Amendment 2 75N91020R00034.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 electronic communication 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 you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication 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 NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

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 APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER 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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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 (Number, 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)

Previous edition unusable

Amendment 2

Nikki Arena, Contracting Officer

The purpose of this Amendment is to: 1) Revise the Statement of Work to add Option A; 2) Revise the Estimate of Effort and Additional Business Proposal Instructions provided in Section L; and 3) Provide answers to questions submitted in response to the solicitation.

Proposal Due Date: December 23, 2020; 2:00PM EST (Unchanged)

National Cancer Institute Office of Acquistion NCI Shady Grove 9606 Medical Center Drive, MSC 9705 Rockville, MD 20850-9705

To all potential offerors 75N91020R00034

1 9

12/11/2020

11/23/2020

12/11/2020

STATEMENT OF WORK

1. Introduction/Background.

The purpose of the Diethylstilbestrol (DES) Exposed Cohorts Follow-up Study, as required by congressional mandate under the DES Research and Education Amendments of 1992, is to continue to monitor individuals participating in studies of DES for cancer risk, and mortality; and to coordinate and support collection of blood samples from the cohort members.

2. Scope and Tasks: Independently and not as an agent of the Government, the contractor shall supply all labor, materials, facilities, equipment, and supplies to perform the following tasks:

• Monitor the cancer incidence among the DES exposed daughters, sons, granddaughters and grandsons, with focus on cancers of the breast, uterus, ovary, prostate, pancreas, and colon and rectum.

• Monitor the mortality of mothers, daughters and sons.

• Coordinate the collection of blood samples from cohort members performed by the sites.

a) Liaison

1) Establish contact with each of the six field centers selected by NCI. Request personal identifiers from the sites that are willing to allow passive follow-up by the contractor. Work with the sites that are unwilling to share personal identifiers to support passive follow-up.

2) Establish contact and coordinate activities as needed with NCI’s computer programming support services contractor.

3) Establish contact and coordinate activities with NCI’s biorepository.

4) Assist in arranging communications or meetings, as needed, between the NCI Contracting Officer Representative and field center staff.

5) Attend and report on such meetings, provide background materials as needed and act on recommendations in consultation with the NCI Contracting Officer Representative.

6) Respond to queries from NCI Contracting Officer Representative. Meet in-person or by phone with NCI Contracting Officer Representative at least quarterly.

b) Development of Study Materials and Manuals

1) Develop and update procedure manuals for the study, in collaboration with the NCI Contracting Officer Representative and field center staff. Work with field centers and NCI Contracting Officer Representative to establish standardized procedures for each of the sub-studies.

2) Assist field centers in developing one newsletter to be sent to cohort members.

RFP 75N91020R00034

Statement of Work

3) Maintain and update the study web site (http://www.desfollowupstudy.org/) with material provided by NCI.

c) Data Preparation and Processing

1) Coordinate and conduct National Death Index searches to determine vital status. Assist in reconciliation of vital status using available sources. Coordinate and conduct state cancer registries searches.

2) Coordinate State Cancer Registry searches to ascertain cancer status.

3) Coordinate the study sites’ effort to collect blood from participants. This includes:

• Providing sites with study materials (e.g., questionnaire which will be developed by NCI)

• Training sites for blood collection effort and responding to questions

• Coordinating with NCI’s computer programming support services contractor to provide lists of eligible participants to the sites

• Receiving questionnaire and other data from the study sites

4) Edit and correct computer files as needed.

5) Maintain a master study file with vital status and response to 1994, 1997, 2001, 2006, 2011, and 2016 follow-up questionnaires, as well as all information obtained from linkage with registries (e.g., NDI, cancer registries) and respond to requests by NCI Contracting Officer Representative.

6) Transmit computerized data files containing edited, corrected data to the NCI Contracting Officer Representative or representative at the completion of each wave of follow-up, or as appropriate.

7) Assist the study centers in ad hoc investigations that arise from the standard data collection.

d) Monitoring, Information Management, Reporting and Documentation

1) Utilize a computerized information system to monitor the progress of data collection.

2) Initiate regular monthly telephone calls to the field centers to monitor progress and address problems during the data collection phases of the study.

3) During the data collection phases of the study, receive final reports from the field centers and provide them to the NCI Contracting Officer Representative for review. During data collection phases, on a quarterly basis, create a combined report from all the field centers to monitor the overall progress of the study.

4) Document all the individual steps in the study and maintain orderly files of all relevant materials, so that any aspect of the study can be reviewed and evaluated by NCI staff at any time during the study.

http://www.desfollowupstudy.org/

Included are the following:

i. Maintain a filing system of all relevant materials, cross-referenced to permit easy access. These materials shall be stored in accordance with requirements of the Privacy Act.

ii. Maintain a log of all decisions made during the study that pertain to study design, conduct, and analysis. Examples of such decisions are criteria for selecting individual cohort members for participation in sub-studies, and coding decisions for questionnaires and medical records.

e) Coordination of Data Collection

The contractor will coordinate with the individual field centers in their performance of the following tasks:

1) Tracing efforts of cohort members who have been lost to follow-up and keeping addresses up to date, within one year, for recently contacted cohort members.

2) Use of quality control procedures to ensure standardization and high quality of data collection.

3) The pooling of non-identified data with other participants in this effort and in analyses shall be approved by the Steering Committee (NOTE: the Steering Committee will consist of one

(1) member from each Center, a representative from the Division of Cancer Epidemiology and Genetics (DCEG) and any consumer advocates and external advisors that provide general oversight to the study.)

4) Attending meetings with the Steering Committee one to two times during the year, by phone, with the Contracting Officer Representative (COR), other collaborators, and members of the Steering Committee to discuss analysis of pooled data and to decide upon procedures for dissemination of data after the completion of the manuscripts prepared from the pooled data.

5) The Contractor shall participate in conference calls to discuss progress on the coordination of data collection as needed.

f) Option A: Blood Collection

The contractor shall also coordinate with the NCI’s research laboratory (currently ATCC) and study sites to arrange Data Collection. The Data will consist of phlebotomy and questionnaires.

The contractor will coordinate with the individual field centers in their performance of the following tasks:

Blood sample collection of up to 1,000 participants and shipment according to NCI protocol.

g) Phase-In: The selected contractor (non-incumbent only) shall be given a Phase-In period to put into place the appropriate oversights and tasks into place. The Contractor shall:

Include a draft Phase-In Plan in its proposal and present Final Phase In Plan to the COR for approval within 7 days of contract award. The Phase In plan shall describe the steps to ensure that:

1) Staff are oriented, trained and available to assume all tasks described in the SOW. IRB approval is provided from the Host institution within 90-days.

2) Documentation for FISMA ATO approval is provided within 90 days.

3) Archived tissue blocks, hard-copies and electronic files of patient questionnaires, and medical record abstracts (without PII) from the incumbent are received within 30 days.

4) Standard Operating Procedures (SOPs) will be provided to the COR for review and approval within 15 days of award.

h) Phase-Out: Ninety (90) day period for transitioning the work to a successor contractor prior to the end of this contract. The work shall include transfer of all data and specimens to the government or successful new contract Awardee.

The Contractor shall develop and submit a draft phase-out transition plan 6 months prior to the expiration date of the contract, which shall describe the contractor strategy for transferring work from this contract to a successor contract. The plan shall include a system for transfer of policies and procedures; transfer of relevant files, records, materials, specimens and data;

transition of all activities, as appropriate. Upon receipt of COR feedback, submit the Final Transition Plan to the Government no later than one month prior to the expiration date of the contract.

The Contractor shall provide the successor Contractor with detailed briefings regarding the policies and procedures for managing all aspects of the project. As part of these detailed briefings, the Contractor shall provide the successor Contractor with all documentation of processes and products, which shall include, but not be limited to, SOPs, materials, training materials, presentations on activities and samples.

i) IT Accessibility Requirements

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

1. Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards- and-guidelines

Item that contains ICT: DES Exposed Cohorts Follow-up Study web site (http://www.desfollowupstudy.org/)

Applicable Functional Performance Criteria: All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when Chapters 4-6 do not address one or more functions of ICT.

Applicable requirements for software features and components: All WCAG Level AA Success Criteria, 502 Interoperability with Assistive Technology, 503 Application

Applicable requirements for hardware features and components: All requirements apply

Applicable support services and documentation: All requirements apply

Item that contains ICT: study web site (http://www.desfollowupstudy.org/).

Based on the above, the applicable Section 508 Standards can be found in the attached PDF document

• ICT Accessibility Requirements Statement per the Revised Section 508 of the Rehabilitation Act: Web-based Information, Documentation and Support

The Vendor shall use the ITIC-developed Voluntary Product Accessibility Template (VPAT) to complete and submit an Accessibility Conformance Report (ACR). The vendor shall use the latest version of the VPAT, which is currently VPAT 2.4Rev 508 (revised February 2020) (posted March 07, 2020).

• This ACR shall be provided to the COR o within (two months of the contract start date) to document a current state review o within six months of the contract initiation date to show that any necessary remediation has been completed, and o at the end of twelve months to demonstrate continued conformance of the website to Section 508 Standards. This annual report shall be submitted at the end of the one-year base period and at the end of each of the four, one-year option periods.

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, item 1.d. on page 55 of the solicitation is hereby amended as follows:

d. ESTIMATE OF EFFORT

It is expected that a completion type contract will be awarded as a result of this SOLICITATION. To assist you in the preparation of your proposal, the Government considers the effort to be approximately 1,826 labor hours. This information is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.

It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:

Labor Hours

Year Estimated Labor Hours Phase-In Period 340 Base Period 128 Option Period 1 204 Option Period 2 44 Option Period 3 208 Option Period 4 44 Phase-Out Period 340 Option A- Blood Collection (non-severable) 518

SECTION L- ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS, item 15 on page 105 of the solicitation is hereby amended as follows:

A Business Proposal shall be prepared in response to this RFP and shall consist of a detailed description of all cost items that are involved in the completion of the statement of work. These would include cost for personnel; computer costs; material and supply costs; and subcontract costs, as appropriate. The breakdown of cost items must be provided by year, along with a summary of the total cost, including a narrative description of how costs were derived for each cost category.

If applicable, submit your organization's most current negotiated indirect rate agreement and approved written travel policy. If your organization does not have negotiated indirect cost rates with the U.S Government, please state the basis used, along with any supporting documentation, for any indirect costs proposed.

Assumptions:

1. Assume six (6) field sites for task a) Liaison. Anticipate that at least two of the six sites will provide the Contractor with the data required to complete the tasks without the sites’ involvement and thus will not need to be paid for their effort.

2. Assume no more than three (3) month transition-in and three (3) month transition-out period.

3. Assume there will be no professional travel.

4. Propose separate budgets for Phase-In Period, Phase-Out Period, and Option A (non-severable).

5. Include a summary tab that takes into account all costs proposed.

Questions and Answers

Coordinating Center for Continuation of Follow-Up of DES-Exposed Cohorts

1. Please confirm that the blood collection will be carried out in the base year of the contract.

Answer: Please include Option A – Blood Collection as a separate cost to the budget.

2. Please confirm that the contractor will not be responsible for paying the study centers for activities associated with conducting the blood collection.

Answer: Yes, the contractor will be responsible for paying the study centers for activities associated with conducting the blood collection.

3. Please confirm that the blood collection will include administration of a questionnaire. If correct, please provide an estimate of length (number of pages or number of questions) and mode of administration (paper or web) for budgeting purposes.

Answer: The blood collection will include a short questionnaire that will be web-based, estimated to be approximately 1 page in length.

4. Please confirm that the newsletter will be prepared and disseminated in the Base Year so that it can be used to promote the blood collection/study.

Answer: Yes, the newsletter will be prepared and disseminated in the Base Year.

5. Assuming that the newsletter will be disseminated both on the website and by mail, will the contractor be responsible for the cost of printing the newsletter and shipping it to the study centers who have retained PII?

Answer: The newsletter to the second generation participants will optimally be distributed by website and email (in cases where the participants e-mail address is known).

6. Will the contractor be responsible for paying postage for mailing the newsletter to participants for whom the coordinating center holds the PII? Should the study centers who retain identifiers include this cost in their subcontract budgets?

Answer: The Contractor will not be responsible for mailing out the newsletter, as it will be web-based.

7. Please confirm that the contract includes only passive follow-up of the cohort and no follow-up questionnaires will be administered.

Answer: Yes, the contract includes only passive follow-up of the cohort and no follow-up questionnaires will be administered.

8. The RFP includes the position of nosologist. For budgeting purposes, please clarify the tasks that will require medical coding.

Answer: The nosologists will be consulted for cancer registry diagnoses in case there are questions.

Questions and Answers

9. For budgeting purposes, please confirm the number and timing of the following linkages:

a. NDI: Two linkages during the 5 year period of performance - in Option Periods 1 and 4

Answer: That is correct.

b. Cancer registries: Two linkages during the 5 year period of performance in Option Periods 1 and 4

Answer: That is correct.

10. If the project schedule is as follows:

Base Period: newsletter and blood collection Option 1: NDI and cancer registry linkages Option 4: NDI and cancer registry linkages

May we adjust the labor hours from the estimates given on page 55 of the RFP to correspond to this schedule without exceeding the total of 1,738 hours for the 5 year period of performance?

Answer: Yes, labor hours may be adjusted to reflect the Offeror’s technical approach. Please provide a budget for Option A – Blood Collection and assume that this will be a non-severable Option that can be exercised at any time during the period of performance of the contract.

11. If the schedule proposed in question 10 is confirmed, please clarify the scope of work for Option

2 (44 hours) and Option 3 (208 hours) Answer: The scope of work for Options 2 and 3 includes maintaining contact with the study centers, maintaining Internal Review Board (IRB) approval for the study, and other maintenance as needed.

12. The period of performance of the current contract ends April 29, 2021. The RFP states that the new award’s period of performance will begin on July 9, 2021. Should we assume that there will be a gap between the 2 contracts?

Answer: Correct, assume there will be a lapse in services.