Amend_No_2-RFP-NIH-NICHD-DESPR-2013-15.pdf

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV 10-83)

PREVIOUS EDITION NOT USABLE Prescribed by GSA FAR (48 CFR) 53.214(a)

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

June 4, 2013

4. REQUISITION/PURCHASE REQ. NO

N/A

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5)

CODE

Office of Acquisitions NICHD Contracts Management Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Executive Building, Suite 7A07

6100 EXECUTIVE BLVD, MSC 7510

BETHESDA, MD 20892-7510

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

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION NO.

RFP-NIH-NICHD-DESPR-2013-15

9B. DATED (SEE ITEM 11)

May 16, 2013

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 in the business proposal; (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, __ is required to sign this document and return ____ copies to the issuing office.

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

Purpose: To amend the RFP-NIH-NICHD-DESPR-2013-15

See continuation pages for Amendment

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

Theresa Koomson, Contracting Officer NICHD Contracts Management Branch

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

04/23/2010

AMENDMENT NO.: 002

CONTINUATION PAGE Page 2 of 5

As a result of this Amendment:

The RFP is amended as follows:

Section J – List of Attachments, Attachment #1, “Packaging and Delivery of Proposal (R&D)”, is modified at paragraph IV, Formatting, Number of Copies, and Page Limitations, subparagraph B. to read as follows:

B. Number of copies and applicable page limitations for paper copies or discs.

THE PAGE LIMIT ON THE BASE IDIQ CONTRACT SHALL NOT EXCEED 25 SINGLE

SPACED PAGES, EXCLUSIVE OF RESUMES OR BIOSKETCHES, LIST OF STANDARD OPERATING

PROCEDURES, DRAFT INFORMATION SECURITY PLAN, SUMMARY OF RELATED

ACTIVITIES, NIST SP 800 53 SELF ASSESSMENT, PROPOSAL COVER SHEET AND THE

TABLE OF CONTENTS.

THE PAGE LIMIT ON THE TASK ONE TECHNICAL PROPOSAL SHALL NOT EXCEED

15 SINGLE SPACED PAGES, EXCLUSIVE OF RESUMES OR BIOSKETCHES, SUMMARY OF RELATED

ACTIVITIES, HHS SECTION 508 PRODUCT ASSESSMENT TEMPLATE, PROPOSAL COVER SHEET AND

THE TABLE OF CONTENTS.

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

Question 1:

The RFP states, “for all web-based systems, open source systems are preferred.” Does this mean open source systems are required?

Answer 1:

They are not required; however, preference will be given to offerors who have access to open source systems.

Question 2:

Is there an existing web-based data management system that supports the NICHD DESPR efforts? What is that system? Is it open source?

Answer 2:

Yes, the current contracters supporting DESPR studies have developed web-based systems. Theresa, can we disclose the systems – some of them are proprietary. One of the contracter currently relies on an open source software (Picture Archiving and Communications System) to store images and associated data.

Question 3:

If a current system is in place for the DESPR studies, should offerors assume it will be transferred to the DCC contractor? Does the government have a transition timeline?

Answer 3:

No, there are no plans to transfer existing systems to the new contractor.

Question 4:

If the potential contractor has an existing data management system that is not open source, will the government fund work to convert to an open source system?

Answer 4:

As long as the conversion is not cost prohibitive.

CONTINUATION PAGE Page 3 of 5

Question 5:

The roles provided in the estimate of effort for the BASE PERIOD are: Principal Investigator – 20%, Programmer 1 – 75%, Linux/droid app programmer – 50%. Does this mean the NICHD assumes a PI and 2 programmers will perform all Base Period tasks? These roles do not seem to match the expertise required for some Base Period tasks (for example, finalize data collection protocols, assist in the development of study user guides, meet all regulatory and procedural requirements regarding the conduct of human research, monitor real-time data quality, etc.) Can the offeror also propose data managers, project managers, etc. for the Base Period?

Answer 5:

The offeror may propose an alternative skill mix within the estimate of total effort/cost. The primary source of the content for data collection, user guides, procedural requirements, etc. will be generated by NICHD and clinical collaborators.

Question 6:

The RFP states that “For All web-based systems, open source systems are preferred.” Can you distinguish between open source systems and systems with open APIs? If a vendor is proposing a superior software solution which requires licensing cost but has open APIs to interface with government systems then will you allow software as an “Other Direct Cost”?

Answer 6:

The offeror may propose an alternative web-based system within the estimate provided by the Government.

Question 7:

Is it a requirement that the PI be located in the Washington DC area?

Answer 7:

No, there is no requirement that the PI be located in the Washington DC area.

Question 8:

In the Estimate of Effort Table (Attachment 5, p. 1) the NICHD provides offerors with percents of effort for the Principal Investigator, Programmer 1, and Linux/Droid Application Developer for Task Order #1. Is the Government assuming that these three roles will provide all of the services outlined in the Task Order #1 Statement of Work (Attachment 3) or is that table simply clarifying the expected amount of effort for those particular roles? It seems this study will require additional personnel to coordinate meeting logistics, data management, statistical analysis, preparation of study materials, etc.

Answer 8:

The offeror may propose an alternative skill mix within the estimate of total effort/cost. The primary source of the content for data collection, user guides, procedural requirements, etc. will be generated by NICHD and clinical collaborators.

Question 9:

Per Attachment 5 (p. 1, item #3), can the NICHD confirm that offerors should only submit a budget and business proposal volume for Task Order #1 and not the IDIQ Base Contract?

Answer 9:

Offerors should only submit a budget for Task Order #1 not the IDIQ Base Contract.

CONTINUATION PAGE Page 4 of 5

Question 10:

For budgetary purposes (site visits, teleconferences, etc.), can the NICHD provide DESPR DCC offerors with an estimated number of clinical sites for the Task Order #1 Asthma Pregnancy Study?

Answer 10:

We anticipate one or two clinical sites but the actual number will depend on the successful proposal.

Question 11:

Will the blood and urine samples that are collected during the Asthma Pregnancy Study be stored at the NICHD’s biospecimen repository or will the DESPR DCC offeror be charged with the task of subcontracting this work to a biorepository vendor?

Answer 11:

Biologic specimens collected will be stored at the NICHD biospecimen repository. An additional subcontract is not needed.

Question 12:

In accordance with Attachment 3 (Task Order 1 Statement of Work, p. 1, item 2), should the DESPR DCC offerors include costs for mobile devices and data plans (smart phone, tablet, etc.) in their budgets for each of the subjects enrolled in the Asthma Pregnancy Study?

Answer 12:

Yes. Particular attention is needed to timing of purchase and activation to ensure that the availability of devices keep pace with recruitment in a cost effective manner.

Question 13:

For the one in-person meeting of study investigators (Attachment 3, Task Order 1 Statement of Work, p. 2, item B.1.xi) during Months 7-12 of the Base Period, including Division, Clinical Center Principal Investigators, and DCC staff in the Rockville, MD/Washington DC area, should the DCC assume that travel costs for the Clinical Center Principal Investigators will be covered by the clinical center contract and not by the DCC?

Answer 13:

Yes, we anticipate the clinical site travel will be covered under another contract.

Question 14:

Can the Government clarify whether the Technical Proposal Attachments (RFP Part III, Section J, p. 38) count against the IDIQ Technical Proposal 25-page limit? The Summary of Related Activities (Attachment 9) is the only attachment specifically named in the page limit exclusions (Attachment 1, p.3, item IV.B and Attachment 5, p.1, item 4). Of particular concern is the inclusion of the lengthy HHS Section 508 Product Assessment Templates (Attachment 11) in the 25-page limit, assuming that the Government is requiring the offeror to submit PATs for each proposed EIT system subject to Section 508.

Answer 14:

Please see revision to Attachment #1, Packaging and Delivery of Proposal (R&D) above.

Question 15:

The RFP Technical Proposal Instructions (p. 63, item 4) state that resumes of all key personnel are required. The Additional Technical and Business Proposal Instructions (Attachment 5, p. 1, item 4) indicate that CVs of the proposed staff should be biosketches. Can the Government clarify whether the offeror may provide a full CV for the

CONTINUATION PAGE Page 5 of 5 proposed Principal Investigator (which will include pertinent peer-reviewed publications as required on Attachment 5,

p. 2, item 5.a) and more succinct narrative biosketches for other personnel and, if so, whether the full CV will count toward the 25-page limit? Or is the Government requesting that CVs for proposed staff be provided in the NIH Biographical Sketch Format Page as available from the PHS Grants pages at http://grants.nih.gov/grants/funding/phs398/phs398.html?

Answer 15:

Either resumes or short biosketches (not to exceed 4 pages) are acceptable and they are both excluded from the page limitation.

Question 16:

From the description available on the solicitation we were not able to determine whether DESPR Is looking for the Cloud based solution or On Premise solution.

Answer 16:

There are no specific requirements in the RFP re: the location of the web-based system. The Offeror is free to propose and on premise solution, an iCloud solution, or a combination of the two.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT