Integrated_N02CP71024-72_Amendment_1.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

Rosa Lopez

The purpose of this amendment is to remove the requirement for the genomic study by updating the following sections of the solicitation: (1) Article B.4. Options Prices; (2) Article C.1.a Statement of Work; (3) Article C.2. Reporting Requirements; (4) Section M.5. Technical Evaluation Factors; (5) Attachment 3 - Statement of Work; (6) Attachment 7 - Additional Technical Proposal Instructions; and (7) Attachment 14 - Additional Business Proposal Instructions.

Proposal Due Date: February 12, 2018; 12:00PM EST (Changed)

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive Rockville, MD 20850

To All Potential Offerors

N02CP71024-72

1 12

01/18/2018

12/06/2017

RFP N02CP71024-72

Amendment 1 Page 1 of 12

Support for Thyroid Cancer and Other Thyroid Diseases in Belarus

N02CP71024-72

AMENDMENT #1

SOLICITATION UPDATES:

1. Article B.4. Option Prices is deleted in its entirety and revised as follows:

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 Items described 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 6 02/15/2019 - 03/14/2020 TBN

Amendment 1 Page 2 of 12

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

02/14/2020

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

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

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

03/14/2021 TBN

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

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

11/29/2021 TBN

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

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

12/31/2021 TBN

Amendment 1 Page 3 of 12

Final Data File, Draft Quality Control Procedures 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, 4A/4B, 7A/7B,10A/10B

Option Period Covered Amount Option 1A 6 months TBN Option 4A 6 months TBN Option 4B 6 months TBN Option 7A 6 months TBN Option 7B 6 months TBN

Option 10A 6 months TBN Option 10B 6 months TBN

Options for Passive follow-up of the Belarusian Main and In-utero Cohorts - 2A, 5A/5B, 8A/8B, 11A/11B

Option Period Covered Amount Option 2A 6 months TBN Option 5A 6 months TBN Option 5B 6 months TBN Option 8A 6 months TBN Option 8B 6 months TBN

Option 11A 6 months TBN Option 11B 6 months TBN

Amendment 1 Page 4 of 12

Options for Update Demographic, Clinical and Epidemiologic Data through a Mail Survey - 3A, 6A/6B, 9A/9B, 12A/12B

Option Period Covered Amount Option 3A 6 months TBN Option 6A 6 months TBN Option 6B 6 months TBN Option 9A 6 months TBN Option 9B 6 months TBN

Option 12A 6 months TBN Option 12B 6 months TBN

2. Article C.1.a. Statement of Work is deleted in its entirety and revised as follows:

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 January 18, 2018, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

3. Article C.2 Reporting Requirements is deleted in its entirety and revised as follows:

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.

Amendment 1 Page 5 of 12

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, dose reconstruction work, and updating of demographic, clinical and epidemiologic data for mothers of the study subjects. 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. For the main cohort, this report shall provide a summary of progress in updating of demographic, clinical and epidemiologic data 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, 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

Amendment 1 Page 6 of 12 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.

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=45:1.0.1.1.5 1&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 REGARDINGINVESTIGATOR 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 MS Access database with the results of medical screening of the in utero cohort, including data entered from the study and data forms including but not limited to recorded 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

Amendment 1 Page 7 of 12 needle aspiration form, hospitalization form, pathological examination form, and report on adverse medical event; 2) Up-to-date master MS Access database of demographic, medical and other relevant information for the subjects of 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 MS Access 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 MS Access 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 duet 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 MS Access databases with demographic, clinical and epidemiologic data that have been collected through mail survey for the subjects of main cohort and for mothers of the subjects of in utero cohort (Option 3A). The first Data File shall be due with the 2nd Quarterly Report.

b. Second Data File The second Data File shall consist of an 1) up-to-date MS Access 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 4A). 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 MS Access database with the results of medical screening of the in utero cohort, including data entered from the study and data forms including but not limited to recorded 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 MS Access master database of demographic, medical and other relevant information for the subjects of 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 MS Access 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 5A, 5B); 4) Up-to-date MS Access database of personal dosimetry interviews for the in-utero cohort created by means of double entry (Options 4A, 4B); 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 4A, 4B); 6) Database of scanned up-to-date images of paper

Amendment 1 Page 8 of 12 copies of interviews for the in-utero cohort (Options 4A, 4B); 7) Up-to-date MS Access databases with demographic, clinical and epidemiologic data that have been collected through mail survey for the subjects of main cohort and for mothers of the subjects of in utero cohort (Option 6A, 6B). 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 MS Access 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 7A). The fourth Data File shall be due with the 7th Quarterly Report.

e. Fifth Data File The fifth Data File shall consist of a 1) up-to-date MS Access database with the results of medical screening of the in-utero cohort, including data entered from the study and data forms including but not limited to recorded 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 MS Access 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 MS Access 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 8A, 8B); 4) Up-to-date MS Access database of personal dosimetry interviews for the in-utero cohort created by means of double entry (Options 7A, 7B); 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 7A, 7B); 6) Database of scanned up-to-date images of paper copies of interviews for the in-utero cohort (Options 7A, 7B); 7) Up-to-date

Amendment 1 Page 9 of 12

MS Access databases with demographic, clinical and epidemiologic data that have been collected through mail survey for the subjects of main cohort and for mothers of the subjects of in utero cohort (Option 9A, 9B). 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 MS Access 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 10A). 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 45calendar 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 MS Access database with the results of medical screening of the in-utero cohort, including data entered from the study and data forms including but not limited to recorded 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 MS Access 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, 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-10group 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 weeks/months), presence of thyroid disorders before or during pregnancy, smoking habit, and other information as specified by NCI; 3) Up-to-date MS Access 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 11A,11B); 4) Up-to-date MS Access database of personal dosimetry interviews for the in-utero cohort created by means of double entry (Options 10A, 10B); 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

Amendment 1 Page 10 of 12 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 10A, 10B); 6) Database of scanned up-to-date images of paper copies of interviews for the in-utero cohort (Options 10A, 10B); 7) Up-to-date MS Access database with demographic, clinical and epidemiologic data that have been collected through mail survey for the subjects of main cohort and for mothers of the subjects of in utero cohort (Option 12A, 12B).

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 1stQuarterly 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 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

Amendment 1 Page 11 of 12 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 SECTIONH 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."

4. Section M.5 – Technical Evaluation Factors (pages 79-80) is deleted in its entirety and revised as follows:

The evaluation criteria are used by the technical evaluation committee when reviewing the technical proposal. The factors below are listed in the order of relative importance. Each factor will be evaluated on an acceptable/unacceptable basis. Selection of an offeror for award will be based upon whether the offeror sufficiently demonstrates the overall ability to perform the prospective contract successfully.

Criterion 1: Technical Approach

Appropriateness and adequacy of the proposed plans for the technical approaches, methodologies, and ability to perform the technical requirements outlined in the Statement of Work (SOW), including the demonstrated ability to perform:

a. Medical Screening Demonstrate ability and experience in conducting medical screening of the in-utero cohort for thyroid cancer and other thyroid diseases.

b. Dose Reconstruction Demonstrate how various tasks for dose reconstruction for the in-utero cohort will be undertaken and how interview data and measurement data will be used in reconstructing radiation doses.

c. Record Linkage Demonstrate how record linkage with the Belarus Cancer Registry and Chernobyl State Registry will be used towards updating databases and maintaining the existing cohort.

d. Mail survey Demonstrate ability and experience in updating of vital status and last known address for the subjects of main cohort.

Amendment 1 Page 12 of 12

Criterion 2: Experience and Capabilities of Senior and Support Personnel

Appropriateness and adequacy of the proposed staffing to perform the technical requirements outlined in the Statement of Work (SOW):

a. Experience and Capabilities of Project Director The Project Director should demonstrate experience and capabilities of administrative and personnel management of the three principal aspects of the BelAm cohort study, i.e., cohort epidemiological study, database management, and dosimetry.

b. Experience and Capabilities of Database Team Leader/Coordinator The Database Team Leader/Coordinator should demonstrate experience and capabilities of managing the BelAm study database.

c. Experience and Capabilities of Dosimetry Team Leader The Dosimetry Team Leader should demonstrate experience and capabilities of performing thyroid and whole-body dose calculations.

d. Experience and Capabilities of Cancer Registry Expert The Cancer Registry Expert should demonstrate experience and capabilities of managing the Belarus Cancer Registry and performing record linkage studies.

e. Experience and Capabilities of Medical Screening Expert The Medical Screening Expert should demonstrate experience and capabilities of conducting medical screening for thyroid cancer and other thyroid diseases.

f. Capabilities of Support Staff Experienced, competent support staff in each of the areas involved in the study, including computer programming, database management, and dose calculations.

Criterion 3: Organizational Approach and Experience

a. Organizational Approach Demonstrate the organizational approach for organizing and managing of medical screening, coordinating activities of record linkage, database management and updating, and dose calculations.

b. Organizational Experience Demonstrate the organizational experience and capabilities of technical requirements in medical screening and developing and carrying out dose reconstruction work.

Overall Proposal Acceptable/Unacceptable

Statement of Work 1/18/2018 Attachment 3 RFP N02CP71024-72 Page 1

Statement of Work

The Chernobyl Research Unit (CRU), Radiation Epidemiology Branch (REB), National Cancer Institute (NCI) is responsible for studies in radiation effects on cancer and other diseases. CRU develops, administers, and evaluates a contract-supported applied research program.

This contract is for the continuation of the “Study of Thyroid Cancer and Other Thyroid Diseases in Belarus”, 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 3,000 persons who were exposed to Chernobyl fallout radiation in-utero and early post-natal life. The main emphasis of this procurement 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.

The specific objectives are: for the in-utero cohort, (1) to conduct medical screening for thyroid cancer and thyroid non-cancer disease; (2) to evaluate the reliability of questionnaire-based doses previously reconstructed; for both the main and in-utero cohorts: (3) to maintain passive follow-up to update occurrences of thyroid cancer, other cancer and thyroid non-cancer disease, through linkage with the Chernobyl State Registry and the National Belarusian Cancer Registry, (4) update demographic, clinical and epidemiologic data through a mail survey.

Medical screening will focus on thyroid cancer but also ascertain a wide spectrum of benign lesions, including benign tumors, nodules, functional changes (hyper- or hypothyroidism, thyroiditis, etc.), which have been associated with radioiodine exposure. At the time of medical screening, NCI also plans to collect information to investigate effects of prenatal radiation exposure on growth and physical development, i.e., head circumference as well as height and weight. Another important aspect of the study is the evaluation of uncertainty of questionnaire-based doses due to memory recall. NCI’s previous study shows that if dose-related measurements are available for study subjects, the quality of individual behavior and dietary data has, in general, a small influence on the results of the retrospective dose assessment. However, direct thyroid measurements are available only for around 15% of mothers of in utero cohort subjects; evaluation of uncertainty in doses due to possibly poor memory recall is important for this study.

Description of Work

The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the U.S. Government as needed to perform the Statement of Work below.

Base Period - Medical screening of the Belarusian in-utero cohort – August 15, 2018 - February 14,

1. Update and verify vital status and last known address of in-utero subjects and their mothers, and contact them according to the procedures described in the study protocol and Operations Manual approved by NCI.

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2. Using the study protocol and Operations Manual approved by NCI, conduct medical screening using fixed and mobile teams in a target of 350 (cumulative 850, including 500 subjects who were screened during feasibility screening in August 2017 – August 2018) in-utero subjects. Project staff will travel to the subject’s residence or other locations for conducting the medical screening.

3. Develop and establish a master database for data from the medical screening, 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, growth and physical development form (head circumference, height and weight measurements).

Option 1A – Evaluation of reliability of dose reconstruction for in-utero cohort – Six Months

1. Locate and contact mothers of in-utero subjects and conduct second personal interviews with a target of 150 (cumulative 300, including 150 mothers who were interviewed during feasibility screening in 2017-early 2018) mothers who shall be selected from mothers who were first interviewed in 2013-2014 using the dosimetry questionnaire and interview manual approved by NCI. Project staff will travel to the cohort subject’s mothers’ residence or other locations for contacting and interviewing.

2. Prepare and provide an accurate, complete and up-to-date Microsoft Access database of personal dosimetry interviews created by means of double entry.

3. Scan the personal dosimetry interviews and create an electronic Microsoft Access database of scanned images of paper interviews.

4. Reconstruct individual doses for 150 subjects of the in-utero cohort with mothers who were interviewed during feasibility screening in 201, early 2018 using the Dosimetry Operations Manual approved by NCI and provide a completed Microsoft Access database of individual calculated (a) pre-and postnatal thyroid doses for subjects, associated input data file and VBA macros used for calculations;

and (b) pre- and postnatal doses to the thyroid and whole body from external irradiation and ingestion of Cs radioisotopes, associated input data file and VBA macros used for calculations.

Option 2A – Passive follow-up of the Belarusian main and in-utero cohorts – Six Months

1. Acquire updated contact and medical diagnostic information, including diagnostic data on thyroid cancer, other cancers, and thyroid non-cancer diseases for the main and in-utero cohort subjects through linkage with the Chernobyl State Registry and obtain information from other sources, if needed for medical follow-up.

2. Create and maintain a master database of the main and in-utero cohorts that links to computerized databases of questionnaires, vital status, tracing history, and other study data, which are to be entered.

Provide the computer programming support necessary to implement and maintain these databases.

3. Update the database for the main and in-utero cohort with information obtained as a result of record linkage to the State Chernobyl Registry and National Belarusian Cancer Registry, and ongoing cleaning procedures. Deliver an accurate, complete and up-to-date electronic database, including cancer registry variables, as specified by NCI.

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4. With input and guidance from NCI, develop and implement procedures needed to assure the quality of data collected, entered and managed. Provide written documentation of the quality control procedures used along with error or problem rates. Maintain comprehensive documentation for the main and in-utero study databases. Use applicable and common security practices for protecting data collected under the contract.

5. Respond to data requests and questions concerning the main and in-utero cohorts and provide support to NCI investigators in their preparation of scientific papers to be published to peer-reviewed Western journals.

Option 3A – Update demographic, clinical and epidemiologic data through a mail survey– Six Months

1. Update vital status and last known address through a mail survey for a target of 1,200 (cumulative 1,500, including 300 subjects for whom information was updated during pilot study in February – August 2018) subjects of the main cohort and contact them as described in the study protocol and Operations Manual approved by NCI.

2. Update vital status and last known address through a mail survey for a target of 450 (cumulative 750, including 300 mothers for whom information was updated during pilot study in February – August 2018) mothers of the subjects of in-utero cohort and contact them as described in the study protocol and Operations Manual approved by NCI.

3. Create and maintain a database of the main and in-utero cohorts that links to computerized databases of questionnaires used to collect information, vital status, tracing history, and other study data, which are to be entered. Provide the computer programming support necessary to implement and maintain these databases.

Option Period 1 - Medical screening of the Belarusian in-utero cohort – February 15, 2019 - February 14, 2020

1. Update and verify vital status and last known address of in-utero subjects and their mothers, and contact them according to the procedures described in the study protocol and Operations Manual approved by NCI.

2. Using the study protocol and Operations Manual approved by NCI, conduct medical screening using fixed and mobile teams in a target of 700 (cumulative 1,550) in utero subjects. Project staff will travel to the subject’s residence or other locations for conducting the medical screening.

3. Update the master database with data from the medical screening, 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, report on adverse medical event, growth and physical development form (head circumference, height and weight measurements).

Option 4A – Evaluation of reliability of dose reconstruction for in-utero cohort – Six Months

1. Locate and contact mothers of in-utero subjects and conduct second personal interviews with a target of 150 (cumulative 600) mothers who shall be selected from mothers who were first interviewed in 2014-

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2015 using the dosimetry questionnaire and interview manual approved by NCI. Project staff will travel to the cohort subject’s mothers’ residence or other locations for contacting and interviewing.

2. Prepare and provide an accurate, complete and up-to-date Microsoft Access database of personal dosimetry interviews created by means of double entry.

3. Scan the personal dosimetry interviews and create an electronic Microsoft Access database of scanned images of paper interviews.

4. Reconstruct individual doses for 150 (cumulative 450) subjects of in-utero cohort with re-interviewed mothers using the Dosimetry Operations Manual approved by NCI and provide a completed Microsoft Access database of individual calculated (a) pre- and postnatal thyroid doses for subjects, associated input data file and VBA macros used for calculations; and (b) pre- and postnatal doses to the thyroid and whole body from external irradiation and ingestion of Cs radioisotopes, associated input data file and VBA macros used for calculations.

Option 4B – Evaluation of reliability of dose reconstruction for in-utero cohort – Six Months

1. Locate and contact mothers of in-utero subjects and conduct second personal interviews with a target of 150 (cumulative 750) mothers who shall be selected from mothers who were first interviewed in 2014- 2015 using the dosimetry questionnaire and interview manual approved by NCI. Project staff will travel to the cohort subject’s mothers’ residence or other locations for contacting and interviewing.

2. Prepare and provide an accurate, complete and up-to-date Microsoft Access database of personal dosimetry interviews created by means of double entry.

3. Scan the personal dosimetry interviews and create an electronic Microsoft Access database of scanned images of paper interviews.

4. Reconstruct individual doses for 150 (cumulative 600) subjects of in-utero cohort with re-interviewed mothers using the Dosimetry Operations Manual approved by NCI and provide a completed Microsoft Access database of individual calculated (a) pre- and postnatal thyroid doses for subjects, associated input data file and VBA macros used for calculations; and (b) pre- and postnatal doses to the thyroid and whole body from external irradiation and ingestion of Cs radioisotopes, associated input data file and VBA macros used for calculations.

Option 5A – Passive follow-up of the Belarusian main and in-utero cohorts – Six Months

1. Acquire updated contact and medical diagnostic information, including diagnostic data on thyroid cancer, other cancers, and thyroid non-cancer diseases for the main and in-utero cohort subjects through linkage with the Chernobyl State Registry and obtain information from other sources, if needed for medical follow-up.

2. Create and maintain a master database of the main and in-utero cohorts that links to computerized databases of questionnaires, vital status, tracing history, and other study data, which are to be entered.

Provide the computer programming support necessary to implement and maintain these databases.

3. Update the database for the main and in-utero cohort with information obtained as a result of record linkage to the State Chernobyl Registry and National Belarusian Cancer Registry, and ongoing cleaning procedures. Deliver an accurate, complete and up-to-date electronic database, including cancer registry variables, as specified by NCI.

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4. With input and guidance from NCI, develop and implement procedures needed to assure the quality…