Amendment_2_07-10-2014.pdf

DHHS: 275- OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE

DATE

07/10/2014

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 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-DIPHR-2014-11

X

9B. DATED (SEE ITEM 11)

June 9, 2014

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 of f ice.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF sect ion headings, including solicitat ion/contract subject matter w here feasible.)

PURPOSE: 1) To Amend ARTICLE F.1, 2) To Amend SECTION J, At tachments #1 and #7 and SECTION L, 2, 3) To specify the mailing address for delivery of the hard copy of the OFFEROR’S Original Technical and Business Proposals, and 4) To provide answ ers in SECTION II based on inquiries to RFP NIH-NICHD-DIPHR-2014-11.

DUE DATE: July 22, 2014, 2:00 PM Local Time (Unchanged)

Except as provided herein, all terms and condit ions of the document referenced in item 9A or 10A, as heretofore changed, remains unchanged and in full force and ef fect .

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER

Lynn Salo, Contracting Off icer 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 Contract ing Off icer)

16C.DATE

SIGNED

07/10/2014

RFP-NIH-NICHD-DIPHR-2014-11

AMENDMENT NO.: 002

CONTINUATION PAGE Page 2 of 9

THIS IS AMENDMENT #2; however, it may appear on the FedBizOpps website as Amendment #3. There are only two (2) amendment to this RFP

As a result of this Amendment:

SECTION I. The RFP is amended as follows:

PARTII, ARTICLE F.1, is amended to only require electronic reports to both the COR and Contracting

Officer. No hard copy reports will be required.

PART III, SECTION J, Attachment 1, Packaging and Delivery of Proposals -- Document amended to include all Reference pages to be excluded from the mandatory page limitation requirement of the Technical Proposal.

PART III, SECTION J, Attachment 7, Additional Technical and Business Proposal Instructions – Document amended to include all Reference pages to be excluded from the mandatory page limitation requirement of the Technical Proposal.

PART IV, SECTION L, 2. Instructions to Offerors, a. General Instructions, 4. Separation of Technical and Business Proposals and Page Limits (Page 51) is hereby amended to include references in the exclusion of the page limitation requirement.

In the writing of the Technical proposal, page limitations for each part are as follows:

Technical Proposal IDIQ Contract - The page limit should not exceed 25 spaced pages, exclusive of biosketches, references, a list of Standard Operating procedures (SOPs), draft Information Security Plan, Summary of Related Activities, NIST SP 800 53 Self Assessment, Proposal cover Sheet and the Table of Contents.

Technical Proposal Administrative Task Order 1 -- The page limit should not exceed 15 spaced pages, references, exclusive of biosketches, a list of Standard Operating procedures (SOPs), draft Information Security Plan, Summary of Related Activities, NIST SP 800 53 Self Assessment, Proposal cover Sheet and the Table of Contents.

Technical Proposal Historical Collections Task Order 2 -- The page limit should not exceed 15 spaced pages, exclusive of biosketches, references, a list of Standard Operating procedures (SOPs), draft Information Security Plan, Summary of Related Activities, NIST SP 800 53 Self Assessment, Proposal cover Sheet and the Table of Contents.

Technical Proposal Asthma Task Order 3 -- The page limit should not exceed 15 spaced pages, exclusive of biosketches, references, a list of Standard Operating procedures (SOPs), draft Information Security Plan, Summary of Related Activities, NIST SP 800 53 Self Assessment, Proposal cover Sheet and the Table of Contents.

SECTION II.

1) This amendment specifies the mailing address for the delivery of the hard copy of the OFFEROR’s Original Technical and Business Proposals to RFP NIH-NICHD-DIPHR-2014-11.

EXTERNAL PACKAGE MARKING: In addition to the address cited below, mark each package as follows:

“REF NO. NIH-NICHD-DIPHR-2014-11

TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY”

TECHNICAL and BUSINESS PROPOSALS

Technical: One ORIGINAL Business: One ORIGINAL

If hand-delivered or delivery service

Lynn Salo, Contracting Officer Alternate: Elizabeth Osinski, Contracting Officer Office of Acquisitions Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Executive Building, Suite 7A07 6100 Executive Boulevard Rockville, Maryland 20852

If using U.S. Postal Service

Lynn Salo, Contracting Officer Alternate: Elizabeth Osinski, Contracting Officer Office of Acquisitions Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Executive Building, Suite 7A07, MSC 7510 6100 Executive Boulevard Rockville, Maryland 20852-7510

NOTE: Please be aware that the U.S. Postal Service’s Express Mail DOES NOT deliver to the Rockville, MD address and delivery to the Bethesda, MD address will result in a delayed delivery to our office in Rockville, MD (up to 3-5 days). If the original paper copy of a proposal is not received at the place, date, and time specified herein, it will be considered a “late proposal.”

2) This amendment provides answers based on inquiries received. The responses are provided for information only as guidance to potential Offerors and do not superseded any terms of the RFP and do not revise or become part of this RFP. Responses are as follows:

1) Asthma Study – Is there any processing needed to fulfill Task Order (aliquoting), or is the process to simply to receive, to store, to distribute, and to archive? (Page 115)

Answer The processing required for this task order would be only inventorying incoming shipments and generating and maintaining a database so samples are easily accessible.

2) Please clarify the statement of “retrieval of samples from research participant’s homes?” Specifically, what are the tasks required to receive from these sites? “Defined plan to receive specimens from multiple sites including clinical centers, research participant's homes, and analytical labs and to properly integrate these specimens and update the relevant inventories of the proper collections in a timely manner, maintaining the integrity of the biospecimens.” (Page 86)

Answer : For a few of our studies, we have subjects ship samples to you directly from their homes. We provide the subjects with barcoded specimen containers and appropriate shipping containers

3) Many of the collections in the Historical Collection are not inventoried" - Can you clarify whether the Historical Collections inventory is accurate (#samples in Attachment 8)? How will the files associated with the non-inventoried samples be transferred to Offerer? What is the anticipated percentage of samples that are not inventoried? (Attachment 7, page 3, paragraph 11c)

Answer : While the total number of samples in the Historical Collection is accurate, there are approximately 575,000 samples in the Historical Collection that are not inventoried and approximately 1,575,000 specimens are not barcoded. We will transfer all the files we have (i.e. included total number of samples and what inventory information). We anticipate future task orders to continue to inventory the samples.

4) The equipment lists an Owl Separation System Gel Electrophoresis box; however the contract does not state any extraction, PCR, etc. Is this piece of equipment relevant to any of the current statement of work tasks?

(Attachment 9, page 2, row 64)

Answer : No, this equipment is not relevant to this project.

5) Will the processing of biospecimens involve any of the following?

Answers : The processing required for the entire project would be only inventorying incoming shipments and generating and maintaining a database so samples are easily accessible. All blood and tissue processing would occur prior to shipment of specimens at the repository. At times, aliquotting is required before shipping samples out and that will be defined in future Task Orders and applies to all of these below.

a. Isolation of PBMC from whole blood, if yes, what is the average number of aliquots?

b. Isolation of serum from whole blood, if yes, what is the average number of aliquots?

c. Isolation of plasma from whole blood, if yes, what is the average number of aliquots?

d. Isolation of DNA from whole blood or blood products (PBMC, buffy coat), if yes, viable cell number/vial to be cryopreserved?

e. Isolation of DNA from tissue (frozen tissue, paraffin-embedded tissue (Attachment 3, B, Page 3)

6) What other types of biospecimens are to be processed beside those listed above if any? (Attachment 3, B, page 3)

Answer : Please see the answer to question 5 above.

7) Will the processing of biospecimens involve receiving and aliquoting the following: (Attachment 3, B, page 3)

Answer : Please refer to the answer in question 5 above.

a. Whole Blood

b. Cord Blood

c. Urine

d. Serum

e. Plasma

f. PBMC

8) The active studies in the Historical Collection indicated total predicted specimens; however it does not indicate how many specimens of the total have already been received. Is this information available? (Attachment 8)

Answer : All studies pertaining to the Historical Collection are concluded and all samples have been received. Some samples are presently being analyzed though we do not expect residual samples to be returned.

9) Please provide clarification of the required format for the deliverables? For example, Article F.1 specifies electronic and hard copies are required for the monthly and annual reports however, in the Task Orders, all deliverables are required to be in electronic format only. (Article F.1 and TOs 1-3)

Answer : ARTICLE F.1 is amended to only require electronic reports to both the COR and Contracting

Officer. No hard copy reports will be required.

10. Are references included in the technical proposal page limit? (N/A)

Answer: References are not included in the Technical Proposal page limit, see amended SECTION I above.

11) The solicitation states that 30,000 specimens will be shipped per month, but does not average how many actual shipments. How many total shipments does this equate to? Assuming more than 1 specimen goes out in a shipment (Page 87)

Answer : We expect an average of 10 shipments a month.

12) Based on past Task Orders, what is the frequency/volume of Task Orders released for access to the Historical Task Order Collection? (Attachment 7, Page 3)

Answer : The Historical Collection is one of our best resources. We see approximately 2-3 Task Orders to access these samples per year.

15) For planning purposes what is the target end date for the initial transition to be complete? The solicitation indicates the current contract end date is February 28, 2016. (Page 2, Attachment 7)

Answer : The transition will take place by February 28, 2016.

16) The solicitation states the requirement to buy 20 additional freezers. Are these freezers intended to replace freezers which are currently listed in the equipment attachment? (Attachment 7, page 2)

Answer : This number does not refer to replacement freezers.

17) Under the Historical Collections SOW it’s stated that access to historical collection specimens will be provided for by separate Task Orders. Will these Task Orders be priced at the time of the request using current data or will the estimations given in the Asthma Task Order be used? (Attachment 5, Page 2)

Answer : Task Orders will be priced at the time of the request.

18) Can other contract mechanisms be considered for this solicitation (e.g., fixed price per unit)?

Answer : Prior to announcing the solicitation, the NICHD investigated many types of contract mechanisms for this award. There are no fixed performance requirements or precise cost elements which can be established in advance for purpose of fixed price per unit contracting. The nature and magnitude of individual cost elements will depend upon factors developed during performance.

19) Please provide a link to the requested SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS which must be included in the Business Proposal.

Answer : The .pdf fillable document is posted with this Amendment #2.

20) For Task Order 2, please provide the number of -20°C, -80°C, and liquid nitrogen freezers in the Historical Collection. We have assumed approximately half of the freezers listed in Attachment 9 of the RFP, but would like actual numbers for the Task Order budget.

Answer : Please refer to Table 1. Not all of the collections are stored in dedicated freezers, so we cannot supply you with a firm list of freezers. However, these are the total number of samples and their storage requirements for the Historic Collections.

21) Does the freezer list in Attachment 9 of the RFP include backup freezers? If not, how many backup freezers should be budgeted at the outset of the award? Which Task Order should they be included in?

Answer : No back up freezers are included. The RFP states that backup freezers should be available to house 10% of all collections if necessary. For proposal purposes, include these costs in the Administrative Task Order.

22) For Task Order 3, will sample processing be required when study samples arrive at the repository or are samples sent in storage configuration?

Answer : If by processing you refer to separating blood or making aliquots, no this is not required for

Task Order 3. The processing required for this task order would be only inventorying incoming shipments and generating and maintaining a database so samples are easily accessible.

23) For Task Order 3, please provide details on the size and number of biospecimen shipments occurring during the trial. Will many small shipments occur, representing individual patient visits, or will the sites collect multiple patient samples and send larger shipments once a month or on some other schedule? Will the contractor be expected to provide shipping boxes to the sites for these shipments? Who will pay the shipping costs for the samples to be shipped to the repository?

Answer : We anticipate that the clinical sites will ship samples to the repository either quarterly or as their limited storage capacity is met. As recruitment for this study has not begun we can only approximate, but anticipate shipments of 2-3 boxes a month.

24) For Task Order 3, please provide the dimensions of the 50 mL urine container. Is this a 50 mL conical tube, a small jar, or other container?

Answer : The 50 mL storage container referred to here is a small jar.

25) For Task Order 3, please provide the dimensions of the PAXgene Tissue container used for Stool and Placenta samples. Are these QIAGEN 765112 PAXgene Tissue containers, or QIAGEN 765312 PAXgene Tissue FIX Containers or another container? Will the sample containers have more than one sample per container or will each sample be in a separate container?

Answer : For purposes of this proposal, assume these PaxGene Tissue containers are the 50mL Tissue Fix containers (Qiagen 765312)

26) Attachment 7, point 7, indicates that the Offeror should plan for the addition of 1-2 new collections per year of approximately 500,000 specimens each, and purchase freezers and racks to accommodate them. What Task Order should this be added to? What temperature freezers are needed? What size vials will be stored? Should the Offeror assume 2 mL vials for all specimens, or will multiple vial sizes be expected?

Answer : Answers to this question are currently unknown and reflect why we are using an IDIQ mechanism for this contract. While we anticipate this rate of growth for our collections based on past repository growth, each new collection will be a separate Task Order with details and costs to be negotiated at the time those Task Orders are proposed. For purposes of this proposal (which relate to availability of the facilities and space required), please assume 2 mL vials to be stored at -70.

27) Attachment 7, point 8, indicates that the new contract must provide 20 new freezers. Are these freezers all - 20°C units, or are some -80°C units? What size units will be required (cu. ft. of units)? What is the inventory configuration/what rack sizes will be needed? What Task Order should the freezers be placed on?

Answer : Please refer back to Question 21.

28) Attachment 7, point 11 indicates that some of the Historical Collection is not currently barcoded. Please provide an estimate of the number of samples that are and are not barcoded. Point 11 also indicates that many of the collections in the Historical Collection are not inventoried; please provide an estimate of the number of samples that are and are not inventoried.

Answer : There are approximately 575,000 samples in the Historical Collection that are not inventoried. Approximately 1,575,000 specimens in the Historical Collection are not barcoded.

29) Attachment 7, point 12 indicates that the cost to move the samples will be borne by the current contractor.

Will the current contractor also be coordinating the move arrangements?

Answer : Arrangements for moving collections will be coordinated between the current contractor, the new contractor, and NICHD.

Questions pertaining to Task Orders #2 and #3

30) For clarity, are the active studies (non-asthma) part of the 4M total samples and how does the historic versus active sample number truly break down? It is not quite clear how the overall number falls into the various potential groups.

Answer : There are approximately 3.5 M samples in the Historical Collection and 1.8 M samples in the

Active Collection.

(A) Does Task Order 2 include historical and future samples from sites 1-4 of DIPHR?

Answer : Task Order 2 includes Historical samples (i.e. studies are concluded) from all 4 of the NICHD

Divisions that use the Repository (DIPHR, PBB, MPIDB, and DIR).

31) What does the clinical data already compiled encompass?

Answer : As many branches of NICHD use the repository, the data complied span the breadth of

NICHD’s mission.

32) What is the status of MTA’s for use of historic and/or active samples? Have these agreements been put in place already and who controls this process? Are these documents available for bidder review?

Answer : Active samples are those that pertain to current studies and no MTAs are necessary. Access to the Historical Collection requires an MTA for each proposal. There is a “standard” MTA in place for some of these samples that can be viewed at https://brads.nichd.nih.gov/Home/

33) Is there IRB approval in place for past and current sample acquisitions for the end-users?

Answer : All of the specimens have been collected with appropriate assurances, which include IRB approvals. Approvals prior to use of specimens are also in place.

34) How are we reimbursed for shipping and sample handling, future Task Order or via end-user fees?

Answer : We require both of these mechanisms. You will either be reimbursed through the Task

Order (NICHD) or end-user fees to be approximately 1-2% of total reimbursement for costs associated with disbursement requests.

35) Who currently owns the freezers used for storage? Are they being transferred as part of the new contract award?

Answer : Currently some of the freezers are owned by NICHD and some are rented. We stated that 20 new freezers need to be purchased to store samples currently housed in rented freezers.

36) Please clarify the current level of efficiency of current storage space and the sizing configuration breakdown of the samples being held at this time?

Answer : While we cannot provide you with specific details, we can say that we have done everything possible to maximize storage efficiency such that the majority of the collections are not housed in dedicated freezers.

37) Please clarify the expectations for inventory turnaround time (request/shipment) related to receipt confirmation.

Answer : This is dependent on each Task Order. For Task order 3, for example, specimens will be shipped to the repository over a period of 3 years and shipped out after all samples are collected.

Other Task Orders require samples to be shipped from the repository after as little as a week post-receipt.

38) Please clarify the expectations for future sample numbers as a breakdown of studies or procurement sites related to shipping and receiving of sample requests. Please clarify the breakdown of domestic and international shipment forecasts by number and type of sample.

Answer : This is dependent on each future Task Order and we cannot specify these requirements at this time.

39) Please clarify the expectations surrounding the attachment of barcode labels to LN2 vial samples; for example, are these labels to be affixed at the sample levels or container level?

Answer : All of the specimen tubes must be barcoded.

Questions pertaining to Task Order #3 https://brads.nichd.nih.gov/Home/

40) What is the breakdown of current operating storage facilities within the NICHD/DIPHR ?

Answer : This information is unavailable. Please base your estimates on what it would cost your organization to fulfill the requirements of the Statement of Work.

41) Please provide clarity on the number of samples to be acquired annually from all current and potential studies?

Answer : This is dependent on each future Task Order and we cannot specify these requirements at this time.

42) Many of the samples be acquired for the asthma study are cellular in nature, why are these samples to be stored at -70C? It would seem that in order to obtain viable cells from these samples in the future they would be better stored at LN2 temperatures.

Answer : We do not need viable cells from these samples but instead store them at -70 as that is sufficient for preservation of our biomarkers.

43) Would the approximated 50,000 samples per month be one at a time or in a series of bulk shipments?

Answer : Please see the answer to question 5, below.

44) There are two different numbers stated in the RFP related to future sample receipt; One, being 80,000 samples per week and another being 50,000 samples per month. Please clarify the difference represented by these two values, both numerically and based on sample origination.

Answer : We anticipate maximum shipments containing up to 80,000 samples per week to the repository. Past experience indicates the repository ships out about 50,000 samples per month, in a total of 10 shipments

45) The term Cognizant Field Office Audits is used, please define this term.

Answer : For Indirect Cost Rates agreements, we will use the cognizant audit agency.

46) What proportion , if any, are the Task Order 3 samples already obtained or still to be collected? As part of this question, is the bidder required to budget for shipment of samples from the procurement sites to the storage facility?

Answer : Subject recruitment for this Task Order will begin in November 2014. We have collected no samples to date. Shipping costs to the repository are covered elsewhere.

47) Please clarify the intent or desire of the contractor to have samples received by the bidder to be divided into aliquots prior to storage, as it seems that the sample formats and sizes will require the generation of daughter samples prior storage.

Answer : All of our specimens will be appropriately aliquotted prior to receipt at the repository. At times the repository will be required to aliquot samples prior to shipment.