Amend No 1-RFP-09-07.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

08/22/2008

4. REQUISITION/PURCHASE REQ. NO

N/A

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5)

CODE

Office of Acquisitions, NICHD Contracts Management Branch National Institutes of Health Executive Building, Suite 7A07

6100 EXECUTIVE BLVD, MSC 7510

BETHESDA, MD 20892-7510

9A. AMENDMENT OF SOLICITATION NO.

RFP-NIH-NICHD-NCS-09-07

9B. DATED (SEE ITEM 11)

07/28/2008

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 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 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: (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, X is required to sign this document and return _1___ copies to the issuing office with your business proposal

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.

Purpose: To amend the RFP-NIH-NICHD-NCS-09-07

The hour and date for receipt of proposals is not extended and remains unchanged, 4:00pm, local time, on 09/15/2008.

See continuation page for Amendment.

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

Theresa A. Koomson, Contracting Officer NICHD Contracts Management Branch

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ____________/s/____________________ (Signature of Contracting Officer)

16C. DATE

SIGNED

08/22/2008

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

PREVIOUS EDITION NOT USABLE Prescribed by GSA FAR (48 CFR) 53.214(a)

RFP-NIH-NICHD-NCS-2009-07

AMENDMENT Number 1

CONTINUATION PAGE Page 2 of 6

As a result of this Amendment:

The RFP is amended as follows:

Section M – Evaluation Factors for Award is modified at paragraph 1. General to add Small Disadvantaged Busines (SDB) participation as the fourth evaluation factor. Therefore paragraph one is revised to read as follows:

1. General

Selection of an offeror for contract award will be based on an evaluation of proposals against four factors. The factors in order of importance are: Technical, Cost, Past Performance and Small Disadvantaged Business (SDB) participation.

Although technical factors are of paramount consideration in the award of the contract, past performance, cost/price and SDB participation are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost. The trade-off process described in FAR 15.101-1 may be employed.

This process permits tradeoffs among cost/price and non-cost factors and allows the Government to consider award to other than the lowest priced or highest technically rated offeror. In any case, the Government intends to make awards to that offeror whose proposal provides the best overall value to the Government.

IT IS MANDATORY THAT ALL OFFERORS PROPOSE ON THE SECONDARY LOCATION FACILITY AS AN OPTION UNDER THIS RFP. The primary and the secondary location facility option will be evaluated and scored separately in accordance with the two sets of evaluation criteria in item 4 below. Both will be scored on a scale of 100 points each.

The Primary Facility will be weighted as 60% of the technical evaluation for this contract award and the Secondary Facility evaluation score, also based on 100 points, will be weighted as 40% of the technical evaluation for award selection. Offerors must propose a separate business proposal for the secondary location option but the technical proposal may either be integrated into your proposal for the primary facility or may be proposed as a separate section within your technical proposal. The technical proposal (including the Primary and Secondary Facility) may not exceed the page limits specified in Section L. Also, see Attachment 7, Additional Business Proposal Instructions for directions on preparation of the costs for the Secondary Location Facility Option.

The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below under Technical Evaluation Criteria.

The following questions and answers have been received in response to the RFP:

Question 1: Referencing Attachment 3, Page 13, #13; the SOW refers to “including a physical security guard”. Should this be interpreted to mean a human being security guard or a lock and similar security hardware, perhaps a gate? If this is interpreted to mean a human being, is the guard to be on duty 24/7 or working hours only?

Answer 1: Section II.C.13. reads "...Provide security measures that ensure the facility and equipment are protected against fire, other environmental hazards, and personal intrusions. The facility security system should have a minimum of two levels, including a physical security guard and employee cardkeys. The facility shall have audible interior and exterior audible alarms for emergency evacuation."

The term "physical security guard" should be interpreted to mean human employee(s) charged with protecting the physical security of the premises against unauthorized access, vandalism, etc.

The requirement should be interpreted to apply to working hours at minimum.

Question 2: In reference to Attachment 3, page 16, J.; please clarify if it is expected that the contractor will receive samples in formaldehyde for aliquoting?

CONTINUATION PAGE Page 3 of 6

Answer 2: Section II.D.13.j. reads "...As recommended in the ISBER Best Practices for Repositories: "Sufficient air circulation must be provided to prevent excess moisture and condensation. Left unchecked, excess humidity can lead to fungal growth, which can possibly affect specimen integrity and may cause health problems for staff. Sufficient space for air circulation is required especially in areas where freezers and refrigerators are employed to prevent excess heat accumulation which may negatively affect compressor function (see Section D2.100). Adequate ventilation is also critical in repositories and where liquid nitrogen and dry ice are used to ensure that sufficient oxygen levels are maintained (see Sections E2.400). Similarly, when services are performed in which potentially harmful vapors are generated (e.g., formaldehyde) the ventilation system should ensure that personnel are protected and that regional and national standards for the specific harmful vapors are met."

(International Society for Biological & Environmental Repositories, 2008)

Tissue samples currently anticipated to be received by the repository do NOT include samples in formaldehyde. They do include paraffin blocks and previously fixed slides of placental and umbilical cord tissue.

Question 3: Will the samples (biospecimen and environmental) be sent to the repository in double-bagged condition from the participating sites, or will the double-bagging need to be undertaken by the repository upon receipt for permanent storage?

Answer 3: Biological samples will be sent to the repository in double-bagged condition and are expected to comply with applicable DOT and IATA packaging requirements. Environmental samples will be shipped to the repository in the container and/or wrapper(s) in which they are expected to be stored. In general, environmental samples will not be double-bagged.

Question 4: What percent of the relevant samples will require DNA or RNA extraction? What percent will require hemocrit testing?

Answer 4: It is not possible at this time to specify precisely the number of samples that will require nucleic acid extraction, as the overall approach to genetic analysis, the number of future case-control studies requiring genetic analysis, and the proportion of participants expected to consent to it have yet to be determined.

It is anticipated that one hundred percent of cord blood samples will require weighing and hemoglobin/hematocrit or CBC determination prior to further processing in order to be able to index future RBC folate measurement, with approximately twice that number of non cord blood whole blood samples, for a total of approximately 300,000 determinations. The number of such determinations by study year is estimated to be 1,700, 8,600, 28,300, 54,400, 75,300, 86,900, and 72,500.

Question 5: Is the NCI IMS capable of calling XML based Web Services? Similarly, does the NCI IMS have any existing Web Services which can be called by external entities?

Answer 5: Note that the response here applies to the *NCS* (not NCI) IMS.

The NCS IMS supports XML transfers. The IMS has the capability to call and use various types of web services including XML based services. The IMS currently does not have an exposed web service available for outside entities.

Question 6: Will the contractor for this RFP be aliquoting any environmental samples, that is, will a laboratory be needed in the Environmental Storage facility?

Answer 6: It is not anticipated that aliquotting of environmental samples or that a separate laboratory for such will be required in the current NCS repository acquisition plan time frame.

Question 7: We understand that the total length of this study is to be ~22 years. What provisions, if any should be made for growth beyond the 7 years of this contract?

Answer 7: It is anticipated that, subject to funding availability, additional samples will be acquired over the life of the study and that the magnitude of sampling events may be on the order of 100,000 per year. More precise guidance on the anticipated growth of the NCS repository collection and related activities cannot be provided at this time.

Question 8: At the top of page 18 of the proposal, it seems that the sentence regarding training is incomplete.

“Contractor/Subcontractor staff shall complete the following additional training prior to performing any work under this contract:

….. “. For cost purposes, what assumptions should be made in the area of training?

CONTINUATION PAGE Page 4 of 6

Answer 8: Section H., Article H.11. Information Security, item d. Information Security Training reads

"...The Contractor shall ensure that each Contractor/Subcontractor employee has completed the NIH Computer Security Awareness Training course at: http://irtsectraining.nih.gov/ prior to performing any contract work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance of the contract.

The Contractor shall maintain a listing by name and title of each Contractor/Subcontractor employee working under this contract that has completed the NIH required training. Any additional security training completed by Contractor/Subcontractor staff shall be included on this listing. [The listing of completed training shall be included in the first technical progress report. (See Article C.2. Reporting Requirements.) Any revisions to this listing as a result of staffing changes shall be submitted with next required technical progress report.]

Contractor/Subcontractor staff shall complete the following additional training prior to performing any work under this contract:

The final sentence above regarding additional training was included inadvertently and should be omitted.

Question 9: Several positions are specified in the RFP as full time requirements (QA, IT, Safety), but listed as part time (0.25) in the Level of Effort estimate. Please clarify.

Answer 9: The volume of NCS participants and related work is not expected to be static, but is anticipated to increase gradually over the first several years following commencement of the study and to peak in the sixth study year. Conversely, depending upon function, the maximum level of effort required for other activities is expected at startup but to decline thereafter. Level of effort estimates have been adjusted to reflect these assumptions.

Question 10: The RFP lists a requirement for storage in the 2° - 8° C range, but no storage requirement in this range is listed in Attachments 1 or 3. Is the storage in this range required, and if so, what amount?

Answer 10: It is correct that the current projected inventory of biospecimens and environmental samples requires either frozen or ambient temperature storage. It is not anticipated that refrigerated storage temperature space is required for long term storage at present. However, the capability may be required at some undetermined future point.

Question 11: Can this work be performed at a foreign location?

Answer 11: No, it is impractical for a domestic study to have a foreign repository.

Question 12: Should the cost of shipping samples to the repository from the sites, NCS Histology lab or the Environmental Processing lab to the repository be included in the repository budget?

Answer 12: Offerors should assume that costs of shipping materials TO the repository will be covered by mechanisms external to the repository budget, and these should NOT be part of the budget.

Question 13: Should the cost of shipping the recycled shipping containers to the NCS Coordinating Center and the cost of the components that will require refurbishment be incorporated into the repository budget?

Answer 13: Yes, the cost of shipping the recycled shipping containers to the NCS Coordinating Center and the cost of the components that will require refurbishment should be incorporated into the repository budget.

Question 14: What samples require processing in a “clean room”? What class clean room is required?

Answer 14: Biological and environmental samples should be processed in separate rooms. Blood and urine processing should be performed in a Biosafety Level 2 hood both as a safety precaution and to avoid environmental contamination of biological specimens.

Question 15: Outside of a unique accession number, what other identifiers must be on the vial label? Would it be acceptable to only include an accession number on the vial with a general description of the material and have all other identifiers contained within the NCS IMS and the RIDMS?

CONTINUATION PAGE Page 5 of 6

Answer 15: Only the vial identification number and specimen type is required on the label.

Question 16: What blood fractions identified in Attachment A-3 will require PBMC isolation, Whole Blood cryopreservation, and DNA extraction?

Answer 16: Whole blood from the ACD tubes will be cryopreserved. All ACD tubes will be processed to cryopreserve the whole blood. Regarding PBMC isolation and DNA extraction, it is anticipated that these activities will be performed only a subset of samples to be identified in the future such that it is not possible to estimate the sample numbers at this time.

Question 17: Will DNA and RNA preparations be performed as they are received or will they be stored for a period of time prior to extraction? If the later, is there a planned time-frame as to when this activity would begin?

Answer 17: Nucleic acid preparations are NOT anticipated to be performed as they are received, but to be stored for a period of time prior to extraction. It is anticipated that these activities will be performed only a subset of samples to be identified in the future such that it is not possible to estimate the sample numbers at this time.

Question 18: The RFP outlines the number of vials to be shipped each year of the contract. What is the average number of vials in each request or how many shipments should be planned to accomplish the distribution of these samples?

Answer 18: At this time it is possible only to estimate the number of shipments to analysis laboratories because these will depend partly on the laboratories that have joined the study and on any planned ancillary studies. Therefore, we estimate the the following approximate number of shipments by study year:

Year 1: 60 Year 2: 245 Year 3: 360 Year 4: 445 Year 5: 117 Year 6: 117 Year 7: 117

We estimate the number of samples per shipment in years 1-4 to be approximately 100 samples per shipment, and in years 5-7 to be approximately 1,000 samples per shipment.

Question 19: Is there an estimation of the number of vials that will require aliquoting during the retrieval and shipping process?

Answer 19: It is anticipated that this will be an infrequent occurrence because samples will be aliquoted in small volumes prior to storage.

Question 20: Should the repository budget for the cost of return sample shipments from the recipient of shipments?

Answer 20: No, the repository should not budget for the cost of return sample shipments from the recipient of shipments.

Question 21: Should the contractor budget for visiting study centers to review or inspect local processing, temporary storage and shipping of specimens?

Answer 21: No, the contractor should not budget for visiting study centers to review or inspect local processing, temporary storage and shipping of specimens.

Question 22: Should the contractor budget for training local specimen collectors in local processing, temporary storage and shipping?

Answer 22: No, the contractor should not budget for training local specimen collectors in local processing, temporary storage and shipping.

Question 23: Should the contractor budget for quality measurements of these samples specifically, such as sectioning in the case of paraffin blocks and pathology review of these and the vaginal slides?

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Answer 23: No, the contractor should not budget for sectioning in the case of paraffin blocks and pathology review of these and the vaginal slides.