Combined Synopsis Solicitation- HEAL PK Testing.pdf

COMBINED SYNOPSIS / SOLICITATION

COMPETITIVE

Title: NINDS HEAL Initiative Rodent Pharmacokinetic (PK) Testing Services

(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 written solicitation will not be issued.

(ii) The solicitation number is 75N95024R00115 and the solicitation is issued as an request for proposal (RFP).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;

FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-5, dated May 22, 2024.

(iv) The associated NAICS code 541380 Testing Laboratories and Services and the small business size standard $19M. This requirement is full and open with no set-aside restrictions.

(v) Description:

The Government requires rodent pharmacokinetic (PK) testing for the purposes of new therapeutics developments.

Please refer to Attachment 1 – Statement of Work.

(vi) Please refer to Attachment 1 – Statement of Work for details and information describing the requirements for the services.

(vii) The anticipated period of performance shall be a 12 month period effective at time of award.

(viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. The following instructions are included as an addendum to this provision.

Cover Page:

The Quoter shall provide the below information on the first page of its response:

1. Solicitation Number: 75N95024R00115

2. Quotation Number

3. Submission and Expiration Date of Quotation

4. Company’s Full Name and Address;

5. Company’s UEI Number, CAGE Code, and TIN Number; and

6. Name, Telephone Number, and Email Address of Person Authorized to Provide

Quotation

Technical Response Format:

Quoter responses shall be no more than ten (10) single-sided pages in length and submitted in PDF format.

This page limit does NOT include:

1. Price Quote/Narrative

2. Representations and Certifications

3. Supplemental Documentation

Technical Response:

Responses to this RFQ must include enough information to establish that the Quoter can provide the required services and satisfy the “specific requirements” described within the SOW and the technical evaluation criteria.

Quotations will be evaluated against the technical factors described in Attachment 2 – Technical Evaluation Criteria.

Quoter should also provide any other information or factors that are relevant to the award decision. Additionally, responses must include a statement specifying the extent of agreement with all terms and conditions included in the solicitation.

Business Response:

Quoters are instructed to submit their price quote as a separate attachment in either PDF or Excel format and include the following information for the base period and option item, as applicable.

Total price (must be clearly stated and represent a firm-fixed-price amount for performance of all work during the purchase order’s period of performance (including options).

Quoters may also provide a narrative describing the basis for their pricing, which should not exceed 2 pages in length.

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, applies to this acquisition. See Attachment 2.

(a) 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. The following factors shall be used to evaluate offers:

The technical factors combined are significantly more important than cost or price, however, the Government will not make an award at a significantly higher price to achieve only slightly superior performance. Price may become the most significant factor for award as quotes become more equal based on other factors.

Technical Factors

Scored technical evaluation factors are listed in the order of their relative importance with points assigned for evaluation purposes. The maximum total score possible is 100 points.

1. Technical Approach (65 points)

• Suitability and feasibility of the proposed technical approach, methods and procedures for satisfying the requirements

• Timelines for deliverables.

2. Management and Staffing Plan (25 points)

• Suitability of experience and ability to effectively conduct, manage, and coordinate the resources to ensure successful operation of the technical plan and carry out the proposed project.

3. Past Performance (10 pts)

The Quoter shall identify up to two (2) awards with the Federal Government and/or commercial customers that demonstrate recent and relevant past performance.

Relevant is defined as work similar in complexity and magnitude to the work described in the Statement of Work.

However, this evaluation will not be conducted on any Quoter whose quotation is determined to be technically unacceptable.

Include the following information:

• Project title

• Description of the project

• Contract number

• Contract amount

• Government Agency/Organization

• Contracting Officer’s name, address, and phone number

• Contract and, if applicable, task order number

• Current status, e.g., completed and/or if in progress, start and estimated completion dates

• Dollar value and type of contract

• Name of company being referenced

• SOW paragraphs that the reference applies to

• Key personnel (please highlight those individuals who worked on the relevant project(s) and are also being proposed for this effort.)

• A brief narrative of why you deem the reference to be relevant to this effort

The Government may also consider information obtained through other sources.

Past performance information will be utilized to determine the quality of the contractor’s past performance as it relates to the probability of success of the required effort.

Other Evaluation Non-Scored Factor: Live Vertebrate Animals Evaluation

As part of the overall technical evaluation of proposals, the reviewers will consider the acceptability of the offeror's description in the VAS of the technical proposal. The discussion of all criteria will be addressed and evaluated. Based on the evaluation of this Section, the VAS may be rated "unacceptable" (i.e., concerns are identified as to the adequacy of the description addressing each of the criteria, or no discussion can be found regarding the VAS), or "acceptable." If the reviewers find that this Section of the technical proposal is "unacceptable" they will provide a narrative supporting their findings.

Price Evaluation

Each Quoter’s price 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 price analysis techniques as described in FAR 13.106-3. Quoters must provide a total firm-fixed price (inclusive of all options) for completion of the work described in the SOW to be considered for award.

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced.

Evaluation of options shall not obligate the Government to exercise the option(s).

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

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

(xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition. See Attachment 4.

(xiii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. See Attachment 3.

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

(xv) Special Contract Requirements

The services under this contract involves live vertebrate animals. Quoters must have an active OLAW Animal Welfare Assurance. In addition, Quoters must include with its quotation:

1. Vertebrate Animal Section (VAS) (see below)

2. Institutional Animal Care and Use Committee (IACUC) project approval. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award.

Vertebrate Animals Section (VAS). The VAS should be no more than two (2) pages and must address the following criteria:

1. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work.

2. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

4. Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

For more discussion regarding the VAS, see NIH Guide Notice NOT-OD-16-006 at:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html

The VAS Worksheet is provided as an attachment to this solicitation to assist in the preparation of the VAS. See Attachment 5.

Animal Welfare. All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at:

http://grants1.nih.gov/grants/olaw/references/phspol.htm.

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the Contractor’s quotation.

The provision at HHSAR 352.270-5a, Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (December 18, 2015).

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals

(PHS Policy) establishes a number of requirements for research activities involving animals. Before awarding a contract to an offeror, the organization shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution’s animal program, facilities, and procedures. Offerors must provide verification of IACUC approval prior to receiving an award involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of http://grants1.nih.gov/grants/olaw/references/phspol.htm

IACUC approval. For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (E-mail:

olaw@od.nih.gov; Phone: 301-496-7163).

(End of provision)

The clause at HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015).

a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail:

ace@aphis.usda.gov; website:

http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

(End of clause)

(xvi) All questions shall be received via email to Sneha Singh at sneha.singh@nih.gov before 11:00

AM Eastern Time, on Monday August 19, 2024.

Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. If applicable, the price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

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/

All responses must be received by Monday August 26, 2024, 11:00 AM Eastern Time and reference number 75N95024R00115. Responses may be submitted electronically to Sneha Singh at sneha.singh@nih.gov..

Fax responses will not be accepted.

(xvii) Attachments:

Attachment 1 – Statement of Work

Attachment 2 – Technical Evaluation Criteria Attachment 3 – Terms & Conditions Attachment 4 – FAR 52.212-5 Attachment 5 – VAS Worksheet Attachment 6 – Invoice Instructions