SF30_SPE3S116R00120006.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO.

See Block 14

4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE SPE3S1 7. ADMINISTERED BY (If other than Item 6) CODE

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

CODE FACILITY CODE

SPE3S116R0012

X

2016 AUG 24

10A. MODIFICATION OF CONTRACT/ORDER NO.

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 OffersX X is extended, is not extended.

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.

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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:

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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).X

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

E. IMPORTANT: Contractor X is not, is required to sign this document and return copies to 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)

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

16B. UNITED STATES OF AMERICA15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

(a) By completing Items 8 and 15, and returning

DLA TROOP SUPPORT

SUBSISTENCE SUPPLY CHAIN

700 ROBBINS AVENUE

PHILADELPHIA PA 19111-5096

15C. DATE SIGNED 16C. DATE SIGNED

D. OTHER (Specify type of modification and authority)

3. EFFECTIVE DATE

Opening/Closing Date Changed to:

2016 AUG 24 / 2016 OCT 08

TIME 3:00 PM

See Attached Continuation Sheet(s).

(X)

CHECK ONE

PAGE OF PAGES

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

13. THIS APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CONTINUED ON NEXT PAGE

The following change applies to Solicitation SPE3S1-16-R-0012:

I. The closing date for all bids on this contract has been extended indefintely

II. The following change applies to PCR-P-049, C-2, § K. Product formulation and ingredients:

Dry powder artificial or natural vanilla flavorings are permitted for use in lieu of Vanilla extract four fold (dry powder) 1/.

1/ Natick has used Bakers International Vanilla Powder D980 (artificial) in successful production runs

III. Below is a compilation of Questions and Answers produced during the solicitation phase.

Question: Is there latitude in meeting the nutrition and ingredient requirements for the performance bar?

Answer: No. Formula and nutrition requirements have been determined by NSRDEC.

Question: Why are you requesting a snack bar food solution to deliver the nutrition targets that you are seeking?

Answer: Formula and format requirements have been determined by NSRDEC.

Question: Are you receptive to other food forms?

Answer: No. Formula and format requirements have been determined by NSRDEC.

Question: Does it have to be consumed only at night?

Answer: Yes. Customer has requested to fill nutrition requirements for specific population.

Question: Can it be a combination of food items or multiple servings of bars, for example, that could meet the specs?

Question: If research supports that bioavailability of 100% DV of calcium is not optimized when delivered during one single eating occasion, would you be receptive to changing the amount required per bar?

Question: If research supports that there are equally important co-nutrients and food ingredients to help support bone density in the prevention of bone fractures, would you be receptive to changing the nutrition targets and potentially the ingredient list?

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SPE3S116R0012-0006

Answer: Not at this time. Formula and format requirements have been determined by NSRDEC. If you have additional research on the topic, NSRDEC & USARIEM may be interested in reviewing for future plans.

Question: There is concern that 1000mg of calcium in a snack bar would not meet the taste expectation criteria in your specs. Based on potential poor palatability, would you consider reducing the amount of calcium?

Question: There are fortification limits for snack/meal bars. The vitamin D fortification ask seems to conflict directly with 21 CFR 172.380 in the Federal Code of Regulations and would not be allowed.

a. 21 CFR 172.380

(4) At levels not to exceed 100 IU per 40 grams in meal replacement bars or other-type bars that are represented for special dietary use in reducing or maintaining body weight in accordance with § 105.66 <https://www.law.cornell.edu/cfr/text/21/105.66> of this chapter.

Answer: Formula and format requirements have been determined by NSRDEC.

Question: Have you petitioned the FDA for approval to fortify to the levels you are requesting?

Answer: TBD.

Question: Is USDA inspector required in the manufacturing plant? If yes please provide a contact.

Answer: At this time, there is no plan for an in-plant USDA inspector to be at the manufacturing facility.

Question: For the analytical testing requirements were are interpreting that the we can perform in-house testing as long as it conforms the testing methodologies specified in the PCR. If we are required to use a government lab please let us know and where we can obtain the testing cost schedule?

Answer: An amendment will be issued clarifying the laboratory testing requirements.

Question: Packing - Is it acceptable to the military to have the inner carton packaging instead of a bulk case of bars? If there are 100 bars snug fit into a bulk shipper there could be higher risk of product damages. We could size a carton to hold ten 65g bars and then pack 10 cartons into a corrugated case for 100 bars / case?

Answer: 100 bars are required per case. The intent is to minimize the waste from excess packing materials.

Question: We have reviewed the product packaging of 1st Strike and Paratrooper bars, please confirm this packaging design is different than the Performance Readiness Bars?

Answer: The packaging design for the PRB is not specific on what the contractor should use as long as the bars are packaged in a foil or metalized laminate that provides an effective light, moisture and oxygen barrier.

Question: Do the PDM need to be packaged in the “actual” bar wrap materials that would be used as part of the commercial sale?

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Answer: The PDM does not have to be in the "actual" bar wrap for PDM submission.

Question: Could wrappers could have slack fill for the initial PDM submission?

Answer: The wrapper may have slack fill for the initial PDM submission.

Question: Can the PDM Samples be developed via Bench Top (Manually)?

Answer: Yes, the PDM can be developed via Bench Top.

(Pre Audit Questionnaire) Question: How will the answers to this questionnaire effect the awarding of the contract?

Answer: Generally, when a contract is awarded to a facility that facility would have already completed the audit process by an Army Vet Personnel allowing the facility to be prepared and ready to meet contractual agreements.

The pre-audit questions are designed to not only to accelerate the auditing process during the time of the audit, but also helps both the company and the auditor to be well prepared for a comprehensive in-depth overview of the entire system and processes.

(Pre Audit Questionnaire) Question: There is reference to supplying copy of company LH and business card of company's audit representative. Do you require actual original hard copy of LH or can it be a reproduction?

Do you require actual business card or can it be a copy?

Answer: Copies are acceptable. However, during the audit process original documents should be provided.

(Pre Audit Questionnaire) Question: Question 9 references directions to the facility. From where?

Answer: From any Major Highway, Interstate etc. EX: Take I-95 to exit 14. Follow Route 37 to Henry St. go 4 miles and our facility is on the Right. You may also find our location via GPS

(Pre Audit Questionnaire) Question: “Question 10”, What levels of key personnel should be listed?

Answer: Anyone who is involved in the oversight of the process. EX: Supervisor, President, QA, Production Manager, the POC for the facility.

(Pre Audit Questionnaire) Question: “Question 20” Is a special label required on the packaging?

Answer: This includes Special Handling instruction "keep Refrigerated"; Allergy labeling etc.

(Pre Audit Questionnaire) Question: “Question 27” Describe the location and the area surrounding your establishment. What kind of information would you be looking for?

A: Is the facility surrounded by businesses or located in a residential area; is it in the city/country;

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rural, suburban, urban, etc.

(Pre Audit Questionnaire) Question: “Question 42” What are the major raw ingredients in your product(s)?

How many ingredients would be it be sufficient to list?

Answer: There are no specific amount that must be listed. Some examples of the MAIN raw ingredients used in your product are:

EX: If you are producing water then water will be the main raw ingredient If you are processing fresh fruits and vegetables these items will be your main raw ingredients. You will discuss where you get the raw ingredients and how they are processed

(Pre Audit Questionnaire) Question: Do the Food Defense questions at end just require a YES or NO answer?

Answer: Yes/No will suffice. These questions will be discussed in-depth during the audit.

Question: Are we required to do analytical and micros before shipping each shipment?

Answer: Analytical and micros are required per lot before all shipments

Question: What exactly are they looking for certificate of compliance to state?

Answer: The Certificate of Compliance states that the product/shipment meets all terms and conditions of the spec.

Question: Is the vanilla powder natural or artificial?

Answer: Artificial or Natural is allowed

Question: how large the successful batches of the Performance Readiness Bars were when the plant trials were done?

Answer: Successful 60 pound runs have been conducted

Question: PCR-P-049 Section L(1)a requires the corn syrup and glycerin to be heated to 180-200 degrees F.

Higher temperatures could impact the nutritional properties and reduce the chewy texture of the bar causing it to be more brittle. Could we limit the temperature to 115 degrees to heat up syrups in our plant configuration?

Answer: Yes, a lower temperature would be acceptable and per C-2, L(1)e, in PCR-P-049 Performance Readiness Bar; " Temperature may be lowered using cold water in kettle jacket if necessary to obtain suitable viscosity of final dough for extrusion".

Question: Regarding testing are the tests that are required to be submitted with the PDMs on pages 2-3 of PCR or on page 9?

Answer: The requirements are listed starting on page 2 (§ C-2, I & J). The methods to ensure that those requirements are met begin on page 9 (§ E-5,B, (1) through (6)).

Question: If results are not available would it be possible to send in PDMs and follow with the results by email of FEDEX within a few days.

Answer: The tests must be performed on the products, in accordance with the PCR, but do not have to accompany the PDMs when they are submitted. If, due to scheduling issues, the PDMs are required to be submitted before the test results are ready, the results can be forwarded when they become available.

Question: Are you requesting that the vanilla extract come in powder form or liquid form or does this not matter?

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Answer: A Powder form

Question: Do we have to use Genesis R&D Food Analysis & Labeling software? We currently provide files from a different software package.

Answer: Using a similar software program would be acceptable.

Question: "The facility we intend to make these bars was previously USAPHC certified when we were making FSR bars. The plant probably will need to be re-certified which is not a problem. However, for purposes of the PDM submission, , Do the PDMs require the USAPHC listing? " (Similar question received: Does the plant which manufactures the bars need to be VETCOM inspected?)

Answer: The Pre-Audit Questionnaire is to be submitted at time of the offer. Listing will not be required for PDM submission but will be required to be listed prior to the start of production.

Question: "a. For purposes of the PDM is it permisable to send the PDMs in with adhesive or printed labels that supply the information requested while waiting for the he final package printwork from our film supplier?"

Answer: Adhesive or printed labels are acceptable for PDM submission.

Question: "Also, on page 7-8 of the solicitation the initial sentences refers to submitting 38 samples but the following discussion refers to only 32 PDMS being required per site."

Answer: Page 109 provides further clarification on the Initial PDM requirements, 32 go to Natick, six go to

DLA.

Question: "Approximately when would the first delivery orders be required?"

Answer: The first delivery order will be required 60 days after an award has been made.

Question: Is the packer required to be ISO compliant, will SQF Level 3 with excellent 98% rating be equivalent ? This is the industry standard for bar plants.

Answer: ISO compliance is not required but an equivalent industry standard must be used. Page 20, Note 1 states that "At the election of the contractor, the contractor may select an industry standard equivalent to ANSI/ISO Q9001; cite the Title, Number, and Date and Tailoring (if any) and check the appropriate box." SQF Level 3 would be considered equivalent to ANSI/ISO Q9001.

Question: What is the cost and scope of the VetCom inspection. What do they audit against, FDA regulations?

Answer: There is no cost for Public Health Center (formerly VETCOM) sanitary audits. The audits are performed using 21 CFR, Part 110, other applicable regulatory requirements, and industry guidelines.

Question: Are micros and analytical tests required to accompany the PDM's or just recommended if you have them completed.

Answer: Yes, all micro and analytical testing in accordance with the PCR are to be completed and test results are to accompany the PDM samples.

Question: This appears to be only a 1-year Period of Performance – given the long term applicability of this

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nutritional requirement, is this the Government’s intention?

Answer: Yes, but a new contract with a longer period of performance is expected in the future after we have gained some experience with this acquisition.

Question: It appears the Government may award contracts to multiple offerors. Considering the LPTA evaluation criteria and the wide quantity range (3.3 – 10.3 million bars) the potential of multiple awards may reduce economies of scale and ultimately increase costs. Will the Government consider a single award?

Answer: We intend to make a single award unless the contractor with the lowest offer cannot produce the quantity required as demand might rise.

Question: If an offeror intends on using a subcontractor (e.g. co-packer) to produce the bars, does the prime need to have his own “higher level” QA program?

Answer: The producer of the bar and the packager must have a "higher level" QA program.

Question: Are all ingredients in the Performance Readiness bar considered “ready to eat”?

Answer: The finished end-item bar must be ready to eat as is.

Question: May an alternate 80% soy protein crisp of the same size be utilized in the formula?

Answer: Natick will have to approve an ingredient that deviates from those listed in the PCR. If an alternative will be utilized than a spec sheet must be sent to Natick to determine approval.

Question: Evaluation criteria does not include past performance or corporate capabilities – is this the Government’s intention?

Answer: It was our intention to not include past performances and corporate capabilities into the evaluation criteria.

Question: Per Section I-2 and FAR 52.219-8, does the Government require the submission of a SB contracting plan prior to contract award?

Answer: Yes, a Small Business contracting plan must be submitted prior to award (if applicable).

Question: What is the Order/Delivery Lead-time? Due to freight considerations for shipments less than full truckloads, will tiered pricing for volume discounts be allowed?

Answer: The Lead-time will be 60 days. Shipments will be for around 300,000 bars unless a case is required for samples.

Question: Since there are multiple destinations and different freight costs can one price be submitted separately for each location or do all four locations need the same delivered price?

Answer: All four locations will have the same price.

Question: Given only one line item is being solicited, need clarification of what the guaranteed Minimum quantity will be and what the min/max quantities are going to be in the event of multiple awards?

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Answer: In the event of multiple awards, the min/max will depend on the percentage of award given.

Question: Given only one line item is being solicited, need clarification of what the guaranteed Minimum quantity will be and what the min/max quantities are going to be in the event of multiple awards?

Answer: In the event of multiple awards, the min/max will depend on the percentage of award given.

Question: Please confirm that a label with jet coding is an acceptable form of master case markings including date of pack/lot number?

Answer: The date of pack and lot number on a pressure sensitive adhesive label would be fine on the side panel immediately to the right of the marked end of the shipping container.

Question: Need clarification as to whether the QSP is required with Submittal, and whether the full IPMP is required or just the IPMP info is requested here? Per M-3, it should be complete IPMP.

Answer: The QSP is required to be submitted. The full IPMP is required to be submitted.

Question: Request permission to reference a current DLA approved Product Protection/Food Defense Plan and IPMP. This would be consistent with the solicitation granted waiver for submitting a PDM if the offeror has an already approved PDM.

Answer: Both plans are required to be submitted.

Question: Does the Government have and/or intend to provide any equipment that can help facilitate the production of the Performance Readiness Bar?

Answer: No, the government does not intend to provide any equipment.

Question: Please clarify how the Government would determine multiple awards given there is only 1 line item?

Would multiple awards be by destination, given the allowance to offer different delivered prices per destination?

Answer: The reason we would make multiple awards is if the lowest acceptable offeror is not able to produce the quantity required.

Question: Is the one hundred cases count mandatory or would it be possible to offer a different size pack to allow for standardization with existing packaging configurations?

Answer: 100 bars per case is required. Other packaging configurations can be presented but must be approved before exercising

All other terms and conditions remain the same.

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