Amendment_001_FBP_SF30.pdf

NSN 7540-01-152-8070 STANDARD FORM 30. (Rev. 10-83) Previous Edition unusable Prescribed by GSA FAR (48 CFR) 53.243

Page of Pages AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. Contract ID Code

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

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

(x) 9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

8. NAME AND ADDRESS OF CONTRACTOR (NO., Street, Country, State and ZIP Code)

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 ______ copies of 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 OR OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your 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 ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

Check One

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 _______ copies to the issuing office.

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

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)

15B. CONTRACTOR/OFFEROR 16B. UNITED STATES OF AMERICA

(Signature of person authorized to sign)

15C. DATE SIGNED

(Signature of Contracting Officer)

16C. DATE SIGNED

Attachment Page

PAGE 2 OF 4 SB1341-13-RQ-0095/001

Solicitation Number SB1341-13-RQ-0032 Description: SRM 3949 Folate Vitamer for Blood Serum.

Amendment 001 – Question and Answers Date: 1/31/2013

Below are the questions submitted to the Government regarding this solicitation. The Government response is in bold print following the question.

Questions:

1. Scope of Work Question 1. Is the 400ug multivitamin tablet dose based on weight? If yes what is dose?

Answer 1 The 400 µg does of folic acid is based on the U.S. Recommended Daily Allowance for adults, which is commonly found in multivitamins. This dose is not specific to a certain body weight.

Questions 2. What is the maximum time allowed before addition of ascorbic acid to the serum?

Answer 2 No specific maximum time allowance has been determined before addition of ascorbic acid to the serum.

2. Specific Tasks Question 3 Please clarify if the filter used is 2 um or 0.22um pore size?

Answer 3.

To clarify, the filter used should be 0.22 µm pore size.

a. What filter material should be used (nitrocellulose, cellulose acetate, glass fiber, polyethersulfone, polyvinylidene difloride)?

The filter material used must be polyvinylidene difluoride.

b. Should the serum pools be tested for bioburden? If yes what method and what is the acceptable level?

The serum pools do not need to be tested for bioburden since they are required to be filtered through a 0.22 µm polyvinylidene difluoride filter.

c. Please specify ultra-cold temperature range?

The ultra-cold temperature range is -60 � C to -80 � C.

d. What are the dimensions for the amber glass bottles?

There are no specific dimensional requirements for the amber glass vials.

However, the vials should be approximately 3 mL to accommodate the specified 1.1 mL fill volumes. Vials are commercially available.

e. Please provide more detail regarding butyl rubber stopper

PAGE 3 OF 4 SB1341-13-RQ-0095/001

There are no specific requirements regarding the butyl rubber stopper other than is be compatible with the amber glass vials and crimp caps chosen.

f. Please specify colors for aluminum crimp cap There are no specific color requirements for the three colors of crimp caps.

Acceptible colors includeblue, red, and green.

g. What if any container closure integrity testing is required?

No container closure integrity testing is required.

h. Please provide details regarding box material, size, shape and closure There are no specific requirements for box material, size, shape, and closure.

i. How many bottles will be packed in one box?

There is no specific requirement regarding how many bottles will be packed in one box.

j. What is the stability of this product, under what conditions?

This product is stable when protected from light, blanketed with an inert gas, and stored under ultra-cold conditions (-60 � C to -80 � C).

k. Does filling require nitrogen, argon, or helium blanketing?

Filling of vials will require blanketing with an inert gas (preferably argon) to enhance long-term stability of the product.

l. Will labels be printed by NIST or will NIST supply label details to be printed by the supplier?

The labels will be printed by NIST and provided to the vendor for labeling of vials.

3. Under "Background" it says that SRM3949 will be "replacement for SRM1955". Why is there no Homocysteine requirement for SRM 3949?

There is no requirement for homocysteine in SRM 3949 due to decreased customer interest in homocysteine and the existence of other NIST SRMs containing a homocysteine value.

4. Under "Scope of Work" it says "contractor shall acquire 3.3L of human serum to prepare the three pools required". Does this mean the material has to be naturally clotted (off the clot) serum, or can “ a contractor” use fresh frozen human plasma and convert it to serum? If only off the clot serum can be used, at what point does NIST specify the acorbic acid be added to the serum?

The RFQ only says "as early as possible" .

It is acceptable practice, if necessary, to use fresh frozen human plasma and convert it to serum as opposed to using only naturally clotted serum. Ascorbic acid should be added to the thawed plasma at the earliest logistically possible time point and prior to its conversion to serum. In addition, the ascorbic acid must be added before the product is amended with additional folates, mixed for homogeneity, and dispensed to avoid folate degradation. No specific maximum time allowance has been determined before addition of ascorbic acid to the serum.

5. Under "Specific Tasks" it says that "the contractor shall collect 5 serum units along with pilot tubes containing a minimum of 1mL serum for three concentration levels (total of 15 serum units)." Does NIST mean ANY 15 serum units, or is it expected that the contractor will have to

PAGE 4 OF 4 SB1341-13-RQ-0095/001

prescreen many, many donor units for the Vitamers of interest in order to select the 15 serum units that will be suitable from a concentration standpoint to allow NIST to devise blending ratios that will result in the achievement of the desired concentration levels?

For the requirement of at least 15 serum units required by NIST for folate screening, NIST does not expect the vendor to prescreen many more units in order to select 15.

(END OF QUESTIONS)

The solicitation close date remains February 08, 2013.

All terms and conditions remain unchanged.

100 BUREAU DRIVE STOP 1640

BUILDING 301 ROOM B129

GAITHERSBURG MD 20899-1640