amendment 2 - DCC -.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

See block 16C below

4. REQUISITION/PURCHASE REQ. NO

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

Office of Acquisitions, NIDDK NICHD Contracts Management Branch National Institutes of Health Executive Building, Suite 7A07

6100 EXECUTIVE BLVD, MSC 7510

BETHESDA MD 20892-7510

9A. AMENDMENT OF SOLICITATION NO.

RFP-NIH-NICHD-DESPR-08-29

9B. DATED (SEE ITEM 11)

Apr 18, 2008

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

All Potential Offerors

10A. MODIFICATION OF CONTRACT/ORDER NO.

CODE

FACILITY CODE

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.

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 one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; 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 you 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.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

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

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)

E. IMPORTANT: Contractor __is not, _X_ is required to sign this document and return _ 1___ copies to the issuing office with your business proposal

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

Purpose:

1) Revise the RFP, Section J, Attachment 4 and 6.

2) Provide clarification based on question received.

The hour and date for receipt of proposals is not extended and remains unchanged, 4:00pm, local time, on June 3, 2008.

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.

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

Elizabeth J. Osinski Contracts Management Branch, OAM, NICHD

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY _____________/s/___________________ (Signature of Contracting Officer)

16C. DATE SIGNED

05/21/08

NSN 7540-01-152-8070 STANDARD FORM 30 (REV 10-83)

PREVIOUS EDITION NOT USABLE Prescribed by GSA FAR (48 CFR) 53.243

RFP-NIH-NICHD-DESPR-08-29 Page 2 of 5 AMENDMENT No. 002

The RFP is amended as follows:

1. RFP, Section J, Attachment 6 “ Supplemental Technical and Business Proposal Instructions”, number 3 “Scientific Advisory Committee:” is revised to read as follows:

It is anticipated that one (1) Scientific Advisory Committee meeting will be held during Phase I, two (2) Scientific Advisory Committee meetings will be held during Phase II (one each year) and that one (1) Scientific Advisory Committee meeting will be held during Phase III.

2. RFP, Section J, Attachment 4 “ Background and Statement of Work for Task Order 1”, letter B “ Phase II: Recruitment and Follow-up (Contract Months 7-30) is revised to read as follows:

Implement the quality control system for monitoring data collection procedures and assuring quality of ultrasonography data; work with the Central Sonologist to produce a report on ultrasonography data quality every four months and distribute the report to the Clinical Site Principal Investigators (by the end of Contract Months 10,14,18,22,26, and 30)

The following questions and answers have been received in response to the RFP:

Question and Response:

1. Question:

What is the current hosting environment and hardware for data base management? Who owns the hardware? Under the new contract, who will own the hardware? Is NICHD going to host DESPR Web-based management tool internally or contractor should host it externally?

Response:

The successful applicant/offeror is expected to have the necessary hardware to support all aspects of the statement of work

2. Question:

Is there source document given from the PIs? If we are not receiving source document, it would be very difficult to perform any error checks.

Response:

NICHD does not typically maintain or have access to any original study documents, particularly those with identifying information. The successful applicant/offeror should ensure that all necessary auditing or related activities including onsite audits or site visits are addressed to ensure the quality of all data.

3. Question:

Does this RFP require the contractor to develop or provide support in developing forms for data collection, recording, and tracking data, CRFs, interventions, AE/SAEs etc. or study centers will develop their own forms and they will sent them to DCC for data management?

Response:

The DCC will assist the NICHD in developing and finalizing all data collection forms and related forms for managing the study, and it also will be responsible for adapting all forms for web based management.

4. Question:

Does NICHD require interim data analysis for study data? If so, does NICHD have any preference for software (SAS or SPSS etc.) for analysis?

Response:

Some of the studies may have this requirement. The specifics will be outlined for each individual task. The successful offeror/applicant is expected to be able to utilize a wide variety of software including statistical freeware packages that eliminate the need for site licenses.

5. Question:

Is there a requirement for reviewing federally regulated documents for compliance? Will there be a requirement to submit these documents for approval on behalf of research or clinical centers?

If such a requirement is needed in a particular study, it will be specified in the statement of work.

RFP-NIH-NICHD-DESPR-08-29 Page 3 of 5

6. Question:

Is it expected from contractor to help in establishing/locating IRBs for research or clinical study centers? Will there be same requirement for Steering Committee set-up?

Response:

All research sites are expected to have their own IRBs (as will NICHD have NIH IRB approval). The DCC is expected to ensure its own IRB approval. The Steering Committee will be established by the Project Officer most likely reflecting the governance document specifically developed for the study.

7. Question:

Will web based data management system be required to act as data/document repository for all the studies? What should be the size of document repository?

Response:

The web based data management system will be required to act as the data/document repository for all studies. The size of document repository will be project-specific and the successful applicant/offeror should establish this based upon the statement of work.

8. Question:

Is the contractor required to provide information on human subject protection in the proposal? Section-H-special contract requirements, article H.1 suggests that Research involving human subjects shall not be conducted under this contract until the protocol developed in Phase I has been approved by NICHD PO, written notice of such approval has been provided by the CO and the contractor has provided to the CO a properly completed Form OMB No. 0990-0263 (formerly Optional Form 310).

Yes, the Offeror should provide information on human subject protection in the proposal.

9. Question:

What is the ideal qualification of the Contractor PI?

As with any PI, he/she should have the qualifications for ensuring the statement of work can be successfully met.

10. Question:

Is the contractor required to submit “Information Security Plan” at this time or submit after the award and within 30 days of the award?

An Information Security Plan should be part of the Proposal.

11. Question:

Is there a need to provide tools for a Web based questionnaires (in addition to uploading digital files and images) to support "e.g., women completing self administered questionnaires or structured interviews, medical record abstraction, pregnancy journals" or the studies already have correspondent tools and the project needs to provide only the means to upload the results (like SAS datasets for example)?

Response:

A web based data management system should include the primary online entry of data among its other services such as uploading/downloading study files and a variety of tools to support web based data management.

12. Question:

Is there intent to have cross-studies (involved in DESPR) results comparison or does each study have a separate result set?

Each study will have its own data system reflecting its particular study design and methodologies.

14 Question:

Is there a page limit count on the business volume in the submission?

The Technical Proposal has a page limit; the Business Proposal does not.

15 Question:

Can the role of the PI be distributed across multiple staff members identified as co-PI’s and can one or more be a subcontractor staff i.e., not an employee of the Prime?

Each study should have a single PI who is an employee of the Prime.

RFP-NIH-NICHD-DESPR-08-29 Page 4 of 5

16 Question:

Proposal Deadline: RFP-NIH-NICHD-DESPR-08-29 indicates 4:00PM local time on June 3, 2008 and FBO.GOV listed Response Date is May 26, 2008. Please clarify.

The Proposal deadline is 4:00 PM local time on June 3, 2008.

17 Question:

How many key personnel resumes would the government wish for vendors to include?

The Offeror should include all Key Personnel resumes and supporting justifications for the first task.

18 Question:

Are there any limitations to the length of resumes for key personnel?

Response:

There is no length limit to the resumes. The information provided should be relevant to the individual’s ability to perform the work successfully.

19 Question:

Is this RFP a new requirement or follow-on contract?

This is a new requirement.

20 Question:

Is there an incumbent? If yes, who is incumbent? What’s the previous contract value?

There is no incumbent for this contract. The amount of work for each task is expected to vary depending on the size and complexity of the study it is supporting.

21 Question:

How many Full Time Equivalents (FTE) do you expected?

See the Estimate of Effort in Section L.1.e. of the RFP.

22 Question:

Does “$200 per day per member” exclude airfare travel for non-local member?

Air fare is in addition to the $200 Honorarium for each Scientific Advisory Board member.

23 Question:

In ATTACHMENT 4, there is a sentence states “This study will recruit 2,400 healthy low risk pregnant women and 600 obese women in the first trimester of pregnancy.” Is “recruit 2,400 healthy low risk pregnant women and 600 obese women in the first trimester of pregnancy” in this contract’s scope? Whose responsibility to recruit 2,400 healthy low risk pregnant women and 600 obese women in the first trimester of pregnancy?

The Study sites will recruit the subjects. This information was provided to help with understanding the study.

24 Question:

In ATTACHMENT 4 III. TECHNICAL REQUIREMENTS for TASK 1: is a sentence states “Develop and test a quality control system for monitoring data collection procedures and assuring quality of ultrasonography data.” Does “a quality control system” mean web-based computer system? If yes, is any integration requirement between quality control system and web-based data management system, or we just develop one system with two components?

The web-based data management system should be inclusive of data quality practices including those that can be implemented in real time.

RFP-NIH-NICHD-DESPR-08-29 Page 5 of 5

25 Question:

In ATTACHMENT 4 III. TECHNICAL REQUIREMENTS for TASK 1: “Test, refine and prepare to implement a web-based data management system for the collection, editing, and correction of data from the Clinical Centers.” Does it mean in using existing a web-based data management system or build up a web-based data management system from scratch?

Tailoring an existing system, preferably one with demonstrated feasibility and utility for prospective observational epidemiologic studies to meet the specifications of the Study, would be desirable.

26 Question:

Who will pay Central Sonologist to produce a report on ultrasonography data quality?

The Central Sonologist will be paid by one of the Study Sites.