Amendment__1_.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

06/03/15

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 answer five questions and correct the links to Attachments 8-14 under Section J, List of Attachments 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

06/03/2015

RFP-NIH-NICHD-IDD-2015-3

Newborn Screening Pilot Studies

Question 1: I am not so familiar with the IDIQ funding vehicle, in particular, I see only one “real task order” #1 for MSP1 and it makes me wonder about how one would go about being on the list for the other task orders that might come up that might be more appealing?

Answer 1: The Government anticipates that it will award approximately five (5) IDIQ contracts. The offerors receiving an IDIQ contract will be part of the Newborn Screening Pilot Studies pool.

As shown in Section M of the RFP, the technical evaluation criteria will be used by the Peer Review Special Emphasis Panel when reviewing the IDIQ and TO1 technical proposals. The technical factors are of paramount consideration in the award of the IDIQ contract and TO1 awards, past performance and cost/price are also important to the overall award decision.

From those offerors selected to receive an IDIQ award, the Government estimates that approximately three (3) offerors will be selected to receive a TO1 (MPS1) award. Task Order 2 will be awarded to those offerors that receive an IDIQ award but did not receive a TO1 award to meet the minimum guarantee of $5,000.

For future task orders, each new requirement or selected disease will be competed among those offerors in the Newborn Screening Pilot Studies pool. The Contracting Officer will prepare and issue a Task Order Request for Proposals (TORFP) for each task order requirement. Generally, the TORFP will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

See Article G.3. “Task Order Procedures” of this RFP for further information.

Question 2: In looking at the SOW for Task Order 2, it is not clear to me whose protocols would be reviewed – section IV – sections a-f?

Answer 2: The protocols reviewed would be those of the contractors performing Task Order 1.

Question 3: Reference the RFP, Section J, List of Attachments: In reviewing the RFP, we have found that the links provided for Attachments 8 – 14 are broken/inoperable.

Therefore, could you please provide either corrected links or actual copies of these documents?

Answer 3: The RFP is hereby amended to reflect corrected links for the Attachments 8-14 as follows:

Attachment 8: Technical Proposal Cost Summary http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost- Summ.pdf

Attachment 9: Summary of Related Activities http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf

Attachment 10: Protection of Human Subject Assurance Identification/IRB Certification/Declaration of Exemption, OMB Form No. 0990-0263 (Formerly Optional Form 310) http://www.hhs.gov/ohrp/assurances/forms/of310.pdf

Attachment 11: Proposal Summary and Data Record, NIH-2043 http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/NIH2043.pdf

Attachment 12: Small Business Subcontracting Plan http://www.hhs.gov/asfr/ogapa/osbdu/Small%20Business/subcontractplan.html

Attachment 13: Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

Attachment 14: Offeror's Points of Contact http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/point-of-contact.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Tech-Prop-Cost-Summ.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/summary-related-activities.pdf http://www.hhs.gov/ohrp/assurances/forms/of310.pdf http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/NIH2043.pdf http://www.hhs.gov/asfr/ogapa/osbdu/Small%20Business/subcontractplan.html http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/point-of-contact.pdf

Question 4: If awarded, is the contract only for 50,000 specimens? If a state screens 50,000 newborns for the pilot study, can that data be used in the study or does the RFP only want data from 50,000 specimens?

Answer 4: Offerors must provide two (2) cost estimates for TO1 (See Attachments 1 and 6 of the RFP):

1.) Proposed Estimated Costs 1 – For cost estimate purposes assume 50,000 subject screenings and include the cost per screening.

2.) Proposed Estimated Costs 2 – For cost estimate purposes base the estimate on the total number of newborn screenings that your Institution/Company estimates can be screened for MPS1 for a period of 18 months and specify the cost per screening.

Period of Performance for TO1: September 29, 2015 - March 28, 2017

Question 5: Is it possible for states to collaborate on this RFP? Certainly, there are disadvantages and advantages to this idea, but is multi-state collaboration allowed by this RFP?

Answer 5: As part of the Newborn Screening Pilot Studies pool, selected offerors/contractors will collaborate with other Newborn Screening Pilot Studies contractors. Offerors may propose subcontracts as a collaborative effort with other institutions or organizations.