RFP_ATTACHMENTS_75N94023R00007.pdf

RFP 75N94023R00007

NIAAA Alcohol Epidemiologic Data System (AEDS)

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

March 15, 2023 Page 1 of 2

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

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

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

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

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

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

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

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

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

https://ecps.nih.gov/ https://ecps.nih.gov/HowToSubmit http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

PACKAGING AND DELIVERY OF PROPOSAL ATTACHMENT 1

March 15, 2023 Page 2 of 2

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

Do not reference one proposal in another.

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

Examples:

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

II. FORMATTING:

Formatting for proposals

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

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

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

3. Font size must be 10 to 12 points.

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

5. Margins must be at least one-inch on all sides.

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

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title:

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

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

Choose one of the following Options:

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

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

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

ATTACHMENT 3, Statement of Work

STATEMENT OF WORK

DATED: January 16, 2023 ATTACHMENT 1

ARTICLE C.1 -- STATEMENT OF WORK

ALCOHOL EPIDEMIOLOGIC DATA SYSTEM (AEDS)

2023 -- 2028

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 (most recent posted is 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 analysis 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 HHSN275201800004C provides NIAAA staff with technical support including expert statistical analysis and statistical 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 https://www.niaaa.nih.gov/about-niaaa/our-work/strategic-plan https://www.niaaa.nih.gov/about-niaaa/our-work/strategic-plan

DATED: January 16, 2023 Page 2

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.

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 https://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 analysis and statistical programming support to the NIAAA to produce epidemiologic Surveillance Reports, as well as to assist NIAAA staff 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 https://www.niaaa.nih.gov/ https://www.niaaa.nih.gov/research/guidelines-and-resources/epidemiologic-data https://alcoholpolicy.niaaa.nih.gov/

DATED: January 16, 2023 Page 3 ongoing projects; and (d) all necessary administrative and epidemiologic research support activities. No activities or analyses shall be undertaken without 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 monthly meetings via teleconference. Often more frequent contact via e-mail, telephone, teleconference and face-to-face meetings will be necessary.

It is expected that most meetings will be held via teleconference. It is anticipated that approximately six (6) one-day meetings on site at NIAAA facilities will be requested each year.

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, statistical 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 in-house computer equipment and software necessary to fulfill all research and service functions, such as laptops, workstations, servers and storage. All computing equipment and software shall be compatible with equipment and software maintained by NIAAA. All computing equipment and software that is part of the system that contains NIAAA data shall be inventoried and secured in accordance with security plan requirements described in the Information Security clauses contained in the contract.

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

DATED: January 16, 2023 Page 4 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 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. 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.

7. 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

DATED: January 16, 2023 Page 5 text of Section 508 Final Standards can be accessed at: https://www.access-board.gov/ict.html .

8. 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. The Contractor is expected to use SAS/SUDAAN and/or STATA software whenever possible. NIAAA will provide licenses for SAS/SUDAAN.

9. 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.

2. Ad-hoc Meetings Facilitate a highly interactive working relationship with NIAAA staff by attending at least monthly meetings via teleconference. Often more frequent contact via e-mail, telephone, teleconference and face-to-face meetings will be necessary. It is expected that most meetings will be held via teleconference. It is anticipated that approximately six (6) one-day meetings on site at NIAAA facilities will be requested each year.

C) Plan of Performance https://www.access-board.gov/ict.html https://www.access-board.gov/ict.html 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

DATED: January 16, 2023 Page 6

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).

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

DATED: January 16, 2023 Page 7 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 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.

DATED: January 16, 2023 Page 8

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) (33 copies)

• State Trends in Alcohol-Related Mortality, 1979-92 (1,255 copies)

• U.S. Apparent Consumption of Alcoholic Beverages (Vol. 1, 4th ed.) (862 copies)

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

• Alcohol Consumption and Problems in the General Population: 1992 NLAES (503 copies)

• State Trends in Drinking Behaviors, 1984-2001 (Vol. 7) (496 copies)

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

• Findings from the 2001-2002 National Epidemiologic Survey (589 copies)

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

• Follow-Up Main Findings 2004-2005 Wave 2 NESARC (1,726 copies)

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

Occurring Drug-Related, Mental Health, and Injury Conditions in the United States (870 copies)

• Alcohol Use and Alcohol Use Disorders in the US (856 copies)

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

Technical support in the form of statistical data analysis and 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:

DATED: January 16, 2023 Page 9

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:

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:

i. 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;

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

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

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

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

iv. US Census data available at:

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

v. 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;

vi. World Health Organization data available at:

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

vii. 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. The contractor will not receive or solicit data that is identifiable in any way. If the contractor receives a request pertaining to such identifiable data, the COR should be notified immediately.

5. Statistical 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 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: January 16, 2023 Page 10 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 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:

DATED: January 16, 2023 Page 11

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.

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 statistical programming 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, statistical 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.

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

DATED: January 16, 2023 Page 12

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.

The Contractor shall submit to the COR and CO, a transition plan, that includes all paper files, reference materials, data files, statistical 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.

ATTACHMENT 4, Reporting Requirements and Deliverables

ATTACHMENT 3 - REPORTING REQUIREMENTS AND DELIVERABLES

DATED: January 16, 2023 Page 1

ARTICLE C.2 -- REPORTING REQUIREMENTS AND DELIVERABLES

Alcohol and Epidemiologic Data System (AEDS) 2023 - 2028

Schedule of Technical Deliverables - Included below is a schedule for the technical deliverables required for this contract:

Deliverable Quantity SOW Reference

Delivery Schedule

Planning Meeting Agenda The Contractor and appropriate Contractor staff shall meet virtually (or in person at NIAAA, at the discretion of the COR) with the Government COR, CO, and appropriate NIAAA staff to plan activities to be conducted during the base period, and any exercised options, during the contract period of performance, with emphasis on activities to be conducted during the base contract year.

1 electronic copy via e-mail to CO, COR and other NIAAA attendees (TBD)

3) B) 1 Within four (4) weeks after Contract start date.

Annual Plan of Performance the Contractor shall submit 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.

1 e-copy to NICHD Contracts [deliverables] Portal https://contracts.nichd.nih.gov

3) C) One (1) draft and final copy per year, starting within five (5) weeks of contract start date, and annually on the Option Start Date in Years 2, 3, 4, and 5 (for tasks to be performed during that applicable 12-month performance period).

For subcontract agreements, one draft copy 30 days prior to the effective date of https://contracts.nichd.nih.gov/

DATED: January 16, 2023 Page 2

Deliverable Quantity SOW Reference

Delivery Schedule the agreement, with a final copy following approval of the draft.

Monthly Progress Report The Contractor shall submit 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.

https://contracts.nichd.nih.gov

3) E) 1. Monthly reports shall be submitted within ten (10) days after the end of the preceding month.

No monthly report is required when the Annual or Final report is due.

Annual Reports The Contractor shall submit each year 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.

https://contracts.nichd.nih.gov

3) E) 2. Annual reports shall be submitted annually on or before the completion date of the applicable 12-month period of performance (Base Period or 12-month Option Period). No Annual Report is due when the Final Report is due.

Surveillance Reports Surveillance Reports on three (3) topics shall be produced

1 electronic copy to CO and COR, delivery as directed by

COR

3) D) 1. The Surveillance report on apparent per capita

DATED: January 16, 2023 Page 3

Deliverable Quantity SOW Reference

Delivery Schedule

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 consumption of alcoholic beverages shall be delivered annually (Once during Base Period, and once during each successive 12-month Option period).

The Surveillance report on Liver Cirrhosis mortality shall be delivered two (2) times in Option Period 1 [second year of contract] and two

(2) times in Option Period 3 [fourth year of contract]

The Surveillance report on underage drinking shall be delivered one (1) time in Option Period 2 [Year 3 of contract].

Alcohol Epidemiologic Data Directory 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.

1 electronic copy to CO and COR, delivery as directed by

COR

3) D) 2. The Contractor shall update the Alcohol Epidemiologic Data Directory one

(1) time during Option Period 3 [fourth year of contract]

Posters and Slides The Contractor shall prepare posters and slides for presentation at research

Review copies sent electronically to CO and COR, delivery as directed by COR

3) G) 8.b. As needed, approximately six (6) posters shall be printed

DATED: January 16, 2023 Page 4

Deliverable Quantity SOW Reference

Delivery Schedule conferences/meetings as required throughout the contract period of performance each year.

Draft Final Report** The Contractor shall submit a draft final report describing the activities and accomplishments of the Contractor in the performance of this https://contracts.nichd.nih.gov

3) E) 3. 60 days prior to the ultimate completion of the contract*

Final Report ** The Contractor shall submit a final report describing the activities and accomplishments of the Contractor in the performance of this contract.

The final report shall be typed double space or space and a half and shall include all illustrations, tables, drawings, charts, data sheets, and other pertinent material as is necessary and sufficient to comprehensively explain the results achieved under the https://contracts.nichd.nih.gov

3) E) 4. 15 days prior to the ultimate completion of the contract*

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

https://contracts.nichd.nih.gov

3) H) 2. 30 days prior to the ultimate completion of the contract* https://contracts.nichd.nih.gov/

DATED: January 16, 2023 Page 5

Deliverable Quantity SOW Reference

Delivery Schedule

Data/Data Sets*** All data and data sets acquired and maintained by the Contractor under the AEDS Contract shall be returned to the NIAAA

As directed by the COR and NIAAA Information Systems Security Officer

3) A) 4. 15 days prior to the ultimate completion of the contract*

*Ultimate completion date of the contract depends on the exercising of options.

**Draft Final Report and Final Report will due 15 days and 1 day respectively before the end of the final period exercised.

***Transition Plan and Data/Data Sets are due at the end of the final period exercised.

Schedule of Information and Physical Access Security Deliverables - Included below is a schedule for the information and physical access security-related deliverables required for this contract (see Article C.2 Reporting Requirements and the related Article in Section H, “Information and Physical Access Security” for full details):

Roster of Employees Requiring Suitability Investigations

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

Initial report due 30 days after contract award and thereafter written notice of updates to CO, COR and NIAAA ISSO, within 5 working days before a new employee assumes a position that requires access to HHS information systems or data; upon departure for departing personnel with such access.

Security Assessment and Authorization (SA&A Package) – Government Owned/Contractor Operated or Contractor Owned/Contractor Operated Resources

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

Due within 90 days after contract award.

Updated thereafter in accordance with the “Government Information Processed on GOCO or COCO Systems Sub-Article in Section H, and as requested by the NIAAA ISSO and directed/approved by the CO

Evidence of Completion of Mandatory HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management Training Course

(link to online course to be provided by NIH)

1 e-copy of completion certificates to CO, COR, Project Officer and NIAAA

ISSO

Within 30 days of contract award and annually thereafter for each annual term option exercised.

Incident Reporting 1 e-copy via e-mail to NIAAA Within 1 hour of discovery

DATED: January 16, 2023 Page 6

ISSO, NIH Incident Response Team (IRT), COR, Project Officer and CO

IT SC&A* 1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

Due three (3) months after contract award with annual assessment and reporting of results/verification that the IT-SC&A remains valid thereafter as requested by the NIAAA ISSO

Reporting of New and Departing Employees

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

Within 5 days of staffing changes and/or departures for positions that require Information Security access/suitability determinations

Vulnerability Scanning Reports

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

First report due 60 days after contract award.

Thereafter, monthly or as requested by the NIAAA ISSO and approved by the

CO.

Certification of Sanitization of Government and Government Activity-Related Files, Information, and Devices

1 e-copy via e-mail to CO, COR, Project Officer and

NIAAA ISSO

2 weeks prior to contract expiration or as specified by the NIAAA ISSO with approval by the CO.

For information stored in a Cloud Environment, data must be available to NIH within one (1) business day from request date.

*[IT-SC&A]

At the completion of the AEDS IT Security Certification and Accreditation (IT-SC&A), a Plan of Action and Milestones (POA&M) will be created to schedule and track the process of any remediation tasks identified during the assessment. Progress on those tasks will be reported within this report.

Schedule of Administrative and Regulatory Deliverables - Included below is a schedule for the administrative and regulatory deliverables required for this contract:

Section 508 Annual Report

– Electronic and Information Technology Accessibility

(see Article C.2. Reporting Requirements and the related Article in Section H)

1 e-copy to NICHD Contracts Portal https://contracts.nichd.nih.gov

November 30 of each year

Report of Gov’t Owned, Contractor Held Property

(see related Article in Section G)

1 e-copy to NICHD Contracts

November 30 of each year (submit negative report if no Gov’t Property)

DATED: January 16, 2023 Page 7

Service Contract Annual Report

(see Article I.4., FAR Clause 52.204-14, “Service Contract Reporting Requirements”)

Electronic submission to www.sam.gov and 1 e-copy to NICHD Contracts Portal

October 31st of each contract year in accordance with FAR 52.204-14

Annual Invention Utilization Report

(see related Article in Section C)

If any inventions to disclose, electronic submission to NIH Interagency Edison reporting system, http://www.iedison.gov and 1 e-copy to NICHD Contracts Portal https://contracts.nichd.nih.gov

If no inventions to disclose, send a negative report to the NICHD Contracts Portal

December 31 of each contract year

Final Invention Statement

(see related Article in Section C)

1 e-copy to NICHD Contracts

On or before the expiration date of the contract

Reporting of Financial Conflict of Interest (FCOI)

(see related Articles in Sections C and H)

1 e-copy via e-mail to the Contracting Officer

[Submit FCOI report and mitigation plan if and when a FCOI is identified]

As applicable, per “Institutional Responsibility Regarding Investigator Conflicts of Interest” Article in Section H of contract; in accordance with 45 CFR Part 94

All electronic reports (also designated as “e-copy” in the chart above) submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at http://www.hhs.gov/web/508/html under “Making Files Accessible.”

All reports required herein, other than those specifically designated to be submitted by e-mail or other method in the “Quantity” column in the chart above, shall be submitted in electronic format via the NICHD Contracts Portal available at the following website:

https://contracts.nichd.nih.gov. The Contractor must provide to the Contracting Officer/Contract Specialist the name of the person(s) submitting electronic reports via the NICHD Contracts Portal in order to initiate access to the Portal.

http://www.sam.gov/ http://www.iedison.gov/ https://contracts.nichd.nih.gov/ https://contracts.nichd.nih.gov/ https://contracts.nichd.nih.gov/ http://www.hhs.gov/web/508/html

ATTACHMENT 5

RFP 75N94023R00007, “NIAAA Alcohol Epidemiologic Data System (AEDS)”

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS

Update per FAC 2023-01 Last updated: 12/2022

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

52.204-8 Annual Representations and Certifications (DEC 2022).

As prescribed in…