Amendment__3.pdf

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE

DATE

See Block 16C

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

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

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch 6100 EXECUTIVE BLVD., Suite 7A07, 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-IDD-2015-3

X

9B. DATED (SEE ITEM 11)

May 20, 2015

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.

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 __1___ copy of the amendment in your 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 FAR 52.243-2. 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) and Contract ARTICLE B.4.

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_ copy in your business proposal 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 to modify the language in Attachment 1 and to provide answers to nineteen (19) questions on RFP NIH-NICHD-IDD-2015-3

- Newborn Screening Pilot Studies.

Cut off period for questions: June 18, 2015 (unchanged)

DUE DATE: July 7, 2015 2:00 PM Local Time (unchanged)

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

Megan Gnall, Contracting Officer NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

/S/

BY

(Signature of Contracting Officer)

16C.DATE

SIGNED

06/22/2015

RFP-NIH-NICHD-IDD-2015-3

Newborn Screening Pilot Studies

1. Attachment 1, PACKAGING AND DELIVERY OF PROPOSAL, as shown under the Technical Proposal column, it is hereby amended to read as follows:

The offeror must submit one Technical Proposal with two (2) sections:

1. IDIQ – total pages should not exceed 50 pages, exclusive of cover page, table of contents, resumes, bibliography/references and any appendices.

2. Task Order 1 – total pages should not exceed 25 pages, exclusive of cover page, table of contents, resumes, bibliography/references and any appendices.

2. Below is a list of questions and answers:

Question 1: Since this is an IDIQ, please clarify how offerors should estimate the total subcontracting dollars for the purpose of developing the IDIQ small business subcontracting plan goals. Or should offerors propose a small business subcontracting plan with goals expressed in terms of percentages only?

Answer 1: The total subcontracting dollars for the purposes of developing the IDIQ small business goals should be based on two million dollars (not in percentages). Also, please see pages 91-93 under paragraph 5 entitled Small Business Subcontracting Plan.

Question 2: Will the agency require a small business subcontracting plan at the task order level, or only at the IDIQ master contract level?

Answer 2: Only at the IDIQ contract level, not at the task order level.

Question 3: If we use digital microfluidics from the company “Baebies” (who has a kit currently under review by FDA) as the platform for screening for MPS1 would this be considered an investigational device or a laboratory developed test?

Answer 3: It will be an investigational device until such time as they get approved.

Question 4: If we use digital microfluidics, would we then be required to obtain consent from parents in a state that uses an opt-out model for regular newborn screening?

Answer 4: Yes, it is an FDA requirement until it is approved.

Question 5: If consent is required by the state or because of use of an IDE, would the additional budgetary needs/required to add a consent model be acceptable?

Answer 5: Yes.

Question 6: For the Technical Proposal, we currently have one combined bibliography/reference for the IDIQ and Task Order 1. Does that make sense to you?

There is a great deal overlap, but I can separate it out if different people will be reviewing IDIQ and Task Order 1.

Answer 6: The bibliography/reference for the IDIQ and TO1 can be combined in one.

Question 7: Does the bibliography/reference "count" in the page limitation for the proposals?

Answer 7: The bibliography/reference does not count in the page limitation. The page limitation is exclusive of cover letter, table of contents, any appendices, including items such as resumes. Attachment 1 of the RFP has been modified to address this.

Question 8: Should the IDIQ, TO1 and TO2 be submitted as 3 separate files?

Answer 8: See Attachment 1 and Attachment 6 of the RFP. Offerors are required to submit one (1) Technical Proposal with two sections: IDIQ and TO1. In addition, Offerors must submit one (1) Business Proposal with two sections: TO1 and TO2.

Each of the proposals, Technical and Business, must be separate and complete in itself.

Question 9: Should any documentation be provided with the IDIQ and task orders to address section 508?

Answer 9: Attachment 1 of the RFP states under the business proposal, that the offeror must provide a brief narrative addressing Information Security (page 63 of the RFP) and Section 508 Compliance (page 89 of the RFP).

Question 10: On Attachment 3a of the RFP, page 2, will the protocol & external documents review come from other NBS labs in the pool just like the IRB document & consent forms review?

Answer 10: Yes.

Question 11: For TO2, what will be reviewed?

Answer 11: The IDIQ SOW covers the TO2 requirements. Therefore, there will be no technical evaluation for TO2. For that reason, Offerors are not required to provide a Technical Proposal for TO2. See Attachment 1 of the RFP.

Question 12: What format should resumes be in?

Answer 12: There is no specific resume format required.

Question 13: Should NIH Biosketches be used?

Answer 13: NIH Biosketches may be used.

Question 14: Do page limits for IDIQ and task orders include cover page and table of contents?

Answer 14: The page limitation is exclusive of cover letter, table of contents, appendices, including items such as resumes. Attachment 1 of the RFP has been modified to address this.

Question 15: Can letters of support be included?

Answer 15: Yes.

Question 16: Should vendor quotes be included for large purchases?

Answer 16: Yes, Offerors are required to provide a basis for pricing of proposed materials, equipment, or any other cost, which include vendor quotes, invoice prices, etc. See Business Proposal Instructions, page 89-98 of the RFP.

Question 17: ARTICLE H.18. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR352.239-73(b) (January 2010), (p. 34) The following Section 508 accessibility standards apply to the content or communications material identified in this Statement of Work:

Software Applications and Operating Systems (§1194.21) Web-based Intranet and Internet Information and Applications (§1194.22) Telecommunications Products (§1194.23) Video or Multimedia Products (§1194.24) Self Contained, Closed Products (§1194.25) Desktop and Portable Computers (§1194.26) Information, documentation, and support (§1194.41

Is this, in fact, the sum total of Section 508 standards which are to apply to the system(s) proposed in response to the Solicitation?

Answer 17: Yes, all of the above standards apply to the RFP.

Question 18: According to amendment #1 and attachment #1, Task Order #1 requires two cost estimates. In addition, a cost estimate is needed for Task Order #2.

Should we complete an excel Spreadsheet of the Breakdown of Proposed Estimated Costs for each of the above with a spreadsheet consolidating the costs for the entire proposal?

Answer 18: See Attachment 1 of the RFP and Amendment 2, Question 15 of the RFP.

Offerors must submit separate individual Excel Spreadsheets of the Breakdown of Proposed Estimated Costs for TO1 and TO2, but not a consolidated cost for the entire proposal.

Question 19: Does this solicitation require one Small Business Subcontracting Plan based on the consolidated costs of our proposal?

Answer 19: The offeror’s submission should include one Small Business Subcontracting Plan based on a total dollar amount of two million dollars.