RFPSisterStudy_Attachments_1-24.pdf

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/home/howto. 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. Hardcopy Submission

1. In addition to submission through eCPS, Offerors shall submit full paper copies of the technical proposal and the business proposal. Hardcopies must be identical to the proposals submitted through eCPS.

2. Hardcopies must be received by the date and time specified in the solicitation.

Shipment and marking shall be indicated below:

External Package Marking:

Mark each package as follows: “RFP NO: NIHES201800001 TO BE OPENED BY

AUTHORIZED GOVERNMENT PERSONNEL ONLY”

NUMBER OF COPIES

TECHNICAL PROPOSAL: 1 ORIGINAL AND 1 COPY TO:

BUSINESS PROPOSAL: 1 ORIGINAL AND 1 COPY TO:

If hand delivered: If using U.S. Postal Service:

Jennifer Smith, Contracting Officer NIEHS, Office of Acquisitions 530 Davis Drive Morrisville, NC 27560

Jennifer Smith, Contracting Officer NIEHS, Office of Acquisitions P.O. Box 12874 Mail Drop K1-05

RTP, NC 27709

*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.

C. Creating and Naming Files for electronic submission:

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 https://ecps.nih.gov/ https://ecps.nih.gov/home/howto 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.

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 AND PAGE LIMITATIONS:

A. Formatting for proposals

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

2. Font size must be 10 to 12 points.

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

4. Pages shall be of standard size (8.5x11). Margins must be at least one-inch on all sides.

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

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 100 pages.

2. Total page count does not include: Title and Back Page; Table of Contents; CVs/resumes;

Appendices; and Section Dividers that do not contain information other than title of Section.

3. Pages in excess of this limitation will be removed from the proposal and will not be considered http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

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 2

ATTACHMENT 3:

STATEMENT OF WORK

THE SISTER STUDY: ENVIRONMENTAL AND GENETIC RISK FACTORS FOR BREAST CANCER

October 15, 2017

CONTENTS

A. Background and Objectives

B. Core Task Activities (Task Order 1)

B.1. Continuity of Service

B.2. Technical & Research Support

General Research Support

Cohort Maintenance

Data Support

Laboratory Support

B.3. Contract Management Plan

B.4. Facilities/Equipment

B.5. Travel Requirements

B.6. Contractor/Subcontractor Responsibility

C. Contract Description and Tasks

C.1 Core Task (Task Order 1)

C.2 Additional Task Areas

D. Replication, Dissemination, or Use of the Results

APPENDIX A

APPENDIX B

Technical Model Plans

Sample Task Orders - Ancillary Collection and/or Analysis of Additional Data and/or Specimens

A. General Background and Objectives

The Epidemiology Branch, Division of Intramural Research, National Institute of Environmental Health Sciences, National Institutes of Health, Department of Health and Human Services (EB, DIR, NIEHS, NIH, DHHS) will utilize this contract to continue an epidemiological study of environmental and genetic risk factors for breast cancer. This R&D Support services contract is intended to provide the support needed to manage and maintain a cohort of more than 50,000 women, most of whom were enrolled between 2003-2009, from throughout the United States and Puerto Rico, who were between the ages of 35 and 74 at enrollment, and had a sister who had breast cancer. Also included in the cohort follow-up are ~1300 participants in a smaller ancillary study of the sisters with breast cancer. Beginning in 2003, prospective data, including biological and environmental specimens, have been collected to address a wide range of research questions related to women’s health.

Appendix A details existing participant enrollment, demographics, sample collection and some current outcomes and response rates.

The Contractor shall work successfully with diverse and challenging populations, including working with community groups and using best practices for collecting information from and sharing research results with community groups and study participants. The Contractor shall use best practices for recruiting and maintaining high retention rates with diverse populations in long-term studies.

The Contractor shall support the Government by administering, managing, and providing operational support in the conduct of the epidemiological research study designed and supervised by the NIH Principal Investigator (PI) alone or in collaboration with other scientists inside or outside of the NIH, and shall carry out directed analyses of data and biological and environmental samples for ultimate publication by NIH investigators in scientific journals. Contractor activities are described in this Statement of Work and shall include the following areas: maintaining high response and retention rates over follow-up years, collecting, handling, analysis, and tracking of environmental and human biological samples; conducting annual updates of contact information, health and vital status or cause of death;

collecting detailed follow-up data triennially; acquiring medical records or physician verification and pathological details to complement questionnaire data; abstracting, keying, editing, updating and recording data; creating the framework with which to address environmental hypotheses through linkage with geographically-based data systems; assuring the quality, integrity and security of data and samples, facilitating data analysis and collaborative studies, and providing statistical analysis support.

Technical support for this epidemiological research study has been provided under contract HHSN291200445525C, awarded on 23 August 2004 and expiring 22 August 2018. This contract is to continue support of this epidemiological research at the NIH. Data and specimens collected under this contract are the property of the US Government. Data and specimen management responsibilities will be transferred from the current contract to this new contract and/or subsequent contract(s). The data and specimens shall be handled according to the Privacy Act, 5 U.S.C. Subsection (e), within the Epidemiology Branch system of records.

B. Core Task Activities (Task Order 1)

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, materials, facilities, and equipment (other than those specified herein) to perform the Statement of Work.

B.1. Continuity of Service

The work to be performed under this contract is a continuation of work presently conducted under contract HHSN291200445525C. In the event of a new contractor, the Contractor shall ensure the orderly, efficient, and safe transition of all contract activities and materials within the first 60 days of contract award. At the direction of the COR, the Contractor shall develop a transition plan to transition all ongoing study activities from the current contract, and assume all responsibilities to conduct the ongoing management of a cohort of up to 60,000 participants (see Appendix A).

During this transition, the Contractor shall integrate or adapt, in accordance with the NIH PI, all study materials and public presence developed and utilized during the prior conduct of the study. The Contractor shall have substantial interaction with the NIEHS Data and Specimen Repository contractor and agrees to exercise best efforts and cooperation in specimen and archive handling responsibilities (see B.2.23).

The continuation of activities under this contract without interruption is important. Upon the expiration of this contract, a successor, either the Government or another Contractor, will continue the study. The Contractor agrees to exercise best efforts and cooperation to effect an orderly and efficient transition to a successor, generally during the final 60 days of the contract.

The Contractor shall, upon the Contracting Officer's or delegate's written notice, (a) furnish phase-in/phase-out services during the last year of the contract period, and (b) negotiate in good faith a plan with a successor to determine the nature and extent of the phase-in/phase-out services required. The plan shall specify a date for transferring responsibility of each division of work described in the plan, and shall be subject to the Contracting Officer's approval. The Contractor shall provide sufficient experienced personnel during the phase-in/phase-out period to ensure that the services required by this contract are maintained at a high level of proficiency.

Transition and phase-in/phase-out activities described here are applicable to the beginning year and final year of the Core task activities and will not be required during any option years unless otherwise directed by the Contracting Officer.

B.2. Technical & Research Support

During the course of the contract, the Contractor shall provide the following research support services:

General Research Support

1. Conduct pilot studies, literature reviews, computer searches, or other activities to determine best technologies, state-of-the-art analysis methods and vendors, standard operating procedures, innovations in communication, capabilities of collaborating institutions, and numbers of eligible study subjects; convene focus groups when appropriate; prepare, pretest, evaluate and produce data collection forms and methods.

2. Prepare training programs, operations and procedure manuals, and other required materials for study personnel. Design, develop, modify, standardize, furnish and maintain study forms and documentation and commercial quality materials, such as questionnaires, communications to participants, forms, brochures, shipping kits, media presentations, lab flow sheets, etc. Provide records management, document each step of the study and maintain, in an orderly and accessible manner, all relevant material so that any aspect of the study may be reviewed and evaluated by the PI, COR and other investigators with little or no prior notice.

3. Maintain a log of scientific decisions made during the study that affect the study design, conduct, or analysis. The log may consist of copies of relevant memos and notes from telephone conversations, but must include, at a minimum, a brief explanation and date of the decision and the name of the NIH staff member responsible for the change. All decisions that affect the cost or schedule of the study shall be referred to the COR, in advance, for approval through the CO via appropriate contract procedures.

4. Provide staff or identify consultants with expertise in the conduct of large cohort epidemiology studies, industrial hygiene/occupational exposure coding, medical record abstraction and coding, medication coding, Spanish language translation, participant interviewing, etc. In accordance with the standard practice, during all phases of contact with participants, it is essential that the Contractor match interviewer to participant gender and race whenever possible. This study will collect sensitive data on health outcomes, reproductive history, sexual orientation, and other personal behaviors. Other epidemiology studies have reported that matching interviewers to participants by gender and race significantly improves response rates, particularly among subgroups that are typically under-represented in population research studies.

a. Moorman PG, Newman B, Millikan RC, Tse C-KJ, Sandler DP. Participation rates in a case-control study: The impact of age, race, and race of interviewer. Ann. Epidemiol. 1999; 9:188-95.

b. Catania, J; Binson, D; Canchola, J, Pollack, L, Hauk, W; and Coates, T. Effects of Interviewer Gender, Interviewer Choice, and Item Context on Responses to Questions Concerning Sexual Behavior. Public Opinion Quarterly 60:3:345-370, 1996.

c. Pollner, M. The effects of interviewer gender in mental health interviews. J Nerv Ment Dis. 1998, Jun;

186(6):369-73.

d. Delamater J. Methodological issues in the study of pre-marital sexuality. Social Methods Res. 1974; 3:30–61.

5. Conduct, document and ensure proper study protocol training for and provide oversight of abstractors, interviewers, coders, and others who will acquire and assemble data, records and samples; provide contract staff with required and applicable safety, certification, privacy and ethics training with regard to human subjects research, Health Insurance Portability and Accountability Act (HIPAA) issues, good practices and standard operating procedures for safe handling of personal and private information, and biological and environmental specimens.

6. Provide administrative support and prepare required materials for Institutional Review Board, Certificates of Confidentiality, and other clearances.

7. Provide relevant/affected personnel to attend weekly, monthly and ad hoc staff meetings and to communicate regularly with NIH investigators, and with agents for parties whose cooperation or approval is needed. Maintain the ability to attend frequent in-person, face-to-face single-site meetings with the COR, NIH Principal Investigators, and NIH and multiple other Contractor staff to monitor activities of the study activities being simultaneously conducted. Face-to-face meetings are crucial to ensure that the study protocol and procedures are being carefully followed and modified when problems develop and will ensure the scientific quality of the study. Since many study activities will be receiving support simultaneously, in-person meetings will occur often/weekly with little warning. The following categories of Contractor staff must be able to meet this requirement: Directors, Managers, Analysts and Specialists as needed.

8. Provide administrative support for necessary travel of contract staff to subcontractor and/or collaborator sites for training, meetings, audits, and other travel as required; prior approval by the CO and COR is required. Provide administrative and travel support for ad hoc advisory meetings and teleconferences of relevant individuals, collaborators, consultants, etc. to aid in study design, logistics, or analysis.

9. Provide all deliverables and reports in accordance with the “Reporting Requirements / Deliverables” section of the contract and any attachment.

10. Upon completion of the Contract, assemble a compendium of all original questionnaires, forms, procedures, operations manual, analyses and other archival study materials to an electronic form suitable for efficient, secure long-term storage. The Contractor shall prepare archival data files for transfer to a designated location at contract completion.

Cohort Maintenance

11. Develop and implement strategies designed to maintain cohort retention and follow-up response rates with full participation from greater than 90% of living participants in a protocol demanding multiple tasks by participants (e.g., completing and returning follow-up questionnaires, medical records release authorizations and other forms). Particular attention shall be paid to retention of participants from lower socioeconomic backgrounds, racial or ethnic minorities, priority age groups, under-represented regions of the country, and groups with high rates of breast cancer and/or high rates of exposure to environmental contaminants.

12. Assume, adapt and maintain a study information website for participants and researchers, with secure data collection and transmission, adhering to federal government policies and guidance, including, but not limited to, compliance with Section 508 of the Workforce Investment Act of 1998, NIH and NIEHS policies, and Privacy Act 5 USC 552a, Rehabilitation Act of 1973, and which follow HHS IMR Policies for usage of web cookies, HHS web standards for usability, clear language, logos, etc.

13. Assist in the development and production of self-administered forms, and complex interviewer-administered and computer-assisted follow-up questionnaires. In addition, the Contractor shall provide advice on technological or other advances in methods for data collection and to maximize participation. The Contractor shall conduct data collection events during the period of performance, with activities such as a brief 1-to-4-page annual contact information and health status update, triennial detailed follow-up questionnaires, and periodic smaller ancillary collections of questionnaire data and/or medical record information.

14. Provide Spanish translation for all material used to correspond with participants:

questionnaires, letters, forms, instructions, website, etc. Provide visual and hearing disability modifications and accommodations for participants.

15. Assemble medical and death records, industrial hygiene, geocoding, diet, reproductive, occupational, environmental monitoring, etc. data and histories; have records evaluated and coded by appropriate nosologists, pathologists, industrial hygienists, clinicians, or other relevant experts and abstractors. For specialized procedures or knowledge not possessed by Contractor staff, develop and manage subcontracts and consultants. CO and COR approvals are required before any subcontract or consultant is awarded. The Contractor will monitor and document the performance and progress of any work done under subcontract in the performance of the study.

16. Identify and validate all new incident cases (~300 per year) of breast cancer in participants over the performance period.

17. Identify and validate other incident cancers, and major health events/diagnoses as specified by the NIH PI.

18. Utilize participant proxy contact information and other available resources to identify incident cancer cases, cases of incapacitation, and deaths in the cohort, and to update addresses and locate persons otherwise lost to follow-up.

Data Support

19. Following designs and decisions of the NIH PI, provide reproducible epidemiologic, statistical, genetic, bioinformatics, descriptive and other data analyses specified by the EB investigator:

identify sets of participants from among the cohort to serve as appropriate comparisons for analyses of environmental and biological factors; analyze high dimensional data; provide documentation of each step of data analysis, including initial analysis plan, initial archival data set(s), data changes or edits, analysis programs, tabular results, final data set, and evidence of reproducibility of published data; provide support for and facilitate receipt of data for pooling projects and meta-analyses; provide support for analysis and interpretation of high dimensional “omics” and other data.

20. Assist in developing NIH-compliant data sharing policies, provide systems for tracking data requests and data delivery, and uses of study data and samples; produce publication-quality graphics, tables, and figures as required for scientific publication of study analyses and findings.

“Public use data” shall conform to up-to-date conventions of privacy, including US privacy laws, OMB and NIST standards of data/information security, encryption and masking of Personally Identifiable Information (PII) such that distinguishing individual identity is not revealed.

21. Receive and fulfill analysis dataset requests from internal NIH and external investigators, and Cohort Consortium projects; provide oversight and guidance for analytic programming for summary variable creation in the format requested by each project, updates to original request and additional data required for analysis. Provide data services such as generating tables for collaborator grant applications. Individual requests may include, for example, 300-2,000 variables. Create outcome event algorithms (e.g., that summarize multiple sources to define prevalent and incident diagnoses), and harmonize data from various sources. For the purpose of proposing a budget, the Offeror shall anticipate the costs for 30 requests per year, of various size, investigator expertise and change requests.

22. Provide a FIPS 199 categorization ‘Moderate’ computing center and network under appropriate NIST, DHHS/NIH, FISMA, OMB, and IRB guidelines, integrating quality assurance and quality control of all data collection systems. Computing system shall have an Information System Security Plan, an updated Plan of Action & Milestones (POA&M) list, and a Certification and Accreditation Program. The Contractor shall complete NIH E-Authentication Threshold Analysis (ETA) and NIH E-Authentication Risk Assessment (ERA), and maintain HHS Privacy Impact Assessment(s) (PIAs) for information system. The computing center shall have capabilities and staffing sufficient for management of a system incorporating existing study data files, new data collections, data management, freezer monitoring, laboratory inventory, telephone and web-assisted interviewing, call center(s) and associated technologies, study management systems, archival data storage, analysis programming including genetic/bioinformatics programming, and analysis of high dimensional data, while adhering to relevant federal government laws, policies, standards and guidance, and in compliance with NIH enterprise architecture, with protections for PII and PHI, and appropriate risk management and risk mitigation systems in place.

Laboratory Support

23. The historical collection of ~4M cohort samples are labeled and tracked using BioSpecimen Inventory System (BSI, Information Management Services, Inc., Silver Spring MD). All samples are transferred for long-term storage at the NIEHS Repository (managed under a separate contract); the Contractor is not responsible for providing long-term storage of samples.

Contractor activities include sample coordination data management, inventory of specimens, receiving and processing of specimens for storage, and tracking specimen movement among Contractor, Repository, subcontractor, and collaborator sites.

24. Provide laboratory capabilities for receipt, inventory, processing, fractioning, bar-code labelling, shipping, and tracking of frozen, refrigerated or ambient samples. The laboratory shall maintain adequate and appropriate cold holding (+4°C, -20°C, -80°C, and LN2) for short-term storage during tasks for receiving, processing, packaging and sending out of study samples, and shall provide and implement a 24-hour-per-day emergency plan for freezer/refrigerator failures, including regular maintenance plan, installed temperature-control back-up systems, and notification of the Contractor staff and COR.

25. Research, evaluate and identify appropriate laboratories for conducting sample analyses; develop and monitor subcontracts with analysis laboratories. Provide assembling, tracking, shipping (and aliquoting if needed) requirements for such analyses. Evaluate quality assurance/quality control of laboratory analyses, coordinate data processing needs for analysis results. CO and COR approvals are required before any subcontract is awarded. The Contractor shall monitor and document the performance and progress of any work done under subcontract in the performance of the study. For the purpose of proposing a budget, the Offeror shall anticipate the costs for sending out 15,000 samples each year in 10 shipments per year to 4 subcontractor laboratories for analysis.

B.3. Contract Management Plan

The Contractor shall prepare an overall Contract Management Plan that will ensure the successful performance of all Core Task contract requirements provided in Section B. The Plan shall include a description of the proposed technical approach for overall project management and internal controls to ensure the safety and integrity of all aspects of the requirement. The Plan shall be in place at the start of the contract and updated and maintained throughout contract performance. The Contract Management Plan shall specifically address the following key areas:

1. Schedule Management: Provide a plan which describes and implements a detailed schedule of events for all core requirements of the contract, including activities for phase-in and phase-out events.

2. Staff Management: Provide a staff management plan that describes roles and responsibilities for all personnel, including a chart of the organizational/management structure of the project.

Include any planned subcontract and/or consultant staff. Provide details of proposed subcontractors and/or consultants; specify plan for scheduling and monitoring progress, and communication with Contractor, CO and COR. Identify management methods to maintain talented staff over the course of the Contract.

3. Facilities Management: Provide a comprehensive plan for the facility that provides for the required study operations, conduct, management, security and monitoring. Describe the proposed computing center. Computer and data security must be in accordance with NIEHS and

NIH requirements. Provide a full description which details and distinguishes existing and proposed facilities and equipment, with floor plans clearly marked with location and function.

4. Project Management: Provide a plan for the overall approach to coordinating, implementing, and completing the core work of the contract, ensuring acceptable performance, monitoring progress, and communicating with the Investigator and COR.

5. Quality Management: Provide a comprehensive plan for quality control/quality assurance and compliance, that will implement appropriate quality management procedures for all activities.

B.4. Facilities/Equipment

The Contractor shall provide all facilities and equipment not otherwise provided by the Government.

Study activities are conducted simultaneously, with more than 50,000 participants located throughout the US and Puerto Rico. To ensure project success and facilitate management, the Contractor shall create and maintain a centralized coordination site for performing and managing study activities.

A list of Government owned property in use on the current contract which will be transferred to the Contractor is provided herein. The Contractor shall provide the usual office and laboratory equipment and supplies, including any necessary specialized software. If equipment is required which is of no future value to the Contractor, or if unusual equipment is necessary for compatibility with existing or future government systems, the CO may approve its purchase under the Contract. All such items of equipment will be the property of the US Government.

B.5. Travel Requirements

The Project Director shall be responsible for managing subcontracts, which may involve limited travel, when deemed necessary by the NIH Principal Investigator, at the discretion of the COR and upon approval by the CO. The Project Director, or other staff shall also attend meetings with collaborators/consultants when their expertise is needed on study-related issues. Long distance travel for other than the Project Director, Managers, or Coordinators is not likely to be required. Travel costs pertaining to the management of the study will be covered by the Contract. The Government will not provide travel funds associated with attending any professional meetings or training workshops for Contract employees, without prior CO approval.

B.6. Contractor/Subcontractor Responsibility

The Contractor shall provide documentation and plans regarding security, liability and insurance for facilities and participant contact.

C. Contract Description and Tasks

The contract shall be structured as a single award Indefinite Delivery/Indefinite Quantity contract.

Services to be furnished under this contract shall be ordered by issuance of Task Orders. The ordering period shall be 10 years in length, beginning at award of the ID/IQ contract.

C.1 Core Task (Task Order 1)

The core work under this ID/IQ contract will encompass the activities provided for in Section B of this Statement of Work and shall make up Task Order 1. This Core Task will consist of a 12-month Base period with the option to extend for up to nine (9) additional 12-month periods. Task Order 1 will be awarded concurrently with award of the ID/IQ contract.

C.2 Additional Task Orders

Additional Task Orders to conduct small, separate ancillary projects for the collection and/or analysis of additional data and/or environmental and/or biological specimens are anticipated and shall be awarded as needed in accordance with specifications provided at the time of each Task Order award.

D. Replication, Dissemination, or Use of the Results

The data and specimens collected under this contract are confidential, and will be used as the basis for the epidemiological studies done by or in collaboration with the Epidemiology Branch, NIEHS only. The information may, by the Government only, be published in scientific journals, made available to Congress or to regulatory agencies, used in correspondence, or possibly given to the news media.

APPENDIX A

Demographic Characteristics The percentages for each characteristic may not add up to 100 due to rounding. The number of missing or not applicable were excluded from the total (N = 50,884) for calculating of percentages.

Age (in years) of Participant at Baseline Enrollment

Number of Participants Percentage

35-44 6,578 13%

45-54 17,520 34%

55-64 17,912 35%

65 or older 8,874 17%

Self-Reported Race/Ethnicity Number of

Participants Percentage

White, non-Hispanic 42,558 84%

Black, non-Hispanic 4,462 9%

Hispanic 2,515 5%

Other 1,334 3%

Missing 15 --

Highest Education Level Attained Number of

Participants Percentage

High school or less 7,805 15%

Some college, no degree 9,957 20%

Associate/technical degree 7,224 14%

Bachelor's degree 13,714 27%

Graduate degree 12,172 24%

Missing 12 --

Income Number of

Participants Percentage

Less than $20,000 2,296 5%

$20,000 - $49,999 10,284 21%

$50,000 - $99,999 19,907 41%

$100,000 - $200,000 12,868 26%

More than $200,000 3,534 7%

Missing 1,995 --

Enrollment by State

State Women Enrolled

Percentage State Women Enrolled

Percentage

Alabama 401 0.8% Montana 248 0.5%

Alaska 123 0.2% Nebraska 485 1.0%

Arizona 1,553 3.1% Nevada 243 0.5%

Arkansas 343 0.7% New Hampshire

308 0.6%

California 4,222 8.3% New Jersey 1,260 2.5%

Colorado 1,212 2.4% New Mexico 278 0.5%

Connecticut 552 1.1% New York 2,579 5.1%

Delaware 162 0.3% North Carolina 1,663 3.3%

District of Columbia 137 0.3% North Dakota 120 0.2%

Florida 3,602 7.1% Ohio 2,072 4.1%

Georgia 1,367 2.7% Oklahoma 423 0.8%

Hawaii 109 0.2% Oregon 890 1.7%

Idaho 233 0.5% Pennsylvania 1,953 3.8%

Illinois 2,613 5.1% Puerto Rico 885 1.7%

Indiana 1,020 2.0% Rhode Island 252 0.5%

Iowa 641 1.3% South Carolina 625 1.2%

Kansas 454 0.9% South Dakota 172 0.3%

Kentucky 609 1.2% Tennessee 863 1.7%

Louisiana 523 1.0% Texas 2,499 4.9%

Maine 344 0.7% Utah 304 0.6%

Maryland 1,470 2.9% Vermont 141 0.3%

Massachusetts 1,126 2.2% Virginia 1,520 3.0%

Michigan 2,280 4.5% Washington 1,532 3.0%

Minnesota 1,031 2.0% West Virginia 261 0.5%

Mississippi 306 0.6% Wisconsin 1,252 2.5%

Missouri 1,531 3.0% Wyoming 92 0.2%

Total 50,884 100.0%

Baseline Specimen Storage Summary per Sister Study Participant

Material type Additive Container Volume Final Storage Temp.

Blood clot None Vial 1 -80C/LN

Lymphocytes ACD Vial 1-2 vials, ~3 million cells/vial

LN

Plasma EDTA Straws 9 X 0.5 ml LN

Serum None Straws 17 X 0.5 ml LN

Whole blood ACD Vial 1 X 4.5 ml -80C/LN

Vial 2 X 1.0 ml LN

Vial 6 X 1.0 ml LN

Whole blood EDTA Vacutainer 1 X 3.0 ml -20C

Vial 1 X 1.0 ml -80C

Filter cards 2 Ambient

Urine None Straws 20 X 0.5 ml LN

Vial 1 X 3.6 ml -80C

5 X 1.0 ml -80C

Toenails None Envelope 2 Ambient

Household dust None Alcohol swabs in sealed plastic bag

6 swabs -20C

Response Rates for Annual and Detailed Follow-Up

Follow-Up Enrolled

(n)

Alive at Start of

Follow-up Period (n)

Deceased During

Follow-Up Period (n)

Completed Questionnaire

(n)

Response Rate* (%)

Annual Health 1 50,884 50,868 66 48,943 96.3 Annual Health 2 50,884 50,702 290 48,384 96.0 Annual Health 3 50,884 50,484 465 47,357 94.7 Detailed Follow-Up 1 50,884 50,765 251 48,069 95.2 Detailed Follow-Up 2 50,884 50,408 558 46,230 92.8

* Response Rate= (Completed + Deceased During Follow-Up) / Alive at Start of Follow-Up

Breast Cancer Outcomes and Hormone Receptor Status N %

Breast Cancer Subtype

Invasive 2,134 74.5

Invasive-ductal 1,516 52.9

Invasive-lobular 185 6.5

Invasive-mixed 142 5.0

Invasive-other/unknown2 291 10.1

In situ 711 24.8

In situ-ductal 599 20.9

In situ-lobular 86 3.0

In situ-mixed 12 0.4

In situ-other/unknown3 14 0.5

Invasiveness unknown4 20 0.7

Stage at Diagnosis

0 627 25.0

I 1,250 49.9

II 478 19.1

III 131 5.2

IV 21 0.8

Unknown, missing, cannot stage 358

Estrogen Receptor Status

Positive 2029 84.2

Negative 375 15.6

Borderline 5 0.2

Unknown, missing, not performed 456

Progesterone Receptor Status

Positive 1,664 71.5

Negative 658 28.3

Borderline 6 0.2

Unknown, missing, not performed 537

HER2 Amplification Status

Positive 256 13.0

Negative 1,672 85.3

Borderline 33 1.7

Unknown, missing, not performed 904

Combined ER, PR, HER2 Status

Triple negative 202 10.7

Triple positive 126 6.7

Mixed positive and negative 1,552 82.6

Unknown, missing, not performed 985

Incident Breast Cancer Cases by Race/Ethnicity5

Non-Hispanic White 2,471 86.3

Non-Hispanic Black 206 7.2

Hispanic 104 3.6

Other 83 2.9

Age at Breast Cancer Diagnosis

Under 50 years of age 372 13.0

50-64 1,424 49.9

65 and older 1,055 37.0

Missing 14

Self-Reported Baseline and Incident Non-Cancerous Conditions as of December 31, 2015

Outcome ICD-10 Code Baseline Cases Incident Cases

Asthma J45 7,541 1,790

Autoimmune Disease M30 0 3

Chronic Ischemic Heart Disease I25 9 218

Congestive Heart Failure I50 340 541

Diabetes E10-E14 2,999 2,771

Heart Attack (Myocardial Infarction) I21 584 768

Hip, Wrist Fractures S62, S72 2,161 2,423

Hypertension I10 14,232 7,363

Multiple Sclerosis G35 334 113

Parkinson’s Disease G20 42 163

Rheumatoid Arthritis M05-M06 1,984 1,182

Stroke I64 359 1,049

Thyroid Disease E01-E07 10,586 5,283

APPENDIX B

Technical Model Plans

According to the details provided in the Statement of Work and referenced resources, for purposes of proposal development and evaluation, the Offeror shall provide a detailed outline of a step-wise approach, key personnel, staffing, and budget estimate for the following six (6) Model Plans:

1. A two-page Model Plan for, during Year 1 of the Contract, maintaining current reported cohort participation response rates.

2. A two-page Model Plan for management of current and future specimens compatible with records and labeling currently managed using BSI.

3. A Model Plan (2-4 pages) for development and administration of a detailed follow-up questionnaire (45-60 minutes in duration, administered triennially to 50,000 participants) collecting data on changes in personal health and environment over the previous 3 years.

4. A two-page Model Plan for, during Year 1 of the Contract, collecting and abstracting medical records, and collecting fixed tissue samples from all new incident breast cancer cases in the cohort.

5. A two-page Model Plan for, during Year 1 of the Contract, tracing 50 participants lost to follow-up.

6. A two-page Model Plan for case-cohort analysis of urinary cadmium and invasive breast cancer, with no restrictions on race or age such that the sample is representative of the cohort as a whole, and a maximum sample size of 4000 participants.

Sample Task Orders - Ancillary Collection and/or Analysis of Additional Data and/or Specimens

In addition to the Core Task Area as described in Section B of the SOW, the Government may award additional Task Orders to conduct small ancillary projects for the collection and/or analysis of additional data and/or environmental and/or biological specimens. Although the specific details of those Tasks are unknown at this time, two sample Tasks are provided below for purposes of proposal development and evaluation. For each sample Task, the Offeror shall provide a 2-page step-wise Model Plan to conduct each of the ancillary projects:

1. In the base year (CY 1), validate all prevalent and incident cases of stroke reported by participants as of December 31, 2015.

2. In Option Year 2 (CY 3), collect from all participants with incident cases of breast cancer diagnosed 5 years prior and from a set of 1200 participant “controls,” home tap water (to be tested for nitrates), home air, house dust, toenails, exhaled breath, 50 mL urine, and the following blood samples: one 3-ml EDTA tan top, one 10-ml EDTA purple top, two 6-ml acid-citrate dextrose (ACD) Solution B yellow top, and two 10-ml red top tubes.

ATTACHMENT 4: REPORTING REQUIREMENTS/DELIVERABLES

Deliverables for this IDIQ contract include data for all activities supported by the Contract, all specimens collected under this Contract, all data analyses performed under this Contract, and documentation. The delivery of the data and data analyses will be as directed by the Contracting Officer’s Representative (COR) and NIH Principal Investigator (PI). Specimens will be delivered to the appropriate processing or storage facilities as directed by the COR. The COR will be immediately notified of any problem associated with the collection or delivery of data or materials.

In addition to the reports required by the other terms of this Contract or as required by individual Task Orders, the Contractor shall prepare and submit the following reports during the period of performance of this Contract:

A. Technical Progress Reports

A.1. Monthly Technical Progress Report

The Monthly Technical Progress Report is designed to help the Contractor, NIH Investigator, and COR document and track recent activities in a timely fashion. The Monthly Technical Progress Report shall 1) provide a management tool for use by NIH in monitoring the progress of activities being performed on the contract; 2) provide the Contractor with a succinct tool for reporting progress in a timely fashion; 3) promptly indicate potential areas of concern; and 4) include the Contractor's analysis of issues affecting personnel, study, analysis or performance.

The Monthly Technical Progress Report shall in most cases be a short exposition of study, analysis or progress for the preceding month, usually less than or equal to 1 page in length. The Report shall include a list of milestones achieved in the preceding month, specific activity, analysis or goals for upcoming month, and any problems or concerns affecting study, analysis or progress and/or personnel performance.

An electronic copy of the Monthly Technical Progress Report shall be delivered to the COR and NIH PI by the 15th day of the following month.

A.2. Monthly Budget Summary Report

A monthly Budget Summary Report will include—or each activity separately monitored, and for the Contract as a whole—the amounts of each activity budget, total expenditures on the activity for the month, summaries of current contract year and cumulative expenditures, projected expenses to complete each activity, and remaining funds (see Example below).

Budget Summary Reports shall be submitted to the COR as MS Excel spreadsheets (or in other spreadsheet software by agreement), and shall be sortable as required by COR.

EXAMPLE Format: Monthly Budget Summary Report

Accounting

Activity Name Performance Period CY Budget Expenditures this Month

CY

Expenditures

CY Balance Cumulative Expenditures

1.01 Gen Admin

07/01/2018- 06/30/2019

1.02 Development

07/01/2018- 06/30/2019

Totals: $ $ $ $

Accounting

Activity Name Performance Period Cumulative Budget

Expenditures this Month

CY

Expenditures

Balance Cumulative Expenditures

1.03 Annual Update

07/01/2018- 06/30/2019

1.04 Detailed Update

07/01/2018- 06/30/2019

1.05 Medical Records

07/01/2018- 06/30/2019

1.06 Validation Study

07/01/2018- 06/30/2019

1.07 … 07/01/2018- 06/30/2019

Totals: $ $ $ $

A.3. Annual Fiscal Year Technical Progress Report and Budget Summary Report

For each fiscal year (October 1 – September 30), the Contractor shall prepare and submit an Annual Fiscal Year Technical Progress Report. The Report shall consist of a descriptive summary by separately monitored activities undertaken and planned during the fiscal year immediately preceding. The format shall be the same as the Monthly Technical Progress Report in A.1 above. The Contractor shall also prepare and submit an Annual Fiscal Year Budget Summary Report. The format shall be the same as the Monthly Budget Summary Report in A.2 above. Annual Budget Summary Reports shall be submitted to the COR both electronically and in hardcopy, with 1 bound paper (hardcopy) within 30 days of end of fiscal year.

A.4. Final Technical Report

The Contractor shall prepare a Final Technical Report summarizing the work performed and results obtained for the entire contract period of performance, to include all Tasks. The report shall be in sufficient detail to describe comprehensively the results achieved for each separately monitored activity.

The Final Report shall be submitted on/before the expiration date of the contract. Neither Monthly nor Quarterly Reports shall be required of the periods when the Final Report is due; however, a separate Annual Fiscal Year Budget Summary Report for the final fiscal year of the contract shall be due, even if it covers less than a complete fiscal year. The Final Report shall be submitted in both electronic and bound paper (hardcopy) form to the COR.

A.5. Specimen Inventory Report

The Contractor shall prepare and submit to the COR an Annual Specimen Inventory Report. Reports shall be submitted to COR by June 30 each year, and at other times upon request. Specimen Inventory Reports shall be submitted in MS Excel spreadsheets (or other spreadsheet software mutually agreed upon), and shall be organized and sortable as specified by the COR. Data for Specimen Inventory Reports shall be extracted from the specimen inventory software. Data reported shall include all specimens related to this contract, in both the holdings of the Contractor as well as the NIEHS Repository. The Contractor shall maintain electronic inventories of specimens related to this contract in both locations. Annual Specimen Inventory Reports shall also include data from the previous year Annual Specimen Inventory Report.

B. Other Deliverables

B.1. Computerized Data

The Contractor shall deliver to the NIH PI, on a mutually specified schedule, all interim data analyses and analysis datasets. The Contractor shall deliver to the COR, at the completion of each separately monitored activity, edited and corrected data, with appropriate documentation, suitable for final analysis. At the termination of the contract, the Contractor shall turn over to the subsequent contractor and/or to the NIH Investigator, at the discretion of the COR, all study data, analysis programs, and datasets.

B.2. Raw Data

The Contractor shall make available, to the COR upon request, all questionnaires, abstract forms, log books, death certificates, etc. At the termination of the contract the Contractor shall turn over to the subsequent contractor and/or to the NIH Investigator, at the discretion of the COR, all data.

B.3. Study Specimens

Specimens shall be delivered or shipped by the Contractor to locations designated by the COR, appropriately inventoried, packaged and labeled, with accompanying subject data sheets clearly marked for ready identification and matched with each corresponding specimen. At the termination of the contract the Contractor shall turn over to the subsequent contractor and/or to the NIH Investigator, at the discretion of the COR, all specimens associated with this contract.

B.4. Contract Management Plan

The Contractor shall submit a Contract Management Plan that will ensure the successful performance of all contract requirements. The Plan shall include a description of the proposed technical approach for overall project management and internal controls to ensure the safety and integrity of all aspects of the requirement. The Plan shall be in place at the start of the contract and updated and maintained throughout contract performance. Refer to Section B.3 of the Statement of Work for additional requirements.

ATTACHMENT 5

Additional Technical Proposal Instructions

These additional Technical Proposal instructions reflect the requirements of the Request for Proposal (RFP). While Section L. of the RFP provides general Technical Proposal instructions, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used along with Section L. to prepare the Technical Proposal. Offerors are advised to give careful consideration to the Statement of Work (SOW) including supplementary material, Technical Evaluation Criteria, and the RFP as a whole in the development of their proposals.

Each Offeror’s proposal, including appendices, shall include a detailed table of contents, be formatted by sections, and be cross-referenced to the Technical Evaluation Criteria. Refer to the Attachment labeled “Packaging and Delivery of Proposals” for complete instructions on proposal submission.

Offerors shall submit a detailed plan which will allow reviewers to judge the capability to accomplish each aspect of the entire SOW.

• The Technical Proposal shall include information on how the project is to be organized, staffed, and managed.

• Information should be provided to demonstrate the understanding of management of time frames for planning and accomplishing the work.

• The Technical Proposal shall be in as much detail as necessary to explain the proposed methods and rationale, and should reflect a clear understanding of the nature of the work being undertaken.

• The Technical Proposal shall include unique arrangements, facilities, equipment, or other factors that the Offeror deems advantageous to the project.

• Offerors should note that with award of the ID/IQ contract, the Government intends to concurrently award Task Order 1, the “Core Task,” which is comprised of the activities in Section B of the Statement of Work. The award of both the ID/IQ contract and Task Order 1 will be made using the information provided in response to this solicitation.

Specific Technical Proposal Evaluation Criteria Instructions

Each Offeror should address the items below in the Technical Proposal. These items are cross-referenced to the appropriate Technical Evaluation Criteria, which should be used as guidance as to how proposals will be evaluated.

A. Technical Evaluation Criteria 1 - Organizational Background and Experience (150 Points Total)

• Discuss prior experience with the specific research and technical support areas described in the SOW, including conducting and managing large epidemiological long-term cohort studies with English and non-English speaking populations; recruiting and retaining under-represented populations; collection of biological…