SOW_75N95024R00037.pdf

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 cultures of 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 not otherwise 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 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.

NOTE: Offerors shall provide details about the transfer of the biorepository and database, and how the transition period will be structured.

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 for research on aging. After the initial characterization of these and other cell lines for sterility and chromosomal abnormalities is 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 reprogramming of induced pluripotent stem cell (iPSC) and transformation of lymphoblastoid cell lines (LCL). Priorities shall be determined by the COR.

NOTE: For estimation purposes, assume a maximum of fifty (50) cell lines to be banked per year and divided as follows:

Twenty-five (25) fibroblast cell lines and/or peripheral blood lymphocyte stocks (PBL) and/or LCL lines per year;

Twenty-five (25) iPSC lines per year.

NOTE: Protocols for cell line establishment, including but not limited to iPSC reprogramming and LCL transformation shall be included in the proposal.

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

NOTE: Provide projected costs for generating additional cell lines, either iPSC or LCL, or any proposed genetic/genomic services as optional.

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.

NOTE: For estimation purposes, assume a maximum of fifty (50) DNA isolations to be performed per year. Detailed protocol for isolation and quality control of DNA preparations shall be included in the proposal.

D. Quality Assurance (QA). Perform systematic QA testing of biospecimen and data according to current research standards. Determine that cells for distribution meet criteria of sterility, safety (including that they be HIV negative where applicable), validation of cell type (species of origin, DNA fingerprinting) and karyotype. The Contractor shall be responsible for testing all newly acquired human cells for the presence of HIV. DNA from human cell lines will be characterized by microsatellite analysis for identification and sex determination purposes.

NOTE: Detailed QA protocols shall be included in the proposal.

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.

NOTE: If the proposal involves changes to the catalog, a detailed plan shall be included with the proposal.

H. Dues and exceptions. Collect from NIA grantees, academic, non-profit and industry/for-profit users costs associated with 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 participation in up to two (2) scientific conferences per year.

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, and 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. Required Reports/Deliverables

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

1. Monthly Contract-Related Summary of Sales Reports

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

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

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 Institute

v. total cell lines shipped by type - human, animal, IMR, and differentiated cell lines

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 in section IV.2. 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.

V. Section 508 Requirement

This requirement is applicable to the Statements of Work (SOW),generated by the Department of

Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board's Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board's standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing http://www.acquisition.gov/

Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

• 36 CFR 1194.21 (all)

• 36 CFR 1194.22 (all)

References:

HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005): https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html

HHS Section 508 Web site: http://508.hhs.gov/

HHS ASPA Web Communications Division Web site:

https://www.hhs.gov/web/index.html

US General Services Administration (GSA) Section 508 Web site:

https://www.section508.gov/

VI. 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;

http://www.section508.gov/ https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html http://508.hhs.gov/ https://www.hhs.gov/web/index.html https://www.section508.gov/ http://www.esrs.gov/

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.