RFP_No_NIHLM2013617.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority:

2. Request for Proposal (RFP) Number:

NIHLM2013617

3. Issue Date:

January 30, 2013

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : NIDDK DATA REPOSITORY

6. ISSUED BY:

National Library of Medicine National Institutes of Health NIDDK Acquisitions Branch 2 Democracy Plaza, Suite 700W 6707 Democracy Blvd, MSC 5455 Bethesda, MD 20892-5455

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 12:00PM local time on March 1, 2013. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

• The NIH will accept questions regarding this procurement submitted no later than close of business local time on Thursday February 7th. Questions and answers will be posted to FedBizOpps. Questions should be submited electronically to baileyrichard@mail.gov

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Richard E. Bailey, Contract Specialist

PHONE: 301-402-1139

e-MAIL: baileyrichard@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Edward J. Kostolansky Contracting Officer Office of Acquisitions National Library of Medicine mailto:baileyrichard@mail.gov http://www.sam.gov

RFP Number : NIHLM2013617

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS cont

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. COMMITMENT OF PUBLIC FUNDS

e. PROMOTING EFFICIENT SPENDING

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Past Performance Information

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12. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Cost and Pricing Data

5. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

6. Salary Rate Limitation

7. Small Business Subcontracting Plan

8. Mentor Protege Program, HHSAR 352.219-70

9. HUBZone Small Business Concerns

10. Total Compensation Plan

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. EVALUATION OF OPTIONS

4. TECHNICAL EVALUATION CRITERIA

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS cont.

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ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The NIDDK Data Repository will continue to: assist study coordinating centers, and the NIDDK Biosample and Genetics Repositories in setting up labeling systems to cross-reference samples and associated data; maintain a central inventory of samples from the NIDDK Biosample and Genetics Repositories, and provide inventory reporting structures for individual studies; receive and test the validity of electronic databases from completed studies; maintain and distribute those databases in response to researcher inquires; create and maintain a website for all of the NIDDK Central Repositories; and carry out activities to the research community about the availability of samples and data.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon during negotiations

ARTICLE B.3. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ .

b. The fixed fee for the Base Period of this contract is $ . For completion contracts: The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer.

Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period

Option Period(s):

Total

[Base Period and Option(s)]

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. DESCRIPTION-SPECIFICATION-WORKSTATEMENT-STATEMENT OF WORK

a. Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government under the terms of this contract, as needed to perform the work set forth below:

I. BACKGROUND INFORMATION

Storing and allowing subsequent use of biological materials and associated data collected in clinical studies is one way for the NIDDK to meet its responsibility to maximize the value of these studies. The NIDDK's Central Repositories' collection of the biosamples and associated clinical, diagnostic, genotypic, pedigree structure and/ or other data is a resource that advances the development of diagnostic and treatment tools for many diseases.

The NIDDK Biosample and Genetics Repositories, which are separately supported, house biological materials collected in large clinical studies. The project described in this Statement of Work, which will be referred to herein as the "Data Repository," stores the data from these large studies, including data associated with the stored biosamples and acts as the Data Coordinating Center for the NIDDK Central Repositories. The Data Repository, acting as a central coordinating entity, facilitates efficient distribution of data and samples. As an archive and distributor of highly usable legacy datasets, the Data Repository also allows re-analysis of these data and, where relevant, of specific biosamples, thus encouraging work by junior investigators, investigators with novel approaches, and others not included in the original funded studies.

Towards the above ends, the objective of this contract will be to continue the Data Repository, in order to accomplish the following in a highly efficient, rapid, secure, and cost-effective manner:

II. OBJECTIVES

• Receive and test the validity of electronic databases from completed studies, and maintain the stored databases

• Maintain stored databases

• Curate data to derive study metadata and descriptive variables that permit Web-based searches of the entire inventory using keywords and other features of samples and datasets

• Carry out activities to support cross-listing of sample inventory with other national and international sample catalogues

• Assist study coordinating centers and the NIDDK Biosample and Genetics Repositories in setting up labeling systems to cross-reference samples and associated data

• Maintain a searchable, up to date central inventory of samples kept at the NIDDK Biosample and Genetics Repositories, and provide inventory reporting structures for individual studies

• Create and maintain a searchable inventory of informed consents associated with each sample

• Create and maintain a website for all of the NIDDK Central Repositories

• Provide timely and informative analyses of databases in response to researcher inquiries about availability of appropriate samples and data

• Provide a system for requesting databases and/or samples, and or distribution of databases and/or stored samples to investigators granted access by the Project Officer, including a Web-based application and application review system

The information systems, consulting, and database archiving tasks outlined in this statement of work are highly technical, and require extensive experience, expertise, and long-term commitment. The data from each study represent the efforts of hundreds of investigators to improve the public health through biomedical research, and the voluntary participation of thousands of patients and family members. The data and samples represent taxpayer funded work by the National Institutes of Health and it is important that these be made available to qualified researchers for the public benefit. The data cannot be replaced without great expense and effort, and, therefore, it is essential that they be protected from loss, damage or misuse. The Contractor's project director

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Because all these studies contain data from human subjects, all staff must be familiar with human subjects protections and be sensitive to the bioethical issues involved in handling subject data. Finally, the Contractor must have a demonstrable long-term interest in providing these services, to ensure that there is continuity throughout the period of the contract.

III. GENERAL DESCRIPTION OF PROPOSED TASKS TO BE PERFORMED

Task 1. Receive and test the accuracy, completeness and validity of electronic databases of participant information from completed studies that include clinical, diagnostic, genotypic, pedigree structure and other data, along with supporting documentation.

a. The Contractor shall work with Data Coordinating Centers and other investigators from NIDDK-funded studies on an ongoing basis during the course of the study to prepare for receiving and testing the accuracy, completeness and validity of electronic databases. Database formats may differ from study to study. Individual studies may contain multiple files linked by encrypted patient identifiers. The Contractor shall work with Data Coordinating Centers of NIDDK-funded projects to ensure that these phenotypic databases are in a format that allows rapid and efficient searching and production of files for distribution.

b. In addition, the Contractor shall ensure that the database is accompanied by supporting documentation that describes the study protocols and summarizes the data collected. The Contractor shall post the Manual of Operations and all relevant data collection and other forms and relevant study materials in electronic and searchable format from each study providing a database, on a Website.

c. The Contractor shall carry out standardized testing of legacy databases to assess their integrity and completeness. The results of this testing shall be posted on a Website.

d. Within 1 month of the award of the contract, the Contractor shall establish a protocol for receipt and testing of databases and submit to the NIDDK Project Officer for approval.

Task 2. Link phenotypic data to high-density genotyping data stored in the dbGAP (database of Genotype and Phenotype) or comparable database.

a. The Contractor shall work cooperatively with the National Center for Biotechnology Information (NCBI) of the National Library of Medicine/NIH to effectively link the stored phenotypic data from studies to genotyping data stored in dbGAP. This cooperation shall include sharing stored materials and data analyses, and providing expert consultation, as needed, on phenotypic parameters.

b. The Contractor shall list all NIDDK studies available for dbGAP. However, studies that have not provided datasets directly to the NIDDK Repository will not be tested in any way to ensure data integrity, completeness or validity.

Task 3. Maintain stored databases and develop descriptive variables to facilitate searching across studies.

a. The Contractor shall not use the data for any purpose other than that specified in this contract, without written approval of the Project Officer.

b. The Contractor shall maintain the finished databases

c. The Contractor shall curate all datasets, including those in dbGAP, to produce a core set of descriptive variables for each study in order to facilitate searching across datasets and sample collections. The descriptive variables will be determined in consultation with the Project Officer, but shall include at a minimum:

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i. disease/condition

ii. study type

iii. study design

iv. sample type, if relevant

v. treatment/medication

vi. demographics of subjects

d. The Contractor shall continue to work with the NHLBI's BioLinCC, NCI's Common BioRepository Model, the P3G Renal DataShaper, and the Global Rare Diseases Patient Registry and Data Repository from the NIH Office of Rare Diseases Research to contribute high-level inventory data to national and international sample catalogues, formats and search engines. The Contractor shall identify additional potential opportunities for sharing information about available samples, as directed by the Project Officer.

e. Within 2 months of the award of the contract, the Contractor shall provide a list of recommended core variables that will be abstracted from each study to the NIDDK Project Officer for approval.

Task 4. Work collaboratively with data coordinating centers (DCC's) from new and ongoing studies and with the NIDDK Genetics and Biosample Repositories to facilitate use of the NIDDK Central Repositories.

a. The Contractor shall provide site identifiers and consult with Repositories Contractors and study investigators on sample labeling methods to facilitate the development of a uniform labeling system.

b. The contractor shall maintain the existing numbering/labeling and tracking system that is used by all Repositories for the storage of data and samples, informed consents, the tracking of data and samples, and the distribution of data and samples. This numbering/labeling system must be used in all correspondence between the Repositories and in all reports and updates to NIDDK to clearly indicate which studies and/or substudies are being considered.

c. The Contractor shall maintain a complete inventory based on files from the Biosample and Genetics Repositories that includes the minimal information agreed upon by the Repository Contractors and the NIDDK Project Officer. The inventory must identify specific sample labels codes on shipped samples, and clearly indicate additions, subtractions, and up to date totals of all sample types.

d. At minimum, the inventory shall include the following fields:

i. Study name

ii. Repository sample id

iii. Aliquot number

iv. Date received

v. Date collected

vi. Sample type

vii. Volume

viii. Status (present, shipped, or withdrawn)

e. In addition, the Contractor shall incorporate inventory data from other repositories storing specific NIDDK sample collections, as directed by the Project Officer, including the HALT-C study (SeraCare) and FIND (NCI- Frederick) collections.

f. The Contractor shall work with studies and with the Biosample and Genetics Repositories Contractors to develop appropriate customized formats and software tools for monitoring sample inventories by individual studies.

g. The Contractor shall establish and maintain a customized, Web-based automated reporting system for use by the NIDDK Project Officer to track sample inventories.

h. Within 1 month of the award of the contract, the Contractor shall have the inventory system established and completely functional. Search tools must be established within 2 months of award.

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Task 5. Develop systems to help ensure protection of the human subjects who contributed the research samples by maintaining the confidentiality of subjects and by maintaining a searchable inventory of informed consents and NIDDK Approval Letters from sample contributors.

a. Datasets will be received without personal identifiers and thus are unlinked to the subjects. The Contractor shall not accept any information, nor use any information collected under this contract, that would permit the Contractor as the keeper of a record system to establish the identity of a given subject or query the databases and retrieve information for an individual subject whose identity is known from some other source.

b. Traditional personal identifiers that may be utilized to establish the identity of individual subjects (e.g., surname, address, social security number, etc.) shall not be provided nor accepted by the Contractor. Instead, the Contractor shall work with the study's Data Coordinating Center, and the NIDDK Biosample and Genetics Repositories to develop an identifier code for each subject that will link the clinical and descriptive data to stored biosamples. Thus, all data received by the Contractor shall be untraceable by the Contractor to their original sources.

c. The Contractor shall not use the data for any purpose other than that specified in this contract, without prior written approval of the Project Officer.

d. The Contractor shall apply to the Office for Human Research Protections (OHRP) at the Department of Health and Human Services for a project assurance number, if such a number has not been assigned to the Contractor. Obtaining a project assurance number represents a binding commitment to minimum standards for the protection of human subjects, which safeguards the rights and welfare of all human research subjects. In addition, the Contractor shall meet the requirements of The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and other relevant government regulations governing health information from human subjects.

e. The Contractor shall obtain blank copies of pertinent and relevant Essential Documents used in the collection of the data received by the Contractor. The Essential Documents shall consist of the parent consent form, other consent forms deemed necessary and the NIDDK Approval Letter. The Contractor shall electronically store information about each Essential Document in an easily searchable Web-based format, including:

i. Site Number

ii. Study Site

iii. Consent Version Date

iv. NIDDK Consent Approved

v. Consent Comment

vi. Specimens Collected

vii. What disease(s) Approve

viii. Genetics Research

ix. Commercial Use

x. Restrictions on Length of Storage

xi. Name of NIDDK Reviewer

f. Within 2 months of the award of the contract, the Contractor shall provide the NIDDK Project Officer with the specifications of the consent tracking system for approval.

Task 6. Maintain a public forum, including a web site, as a resource for users of the Data Repository, and as a tool for public education about the Data Repository and its goals, including a list of publications resulting from use of NIDDK Central Repository samples.

a. In coordination with the NIDDK Biosample and Genetics Repositories, the Contractor shall create, maintain, and regularly update a public Web site, with appropriate links to other NIDDK, government, professional organization, and foundation sites. The site will include data regarding the resources, policies, and other information of each NIDDK repository. The Web site shall include tables of descriptive information describing the current status of each repository, including a brief description of each study, and searchable versions of all relevant study forms and manuals.

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b. The Website shall incorporate functions and applications as described in detail elsewhere in this Statement of Work, including Web-based systems for

i. searching sample inventories

ii. applying for access to data and samples

iii. reviewing requests for access to data and samples

iv. searching for informed consents and related documents associated with samples

v. tracking sample and data distribution

vi. tracking inquiries about samples or data

c. The Contractor shall solicit a list of publications from researchers who received data from the repository which have resulted from the use of the data and document these on the website. The Contractor will solicit this information from data recipients at least annually. In addition, the Contractor shall solicit and post similar lists from the NIDDK Biosample and Genetic Repositories. The Contractor shall also search relevant scientific literature databases, including those maintained by the National Library of Medicine, to identify publications that used data supplied by the NIDDK Data Repository. Electronic literature searches shall be carried out at least every 3 months.

d. Specifications and sample pages from the Web site shall be provided to the NIDDK Project Officer within 1 month of award. The Web site should be established within 2 months of contract award.

Task 7. Provide timely and accurate analyses of databases regarding the availability of data or samples, including the determination of the feasibility of the repository to meet the needs of a research request, such as the number of samples available that meet specific criteria.

a. The Contractor shall be able to query the various databases to respond to inquiries from researchers and from the NIDDK about the data, and/or about the biosamples that are stored by the NIDDK Genetics and Biosample Repositories. These queries will be limited to questions about the contents of the databases, such as number of cases or events. It is not intended for this function to serve as an analytical support for original research. Given that this is a highly detailed and complex task, the Contractor shall ensure that the contract is staffed at all times by personnel who are qualified to maintain and search databases.

b. When investigators request that the Contractor query the database or databases in the repository, the Contractor shall respond to that request in a timely manner. Responses to queries should be provided within a maximum of 2 weeks after the request is received. The Contractor shall develop a standard Letter of Agreement that will be signed by researchers making requests.

c. The Contractor shall charge fees for carrying out detailed queries of stored databases for inquiries that require more than 2 hours of effort. Within 2 months of the award of the contract, the Contractor shall establish an appropriate system for the accounting and reporting of fees in accordance with the fee schedule established jointly with NIDDK. The Project Officer retains the right to waive the access charge for a recipient. The Contractor shall establish a process, with approval of the Contracting Officer, to ensure that all such fees are promptly collected and accounted for accurately, and offset against contract costs in a proper and timely manner. The Contractor shall not distribute materials before payment in full is received, unless the Project Officer has waived the fees. Payment shall be in the most expeditious format (e.g., check, purchase order, electronic transfer) possible. Income received from fees charged shall be utilized to offset contract costs. Such income shall be reflected on the Contractor's invoice for the month it is received.

Task 8. Provide a system for requesting databases and/or samples, for distribution of databases and/or stored samples to investigators granted access by the Project Officer.

a. The Contractor shall create or maintain a Web-based Data/Sample Request System to facilitate review of applications for access to databases from the NIDDK Central Repositories, allowing distribution of materials to reviewers, recording of reviews, recording of final decisions, and maintenance of relevant documentation.

Specifically, the Contractor shall have systems for:

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i. Requesting datasets, with scientific review by NIDDK staff - requesters must submit requests, a signed Material Transfer Agreement, and an IRB approval

ii. Requesting renewable samples (such as DNA from cell lines or cell lines) , with scientific review by NIDDK staff - requesters must submit requests, a signed Material Transfer Agreement, an IRB approval, and a list of samples

iii. Requesting samples by study-approved ancillary study investigators, where no scientific review is required -requesters must submit requests, a signed Material Transfer Agreement, an IRB approval, a list of samples, and an approval letter from the parent study

iv. Requesting samples by contributing study investigators, where no scientific review is required - requesters must submit a list of samples

b. When investigators are granted access by the Project Officer for the requested data, the Contractor shall transmit the requested data within 2 weeks of NIDDK approval.

c. When investigators are granted access to samples, the Contractor shall develop a system for promptly notifying the Repository or Repositories holding the samples and monitoring fulfillment of the request.

d. The Contractor shall maintain a database that records all inquiries about the stored data, samples, and databases, and that lists all requests for samples, copies of databases or portions of databases. The database shall include the System assigned ID #, date of the request or inquiry, the name, phone number and affiliation of the inquirer and the date and nature of response by the Contractor.

e. The Contractor shall maintain a database that records all data and sample distributions. The system must be linked to the original request documents and include the following elements:

i. System assigned Request ID #

ii. Repository

iii. Requestor name

iv. Site/Institution

v. Study Name

vi. Primary Investigator

vii. Date of Request

viii. Sample Type

ix. Number of Samples

x. Shipped Date

f. The Contractor shall charge fees to recover costs associated with sample requests. Within 2 months of the award of the contract, the Contractor shall establish an appropriate system for:

i. Obtaining an estimate of costs from the appropriate Repository in accordance with the fee schedule established jointly with NIDDK

ii. Providing the estimate to the requester and obtaining requester approval of the estimated fees

iii. Obtaining a final cost for the samples from the appropriate Repository once the order has been finalized

iv. Providing the final invoice to the requester and ensuring payment of costs. The Contractor shall not distribute materials before payment in full is received, unless the Project Officer has waived the fees. Payment shall be in the most expeditious format (e.g., check, purchase order, electronic transfer) possible. Income received from fees charged shall be utilized to offset contract costs. Such income shall be reflected on the Contractor's invoice for the month it is received. The Contractor shall establish a process, with approval of the Contracting Officer, to ensure that all such fees are promptly collected and accounted for accurately, and offset against contract costs in a proper and timely manner.

Task 9. Establish and maintain general Quality Control (QC) and Quality Assurance (QA) programs.

The Contractor shall develop and implement general QA/QC programs covering activities critical for the successful operation of the repository. These are general operating procedures that are not specific to particular databases. The QA/QC programs shall include, but not be limited to:

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(a) Protocols for assessing the integrity of the databases

(b) Plans for tracking the quality and speed of responses to inquiries and requests

(c) Protocols for assessing the usability of the databases and supporting materials that are distributed

The Contractor shall submit, within 8 calendar weeks of award, a detailed protocol for these general QA/QC procedures that will be implemented for any and all databases acquired by the repository. Revisions specified by the Project Officer will be completed within 2 weeks, and the final version will then be submitted for approval by the Project Officer.

Task 10. Provide security and back-up systems and a plan for disaster recovery.

a. The Contractor shall establish systems to prevent loss of data and databases in case of physical damage or equipment failure. This includes a daily backup of all changes to electronic databases to protect against the accidental data loss. In addition, a backup copy of each database shall be stored in remote, secure location in a waterproof and fireproof container. This remote backup copy shall be updated weekly if there are any changes to the database. In addition, the Contractor shall establish systems that prevent electronic or physical access to data or computers storing data by unauthorized individuals.

b. The Contractor shall provide, within 8 calendar weeks of award, a detailed protocol describing security and back-up systems. Revisions specified by the Project Officer will be completed within 2 weeks, and the final version will then be submitted for approval by the Project Officer. The protocol shall be updated annually.

Task 11. Work in a cooperative fashion with the Project Officer, the External Expert Committee, and the Steering Committee.

The Contractor shall cooperate with the Project Officer, the External Expert Committee, and with Contractors and their representatives from the NIDDK Biosample and Genetics Repositories, through participation in the Steering Committee and through other activities. This includes, but is not limited to, cooperation in developing a sample labeling system, methods for cross-referencing, and database integration. In addition, the Contractor shall facilitate site visits by the Project Officer, the Steering Committee, and other groups, as directed in writing by the Project Officer.

ARTICLE C.2. REPORTING REQUIREMENTS

a. Technical Progress Reports In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports during the period of performance of this contract:

1. Web Based On-demand Reports: the contractor shall provide data and samples reporting structures for individual studies and bio and genetic repositories to include the following:

a. Detailed and summary listings listing of samples in inventory by sample types and repository, for a time period determinable by the user

b. Detailed and summary searchable information about data and sample requests received by the contractor, broken out by ancillary, external and internal requests, for a time period determinable by the user and to include fulfillment status of the requests

c. Detailed and summary searchable information about SDUCs, DUCs and MTAs received/executed for a time period determinable by the user

d. A study by study view of sample availability dates

e. A searchable listing of expired SDUCs and DUCs detailing request ID, study, contact information and expiration date

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2. Monthly: The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. Each monthly report submitted to the Project Officer shall include the following:

a. Income generated during that month, used as offset against that month's charges.

b. Specific study activities undertaken during the month such as curation and archiving, listed by study

c. Status report of study curation completion and progress towards completion

d. List of other activities undertaken during the month such as informed consent tracking, publications or database update and maintenance activities

e. Previous month's action items from conference(s) with NIDDK and completion status

f. Summary of visits to Website, broken out by external and internal access, and frequency of visits to study-specific data by the specific study group.

3. Quarterly: This report shall include a summation of the monthly progress reports. A monthly report will not be submitted for the final month of the quarter. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. Each quarterly report shall contain:

a. Summary of monthly income generated during the quarter

b. Summary of major Website enhancement and additions

c. Travel and communications undertaken during the quarter

d. Summary of progress in developing informed consent database cumulative and in the past quarter

e. Biosample and Genetic Repository LIMS coordination and activities undertaken during the quarter

f. Outreach and publications activities

g. Activities in developing specific protocols and Standard Operating Procedures

h. Curation completion progress and status report for the quarter

i. Sample data loading validation activities

j. Sample inventory QC activities undertaken with the Biosample and Genetics Repositories in the previous quarter

k. Budget performance for the quarter and cumulative to include total contract value, amount and percentage expended against the contract value, expenses incurred on operational and maintenance activities and expenses incurred on specific study activities.

l. Summary of visits to Website for the previous quarter, broken out by external and internal access, and frequency of visits to study-specific data by the specific study group.

4. Annually: This report shall include a summation of the results of the entire contract work for the period covered. An annual report will not be required for the period when the Final Report is due. A monthly/quarterly report shall not be submitted when an Annual Report is due. A brief annual report shall be compiled to summarize:

a. budget performance information to include income received over the past year

b. curation completion

c. Summary and monthly totals of visits to Website, broken out by external and internal access, and frequency of visits to study-specific data by the specific study group

d. overview of project specific activities contained in that year's monthly and quarterly reports

e. major changes over the past year, including new facilities, information systems and security systems added during the year

f. any planned major expansions or system changes.

5. Final report: This report shall consist of the work performed and results obtained for the entire contract period of performance as stated in Section F of this contract. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted on or before the last day of the contract performance period. An annual report shall not be required for the period when the Final Report is due. A final report, including an executive summary, shall summarize all of the activities conducted under the contract, at the time of the contract end or contract transfer to another Contractor.

6. Summary of Salient Results The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

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b. Other Reports/Deliverables

1. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty

(30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-RA within thirty

(30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. FIPS 199 Assessment

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In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

e. IT Security Certification and Accreditation (IT-SC&A)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS

f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS

g. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: http://ocio.nih.gov/docs/public/Nondisclosure.pdf.

http://ocio.nih.gov/docs/public/Nondisclosure.pdf

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(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

h. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

2. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/od under "Vendor Information and Documents."

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in Section F of this RFP.

The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer Officer of Acquisitions, NLM NIDDK Acquisition Branch 2 Democracy Plaza, 700W 6707 Democracy Blvd, MSC 5455

Bethesda, Maryland 20892-

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.hhs.gov/od http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, Project Officer is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Institute of Health 2 Democracy Plaza 6707 Democracy Blvd., MSC 5458 Bethesda, MD 20892

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

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be one year from the contract award date.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

Option 1 Contract Year 2

Option 2 Contract Year 3

Option 3 Contract Year 4

Option 4 Contract Year 5

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the Service Items specified in the Delivery Schedule which are described in SECTION C of this contract.

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text.