RFP 75N95024R00037 - Attachments.pdf

RFP 75N95024R00037

Packing and Delivery of Proposal Attachment 1

Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with FAR Clause 52.215-1 Instructions to Offerors – Competitive Acquisition.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Business Proposal PDF file. Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

RFP 75N95024R00037

Packing and Delivery of Proposal Attachment 1 forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number, and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf Business Proposal: XYZ Company_NIHAI2012001_Business.pdf Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations – (see Additional Technical Proposal Instructions):

1. The total page count of the Technical Proposal is described in the Additional Technical Proposal Instructions (Attachment # 4).

2. Total page count does not include:

a. Table of Contents; Section Dividers that do not contain information other than title of Section; Demonstration of Compliance with Section 508, Appendices.

b. Curriculum Vitae (CV)/Resumes.

3. Pages exceeding limitations will be removed from the proposal and will not be considered.

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title:

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

Do intend to submit a proposal Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

Attachment 2

Statement of Work – May 2024 ATTACHMENT 3 RFP No.75N95024R00037 Page 1 of 4

STATEMENT OF WORK

NIA Aging Cell Repository

Selection, Production, Characterization and Distribution of Cultured Cells and DNA for

Research on Aging

I. Background

A repository of human cells, selected for their possible application in understanding the process of aging, was established by the National Institute for Child Health and Human Development in 1974.

This repository came under the National Institute on Aging (NIA)’s direction in 1976 and has since been expanded to include animal in addition to human cell cultures. The repository has served the scientific community conducting research on aging by providing investigators with high quality, well-characterized cell lines and selected DNA stocks for studying the biology of aging.

II. Objectives

The scope of this repository is to obtain, produce, characterize, store, and distribute cell lines and DNA to the aging research community. The principal goal is to facilitate studies on aging by providing high quality, uncontaminated and well-characterized cell cultures and DNA which are otherwise not readily available.

This statement of work is to continue the cell repository for five (5) years. During this period, the Contractor shall be responsible for: maintaining the current cell stocks frozen in liquid nitrogen;

establishing new cell lines; isolating DNA from cell lines and maintaining stocks; conducting applied research activities related to improving the services of the repository (including but not limited to developing new protocols for nonhuman primate cell reprogramming); distributing cell cultures and DNA to investigators; maintaining a web-based catalog for public access; maintaining and adding to the bibliography associated with the distributed cell lines; and maintaining a comprehensive computerized data management system for the repository.

Performance of quality controls throughout the workflow shall be the responsibility of the Contractor for this repository. The Contractor shall maintain its high level of performance and quality of cell lines at each step of their handling.

III. Work to be Performed

Independently, and not as an agent of the Government, the Contractor shall provide all necessary personnel, facilities, supplies and services (except for those to be furnished by the Government as specified elsewhere in the contract agreement) to perform the work required by this statement of work.

Specifically, the Contractor shall perform the following:

A. Initial set up of the repository. If necessary, transfer the existing cell and DNA biorepository from the current Contractor’s facility to the new Contractor’s facility and inventory its content in a safe and secure manner that prevents thawing of any frozen samples and maintains the integrity and organization of all biospecimens. The transfer shall be

RFP No.75N95024R00037 Page 2 of 4 accomplished within thirty (30) calendar days from the start of the contract. The successor contractor will have up to ninety (90) days upon award of the contract to perform a full inventory of the cell repository holdings.

B. Select, produce, characterize and store animal and human cell lines for distribution. This includes cell stocks currently held in the cell repository and new cell lines either acquired from external sources or established by the Contractor. Selection of new cell lines shall be done in consultation with the Contracting Officer’s Representative (COR), who shall periodically evaluate the existing stocks and potential demand for cell lines to establish priorities.

• Continue to bank and distribute IMR 90 and IMR 91 as well as other human and animal cell lines currently in the catalog for research on aging. After the initial characterization of these cell lines for sterility and chromosomal abnormalities has been accomplished, any further characterization shall be based on grantee needs and the relative merit evaluated jointly by the COR and the Contractor.

• Available cell lines from external sources shall be obtained at the optimal passage (often the earliest), at no cost to the Government whenever possible, expanded, characterized and stored. Data requested of the originator shall include original cell characterization, authorization for distribution, and documentation of donor consent for use when human cells are obtained. When possible, clinical and/or genetic information should be sourced and linked to the cell line.

• New cell lines shall be established and banked according to grantee demand and/or

COR’s recommendations. Those include but are not limited to establishment of fibroblast cell lines from skin biopsies, reprogramming of induced pluripotent stem cell (iPSC) and transformation of lymphoblastoid cell lines (LCL). Priorities shall be determined by the NIA Contracting Officer’s Representative (COR).

• Provision for genetic, and/or genomic services required for deep characterization of selected cell lines as determined in conjunction with the COR.

C. Maintain current stock and purify new DNA samples from cell lines for distribution.

Additional characterization may be required by the COR. The cell lines from which DNA shall be isolated include those cell lines from which DNA is already included in the Aging Cell Repository catalog and new cell lines identified or approved by the COR.

D. Quality Assurance (QA). Perform systematic QA testing of biospecimen and data according to current research standards. Determine that cell lines for distribution meet criteria of sterility (including mycoplasma testing), safety (including but not limited to HIV-negativity), validation of cell type (species of origin, DNA fingerprinting), and karyotype.

The Contractor shall be responsible for testing all newly acquired human and nonhuman primate cells for the presence of HIV and any other pathogen that can pose a risk to human health as established by current biosafety practices and in agreement with the COR. DNA from human cell lines will be characterized by microsatellite analysis for identification and sex determination purposes.

RFP No.75N95024R00037 Page 3 of 4

E. Repository maintenance. Maintain safe storage of cell lines and DNA. The repository storage must be equipped with alarm systems that are constantly monitored to ensure that storage tank and freezer temperatures do not rise due to liquid-nitrogen loss or other mechanical failure. In addition, the Contractor shall maintain a minimum of two back-up facilities, separate from the repository, for storing ampules of each of the NIA cell lines as a safeguard against accidental loss. The Contractor shall maintain such back-up facilities sufficient to accommodate a maximum of 100 ampules each of IMR-90 and IMR-91 and 5- 6 ampules of each NIA cell line. Cells stored at these back-up facilities are not for distribution or use by the Contractor or any subcontractor without written approval by the

COR.

F. Cell and DNA distribution. Ship cells by standard procedures (e.g., frozen ampules with dry ice or flask cultures at room temperature) to investigators and laboratories conducting research on aging. The number of cell lines to be shipped is typically approximately 1,200 per year. If requests are made for limited resources, the Contractor shall consult with the COR for procedures to follow. The Contractor shall select a carrier for the shipment of the cultures that ensures the viability of the cultures is not lost in transit.

• The Government has title to all products produced under the contract. Approval for distribution of cell cultures shall rest with the COR, who may delegate this responsibility to the Contractor under guidelines formulated by mutual agreement of the Government and the Contractor. The Contractor shall ship material only to institutions known to be involved in biomedical research and shall consult with the COR in questionable cases. The Government reserves the right to impose additional restrictions on the distribution of any materials or cultures resulting from this contract.

The Contractor shall distribute lymphoid and virally transformed cell cultures only to organizations which, in addition to other assurances, have executed an agreement to comply with minimum safety guidelines as specified by HHSAR 352.223-70 (or its current replacement).

G. Online catalog. Prepare, maintain, and provide customer support for a comprehensive online catalog with an easily accessible format. The online catalog shall include, at a minimum, all available cell lines and DNA samples and as much information about them as is currently available. Customer support includes but is not limited to catalog interrogation, biomaterials availability, and ordering assistance.

H. Dues and exceptions. Collect from NIA/NIH grantees, academic, non-profit, and industry/for-profit users costs associated with distributing cell cultures and DNA samples requested from the repository. The Contractor shall charge appropriate fees as determined by the Government. Prices are subject to change. The Government will have the authority to waive these charges in special cases. The actual cost of the packaging, special handling, and all other related shipping charges incident to any transaction shall be borne by the user.

I. Marketing. Promote the NIA Cell Repository to the scientific community through dissemination of information by a variety of means, including, but not limited to publication of descriptions of the collections, webinars, and one (1) person participation in up to two

RFP No.75N95024R00037 Page 4 of 4

(2) scientific conferences held in the continental USA per year with the option to sponsor a booth.

J. Data management. Maintain a comprehensive data management system to maximize utility of all aspects of the repository. The database shall include, but shall not be limited to, records on individual cell lines and DNA stocks, and their status, user requests, shipments, billings made, and payments received, as well as a bibliography of publications citing the use of cell lines and DNA obtained from the repository. The Contractor shall make available the following information for users and for the Government as indicated:

• Properties of cell lines contained in the repository, to be updated on a continuing basis as information is available. This updated information shall be made accessible to users in the form of a data sheet on each cell line to be distributed. These data should include but are not limited to: 1) original diagnosis if applicable; 2) originating laboratory and original reference; 3) number of cell generations or passages since original isolate was made; 4) karyotype, biochemical characterization, HLA type, etc., as appropriate; and

5) available cell lines suitable as controls in assays for a specific phenotype exhibited by a certain cell culture.

• Use of the repository cell stocks and DNA by the scientific community. These data shall be readily accessible to the Government and shall be updated to give the following minimal types of information: 1) a record of requests and shipments made; 2) shipments categorized by specific cell line and by user; 3) shipments categorized by type of receiver - Academic, Government, Industrial, or Non-profit Institute; and 4) an inventory of the remaining stock of vials of each cell line.

K. Closeout activities. If necessary, transfer the Aging Cell Repository and associated data to a new Contractor at the end of the contract period of performance.

IV. Contract Closeout

In accordance with FAR 4.804-5, within sixty (60) days of contract expiration/completion, the Contractor shall be responsible for and provide the following items:

a) Indirect cost rate proposals for all years (in which a proposal was not previously submitted);

b) Final property inventory (excluding intellectual property) and Standard Forms 1428 and

1429 (if applicable);

c) Settling all subcontract costs and any issues thereunder;

d) Subcontracting compliance reports for all years to the electronic subcontract reporting system at http://www.esrs.gov (if applicable);

e) Final patent and royalty reports;

f) A Contractor's release of claim, i.e., Contractor's closing statement; and Contractor's

Assignment of Refunds, Rebates, and Credits; and

g) A final invoice or completion voucher.

http://www.esrs.gov/

REPORTING REQUIREMENTS ATTACHMENT 4

RFP No.75N95024R00037 Page 1 of 4

REPORTING REQUIREMENTS AND OTHER DELIVERABLES

All reports shall be submitted in an electronic format approved by the Contracting Officer’s Representative (COR) and electronic files shall be sent by e-mail to the COR and the Contracting Officer (CO) with secure protocols when needed, unless otherwise stated. All reports shall include:

• Contract number

• Contract title

• Period of performance being reported

• Date of submission

Required Reports/Deliverables

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and deliver the following reports:

1. Monthly Contract-Related Summary of Sales (Contract Related Income) Reports

The Contractor shall submit a monthly Contract Related Income Report. The report shall keep an accurate account of all sales of research biomaterials, separate from other fiscal aspects of this contract. In addition to submitting one (1) copy to the COR and one (1) copy to the Contracting Officer, the Contractor shall submit one (1) copy of the report to NIA, Financial Management Brach (FMB) at niabudget@mail.nih.gov.

2. Quarterly Progress Reports

The Contractor shall submit a Quarterly Progress Report. The first report shall cover the period consisting of the first full three (3) calendar months following the effective date of the contract and any fractional part of the initial month. Thereafter, the report shall consist of three (3) calendar months. Reports shall be due on or before the 30th of the month following the reporting period. The Contractor shall submit one (1) copy to the COR and one (1) copy to the Contracting Officer.

Quarterly progress reports shall include but are not limited to:

a) brief description of the work performed during the reporting period

b) description of new cell lines made or acquired during the reporting period, including the status of the characterization

c) description of the characterization of any existing cell lines performed during the reporting period

d) the total number of cell lines included in the catalog at the end of the reporting period

e) identification of nucleic acid preparations made during the reporting period

f) the total number of cell lines for which nucleic acid is available

RFP No.75N95024R00037 Page 2 of 4

g) a breakdown of the number of cell lines shipped, identifying:

i. total cell lines shipped in the current contract quarter

ii. total cell lines shipped in the current contract year

iii. cumulative total cell lines by year shipped from the date of contract award

iv. total cell lines shipped to the different categories of users - Academic, Government, Industrial, and Non-profit Institutions

v. total cell lines shipped by type – human (subdivided by cell type, e.g., IMR, primary, iPSCs, LCL, and by collection) and animal (subdivided by species and cell type)

vi. total cell lines shipped to foreign Institutions

h) total number of vials of nucleic acids shipped, including a breakdown by category of user and by panel or cell line category

i) total number of vials of nucleic acids shipped to foreign Institutions

j) the anticipated work plan of the following quarter

3. Final Report

The Contractor shall submit a Final Report which shall be due on or before the contract completion date. The Final Report shall be prepared in the same format as the quarterly progress reports to include corresponding yearly data and the last quarter progress as described above. The Final Report shall reflect the status of the Aging Cell Repository at the end of the contract period. The Contractor shall submit one (1) copy of the Final Report to the COR and one (1) copy to the Contracting Officer.

4. Summary of Salient Results.

The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

5. Contract Closeout.

In accordance with FAR 4.804, within sixty (60) calendar days of the contract task order expiration/completion, the Contractor shall be responsible for and provide the following items:

a) Indirect cost rate proposals for all years (in which a proposal was not previously submitted);

b) Final property inventory (excluding intellectual property) and Standard Forms 1428 and 1429 (if applicable);

c) Settling all subcontract costs and any issues thereunder;

d) Subcontracting compliance reports for all years to the electronic subcontract reporting

RFP No.75N95024R00037 Page 3 of 4 system at http://www.esrs.gov (if applicable);

e) Final patent and royalty reports;

f) A contractor’s release of claims, i.e., contractor’s closing statement; Contractor’s Assignment of Refunds, Rebates, and Credits; and

g) A final invoice or completion voucher.

Summary of Deliverables

Deliverable Quantity Delivery Schedule Contract Related Income Report

1 to COR 1 to CO 1 to FMB

Monthly

Quarterly Progress Report

1 to COR 1 to CO

Thirty (30) calendar days after each three (3) month period of the contract

Annual Invention Disclosure Report

1 to CO 60 calendar days after the anniversary date of the contract each year

Final Report

1 to COR 1 to CO

On or before the completion date of the contract

Final Invention Report 1 to CO On or before the completion date of the contract

Summary of Salient Results

1 to COR 1 to CO

On or before the completion date of the contract

Invention disclosure reports, the confirmatory license, and the government support certification

Division of Extramural Inventions and Technology Resources, OPERA, NIH

On or before the completion date of the contract

Monthly Summary of Sales

1 to COR 1 to CO

Monthly

Contract Closeout To CO As described under item (5) above

INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

Contractor Non- Disclosure Agreements

(NDA)

1 to COR 1 to CO

Prior to Performing Work Under this acquisition

Roster of Employees Requiring Suitability Investigations

1 to COR 1 to CO

Fourteen (14) calendar days after the effective date of the contract

NIH Contractor Employee Separation Checklist

1 to COR 1 to CO

Within two (2) days of the employee’s exit from the contract

System Security Plan

(SSP)

1 to COR 1 to CO

Within 30 days after contract award

RFP No.75N95024R00037 Page 4 of 4

Deliverable Quantity Delivery Schedule Security Assessment Plan/Report

(SAP/SAR)

1 to COR 1 to CO

30 days after contract award

Independent Assessment

1 to COR 1 to CO

90 days after contract award

Plan of Actions and Milestones (POA&M)

1 to COR 1 to CO

30 days after contract award.

Contingency Plan and Contingency Plan Test

1 to COR 1 to CO

60 days after contract award.

RFP No.75N95024R00037 ATTACHMENT 5

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

52.204-8 Annual Representations and Certifications (Feb 2024).

As prescribed in 4.1202(a), insert the following provision:

Annual Representations and Certifications (Feb 2024)

(a)

(1) The North American Industry Classification System (NAICS) code for this acquisition is [insert NAICS code].

(2) The small business size standard is [insert size standard].

(3) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519 if the acquisition—

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b)

(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7, System for Award Management, is not included in this solicitation, and the Offeror has an active registration in the System for Award Management (SAM), the Offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The Offeror shall indicate which option applies by checking one of the following boxes:

(i) □ Paragraph (d) applies.

(ii) □ Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)

(1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

https://www.acquisition.gov/far/4.1202#FAR_4_1202 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7

RFP No.75N95024R00037 ATTACHMENT 5

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless–

(A) The acquisition is to be made under the simplified acquisition procedures in part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures;

or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that-

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.204-26, Covered Telecommunications Equipment or Services-Representation. This provision applies to all solicitations.

(vii) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations-Representation.

(viii) 52.209-5, CertificationRegarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(ix) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(x) 52.214-14, Place of Performance-Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(xi) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xii) 52.219-1, Small Business Program Representations (Basic, Alternates I, and II). This provision applies to solicitations when the contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii).

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast https://www.acquisition.gov/far/52.203-2#FAR_52_203_2 https://www.acquisition.gov/far/part-13#FAR_Part_13 https://www.acquisition.gov/far/52.203-11#FAR_52_203_11 https://www.acquisition.gov/far/52.203-18#FAR_52_203_18 https://www.acquisition.gov/far/52.204-3#FAR_52_204_3 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.204-5#FAR_52_204_5 https://www.acquisition.gov/far/52.204-26#FAR_52_204_26 https://www.acquisition.gov/far/52.209-2#FAR_52_209_2 https://www.acquisition.gov/far/52.209-5#FAR_52_209_5 https://www.acquisition.gov/far/52.209-11#FAR_52_209_11 https://www.acquisition.gov/far/52.214-14#FAR_52_214_14 https://www.acquisition.gov/far/52.215-6#FAR_52_215_6 https://www.acquisition.gov/far/52.219-1#FAR_52_219_1 https://www.acquisition.gov/far/part-19#FAR_Part_19 https://www.acquisition.gov/far/19.000#FAR_19_000

RFP No.75N95024R00037 ATTACHMENT 5

Guard.

(C) The provision with its Alternate II applies to solicitations that will result in a multiple-award contract with more than one NAICS code assigned.

(xiii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii).

(xiv) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xvi) 52.222-38, Compliance with Veterans’ Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial products or commercial services.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA–designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA–designated items.

(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals- Representation. This provision applies to solicitations that include the clause at 52.204-7.)

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American-Free Trade Agreements-Israeli Trade Act Certificate. (Basic, Alternates II and III.) This provision applies to solicitations containing the clause at 52.225-3.

(A) If the acquisition value is less than $50,000, the basic provision applies.

(B) If the acquisition value is $50,000 or more but is less than $100,000, the provision with its Alternate II applies.

(C) If the acquisition value is $100,000 or more but is less than $102,280, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan- Certification. This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-Representation and Certifications. This provision applies to all https://www.acquisition.gov/far/52.219-2#FAR_52_219_2 https://www.acquisition.gov/far/part-19#FAR_Part_19 https://www.acquisition.gov/far/19.000#FAR_19_000 https://www.acquisition.gov/far/52.222-22#FAR_52_222_22 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-25#FAR_52_222_25 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-38#FAR_52_222_38 https://www.acquisition.gov/far/52.223-1#FAR_52_223_1 https://www.acquisition.gov/far/52.223-2#FAR_52_223_2 https://www.acquisition.gov/far/52.223-4#FAR_52_223_4 https://www.acquisition.gov/far/52.223-22#FAR_52_223_22 https://www.acquisition.gov/far/52.204-7#FAR_52_204_7 https://www.acquisition.gov/far/52.225-2#FAR_52_225_2 https://www.acquisition.gov/far/52.225-1#FAR_52_225_1 https://www.acquisition.gov/far/52.225-4#FAR_52_225_4 https://www.acquisition.gov/far/52.225-3#FAR_52_225_3 https://www.acquisition.gov/far/52.225-6#FAR_52_225_6 https://www.acquisition.gov/far/52.225-5#FAR_52_225_5 https://www.acquisition.gov/far/52.225-20#FAR_52_225_20 https://www.acquisition.gov/far/52.225-25#FAR_52_225_25

RFP No.75N95024R00037 ATTACHMENT 5 solicitations.

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.]

(i) 52.204-17, Ownership or Control of Offeror.

(ii) 52.204-20, Predecessor of Offeror.

(iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

(iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment- Certification.

(v) 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification.

(vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA– Designated Products (Alternate I only).

(vii) 52.227-6, Royalty Information.

(A) Basic.

(B) Alternate I.

(viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically in SAM website accessed through https://www.sam.gov. After reviewing the SAM information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

https://www.acquisition.gov/far/52.226-2#FAR_52_226_2 https://www.acquisition.gov/far/52.204-17#FAR_52_204_17 https://www.acquisition.gov/far/52.204-20#FAR_52_204_20 https://www.acquisition.gov/far/52.222-18#FAR_52_222_18 https://www.acquisition.gov/far/52.222-48#FAR_52_222_48 https://www.acquisition.gov/far/52.222-52#FAR_52_222_52 https://www.acquisition.gov/far/52.223-9#FAR_52_223_9 https://www.acquisition.gov/far/52.227-6#FAR_52_227_6 https://www.acquisition.gov/far/52.227-15#FAR_52_227_15 https://www.sam.gov/ https://www.acquisition.gov/far/4.1201#FAR_4_1201

RFP No.75N95024R00037 ATTACHMENT 5

FAR Clause # Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of provision)

Alternate I (Mar 2023). As prescribed in 4.1202(a) , substitute the following paragraph (a) for paragraph (a) of the basic provision:

(a)(1) The North American Industry Classification System (NAICS) codes and corresponding size standards for this acquisition are as follows; the categories or portions these NAICS codes are assigned to are specified elsewhere in the solicitation:

NAICS Code Size standard

[Contracting Officer to insert NAICS codes and size standards].

(2) The small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce, (i.e., nonmanufacturer), is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition—

(i) Is set aside for small business and has a value above the simplified acquisition threshold;

(ii) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(iii) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

https://www.acquisition.gov/far/4.1202#FAR_4_1202

Description:

[Name, Part Number and Description, manufacturer, and National Stock Number (if needed for additional identification tracking and/or disposition).]

Quantity/ Unit of Measure

Unit Acquisition

Cost

Item Identifier NIA Usage NE Notes

LABs94K-CS 2 $39,678.00 ✔ Sample storage

Battery Back-UP 2 $440.00 ✔ Sample storage

Gas Bypass 2 $1,660.30 ✔ Sample storage

Stainless Steel – 15 High for Standard 100/81 Boxes

60 $76.08 ✔ Sample storage

Stainless Steel – 15 High for Standard 100/81 Boxes

12 $51.40 ✔ Sample storage

TubeWrtier 360 MicroID 1 $44,731.93 20263 ✔ Cell culture lab

Cytation 5 1 $85,125.00 20264 ✔ Cell culture lab 09/27/22 Donation of Contractor Aquired Property received

TapeStation System 1 $34,043.07 20265 ✔ Molecular biology lab Replaced with #20069 in May 2017.

TapeStation System 1 $0.00 20266 ✔ Molecular biology lab

Clean Bench – 4ft Model 1 $5,660.28 19361 ✔ Stem cell lab

PCR System – real time fast 1 $79,986.67 19362 ✔ Stem cell lab

Incubator (CO2) w/RH 02 1 $7,463.33 19449 ✔ Cell culture lab

Incubator (CO2) w/RH 02 1 $7,463.33 19450 ✔ Cell culture lab

Incubator (CO2) w/RH 02 1 $7,463.33 19466 ✔ Cell culture lab

Microscope (florescent) 1 $26,207.41 19459 ✔ Cell culture lab

Decapper – Recapper 24 well 1 $9,006.00 19742 ✔ Molecular biology lab

Microscope – Orthoplan 1 $8,000.00 7830 ✔ Stem cell lab Permission from NIA to dispose 09/27/17

PCR System – fast realtime monitor 1 $0.00 18928 ✔ Stem cell lab Permission from NIA to dispose 09/27/17

PCR System – fast realtime cpu 1 $0.00 18929 ✔ Stem cell lab Permission from NIA to dispose 09/27/17

Kitchen Restock-Everest 3 Section Reach In Refrigerator, 54-85 CU. FT

1 $5,007.00 ESR3 ✔ Cell culture lab

Logos Biosystems, Inc. Automated Cell Counter

1 $14,049.80 L70001 ✔ Just purchased, not received yet, but will be used on NIA cells in cell culture lab

VWR-Rocking platform shakers 4 $3,908.72 10127-872 ✔ Just purchased, not received yet, but will be used on NIA cells in mol bio lab

Labrepco-Freezer (-20 degrees) 1 $1,397.00 LHP-5-UFMB ✔ Molecular biology lab

VWR-Dry Block Heater 1 $658.92 75838-270 ✔ Molecular biology lab

VWR-Heating Blocks 1 $102.64 13259-286 ✔ Molecular biology lab

VWR-Nutating Mixer 1 $241.77 76595-802 ✔ Just purchased, not received yet, but will be used on NIA cells in mol bio lab

VWR-Orbital Shaker 1 $941.02 89032-088 ✔ Molecular biology lab

Thomas Scientific-Aspiration system 2 $4,764.26 727203 ✔ Cell culture lab

Avantor-Hot Stirrer 1 $616.67 97042-674 ✔ Cell culture lab

GOVERNMENT FURNISHED PROPERTY

Furnished “As-Is”

* YES NO

ADDITIONALPROPOSAL INSTRUCTIONS ATTACHMENT 7

RFP No.75N95024R00037 Page 1 of 1

ADDITIONAL PROPOSAL INSTRUCTIONS and UNIFORM BUDGET ASSUMPTIONS

NIA Aging Cell Repository

In addition to the instructions and format requirements for the Proposal that are contained in Section L of the solicitation, the information presented in this attachment is intended to provide uniform budget assumptions that apply to the solicitation.

Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the technical evaluation factors, and the RFP as a whole, in the development of their proposal. The information requested here should be used as further guidance for the development of the Business Proposal.

• Protocols for cell line establishment, including but not limited to fibroblast cell lines, iPSC reprogramming and LCL transformation, and for isolation and quality control of DNA preparations shall be included in the proposal.

• Assume a maximum of fifty (50) cell lines to be banked per year and divided as follows:

Thirty-five (35) fibroblast cell lines and/or peripheral blood lymphocyte stocks (PBL) and/or LCL lines per year; Fifteen (15) iPSC lines per year. Provide projected costs for generating additional cell lines as optional.

• Assume a maximum of fifty (50) DNA isolations to be performed per year. Provide projected costs for additional DNA isolation as optional.

TECHNICAL PROPOSAL COST INFORMATION/SUMMARY OF LABOR

AND DIRECT COSTS

DIRECT LABOR:

Labor Category (Hours)

Year 1 (Hours)

Year 2 (Hours)

Year 3 (Hours)

Year 4 (Hours)

Year 5 (Hours)

Year 6 (Hours)

Year 7 (Hours) Total

(Title and Name - use additional pages as necessary)

Total Hours

DIRECT LABOR COST:

MATERIAL COST:

TRAVEL COST: $ $ $ $ $ $ $ $

OTHER (Specify):

TOTAL DIRECT COST:

Specific Instructions:

1. Do not include any individual salary information

2. Do not include any indirect cost or fee.

3. Do not submit the total amount of proposal.

4. Submit this information as a portion of the Technical Proposal.

Technical Proposal Cost Information/Summary of Labor and Direct Costs Page 1 of 1 (1/2011)

Attachment 8

SUMMARY OF RELATED ACTIVITIES

The following specific information must be provided by the offeror pertaining to the Project Director, Principal Investigator, and each of any other proposed key professional individuals designated for performance under any resulting contract.

a. Identify the total amount of all presently active federal contracts/cooperative agreements/grants and commercial agreements citing the committed levels of effort for those projects for each of the key individuals* in this proposal.

Professional's Name and Title/Position:

Identifying Number Agency Total Effort Committed

*If an individual has no obligation(s), so state.

b. Provide the total number of outstanding proposals, exclusive of the instant proposal, having been submitted by your organization, not presently accepted but in an anticipatory stage, which will commit levels of effort by the proposed professional individuals*.

Professional's Name and Title/Position:

Identifying Number Agency Total Effort Committed

*If no commitment of effort is intended, so state.

c. Provide a statement of the level of effort to be dedicated to any resultant contract awarded to your organization for those individuals designated and cited in this proposal.

Name Title/Position Total Proposed Effort

Summary of Related Activities Page 1 of 1 (1/2011)

Attachment 9

OMB No. 0990-0263 Approved for use through June 30, 2024

Attachment 10

Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule)

Policy: Research activities involving human subjects may not be conducted or supported by the Departments and Agencies adopting the Common Rule unless the activities are exempt from or approved in accordance with the Common Rule. The “pre-2018 Common Rule (or pre-2018 Requirements)” was originally promulgated in 1991 and amended on June 23, 2005 (70 FR 36325). The “2018 Common Rule (or 2018 Requirements)” was originally published on January 19, 2017 (82 FR 7149) and amended on January 22, 2018 (83 FR 2885) and June 19, 2018 (83 FR 28497). The categories of exempt research are provided in Section 101(b) of the pre-2018 Common Rule and Section 104(d) of the 2018 Common Rule.

The pre-2018 Common Rule requires institutions to certify that each application or proposal for research has been reviewed and approved by an Institutional Review Board (IRB) (Section 103(f)). The 2018 Common Rule requires institutions to certify that each proposed research study has been reviewed and approved by an IRB (Section 103(d)). Institutions must have an assurance of compliance that applies to the research to be conducted and should submit certification of IRB review and approval with each application or proposal, or proposed research study, unless otherwise advised by the Department or Agency.

1. Request Type

[ ] ORIGINAL

[ CONTINUATION

[ ] EXEMPTION

2. Type of Mechanism

[ ] GRANT

[ ] CONTRACT

[ ] FELLOWSHIP

[ ] COOPERATIVE

AGREEMENT

[ ] OTHER:

3. Name of Federal Department or Agency and, if known, Application or Proposal Identification No.

4. Title of Application or Activity 5. Name of Principal Investigator, Program Director, Fellow, or Other

6. Assurance Status of this Project (Respond to one of the following)

[ ] This Assurance, on file with the Department of Health and Human Services, covers this activity:

Assurance Identification No. , the expiration date IRB Registration No.

[ ] This Assurance, on file with (agency/dept) , covers this activity.

Assurance No. , the expiration date IRB Registration/Identification No. (if applicable)

[ ] No assurance has been filed for this institution. This institution declares that it will provide an Assurance and Certification of IRB review and approval upon request.

[ ] Exemption Status: Human subjects are involved, but this activity qualifies for exemption under the pre-2018 Common Rule, Section 101(b), paragraph .

[ ] Exemption Status: Human subjects are involved, but this activity qualifies for exemption under the 2018 Common Rule, Section 104(d), paragraph

7. Certification of IRB Review (Respond to one of the following IF you have an Assurance on file)

[ ] This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations.

by:

[ ] Full IRB Review on (date of IRB meeting) or [ ] Expedited Review on (date)

[ ] If less than one year approval, provide expiration date

[ ] This activity contains multiple projects, some of which have not been reviewed. The IRB has granted approval on condition that all projects covered by the Common Rule will be reviewed and approved before they are initiated and that appropriate further certification will be submitted.

8. Comments

9. The official signing below certifies that the information provided above is correct and that, as required, future reviews will be

10. Name and Address of Institution performed until study closure and certification will be provided.

11. Phone No. (with area code)

12. Email:

13. Name of Official 14. Title

15. Signature 16. Date

Authorized for local Reproduction

Sponsored by HHS

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0990-0263. The time required to complete this information collection is estimated to average 30 minutes per response. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer.

Table of Contents Updated July 31, 2007

Originally provided by the Social Security Administration Section 508 Program

HHS Guide to Completing the Section 508 Evaluation Template

Section 508 Evaluation Template

SECTION J – SECTION 508 PRODUCT ASSESSMENT TEMPLATE ATTACHMENT 11

HHS Guide to Completing the Section 508 Evaluation Template

Purpose:

This document provides Vendors with instructions on completing the Section 508 Evaluation Template for the US Department of Health and Human Services

Background:

In 2001, the Information Technology Industry Council partnered with the General Services Administration to create a tool that would assist Federal contracting and procurement officials in fulfilling the market research requirements specified in Section 508. The result of their collaboration was the 508 Evaluation Template – a simple, web-based checklist that allows Vendors to document how their product did or did not meet the various Section 508 Requirements.

How the Section 508 Evaluation Template is organized:

This template is also known as the Voluntary Product Accessibility Template (VPAT)

The Section 508 Evaluation Template consists of a long series of tables. The Summary Table is used to provide a sense of your product’s overall “level-of-conformance” with the Section 508 Standards.