Attachment_2_-_Reporting_and_Deliverable_Requirements.pdf

Attachment 2 – Reporting and Deliverable Requirements

Reporting Requirements and Deliverables for Topic Area 1: Whole Genome Sequencing

XVI. Additional terms and conditions applicable to this requirement.

(1) REPORTING REQUIREMENTS

1. Technical Progress Reports

a. Weekly Progress Reports (See Item 10 below) The Contractor shall submit a weekly report describing the activities during the reporting period, and the activities planned for the ensuing reporting period. The initial reporting period consists of the first full week of performance plus any fractional part of the initial week. As a minimum, this report shall include:

i. A qualitative description of overall progress, including the status of the Whole Genome

Sequencing (WGS), the weekly and monthly QC data (used here and throughout encompassing quality assurance and quality control activities), the weekly and monthly production, completeness, mean coverage, heterozygosity, fraction of coverage at 2/3 of the mean, median library insert size, % of bases above Q10, Q20, and Q30 for the given read size, known (filtered) SNV Ti/Tv Ratio, and novel (filtered) SNV Ti/Tv Ratio.

Status data should include: initial QC data parsed into “not yet processed,” “failed,” and passed; number of samples attempted sequencing parsed into “in progress,” “failed sequencing, “and “passed sequencing (and passed all QC)”; and “number of samples submitted to IRC.”

ii. An indication of any current problems that may impede performance, and proposed corrective action;

iii. A discussion of the work to be performed during the next reporting period; and

iv. Recommendations.

b. Final Report (See Item 12 below)

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Contractor shall provide the Contracting Officer with copies of the final report in draft form 30 Calendar days prior to the delivery date for the final version of the final report. The Project Officer shall review the draft report and provide the Contracting Officer with comments within 15 Calendar days after receipt. The Contractor, if necessary shall correct the final report.

2. Other Reports/Deliverables

a. Final Manual of Operations (See Item 1 below) Within one (1) month of contract award, the Contractor shall deliver a final copy of the Manual of Operations included in their proposal. The final Manual of Operations will incorporate all changes or modifications agreed upon by the Government and the Contractor during contract negotiations and the first month of contract performance. At a minimum, the final Manual of Operations shall contain the following:

i. Detailed description of sample receipt, storage, and tracking methodology assuring participant confidentiality, including:

1. Procedures for the receipt of samples and data, including, if necessary, completion of distribution agreements with participating studies and providing evidence of the Contractor's Institutional Review Board approval.

2. Required procedures for DNA preparation, aliquotting, labeling, and shipping, and minimum acceptable standards for DNA quantity and quality for samples submitted for sequencing.

3. Provision for whole genome amplification if submitted DNA samples are not sufficient for proposed analyses.

4. Procedures for tracking data and sample identification information for samples submitted for whole genome sequencing.

5. Methods for electronic and genetic tracking of samples including but not limited to genetic barcodes and gender identification; minimization of sample switches, losses, and cross contamination; tracking of work, and details of the in-house Laboratory

Information Management System (LIMS).

6. Methods for storage of DNA samples and back-up plans.

7. Recommendations for sample platting and other strategies to assist in minimizing batch effects and other biases.

8. Updates in the above agreed to between the Government and the Contractor.

ii. Detailed description of the large-scale WGS method, including:

1. Methods for optimizing and evaluating the WGS method and platform.

2. Instrumentation and robotics necessary to perform whole genome sequencing and procedures for equipment calibration and maintenance.

3. Methods for incorporating technology development to increase efficiency, quality and throughput.

4. Laboratory information management systems to be used, including software, nonproprietary platform, hardware, query system, transmission requirements, backups, and security.

5. A detailed workflow of WGS analysis and QC (which may include): quantification, post library prep, on-instrument sequencing raw data and post genome build, preprocessing, mapping, post-alignment processing, variant calling, annotation, and prioritization, including criteria, the tools used and versioning.

iii. Detailed description of laboratory QC procedures, including:

1. Methods to reduce or eliminate systematic errors.

2. Source and frequency of use of internal standards, repeat samples, and blank samples.

3. Procedures for computational checking and rechecking, assessment of reading errors and data consistency, and calculation of error rate and failure rate of sequencing attempts and for samples.

4. Methods for routine alternate procedures to be used when DNA samples or sequencing fails.

5. Methods to reduce or eliminate errors in computational and informatics aspects of the sequencing.

6. Methods for identifying sample mix-ups.

7. Procedures for identifying and implementing corrective actions based on QC.

iv. Detailed description of genetic analysis and bioinformatics for data cleaning including:

1. Procedures for genetic analysis including but not limited to the evaluation of Mendelian inconsistencies and checks for Hardy-Weinberg equilibrium, as well as internal standards and QC/QA used in the workflow of WGS analysis: raw data QC, preprocessing, mapping, post-alignment processing, variant calling, annotation, and prioritization.

2. Methods for correcting inconsistencies and handling inconsistent data to maximize accuracy.

v. Detailed description of informatics used for sequencing, database management, and data transfer including:

1. Software and hardware system components, including commercial products and custom software developed for support of database, associated informatics functions, and protocols and formats for data transfer, including a description of the rationale for the chosen database information model and past experience with it. Offerors should catalog proprietary and open-source elements, and identify specific license limitations including terms that could potentially affect future resource access and portability. For customized applications, describe the use of industry and informatics best practices in the development of the components. Data information management systems to be used, including software, nonproprietary platform(s), hardware, backups, and security.

Item Activity Deliverable Month(s) After Contract

Award

(1) Final Manual of Operations Copies to Contracting Officer (CO) and Contracting Officer Representative (COR)

Within 30 days of the start of the contract period

(2) Certifications for any required security clearances, security awareness training, system security plan, Non Disclosure Agreements, and IRB authorization

Copies to CO, and COR, Within 30 days of the start of the contract period

(3) Pilot QC of representative cohort(s) DNA samples and TOPMed controls

Report sent to COR, designated cohort, and NHLBI designated

DCC

Within 7 days

(4) Perform initial whole genome sequencing (WGS) of 150 samples and delivery of data in formats specified

All data via delivery requested by

NHLBI - TBD

Within 6 weeks after receipt of samples

(5) Complete whole genome sequencing on all samples received at a minimum of 150 samples per week during production

Within 11 months of Contract Initiation

(6) Preform requested QC, data cleaning, preprocessing, mapping, post-alignment processing, variant calling, annotation, and prioritization.

Cleaned data set securely delivered to NHLBI designated IRC, and/or dbGaP.

Monthly, as sequences are completed, to allow for QC by designated NHLBI recipient(s)

(7) Provide completed WGS data set(s) for all project(s)

Final data sets securely delivered to NHLBI designated IRC, and/or dbGaP and designated cohort(s) if requested

At the close of the contract period

(8) Participation (as needed) in TOPMed conducted data quality and data deposition calls

Participate in Conference Calls and Emails to clarify issues regarding QC and data delivery

As needed

(9) Participation (if requested) in biannual TOPMed meeting

One day meeting in Bethesda, MD Twice a year as requested by NHLBI

(10) Weekly Progress Reports Weekly

(11) Draft of Final Report Within 30 days of the close of the contract period

(12) Final Report At the close of the Contract Period

(13) All Stored Data (if requested by

NHLBI)

At the close of the Contract Period (with options for 6 and 12 month additional storage)

Deliveries required by the Contractor shall be made as set forth in the contract and as prescribed with FAR Clause 52.212-4, to the address/addressee listed below. The items shall be addressed and delivered to as specified below:

Addressee Deliverable Item No. Quantity COR Items (1) through

(13) One (1) hard copy and one (1) electronic copy/CD (archival)

Contracting Officer Items (1), (11), and (12)

One (1) hard copy and one (1) electronic copy/CD (archival)

NHLBI designated data repositories

Items (2), (3), (4), (6), (7), and (13)

Encrypted and secured delivery via electronic transfer or RAID storage at NHLBI direction

NHLBI designate cohort(s) Items (3), (4), and (7) Encrypted and secured delivery via electronic transfer

Reporting Requirements and Deliverables for Topic Area 2: Genome Wide-Methylation Profiles

(1) REPORTING REQUIREMENTS

(b) Reporting and Deliverable Requirements

1. Technical Progress Reports

a. Bi-Weekly Progress Reports (See Item 7 below)

The Contractor shall submit a bi-weekly report describing the activities during the reporting period, and the activities planned for the ensuing reporting period. The initial reporting period consists of the first two full weeks of performance. As a minimum, this report shall include:

i. A qualitative description of overall progress, including the status of the genome-wide DNA methylation profiling, the bi-weekly and monthly QC data, the bi-weekly and monthly profiling completeness. Status data should include: number of samples attempted profiling parsed into “in progress,” “failed profiling, “and “passed profiling (and passed all QC)”; and “number of samples submitted to IRC.”

ii. An indication of any current problems that may impede performance, and proposed corrective action;

b. Final Report (See Item 9 below)

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Contractor shall provide the Contracting Officer with copies of the final report in draft form 30 Calendar days prior to the delivery date for the final version of the final report. The Project Officer shall review the draft report and provide the Contracting Officer with comments within 15 Calendar days after receipt. The Contractor, if necessary shall correct the final report.

Within one (1) month of contract award, the Contractor shall deliver a final copy of the Manual of Operations included in their proposal. The final Manual of Operations will incorporate all changes or modifications agreed upon by the Government and the Contractor during contract negotiations and the first month of contract performance. At a minimum, the final Manual of Operations shall contain the following:

i. Detailed description of sample receipt, storage, and tracking methodology assuring participant confidentiality, including:

1. Procedures for the receipt of samples and data, including, if necessary, completion of distribution agreements with participating studies and providing evidence of the Contractor's Institutional Review Board approval.

2. Required procedures for DNA preparation, aliquotting, labeling, and shipping, and minimum acceptable standards for DNA quantity and quality for samples submitted for profiling.

3. Procedures for tracking data and sample identification information for samples submitted for genome-wide methylation profiling.

4. Methods for electronic tracking of samples including but not limited to barcodes; minimization of sample switches, losses, and cross contamination;

tracking of work, and details of the in-house Laboratory Information Management System (LIMS).

5. Methods for storage of DNA samples and back-up plans.

6. Recommendations for sample preparation and other strategies to assist in minimizing batch effects and other biases.

7. Updates in the above agreed to between the Government and the Contractor.

ii. Detailed description of the genome-wide DNA methylation profiling method, including:

1. Methods for optimizing and evaluating genome-wide DNA methylation and platform.

2. Instrumentation necessary to perform genome-wide DNA methylation profiling and procedures for equipment calibration and maintenance.

3. Methods for incorporating approaches to increase efficiency, quality and throughput.

4. Laboratory information management systems to be used, including software, nonproprietary platform, hardware, query system, transmission requirements, backups, and security.

5. A detailed workflow of genome-wide DNA methylation analysis and QC.

iii. Detailed description of laboratory QC procedures, including:

1. Methods to reduce or eliminate systematic errors.

2. Source and frequency of use of internal standards, repeat samples, and blank samples.

3. Procedures for computational checking and rechecking, assessment of reading errors and data consistency, and calculation of error rate and failure rate of sequencing attempts and for samples.

4. Methods for routine alternate procedures to be used when genome-wide DNA methylation profiling fails.

5. Methods to reduce or eliminate errors in computational and informatics aspects of the sequencing.

iv. Detailed description of analysis and bioinformatics for data cleaning including:

1. Procedures for analysis including but not limited to checks for internal standards and QC/QA used in the workflow of genome-wide DNA methylation analysis: raw data QC, preprocessing and mapping.

2. Methods for correcting inconsistencies and handling inconsistent data to maximize accuracy.

v. Detailed description of informatics used for genome-wide DNA methylation profiling, database management, and data transfer including:

1. Software and hardware system components, including commercial products and custom software developed for support of database, associated informatics functions, and protocols and formats for data transfer, Including a description of the rationale for the chosen database information model and past experience with it. Offerors should catalog proprietary and open-source elements, and identify specific license limitations including terms that could potentially affect future resource access and portability. For customized applications, describe the use of industry and informatics best practices in the development of the components. Data information management systems to be used, including software, nonproprietary platform(s), hardware, backups, and security.

(1) Final Manual of Operations Copies to Contracting Officer and

Contracting Officer Representative

Within 30 days of the start of the contract period

(2) Certifications for any required security clearances, security awareness training, system security plan, Non Disclosure Agreements, and IRB authorization

Copies to Contracting Officer, Contracting Officer Representative

Within 30 days of the start of the contract period

(3) Provide progress reports on the status of methylation and associated quality control measures

Report delivered to Contracting officer, Contracting Officer Representative and/or NHLBI designated IRC

Bi-weekly

(4) Provide timeline for generating genome-wide methylation profiles at 90 days, 6 months, 9 months and 1 year

Copies to Contracting officer, Contracting Officer Representative

Within 30 days of the start of the contract period

(5) Provide completed genome-wide methylation profile data for all samples provided

Final data sets securely delivered to NHLBI designated IRC, and/or dbGaP and designated cohort(s) if requested

At the close of the contract period

(6) Participation (as needed) in TOPMed conducted data quality and data deposition

Conference Calls and Emails to clarify issues regarding QC and data

As needed

(7) Bi-Weekly Reports Bi-Weekly

(8) Draft of Final Report At the close of the

Contract Period

(9) Final Report At the close of the

Contract Period

(10) All Stored Data (if requested by

NHLBI)

At the close of the Contract Period (with options for 6 and 12

Deliveries required by the Contractor shall be made as set forth in the contract and as prescribed with FAR Clause 52.212-4, to the address/addressee listed below. The items shall be addressed and delivered to as specified below:

Addressee Deliverable Item No. Quantity COR Items (1) through (5) and

(7) through (10) One (1) hard copy and one (1) electronic copy/CD (archival)

Contracting Officer Items (1), (3), (4), (8) and (9)

One (1) hard copy and one (1) electronic copy/CD (archival)

NHLBI designated data repositories

Items (5), and (10) Encrypted and secured delivery via electronic transfer or RAID storage at NHLBI direction

NHLBI designate cohort(s)

Items (5) Encrypted and secured delivery via electronic transfer

Reporting Requirements and Deliverables for Topic Area 3: RNA Sequencing Profiles

(1) REPORTING REQUIREMENTS

(a) Reporting and Deliverable Requirements

1. Technical Progress Reports

a. Bi-Weekly Progress Reports (See Item 7 below)

The Contractor shall submit a bi-weekly report describing the activities during the reporting period, and the activities planned for the ensuing reporting period. The initial reporting period consists of the first two full weeks of performance. As a minimum, this report shall include:

i. A qualitative description of overall progress, including the status of the RNA sequence profiling, the bi-weekly and monthly QC data, the bi-weekly and monthly profiling completeness. Status data should include: number of samples attempted profiling parsed into “in progress,” “failed profiling, “and “passed profiling (and passed all QC)”; and “number of samples submitted to IRC.”

ii. An indication of any current problems that may impede performance, and proposed corrective action;

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Contractor shall provide the Contracting Officer with copies of the final report in draft form 30 Calendar days prior to the delivery date for the final version of the final report. The Project Officer shall review the draft report and provide the Contracting Officer with comments within 15 Calendar days after receipt. The Contractor, if necessary shall correct the final report.

Within one (1) month of contract award, the Contractor shall deliver a final copy of the Manual of Operations included in their proposal. The final Manual of Operations will incorporate all changes or modifications agreed upon by the Government and the Contractor during contract negotiations and the first month of contract performance. At a minimum, the final Manual of Operations shall contain the following:

i. Detailed description of sample receipt, storage, and tracking methodology assuring participant confidentiality, including:

1. Procedures for the receipt of samples and data, including, if necessary, completion of distribution agreements with participating studies and providing evidence of the Contractor's Institutional Review Board approval.

2. Required procedures for RNA preparation, aliquotting, labeling, and shipping, and minimum acceptable standards for RNA quantity and quality for samples submitted for profiling.

3. Procedures for tracking data and sample identification information for samples submitted for RNA Sequence profiling.

4. Methods for electronic tracking of samples including but not limited to barcodes;

minimization of sample switches, losses, and cross contamination; tracking of work, and details of the in-house Laboratory Information Management System

(LIMS).

5. Methods for storage of RNA samples and back-up plans.

6. Recommendations for sample preparation and other strategies to assist in

ii. Detailed description of the RNA sequencing method, including:

1. Methods for optimizing and evaluating RNA sequence profiles and platform.

2. Instrumentation necessary to perform RNA sequence profiling and procedures for equipment calibration and maintenance.

3. Methods for incorporating approaches to increase efficiency, quality and throughput.

4. Laboratory information management systems to be used, including software, nonproprietary platform, hardware, query system, transmission requirements, backups, and security.

5. A detailed workflow of RNA sequence analysis and QC.

iii. Detailed description of laboratory QC procedures, including:

1. Methods to reduce or eliminate systematic errors.

2. Source and frequency of use of internal standards, repeat samples, and blank samples.

3. Procedures for computational checking and rechecking, assessment of reading errors and data consistency, and calculation of error rate and failure rate of sequencing attempts and for samples.

4. Methods for routine alternate procedures to be used when RNA sequence profiling fails.

5. Methods to reduce or eliminate errors in computational and informatics aspects of the sequencing.

1. Procedures for analysis including but not limited to checks for internal standards and QC/QA used in the workflow of RNA sequence analysis: raw data QC, preprocessing and mapping.

v. Detailed description of informatics used in RNA sequence profiling, database management, and data transfer including:

1. Software and hardware system components, including commercial products and custom software developed for support of database, associated informatics functions, and protocols and formats for data transfer, Including a description of the rationale for the chosen database information model and past experience with it. Offerors should catalog proprietary and open-source elements, and identify specific license limitations including terms that could potentially affect future resource access and portability. For customized applications, describe the use of industry and informatics best practices in the development of the

(1) Final Manual of Operations Copies to Contracting Officer and

Contracting Officer Representative

Within 30 days of the start of the contract period

(2) Certifications for any required security clearances, security awareness training, system security plan, Non Disclosure Agreements, and IRB authorization

Copies to Contracting Officer, Contracting Officer Representative

Within 30 days of the start of the contract period

(3) Provide progress reports on the status of RNA sequencing and associated quality control measures

Report delivered to Contracting officer, Contracting Officer Representative and/or NHLBI designated IRC

Bi-weekly

(4) Provide timeline for generating genome-wide RNA sequencing profiles at 90 days, 6 months, 9 months and 1 year

Copies to Contracting officer, Contracting Officer Representative

Within 30 days of the start of the contract period

(5) Provide completed genome-wide RNA sequencing profile data for all samples provided

Final data sets securely delivered to NHLBI designated IRC, and/or dbGaP and designated cohort(s) if requested

At the close of the contract period

(6) Participation (as needed) in TOPMed conducted data quality and data deposition

Conference Calls and Emails to clarify issues regarding QC and data

As needed

(7) Bi-Weekly Reports Bi-Weekly

(8) Draft of Final Report At the close of the

Contract Period

(9) Final Report At the close of the

Contract Period

(10) All Stored Data (if requested by

NHLBI)

At the close of the Contract Period (with options for 6 and 12

Deliveries required by the Contractor shall be made as set forth in the contract and as prescribed with FAR Clause 52.212-4, to the address/addressee listed below. The items shall be addressed and delivered to as specified below:

Addressee Deliverable Item No. Quantity COR Items (1) through (5) and

(7) through (10) One (1) hard copy and one (1) electronic copy/CD (archival)

Contracting Officer Items (1), (3), (4), (8) and (9)

One (1) hard copy and one (1) electronic copy/CD (archival)

NHLBI designated data repositories

Items (5), and (10) Encrypted and secured delivery via electronic transfer or RAID storage at NHLBI direction

NHLBI designate

Reporting Requirements and Deliverables for Topic Area 4: Metabolic Profiles

(1) REPORTING REQUIREMENTS

(a) Reporting and Deliverable Requirements

1. Technical Progress Reports

a. Bi-Weekly Progress Reports (See Item 7 below)

The Contractor shall submit a bi-weekly report describing the activities during the reporting period, and the activities planned for the ensuing reporting period. The initial reporting period consists of the first two full weeks of performance. As a minimum, this report shall include:

i. A qualitative description of overall progress, including the status of the metabolite profiling, the bi-weekly and monthly QC data, the bi-weekly and monthly profiling completeness. Status data should include: number of samples attempted profiling parsed into “in progress,” “failed profiling, “and “passed profiling (and passed all QC)”; and “number of samples submitted to IRC.”

ii. An indication of any current problems that may impede performance, and proposed corrective action;

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Contractor shall provide the Contracting Officer with copies of the final report in draft form 30 Calendar days prior to the delivery date for the final version of the final report. The Project Officer shall review the draft report and provide the Contracting Officer with comments within 15 Calendar days after receipt. The Contractor, if necessary shall correct the final report.

Within one (1) month of contract award, the Contractor shall deliver a final copy of the Manual of Operations included in their proposal. The final Manual of Operations will incorporate all changes or modifications agreed upon by the Government and the Contractor during contract negotiations and the first month of contract performance. At a minimum, the final Manual of Operations shall contain the following:

i. Detailed description of sample receipt, storage, and tracking methodology assuring participant confidentiality, including:

1. Procedures for the receipt of samples and data, including, if necessary, completion of distribution agreements with participating studies and providing evidence of the Contractor's Institutional Review Board approval.

2. Required procedures for sample preparation, aliquotting, labeling, and shipping, and minimum acceptable standards for quantity and quality of samples submitted for profiling.

3. Procedures for tracking data and sample identification information for samples submitted for metabolite profiling.

4. Methods for electronic tracking of samples including but not limited to barcodes;

minimization of sample switches, losses, and cross contamination; tracking of work, and details of the in-house Laboratory Information Management System

(LIMS).

5. Methods for storage of samples and back-up plans.

6. Recommendations for sample preparation and other strategies to assist in

ii. Detailed description of the metabolite profiling method, including:

1. Methods for optimizing and evaluating metabolite profiles and platform.

2. Instrumentation necessary to perform metabolite profiling and procedures for equipment calibration and maintenance.

3. Methods for incorporating approaches to increase efficiency, quality and throughput.

4. Laboratory information management systems to be used, including software, nonproprietary platform, hardware, query system, transmission requirements, backups, and security.

5. A detailed workflow of metabolite profile analysis and QC.

iii. Detailed description of laboratory QC procedures, including:

1. Methods to reduce or eliminate systematic errors.

2. Source and frequency of use of internal standards, repeat samples, and blank samples.

3. Procedures for computational checking and rechecking, assessment of reading errors and data consistency, and calculation of error rate and failure rate of sequencing attempts and for samples.

4. Methods for routine alternate procedures to be used when metabolite profiling fails.

5. Methods to reduce or eliminate errors in computational and informatics aspects of the sequencing.

1. Procedures for analysis including but not limited to checks for internal standards and QC/QA used in the workflow of metabolite profile analysis: raw data QC, preprocessing and mapping.

v. Detailed description of informatics used in metabolite profiling, database management, and data transfer including:

1. Software and hardware system components, including commercial products and custom software developed for support of database, associated informatics functions, and protocols and formats for data transfer, Including a description of the rationale for the chosen database information model and past experience with it. Offerors should catalog proprietary and open-source elements, and identify specific license limitations including terms that could potentially affect future resource access and portability. For customized applications, describe the use of industry and informatics best practices in the development of the

(1) Final Manual of Operations Copies to Contracting Officer and

Contracting Officer Representative

Within 30 days of the start of the contract period

(2) Certifications for any required security clearances, security awareness training, system security plan, Non Disclosure Agreements, and IRB authorization

Copies to Contracting Officer, Contracting Officer Representative

Within 30 days of the start of the contract period

(3) Provide progress reports on the status of metabolic profiles and associated quality control measures

Report delivered to Contracting officer, Contracting Officer Representative and/or NHLBI designated IRC

Bi-weekly

(4) Provide timeline for generating genome-wide metabolic profiles at 90 days, 6 months, 9 months and 1 year

Copies to Contracting officer, Contracting Officer Representative

Within 30 days of the start of the contract period

(5) Provide completed genome-wide metabolic profile data for all samples provided

Final data sets securely delivered to NHLBI designated IRC, and/or dbGaP and designated cohort(s) if requested

At the close of the contract period

(6) Participation (as needed) in TOPMed conducted data quality and data deposition

Conference Calls and Emails to clarify issues regarding QC and data

As needed

(7) Bi-Weekly Reports Bi-Weekly

(8) Draft of Final Report At the close of the

Contract Period

(9) Final Report At the close of the

Contract Period

(10) All Stored Data (if requested by

NHLBI)

At the close of the Contract Period (with options for 6 and 12

Deliveries required by the Contractor shall be made as set forth in the contract and as prescribed with FAR Clause 52.212-4, to the address/addressee listed below. The items shall be addressed and delivered to as specified below:

Addressee Deliverable Item No. Quantity COR Items (1) through (5) and

(7) through (10) One (1) hard copy and one (1) electronic copy/CD (archival)

Contracting Officer Items (1), (3), (4), (8) and (9)

One (1) hard copy and one (1) electronic copy/CD (archival)

NHLBI designated data repositories

Items (5), and (10) Encrypted and secured delivery via electronic transfer or RAID storage at NHLBI direction

NHLBI designate