Attachment_3_SOW_6.28.18.pdf

STATEMENT OF WORK

DATED: June 28, 2018 ATTACHMENT 3

ALCOHOL EPIDEMIOLOGIC DATA SYSTEM (AEDS)

NIH-NICHD-2018-09

1) BACKGROUND and INTRODUCTION:

The National Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of the National Institutes of Health, U.S. Department of Health and Human Services, is the lead agency in this country for research on alcohol abuse, alcoholism, and other health effects of alcohol. NIAAA provides leadership in the national effort to reduce alcohol-related problems by: 1) conducting and supporting research in a wide range of scientific areas including genetics, neuroscience, epidemiology, health risks and benefits of alcohol consumption, prevention, and treatment; 2) coordinating and collaborating with other research institutes and Federal Programs on alcohol-related issues; 3) collaborating with international, national, state, and local institutions, organizations, agencies, and programs engaged in alcohol-related work; and 4) translating and disseminating research findings to health care providers, researchers, policymakers, and the public.

NIAAA research is guided by the NIAAA 5 Year Strategic Plan FY 2017-2021: which sets forth research opportunities to increase understanding of why, how, and when people drink, and the development of alcohol use disorders (AUD). The Strategic Plan is available at https://www.niaaa.nih.gov/about-niaaa/our-work/strategic-plan. It serves as a roadmap for optimizing the allocation of NIAAA’s resources to areas of alcohol research most likely to benefit from additional support, translating scientific discoveries for the benefit of the public, and continuing to build on NIAAA’s position as the nation’s key source of evidence-based information on alcohol and health. Over the next five years, NIAAA will prioritize the following goals:

Goal 1: Identify Mechanisms of Alcohol Action, Alcohol-Related Pathology, and Recovery.

Goal 2: Improve Diagnosis and Tracking of Alcohol Misuse, Alcohol Use Disorder, and Alcohol-Related Consequences.

Goal 3: Develop and Improve Strategies to Prevent Alcohol Misuse, Alcohol Use Disorder, and Alcohol-Related Consequences.

Goal 4: Develop and Improve Treatments for Alcohol Misuse, Alcohol Use Disorder, Co-Occurring Conditions, and Alcohol-Related Consequences.

Goal 5: Enhance the Public Health Impact of NIAAA-Supported Research.

AEDS is a contract-funded effort in support of the NIAAA mission to provide in-house statistical and programming support for use by NIAAA staff who are conducting alcohol-related epidemiologic research. The current AEDS Contract, administered by CSR, Inc.

under contract number HHSN275201300016C provides NIAAA staff with technical support including expert statistical analysis and computer programming to facilitate publication by NIAAA staff of secondary analyses of epidemiologic survey and other data in reports and scientific journals. Major products are Surveillance Reports which are published on the NIAAA website (https://www.niaaa.nih.gov/) and scientific manuscripts which are published in peer-reviewed journals. Technical support services of the AEDS Contract are available for use by in-house NIAAA staff.

https://www.niaaa.nih.gov/about-niaaa/our-work/strategic-plan https://www.niaaa.nih.gov/

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The Contract supports alcohol-related epidemiologic research in numerous scientific areas including but not limited to: alcohol-related morbidity and mortality; alcohol-related unintentional and intentional injuries; alcohol screening and brief interventions; alcohol-related health disparities; and, interactions between alcohol and lifestyle risk factors including diet, exercise, and smoking. The Contract supports preparation by the Contractor of Surveillance Reports on national trends in per capita alcohol consumption, national trends in liver cirrhosis, and national trends in youth drinking. Examples of these Surveillance Reports are available at:

https://www.niaaa.nih.gov/research/guidelines-and-resources/epidemiologic-data.

The Contract coordinates with another NIAAA Contract, the Alcohol Policy Information System (APIS) by performing, on request from the AEDS Contracting Officer Representative (COR), data linkage between existing datasets containing problem indicator data and alcohol policy data available from APIS. APIS is an online resource that provides detailed information on selected alcohol policies across the United States. The site is found at http://www.alcoholpolicy.niaaa.nih.gov. NIAAA encourages researchers to combine the alcohol policy information in the APIS system with problem indicator data to produce studies that assess the impact of these alcohol policies.

NIAAA maintains a collection of material composed of survey data, statistical tabulations, reports, and technical papers not easily found elsewhere and relevant to epidemiological descriptions of and investigations into alcohol abuse and alcoholism. These holdings consist of electronic, hard-copy, and microfiche documents and other non-bibliographic types of data files.

These materials may be archived or used by the Contractor as needed.

2) Scope

The scope of this contract is to provide statistical and computer programming support to produce epidemiologic Surveillance Reports, as well as to assist in the production of alcohol-related epidemiologic manuscripts.

3) Technical Requirements

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below. Specifically, the Contractor shall:

A) Project Management

1. Provide all necessary personnel, material, equipment, facilities, and services for the development and the maintenance of the AEDS. This will include all activities and personnel to provide for: (a) acquisition and statistical/programming/processing of existing alcohol-epidemiologic data files and preparation of supporting documentation; (b) preparation of alcohol-related detailed epidemiologic data and scientific reports; (c) maintenance of a minimal library containing historical documents and documents needed for ongoing projects; and (d) all necessary administrative and epidemiologic research support activities. No activities or analyses shall be undertaken without https://www.niaaa.nih.gov/research/guidelines-and-resources/epidemiologic-data http://www.alcoholpolicy.niaaa.nih.gov/

DATED: June 28, 2018 Page 3 consent from the COR.

2. Have the responsibility for the development, conduct, and periodic reporting of surveillance activity under the close technical monitoring of the COR. This surveillance responsibility includes periodic tracking of selected data to assess progress toward reaching national objectives related to alcohol. In addition, the Contractor may be expected to provide responses to intermittent requests (about 40 per month) for quantitative information from NIAAA and outside requestors.

3. Facilitate a highly interactive working relationship with NIAAA staff by attending at least weekly meetings via teleconference. Often more frequent contact via e-mail, telephone and face-to-face meetings will be necessary. It is expected that most meetings will be held via teleconference.

4. All data and data sets acquired and maintained by the Contractor under the

AEDS Contract shall be returned to the NIAAA COR and CO. These data sets shall be provided in a format compatible with software used at NIAAA and shall be accompanied by detailed documentation.

5. The Contractor shall provide all necessary administrative, clerical, computational, programming, graphical, writing/scientific editing, and statistical support to facilitate and fulfill all research and related functions.

With respect to the management of electronic data, the following general requirements are identified:

a. The Contractor shall provide all in-house computer equipment and software necessary to fulfill all research and service functions, which may include, but are not limited to, computers, computer servers, SUN workstations and all necessary peripherals for data storage, and Internet access to support secure, FIPS 140-2 certified, file transfer. All computing equipment and software shall be compatible with that equipment and software maintained by NIAAA.

b. The Contractor shall determine and define proposed approaches, schedules, priorities, development approaches, and operation plans for review and approval by the CO and COR prior to the implementation of any development activities.

c. The Contractor shall adopt and implement, at a minimum, the policies, procedures, rules of behavior, controls and standards of the HHS and NIH Information Security Programs to ensure the integrity, confidentiality, and availability of Federal information and Federal information systems for which the Contractor will be responsible under this statement of work, or to which it may

DATED: June 28, 2018 Page 4 otherwise have access to as a result of this Statement of Work.

d. The Contractor shall document all procedures employed in operating the AEDS systems to ensure that the process by which any particular information item was identified, acquired, processed, and incorporated into AEDS can be completely understood; and provide an up-to-date and transparent description of procedures that can facilitate training and help users resolve detailed questions.

1. The Contractor will document procedures used in all aspects of information security, handling, storage, retrieval, delivery, display, and system operation and procedures pertaining to selection of changes in computer hardware and software and in system design and functionality. This includes documentation that describes changes in procedures, including the dates on which changes were implemented and a summary of the rationale for each change.

e. The Contractor will maintain the documentation in an archive that is accessible by project staff, the COR, and others as directed by the COR. The content shall be delivered electronically.

6. Any direct access to NIH computing resources, if required, shall be performed with Government-furnished equipment over secure, NIH provided, channels.

7. Interface with or adaptation of existing statistical and application packages at computer processing sites shall be provided by the Contractor as necessary, for support of all activities.

8. All software documentation and reports shall be submitted electronically in a version of Word/Office compatible with Government computer systems, such as Office 365. Included in this documentation shall be the accessibility reports for each document submitted which will serve to document to the Government that work was completed according to the Statement of Work as it pertains to accessibility issues and material content. Material will be delivered to the Government electronically. All deliverables in this contract designed to be made available on the NIAAA website shall be in compliance with all requirements applicable to agencies of the DHHS and NIH. This specifically includes requirements pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by P.L. 105-220 under Title IV (Rehabilitation Act Amendments of 1998) specified in the Electronic and Information Technology Accessibility Standards set forth by the Architectural and Transportation Barriers Compliance Board in 36 CFR Part 1194. This specifically includes requirements mentioned in Appendix A: Section 508 Accessibility Standards. The Complete text of Section 508 Final Standards can be accessed at: http://www.access-board.gov/508.htm http://www.access-board.gov/508.htm http://www.access-board.gov/508.htm

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9. Specific tasks under this contract shall be accomplished under the technical and scientific monitoring of the COR and are described below. For each product, the COR shall grant approval, with concurrence from the CO, of all major aspects of product development including selection of topic, data sets to be analyzed, major analytic approaches, literature reviewed, draft final product and final product. The Contractor shall estimate the level of effort required for each product and the estimated schedule of measurable milestones for each product.

Anticipated activities to support products include, but are not limited to, generating SAS/SUDAAN or STATA files, data extraction and reorganization, tabular presentation, targeted literature searches, targeted literature reviews, statistical computer programming and processing, computation of rates and statistical tests of significance and association, computation of statistical trends using advanced statistical methods such as joinpoint analysis, statistical adjustments, and preparation of draft and final reports. The Contractor is responsible for obtaining relevant datasets and reference materials for data analysis. All data from the previous contract will be transferred to the new Contractor. There are no specific hardware and software requirements. The Contractor is expected to use SAS/SUDAAN and/or STATA software whenever possible. NIAAA will provide licenses for SAS/SUDAAN.

10. All deliverables in this contract shall be in compliance with all requirements applicable to agencies of the DHHS and NIH. This specifically includes requirements mentioned the refreshed 508 guidelines, which can be found at:

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines. The NIH provides tools and resources for 508 Compliance at:

https://ocio.nih.gov/ITGovPolicy/NIH508/Pages/Resources.aspx

B) Meetings and Teleconferences

1. Planning Meeting Within four (4) weeks of contract award, the Contractor and appropriate Contractor staff shall meet in-person at NIAAA with the CO and COR and appropriate NIAAA staff to plan activities to be conducted during the one (1) year Base Period, and the four (4) Option Periods that constitute the contract’s period of performance, with emphasis on activities to be conducted during the Base Period.

C) Plan of Performance

1. Within five (5) weeks of contract award, the Contractor shall submit to the CO and COR electronic copies of a report including (1) a general outline of issues discussed, and directions proposed at the Planning Meeting, and (2) a draft plan of performance for the first contract year. The draft plan shall include a detailed time schedule for completion of all tasks, projected personnel and fund expenditures.

2. The Contractor shall also submit for approval to the CO and COR electronic copies of a draft plan of performance at the beginning of Year 2, Year 3, Year 4, and Year 5 (for tasks to be conducted during each of those option years).

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://ocio.nih.gov/ITGovPolicy/NIH508/Pages/Resources.aspx

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Following approval, the final plan of performance for each year shall be submitted to the CO and COR as electronic copies.

3. The Contractor shall also submit to the CO and COR electronic copies of a draft plan of performance and final plan of performance for each subcontract or similar agreement under this contract (on the effective date of the agreement).

D) Task 1 - Prepare Reports

Reports to be prepared by the Contractor are Surveillance Reports on three (3) topics and an Epidemiologic Data Directory.

1. Surveillance Reports and Data Directory

The Contractor shall prepare Surveillance Reports using survey and other data. The Contractor shall access data sets and related materials necessary for analyses in the most efficient and economic manner.

AEDS Surveillance Reports are a well-established mechanism by which researchers, policy makers and other interested individuals track alcohol-related information over time. Surveillance Reports on three (3) topics shall be produced. These three

(3) topics are:

a. Apparent per capita consumption of alcoholic beverages;

b. Liver cirrhosis mortality;

c. Trends in underage drinking in the United States

Copies of past reports on these topics are available at

The Surveillance report on apparent per capita consumption of alcoholic beverages shall be delivered annually (during each year of the contract). The Surveillance report on Liver Cirrhosis mortality shall be delivered two (2) times in years two (2) and four (4) of the contract. The Surveillance report on underage drinking shall be delivered one (1) time in year three (3) of the contract.

Prior to the initiation of each surveillance report on each topic, Contractor staff will review recent literature in the given area and recommend for consideration to the COR updates, changes, additions and refinements which would more accurately reflect the state-of-the-science while, at the same time, retaining comparability with previous versions to retain the report’s utility in tracking trends.

The Contractor shall use state-of-the art statistical methodology in examining the significance of trends in data included in the Surveillance Reports. This statistical methodology includes, but is not limited to, joinpoint analyses of trends. The statistical methodology used in all Surveillance Reports shall be approved by the COR. Whenever possible, State level data shall be reported.

2. Alcohol Epidemiologic Data Directory

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The Alcohol Epidemiologic Data Directory is a report that provides a current listing of surveys and other relevant data suitable for epidemiologic research on alcohol.

Most data sets described in this document are national in scope. A copy of the Alcohol Epidemiologic Data Directory is available at https://www.niaaa.nih.gov/research/guidelines-and-resources/epidemiologic-data. The Contractor shall update the Alcohol Epidemiologic Data Directory one

(1) time during the contract in Year four (4) of the contract.

E) Other Reports The following reports shall be prepared by the Contractor.

1. Monthly Progress Reports The Contractor shall submit to the CO and COR electronic copies of a monthly report briefly stating the progress made on each task, including percent completion of the project as of the end of the reporting period. The report shall include work completed and in-progress, difficulties encountered during the reporting period and remedial action taken, and a statement of activity anticipated during the subsequent reporting period. The reports shall also include any changes of personnel concerned with the project. Monthly reports shall be submitted within ten days after the end of the preceding month.

2. Annual Progress Report The Contractor shall submit each year to the CO and COR electronic copies of an annual report summarizing progress made on each task. The report shall include work completed and in-progress. The report shall also include any changes of personnel concerned with the project. The annual report shall be submitted no later than 10 days before the end of the contract year.

3. Draft Final Report The Contractor shall submit an electronic draft final report describing the activities and accomplishments of the Contractor in the performance of this contract within two (2) months prior to the completion of the period of performance. The Government will review and return the approved draft with comments, if necessary, within thirty (30) calendar days. The draft report shall be formatted so that lines are double spaced and shall include all illustrations, tables, drawings, charts, and other pertinent material as is necessary and sufficient to comprehensively explain the results achieved under the contract.

4. Final Report Within fifteen (15) calendar days prior to completion of the period of performance, the Contractor shall submit to the COR and CO an electronic copy of the Final Report.

F) Storage of Prior Reports The Contractor shall warehouse hard copies of publications warehoused by the previous contractor. These are listed below:

• County Alcohol Problem Indicators 1986-90 (Vol. 3) (40 copies)

• State Trends in Alcohol-Related Mortality, 1979-92 (1,272 copies)

• U.S. Apparent Consumption of Alcoholic Beverages (Vol. 1, 4th ed.) (883 copies)

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• U.S. Apparent Consumption of Alcoholic Beverages (Vol. 1, 3rd ed.) (14 copies)

• Drinking in the United States: Main Findings From the 1992 National Longitudinal

Alcohol Epidemiologic Survey (NLAES) (Vol. 6, 1st ed.) (1 copy)

• Alcohol Consumption and Problems in the General Population: 1992 NLAES (517 copies)

• Alcohol Use and Alcohol Use Disorders in the United States: Main

• Findings from the 2001-2002 National Epidemiologic Survey (619 copies)

• Alcohol Use and Alcohol Use Disorders in the United States, A 3 Year

• Follow-Up Main Findings 2004-2005 Wave 2 NESARC (1758 copies)

• Alcohol-Related Emergency Department Visits and Hospitalizations and Their Co-

Occurring Drug-Related, Mental Health, and Injury Conditions in the United States (899 copies)

• Alcohol Use and Alcohol Use Disorders in the US (925 copies)

G) Task 2 - Technical Support for Epidemiologic Research and Queries

Technical support in the form of statistical data analysis, computer programming, and scientific writing shall be performed to support NIAAA staff in in-house research projects that result in data-related products including data tables and in scientific manuscripts which may be published in peer-reviewed journals. Technical support shall also be performed to assist NIAAA staff, which includes the Office of the Director, answer questions regarding alcohol epidemiology by performing data analyses or accessing existing reports or manuscripts. Topics shall include, but are not limited to, current statistics on prevalence of alcohol consumption, alcohol use disorders, alcohol use risk factors, alcohol-related morbidity and mortality, and other alcohol-related topics including co-use of alcohol and other drugs including marijuana and opioids. Technical support for research and queries and other related activities typically requires the Contractor to perform statistical data analysis of secondary epidemiologic datasets.

Technical support may also require the Contractor to search for, read, and summarize data available from existing reports. These existing reports are available from government agencies and other sources and include, but are not limited to, government and non-government agency reports and published scientific manuscripts. All technical assistance requests from NIAAA staff require pre-approval by the COR and concurrence by the CO. Technical assistance provided by the Contractor shall include, but is not limited to the following activities:

1. Providing technical support to NIAAA staff on approximately eight (8) scientific manuscripts per contract year on request from the CO and COR. Contract staff may be included as co-authors.

2. Providing technical support NIAAA staff on approximately six (6) abstracts suitable for presentation at conferences. Abstracts typically arise during manuscript development. Contract staff may be included as co-authors. Stand-alone abstracts, i.e., abstracts not generated during manuscript development, shall not be developed except on request by the CO and COR.

3. Technical support required for Technical Support for Epidemiologic Research and Queries activities 1 and 2 includes, but is not limited to:

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a. Statistical analysis of public-use epidemiologic datasets and/or other public data. Examples of data sources frequently used by NIAAA staff include, but are not limited to:

b. US population surveys and vital statistics from the National Center for Health Statistics (for example, the National Nutrition and Health Examination Survey, NHANES), provider surveys (for example, the National Ambulatory Health Care Survey), and vital records (for example, the National Death Index). These datasets are available at: https://www.cdc.gov/nchs/index.htm;

c. National Survey on Drug Use and Health (NSDUH) available at:

https://www.samhsa.gov/data/population-data-nsduh;

d. US traffic data (Fatality Analysis Reporting System) available at:

https://www.cdc.gov/nchs/data_access/vitalstatsonline.htm;

e. US Census data available at:

https://www.cdc.gov/nchs/data_access/vitalstatsonline.htm;

f. Local, State, or regional surveys of alcohol (for example, the Behavioral Risk Factor Surveillance System, BRFSS) available at:

https://www.cdc.gov/brfss/data_documentation/index.htm;

g. World Health Organization data available at:

http://www.who.int/healthinfo/statistics/en/;

h. NIAAA Alcohol Policy Information System data (APIS) available at:

https://alcoholpolicy.niaaa.nih.gov/;

4. Assistance with epidemiologic data analysis including: identification of relevant datasets, data cleaning, data file setup, formatting, statistical consultation, statistical programming, preparation of dataset documentation.

5. Computer programming of public use and other public data using software including, but not limited to the following statistical software: SAS, SUDAAN, and STATA. Licenses for SAS and SUDAAN are provided by NIAAA.

6. Preparation of background materials relevant to an ongoing data analysis such as performing targeted literature searches and preparing targeted literature reviews.

7. Writing the methods and results sections of scientific manuscripts for which the Contractor has generated data on request from the COR.

8. Other activities to be performed are:

a. Responding to queries from the NIAAA OD and NIAAA staff about alcohol consumption and related information that requires the Contractor to perform data analyses (for example, run data from the National Survey on Drug Use and Health [NSDUH]) to determine the prevalence of alcohol use among specified demographic subgroups in the US population) or to search for and examine published reports that include alcohol data. On average, approximately two (2) queries per month are anticipated. The effort for any one query is limited, with approximately three-fourths (75%) answerable in two (2) to eight (8) hours. The Contractor shall provide https://www.cdc.gov/nchs/index.htm https://www.samhsa.gov/data/population-data-nsduh https://www.cdc.gov/nchs/data_access/vitalstatsonline.htm https://www.cdc.gov/brfss/data_documentation/index.htm http://www.who.int/healthinfo/statistics/en/ https://alcoholpolicy.niaaa.nih.gov/

DATED: June 28, 2018 Page 10 tables within 24 hours. If an unforeseen delay occurs or additional time is needed, the Contractor shall notify the recipient of the delay and the expected delivery date.

b. Preparation of slides and posters based on data analyses performed by the Contractor (including formatting, printing of graphics, and printing of posters) for presentation at conferences, seminars and other research-related settings; and, printing of all other posters developed by the Division of Epidemiology and Prevention Research that do not involve analyses by the Contractor but do support NIAAA’s mission in Epidemiology.

Approximately six (6) posters shall be printed each year on request from the COR and concurrence by the CO.

c. Providing statistical tabular summaries upon request from the COR and concurrence from the CO. These tables are typically requested by the Office of the Director of NIAAA to answer specific questions posed by the Office of the Director or by staff seeking to respond to inquiries by outside investigators, other government agencies, or the public. The Contractor shall provide tables within 24 hours. If an unforeseen delay occurs, the Contractor shall notify the recipient of the delay and the expected delivery date.

d. Linking existing datasets with data from the NIAAA Alcohol Policy Information System (APIS). APIS is maintained through a separate contract.

i. APIS collects and provides authoritative, detailed information on alcohol-related laws and regulations through a public website with user-searchable information including policy summaries, full texts of laws and regulation, and charts, maps, and other displays.

ii. The AEDS Contract shall provide technical assistance for epidemiologic data analyses using APIS performed by researchers by:

1. Evaluating, on request of the COR and approval from the CO, the feasibility of linking specified epidemiologic data or datasets to APIS to facilitate epidemiologic research on a linked dataset, for example NIAAA’s data on Apparent Per Capita Alcohol Consumption, available at:

https://pubs.niaaa.nih.gov/publications/surveillance.htm

2. Performing linkages. Approximately four to six (4-6) linkages shall be performed each year on request from the COR with concurrence from the CO. The Contractor shall provide formatting and appropriate documentation for each linked dataset.

3. Linked data shall be transmitted within one week of receipt. If an unforeseen delay occurs, the contractor shall notify the recipient of the delay and the expected delivery date.

https://pubs.niaaa.nih.gov/publications/surveillance.htm

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iii. The Contractor shall become familiar with the universe of possible data sets of interest, to track the availability of such data sets and take necessary steps to access or acquire those necessary for surveillance and analysis. Controls shall be implemented which are appropriate with data sources for data protection. The Contractor shall provide quality assurance regarding protection of data. The Contractor shall develop and maintain all electronic data systems required for AEDS to serve effectively as an epidemiologic research and support resource to NIAAA.

iv. For all technical support requests from NIAAA the Contractor shall, within normal business hours, immediately confirm receipt to the CO and COR of the request from NIAAA. The Contractor response shall include an estimated time frame to provide the requested information.

H) Initial and Final Transition

1. Initial Transition

In the event of transition to a new contractor, ensure an orderly, secure and efficient transition from the predecessor contractor, as follows:

The contractor shall receive from the previous contract all paper files, reference materials, data files, computer programs, presentation materials, and other information and materials obtained or generated in the performance of the previous contract necessary to do the work under this Statement of Work. This data and material will be discussed at the Planning Meeting described in 3) B.1 of the Statement of Work and will be transitioned to the new contractor by the COR and CO in a timely manner as agreed to in the Planning Meeting.

2. Final Transition

The Contractor shall facilitate and ensure the smooth continuation of AEDS operations and performance of the various contract activities by the successor organization.

At the completion, the Contractor shall submit to the COR and CO, a transition plan, that includes all paper files, reference materials, data files, computer programs, presentation materials, and other information and materials obtained or generated in the performance of the contract and not already included in previous submissions. The disposition of all equipment purchased or leased with contract funds will be determined by the CO at the time of transition.