RFP-NIH-NICHD-OER-2020-10 Live TOC.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority:

2. Request for Proposal (RFP) Number:

NIH-NICHD-OER-2020-10

3. Issue Date:

June 26, 2020

4. Set Aside:

[ ] No

[X] Yes See Part IV Section L

5. Title : Needs Assessments for HHS/NIH SBIR/STTR

6. ISSUED BY:

Office of Acquisitions Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 2 PM local time on July 27, 2020. Offers will be valid for 120 days unless a different period is specified by 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 DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF 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 THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--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. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Jeremy White, Contracting Officer

PHONE: 301-402-4572

e-MAIL: jeremy.white@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Questions regarding this Request for Proposal will be accepted until July 14, 2020. Only written questions will be accepted. Send any questions to jeremy.white@nih.gov. All responses will be provided by an amendment to this solicitation.

Jeremy White Contracting Officer Office of Acquisitions http://www.sam.gov

RFP Number : NIH-NICHD-OER-2020-10

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NOTICE OF SMALL BUSINESS SET-ASIDE

c. NAICS CODE AND SIZE STANDARD

d. TYPE OF CONTRACT AND NUMBER OF AWARDS

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Standards for Privacy of Individually Identifiable Health Information

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

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11. Certification of Filing and Payment of Taxes

12. Past Performance Information

13. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. HUBZone Small Business Concerns

5. Total Compensation Plan

6. Other Administrative Data

7. Qualifications of the Offeror

8. Subcontractors

9. Proposer's Annual Financial Report

10. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION FACTORS

5. PAST PERFORMANCE FACTOR

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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

This solicitation is seeking services to provide Needs Assessment Reports that prioritize the technical and business needs of selected companies that are developing products/services with HHS/NIH SBIR/STTR funding.

ARTICLE B.2. PRICES

1. The total fixed price of this contract is $ .

2. 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:

SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD

Description of Item Quantity (Units)

Unit Price($) Total ($)

Needs Assessments 400

ARTICLE B.3. OPTION PRICES

1. 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.

2. Pursuant to FAR Clause 52.217-9 set forth in ARTICLE I.3. ADDITIONAL 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.

3. Upon the delivery and acceptance of the Option Itemsdescribed 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:

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Option Period Description of Option Items

Quantity Minimum Unit Price Total Price of Option

Option Period 1 Needs Assessments

Option Period 2 Needs Assessments

Option Period 3 Needs Assessments

Option Period 4 Needs Assessments

4. Pursuant to FAR Clause 52.217-6 set forth in ARTICLE I.3. ADDITIONAL 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.

5. Upon the delivery and acceptance of the Option Items described 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:

Period Description Optional Quantity Unit Price Total Price of Option

Option Period 1 Needs Assessments

Option Period 2 Needs Assessments

Option Period 3 Needs Assessments

Option Period 4 Needs Assessments

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific 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.

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SECTION C - DESCRIPTION

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 26, 2020, 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. All those reports and deliverables noted as to be delivered via NICHD Contracts Portal shall be submitted through said system. All deliverables submitted through the NICHD Contracts Portal shall be submitted at hte following website: https://contracts.nichd.nih.gov. The Contractor must provide the name of the person(s) submitting electronic reports via the NICHD COntracts Portal to the Contrating Officer in order to initiate access to the Portal.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, 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.]

[X] Monthly [ ] Quarterly [ ] Semi-Annually [ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] 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. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

https://contracts.nichd.nih.gov http://www.hhs.gov/web/508/index.html

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45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/ contracting/technology/vendors.html under "Vendor Information and Documents."

http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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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, To be Announced Upon Award is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Office of Extramural Research National Institutes of Health 6705 Rockledge Drive Rockledge One Bethesda, Maryland 20892

Acceptance 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).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

1. The period of performance of this contract shall be from September 1, 2020 through August 31, 2021.

2. 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 Period Option Period 1 September 1, 2021 - August 31, 2022 Option Period 2 September 1, 2022 - August 31, 2023 Option Period 3 September 1, 2023 - August 31, 2024 Option Period 4 September 1, 2024 - August 31, 2025

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final 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 items in accordance with the stated delivery schedule found in Section J, Attachment 3, "Reporting Requirements/Deliverables".:

1. Deliveries of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b.

DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract.

2. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above Mondays through Fridays (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EST only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

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 applicable to this contract.

52.242-17, Government Delay of Work (April 1984).

https://www.acquisition.gov/?q=browsefar

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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 announced at time of 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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.]

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.

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

TBD Project Manager

TBD Medical Product Regulation Subject Matter Expert

(SME)

TBD Life Science Industry Market Research SME

TBD Life Science Industry Business Development SME

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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.

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

Room

MSC

E-mail:

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."]

Central Point of Distribution:

The Contractor shall submit an electronic copy of the payment request to the Central Point of Distribution mailbox. 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."]

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.

ARTICLE G.4. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real

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ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

1. 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 within 30 days of the end of the contract period.

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.

2. 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 http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://www.cpars.gov

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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. 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.3. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.4. PRIVACY ACT, HHSAR 352.224-70 (December 2015)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations.

The term "system of records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)).

The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in CFR 45 part 5b and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement:

(a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform;

and

(b) specifies the disposition to be made of such records upon completion of contract performance.

ARTICLE H.5. 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 52.217-6, Option for Increased Quantity ; FAR Clause 52.217-8, Option to Extend Services; or 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.

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ARTICLE H.6. ACCESS TO NATIONAL INSTITUTES OF HEALTH (NIH) ELECTRONIC MAIL

All Contractor staff that have access to and use of NIH electronic mail (e-mail) must identify themselves as contractors on all outgoing e-mail messages, including those that are sent in reply or are forwarded to another user. To best comply with this requirement, the Contractor staff shall set up an e-mail signature ("AutoSignature") or an electronic business card ("V-card") on each Contractor employee's computer system and/or Personal Digital Assistant (PDA) that will automatically display "Contractor" in the signature area of all e-mails sent.

ARTICLE H.7. 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.

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:

TBD

ARTICLE H.8. 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 http://oig.hhs.gov/fraud/hotline/

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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

https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors

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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 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.

b. Alternate I (February 2002), of FAR Clause 52.232-25, Prompt Payment (Jan 2017)

c. Alternate I (April 1984) of FAR Clause 52.243-1, Changes, Fixed Price (August 1987), is hereby deleted in its entirety and Alternate II (April 1984) of FAR Clause 52.243-1, Changes, Fixed Price (August 1987), is substituted therefor.

d. FAR Clause 52.249-4, Termination for Convenience of the Government (Services) (Short Form) (April 1984), is deleted in its entirety and FAR Clause 52.249-2, Termination for Convenience of the Government (Fixed Price) (April 2012) is substituted therefor.

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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 52.203-13, Contractor Code of Business Ethics and Conduct (October 2015).

2. FAR Clause 52.203-14, Display of Hotline Poster(s) (October 2015).

".....(3) Any required posters may be obtained as follows:

Poster(s) Obtain From"

HHS Contractor Code of Ethics and Business Conduct Poster http://oig.hhs.gov/fraud/report-fraud/OIG_Hotline_Poster.pdf

3. FAR Clause 52.204-14, Service Contract Reporting Requirements (October 2016).

4. FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations (November 2015).

5. FAR Clause 52.210-1, Market Research (April 2011).

6. FAR Clause 52.217-6, Option for Increased Quantity (March 1989).

"....The Contracting Officer may exercise the option by written notice to the Contractor within 30 days ...."

7. FAR Clause 52.217-7, Option for Increased Quantity - Separately Priced Line Item (March 1989).

"....The Contracting Officer may exercise the option by written notice to the Contractor within 30 days ...."

8. 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 .

9. FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (October 2014).

"(c) Waiver of evaluation preference [ ] Offeror elects to waive the evaluation preference."

http://oig.hhs.gov/fraud/report-fraud/OIG_Hotline_Poster.pdf http://oig.hhs.gov/fraud/report-fraud/OIG_Hotline_Poster.pdf

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10. FAR Clause 52.219-6, Notice of Total Small Business Set-Aside (November 2011).

Alternate I (November 2011) is not applicable to this contract.

Alternate II (November 2011) is not applicable to this contract.

11. FAR Clause 52.219-14, Limitations on Subcontracting (November 2011).

12. FAR Clause 52.227-14, Rights in Data - General (May 2014).

13. FAR Clause 52.232-18, Availability of Funds (April 1984).

14. FAR Clause 52.237-3, Continuity of Services (January 1991).

15. FAR Clause 52.244-5, Competition in Subcontracting (December 1996).

16. FAR Clause 52.245-1, Government Property (Jan 2017).

17. FAR Clause 52.245-9, Use and Charges (April 2012).

18. FAR Clause 52.251-1, Government Supply Sources (April 2012).

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER

3) CLAUSES:

1. HHSAR Clause 352.208-70, Printing and Duplication (December 2015)

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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 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (June 2016)

a. Definitions . As used in this clause--

"Covered contractor information system" means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

"Federal contract information" means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

"Information" means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

"Information system" means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

"Safeguarding" means measures or controls that are prescribed to protect information systems.

b. Safeguarding requirements and procedures.

1. The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

i. Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

ii. Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

iii. Verify and control/limit connections to and use of external information systems.

iv. Control information posted or processed on publicly accessible information systems.

v. Identify information system users, processes acting on behalf of users, or devices.

vi. Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

vii. Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

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viii. Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

ix. Escort visitors and monitor visitor activity; maintain audit logs of physical access;

and control and manage physical access devices.

x. Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

xi. Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

xii. Identify, report, and correct information and information system flaws in a timely manner.

xiii. Provide protection from malicious code at appropriate locations within organizational information systems.

xiv. Update malicious code protection mechanisms when new releases are available.

xv. Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

2. Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

c. Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial items, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

2. FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (July 2013)

As prescribed in 9.104-7(c), insert the following clause:

a. The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the System for Award Management (SAM) database at http://www.acquisition.gov.

b. As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub. L. 111-212), all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two segments--

1. The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by--

i. Government personnel and authorized users performing business on behalf of the Government; or http://www.acquisition.gov/

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ii. The Contractor, when viewing data on itself; and

2. The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for--

i. Past performance reviews required by subpart 42.15;

ii. Information that was entered prior to April 15, 2011; or

iii. Information that is withdrawn during the 14-calendar-day waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

c. The Contractor will receive notification when the Government posts new information to the Contractor's record.

1. If the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within 7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable information. The contractor must cite 52.209-9 and request removal within 7 calendar days of the posting to FAPIIS.

2. The Contractor will also have an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained, i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

3. As required by section 3010 of Pub. L. 111-212, all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available.

d. Public requests for system information posted prior to April 15, 2011, will be handled under Freedom of Information Act procedures, including, where appropriate, procedures promulgated under E.O. 12600.

(End of clause)

3. FAR Clause 52.217-9, Option to Extend the Term of the Contract (March 2000).

1. The Government may extend the term of this contract by written notice to the Contractor within 60 days ; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60days before the contract expires. The preliminary notice does not commit the Government to an extension.

2. If the Government exercises this option, the extended contract shall be considered to include this option clause.

3. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66 months[MONTHS/YEARS].

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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)

Attached at end of document

Attachment 2: Statement of Work Attached at end of document

Attachment 3: Reporting Requirements/Deliverables Attached at end of document

Attachment 4: Section K - Representations, Certifications, and Other Statements of Offerors http://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files

TECHNICAL PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 5: Technical Proposal Cost Summary http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/Tech-Prop-Cost- Summ.pdf

Attachment 6: Summary of Related Activities http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/summary-related-activities.pdf

Attachment 7: HHS Section 508 Product Assessment Template http://www.hhs.gov/web/508/contracting/ technology/vendors.html

Attachment 8: Additional Technical/Business Proposal Instructions

Attached at end of document

BUSINESS PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 9: Proposal Summary and Data Record, NIH-2043 http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/NIH2043.pdf

Attachment 10: Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/ sites/default/files/DFASDocs/ buscntrctprpslsprdsht08-2014_508.xlsx

Attachment 11: Offeror's Points of Contact http://oamp.od.nih.gov/sites/default/files/ DGS/contracting-forms/point-of-contact.pdf

Attachment 12: Disclosure of Lobbying Activities, OMB Form SF-LLL http://www.gsa.gov/portal/forms/ download/116430 http://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files http://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/NIH2043.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/NIH2043.pdf https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/point-of-contact.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/point-of-contact.pdf http://www.gsa.gov/portal/forms/download/116430

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INFORMATIONAL ATTACHMENTS

Attachment No. Title Location

Attachment 13: 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 14: Disclosure of Lobbying Activities, OMB Form SF-LLL http://www.gsa.gov/portal/forms/ download/116430 http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/rc2_508.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/rc2_508.pdf

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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)…