N02CP51018-70_Amendment_2.pdf

NATIONAL CANCER INSTITUE

N02CP51018-70

QUESTIONS AND ANSWERS

The following are answers to questions received from potential offerors.

Question 1:

In Amendment 1, Attachment 1, item II.A.2, states that “In addition to discs, offerors are required to submit an electronic copy of proposals……” Is it correct that discs are required in addition to the electronic submission through the eCPS?

Answer 1:

Discs are not required.

Question 2:

In Amendment 1, Attachment 1, item III.B.1 states that the entire technical proposal package is 50 pages including appendices and attachments. It also indicates what is excluded from the page count. However, the exclusions do not mention the HHS Section 508 Product Assessment Template and the Summary of Related Activities forms. May those documents also be excluded from the 50 page limit?

Answer 2:

The HHS Section 508 Product Assessment Template and the Summary of Related Activities forms are excluded from the 50-page limitation.

Question 3:

The SOW (Attachment III) does not include the task of assigning ICD-9 codes to the questionnaires and pathology reports. Please confirm whether or not the task of ICD coding should be included in the SOW.

Answer 3:

Yes, the SOW should include ICD coding of the questionnaires and the pathology reports.

See updated SOW dated 4/5/2016.

RFP N02CP51018-70 Questions and Answers Amendment 2 Page 2 of 2

Attachment 1 – Packaging and Delivery of Proposals

RFP Number: N02CP51018-70

Packaging and Delivery of the Proposal for Research and Development and Research and Development Support—for Use with eCPS

I. PROPOSAL SUBMISSION

A. The National Cancer Institute (NCI) currently requires proposals to be submitted via Online.

II. ONLINE SUBMISSION OF ELECTRONIC PROPOSALS

A. eCPS PROPOSAL SUBMISSION PROCESS.

1. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/NCI/home/howto

2. Offerors are required to submit an electronic copy of proposals online through the

NCI electronic Contract Proposal Submission (eCPS) website at:

https://ecps.nih.gov/NCI.

III. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals submitted online through eCPS:

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

2. Font size must be 10 to 12 points.

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

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

5. Offerors shall only use letter-sized pages (8.5 x 11”).

6. The proposal with pagination, including appendices, shall have formatted sections, cross-referenced, and include a detailed Table of Contents with page references.

7. Each of the proposals, Technical and Business, must be separate and complete in itself, so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the other.

8. Your proposal shall be organized as specified in SECTION L.2. General Instructions.

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

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

Attachment 1 – Packaging and Delivery of Proposals

RFP Number: N02CP51018-70

B. Number of copies and applicable page limitations:

1. The total page limitation for the entire technical proposal package is 50 pages, including appendices and attachments. Total page count does not include: Title Page and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; Resumes/CVs; HHS Section 508 Product Assessment Template; and Summary of Related Activities forms.

2. Pages in excess of this limitation will be removed from the proposal and will not be considered.

SUBMISSION AND APPLICABLE PAGE LIMITATIONS

Document Items to be Submitted

Page Limits

Technical Proposal

ONLINE (using the eCPS website) One (1)electronic copy of the Technical Proposal (including all Attachments)

Business Proposal

ONLINE (using the eCPS website) One (1) submission containing two files, as instructed below.

1. One (1) electronic PDF copy of the

Business Proposal (with all Attachments including the PDF rendering of the Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet).

2. One (1) Electronic Cost Proposal Excel Workbook See Solicitation Section J, Attachment entitled Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet to access the Excel Workbook. Microsoft Excel 2007 version or later is required.

N/A http://oamp.od.nih.gov/Division/DFAS/spshexcl.xls

STATEMENT OF WORK

1. Introduction/Background.

The purpose of the DES Exposed Cohorts Follow-up Study, as required by congressional mandate under the DES Research and Education legislation, is to continue to monitor individuals participating in studies of DES for cancer risk, particularly among daughters as they approach menopause and among DES-exposed sons; assess the impact of and the risks associated with exposure to other hormones such as hormone replacement therapy in DES-exposed mothers and daughters; and study whether DES-exposed women and men will develop non-reproductive conditions.

2. References:

This acquisition includes reference materials

This acquisition does not include reference materials.

3. Scope and Tasks: 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 and granddaughters compared with external and internal rates, with particular focus on cancers of the breast, uterus, ovary, prostate and colon and rectum.

• Monitor the mortality of mothers, daughters and sons.

• Monitor the incidence of validated diagnoses of cardiovascular disease, and reported diagnoses of diabetes, osteoporosis, fractures, hypertension and high cholesterol comparing DES exposed with unexposed sons and daughters.

• Monitor the incidence of preneoplastic events (in particular, CIN2+) and the incidence of benign lesions of the breast and urogenital tract among the exposed and unexposed daughters and granddaughters.

• Continue to evaluate differences in reproductive experience among the granddaughters.

• Compare mammographic densities between DES exposed and unexposed daughters.

Attachment #03 – Statement of Work – 4/5/2016 RFP N02CP51018-70

a) Liaison

1) Establish contact with each of the four field centers selected by NCI.

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

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

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

5) Respond to queries from NCI Contracting Officer Representative. Meet in-person with NCI Contracting Officer Representative at least quarterly.

b) Development of Study Materials and Manuals

1) Develop mail questionnaires to be sent to selected subpopulations as needed, in collaboration with the NCI Contracting Officer Representative and field center staff.

2) 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.

3) Assist field centers in developing newsletters to be sent to cohort members.

4) Assign ICD-9 codes to the questionnaires, and to the pathology reports for high grade cervical, vulvar and vaginal disease and malignant melanoma skin cancer.

Organize logistical aspects of pathology slide review for diagnoses of high grade cervical, vaginal, and vulvar intraepithelial neoplasia, by receiving slides from field centers, and developing a tracking system for sending and receiving the slides to and from the designated central pathologist. The coordinating center will provide storage for the pathology slides returned from the pathologist or will return the slides to the field center in the case that the hospital has requested them back. The coordinating center is not responsible for the pathologist=s slide review costs.

5) Maintain and update the study web site (http://www.desfollowupstudy.org/).

6) Assist in organization of materials for package submitted to NCI Institutional

Review Board.

Attachment #03 – Statement of Work – 4/5/2016 RFP N02CP51018-70

c) Data Preparation and Processing

1) Receive mail questionnaires and abstract forms from field centers for data entry.

2) 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.

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

4) Scan mailed questionnaires. Enter data from questionnaires and abstract forms as needed.

5) Edit and correct computer files as needed.

6) Maintain a master study file with vital status and response to 1994, 1997, 2001, 2006, 2011 and next follow-up questionnaires and respond to requests by NCI Contracting Officer Representative.

7) 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.

8) 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 phase of the study.

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

Attachment #03 – Statement of Work – 4/5/2016 RFP N02CP51018-70

4) Document all of 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 course of the study.

Included are the following:

i. Type letters, forms and other documents necessary to conduct the study.

ii. 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.

iii. 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.

Attachment #03 – Statement of Work – 4/5/2016 RFP N02CP51018-70