RFP Amendment 4 - Female.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 3

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

4 (Four) See Block 16C N/A N/A

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

CODE N/A

Eunice Kennedy Shriver National Institute of Child Health and Human Development Office of Acquisitions, NICHD Branch 6100 Executive Blvd, Rm. 7A-07, MSC 7510 Bethesda, MD 20892-7510

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) X

9A. AMENDMENT OF SOLICITATION NO.

TO ALL PROSPECTIVE OFFERORS

NIH-NICHD-CRHB-2012-03

9B. DATED (SEE ITEM 11)

May 2, 2012

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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 DATA 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 data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

N/A

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 RFP No. NIH-NICHD-CRHB-2012-03 and to provide answers to questions received regarding the RFP. See page 2.

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 (Type or print)

Alice M. Pagán Contracting Officer, OA, NICHD, NIH, DHHS

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY

______________/s/_________________________

(Signature of Contracting Officer)

7/30/2012

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

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

Amendment No. 4 to RFP NIH-NICHD-CRHB-2012-03 Page 2 of 3

RFP No. NIH-NICHD-CRHB-2012-04 is amended as follows:

A. Page 97-98, Section M, e - HIV Antiviral Treatment Trials, is hereby removed from this RFP.

Answers to questions received regarding this RFP, please note that individual questions may have been combined or reworded.

Questions

1. Question: Is the proposal due to arrive on the 3 rd or to be sent and postmarked by the 3 rd

Answer: Proposals are due on August 3, 2012 no later than 4:00p.m. ET. The original proposals have to be received at the place, date, and time specified. See page 1 (no. 8-9) and Attachment No. 1 of the RFP.

2. Question: This is a question concerning p.76-77 of the RFP regarding the extent of the site's role and responsibilities related to the security requirements in the RFP. In previous submissions the entity that hosts the server that stores the clinical trial data is the entity responsible for providing the security plan, risk assessment, IT-SC&A, etc… through the Statistical and Clinical Trials Coordinating Center. The subcontractors that access, process this server data have only been required to identify the employees that will be accessing the data and to take the required employee training.

Answer: Yes, all sites will have to comply with this requirement. As prescribed in HHSAR 339.7103, HHSAR clause 352.239-7 (January 2010), applies to contractors who run information systems on behalf of agencies. It covers information collected or maintained by or on behalf of an agency; and information systems used or operated by an agency or by a contractor of an agency or other organization on behalf of the agency. Sites will be collecting data on behalf of NICHD and FISMA applies to the systems that are used to process the data. See page 26 of the RFP, letter B. Security Requirements For Federal Information

Technology Resources, HHSAR 352.239-72, (January 2010).

3. Question: On page 97 there is a reference to addressing the provision of HIV Antiviral Treatment Trials. I assume that this does not apply to this RFP and that we do not need to address this. Is that correct?

Answer: Correct, this section does not apply to this acquisition.

4. Question: Can you please let me know if the NICHD requires original signatures on the Business

Proposals for RFP NIH-NICHD-CRHB-2012-03 or if scanned versions will be accepted?

Answer: A scanned image of the person authorized to sign the proposal is acceptable.

5. Question: Is a fax signature acceptable for all subcontractors since their office is not local?

Answer: A fax signature is acceptable for proposed subcontractors.

6. Question: Attachment No. 8 – Summary of Related Activities, only seems appropriate for TO1 and TO2.

Should it be omitted for the IDIQ the technical proposal? Who should be listed under letter c?

Answer: Yes, Attachment No. 8 only applies to TO1 and TO2. Under letter c, provide the level of effort that the designated individuals will be committing to resultant contracts for CCTN.

7. Question: Do we have to submit Attachment No. 8 for proposed subcontractors?

Answer: No, offerors are not required to submit Attachment No. 8 for proposed subcontractors.

Amendment No. 4 to RFP NIH-NICHD-CRHB-2012-03 Page 3 of 3

8. Amendment # 3 indicates that the PK proposal has to be submitted as a separate budget under TO2 business proposal. For clarification, does the PK total budget amount get included in the total cost amount on TO2 NIH 2043 or should a separate NIH 2043 has to be submitted under TO2 business proposal for

PK?

Answer: Please include a separate NIH 2043 with the PK business proposal.

9. Question: This question is for both TO1 and TO2. Regarding the question on NIH 2043 that asks for the

“estimated direct costs in proposed year,” what information are you looking for? Would you like the cost of only year 1 (of the 7) for TO1 and an average per year for TO2 (to line up with the estimated time required per year that it asks in the previous field)? Or would you like the total cost of each of the projects since this serves as a summary of the budget? And can you confirm that you only want the direct costs

(not including indirect)?

Answer: Please provide estimated direct costs for the entire project, do not include indirect costs.

10. Question: We have a question regarding Task Order #2 of this proposal. We have listed a “to be named” ultrasonographer to provide acquisition of the ultrasound images for the study. Are we able to request compensation for the technical component of the ultrasound scan using Medicare re-imbursement rates?

Answer: Yes.