N02CP71024-72_Issued_12.6.17.pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92-218 as amended

2. Request for Proposal (RFP) Number:

N02CP71024-72

3. Issue Date:

December 6, 2017

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Support for Thyroid Cancer and Other Thyroid Diseases in Belarus

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E610 Bethesda, MD 20892, MSC 9704

7. SUBMIT OFFERS TO:

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

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 12:00 PM EST time on January 22, 2018. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

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

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH HHSAR Clause 352.215-70, "Late Proposals and Revisions"

LOCATED IN SECTION L.1. OF THIS SOLICITATION.

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

11. FOR INFORMATION CALL: Gary Debes, Contract Specialist

PHONE: 240-276-7605

e-MAIL: gary.debes@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cutoff day for questions is 10:00 AM EST on December 20, 2017.

Secondary Point of Contact:

Rosa Lopez, Contracting Officer rosa.lopez@nih.gov http://www.sam.gov mailto:rosa.lopez@nih.gov

RFP Number : N02CP71024-72

- 2 -

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. TYPE OF CONTRACT AND NUMBER OF AWARDS

b. COMMITMENT OF PUBLIC FUNDS

c. COMMUNICATIONS PRIOR TO CONTRACT AWARD

d. RELEASE OF INFORMATION

e. PREPARATION COSTS

f. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

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

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

13. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

- 3 -

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

Notice to Offerors of Requirements, Protection of Human Subjects, HHSAR 270-4(a)

Instructions to Offerors Regarding Protection of Human Subjects

Required Education in the Protection of Human Research Participants

Inclusion of Women and Minorities in Research Involving Human Subjects

Inclusion of Children in Research Involving Human Subjects

Research Involving Human Fetal Tissue

Human Stem Cell Research

5. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Cost and Pricing Data

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

5. Other Administrative Data

6. Qualifications of the Offeror

7. Subcontractors

8. Proposer's Annual Financial Report

9. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. EVALUATION OF OPTIONS

5. TECHNICAL EVALUATION FACTORS

6. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

- 4 -

PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

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

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This contract is for the continuation of a large-scale epidemiological study detecting thyroid and other pathology in persons who have been exposed to radiation as released by the accident at the Chernobyl Nuclear Power Station in April 26, 1986. The study involves two cohorts: (1) the “main cohort” that was established in the late 1990s and consists of approximately 12,000 subjects who were age 18 or under at the time of the accident, had their dose to the thyroid gland measured, and lived in the Chernobyl affected areas in Belarus; and (2) the “in-utero cohort” that was established in 2017 and consists of approximately 2,800 persons who were exposed to Chernobyl fallout radiation in-utero and early post-natal life. The main emphasis of this contract is to conduct medical screening for thyroid cancer and diseases in the recently established in-utero cohort. The main cohort, after having undergone three cycles of thyroid screening, transitioned to linkage-based passive follow-up.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. PRICES

a. The total fixed price of this contract is $ To Be Negotiated.

b. Upon delivery and acceptance of the item(s) and/or service(s) specified in the DELIVERY Article in SECTION F and described in SECTION C, the Contractor shall be paid as follows

Invoice # Period Covered Due Date Amount of Payment

Quarterly Progress Report 1, Operations Manual for Medical Screening

1 08/15/2018 - 11/14/2018

11/29/2018 TBN

Quarterly Progress Report 2, First Data File, Dosimetry Operation Manual, User's Guide to First Data File

2 11/15/2018 - 02/14/2019

03/14/2019 TBN

- 5 -

ARTICLE B.4. OPTION PRICES

a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.

b. Pursuant to FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, and FAR 52.217-9 Option to Extend the Term of the Contract set forth in ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT, the Government may, by unilateral contract modification, require the Contractor to perform the Options specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/ these option(s), notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The fixed price of this contract will be increased as set forth in paragraph c., below.

c. Upon the delivery and acceptance of the Option Itemsdescribed in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below:

OPTIONS TO EXTEND THE TERM OF THE CONTRACT

Option Period 1

Invoice # Period Covered Due Date Amount of Payment Quarterly Progress Report 3

3 02/15/2019 - 05/14/2019

05/29/2019 TBN

Quarterly Progress Report 4, Second Data File

4 05/15/2019 - 08/14/2019

08/29/2019 TBN

Quarterly Progress Report 5

5 08/15/2019 - 11/14/2019

11/29/2019 TBN

Annual Progress Report, Annual Technical Progress Report For Clinical Research Populations, Third Data File

6 02/15/2019 - 02/14/2020

03/14/2020 TBN

Option Period 2

Invoice # Period Covered Due Date Amount of Payment Quarterly Progress Report 6

7 02/15/2020 - 05/14/2020

05/29/2020 TBN

Quarterly Progress Report 7, Fourth Data File

8 05/15/2020 - 08/14/2020

08/29/2020 TBN

Quarterly Progress Report 8

9 08/15/2020 - 11/14/2020

11/29/2020 TBN

Annual Progress Report, Annual Technical Progress Report For Clinical Research Populations, Fifth Data File, User's

10 02/15/2020 - 02/14/2021

03/14/2021 TBN

- 6 -

Invoice # Period Covered Due Date Amount of Payment Guide to Fifth Data File

Option Period 3

Invoice # Period Covered Due Date Amount of Payment Quarterly Progress Report 9

11 02/15/2021 - 05/14/2021

05/29/2021 TBN

Quarterly Progress Report 10, Sixth Data File

12 05/15/2021 - 08/14/2021

08/29/2021 TBN

Quarterly Progress Report 11

13 08/15/2021 - 11/14/2021

11/29/2021 TBN

Draft Final Report, Draft Final Data File, Draft User's Guide to first Data File

14 08/15/2018 - 12/31/2021

12/31/2021 TBN

Final Report, Annual Technical Progress Report For Clinical Research Populations, Final Data File, User's Guide to Final Data File, Quality Control Procedures

15 08/15/2018- 02/14/2022

02/14/2022 TBN

OPTIONS FOR INCREASED QUANTITY: (The fixed price of the deliverables in the respective period [base period or option period] will be increased upon the exercise of an option quantity)

Options for Evaluation of Reliability of Dose Reconstruction for In-utero Cohort - 1A/1B, 5A/5B, 9A/9B, 13A/13B

Option Period Covered Amount

Option 1A 6 months TBN

Option 1B 6 months TBN

Option 5A 6 months TBN

Option 5B 6 months TBN

Option 9A 6 months TBN

Option 9B 6 months TBN

Option 13A 6 months TBN

Option 13B 6 months TBN

Options for Passive follow-up of the Belarusian Main and In-utero Cohorts - 2A/2B, 6A/6B, 10A/10B, 14A/14B

Option Period Covered Amount Option 2A 6 months TBN Option 2B 6 months TBN Option 6A 6 months TBN Option 6B 6 months TBN Option 10A 6 months TBN Option 10B 6 months TBN Option 14A 6 months TBN

- 7 -

Option Period Covered Amount Option 14B 6 months TBN

Options for Support of Genomic Study - 3A/3B, 7A/87, 11A/11B, 15A/15B

Option Period Covered Amount Option 3A 6 months TBN Option 3B 6 months TBN Option 7A 6 months TBN Option 7B 6 months TBN Option 11A 6 months TBN Option 11B 6 months TBN Option 15A 6 months TBN Option 15B 6 months TBN

Options for Collection of Individual Data on the Thyroid Cancer Risk Factors and Other Information through Mail Survey - 4A/4B, 8A/8B, 12A/12B, 16A/16B

Option Period Covered Amount Option 4A 6 months TBN Option 4B 6 months TBN Option 8A 6 months TBN Option 8B 6 months TBN Option 12A 6 months TBN Option 12B 6 months TBN Option 16A 6 months TBN Option 16B 6 months TBN

ARTICLE B.5. ADVANCE UNDERSTANDINGS

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

- 8 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to 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, dated August 15, 2018, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format.

All electronic reports 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/index.html under "Making Files Accessible."

All reports required herein shall be submitted electronically via email as attachments to the following NCI Branch Distribution mailbox: ncibrancheinvoices@mail.nih.gov.

NOTE: Hard copies of reports are no longer required and shall no longer be mailed to the NCI OA. Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50MB, the contractor shall divide the deliverable into files of 50MB each. All deliverables should be limited to five file attachments or less.

In cases where it is necessary, more than five attachments will be accepted.

The subject line of the email shall read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

All data transfer of PII or sensitive information to the NCI shall be encrypted.

a. Technical Progress Reports

1. Quarterly Progress Reports

This report shall include a summation of the progress, a description of the activities during the reporting period for each separate component of the study, and the activities planned for the ensuing reporting period. For the in-utero cohort, the report shall include information on the status of the medical screening of cohort subjects performed, interviews performed of the study subjects' mothers, medical screening forms completed and entered into the databases, completed and scanned interview forms, and dose reconstruction work. The summation shall include information on the main and in-utero cohort follow-up status based on registry linkage and updated databases shall be provided, and describe results of providing support for the study of genome characterization of thyroid cancer conducted by NCI in Belarus. For the main cohort, this report shall provide a summary of conducted clinical follow-up of cohort subjects with previously diagnosed thyroid cancer and progress in collection of data on thyroid cancer risk factors and other information through mail survey.

Templates of tables to be included in the report will be provided by NCI. The first quarterly report shall cover the first full three months of performance including any fraction of the initial month. Thereafter, http://www.hhs.gov/web/508/index.html mailto:ncibrancheinvoices@mail.nih.gov

- 9 -the quarterly report shall covert full three calendar months. A Quarterly Report will not be submitted when the Annual Progress Report or Final Report is due. The first Quarterly Report shall be due November 29th, 2018. Thereafter, reports shall be due on or before the 15th calendar day following each reporting period.

2. Annual Progress Reports

This annual report shall include a summation of the results of the study of the entire contract work for the period covered. The first Annual Report shall be due March 14, 2020. Thereafter, reports shall be due on or before the 30th calendar day following each reporting period. An Annual Report will not be required for the period when the Final Report is due. A Quarterly Report shall not be submitted when an Annual Report is due.

3. Final Report

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. An Annual report will not be required for the period when the Final Report is due.

The Contractor shall provide the Contracting Officer with 2 copies of the Final Report in draft form in accordance with the DELIVERIES Article in SECTION F of this contract 45 calendar days prior to the expiration date of this contract. The Contracting Officer's Representative (COR) will review the draft report and provide the Contracting Officer with comments within 15 calendar days after receipt.

The Final Report shall be corrected by the Contractor, if necessary and the final version delivered as specified in the above paragraph.

4. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract.

The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website: http://grants.nih.gov/ grants/funding/women_min/women_min.htm.

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/ gender, race and/or ethnicity.

http://grants.nih.gov/grants/funding/women_min/women_min.htm http://grants.nih.gov/grants/funding/women_min/women_min.htm

- 10 -

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Data Files

The Contracting Officer's Representative shall be provided access to data files during performance of the contract to conduct collaborative preliminary analyses. The data provided shall be edited and corrected (suitable for analysis) and sent with appropriate documentation on a storage medium to facilitate easy transfer to NCI equipment.

a. First Data File

The first Data File shall consist of an 1) up-to-date database with the results of medical screening of the in utero cohort, including data recorded on the study and data forms including but not limited to laboratory and clinical information, blood collection and processing form, ultrasound examination form, thyroid palpation form, prior medical history form, laboratory blood examination form, endocrine summary and recommendation form, fine needle aspiration form, hospitalization form, pathological examination form, and report on adverse medical event; 2) Up-to-date master database of demographic, medical and other relevant information for in-utero cohort, including data on thyroid cancer risk factors (e.g., reproductive history, height, weight, smoking, and alcohol consumption) that have been collected during medical screening; 3) Up-to-date databases for the main and in utero cohorts with information obtained as a result of record linkage to the State Chernobyl Registry and National Belarusian Cancer Registry, including cancer registry variables as specified by NCI (Options 2A); 4) Up-to-date database of personal dosimetry interviews for the in-utero cohort created by means of double entry (Options 1A); 5) Database with individual pre- and postnatal doses to the thyroid due to iodine-131 intakes and individual pre- and postnatal (5-year after birth) thyroid and whole body doses from external irradiation and ingestion of cesium radioisotopes for in-utero cohort subjects with interviewed up-to-date mothers and associated input data file and Visual Basic for Applications (VBA) macros used for calculations (Options 1A); 6) Database of scanned up-to-date images of paper copies of interviews for the in-utero cohort (Options 1A); 7) Up-to-date database of the main cohort with demographic, epidemiological, dosimetry and clinical information for the subjects of the study of genome characterization of thyroid cancer (Options 3A); 8) Up-to-date database with demographic, clinical and epidemiologic data for the that have been collected through mail survey (Option 4A). The first Data File shall be due with the 1st Quarterly Report.

b. Second Data File

The second Data File shall consist of an 1) up-to-date database of personal dosimetry interviews for the in-utero cohort created by means of double entry; 2) Database with individual pre- and postnatal doses to the thyroid due to iodine-131 intakes and individual pre- and postnatal (5-year after birth) thyroid and whole body doses from external irradiation and ingestion of cesium radioisotopes for in-utero cohort subjects with interviewed up-to-date mothers and associated input data file and Visual http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

- 11 -

Basic for Applications (VBA) macros used for calculations (Option 5A). The second Data File shall be due with the 4th Quarterly Report.

c. Third Data File

The third Data File shall consist of an 1) up-to-date database with the results of medical screening of the in utero cohort, including data recorded on the study and data forms including but not limited to laboratory and clinical information, blood collection and processing form, ultrasound examination form, thyroid palpation form, prior medical history form, laboratory blood examination form, endocrine summary and recommendation form, fine needle aspiration form, hospitalization form, pathological examination form, and report on adverse medical event; 2) Up-to-date master database of demographic, medical and other relevant information for in-utero cohort, including data on thyroid cancer risk factors (e.g., reproductive history, height, weight, smoking, and alcohol consumption) that have been collected during medical screening; 3) Up-to-date databases for the main and in utero cohorts with information obtained as a result of record linkage to the State Chernobyl Registry and National Belarusian Cancer Registry, including cancer registry variables as specified by NCI (Options 6A, 6B); 4) Up-to-date database of personal dosimetry interviews for the in-utero cohort created by means of double entry (Options 5A, 5B); 5) Database with individual pre- and postnatal doses to the thyroid due to iodine-131 intakes and individual pre- and postnatal (5-year after birth) thyroid and whole body doses from external irradiation and ingestion of cesium radioisotopes for in-utero cohort subjects with interviewed up-to-date mothers and associated input data file and Visual Basic for Applications (VBA) macros used for calculations (Options 5A, 5B); 6) Database of scanned up-to-date images of paper copies of interviews for the in-utero cohort (Options 5A, 5B); 7) Up-to-date database of the main cohort with demographic, epidemiological, dosimetry and clinical information for the subjects of the study of genome characterization of thyroid cancer (Options 7A, 7B); 8) Up-to-date database with demographic, clinical and epidemiologic data for the that have been collected through mail survey (Option 8A, 8B). The third Data File shall be due with the 1st Annual Report.

d. Fourth Data File

The fourth Data File shall consist of an 1) up-to-date database of personal dosimetry interviews for the in-utero cohort created by means of double entry; 2) Database with individual pre- and postnatal doses to the thyroid due to iodine-131 intakes and individual pre- and postnatal (5-year after birth) thyroid and whole body doses from external irradiation and ingestion of cesium radioisotopes for in-utero cohort subjects with interviewed up-to-date mothers and associated input data file and Visual Basic for Applications (VBA) macros used for calculations (Option 9A). The fourth Data File shall be due with the 8th Quarterly Report.

e. Fifth Data File

The fifth Data File shall consist of a 1) up-to-date database with the results of medical screening of the in-utero cohort, including data recorded on the study and data forms including but not limited to laboratory and clinical information, blood collection and processing form, ultrasound examination form, thyroid palpation form, prior medical history form, laboratory blood examination form, endocrine summary and recommendation form, fine needle aspiration form, hospitalization form, pathological examination form, and report on adverse medical event; 2) Master database of demographic, medical and other relevant information as specified by NCI for the in-utero cohort. The master database shall include the following tables: (i) Demographic data, including unique identification number (ID), gender, indication of twin birth (yes/no), date of birth in full (day, month and year of birth), place of birth (oblast, raion and settlement), date of last known vital status, vital status (alive, dead, migrated, lost to follow-up), last known address, for those who are deceased, cause of death (ICD-10 group and subgroup codes); (ii) Cancer diagnostic data, including ID, date of cancer diagnosis (day, month and year), diagnosis (ICD-10 group and subgroup code), morphological verification; (iii) Non-cancer thyroid disease data, including ID, date of diagnosis (day, month and year), diagnosis (ICD-10 group and subgroup code); (iv) Risk factors data as available, including ID, weight and height at birth, smoking habit (yes/ no), history of thyroid diseases in close relatives. In case of multiple diagnoses in one person, corresponding tables shall contain additional columns with date of cancer or non-cancer disease diagnosis (day, month and year), diagnosis (ICD-10 group and subgroup code).

- 12 -

The master database file shall also include table with information on subject's mother: year of birth, duration of this specific pregnancy (preterm, full-term, post-term in weeks/months), presence of thyroid disorders before or during pregnancy, smoking habit, and other information as specified by NCI; 3) Up-to-date databases for the main and in utero cohorts with information obtained as a result of record linkage to the State Chernobyl Registry and National Belarusian Cancer Registry, including cancer registry variables as specified by NCI (Options 10A, 10B); 4) Up-to-date database of personal dosimetry interviews for the in-utero cohort created by means of double entry (Options 9A, 9B); 5) Database with individual pre- and postnatal doses to the thyroid due to iodine-131 intakes and individual pre- and postnatal (5-year after birth) thyroid and whole body doses from external irradiation and ingestion of cesium radioisotopes for in-utero cohort subjects with interviewed up-to-date mothers and associated input data file and Visual Basic for Applications (VBA) macros used for calculations (Options 9A, 9B); 6) Database of scanned up-to-date images of paper copies of interviews for the in-utero cohort (Options 9A, 9B); 7) Up-to-date database of the main cohort with demographic, epidemiological, dosimetry and clinical information for the subjects of the study of genome characterization of thyroid cancer (Options 11A, 11B); 8) Up-to-date database with demographic, clinical and epidemiologic data for the that have been collected through mail survey (Option 12A, 12B). The fifth Data File shall be due with the 2nd Annual Report.

f. Sixth Data File

The sixth Data File shall consist of an 1) up-to-date database of personal dosimetry interviews for the in-utero cohort created by means of double entry; 2) Database with individual pre- and postnatal doses to the thyroid due to iodine-131 intakes and individual pre- and postnatal (5-year after birth) thyroid and whole body doses from external irradiation and ingestion of cesium radioisotopes for in-utero cohort subjects with interviewed up-to-date mothers and associated input data file and Visual Basic for Applications (VBA) macros used for calculations (Option 13A). The sixth Data File shall be due with the 10th Quarterly Report.

g. Final Data File

The Contractor shall provide the Contracting Officer with the final Data File identified below 45 calendar days prior to the expiration date of this contract. The Contracting Officer's Representative (COR) will review the Data File and provide the Contracting Officer with comments within 15 calendar days after receipt. The Data File shall be corrected by the Contractor, if necessary and the final version delivered. The File shall consist of a 1) up-to-date database with the results of medical screening of the in-utero cohort, including data recorded on the study and data forms including but not limited to laboratory and clinical information, blood collection and processing form, ultrasound examination form, thyroid palpation form, prior medical history form, laboratory blood examination form, endocrine summary and recommendation form, fine needle aspiration form, hospitalization form, pathological examination form, and report on adverse medical event; 2) Master database of demographic, medical and other relevant information as specified by NCI for the in-utero cohort.

The master database shall include the following tables: (i) Demographic data, including unique identification number (ID), gender, indication of twin birth (yes/no), date of birth in full (day, month and year of birth), place of birth (oblast, raion and settlement), date of last known vital status, vital status (alive, dead, migrated, lost to follow-up), last known address, for those who are deceased, cause of death (ICD-10 group and subgroup codes); (ii) Cancer diagnostic data, including ID, date of cancer diagnosis (day, month and year), diagnosis (ICD-10 group and subgroup code), morphological verification; (iii) Non-cancer thyroid disease data, including ID, date of diagnosis (day, month and year), diagnosis (ICD-10 group and subgroup code); (iv) Risk factors data as available, including ID, weight and height at birth, smoking habit (yes/ no), history of thyroid diseases in close relatives.

In case of multiple diagnoses in one person, corresponding tables shall contain additional columns with date of cancer or non-cancer disease diagnosis (day, month and year), diagnosis (ICD-10 group and subgroup code). The master database file shall also include table with information on subject's mother: year of birth, duration of this specific pregnancy (preterm, full-term, post-term in weeks/months), presence of thyroid disorders before or during pregnancy, smoking habit, and other information as specified by NCI; 3) Up-to-date databases for the main and in utero cohorts with information obtained as a result of record linkage to the State Chernobyl Registry and National

- 13 -

Belarusian Cancer Registry, including cancer registry variables as specified by NCI (Options 17A, 17B); 4) Up-to-date database of personal dosimetry interviews for the in-utero cohort created by means of double entry (Options 13A, 13B); 5) Database with individual pre- and postnatal doses to the thyroid due to iodine-131 intakes and individual pre- and postnatal (5-year after birth) thyroid and whole body doses from external irradiation and ingestion of cesium radioisotopes for in-utero cohort subjects with interviewed up-to-date mothers and associated input data file and Visual Basic for Applications (VBA) macros used for calculations (Options 13A, 13B); 6) Database of scanned up-to-date images of paper copies of interviews for the in-utero cohort (Options 13A, 13B); 7) Up-to-date database of the main cohort with demographic, epidemiological, dosimetry and clinical information for the subjects of the study of genome characterization of thyroid cancer (Options 15A, 15B); 8) Up-to-date database with demographic, clinical and epidemiologic data for the that have been collected through mail survey. (Option 16A, 16B).

3. Technical documentation:

The Contractor shall submit to the Contracting Officer's Representative (COR) technical documentation describing the methods for calculation of the pre- and post natal doses for the in-utero cohort, user guides for the databases in a format and on storage medium to facilitate easy transfer to NCI equipment. The following documentation is due:

a. Operations Manual for Medical Screening

The Operations Manual for Medical Screening shall describe the logistic, procedures and forms to conduct medical screening of the subjects of the in-utero cohort. The Manual shall be due with the 1st Quarterly Progress Report.

b. Dosimetry Operations Manual

The Dosimetry Operation Manual shall describe the methods to calculate pre- and postnatal doses to the thyroid due to iodine-131 intakes and pre- and postnatal (5-year after birth) thyroid and whole body doses from external irradiation and ingestion of cesium radioisotopes for all subjects of the in-utero cohort. The Manual shall be due with the first Data File, 30 days after the Anniversary Date of the Contract.

c. User's Guide to first Data File

Written documentation (user's guide) for both the main and in-utero study databases that provides usage instructions on the first Data File shall be due with the first Data File, 30 days after the Anniversary Date of the Contract.

d. User's Guide to fifth Data File

Written documentation (user's guide) for both the main and in-utero study databases that provides usage instructions on the fifth Data File shall be due with the 2nd Annual Report and fifth Data File.

e. User's Guide to final Data File

The Contractor shall provide the Contracting Officer with written documentation (user's guide) for the main and in-utero study databases providing usage instructions on the final Data File 45 calendar days prior to the expiration date of this contract. The Contracting Officer's Representative (COR) will review the documentation and provide the Contracting Officer with comments within 15 calendar days after receipt. The written documentation shall be corrected by the Contractor, if necessary and the final version delivered.

f. Quality Control Procedures

The Contractor shall provide the Contracting Officer with written documentation of the quality control procedures used along with error or problem rates (for both in-utero and main cohorts) 45 calendar

- 14 -days prior to the expiration date of this contract. The Contracting Officer's Representative (COR) will review the documentation and provide the Contracting Officer with comments within 15 calendar days after receipt. The written documentation shall be corrected by the Contractor, if necessary and the final version delivered.

4. Section 508 Annual Report

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

http://www.hhs.gov/web/508/contracting/technology/vendors.html

- 15 -

SECTION D - PACKAGING, MARKING AND SHIPPING

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

ARTICLE D.1. PACKAGING

Biological samples shall be protected from extreme temperatures by the use of insulated containers or other acceptable means as needed. A portable liquid nitrogen container for transport of frozen samples must also be used as needed.

ARTICLE D.2. SHIPPING

The Contractor shall transport all samples according to standards required by the International Air Transport Association (IATA) as well as any other applicable transportation requirements.

- 16 -

SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, the Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Division of Cancer Epidemiology & Genetics National Cancer Institute National Institutes of Health 9609 Medical Center Drive Bethesda, MD 20892 MSC 9704

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

FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996).

FAR Clause 52.246-16, Responsibility for Supplies (April 1984).

- 17 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from August 15, 2018 through February 14, 2019.

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

Option Option Period Option Period 1 February 15, 2019 - February 14, 2020 Option Period 2 February 15, 2020 - February 14, 2021 Option Period 3 February 15, 2021 - February 14, 2022

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

b.

Item # Type of Report No. of Copies Due Date a.1. Quarterly Progress Report 2 Copies- COR 1 Copy- CO

The first report shall be due November 29th, 2018. The first reporting period consists of the first full three months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months and shall be due on or before the 15th calendar day following each reporting period.

a.2. Annual Progress Report 2 Copies- COR 1 Copy- CO

The first report shall cover the period from February 15, 2019 through February 14, 2020 of this Contract and shall be due 30 days after the Anniversary Date of the Contract. Thereafter, reports shall be due on or before the 30th calendar day following the reporting period.

- 18 -

Item # Type of Report No. of Copies Due Date a.3. Draft Final Report 2 Copies- COR 1 Copy- CO

45 calendar days prior to the expiration date of the Contract.

a.3. Final Report 2 Copies- COR 1 Copy- CO

Due on or before the completion date of the Contract.

a.4. Annual Technical Progress Report for Clinical Research Study Populations

2 Copies- COR 1 Copy- CO

The first report shall cover the period from February 15, 2019 through February 14, 2020 of this Contract and shall be due 30 days after the Anniversary Date of the Contract. Thereafter, reports shall be due on or before the 30th calendar day following the reporting period.

b.1. Reporting of Financial Conflict of Interest (FCOI)

1 Copy- CO All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format.

Thereafter,reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

b.2. Data Files 2 Copies- COR 1 Copy- CO

The first File shall be due with the second Quarterly Report. Thereafter, the second Data File shall be due with the fourth Quarterly Report, third Data File with the first Annual Report, fourth Data File with the seventh Quarterly Report, fifth Data File with the second Annual Report, sixth Data File with the tenth Quarterly Report. The final Data File shall be due 45 calendar days prior to the expiration date of the contract and any revisions to the final Data File shall be due on or before the

- 19 -

Item # Type of Report No. of Copies Due Date completion date of the contract.

b.3.a. Operations Manual for Medical Screening

2 Copies- COR 1 Copy- CO

The Operations Manual for Medical Screening shall be due with the first Quarterly Report.

b.3.b. Dosimetry Operations Manual

2 Copies- COR 1 Copy- CO

The Manual shall be due with the second Quarterly Report b.3.c through b.3.e. User's Guide 2 Copies- COR 1 Copy- CO

The User's Guide to the first Data File shall be due with the first Data File and for the fifth Data File shall be due with the fifth Data File. The User's Guide to the final Data File shall be due 45 calendar days prior to the expiration date of the contract and any revisions to the User Guide shall be due on or before the completion date of the contract.

b.3.f. Quality Control Procedures 2 Copies- COR 1 Copy- CO

The Quality Control Procedures shall be due 45 calendar days prior to the expiration date of the contract and any revisions to the Procedures shall be due on or before the completion date of the contract.

b.4. Section 508 Annual Report 1 Copy-Contracting Officer

(CO)

Annually on the anniversary date of the contract.

c. The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity Contracting Officer (to be determined) ncibrancheinvoices@mail.nih.gov a.1. through a.4., b.1., b.2., b.3.a.

through b.3.f., and b.4.

One (1) Electronic Copy

Contracting Officer Representative (to be determined) a.1. through a.4., b.2., b.3.a.

through b.3.f.

One (1) Electronic Copy

- 20 -

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

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is not applicable to this contract.

52.242-17, Government Delay of Work (April 1984).

https://www.acquisition.gov/?q=browsefar

- 21 -

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

To be specified prior to award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

To be determined at the time of award

ARTICLE G.3. INVOICE SUBMISSION

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract.

The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

- 22 -

1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One courtesy copy of the original invoice shall be submitted electronically as follows:

1. The Contractor shall scan the original payment request (invoice) in Adobe Portable Document Format (PDF) along with the necessary supporting documentation as one single attachment.

2. Save the single attachment (scanned invoice along with any…