ALS_Full_Biorepository_Question_Amendment_01.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

1 5

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

6/25/2015

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

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

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

TO ALL POTENTIAL OFFERORS

X

9A. AMENDMENT OF SOLICITATION NO.

2015-N-17148

9B. DATED (See Item 11)

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, X 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 copies 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 ACKNOWLEGMENT

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

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 copies to the issuing office.

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

The purpose of this amendment is to:

A) Provide the responses to the questions

CONTINUATION ON PAGE 2

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 OF CONTRACTING OFFICER

Betty Vannoy

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

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

PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GSA

FAR (48 CFR) 53.243

ITEM 10A.

Question 1: For C.5 points 1 and 2, pages 7-8, will protocols used for the pilot program be made available to the successful contractor?

RESPONSE: Yes

Question 2: For C.5 points 1 and 2, will the personnel that led the pilot program be available for consultation at the initiation of the contract to provide their experiences on what worked well and what did not in the pilot program?

RESPONSE: It is anticipated there may be an overlaps between the start of the new contract and the end of the pilot program and ATSDR will be available to respond to any inquiries/questions about the project.

Question 3: C.5 point 2 on page 8 of 83: “Post-mortem biospecimens will be collected from 12–30 ALS Registry enrollees per year. Previously collected samples from the pilot study will undergo RNA extraction and DNA extraction. This DNA and RNA analysis will also apply for future collections. b. Post-mortem biospecimens collected will include whole brain and spinal cords, cerebrospinal fluid (CSF), bone, muscle, and skin.”

What are the specific collection requirements per case, per tissue; number of aliquots, quantity per aliquot, preparation type (frozen, FFPE, etc.) temperature requirement for aliquots/shipping per case. This data would be helpful in establishing a proposed budget.

RESPONSE:

Below are the current in-home collection requirements based upon the pilot study. The collection requirements are subject to change and will be finalized when the project is awarded.

Whole blood (10 ml EDTA)

Plasma 0.5 ml aliquots (8)

Buffy coat 1.0 ml

RBC 1.0 ml (2)

Metals Free blood (6 ml EDTA)

Whole blood 1.8 ml (3)

Blood (8 ml red top)

Serum 0.5 ml (8)

PAXgene tube (2)

Urine

1.8 ml (10)

4.5 ml with Hg preservative

10 ml (3)

Hair

½ oz. glass jar

Nails

2 ml cryovial

In-home collections are shipped at room temperature while post-mortem collections are shipped at -20oC. Standard and approved shipping procedures for the shipment of biospecimes are used.

Question 4: C.5 point 2 on page 8 of 83: “Brain and spinal cord tissue will be processed and stored in an appropriate facility according to the sample protocol and procedures of the

VA ALS Registry Brain Banking Program

(http://www.research.va.gov/programs/tissue_banking/als/).”

Where are the specific SOPs available? This website does not link to specific SOPs. Should we reach out to the VA for this information? Can we get the protocols and procedures? Or are we expected to develop our own SOPs? This data would be helpful in establishing a proposed budget.

RESPONSE: The offerors can decide if they wish to contact the VA for these SOPs, http://www.research.va.gov/programs/tissue_banking/als/.

ATSDR does not have access to these SOPs.

Question 5: Concerning C.5 point 3 on page 8, where are specimens from the pilot currently housed? How many total specimens are in the pilot collection? Please provide total samples for each sample size.

RESPONSE: Specimens are currently being housed at Fisher Bio-Services (in-home collections) and Boston VA (post-mortem collections).In home collections (blood, hair, urine, saliva, and nails) are currently over 600 samples and the post-mortem collections

(brain, spinal cord, cerebrospinal fluid, bone, muscle, and skin) are 12.

Question 6: Concerning C.5 point 3 on page 8, will the storage units currently being used for the pilot specimens be transferred as well the specimens? If so, please provide a list of the units by manufacturer, type, and model number.

RESPONSE: No, storage units will not be transferred, only the specimens themselves (in-home and post-mortem collections).

Question 7: Concerning C.5 point 3 on page 8, what is the timeline for transition of the pilot specimens and data to the new contractor?

RESPONSE: For establishing a proposed budget, ATSDR hopes this will be done within three months of the start date of the contract.

http://www.research.va.gov/programs/tissue_banking/als/

Question 8: Is the cost-recovery mechanism described in point 10 of C.5 on page 8 of the solicitation expected to cover the full cost for specimen storage in addition to the cost for sample dissemination? (This implies that individual sample costs will be influenced by the time the sample has been in storage.)

RESPONSE: No. The cost-recovery is minimal and will not cover all costs associated with storage of the specimens. The cost recovery is for retrieval and dissemination.

Question 9: C.5, 2.b Biorepository Post-Mortem Specimen collection (page 8): What is the purpose of the post-mortem skin collection?

RESPONSE: The collection of skin is for the creation of fibroblast cell lines.

Question 10: L.13 and L.14 h) (pages 72 & 75): the RFP provides instructions for past performance in both the Technical volume and the Business volume. Is past performance information to be included in both volumes? If yes, can the same information be submitted for both sections?

RESPONSE: Yes, past performance information should be included in both volumes.

Yes, it is possible to have the same information depending on the relevant past experience provided.

Question 11: L.14h) Past/Present Performance Information (page 75): It is unclear if the minimum of 3 past performance references are to include the prime and subcontractors

(i.e., 1 from the prime and 1 from each of 2 subcontractors) or is the government expecting to see a minimum of 3 references from the prime and 3 from each of the major subcontractors? If it is the latter, can the page limit be extended to 20 pages to allow us to report sufficient information on the prime bidder and each of our subcontractors?

RESPONSE: A minimum of three references are required.

Question 12: L.14g) (page 75): Does “fringe benefits” refer to providing a list of fringe benefits per employee or the fringe benefit rate for each employee?

RESPONSE: Offerors should identify and show how they calculated the loaded hourly rate(s) proposed per Offeror’s team members.

Question 13: L.14g) (page 75): Is the government asking to see a full cost build up of our fixed price proposal to include base salary, ODCs, applicable overhead and indirects and fee? Or is the government only interested in seeing the base salary of proposed personnel?

RESPONSE: The Offeror must identify the labor category(s) to be utilized for this effort, a description of the skills and experience per category, and the hourly rate(s) proposed, and any other proposed associated costs, for calculating the proposed cost for this effort.

Subcontractor rate information shall also be included, if applicable. List all other direct costs necessary for the performance of this project. If fully loaded hourly rate(s) are proposed, then we encourage offerors to provide an explanation/calculation of those rates.

c) Except as provided herein, all terms and conditions of the document referenced in Item 9A, as heretofore changed, remains unchanged and in full force and effect.

END OF AMENDMENT