75N95020Q00006.pdf

COMBINED SYNOPSIS / SOLICITATION-COMPETITIVE

Title: Small Business Innovation Research Professional Support Services Issuing Organization: National Institute on Drug Abuse (NIDA)

NAICS CODE: 541990

RFP Number: 75N95020Q00006

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N95020Q00006and the solicitation is issued as a Request for Proposal (RFP) as a total set aside for small business vendors.

In accordance with FAR 12.102(b), this acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 15—Contracting by Negotiation and FAR Part 12—Acquisition of Commercial Items. This requirement is expected to exceed the simplified acquisition threshold. A fixed-price type of contract is contemplated for this requirement.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-05 / 03-30-2020.

(iv) The North American Industry Classification System (NAICS) code for this procurement is 541990 – All Other Professional, Scientific, and Technical Services with associated small business size standard of $15 Million.

Award for this requirement will be contingent on the availability of funds (See FAR 52.232-18, Availability of Funds – April 1984). This RFP does not commit the Government to pay the costs for offerors to prepare and submit a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds on any resulting contract.

All responsible small business sources may submit a proposal which shall be considered by the Government.

(v) The following describes the list of line item number(s) and items, quantities, and units of measure (including option(s), if applicable). Offerors can use the below in submitting its price.

a. The total fixed price of the base period (year 1) of this contract is $ _____________.

b. Upon presentation of a proper invoice and delivery and acceptance of the item(s) and/or service(s) described in the Statement of Work and the deliverables of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor as set forth in the following payment schedule:

PAYMENT SCHEDULE (CONTRACT YEAR 1)

Item(s) Item

Description Price ($) Total ($)

1 -11 Monthly Progress Report (Months 1-11)

Final Report (becomes annual report if options are exercised)

c. Unless the Government exercises its option(s) pursuant to FAR Clause 52.217-9/Option to Extend, this contract consists only of the Base Period specified in the Statement of Work for the price set forth in the chart above.

d. Pursuant to FAR Clause 52.217-7, Option for Increased Quantity- Separately Priced Line Item, and FAR Clause 52.217-9 Option to Extend the Term of the Contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) and Option Quantities specified in the Statement of Work. 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 xiii of this solicitation. The fixed price of this contract will be increased as set forth in paragraph e., below.

e. Upon presentation of a proper invoice and delivery and acceptance of the item(s) and/or service(s) described in the Statement of Work and the deliverables of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor as set forth in the following payment schedule:

PAYMENT SCHEDULE (CONTRACT YEARS 2 and 3 – if options are exercised) Item(s) Item

Description Price ($) Total ($)

13-23 Monthly Progress Report (Months 13- 23)

Final Report (becomes annual report if options are exercised)

25-35 Monthly Progress Report (Months 25- 35)

Item(s) Item Description

Price ($) Total ($)

36 Final Report

(vi) Project Requirements:

Please see the attached Statement of Work for further details regarding project requirements.

(vii) Date(s) and Place(s) of delivery, acceptance, and FOB point

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.

The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided. For the purpose of this SECTION, the Contracting Officer's Representative is the authorized representative of the Contracting Officer.

All deliverables shall be submitted in electronic format by email, unless directed otherwise by the

NIDA COR.

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

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).

(viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

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, price, and past performance. Although technical factors are of paramount consideration in the award of the contract, price and past performance are also important to the overall contract award decision. All evaluation factors other than price, when combined, are significantly more important than price. The Government intends to make an award 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.

The evaluation factors are used when reviewing the technical proposals. The factors below are listed with weights assigned to indicate relative importance for evaluation purposes, i.e., a higher weight indicates higher importance.

NOTE: The Contract’s proposal must include detailed resume as this will be the primary document evaluated. Separate Business and Technical Proposals are required.

Factor 1. Key personnel professional experience in developing NIH SBIR and STTR programs (40 points).

We will evaluate key personnel proposed for length and breadth of demonstrated business development experience in life sciences for the small business research programs, specifically, for NIH SBIR and STTR. We will evaluate key personnel proposed for productivity and success in the SBIR and STTR business development role.

We will evaluate key personnel professional experience for preparation of reports, presentations, analyses, marketing and outreach materials and work on product development. In addition, we will evaluate experience showing use of expertise to identify or anticipate problems early, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources.

We will evaluate key personnel experience with NIH databases for efforts involving familiarity and proficiency. Examples of these include, but are not limited to, the NIH Query/View/Report System (QVR), the NIH Research Portfolio Online Reporting Tools (NIH REPORTER), the Scientific Publication Information Retrieval & Evaluation System (SPIRES), and expertise with exceptional use of Microsoft Excel, PowerPoint, Publisher and various publishing tools for animated presentations and animated videos.

Factor 2. Key personnel education and certifications (30 points)

We will evaluate key personnel proposed for conformance to the key personnel qualifications identified in the statement of work as well as for additional education and certifications related to the statement of work requirements. We will evaluate advanced education and certifications, as well as other evidence of advanced expertize applicable to business development in life sciences.

Factor 3. Key personnel collaborative team experience (30 points)

We will evaluate key personnel proposed for length and breadth of demonstrated experience collaborating with multi-disciplinary teams.

Price Evaluation

Offerors price quote 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. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable.

Offeror shall provide a technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. Offerors may also submit such things as product literature, product samples (if requested), technical features and warranty provisions.

The Offeror is to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer.

Past Performance Evaluation

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.

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.

The Key personnel proposed shall provide at least two (2) past performance references with knowledge of contractor’s relevant skills and experiences related to the requirements outlined in the statement of work. References should include the following information:

a) Name of organization

b) Brief description of contractor responsibilities

c) Point of contact name, title and telephone number

Past performances shall be evaluated for relevance to the current requirements as well as customer satisfaction in reference to the following:

1) interpersonal skills

2) attention to detail

3) computer and software literacy

4) writing communication and presentation skills

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).

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(x) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications Commercial Items, applies to this acquisition. Offerors MUST include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with their offer, OR provide a copy of the valid certifications registrations and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet.

In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

http://www.sam.gov/

(xi) The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xi) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items, applies to this acquisition. The provisions are attached to this solicitation.

(xii) Additional Contract Requirement(s) or terms and conditions:

FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor

FAR Clause 52.227-17, Rights in Data--Special Works (December 2007)

FAR Clause 52.217-7 Option for Increased Quantity-Separately Priced Line Item.

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 15 days of the contract expiration. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

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 prior to contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 5 days 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 3 years.

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 in contract 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.

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

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

2. Two copies of the invoice shall be submitted electronically to the following approving official:

The NIDA Contracting Officer

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 R&D Contracts Management Branch.

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.

d. Invoice Matching Option. This contract requires a two-way match.

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: Small Business Innovation Research Professional Support Services

g. Contract Line Items as follows:

Line Item # Line Item Description

3. TBD

PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (December 2013)

Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

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 following the anniversary date of contract award, if options are exercised.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted fourteen 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.

f. 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

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 http://www.cpars.gov/ 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.

(End of clause)

45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at:

http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.

The Privacy Act System of Records applicable to this project is Number 09-25-0200. This document is incorporated into this contract as an Attachment in SECTION J of this contract.

This document is also available at:

http://oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm.

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 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 .

Electronic and Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

a. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

b. Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508 . The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and standards/communications-and-it/about-the-section-508-standards .

COMMUNICATIONS MATERIALS AND SERVICES

To build and maintain public trust; promote credibility and consistency; minimize consistency and frustration; and contribute to efforts aimed at leveraging reduced resources and eliminating waste in Government, the Contractor shall ensure that all materials generated and/or services provided under this contract, comply with all applicable NIH policy and procedures published by the NIH Office of Management Assessment in conjunction with the NIH Office of Communications and Public Liaison as set forth below.

http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html http://oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm http://oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf

This acquisition requires the contractor to:

[X ] Prepare, review, and/or distribute NIH Publications and Audiovisuals.

NIH Policy Manual Chapter 1183, "NIH Publications & Audiovisuals: Preparation, Review, Approval & Distribution," is applicable to this contract.

http://oma1.od.nih.gov/manualchapters/management/1183/ .

[X ] Use the NIH name and logo.

NIH Policy Manual Chapter 1186, "Use of NIH Names and Logos," is applicable to this contract. http://oma1.od.nih.gov/manualchapters/management/1186/ .

[X] Create and/or Manage a Public Website which includes NIH hosted social media site(s), Web application(s) and mobile Web Site(s).

NIH Policy Manual Chapter 2804, "Public-Facing Web Management," is applicable to this contract. http://oma1.od.nih.gov/manualchapters/management/2804/ .

[ ] Create and/or Manage an NIH Website that maintains and disseminates personal information.

NIH Policy Manual Chapter 2805, "NIH Web Privacy Policy," is applicable to this contract. http://oma1.od.nih.gov/manualchapters/management/2805/ .

[ ] Create and/or Manage an NIH hosted and/or funded social media site(s), Web application(s) and mobile Web site(s).

NIH Policy Manual Chapter 2809, "NIH Social and New Media Policy," is applicable to this contract. http://oma1.od.nih.gov/manualchapters/management/2809/ .

Additional Standards applicable to this contract are identified in the Statement of Work. If it is determined by the Government that products, services, and deliverables provided by the Contractor do not conform to standards described in these directives, remediation to an acceptable level of conformance shall be the responsibility of the Contractor at its own expense.

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.

CONTRACTOR'S USE OF LIBRARY RESOURCES AT NIH

The Contractor is authorized to use library resources at NIH in the same manner as NIH staff. The Contractor's approved use of these resources is limited to performing the requirements of this contract. The Contractor shall not use library resources at NIH in a manner that exceeds the Fair Use limitations codified in 17 U.S.C. sec. 107 of the Copyright Act. Contractors shall not share access to library resources at NIH with, perform searches for, or provide results to, non-NIH users, i.e. collaborators at other universities or research centers.

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: All data collected, generated, manipulated, or otherwise processed under this contract.

(xiv)The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation. The Offeror's technical approach shall indicate compliance with the Scope of Work, and describe an essential understanding of the requirements involved in accomplishing the work.

Basic cost and price information in the Offerors business proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required services. The price proposal must include the monthly maintenance rate for the manufacturer-certified technicians to provide required service coverage, with an estimate of the number of hours required, breakdown and rationale for any other direct costs or materials, and the total amount. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; trade-in considerations; warranty considerations; maintenance and service coverage availability; serial, product or catalog number(s); product description; delivery terms, and prompt payment discount terms.

(xv) All responses must be received no later than the date and time specified in this announcement

- May 18, 2020 at 2:00 PM EST. Late responses will not be accepted. All responses must reference solicitation number 75N95020Q00006.

(xvi) Responses must be submitted electronically to tracy.cain@nih.gov. Facsimile responses will not be accepted. For information regarding this solicitation, please contact Tracy Cain by email at tracy.cain@nih.gov.

mailto:tracy.cain@nih.gov

RFP No. 75N95020Q00006 Attachment 1

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Senior Business Development Manager (Life Sciences/Biotech) for SBIR/STTR Programs of the National Institute on Drug Abuse (NIDA)

Statement of Need and Purpose:

The purpose of this requirement is to procure the services of a business development specialist in support of Small Business Innovation Research (SBIR/STTR) programs of the National Institute on Drug Abuse (NIDA).

Background Information and Objective:

NIDA's mission is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. This charge has two critical components. The first is conducting and supporting research across a broad range of disciplines. The second is ensuring the rapid and effective dissemination, using the results of that research to significantly improve prevention and treatment, and informing policy as it relates to drug abuse and addiction. NIDA Small Business Innovation Research (SBIR/STTR) programs contribute significantly to both critical components by researching and developing the commercial products and services for NIDA’s constituency, academic researchers, practitioners and patients.

The objective of the requirement is to provide NIDA with professional services of (one) (1) experienced contractor in support of SBIR/STTR program. The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The contractor shall support a range of activities designed to increase NIDA’s momentum in life science technology commercialization and to facilitate the maturation of NIDA’s Small Business Programs.

Period of Performance:

The period of performance is one 12-month base year from the date of award and two (2) 12-month option periods.

SCOPE OF WORK

General Requirements:

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 below:

1. NIDA seeks to improve the quality and quantity of grant applications in its SBIR and STTR programs portfolio. The Contractor shall be responsible for:

o Providing NIDA with reports detailing feedback on inquiries and draft applications received from small businesses interested in SBIR and STTR funding;

o Providing NIDA with reports identifying and nominating applications for potential transfer from other NIH Institutes to NIDA; and o Conducting extensive and informed outreach to attract new small business concerns (SBCs) to apply to NIDA’s SBIR/STTR program.

NOTE: The Contractor shall not conduct proposal evaluations for contract awards. Those evaluations will be done by NIDA CORs and in accordance with peer review procedures as specified in NIH Manual Chapter 6315-1 Initiation, Review, Evaluation, and Award of Research & Development (R&D) Contracts.

2. The Contractor shall serve as an industry resource to NIDA staff, and produce as needed reports on strategic technology development related to key areas of SBIR/STTR programs, which includes, but is not limited to, Health IT, Diagnostics, Medical Devices, Research Tools and Therapeutics for substance use disorders (SUD).

3. The Contractor shall provide professional support services to NIDA’s Director of the Office of Translational Initiatives and Program Innovations (OTIPI), who is responsible for coordinating and managing the NIDA SBIR program.

4. The Contractor shall provide recommendations to assist with assuring the commercialization of NIDA-sponsored tools and technologies with the goal of giving patients access to cutting-edge innovations through a wide range of creative concepts, practices, and procedures.

5. The Contractor shall work with NIDA to strengthen the collaborations between academic labs and small businesses supported by NIDA by participating in the Reach HUB Initiative, establishing collaborations with academic Technology Transfer Offices, academic incubators and accelerators, and advising the academic researchers participating in NIDA-sponsored research education programs, such as R25 or Prize Competitions.

Specific Requirements:

Independently and under the direction of the Contracting Officer’s Representative (COR), the contractor shall:

1. Research and analyze SBIR/STTR data, which includes past and current funding and application submission information, success rates in Ph III, success rates in the transition from Ph I to Ph II, success rates in regulatory submissions to US FDA, commercially relevant and commercially successful technologies in the areas of drugs, vaccines, therapeutics, diagnostics, medical devices and health information technology supported by NIDA, and provide reports detailing findings.

2. Assist in preparation of presentations, briefing materials for the NIDA senior leadership, outreach materials, and journal publications.

3. Provide weekly activity update reports and participate in weekly OTIPI meetings.

4. Conduct valuations of the NIDA-supported company’s products, and provide reports detailing findings as necessary.

5. Conduct research into market and commercial developments and provide reports identifying commercially relevant technologies in the areas of drugs, vaccines, therapeutics, diagnostics, medical devices, and health information technology that are suitable for the SBIR/STTR programs.

6. Evaluate new and emerging business opportunities for SBIR and STTR programs such as Phase III strategies, out-licensing, collaborative research and development agreements, and joint ventures, and provide reports detailing findings.

7. Develop educational programs for the NIDA grantees, including the programs on FDA regulatory training, program management, technology transfer, and training in entrepreneurship such as linking product-development activities to regulatory requirements and the needs of the marketplace.

8. Provide recommendations for the development of programs supporting partnering or strategic alliance, such as, but not limited to, “matchmaking” programs bringing together NIDA-sponsored small businesses and large pharmaceutical, biotech companies, accelerators, incubators, venture capitalists.

9. Assist in coordination of the investor forums, conferences, and other matchmaking and networking opportunities for small business companies, academic scientists, professional associations, and other strategic partners.

10. Contribute to data gathering and writing the manuscripts, both “white papers” and peer-reviewed manuscripts for publications in the scientific magazines such as Nature Biotech, European Molecular Biology Organization Journal (EMBO), and Proceedings of the National Academy of Sciences Journal

(PNAS).

LEVEL OF EFFORT:

The estimated level of effort for this requirement is 1840 hours of labor in the 12-month base period, with two one-year option periods.

GOVERNMENT RESPONSIBILITIES

The Government will provide workplace, access to databases (if subscription-based) used in SBIR/STTR programs, telephone and laptop computer for on-site contractor personnel. The contractor will perform work at the NIDA’s facility, newly remodeled office space at NIH Main Campus, Building 31 Suite (1B-59). This excludes federal holidays or when the facility is closed (e.g. weather emergencies).

A Contracting Officer Representative (COR) will be appointed to oversee the contract.

DELIVERY OR DELIVERABLES

Timely submission of deliverables is essential to successful completing of this requirement. For activities related to SBIR/STTR data mining, the contractor is expected to deliver statistical reports in a form of Excel tables and MS Power Point layouts monthly, on a last Wednesday of each month. Extensive narrative (2 pages minimum) should accompany those reports. Both “hard copy” and “electronic copy” will be required. All “hard copy” deliverables will be submitted on recycled-content paper and printed double-sided. For planning purposes, the government’s review of the draft deliverable will be provided within 5 calendar days from date of receipt. Contractor is expected to actively participate in bi-weekly meetings of NIDA SBIR Coordinating Committee, which takes place on Wednesday and weekly OTIPI meetings.

REPORTING REQUIREMENTS

The contractor is required to provide written progress reports monthly for the entire project period, plus additional reports and written deliverables as described under Specific Requirements above. In addition, at the end of each year either a final or annual report (if options are exercised) will be due. The electronic copy (original) and 2 PDF copies are required for monthly, annual and final progress reports. The progress reports shall cover all work completed during the specified period and shall present the work to be accomplished during the subsequent period. This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation. This monthly, annual or final report will be submitted with the monthly invoice.

OTHER CONSIDERATIONS

OPTIONS

The contract shall consist of one (1) 12-month base period plus two (2) 12-month option periods.

Travel:

Option Quantity 1: Conference Attendance/Travel.

$2,500 in direct costs for travel and registration fees for conference attendance as directed and required by the

NIDA COR.

At the direction of the NIDA COR, and after the Government obtains approval under the HHS Policy on Promoting Efficient Spending, and the Contracting Officer approves, the Contractor shall travel to attend Demo Days (where startups present their ideas/concepts), such as IndieBio, Y Combinator, or 1776vc, conferences, such as the Bio International Convention and Society for Neuroscience, or early investment forums such as BIO CEO and Investor Conference, RESI or AdvaMed.

All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer and authorized by the Contracting Officer’s Representative prior to being finalized or invoiced.

Subject to prior approval, travel reimbursement will be provided for such required travel, including conference registration fees. Please note that time spent traveling may not be billed to the Government. Please see the Federal Travel Regulations for allowable travel expenses, such as fares, rental fees, mileage payments and other expenses related to transportation per FTR301-10.2

This option may be exercised up to eight times per year.

For planning purposes, the contractor shall travel 2-4 times per year.

Please note that time spent traveling may not be billed to the Government. Please see the Federal Travel Regulations for allowable travel expenses, such as fares, rental fees, mileage payments and other expenses related to transportation per FTR301-10.2

Key Personnel:

The contractor employee providing services for this effort shall be considered key personnel.

Key personnel requirements are as follows:

• MBA degree with MS or BS degree in life sciences, or equivalent

• At least 5 years of experience in the field of pharmaceutical and biotech business development or project management. Experience must include efforts in development of SBIR/STTR programs in life sciences

• Experience with statistical data analysis, data reporting and management

• Demonstrated deep understanding and practical knowledge of SBIR and STTR programs

• Proficiency with using internal government databases, such as Query View Report (QVR), Federal Reporter, and Scientific Publication Information Retrieval & Evaluation System (SPIRES) or other similar government databases

• Proficiency with using commercial databases such as Citeline, TR Integrity, or other similar commercial databases

• Proficiency in biotechnology valuations methods and current business development practices

• Expertise with using Microsoft Excel, PowerPoint, Publisher; and various publishing tools for animated presentations and animated videos

• Understanding and practical knowledge of SBIR and STTR program elements pertaining to eligibility requirements, receipt and referral processes, peer review processes, budget allocations (e.g. 3rd party rules), funding mechanisms (Principal Investigator-initiated vs Targeted research), and differences between Requests for Applications (RFAs) and Requests for Proposals (RFPs).

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.

Data Rights:

NIDA shall have unlimited rights to as ownership of all deliverables provided under this procurement including reports, analyses, recommendations, slide decks, videos and all other deliverables. In addition, it include any additional deliverables required by contract change. The definition “unlimited rights” is contained in FAR 27.401, Definitions. NIDA will use the Data Rights, Special Works Clause in the resultant contract.

Section 508—Electronic and Information Technology Standards:

Section 508 Compliance…