLE INFORMATION (PII) - NOTIFICATION OF DATA BREACH The Contractor shall report all suspected or confirmed incidents involving the loss and/or disclosure of PII in electronic or physical form. Notification shall be made to the NIH Incident Response Team (IRT) via email ( IRT@mail.nih.gov) within one hour of discovering the incident. The Contractor shall follow up with IRT by completing and submitting one of the applicable two forms below within three (3) work days of incident discovery: NIH PII Spillage Report at: https://ocio.nih.gov/InfoSecurity/Policy/ Documents/NIH_PII_Spillage_Proced.doc NIH Lost or Stolen Assets Report at: https://ocio.nih.gov/InfoSecurity/ Policy/Documents/ISSO_Stolen_Device-Media_Handling_Procedures.doc 11. Solicitation Provisions Incorporated by Reference, FAR 52.252-1 (February 1998) This Solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.acquisition.gov/far/index.html. FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1): a. System for Award Management, FAR Provision 52.204-7 (October 2016). Alternate I (July 2013) is not applicable to this solicitation. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 32 - b. Order of Precedence-Uniform Contract Format, FAR Clause 52.215-8, (October 1997). b. TECHNICAL PROPOSAL INSTRUCTIONS A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical proposal should reflect a clear understanding of the nature of the work being undertaken. The technical proposal must include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate your understanding and management of important events or tasks. Note to Offerors: Beginning May 25, 2008, the offeror shall include the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research. 1. Technical Discussions The technical discussion included in the technical proposal should respond to the items set forth below: a. Statement of Work 1. Objectives State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it. 2. Approach The offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives. Proposals which merely restate the requirements of the Government's scope of work will not be eligible for award. Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed. 3. Methods Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and any unusual expenses you anticipate. 4. Schedule Provide a schedule for completion of the work and delivery of items specified in the statement of work. Performance or delivery schedules shall be indicated for phases or segments of work, as applicable, by contract year as well as for the overall contract. Schedules shall be shown in terms of calendar months from the date of authorization to proceed or, where applicable, from the date of a stated event, as for example, receipt of a required approval by the Contracting Officer. Unless the request for proposal indicates that the stipulated schedules are mandatory, they shall be treated as desired or recommended schedules. In this event, proposals based upon the offeror's best alternative schedule, involving no overtime, extra shift or other premium, will be accepted for consideration. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 33 - b. Personnel Describe the experience and qualifications of personnel who will be assigned for direct work on this program. Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program. OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL OTHER PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE OFFEROR TO CORRECT THE TIME COMMITMENT. 1. Single Principal Investigator/Project Director List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible. 2. Other Investigators List all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible. 3. Additional Personnel List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement. Commitment letters for use of consultants and other personnel to be hired must include: • The specific items or expertise they will provide. • Their availability to the project and the amount of time anticipated. • Willingness to act as a consultant. • How rights to publications and patents will be handled. 4. Resumes RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 34 - Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications. 2. Other Considerations Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include: a. Any agreements and/or arrangements with subcontractor(s). Provide as much detail as necessary to explain how the statement of work will be accomplished within this working relationship. b. Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project. c. Equipment and unusual operating procedures established to protect personnel from hazards associated with this project. d. Other factors you feel are important and support your proposed research. e. Recommendations for changing reporting requirements if such changes would be more compatible with the offeror's proposed schedules. 3. Technical Evaluation Proposals will be technically evaluated in accordance with SECTION M - Evaluation Factors for Award of this solicitation. c. BUSINESS PROPOSAL INSTRUCTIONS 1. Basic Cost/Price Information The business proposal must contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. These elements will include, as applicable, direct labor, fringe benefits, travel, materials, subcontracts, purchased parts, shipping, indirect costs and rate, fee, and profit. 2. Proposal Cover Sheet The following information shall be provided on the first page of your pricing proposal: 1. Solicitation, contract, and/or modification number; 2. Name and address of Offeror; 3. Name and telephone number of point of contact; 4. Name, address, and telephone number of Contract Administration Office, (if available); 5. Name, address, and telephone number of Audit Office (if available); 6. Proposed cost and/or price; profit or fee (as applicable); and total; 7. The following statement: By submitting this proposal, the offeror, if selected for discussions, grants the contracting officer or an authorized representative the right to examine, at any time before award, any of those books, records, documents, or other records directly pertinent to the information requested or submitted. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 35 - 8. Date of submission; and 9. Name, title and signature of authorized representative. This cover sheet information is for use by offerors to submit information to the Government when certified cost or pricing data are not required but information to help establish price reasonableness or cost realism is necessary. Such information is not required to be certified in accordance with FAR 15.406-2. 3. Data Other than Certified Cost or Pricing Data a. Data submitted shall be sufficient to permit the Contracting Officer and authorized representatives to determine price reasonableness or cost realism, e.g., data to support an analysis of material costs (when sufficient data on labor and overhead rates is already available), or data on prices and quantities at which the offeror has previously sold the same or similar items. Data submitted must support the price proposed. The offeror shall include sufficient detail or cross references to clearly establish the relationship of the data provided to the price proposed. The offeror shall support any data provided with explanations or supporting rationale, as needed, to permit the Contracting Officer and authorized representative to evaluate the documentation. [Unless otherwise stated in this solicitation, the information may be submitted in the offeror's own format.] 4. Salary Rate Limitation Offerors are advised that no NIH funds may be used to pay the direct annual salary of an individual through any contract awarded as a result of this solicitation at a rate in excess of the Executive Schedule, Level II* (direct salary is exclusive of Overhead, Fringe Benefits and General and Administrative expenses, also referred to as "indirect cost" or "facilities and administrative (F&A) costs"). Direct salary has the same meaning as the term "institutional base salary." An individual's direct salary (or institutional base salary) is the annual compensation that the Contractor pays for an individual's appointment whether that individual's time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the Contractor. This does not preclude the offeror from absorbing that portion of an employee's annual salary (plus the dollar amount for fringe benefits and associated indirect costs) that exceeds a rate of the Executive Schedule, Level II*. The Executive Schedule, Level II* annual salary rate limitation also applies to individuals proposed under subcontracts and to consultants. LINK TO EXECUTIVE SCHEDULE RATES OF PAY: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/ (For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.) *Note to Offerors: The current Fiscal Year Executive Level II Salary Rate shall be adhered to in the preparation of your proposal. All costs associated with any resultant contract award shall be in compliance with the current Fiscal Year Executive Level II Salary rates. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 36 - 5. Other Administrative Data a. Submission of Electronic Funds Transfer Information with Offer, FAR Clause 52.232-38 (JULY 2013) The offeror shall provide, with its offer, the following information that is required to make payment by electronic funds transfer (EFT) under any contract that results from this solicitation. This submission satisfies the requirement to provide EFT information under paragraphs (b)(1) and (j) of the clause at 52.232 34, Payment by Electronic Funds Transfer Other than System for Award Management. (1) The solicitation number (or other procurement identification number). (2) The offeror's name and remittance address, as stated in the offer. (3) The signature (manual or electronic, as appropriate), title, and telephone number of the offeror's official authorized to provide this information. (4) The name, address, and 9 digit Routing Transit Number of the offeror's financial agent. (5) The offeror's account number and the type of account (checking, savings, or lockbox). (6) If applicable, the Fedwire Transfer System telegraphic abbreviation of the offeror's financial agent. (7) If applicable, the offeror shall also provide the name, address, telegraphic abbreviation, and 9 digit Routing Transit Number of the correspondent financial institution receiving the wire transfer payment if the offeror's financial agent is not directly on line to the Fedwire and, therefore, not the receiver of the wire transfer payment. (End of Provision) b. Financial Capacity The offeror shall indicate if it has the necessary financial capacity, working capital, and other resources to perform the contract without assistance from any outside source. If not, indicate the amount required and the anticipated source. c. Incremental Funding An incrementally funded contract is a contract in which funds are obligated, as they become available, to cover specific periods of performance. 6. Qualifications of the Offeror You are requested to submit a summary of your "General Experience, Organizational Experience Related to this RFP, Performance History and Pertinent Contracts." a. General Experience General experience is defined as general background, experience and qualifications of the offeror. A discussion of proposed facilities which can be devoted to the project may be appropriate. b. Organizational Experience Related to the RFP Organizational experience is defined as the accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall offeror or RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 37 - corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in this RFP. c. Performance History Performance history is defined as meeting contract objectives within delivery and cost schedules on efforts, either past or on-going, which is comparable or related to the effort required by this RFP. d. Pertinent Contracts Pertinent contracts is defined as a listing of each related contract completed within the last three years or currently in process. The listing should include: 1) the contract number; 2) contracting agency; 3) contract dollar value; 4) dates contract began and ended (or ends); 5) description of contract work; 6) explanation of relevance of work to this RFP; 7) actual delivery and cost performance versus delivery and cost agreed to in the contract(s). For award fee contracts, separately state in dollars the base fee and award fee available and the award fee actually received. The same type of organizational experience and past performance data should be submitted. e. Pertinent Grants List grants supported by the Government that involved similar or related work to that called for in this RFP. Include the grant number, involved agency, names of the grant specialist and the Science Administrator, identification of the work, and when performed. You are cautioned that omission or an inadequate or inaccurate response to this very important RFP requirement could have a negative effect on the overall selection process. Experience and past performance are factors which are relevant to the ability of the offerors to perform and are considered in the source selection process. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 38 - SECTION M - EVALUATION FACTORS FOR AWARD 1. GENERAL Selection of an offeror for contract award will be based on an evaluation of proposals against three factors. The factors in order of importance are: technical, cost, and past performance. Although technical factors are of paramount consideration in the award of the contract, past performance and cost/price are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make an award(s) to that offeror whose proposal provides the best overall value to the Government. 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 SOLICITATION. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the SOLICITATION. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors listed below. 2. COST/PRICE EVALUATION Offeror(s) cost/price proposal will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404. 3. EVALUATION OF OPTIONS It is anticipated that any contract(s) awarded from this solicitation will contain option provision(s) and period(s). In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s). 4. TECHNICAL EVALUATION FACTORS The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. The factors below are listed in the order of relative importance with weights assigned for evaluation purposes. Subfactors are listed in order of relative importance. POINTS a. TECHNICAL APPROACH/OTHER CONSIDERATIONS 80 (1) Quality of Specimens: Assuming commercial shipping services are utilized (not Government-provided services), the perceived ability to provide/deliver approved cases to NIMH as soon as possible after death; after a referred case is approved by the NIMH for donation, specimens must be received within 12 hours from extraction and no later than 36 hours after death; the Contractor RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 39 - must mitigate any possible shipping delays, or logistical problems, due to location/distance from NIMH; (2) Annual Estimated Volume of Referrals: The projected annual volume of quality cases that could potentially be referred to the NIMH for consent (with a sufficient annual volume of total autopsy cases to reasonably support the projections); a higher volume of referrals is considered more valuable to the government than fewer; (3) Facilities: Appropriateness and availability of laboratory space, facilities and equipment to accomplish the contract objectives; approval from the appropriate Governmental body(ies) that sanction the extraction, processing, and donation of human organs; the possession of any required permits, licenses, etc. b. PERSONNEL 20 (1) The demonstrated qualifications, availability, and experience of proposed professional and technical personnel to perform the tasks of this contract, as evidenced by resumes and discussion. __________ TOTAL POINTS 100 POINTS 5. PAST PERFORMANCE FACTOR Offeror's past performance information will be evaluated subsequent to the technical evaluation. However, this evaluation will not be conducted on any offeror whose proposal is determined to be technically unacceptable. The evaluation will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. The government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information. When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer. The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance. RFP Number : HHS-NIHNIDA(SSSA)RFP-17-384 - 40 - The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror. _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ PACKAGING AND DELIVERY OF PROPOSALS Your proposal shall be organized as specified in SECTION L.2. General Instructions. Shipment and marking shall be as indicated below. EXTERNAL PACKAGE MARKING In addition to the address cited below, mark each package as follows: "RFP NO: ____________________________________________ TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY" PLEASE READ THE FOLLOWING INFORMATION CAREFULLY: NUMBER OF COPIES TECHNICAL PROPOSAL: ORIGINAL* AND BUSINESS PROPOSAL: ORIGINAL* AND If hand-delivered or delivery service _____________________________ _____________________________ COPIES TO: COPIES TO: If using U.S. Postal Service *THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES. NOTE: Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address AND delivery to the Bethesda, Maryland address will result in a delayed delivery to our office in Rockville, MD (up to 3 - 5 days). If a proposal is not received at the place, date, and time specified herein, it will be considered a "late proposal." Page 1 of 1 Attachment 1 [A separate CD shall be submitted for the Technical Proposal and Business Proposal information.] HHS-NIH-NIDA(SSSA)-RFP-17-384 PROPOSAL INTENT RESPONSE FORM RFP No: RFP Title: Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation. Choose one of the following Options: Do intend to submit a proposal Do Not intend to submit a proposal If you are not responding to this RFP, please provide your reason(s): Please provide the following contact information: Name (First, Middle Initial, Last): Title: Organization: E-mail: Attachment 2 Page 1 of 8 Attachment 3 - Statement of Work June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection ATTACHMENT 3 STATEMENT OF WORK TITLE: NIMH POSTMORTEM HUMAN BRAIN COLLECTION STATEMENT OF WORK A. GENERAL INFORMATION Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work set forth below. The Contracting Officer's Representative (COR) (previously termed the Government Project Officer), whose position is defined in Section G of the contract, shall monitor the technical aspects of work under the contract. The Contractor shall use state-of-the-art methodologies and protocols to achieve all of the requirements below. B. BACKGROUND INFORMATION The Human Brain Collection Core (HBCC) at the National Institute of Mental Health (NIMH), explores the causes, consequences and potential treatments of numerous neurological and psychiatric disorders. HBCC research is supplemented by studying postmortem brain tissue from both psychiatrically healthy and afflicted individuals in order to establish the neuropathological changes underlying these complex neuropsychological disorders. This research will lead to improved diagnosis, treatment and/or prevention of these illnesses and their consequences. Page 2 of 8 Attachment 3 - Statement of Work June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection C. PURPOSE OR OBJECTIVE OF THE REQUIREMENT 1. The Contractor shall provide contract services to the Human Brain Collection Core (HBCC) at NIMH, to acquire donor specimens for HBCC research purposes during the contract period, based upon the protocol outlined below. The services are to procure human postmortem brain tissue, including various other specimens (dura, hair, blood, pituitary) at autopsy, and provide these specimens to HBCC. The Contractor also provides information contained in the death investigation report and any other medical/toxicological information related to the donor. The donated postmortem human brain specimens will be used for research by the HBCC into the neurobiology of complex mental disorders, and also distributed to approved/qualified outside investigators for research. 2. The objective of this contract is to acquire all available and appropriate donor specimens (according to HBCC inclusion/exclusion criteria) per contract year for inclusion into the NIMH brain bank. Historically sources have referred approximately 200 total cases annually to the HBCC, with an average of 50-60 of these specimens accepted into the repository; however, the HBCC has the capacity to accept up to ~150 specimens per year. 3. The Contractor shall make a good faith effort to identify and refer all appropriate specimens to the NIMH COR for potential consent. The actual donor acquisitions will be reported periodically. D. CONTRACTOR REQUIREMENTS - PROTOCOL On a daily basis, the Contractor shall review case documents for potential donation and determine which cases may be eligible for HBCC research (see below for Page 3 of 8 Attachment 3 - Statement of Work June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection inclusion/exclusion criteria). Eligible cases include t hos e with a reasonable suspicion of a history of mental or neurological illness (particularly schizophrenia), or as non-psychiatric controls across the lifespan. The Contractor shall obtain basic clinical histories from the police detectives or other collateral information to help determine eligibility. Brains from all ages (including children), both sexes, and all races are eligible. 1. Inclusion criteria: a. Brain tissue is needed from individuals suffering from a variety of neuropsychiatric disorders, including schizophrenia, anxiety disorders, suicide, bipolar disorder, depression, and substance use disorders (cocaine, alcohol, heroin or the like). b. In addition, brains from individuals without a history of neuropsychiatric disease will be needed as controls. 2. Exclusion criteria: a. Severe mental retardation. b. Well documented, long lasting seizure disorder. c. Infections known to affect the brain such as syphilis, tuberculosis, with the exception of HIV infection. d. The body is decomposed. We consider collecting the brain up to three days after death. e. There is obvious damage to the brain by closed head injury or other trauma (gunshot wound, fall, etc.). Page 4 of 8 Attachment 3 - Statement of Work June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection f. There are brain infarcts, hemorrhages, tumors, stroke, or other brain lesions that destroy the normal brain structure. g. The patient has been maintained on a respirator (ventilator) for more than 12 hours. h. Major sepsis. i. Serious renal or hepatic disease. j. Multiple sclerosis (MS), Alzheimer's disease and other dementias and degenerative diseases. 3. Once a case is identified/selected, the Contractor shall contact HBCC personnel and provide: 1) the general background of the case (name, demographics, circumstances of death, medical and social history); and 2) the name, relationship and telephone number of the decedent's next-of-kin. 4. HBCC staff will promptly contact the next-of-kin to obtain permission (via a recorded telephone call) to obtain the deceased subject's brain and skull contents for research (including dura, pituitary, and blood and hair sample). HBCC staff will also solicit the release of medical records from decedent's treatment facilities. 5. Extraction and Shipping a. Once permission is obtained by HBCC personnel, the Contractor shall be notified by phone to procure the brain, a hair sample with a small piece of contiguous scalp, and 40cc of blood. The Contractor will begin extraction promptly upon notification of approval from the NIMH; whenever possible, the process should begin within 24 hours of death; unless approved by the NIMH Contracting Officer's Representative Page 5 of 8 Attachment 3 - Statement of Work June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection (COR). The Contractor will provide to the HBCC any relevant documents related to a specimen including cause and manner of death, relevant history and/or toxicology in order to allow optimal characterization of the specimen. b. After extraction, the Contractor shall promptly prepare the specimens for shipping to the NIMH. Shipping will either be performed by the Contractor or through a commercial source, and costs reimbursed through the contract. c. Prior to shipping, the NIMH shall be contacted with shipping details, including the overnight courier tracking number. d. Shipments must be received no later than 12 hours from extraction. In no case will specimens be accepted by NIMH beyond 36 hours after death; a much shorter time period is sought after. e. The Contractor will ensure that specimens are packaged in accordance with all federal, state and local regulations. E. OTHER TERMS 1. The acquisition and supply of all human specimen material used under this contract shall be obtained by the Contractor in full compliance with applicable state and local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. 2. NIMH HBCC will provide to the Contractor neuropathology reports after the examination of the donated cases. Macroscopic reports will be Page 6 of 8 Attachment 3 - Statement of Work June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection provided within ~48 hours from the time of obtaining brain tissues, and microscopic reports will be provided in 2-3 months. 3. No Government property will be provided to the Contractor (e.g., equipment, workspace or computers). 4. The Contractor will not have access to any government facilities. 5. The Contractor shall utilize qualified personnel to perform this contract (i.e., an experienced medical doctor with specialization in forensic pathology). 6. Option to Extend the Term of the Contract If the Government exercises these options in the contract, the Contractor shall perform in accordance with this Statement of Work for any/all option periods. 7. Safety a. The Contractor shall provide personnel with protective garments, equipment, training and sufficient monitoring to assure safe handling of potentially hazardous and infectious materials. The Contractor shall comply with all applicable health and safety regulations while conducting work set forth herein and with HHSAR 352.223-70. All/any subcontractors shall follow the same regulations. The Contractor shall assure that all personnel are properly trained and have adequate expertise for the roles they will serve under this contract. In particular, the Contractor will use trained technicians for quality assurance involved in tissue preparation. Page 7 of 8 Attachment 3 - Statement of Work June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection b. The Contractor shall report any accidents regarding exposure, equipment failure resulting in damage to, or loss of tissues, or violations of ethical code of conduct or other breaches of contract terms immediately to the COR F. REPORTING REQUIREMENTS AND DELIVERABLES In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the DELIVERIES Article in SECTION F of this contract: 1. Technical Progress Reports a. All technical reports shall be submitted to the Contracting Officer's Representative (COR) electronically, in Microsoft Excel or Microsoft Word format for PCs. The Contracting Officer shall also receive electronic copies of all Semi-Annual and the Final Technical Reports, in addition to signed hard copies of each Annual Report and the Final Report. The specific content of technical reports will be determined by the COR, but it is not expected that reports will exceed 1 page in length. If options to extend the term of this contract are exercised, this reporting schedule will continue during any/all contract extensions. b. Scheduled/Recurring Progress Reports (1) Semi-Annual Progress Report(s) Semi Annual Reports shall be submitted to the COR within 15 calendar days after the end of each 6-month contract period. The Semi-Annual Report shall be a summation of the work performed and results obtained for the previous 6-months. Page 8 of 8 Attachment 3 - Statement of Work June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection (2) Annual Report(s) Annual Reports shall be submitted to the COR within 15 calendar days after the end of each 12 - month contract period. This report is to include a summation of the work performed and results obtained for the entire contract year of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. A semi-annual report is not required when an annual report is due. (3) Final Report i. This report is to include a summation of the work performed and results obtained for the entire contract period of performance. ii. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. An Annual report will not be required for the period when the Final Report is due. iii. If options to extend the term of this contract are exercised, Final Reports will be due at the end of the revised/extended period of performance. Page 1 of 2 Attachment 4 - Additional Proposal Instructions June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection ATTACHMENT 4 ADDITIONAL PROPOSAL INSTRUCTIONS TITLE: NIMH POSTMORTEM HUMAN BRAIN COLLECTION Note: this attachment provides clarification/additional information to the RFP instructions in Section L of the RFP. It is important to read Section L, Section M, this attachment, and the Statement of Work to prepare proposals. I. TECHNICAL AND COST/PRICE PROPOSALS A. Technical Proposals  See Section L of the RFP; as discussed, detail your qualifications, experience, personnel, and resources to perform this work, based upon the Statement of Work (Attachment 3) and the Technical Evaluation Criteria (Section M in the RFP). B. Cost/Price Proposals  See Section L of the RFP, and Attachment 8 (Contract Pricing Chart). C. Length of Proposals  The NIH is not interested in lengthy or elaborate proposals, which are difficult for the Government to evaluate and time-consuming for offerors to prepare. A shorter, concise, well-organized proposal is optimal. It is suggested that Technical Proposals be no longer than 10 -15 pages, and Business/Cost Proposals no longer than 5-10 pages, and can be much less as determined by the offeror (single-spaced, double-sided, excluding cover pages, attachments, etc.). Keep in mind that the Government must have sufficient information to do an initial evaluation to rank proposals.  THE INSTRUCTIONS IN SECTION L ARE LENGTHY - THEY ARE GENERATED AUTOMATICALLY BY AN RFP/CONTRACT DOCUMENT SYSTEM FOR A VARIETY OF COMPETITIVE SITUATIONS. QUESTIONS CAN BE ADDRESSED AS SPECIFIED ON THE FACE PAGE OF THIS SOLICITATION. II. OTHER IMPORTANT INFORMATION A. Proposals from States States/jurisdictions that are interested in supporting the NIMH brainbank from multiple collection sites, can include more than one site in a single proposal for a single contract. If this is Page 2 of 2 Attachment 4 - Additional Proposal Instructions June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection proposed, explain how contract administration will be handled and what entity would be the legal offeror. The cost/business proposal should provide a separate cost proposal from each site, and a summary rollup. The Technical Proposal should discuss the qualifications and expertise at each site. B. Evaluation of Proposals 1. Section M in the RFP lists the evaluation factors for award(s). While all proposals will be considered, the Government is less interested in proposals for very small numbers of specimens, or proposals where the organization's location may contribute to very high transportation/shipment costs and longer specimen delivery times. 2. As detailed in Section M of the RFP, proposals will be ranked and awarded based upon a "best value" approach, with a combination of factors considered: Technical Approach 80 Points Perceived Quality of the Specimens Annual Estimated Volume of Referrals Facilities Personnel 20 Points Total 100 Points 3. Other Factors This is a competitive acquisition where cost/price is an important factor in making awards (i.e., a best value approach will be utilized for this acquisition, where technical is paramount but cost is a factor). Cost/price will also dictate the total possible number of awards, based upon a final ranking of proposals received. Also, any comparable past performance providing specimens for research purposes will be considered. Page 1 of 11 [ ] [ ] SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS Updated through FAC 2005-89 Last updated: 07/2016 This SECTION is made up of six parts as follows: 1.Annual Representations and Certifications, FAR 52.204-82.Commercial and Government Entity Code Reporting, FAR 52.204-163.Predecessor of Offeror, FAR 52.204-204.Information Regarding Responsibility Matters, FAR 52.209-75.Cost Accounting Standards6.Certification Regarding Trafficking in Persons Compliance Plan7.Certification Regarding Environmental Tobacco Smoke8.Certification of Institutional on Financial Conflicts of Interest9.Disaster or Emergency Area RepresentationTo Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications: 1.ANNUAL REPRESENTATIONS AND CERTIFICATIONS (APRIL 2016), FAR Provision 52.204-8(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is [insert NAICS code]. i.The Small Business Size Standard is[insert size standard]. ii.The small business size standard for a concern which submits an offer in its own name, other thanon a construction or service contract, but which proposes to furnish a product which it did notitself manufacture, is 500 employees.(b) (1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies. i.If the provision at 52.204-7 is not included in this solicitation, and the offeror is currentlyregistered in System for Award Management (SAM), and Representations and Certificationssection of SAM has completed the Representations and Certifications section of SAM electronically,the offeror may choose to use paragraph (d) of this provision instead of completing thecorresponding individual representations and certifications in the solicitation. The offeror shallindicate which option applies by checking one of the following boxes:(i) Paragraph (d) applies. (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation. [See Individual Representations and Certifications] (c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated: (i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless- Attachment 5 RFP# HHS-NIH-NIDA(SSSA)-RFP-17-384 Page 2 of 11 (A) The acquisition is to be made under the simplified acquisition procedures in Part 13; (B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or (C) The solicitation is for utility services for which rates are set by law or regulation. (ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000. (iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management. (iv) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that- (A) Are not set aside for small business concerns; (B) Exceed the simplified acquisition threshold; and (C) Are for contracts that will be performed in the United States or its outlying areas. (v) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations- Representation. (vi) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold. (vii) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or Felony Conviction under any Federal Law. (viii) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government. (ix) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government. (x) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas. (A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard. (B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard. (xi) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas. (xii) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity. Page 3 of 11 (xii)52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity. (xiii) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items. (xiv)52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts. (xv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA-designated items. (xvi) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1. (xvii) 52.225-4, Buy American--Free Trade Agreements-Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3. (A) If the acquisition value is less than $25,000, the basic provision applies. (B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies. (C) If the acquisition value is $50,000 or more but is less than $79,507, the provision with its Alternate II applies. (D) If the acquisition value is $79,507 or more but is less than $100,000, the provision with its Alternate III applies. (xviii)52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5. (xix) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-- Certification. This provision applies to all solicitations. (xx) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certification. This provision applies to all solicitations. (xxi) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions. Page 4 of 11 (2) The following certifications are applicable as indicated by the Contracting Officer: [Contracting Officer check as appropriate.] (i) 52.204-17, Ownership or Control of Offeror (ii) 52.204-20, Predecessor of Of feror (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products. (iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification. (v) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification. (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Alternate I only). (vii)52.227-6, Royalty Information. (A) Basic. (B) Alternate I. (viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software. (d) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://sam.gov. After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. FAR Clause No. Title Date Change Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representationsand certifications posted on SAM. (End of Provision) Page 5 of 11 2. COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING, (JUL 2016) FAR Provision 52.204-16 Note to Offeror: This provision is incorporated by reference and is applicable when the resultant contract will contain FAR Provision 52.204-6 or FAR Provision 52.204-7. 3. PREDECESSOR OF OFFEROR, (JUL 2016) FAR Provision 52.204-20 (a) Definitions. As used in this provision- Commercial and Government Entity (CAGE) code means- (1) An identifier assigned to entities located in the United States and its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity; or (2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by NATO's Support Agency (NSPA) to entities located outside the United States and its outlying areas that DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as an NCAGE code. Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor. Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances. (b) The Offeror represents that it is or is not a successor to a predecessor that held a Federal contract or grant within the last three years. (c) If the Offeror has indicated "is" in paragraph (b) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order): Predecessor CAGE code: ____ (or mark "Unknown"). Predecessor legal name: ____. (Do not use a "doing business as" name). (End of provision) 4. INFORMATION REGARDING RESPONSIBILITY MATTERS, (JUL 2013) FAR Provision 52.209-7 Note to Offeror: This provision is applicable when the resultant contract is expected to exceed $500,000. (a) Definitions. As used in this provision- Page 6 of 11 [ ] [ ] Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables. Federal contracts and grants with total value greater than $10,000,000 means-- (1) The total value of all current, active contracts and grants, including all priced options; and (2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multipleaward Schedules). Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions). (b) The offeror has does not have current active Federal contracts and grants with total value greater than $10,000,000. (c) If the offeror checked "has" in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information: (1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions: (i) In a criminal proceeding, a conviction. (ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more. (iii) In an administrative proceeding, a finding of fault and liability that results in- (A) The payment of a monetary fine or penalty of $5,000 or more; or (B) The payment of a reimbursement, restitution, or damages in excess of $100,000. (iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision. (2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence. Page 7 of 11 (d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database at www.acquisition.gov (see 52.204-7). 5. COST ACCOUNTING STANDARDS (1) Cost Accounting Standards Notices and Certification (October 2015), FAR Provision 52.230-1 Note: This notice does not apply to small businesses or foreign governments. This notice is in three parts, identified by Roman numerals I through III. Offerors shall examine each part and provide the requested information in order to determine Cost Accounting Standards (CAS) requirements applicable to any resultant contract. If the offeror is an educational institution, Part II does not apply unless the contemplated contract will be subject to full or modified CAS-coverage pursuant to 48 CFR 9903.201- 2(C)(5) or 9903.201-2(c)(6), respectively. I. Disclosure Statement -- Cost Accounting Practices and Certification (a) Any contract in excess of $750,000 resulting from this solicitation will be subject to the requirements of the Cost Accounting Standards Board (48 CFR Chapter 99), except for those contracts which are exempt as specified in 9903.201-1. (b) Any offeror submitting a proposal which, if accepted, will result in a contract subject to the requirements of 48 CFR Chapter 99 must, as a condition of contracting, submit a Disclosure Statement as required by 9903.202. When required, the Disclosure Statement must be submitted as a part of the offeror's proposal under this solicitation unless the offeror has already submitted a Disclosure Statement disclosing the practices used in connection with the pricing of this proposal. If an applicable Disclosure Statement has already been submitted, the offeror may satisfy the requirement for submission by providing the information requested in paragraph (c) of Part I of this provision. CAUTION: In the absence of specific regulations or agreement, a practice disclosed in a Disclosure Statement shall not, by virtue of such disclosure, be deemed to be a proper, approved, or agreed-to practice for pricing proposals or accumulating and reporting contract performance cost data. Page 8 of 11 [ ] [ ] [ ] (c) Check the appropriate box below: (1) Certificate of Concurrent Submission of Disclosure Statement. The offeror hereby certifies that, as part of the offer, copies of the Disclosure Statement have been submitted as follows: (i) original and one copy to the cognizant Administrative Contracting Officer (ACO), or cognizant Federal agency official authorized to act in that capacity (Federal official), as applicable, and; (ii) one copy to the cognizant Federal auditor. (Disclosure must be on Form No. CASB DS-1 or CASB DS-2, as applicable.. Forms may be obtained from the cognizant ACO or Federal official and/or from the looseleaf version of the Federal Acquisition Regulation). Date of Disclosure Statement: Name and Address of Cognizant ACO or Federal Official Where Filed: _ The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the Disclosure Statement. (2) Certificate of Previously Submitted Disclosure Statement. The offeror hereby certifies that the required Disclosure Statement was filed as follows: Date of Disclosure Statement: Name and Address of Cognizant ACO or Federal Official Where Filed: The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the applicable Disclosure Statement. (3) Certificate of Monetary Exemption. The offeror hereby certifies that the offeror together with all divisions, subsidiaries, and affiliates under common control, did not receive net awards of negotiated prime contracts and subcontracts subject to CAS totaling more than $50 million or more in the cost accounting period immediately preceding the period in which this proposal was submitted. The offeror further certifies that if such status Page 9 of 11 [ ] [ ] [ ] [ ] changes before an award resulting from this proposal, the offeror will advise the Contracting Officer immediately. (4) Certificate of Interim Exemption. The offeror hereby certifies that: (i) the offeror first exceeded the monetary exemption for disclosure, as defined in (3) of this subsection, in the cost accounting period immediately preceding the period in which this offer was submitted, and (ii) in accordance with 48 CFR 9903.202-1, the offeror is not yet required to submit a Disclosure Statement. The offeror further certifies that if an award resulting from this proposal has not been made within 90 days after the end of that period, the offeror will immediately submit a revised certificate to the Contracting Officer, in the form specified under subparagraph (c)(1) or (c)(2) of Part I of this provision, as appropriate, to verify submission of a completed Disclosure Statement. CAUTION: Offerors currently required to disclose because they were awarded a CAS- covered prime contract or subcontract of $50 million or more in the current cost accounting period may not claim this exemption (4). Further, the exemption applies only in connection with proposals submitted before expiration of the 90-day period following the cost accounting period in which the monetary exemption was exceeded. (5) Certificate of Disclosure Statement Due Date by Educational Institution. (ALTERNATE I - April 1996) If the offeror is an educational institution that, under the transition provisions of 48 CFR 9903- 202-1(f), is or will be required to submit a Disclosure Statement after receipt of this award, the offeror hereby certifies that (check one and complete): (i) A Disclosure Statement filing Due Date of _ has been established with the cognizant Federal agency. (ii) The Disclosure Statement will be submitted within the 6-month period ending _ months after receipt of this award. Name and Address of Cognizant ACO or Federal Official Where Filed: Page 10 of 11 [ ] [ ] [ ] [ ] [ ] II. Cost Accounting Standards-Eligibility for Modified Contract Coverage If the offeror is eligible to use the modified provisions of 48 CFR 9903.201-2(b) and elects to do so, the offeror shall indicate by checking the box below. Checking the box below shall mean that the resultant contract is subject to the Disclosure and Consistency of Cost Accounting Practices clause in lieu of the Cost Accounting Standards clause. The offeror hereby claims an exemption from the Cost Accounting Standards clause under the provisions of 48 CFR 9903.201-2(b) and certifies that the offeror is eligible for use of the Disclosure and Consistency of Cost Accounting Practices clause because during the cost accounting period immediately preceding the period in which this proposal was submitted, the offeror received less than $50 million in awards of CAS-covered prime contracts and subcontracts. The offeror further certifies that if such status changes before an award resulting from this proposal, the offeror will advise the Contracting Officer immediately. CAUTION: An offeror may not claim the above eligibility for modified contract coverage if this proposal is expected to result in the award of a CAS-covered contract of $50 million or more or if, during its current cost accounting period, the offeror has been awarded a single CAScovered prime contract or subcontract of $50 million or more. III. Additional Cost Accounting Standards Applicable to Existing Contracts The offeror shall indicate below whether award of the contemplated contract would, in accordance with subparagraph (a)(3) of the Cost Accounting Standards Clause, require a change in established cost accounting practices affecting existing contracts and subcontracts. YES NO (2) Proposal Disclosure-Cost Accounting Practice Changes, (March 2005)(FAR Provision 52.230-7) The offeror shall check "yes" below if the contract award will result in a required or unilateral change in cost accounting practice, including unilateral changes requested to be desirable changes. YES NO If the offeror checked "Yes" above, the offeror shall- (1) Prepare the price proposal in response to the solicitation using the changed practice for the period of performance for which the practice will be used; and (2) Submit a description of the changed cost accounting practice to the Contracting Officer and the Cognizant Federal Agency Official as pricing support for the proposal. Page 11 of 11 6. CERTIFCATION REGARDING TRAFFICKING IN PERSONS COMPLIANCE PLAN (March 2015), FAR Provision 52-222-56 Note to offeror: This provision is applicable when services will be performed outside of the United States; and the estimated value exceeds $500,000. (a) The term "commercially available off-the-shelf (COTS) item," is defined in the clause of this solicitation entitled "Combating Trafficking in Persons" (FAR clause 52.222-50). (b) The apparent successful offeror shall submit, prior to award, a certification, as specified in paragraph (c) of this provision, for the portion (If any) of the contract that- (1) Is for supplies, other than commercially available off-the-shelf, to be acquired outside of the United States, or services to be performed outside the United States; and (2) Has an estimated value that exceeds $500,000. (c) The certification shall state that- 7. It has implemented a compliance plan to prevent any prohibited activities identified in paragraph (b) of the clause at 52.222-50, Combating Trafficking in Persons, and to monitor, detect, and terminate the contract with a subcontractor engaging in prohibited activities identified at paragraph (b) of the clause at 52.222-50, Combating Trafficking in Persons; and 8. After having conducted due diligence, either- (a) To best of the offeror's knowledge and belief, neither it nor any of its proposed agents, subcontractors, or their agents is engaged in any such activities; or (b) If abuses relating to any of the prohibited activities identified in 52.222-50(b) have been found, the offeror or proposed subcontractor has taken the appropriate remedial and referral actions. (End of Provision) 6. CERTIFICATION REGARDING ENVIRONMENTAL TOBACCO SMOKE (December 1994) Public Law 103-227, also known as the Pro-Children Act of 1994 (Act), requires that smoking not be permitted in any portion of any indoor facility owned or leased or contracted for by an entity and used routinely or regularly for the provision of health, day care, early childhood development services, education or library services to children under the age of 18, if the services are funded by Federal programs either directly or through State or local governments, by Federal grant, contract, loan, or loan guarantee. The law also applies to children's services that are provided in indoor facilities that are constructed, operated, or Page 10 of 11 maintained with such federal funds. The law does not apply to children's services provided in private residences; portions of facilities used for inpatient drug or alcohol treatment; service providers whose sole source of applicable federal funds is Medicare or Medicaid; or facilities where WIC coupons are redeemed. Failure to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up to $1,000 for each violation and/or the imposition of an administrative compliance order on the responsible entity. By submission of its signed offer, the offeror/contractor (for acquisitions) or applicant/grantee (for grants) certifies that the submitting organization will comply with the requirements of the Act and will not allow smoking within any portion of any indoor facility used for the provision of services for children as defined by the Act. The submitting organization agrees that it will require that the language of this certification be included in any subawards which contain provisions for children's services and that all subrecipients shall certify accordingly. 7. CERTIFICATION OF INSTITUTIONAL POLICY ON FINANCIAL CONFLICTS OF INTEREST Note: This certification is applicable to all Research and Development (R&D) Contracts except Phase I SBIR/STTR and Contracts with Federal Agencies. By Submission of its signed offer, the offeror certifies that: (1) there is in effect at the Institution (the term Institution includes any contractor, public or private, excluding a Federal agency) an up-to-date, written and enforced administrative process to identify and manage, financial conflicts of interest with respect to all research projects for which funding is sought or received from the NIH; (2) the Institution shall promote and enforce Investigator compliance with this part's requirements including those pertaining to disclosure of significant financial interests; (3) the Institution shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to NIH consistent with this part; (4) the Institution agrees to make information available, promptly upon request, to the Contracting Officer relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of a financial conflict of interest; and (5) the Institution shall fully comply with the requirements of 45 CFR Part 94. 8. DISASTER OR EMERGENCY AREA REPRESENTATION, (Aug 2006), FAR Provision 52.226-3 Note: This provision is applicable for acquisitions that are set-aside for a Disaster or Emergency Area under FAR Subpart 26.2. See Section L.1. of the Solicitation, paragraph entitled "Notice of Disaster or Emergency Area Set-Aside." a. Set-aside area. The area covered in this contract is: _ [Contracting Officer to fill in with definite geographic boundaries.] Page 11 of 11 b. Representations. The offeror represents as part of its offer that it [ ] is, [ ] is not a firm residing or primarily doing business in the designated area. c. Factors to be considered in determining whether a firm resides or primarily does business in the designated area include- (1) Location(s) of the firm's permanent office(s) and date any office in the designated area(s) was established; (2) Existing state licenses; (3) Record of past work in the designated area(s) (e.g., how much and for how long); (4) Number of permanent employees the firm employs in the designated area; (5) Membership in local and state organizations in the designated area; and (6) Other evidence that establishes the firm resides or primarily does business in the designated area. (e) If the offeror represents it is a firm residing or primarily doing business in the designated area, the offeror shall furnish documentation to support its representation if requested by the Contracting Officer. The solicitation may require the offeror to submit with its offer documentation to support the representation. (End of Provision) Page 1 of 3 Attachment 8 - Contract Pricing Chart June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection ATTACHMENT 8 CONTRACT PRICING CHART NIMH POSTMORTEM HUMAN BRAIN COLLECTION Assumptions/Proposal Instructions for Estimating the Volume of Case Referrals, Donations, and Associated Costs 1. Offerors will need to calculate/estimate the number of contract referrals and donations, and the associated costs and effort to provide all contract services. Read the Statement of Work carefully to understand the scope of services. 2. Based upon the Government's historical data from two (2) MEO NIMH contract sources, the Government has received a total of ~165 referred cases/yr., where ~58 consents to donate/yr. were obtained by NIMH; each of these sites performed in the range of 600 - 800 total autopsies per year. (This data varies each year, but is provided as information for offerors.) 3. It is assumed that the total number of autopsies may be somewhat indicative of the total possible referrals and subsequent donations. 4. It is understood that estimating referrals and donations is difficult and will vary from year to year, and that the Contractor has no control over the number of cases presented for autopsy, or those that may be suitable for inclusion into the NIMH brainbank. However, based upon some historical data, the NIMH has presented some statistics/metrics below that may help. 5. In the chart below use your historical data on autopsies as a basis to estimate/project: a. the annual number of referrals that may meet the inclusion criteria in the Statement of Work; Page 2 of 3 Attachment 8 - Contract Pricing Chart June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection b. the number of consents for donation; and c. your associated annual costs (including estimated contract hours involved in referrals, extractions, and shipments, and communications with NIMH. 6. The estimated number of donations will involve actual extractions and shipments. While the necessary extraction effort will be intermittent, review of autopsy cases and referrals to NIMH are more regular and on-going activities. 7. Use current labor rates and other costs, fringe benefit rates/costs, indirect rates/costs, etc., and assume the same level of services/effort each year, with only out-year increases for salary, etc. (as applicable); Justification 8. It is important to provide a narrative discussion of how costs/prices were developed (i.e., the basis of the estimate) in the cost/business proposal (e.g., how the labor effort was estimated, how indirect costs were estimated, etc.?) 9. Provide supporting source documentation for proposed costs/prices (i.e., salaries, indirect costs, and other direct costs). Shipping 10. The estimated cost for shipping should be based upon a written quote/estimate from a commercial supplier (submit with proposal). Total yearly cost will be based upon the estimated number of extractions, with escalation each year (as applicable). Page 3 of 3 Attachment 8 - Contract Pricing Chart June 8, 2017 HHS-NIH-NIDA(SSSA)-RFP-17-384 NIMH Postmortem Human Brain Collection Complete the following chart and return with your Cost/Business Proposal: CONTRACT PRICING CHART Services and Costs Base Year 1 Option Year 2 Option Year 3 Option Year 4 Option Year 5 Totals Volume of Services (Estimated Metrics) 1. No. of Autopsies/yr. 2. Case Referrals: (assume 12% of autopsies) 3. Consents Donations/consents obtained by NIMH (assume 35% of referrals) Costs/Labor Hours 1. Direct Labor $ $ $ $ $ $ (Labor Hours) 2. Other Direct Costs (list) $ $ $ $ $ $ 3. Indirect Costs $ $ $ $ $ $ 4. Total Yearly Cost (for referrals, extractions, communications with NIMH, reporting, etc.) $ $ $ $ $ $ 5. Cost of Shipments to NIMH (based upon estimated # of donations) $ $ $ $ $ $ 6. Grand Totals (Sum of 4. and 5. above) $ $ $ $ $ $
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A -- NIMH POSTMORTEM HUMAN BRAIN COLLECTION - Request for Proposal