Amendment3for RFP-NICHD-DESPR-09-01.PDF

DHHS: 267- OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE

DATE

October 7, 2008

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

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, OA Executive Building, Suite 7A07

6100 EXECUTIVE BLVD MSC 7510

BETHESDA MD 20892-7510

9A. AMENDMENT OF SOLICITATION NO.

RFP NIH-NICHD-DESPR-09-01

X

9B. DATED (SEE ITEM 11)

August 1, 2008

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

TO 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 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 __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 provide further clarifications to questions submitted by potential Offerors

DUE DATE: October 22, 2008, 1:30 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

Lynn Salo, 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

October 7, 2008

RFP NIH-DESPR-09-01

Amendment #3

Repository for Storage, Monitoring and Distribution of NICHD Biological

Specimens

The following clarifications are provided as a response to questions submitted by the public to the above referenced Request for Proposal for the benefit of all potential Offerors.

Preamble: This project is a service contract for the continued storing, monitoring and distributing blood, urine, tissue and other samples currently be collected by 24 NICHD programs. These collections have been maintained by a Government Contractor since 1992 having begun with one collection. It has expanded over the years and has been re-competed three times. The current Contractor is Fisher BioServices, 625 Lofstrand Lane, Rockville, MD 20850.

The Offeror must show flexibility with this work since it maintains many different and unrelated collections from various program areas of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). There is no easy formula to determine how much work will be required at any given time. The Project Officer will prioritize work requests when and if the work load exceeds the Contractor’s ability to process samples in a timely manner. Examples of requests are 1) shipping samples out (with or without aliquoting), 2) entering samples received into the inventory, and 3) re-inventorying old collections.

Further clarification for the description of freezer temperatures, there are basically three types of storage freezers. They are:

-20 Walk-in Freezer encompassing 2,250 cubic feet.

-70 (This can be described as Ultra Low with temperatures held at -70oC to -80oC . None of the NICHD collections is required to be held below -80oC in these freezers.)

Liquid Nitrogen

All Offerors are reminded of the crucial information found in SECTION M of the Request for Proposals. There you will find the Evaluation Factors for Award and a description of how all proposals are evaluated.

NO FURTHER QUESTIONS WILL BE ENTERTAINED AFTER OCTOBER 9, 2008.

1. It is pointed out in the answer to the first question of amendment #2, dated

October 1, 2008, that two studies, the EAGeR and PHACS may contribute an additional 1,000,000 samples in the next year alone. Otherwise it is estimated that the inventory will grow at a pace of 1.5 studies or around 5% per year. Are both of these statements true?

Answer: Yes.

Q: This makes a marked difference in the number of freezers that the contractor must plan for—actually nearly a third to a half more freezers would be needed for the extra 1,000,000-1,500,000 specimens delivered in a single year (the EAGeR and PHACS samples are to be stored at -70oC). These two studies alone essentially double the estimate for the freezer needs and must involve a huge amount of shipping. Who will be responsible for the cost of this shipping?

Answer: The contractor will bear the costs of shipping samples to testing laboratories.

2. In answer #2 of amendment #2, dated October 1, 2008, the NICHD lists its present number of freezers used to store the inventory. However, there appears to be a discrepancy between this number and the number of freezers listed in Attachment #4 of the RFP. Can the NICHD verify how many freezers and how many liquid nitrogen storage tanks will be available for use by the successful contractor?

Answer: This is a correction to the answer on October 1st.

Ultra Low 73 (14, changed from 20, are Government owned) Liquid Nitrogen 11 (6, changed from 5, are Government owned)

3. In answer #3 of amendment #2, dated October 1, 2008, the NICHD indicates that there are 11 liquid nitrogen tanks currently used to store approximately 175,000 samples. Can the NICHD provide further clarification for question #3 as to the exact number of liquid nitrogen freezers, number of specimens contained, the size of the vials in the freezers, and the exact size of the freezers?

Answer: There are six Government owned liquid nitrogen freezers (Forma models 740 and 8053) is identified in Attachment #4 of the RFP. Our best estimate is a total of 175,000 samples to be maintained in liquid nitrogen. The size of the vials are standard 2 ml cryovials. The Contractor should provide additional liquid nitrogen storage to accommodate this number.

4. Please provide further clarification for the shipping costs as estimated to be approximately $500 per month in the light of potential shipments of 1,000,000 to 1,500,000 samples in a single year.

Answer: For proposal purposes, an average of $500 per month may be used.

5. In answers #5 and #6 of amendment #2, dated October 1, 2008, shipping costs are discussed. A further question, who is responsible for the initial shipment of specimens/inventory into the repository?

Answer: The clinical site laboratory will be responsible for shipping costs for all inventory coming into the repository. Many of these collections have not yet been funded for further research, but the samples are being held until such time as needed for future research protocols. The $500 per month shipping costs is a reasonable estimate for proposal preparation purposes.

6. The NICHD indicates that older specimens may have personal identifiers associated with them. Will these all be removed before shipping to the contractor? If yes, when is this anticipated to be accomplished?

Answer: When older specimens are requested to be used for further research, samples will be aliquoted into new vials without identifiers before being shipped out. There is no way to predict when this may happen.

7. What is the estimated number of samples per year that will have to be thawed and redistributed to other labeled vials as opposed to simply pulling specimens and shipping to other laboratories? What sort of vials will be used to redistribute these samples?

Answer: Samples in many of the newer collections have been aliquoted before storage. The older collections such as CCP and CPEP must be aliquoted before shipping. At this time we cannot predict when projects using these samples will be funded nor type of vial to be used.

8. Further clarification to question #19 of amendment #2, dated October 1, 2008, are provided as follows:

a) Are there any -20oC freezers besides the -20oC walk in freezer?

Answer: No

b) How many of the -86oC freezers are owned by the government? (14, 15, or 20) Answer: See answer to question #2 above.

c) Regardless of how many -86oC freezers are owned by the government, how many (14, 15, or 20) will be available to the successful Contractor/Offeror?

Answer: 14. Every Government owned freezer will accompany the repository inventory.

d) How many of the liquid nitrogen storage tanks are owned by the government (5 or 6) Answer: Six.

e) Regardless of how many LN2 tanks are owned by the government, how many will be available to the successful Contractor/Offeror?

Answer: Six. Every Government own LN2 tank will accompany the repository inventory.

f) What are the makes, models and sizes of the remaining 5 (or 6) LN2 storage tanks?

Answer: The Contractor should be prepared to provide additional liquid nitrogen storage to accommodate the current inventory as necessary.

9. In answer to question #31 of amendment #2, dated October 1, 2008, who is the

“incumbent contractor?”

Answer: The incumbent contractor is Fisher BioServices, 14665 Rothgeb Dr., Rockville, Maryland 20850. They are the Government Contractor coordinating all the logistics of monitoring, storing, and distributing the NICHD biological specimens at this time.

10. In question #35 of amendment #2, dated October 1, 2008, who is the “current contractor” that will pay for the relocation costs?

Answer: Fisher BioServices 14665 Rothgeb Drive Rockville, Maryland 20850

11. How will the shipments from the participating studies be determined? Will the repository be involved in planning these shipments?

Answer: The Contractor will receive direction from the NICHD Project Officer as to whom and when the specimens will be shipped. Normally, a plan to keep shipping costs to a minimum will be followed.

12. How will the shipments to other laboratories be determined? Will this be the sole responsibility of the NICHD Project Officer or will there be an interactive relationship with the repository, NICHD Project Officer and the sending/receiving laboratory?

Answer: There will be interaction between the three identified parties in order to accomplish the required logistical processes.