Amendment_001-RFP-75N94022R00005_NIDDK_Biorepository_09_27_2022_3.pdf

OMB Approval 2700-0042

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 8

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

001 September 27, 2022 N/A

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

Office of Acquisitions NICHD Contracts Management Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health

6710B ROCKLEDGE DRIVE

BETHESDA, MD 20892-7000

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) X 9A. AMENDMENT OF SOLICITATION NO.

TO ALL POTENTIAL OFFERORS

RFP 75N94022R00005

9B. DATED (SEE ITEM 11)

August 30, 2022

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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)

N/A

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, is required to sign this document and return copy.

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

PURPOSE: To amend Request for Proposal (RFP) No. 75N94022R00005 entitled “National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Biospecimen Repository” to provide answers to questions.

DUE DATE: Until October 14, 2022, 4:00 PM Local Time (Eastern Standard Time (EST) (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 (Type or print)

Theresa Ranjit, Contracting Officer NICHD Contracts Management Branch, OA

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY _______________/S/________________

(Signature of Contracting Officer)

06/26/2018

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

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

RFP 75N94022R00005

Amendment Number 01

A. As a result of this Amendment the RFP is amended as follows:

SECION J – LIST OF ATTACHMENTS is modified to replace the Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website.

SECTION M – EVALUATION FACTORS FOR AWARD is modified at paragraph 6. Technical Evaluation Factors to read as follows:

6. TECHNICAL EVALUATION FACTORS

The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. The factors below are listed in the order of relative importance with weights assigned for evaluation purposes. The technical score will be based on an evaluation of the technical proposals comprised of Task Order 1 (Task Area A) and the Sample Task Order (Task Area B) along with the total combined proposed costs of Task Order 1 (Task Area A) and the Sample Task Order (Task Area B).

B. This Amendment provides answers to questions received regarding this RFP.

Question 1:

Is it correct that NIDDK asks offerors to write three separate technical proposals (each one conformed to Section L instructions) bound together in one single pdf document, with the first of the three proposals, an IDIQ proposal; the second proposal, a proposal for Task Order 1; and the third proposal, a proposal for Sample Task Order 2? If this is not correct, please provide the government’s desired organization of the proposal.

Answer:

All offerors must submit one (1) Technical Proposal in order to be considered for award with two (2) sections:

1) Task Order 1 (Task Area A)

2) Sample Task Order (Task Area B)

Question 2:

Regarding the listing of government property, can you please provide the make, model number, serial number, approximate age, capacity, and acquisition date of the current inventory?

Answer:

For proposal purposes, please refer to the Additional Proposal Information and Instructions in Attachment 6 that describes the government property. A full inventory will be provided when the contract is awarded. The following additional summary detail is provided:

Government-furnished property (GFP) is comprised of mechanical freezer units (227 from which 211 are in use), refrigerator units (2, from which 0 are in use), and liquid nitrogen tank units (15, from which 15 are in use) from various make and models including Harris, MVE Chart, Panasonic, Revco, Sanyo, So-Low, Taylor Wharton, and Thermo-Fisher. GFP are located within primary and backup facilities. A proportion of these units have been acquired in recent years and remain under manufacturer’s warranty.

Question 3:

Will maintenance records be available for the items?

Age ranges from 6 to 20 years.

Answer:

Maintenance records will be included in the resultant transition contract.

Question 4:

In Attachment 6, page 1 Task Order 1 (Task Area A) the RFP states that “It is anticipated that Task Order 1 (Task Area A) will be awarded concurrently with the IDIQ contract. This Task Order will be a hybrid cost reimbursement type with some firm-fix price aspects and will consist of a one-year Base Period with nine (9) one-year option periods as shown below:”

We’d like to request clarification on which elements will be firm fixed price and which will be cost plus.

Answer:

The Government anticipates firm fixed price on elements of the Statement of Work (SOW) which are easily determined within the daily operations management and enhancement technical elements, while cost plus fix fee on elements of the SOW that are not easily determined. Example of firm fix price elements within Task Order 1 (Task Area A) include, but are not limited to:

i. Receive and inventory biospecimens

ii. Storage and maintenance of biospecimens

iii. Pull and Ship

iv. Aliquot services for outgoing vials

v. Nucleic acid extraction from cell and other materials

vi. Cell expansion, regrowth, and cryopreservation

vii. Supplies (shipper box and waybill) and kitting (pre-printed vial labels and cryovials)

Firm fixed price elements and/or cost-plus elements will be negotiated at the time of task order award.

Question 5:

Also, in Attachment 6 page 1- We understand shipping costs are paid for by the requestor for external and ancillary requests. In Attachment 6 it is stated that 75% of requests are internal and ancillary and 25% are external. Can we assume that the shipping costs for the 75% of requests that are internal (and possibly ancillary) should be covered by the contractor?

Answer:

Assumption is that ancillary requests are paid by the requesting party.

Question 6:

Attachment 3, page 4 in which the RFP refers to the following contractor requirement “Partnering with other biorepositories (NIH (including intramural) or otherwise) to develop common portals to search across repository collections”. We are interpreting this as meaning the Contractor will collaborate with other entities to enable the team to develop common portals to search across repository collections and would provide data that could be shared and that the Contractor is not responsible for the setup, maintenance, hosting and control of the common Biorepository Portals. Is this an accurate interpretation?

Answer:

Yes, interpretation is accurate.

Question 7:

Do the turn-around-time requests (e.g., the “96 hours from receipt” to fulfill a request of 100 vials or less in Attachment 4 Page 9) account for business days, holidays and weekends?

Answer:

Assumptions for turn-around-times exclude holidays and weekends.

Question 8:

To enable accurate budgeting, can more details be provided for the following technical elements?

a. Manual and automated PCR:

i. Number of assays

ii. Number of targets

iii. Estimated number of samples

b. Whole genome sequencing:

i. Matrix for each assay

ii. Estimated number of samples

c. Tissue sectioning

i. Estimated number of samples

d. IHC

i. Number of assays

ii. Targets

iii. Estimated number of samples

e. iPSC generation

i. How many iPSC clones do you expect to establish?

ii. How do you want to confirm the in vitro differentiation?

iii. Do you want to do G-Band Karyotyping? If so, how many clones do you want to assess?

Answer:

Manual and automated PCR, WGS, tissue sectioning, IHC, and iPSC generation are examples of possible expansion technical elements under the Sample Task Order (Task Area B). The Government is providing these technical elements as an example only, to allow the review panel to evaluate offeror’s capability and experience, whether internal or through association (small business subcontract), to provide the facilities and equipment to expand and improve resources against the sample task. It does not imply intent to award task order, and therefore Government is not able to provide exact details. For proposal purposes only of the Sample Task under Task Area B, offerors may use the following assumptions:

500 manual, single target PCR (48 samples ea.)

2,000 automated, single or multiplex target PCR (96 samples ea.)

6 WGS reactions (16 samples ea.)

50 Formalin-Fixed-Paraffin-Embedded tissue sectioning (block) with IHC 250 iPSC generation (assumes 250 parent sample, single colony targets, assumes pluripotency testing and differentiation protocols are included)

Question 9:

What is the number of LN2 units by age, make, and model? What is the number of mechanical freezers by age, make, and model? What is the number of other refrigeration units by age, make, and model?

Answer:

Please refer to answer #2 above.

Question 10:

Is the collection of specimens completely housed in Government-owned equipment or are specimens also housed in contractor-owned equipment?

Answer:

Specimens housed within the current primary and backup facilities are stored in Government-owned equipment.

Question 11:

Are backup storage units that support the collections Government-owned, contractor-owned, or a combination of both? If it is a combination of both, what is the Government’s property and what is the contractor’s?

Answer:

Please refer to answer #10 above.

Question 12:

How many of the other refrigeration units currently in use at the Repository are owned by the incumbent contractor? How many of the room temp units currently in use at the Repository is government-owned equipment? How many of the room temp units currently in use at the Repository are owned by the incumbent contractor?

Answer:

Refer to answer #2 for refrigerator units. Although the Government has room temperature specimens as part of its collections, the Government does not own or maintains inventory of room temperature units.

Question 13:

Is any of the lab equipment used to perform services government-owned equipment to be transferred to the awardee? If so, what is this equipment?

Answer:

No. GFP is comprised of mechanical freezers, refrigerators, and liquid nitrogen (LN2) tanks (see answer #2 above).

Question 14:

Please provide a list of equipment that would be transferred to the contract that results from this acquisition to include the make, model, serial number, age, acquisition date, and the capacity each is filled, if applicable.

Answer:

Please refer to answer #2 above.

Question 15:

Does the government have a specific or preferred limit on the physical distance between the NIH campus and the main repository and backup facility? If so, what is the limit?

Answer:

The Government does not have a preference.

Question 16:

Post-pandemic global supply chain issues continue to present challenges to securing facility infrastructure components (generators, etc.) to provision repositories on a timely basis. Are there accommodations currently in effect to address these challenges?

Furthermore, the biorepository infrastructure has unique requirements that require significant expense.

Developing and qualifying a facility that accommodates many freezers and addresses the specific requirements of the NIDDK Biorepository requires more than 10 calendar weeks. Prospectively fitting such a facility to potentially sit vacant is a significant risk to all vendors but the incumbent, thus creating a potentially insurmountable competitive disadvantage to all other offerors. What accommodations will the Government make to allow competitors to prepare a repository as it fosters a competitive acquisition?

Please refer to technical evaluation criteria. Offerors will be evaluated on their “capability and experience to provide the facilities, processing equipment and storage space… as identified in the SOW.” As such the Government does not anticipate the provision or accommodation to secure facility infrastructure. The Government will negotiate the 10 calendar week requirements if the need arises to ensure efficient transfer of Government owned resources.

Question 17:

For each the five services quoted in the left column and taken from the end of page 147 and the top of page 148, is there a base unit count or a single-use assay (for example, one EBV transformation or one request for X number of EBV transformations? If the latter, then how many should we expect?)

Answer:

The services referenced (transform lymphocytes & extract DNA, grow/regrow cell lines, cryopreserve blood derivatives, nucleic acid extraction, and genomic amplification) under Task Order 1 (Task Area A ) Level of Effort Estimates are for proposal purposes only. Assume the unit of measure for each of these five services is one (1) parent specimen.

Question 18:

On page 92 in Section L of the RFP in, “B. Technical Discussions,” the instructions state, “A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished.” There are three statements of work in the attachments. Attachment 3 provides an IDIQ Statement of Work; Attachment 4 provides a statement of work for Task Order 1; and Attachment 5 provides a statement of work for Sample Task Order 2.

On page 120 in Attachment 1, the instructions state, “The offeror must submit one (1) separate electronic PDF file for the Technical Proposal(s): Task Order 1 (Task Area A): Not to Exceed 30 pages; Sample Task Order (Task Area B): Not to Exceed 20 pages”

Is it correct that NIDDK asks offerors to write three separate technical proposals (each one conformed to Section L instructions) bound together in one single pdf document, with the first of the three proposals, an IDIQ proposal having no page limit; the second proposal, a proposal for Task Order 1, having a 30 page limit;

and the third proposal, a proposal for Sample Task Order 2, having a 20 page limit? If that is not correct, does the government want two separate technical proposals (each conformed to Section L instructions) bound together in one single pdf document, with the first of the two proposals, a proposal for Task Order 1, having a 30 page limit, and the second proposal, a proposal for Sample Task Order 2, having a 20 page limit?

If neither of these is correct, please clarify the government’s expectations about the organization of the proposal. Given the ambiguity of these instructions, would the Government consider an extension to the deadline to provide offerors time in writing to these instructions.

Answer:

Please refer to answer #1 for the number of technical proposals to be submitted. The Government is not considering extending the timeline at this time.

Question 19:

The Government indicates that the “Task Order will be a hybrid cost reimbursement type with some firm-fix prices aspects.” Please provide the details as to what is expected for the firm fixed price aspects and what is anticipated to be cost reimbursement so that offerors can prepare offers accordingly.

Please refer to answer #4 above.

Question 20:

In Attachment 6, there is a statement to “assume offeror will cover courier costs to ship out supplies and costs for batch incoming shipments.” Please provide the distance that supplies would be sent to accurately calculate any shipping costs associated with these activities.

Answer:

It is anticipated that supplies will need to be shipped to various sites across the United States and outside the United States for active and concluded studies. Please refer to level of effort estimates, and item #4.

Question 21:

For pricing purposes, please clarify the quantities required/specified in Attachment 6 (RFP Page 147).

1. “500 Provide shipping materials (including pre-paid air bill), vial labels, and ship biospecimen kitting supplies to clinical sites or designated locations as needed.” Are these Annual shipments or monthly shipments? Please provide the anticipated number of labels and the number of kits to be included in each shipment.

2. “It is anticipated that ongoing studies will submit 3 monthly orders for barcoded vial labels.” Please provide the number of labels per request or the number of labels to be requested annually.

3. “Assume offeror will cover courier costs to ship out supplies and costs for batch incoming shipments.” Are return shipper kits to be included in these shipments as well or is that a cost of the site/sender?

Note that the quantities mentioned on the Level of Effort Estimates are for proposal purposes only. Assume the 500 shipments for supplies and kitting will take place at different times as requested by clinical sites and approved by NIDDK. For incoming samples, shipper box and waybill needs may range from monthly, quarterly, bi-annual, or annual intervals. Needs for pre-printed vial labels out to clinical sites per request will vary by study -assume 200,000 labels per year in total. Offeror should assume that pre-assembled kits will be shipped out to clinical sites with pre-paid return waybills.

Question 22:

For pricing purposes, please provide the anticipated number of kits the government anticipates for each year of the contract and a representation of the items in each kit, including the quantities of each component within each kit.

Answer:

Refer to Level of Effort Estimates in the RFP. For proposal purposes, offeror should assume 500 shipping and kitting supplies requests per year (shipper boxes plus pre-paid waybill (80%), pre-printed vial labels (10%), or pre-assembled kits/cryovial requests (10%)). The proportion of each component is anticipated to vary year over year. Optional quantities to be placed as needed.

Question 23:

For pricing purposes, what quantities of biospecimen supplies should the offeror assumes, it will send to designated studies?

Answer:

Refer to answer #22 above. Needs will vary by study. In general, clinical sites may have needs for pre-assembled blood collection kits, cryovials, pre-printed vial labels, shipper boxes plus pre-paid waybill.

Question 24:

Please clarify whether CAP accreditation and ISO certification are requirements for a contractor to be considered a compliant offeror for this acquisition, or whether this requirement is an expectation of the offeror only upon an award.

Since CAP and ISO are facility-based, are there any accommodations to allow a contractor to acquire these certifications for the specific facilities that would support the work under a contract awarded as part of this solicitation after an award?

Answer:

The Government will not accommodate for an offeror to acquire CAP Biorepository Accreditation, or to become compliant with the ISO general requirements for Biobanking. The Government prefers, does not require, these accreditations and certifications be possessed at the time of submitting a proposal and maintained through the life of the contract.

Question 25:

For Task Area B, the evaluation criteria references budgets and pricing for this sample task order. What are the uniform cost assumptions that offerors should use to develop their budgets?

Refer to item #8 and Additional Proposal Information and Instructions in the RFP.

Packaging and Delivery of Proposals Page 1 of 2

Attachment 1

Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted on paper or by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/HowToSubmit. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation. If your proposal is not received by the date and time specified in the solicitation, it will be considered a “late proposal,” in accordance with HHSAR Clause 352.215-70 - Late Proposals and Revisions

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned but must be merged into the Business Proposal PDF file. Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

http://oamp.od.nih.gov/sites/default/files/DGS/contracting-http://oamp.od.nih.gov/sites/default/files/DGS/contracting-

Packaging and Delivery of Proposals Page 2 of 2

Attachment 1

4. Each of the proposals, Technical and Business, must be separate and complete in itself. This applies for each Task Area proposal submission. Do not reference one proposal in another.

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIDDK20201_A_Technical.pdf Business Proposal: XYZ Company_NIDDK20201_A_Business.pdf Excel Workbook: XYZ Company_NIDDK20201_A_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

Failure to submit proposals adhering to the below instructions by the proposal due date will be considered unresponsive. Offerors must write their proposal using the formatting instructions below:

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

B. Page limitations:

TECHNICAL PROPOSAL BUSINESS PROPOSAL

The offeror must submit one (1) electronic PDF file for the Technical Proposal with two (2) sections:

Task Order 1 (Task Area A): Not to Exceed 30 pages

Sample Task Order (Task Area B): Not to Exceed 20 pages

The offeror must submit one (1) separate electronic PDF file for the Business Proposal(s):

In addition, the Offerors must include the Excel Spreadsheet with the Breakdowns of the Proposed Estimated Costs

This page limitation does not include the cover sheet, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template. Appendices shall not exceed a total of 10 pages.