75N95022R00013_Amn 2_S.pdf

Nancy L. Lamon-kritikos -S Digitally signed by Nancy L. Lamon-kritikos -S Date: 2022.02.28 20:38:21 -05'00'

Questions and Answers, Part 2

Request for Proposals (RFP) Number: 75N95022R00013

Project Title: Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders

Question Number Question and Answer

43.

Reference: Section F – Deliveries or Performance, Article F.2.

Deliveries

Question: Is the intent to make all Intellectual Property on the list of deliverables in Section F available to the public?

Answer: Intellectual Property that is confidential is not shared publicly unless required by law.

This contract requirement includes a “Determination of Exceptional Circumstances” and incorporates HHSAR clauses 352.227-11 Patent Rights—Exceptional Circumstances (Sept 2014) and 352.227-14 Rights in Data—Exceptional Circumstances (Sept 2014).

All data generated on the compounds provided by the Government, along with any summary reports compiled, are considered confidential based on the pre-existing agreements that the NINDS has established with compound sponsors/contributors. The contract restricts and prohibits the Contractor’s right to use, release to others, reproduce, distribute or publish data or other information resulting from testing/evaluations performed under contract. Such data shall not be releasable under the Freedom of Information Act (FOIA) as it is considered proprietary, i.e., trade secrets, and, therefore, could be determined to be exempt from FOIA. Restricted access to data and materials will be maintained at the Contractor’s facility in a secured manner. Special notices or other safeguards will be affixed to any packages containing such data.

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting

Project Title: Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders

Question Number Question and Answer

Officer.

44.

The RFP lists a maximum value of $149,200,000.

Question: For purposes of developing the SB Plan, is it appropriate to assume the full $149,200,000 will be spread equally across 8-year ordering period?

Answer: Yes, this approach is acceptable for the purpose of the Small Business Subcontracting Plan.

45.

Question: ARTICLE I.6.c includes a placeholder for a request for additional wage determinations outside of the NCR. Does the Government require Offerors to include the request for additional wage determinations by city and state during the question period of the solicitation period or after contract award?

Answer: If the wage determination(s) are required by the offeror to submit a proposal that complies with 52.222-41 Service Contract Labor Standards, the offeror may request additional wage rate determinations in writing.

46.

Question: The Government requires evidence for proposal to be reviewed and approved by IACUC. However, this is unusual at this stage of a proposal. Please clarify the mandatory qualification requirement and if the Offeror is required to have its proposed studies in Sample Task Order 4 reviewed and approved by the IACUC?

Answer: Offerors (or subcontractors, if applicable) should have approved IACUC protocols for their animal activities.

47.

Question: Section L General Instructions stipulate “Each of the parts shall be separate and complete in itself so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.” Section L Business Proposal Instructions stipulate the requirement for a Small Business Subcontracting Plan. However, Section M stipulates the evaluation criteria of the Small Business

Subcontracting Plan as a non-scored factor of the Technical Evaluation. Please clarify if the Government requires Offerors to include the Small Business Subcontracting Plan in both Technical and Business proposals to comply with general instructions for both technical and business proposals.

Answer: Offerors should only include a completed small business subcontracting plan within their business proposals, NOT their technical proposals. Section M has been clarified to address this inconsistency.

48.

Reference: A12 – Business Proposal Budget Template_TO_2 (Subcontracts tab)

Question: Instructions stipulate “A complete breakdown and summary sheet for each proposed subcontract must be included with the prime proposal. The same format should be used for both the prime and subcontract proposals.” Will the Government accept proposed subcontractor(s) submitting its sealed detailed pricing directly to the Government?

Answer: No, offerors must include all relevant documentation with their proposals. The pricing information required should be appropriate to the proposal. For example, if an offeror is proposing subcontracted work on a fixed-price basis, a breakdown of all cost elements might not be appropriate.

49.

Reference: A13 – Business Proposal Budget Template_TO_3 (Subcontracts tab)

Question: Instructions stipulate “A complete breakdown and summary sheet for each proposed subcontract must be included with the prime proposal. The same format should be used for both the prime and subcontract proposals.” Will the Government accept proposed subcontractor(s) submitting its sealed detailed pricing directly to the Government?

Answer: Please see response to previous question.

50. Reference: A14 – Business Proposal Budget Template_TO_4 (Subcontracts tab)

Question: Instructions stipulate “A complete breakdown and summary sheet for each proposed subcontract must be included with the prime proposal. The same format should be used for both the prime and subcontract proposals.” Will the Government accept proposed subcontractor(s) submitting its sealed detailed pricing directly to the Government?

51.

Question: RFP section states “For studies involving animals only the Contractor shall maintain such assurance for the duration of this contract, and any subcontractors performing work under this contract involving the use of animals shall also obtain and maintain an approved Animal Welfare Assurance.” If all the animal facilities and activities using animals are in subcontracted facilities, is the prime contractor required to register with the Office of Laboratory Animal Welfare (OLAW) and obtain an approved Animal Welfare Assurance?

Answer: The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) requires that institutions have an OLAW-approved Animal Welfare Assurance before carrying out any activities involving live vertebrate animals. U.S. institutions that receive PHS funds through a contract award are to use the Interinstitutional Assurance when the institution does not have their own:

• animal care and use program

• facilities to house animals

• Institutional Animal Care and Use Committee (IACUC); and

• does not conduct animal research on-site.

For additional information, refer to OLAW and the following website:

https://olaw.nih.gov/resources/documents/interinstitutional-assurance.htm https://olaw.nih.gov/resources/documents/https/olaw.nih.gov/policies-laws/phs-policy.htm https://olaw.nih.gov/resources/documents/interinstitutional-assurance.htm https://olaw.nih.gov/resources/documents/interinstitutional-assurance.htm

52.

Question: Section states “Additionally, the Contractor's Institutional Animal Care and Use Committee (IACUC) shall approve all animal procedures under this contract.” If all the animal facilities and activities using animals are in subcontracted facilities, is the prime contractor required to establish an Institutional Animal Care and Use Committee (IACUC), or may the prime contractor rely upon the IACUC of its subcontractors?

53.

Question: RFP section states “The contractor shall also be fully accredited by AAALAC international.” If all animal facilities and activities using animals are in subcontracted facilities, is the prime contractor required to be fully accredited by the AAALAC international, or is it sufficient for only the subcontracted laboratories to be fully accredited by AAALAC international?

Answer: No, the prime is not required to be certified if all animal facilities and activities using animals are in subcontracted facilities.

54.

Question: The Government requires a copy of the most recent FDA GLP inspection report for all proposed laboratory facilities for the proposal. However, most companies inspected by the FDA do not release their inspection report due to confidentially concerns and not all laboratories are inspected by the FDA. Is it acceptable to provide a table referencing the inspection history by the FDA and if findings were noted instead of the inspection report?

Answer: Yes, information may be submitted in this format.

55.

Question: The Government requires a copy of the most recent FDA cGMP inspection report for all proposed manufacturing facilities for the proposal. However, most companies inspected by the FDA do not release their inspection report due to confidentially concerns and not all manufacturers are inspected by the FDA. Is it acceptable to provide a table referencing the inspection history by the FDA and if findings were noted instead of the inspection report?

Answer: Yes, information may be submitted in this format.

56.

Question: Is NIH/NINDS intending to acquire a license agreement for the use of the AAV9 vector?

Answer: For the purpose of this sample task order, assume that a license agreement for the use of the AAV9 is not needed. We are using AAV9 only as an example for proposal development.

57. Reference:

RFP pg. 11, section “INFORMATION AND/OR PHYSICAL SECURITY,” paragraph A, states in part: “If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three (3) months after contract award.

Question:

Please clarify if the requirement is that a contractor must obtain an ATO within 3 months after contract award, or if the contractor must submit the required documentation in support of the application for an ATO within 3 months after award.

Answer: Yes, NIH requires completed ATO Packages within 3 months of contract award.

58.

Question:

For offerors that have current ATOs issued by other agencies, what is the process and timing for assessing whether the ATO would be acceptable for this program?

Answer: The answer to this question will depend on the contractor, their existing environment, and the agency that granted the ATO. For example, the awardee may need to create a segregated environment to execute this contract to avoid commingling of Federal data. The Contracting Officer and ISSO would need to review the ATO Package from the other agency to determine this.

59. Reference:

RFP pg. 11-12, section “INFORMATION AND/OR PHYSICAL SECURITY,” paragraph B, states in part: “The NIH should determine which security control baseline applies and then make a determination on the appropriateness/necessity of obtaining an independent assessment.”

Question:

Per the NIST 800-60, “Security categorization is a prerequisite activity for the C&A process.” When will NIH make the determination of which security control baseline applies?

Shouldn’t the ATO timeline start only after this information is provided? Will this determination be made at the IDIQ level or at the task order level? If an independent assessment is required, will that affect the 3-month requirement to obtain an ATO described in paragraph A?

Answer: The FIPS 199 Security Categorization process involves categorizing the overall system by assigning impact scores of Low, Moderate, or High to each data type processed by the system. This activity is preliminary to selecting the NIST SP 800-53 security control baseline, constructing the SSP, and proceeding to the SCA. If the system is categorized as a Low system, NIH does not require an independent assessor. NIH requires independent assessment when the FIPS 199 Security Categorization results in an Overall score of Moderate or higher.

60.

RFP pg. 111, section H, “Applicability,” states that the requirements of the INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY section applies when the contract or task order includes either Access to Government Information or when a contractor will operate a Federal system and information technology containing data that supports the HHS mission.

Question: Based on the scope described in the RFP and attached SOW, we do not believe the contractor will be operating a Federal system within the meaning of this clause under this program. If this is not correct, can you provide an example of a Federal system we would be operating?

Answer: The definition of a Federal information system is as follows: “Federal information means, in accordance with OMB Circular A-130, Management of Federal Information Resources, Appendix 3 (Security of Federal Automated Information Resources), information created, collected, processed, disseminated, or disposed of by or for the Federal Government.”

The SOW states that “Upon completion of a study under Task Area 2, the Government may require that all study documentation including, but not limited to, laboratory notebooks, source documents, monitoring logs, regulatory documents, observations, or notations of activities and all reports and records necessary for the evaluation and reconstruction of the research study, as well as databases on disk or tape, be placed in secure storage.” The SOW furthermore states: “During this period, the Contractor will be responsible for the integrity and organization of the material and its confidentiality.” The fact that the contractor is responsible for the integrity of the material implies that a Federal information system and/or Federal data are likely involved.

https://www.lawinsider.com/dictionary/federal-information

61. Reference:

RPG pg. 42, section ARTICLE H.18.1., INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY, section A.4.c., states: “Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system.”

Question:

Does the Government anticipate that the information under this program can be managed on contractor systems?

Answer: The reference above speaks to contractor systems that are operated on behalf of an agency. When a contractor is operating a system on behalf of an agency, the system may meet the definition of a Federal information system. See the OMB Circular A-130 definition of Federal information system above. NIST also defines Federal information system. The NIST definition is as follows: “An information system used or operated by an executive agency, by a contractor of an executive agency, or by another organization on behalf of an executive agency.”

https://www.lawinsider.com/dictionary/federal-information

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

Selection of offeror(s) for contract award will be based on an evaluation of proposals against three factors. The factors in order of importance are mandatory qualifications, technical, cost, and past performance. Although technical factors are of paramount consideration in the award of the contract, past performance and cost/price are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make award(s) to the offeror(s) whose proposal(s) provides the best overall value to the Government. The Government reserves the right to make multiple awards if it determines it to be in its best interest.

The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the SOLICITATION. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the SOLICITATION. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors listed below.

2. COST/PRICE EVALUATION

Offeror(s) cost/price proposal will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the Government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404.

Cost Realism: The specific elements of each offeror(s) proposed costs are realistic when the proposed cost elements are evaluated and found to: 1) be realistic for the work to be performed; 2) reflect a clear understanding of the requirements; and 3) be consistent with the unique methods of performance and materials described in the offeror(s) technical proposal.

Cost Realism will be evaluated only on the offeror(s) inputs which the Government will use to determine the most probable cost to perform the contract in a manner consistent with the offeror's proposal. Cost realism analysis will be conducted in accordance with FAR 15.404-1(d).

The result of the cost realism analysis will be considered in the making the best value tradeoff decision.

3. EVALUATION OF OPTIONS

It is anticipated that any contract(s) awarded from this solicitation will contain option provision(s) and period(s).

In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s).

4. MANDATORY QUALIFICATION CRITERIA

Listed below are mandatory qualification criteria. THE OFFEROR SHALL INCLUDE ALL

INFORMATION WHICH DOCUMENTS AND/OR SUPPORTS THE QUALIFICATION CRITERIA IN ONE

CLEARLY MARKED SECTION OF ITS TECHNICAL PROPOSAL.

The qualification criteria establish conditions that must be met at the time of receipt of Final Proposal Revisions (FPRs) by the Contracting Officer in order for your proposal to be considered any further for award.

Mandatory Qualification Criteria Pass or

Fail

A. DETERMINATION OF EXCEPTIONAL CIRCUMSTANCES

A Determination of Exceptional Circumstances to incorporate HHSAR Clauses 352.227-11 and HHSAR 352.227-14 has been approved for use by the NINDS for this acquisition. The edited HHSAR Clauses at 352.227-11, Patent Rights- Exceptional Circumstances and 352.227-14, Rights in Data – Exceptional Circumstances, which are included in full text in Article I.4. of the uniform contract schedule of this RFP, will be made a part of any resultant contract(s) under this solicitation. As such, any prospective Offeror must certify and agree that to be considered for award and if selected for award a contract that they do accept and will abide by the terms and conditions of these clauses. The Offeror shall complete and sign the Attachment “DEC Acknowledgement” and include it with their Technical Proposal which evidences the Offeror’s acknowledgment and acceptance of the terms and conditions of HHSAR Clauses at 352.227-11 and 352.227-14.

B. DEA RESEARCH REGISTRATION

This project involves the use of scheduled drugs under the Controlled Substances Act of 1970. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that the Offeror (prime and/or subcontractor) possess a DEA Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970. In addition, the successful Offeror (prime and/or subcontractor) must either possess, or demonstrate the ability to obtain a DEA registration for Schedule I controlled substances.

C. ANIMAL WELFARE

This research involves the use of animals. For all proposed animal facilities (prime and/or subcontractor), the Offeror must demonstrate understanding and compliance with the NIH Guide for Care and Use of Laboratory Animals and provide sufficient evidence that the proposed animal facilities:

a) Have an approved Animal Welfare Assurance from the Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW) (http://www.grants.nih.gov/grants/olaw/olaw.htm), Office of the Director, NIH, as required by Section I-43-30 of the Public Health Service Policy on Humane Care and Use of Laboratory Animals.

b) Had its proposal reviewed and approved by the Institution's Animal Care and Use Committee (IACUC). Evidence that its proposal was reviewed and approved by the IACUC for prime and/or subcontractor sites must be included with the proposal.

c) Are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. Information about AAALAC accreditation is available at www.aaalac.org. A copy of the offeror’s latest AAALAC accreditation report must be included with the proposal.

D. GLP Compliance

All laboratory facilities (prime and/or subcontractor) must comply with the U.S.

Food and Drug Administration's (FDA) Good Laboratory Practice Regulations (GLP). A copy of the most recent FDA GLP inspection report (and/or a table referencing the inspection history by the FDA and if findings were noted) for all proposed laboratory facilities must be included with Offeror’s proposal.

E. cGMP Compliance

All manufacturing facilities (prime and/or subcontractor) must comply with the FDA’s current Good Manufacturing Practices (cGMP). A copy of the most recent FDA cGMP inspection report (and/or a table referencing the inspection history by the FDA and if findings were noted) for all proposed manufacturing facilities must be included with Offeror’s proposal.

http://www.grants.nih.gov/grants/olaw/olaw.htm

5. TECHNICAL EVALUATION FACTORS

The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. The factors below are listed with weights assigned to indicate relative importance for evaluation purposes.

Offerors must address all aspects of the Statement of Work in its proposal by providing a response, in separate sections of its proposal, for: (1) Sample Task Order No. 1 Contract Kick-off Meeting and Project Management Plan, (2) an overall response for Task Area 1 and separate technical responses for Sample Task Orders Nos. 2 and 3 (which fall under Task Area 1), and (3) an overall proposal response for Task Area 2 and a separate technical response for Sample Task Order No. 4 (which falls under Performance Area 2). Offerors must provide sufficient information to allow evaluation of its proposal against the Technical Evaluation Criteria listed below.

Offerors are advised and cautioned that proposals will be evaluated solely on the information provided in the proposal. Failure to provide any of the information required by the solicitation will result in a less than favorable evaluation of the proposal.

OFFERORS’ PROPOSALS MUST DEMONSTRATE THAT THEY ARE CAPABLE OF PROVIDING

SUPPORT (EITHER IN-HOUSE AND/OR THROUGH SUBSCONRACTS) FOR ALL REQUIRED

MANUFACTURING AND NONCLINICAL STUDIES.

OFFERORS ARE ALSO ADVISED TO REFER TO “ADDITIONAL TECHNICAL PROPOSAL

INSTRUCTIONS” OF THIS SOLICITATION FOR GUIDANCE AND INFORMATION RELATED TO

PREPARATION OF YOUR TECHNICAL PROPOSAL.

Scored Technical Evaluation Factors

Possible Points

A. TECHNICAL APPROACH

1. Task Area 1 - Manufacturing

a) Quality of technical approach for Task Area 1, as demonstrated by the overall proposal and responses to Sample Task Orders 2 and 3.

b) Ability to perform all technical requirements for Task Area 1 as described in the Statement of Work (SOW) for Base Contract.

c) Demonstrated (in-house and/or through subcontract) capabilities and successful track record in cGMP manufacturing of various biologics including but not limited to AAVs, ASOs, antibodies and peptides.

d) Demonstrated (in-house and/or through subcontract) capabilities in the following areas:

(1) Technology-transfer of an R&D laboratory scale process from a research facility to the Offeror

(2) Biological therapeutics manufacturing process development

(3) Analytical Methods Development

(4) Chemistry, manufacturing, and controls (CMC) development

(5) Small-scale manufacture, scale-up, engineering runs and/or manufacturing under current Good Manufacturing Practice (cGMP)

(6) Formulation and Dosage Form Manufacture and Validation

(7) Fill-finish, release testing, stability testing, validation and other associated tasks

e) Demonstrated capacity of the Offeror (including subcontractors) to execute at least 5 full-service manufacturing studies per year

2. Task Area 2 - Nonclinical Studies

a) Quality of technical approach for Task Area 2, as demonstrated by the overall proposal and responses to Sample Task Order 4.

b) Ability to perform all technical requirements for Task Area 2 as described in the Statement of Work (SOW) for Base Contract.

c) Demonstrated in-house or through subcontract capabilities a successful track record in executing nonclinical GLP studies with various biologics including AAVs, ASOs, antibodies, peptides, etc. Study types include but are not limited to:

o Bioassay development and/or qualification/validation o Efficacy studies in in vitro, in vivo or ex vivo, including modeling neurological disease using patient derived iPSCs or in animal models o ADME studies o Single-dose and/or repeat-dose safety PK/PD studies (pulmonary, cardiovascular, or other) o Toxicology (reproductive toxicology, carcinogenesis, single-dose and/or repeat dose safety studies, or other) in small animal models and/or NHPs

d) Demonstrated capacity of the Offeror (including subcontractors) to conduct at least 28 nonclinical studies per year, consisting of a range of studies such as bioassay development and/or qualification/validation, efficacy, toxicology, PK/PD, and ADME studies

e) Adequacy of proposed plan to address relevant biological variables, including sex, for studies in vertebrate animals and/or human materials

f) Demonstrated ability of the Prime Offeror and subcontractors to complete required nonclinical study reports and documentation that will enable regulatory filing and evaluation of biological therapeutics in clinical trials for NIH drug development programs

B. PERSONNEL QUALIFICATIONS

1. Head Program Manager

• The Offeror’s Head Program Manager (PM) will be responsible for overall administration of the contract and will be the main liaison with the NIH

• The Head PM will have had significant experience managing large programs involving various study types and subcontractors

• Availability and qualifications of the Head PM

• Demonstrated relevant experience of Head PM in managing an interdisciplinary team to conduct the outlined studies required in the Statement of Work

• Suitability and adequacy of the Head PM's expertise in the biologics product development field

• Scientific accomplishments of Head PM supporting the management of this project as evidenced by bibliography and resume including a list of publications, and/or study reports and/or invitations to speak at scientific conferences relevant to the Statement of Work

• Documented availability for the proposed project in relation to other commitments

• Documented experience managing similarly complex projects

2. Other Scientific and Technical Personnel

• Expertise, experience, and demonstrated availability of proposed senior scientific staff including Principal Investigators, Study Directors, project managers, and other technical personnel

• Suitability and adequacy of recent scientific accomplishments of senior scientific and technical staff to this project as evidenced by bibliographies and resumes (including study reports and publications)

• Suitability and adequacy of the training, experience and qualifications of other personnel in laboratory animal care and in laboratory techniques required to conduct studies in the Statement of Work

• Extent of experience of the proposed staff collaborating as a study team

• The above criteria are also applied to any subcontractor personnel

3. Staffing Plan and Organizational Support Demonstrated efficient administration and staffing of the project, organizational support for the studies, and coordination of the resources to ensure time commitments for deliverables can be met including:

• Appropriateness and efficiency of the staffing plan to accomplish the work;

organizational chart delineating lines of authority, areas of management for specific tasks, reporting responsibilities, coordination with NINDS.

• Appropriateness of staffing plan and Offeror’s team (prime, subcontractors and any consultants) and how they will effectively support all subtasks in Sample Task Order 1-4

• Evidence of organizational support for proposed work

• Extent of organizational ability to provide appropriate manpower and resources to perform requirements described in the Statement of Work

• Capability of planned staffing to meet the concurrent workload requirements defined by number of investigational compounds in the two task areas outlined in the Statement of Work

• Adequacy of administrative/coordinating staff to support the statement of work

• Clear and appropriate lines of responsibility and accountability for each of the required services

C. FACILITIES AND EQUIPMENT

Documented capacity, availability and appropriateness of the Contractor and Subcontractor facilities (including office, laboratory space, animal housing, manufacturing suites and facilities); equipment, computers and resources necessary to meet the requirements specified in the Solicitation:

Points to consider

• Suitability and availability of the animal facilities: the proposed studies require that large numbers of rodent and non-rodent species are fed and housed.

Further, potentially various species of animals including NHPs will be required, and special attention will be given to adequate space and evidence of all animal compliance regulations.

• Suitability and availability of laboratory equipment and specialized testing equipment.

• Availability of appropriate equipment to accomplish the proposed in-house or subcontracted tasks, including but not limited to:

• Biologics formulation

• Development of Bioanalytical Methods

• Bioanalytical assay development

• Fill-finish and labeling equipment

• cGMP freezer storage capabilities and capacity for manufactured biologics

• Suitability and availability of manufacturing facilities, including cGMP space, number of manufacturing suites and appropriate equipment for manufacturing the various biologics required

• Number and size of bioreactors currently available in-house or in subcontractor facilities

• Types of biologics modalities that have been manufactured in Contractor’s or Subcontractor’s facilities

• Adequacy of Data collection (i.e. video EEG, locomotor activity monitor; CMC data) and computerization

• Suitability of systems for data/records and agents archiving

D. QUALITY SYSTEMS

a) Offerors should describe in detail the Quality Systems that are in Offeror’s and at

Subcontractor’s facilities

b) Suitability of Quality Control and Quality Assurance Systems in place at Offeror and Subcontractor facilities

c) Quality of recent FDA, or other audit findings

d) Effectiveness of Study report and data quality control procedures

e) Adequacy of the safety and security procedures for information/data that will be furnished and produced in performance of the SOW

f) Adequacy of practices and policies to ensure the protection of proprietary information. Previous experience in protecting proprietary information will be considered

g) Sufficiency of proposed strategy to ensure a robust and unbiased approach, as appropriate for the work proposed.

E. PROJECT MANAGEMENT PLAN

a) Effectiveness of Offeror’s plan for managing the project, including tasks and resources

b) Plan demonstrates that Offeror and subcontractors understand the technical requirements as received from the NINDS and can effectively articulate those requirements to prospective subcontractors.

c) Plan demonstrates how Offeror will assess the capability of each subcontractor, make a best judgement decision to align the NINDS requirements with subcontractor capabilities, effectively procure and coordinate activities with subcontractors, and maintain effective communications between the Offeror, subcontractors, and NIH staff

d) Plan demonstrates that Offeror will be able to rapidly identify and engage high quality and reputable subcontractors in a variety of biologics manufacturing and/or nonclinical studies areas after performing an analysis of NIH needs and that it will be able to facilitate these subcontractor collaborations

e) Suitability of Offeror’s plan for directing and overseeing multiple, concurrent subcontractor activities

f) Effectiveness of communication plan between NIH, Offeror and subcontractors

g) Extent of Offeror’s risk assessment analysis, listed assumptions, and mitigation plans

h) Appropriateness of plan for coordination and logistics of any tasks to be subcontracted including capability and expertise to monitor, inspect, accept and manage risks with any subcontracted work

i) Extent of prior history working with any proposed subcontractors and organizational record of successfully managing subcontractors if subcontracts are included in the proposal

j) Effectiveness of procedures for closely monitoring, coordinating, and managing all contract activities and for interacting with the COR, Contracting Officer, and Contributor

k) Demonstrated ability to rapidly adapt and complete tasks where the requirements may be subject to frequent change and fluctuations

TOTAL POSSIBLE POINTS 200

Non-Scored Technical Evaluation Factors

A. LIVE VERTEBRATE ANIMALS EVALUATION

The offerors proposal must include, as a separate section of the Technical Proposal titled "Vertebrate Animal Section," (VAS) a complete, concise (no more than 1-2 pages) description addressing the following criteria. (See NIH Guide Notice NOT-OD-16-006 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html ):

a. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Request for Proposal (RFP) Statement of Work. Identify the species, strains, ages, sex and total number of animals by species to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

b. 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).

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

d. 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.

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.

If the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to address the concerns raised by reviewers. You will be able to further discuss and/or clarify your position until submission of your Final Proposal Revision (FPR). Once discussions are closed with the submission of your FPR, if your proposed description under the VAS is still found to be unacceptable, then your proposal may not be considered further for award.

B. EVALUATION OF AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES

If the offeror has proposed the use of key biological and/or chemical resources, the offeror's plan for authentication will be reviewed for adequacy.

Any concerns associated with key biological and/or chemical resource authentication raised during the review process will need to be resolved prior to award.

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

C. EVALUATION OF DATA SHARING PLAN

The offeror's plan for the sharing of final research data, or, if data sharing is not possible, the offeror's documentation of its inability to share research data, shall be assessed for appropriateness and adequacy.

D. EVALUATION OF PLAN FOR SHARING MODEL ORGANISMS FOR BIOMEDICAL RESEARCH

The offeror's proposal must address the plans for sharing model organisms, OR state appropriate reasons why such sharing is restricted or not possible. Offerors must also address as part of the sharing plan if, or how, they will exercise their intellectual property rights while making model organisms and research resources available to the broader scientific community. The discussion areas regarding intellectual property outlined in Section L should be addressed.

If your proposal does not include a plan, appropriate reasons for restricting sharing, or, if the plan in your proposal is considered "unacceptable," and the Government includes your proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify your plan for sharing model organisms during discussions and in your Final Proposal Revision (FPR). If your plan for sharing model organisms is still considered "unacceptable," or your justification for restricting sharing is still considered inappropriate by the Government after discussions, your proposal may not be considered further for award.

6. PAST PERFORMANCE FACTOR

Offeror's past performance information will be evaluated subsequent to the technical evaluation. However, this evaluation will not be conducted on any offeror whose proposal is determined to be technically unacceptable.

The evaluation will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance.

The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers relevant information.

When assessing performance risks, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror's record of performing according to specifications, including standards of good workmanship; the offeror's record of controlling and forecasting costs; the offeror's adherence to contract schedules, including the administrative aspects of performance; the offeror's reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror's business-like concern for the interest of the customer.

The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance.

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.

7. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY - SECTION

Offeror's Section 508 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 offeror's proposal must demonstrate compliance with the "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194 for all electronic and information technology (EIT)products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports.

8. SUBCONTRACTING PROGRAM EVALUATION FACTOR

Offeror's subcontracting program 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 offeror's proposed Small Business Subcontracting Plan will be evaluated to determine whether it represents the maximum practicable opportunity for subcontracting. Because the offeror's record of previous performance in carrying out the intent of the subcontracting program will be considered as a significant sub-factor, each offeror is encouraged to submit subcontracting plans and documentation that demonstrates their prior corporate support for small, small disadvantaged, women-owned small, HUBZone small, veteran-owned small, and service- disabled veteran-owned small business suppliers.

If offers are received from both large and small businesses, the small business offerors shall receive the maximum possible consideration for this factor.