0 - T1057 BA_1 QA 110317.pdf

New Jersey Is an Equal Opportunity Employer • Printed on Recycled and Recyclable Paper

CHRIS CHRISTIE

Governor

State of New Jersey

DEPARTMENT OF THE TREASURY

DIVISION OF PURCHASE AND PROPERTY

PROCUREMENT BUREAU

33 WEST STATE STREET

P. O. BOX 230

TRENTON, NEW JERSEY 08625-0230

FORD M. SCUDDER

State Treasurer

KIM GUADAGNO

Lt. Governor

MAURICE A. GRIFFIN

Acting Director https://www.njstart.gov

November 03, 2017

To: All Interested Vendors {Bidders}

Re: Bid Solicitation {RFP} #: 18DPP00157 - T1057–WIC Infant Formula Rebate: DOH

Quote {Proposal} Submission Due Date: November 30, 2017 (2:00 p.m. ET)

Bid Amendment {Addendum} #1

The following constitutes Bid Amendment {Addendum} #1 to the above referenced Bid Solicitation {RFP}:

This Bid Amendment {Addendum} includes answers to questions; and

Please note that for all additions, deletions, clarifications and modifications to the Bid Solicitation {RFP} # 18DPP00157, please refer to the revised Bid Solicitation {RFP} titled, “T1057 WIC Rebate Revised RFP 11/3/17”, and the revised Infant Formula Rebate Tab Sheet (Price Schedule) titled, “T1057 Revised Price Schedule 11/03/17. ”

It is the sole responsibility of the Vendor {Bidder} to be knowledgeable of all of the additions, deletions, clarifications, and modifications to the Bid Solicitation {RFP} and/or the New Jersey Standard Terms and Conditions (SSTC) relative to this Bid Solicitation {RFP} as set forth in all Bid Amendments {Addenda}.

All other instructions, terms, and conditions of the Bid Solicitation {RFP} shall remain the same.

Bid Solicitation {RFP} # 18DPP00157 T1057 – WIC Infant Formula Rebate: DOH

Answers to Questions

Each question is referenced by the appropriate Bid Solicitation {RFP} page number(s) and section where applicable.

RFP Section Reference

Question (Bolded) and Answer

General Question

Cover Page

The Event table does not indicate when the intent to award, protest period, and award will take place. Please include on the timeline

The State will not provide this information, as there is no specific timeline for these events at this time.

General Question

Cover Page

Please confirm the State will fully cooperate with the Contractor when the Contractor is conducting an audit and please further confirm the State will comply with all reasonable requests for information necessary to conduct a proper audit.

The State confirms that WIC Services will fully cooperate with the awarded Vendor {Contractor} when it conducts an audit, and that WIC Services will comply with all reasonable requests for information necessary to conduct a proper audit.

Section 1.1

Purpose and Intent

The third paragraph of this section states an award will be made to the Vendor offering "the lowest net price or, the highest rebate for Infant Formula"? If a State intends to evaluate WIC infant formula bids based on the highest rebate, Federal law and USDA regulations require the State to demonstrate to FNS satisfaction that it has performed a specified analysis before issuing the bid solicitation.

Has the State performed this analysis and submitted such analysis to FNS? If no, we urge the State to delete "or, the highest rebate" in this section and delete all references to "highest rebate" in other parts of this solicitation. Please confirm these changes will be made if the State has not done the required analysis and received approval from FNS to evaluate bids based on the highest rebate.

Please further confirm bids will be evaluated based on the lowest monthly net price.

The State confirms that in accordance with 7 CFR 246.16a - Infant Formula and Authorized Foods Cost Containment, the awarded rebate will be based upon lowest total monthly net price for infant formula. Please reference pages 5 and 52 of the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised RFP 11/3/17.”

Purpose and Intent

What is meant by the "State may award any and all price lines"? We request this phrase be deleted from this section.

It is at the State's discretion if it will award a contract for all lines represented on its Price/Rebate Sheet. If the State determines that a Vendor {Bidder} is not responsive or responsible, it reserves the right not to award any and all price lines. The State does not accept the proposed modification to the Bid Solicitation {RFP}.

Purpose and Intent

What is meant by the State "reserves the right to separately procure individual requirements that are the subject of the Blanket P.O."? We request this phrase be deleted from this section.

Please reference page 5 of the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised

RFP 11/3/17.”

Purpose and Intent

Please confirm the state intends to award the entire contract to one manufacturer.

Pursuant to Bid Solicitation {RFP} Section 1.1, Purpose and Intent, it is the State's intent to award a Master Blanket Purchase Order (Blanket P.O.) {Contract} to a sole responsive and responsible Vendor {Bidder}.

Reference

Question (Bolded) and Answer

Section 1.2

Background

The existing infant formula contract has been extended by five months to February 28, 2018. Would the State provide a brief explanation of the reasons the current contract has been extended?

The current contract awarded to Mead Johnson Nutritionals (contract # A82097), originally procured under Solicitation 13-X-22490, was extended to allow for the reprocurement of the contract.

Section 1.2

Background

In order to better understand the provisions of this RFP and the resulting contract, please cite the specific provision(s) in the previous contract that was used to extend the current contract for five additional months. Section 5.3 of the previous contract stated: "In the event that a new contract has not been awarded prior to the contract expiration date, as may be extended herein, it shall be incumbent upon the contractor to continue the contract under the same terms and conditions until a new contract can be completely operational. At no time shall this transition period extend more than 120 days beyond the expiration date of the contract."

The current contract awarded to Mead Johnson Nutritionals (contract # A82097), originally procured under Solicitation 13-X-22490, was extended under the contract's accompanying New Jersey Standard Terms and Conditions (SSTC), which states, "Unless the bidder/offeror is specifically instructed otherwise in the Request for Proposals (RFP), the following terms and conditions shall apply to all contracts or purchase agreements made with the State of New Jersey."

Specifically, the contract was extended in accordance with Section 5.3, Contract Term and Extension Option, of the State Standard Terms & Conditions which states, "If, in the opinion of the Director, it is in the best interest of the State to extend a contract, the contractor shall be so notified of the Director’s Intent at least thirty (30) days prior to the expiration date of the existing contract. The contractor shall have fifteen (15) calendar days to respond to the Director's request to extend the term and period of performance of the contract. If the contractor agrees to the extension, all terms and conditions including pricing of the original contract shall apply unless more favorable terms for the State have been negotiated." It is noted that the quester has referenced Solicitation 13-X-22490 Section 5.3, Contract Transition Period, of the Bid Solicitation {RFP} which to date, has not been implemented by the State.

Background

The Program participation and Rebate-Eligible Infant Formula Units tables only provide data through the end of 2016. With the significant declines in WIC participation in recent years, these data tables are inadequate for potential bidders (other than the current contract holder) to adequately evaluate this bid opportunity. To ensure all bidders have a level playing field prior to submitting bids, we strongly urge the State to update these tables with the most current information available. We also urge the State to provide all bidders with copies of the rebate invoices that have been sent to the current contract holder through August 2017.

The State has updated the data tables demonstrated in the referenced section of the Bid Solicitation {RFP}. Please reference pages 5-8 of the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised RFP 11/3/17,” and the updated Attachment #1 - Sample Infant Formula Rebate Invoice as it provides rebate invoices up to September 2017.

Background

Federal Regulations Section 246.16a(c)(3) requires State agencies to use the most recent available participation data and usage rates in evaluating bids, and section 246.16a(c)(4) requires that infant participation data include at least 6 months of the most recent average infant participation information. The information included is a year old. Please provide the most recent six months of data to ensure all bidders have access to the same information as the current contracted manufacturer to include: a. Six months of the most recent participation information b. Six months of the most recent formula redemption by brand, unit size, and c. Six months of the most recent formula redemption information for all formula to include contract, non-contract non-exempt, and non-contract exempt products by all manufacturers

Please reference the answer to question #9, of this Bid Amendment {Addendum}.

Reference

Question (Bolded) and Answer

Section 1.2

Background

Please indicate what percentage of infants that are enrolled in the WIC program were enrolled with incomes higher than 185% of the Federal poverty level.

The State cannot provide this information as current reporting mechanisms do not account for such. It is noted that the current reporting system utilized in the clinics, rejects the Participant’s information unless clinic staff inputs that the individual participated in one (1) od the programs for adjunctive eligibility. Participants who are able to provide appropriate proof of their participation in Medicaid, Temporary Aid to Families (TANF) and Supplemental Nutrition Assistance Program (SNAP) are adjunctively eligible (regardless of income) for the WIC Program. In these cases, WIC Services is not required to verify household income.

Background

Please indicate what percentage of infants that are enrolled in the WIC program were enrolled via adjunctive eligibility (i.e., they demonstrated active participation in SNAP, TANF, Medicaid or CHIP).

Approximately 81% of WIC enrolled infants are adjunctively income eligible.

Background

The numbers provided in the column labeled Exempt Medically Necessary Formula include women, infants and children. Please provide a breakout for the number of infants only receiving medically necessary formula?

The actual number of Infants that received and redeemed WIC checks for exempt medically necessary formula from February 2017 to July 2017 can be found below:

Month Received and Redeemed Checks

February 2,412

March 2,446

April 2,388

May 2,432

June 2,431

July 2,419

Background

Please explain the formula categories tied to this table.

In accordance with Bid Solicitation {RFP} Section 2.3, Blanket P.O. {Contract}-Specific Definitions/Acronyms:

Rebate-Eligible Formula - Standard Formulas (milk based and soy based) approved via a Bid Solicitation {RFP}/Blanket P.O. {Contract}.

Non-Rebate-Eligible Formula - All standard milk based and soy based infant formula that is not covered by an infant formula cost containment Blanket P.O. {Contract} awarded by the State agency.

Exempt Medically Necessary Formulas - Infant formula intended for commercial or charitable distribution which is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems

(21CFR 107.3).

Section 1.2.1

WIC ACCESS

Please provide the percentage of infants that are issued benefits 3 months at a time, 2 months at a time and 1 month at a time respectively.

By default, Participants are issued three (3) months of benefits (checks) at a time. However, if a nutritionist or participant feels that it would be beneficial to increase the frequency of clinic visits (once a month or bimonthly) this can be accomplished manually by the clinic staff.

Circumstances that may warrant this option include formula or food tolerance concerns, physician requests, home security issues; participant requires more frequent counseling, etc.

Since the frequency of pick up, other than tri-monthly, is manually controlled, the State is unable

Reference

Question (Bolded) and Answer to provide an accurate percentage of each pick up type. It is noted that the majority of Participants (over 90%) are issued checks on a tri-monthly basis.

WIC ACCESS

Please confirm the following:

A. The Contractor will not be required to pay rebates on quantities of infant formula in excess of the federal monthly maximums; and

The State confirms this statement. The State’s WIC Program issues benefits through its WIC Access computer system. As part of the system there are safeguards in the application that prevent providing infant formula in excess of the federal monthly maximums for each infant on the program. The Vendor {Contractor} would therefore not be required to pay rebates in excess, as the condition would not exist.

B. If rebates for quantities in excess of the federal monthly maximums are billed and rebated in error, the amounts associated with the over issuance and redemption will be reimbursed to the Contractor upon discovery. If any portion of above is not confirmed, please provide a detailed explanation of why such portion was not confirmed.

Please reference the answer to Part “A” of this question.

WIC Access

Does the State issue its checks on a rolling basis to participants? For example, if a participant receives their three months' worth of checks on March 15, are the March checks prorated to cover the remainder of March with the other checks having a first day to use of April 1 and May 1 respectively? If the State does not prorate, do the three months of checks have a first day to use of March 15, April 15, and May 15?

The WIC software application will prorate the checks; however, it keeps the “first date to use” listed as when the checks were supposed to be issued. Using the provided example, if a Participant was supposed to pick up checks on March 1 (for March, April, and May) but instead pick up the checks on March 15, the March check would be prorated for the remainder of March.

The April and May checks would both demonstrate a start date of the 1st.

WIC Access

Do participants receive four infant formula checks per month? If no, how many infant formula checks do participants receive each month? Does this depend on the form of infant formula provided? Please provide check images provided to participants receiving infant formula for each of the forms provided.

Infant formula, regardless of the form and quantity prescribed by the nutritionist, is issued using a maximum of two (2) checks per month, If an infant is provided with half or less than half of the monthly allotment of formula the infant would receive the prescribed formula on one infant formula check for the month. Please reference Attachment #4, Sample NJ WIC Check.

WIC Access

How does the State assess the price of infant formula and other foods during its semi-annual review? Would the State consider performing these reviews quarterly rather than semi-annually?

Vendors throughout the State are divided into peer groups based upon size, the number of cash registers present at its stores, and the different regions of the State. WIC Services will assess the price of infant formula and other foods during its semiannual vendor review, where the price of food is averaged among the individual groups and again averaged by geographical region. At this time, the State does not accept the proposed modification to its review process.

WIC Access

Have there been any disputes between the State and the current vendor regarding the partial redemption calculations? If yes, we request copies of correspondence or other documentation outlining the disputed issues regarding the State's calculation of partial redemptions.

Reference

Question (Bolded) and Answer

To date, there have been no disputes between the State and the current contractor regarding partial redemption calculations.

WIC Access

When does NJ intend to fully transition to EBT? Does the state anticipate an impact to the systems or rebates as a part of this transition?

In accordance with the United States Department of Agriculture’s (USDA) mandate, the State’s will be compliant with EBT requirements by October 2020. There is no anticipation of any changes to the state’s systems or its rebates.

Section 1.2.2 WIC Issuance of Infant Formula

It is imperative for a bidder to understand how the State will conduct its WIC Program and to be able to rely on the State's responses to the questions about the conduct of the WIC Program in submitting a bid.

In conducting its WIC Program, will the State allow the issuance of any formulas that do not meet the minimum WIC requirements as specified in Table 4 at 246.10(e)(12)? Table 4 of this section states that infant formula must: (1) meet the definition for an infant formula in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and meet the requirements for an infant formula under section 412 of the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 350a) and the regulations at 21 CFR parts 106 and 107; (2) be designed for enteral digestion via an oral or tube feeding; (3) provide at least 10 mg iron per liter at standard dilution; (4) provide at least 67 kilocalories per 100 milliliters (approximately 20 kcal/oz.) at standard dilution; and (5) not require the addition of any ingredients other than water prior to being served in a liquid state.

In accordance with Bid Solicitation {RFP} Section 3.3.1, Infant Formula Specification, “The Vendor {Contractor} shall ensure that all Infant Formulas provided for issuance by WIC Services meet at a minimum, the requirements identified in:

A. Federal Food, Drug, and Cosmetic Act (FD&C Act) at:

https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCos meticActFDCAct/default.htm;

B. Infant Formula requirements as determined by the United States Food and Drug Administration (FDA) at: https://www.fda.gov/Food/GuidanceRegulation; and

C. Minimum Requirements and Specifications for Supplemental Foods, 7 CFR 246.10(e)(12) Table 4.

The State will not allow for the issuance of any formula that does not meet the minimum requirements as already demonstrated in the Bid Solicitation {RFP} and further confirmed by 7 CFR 246.10(e)(12) Table 4.

WIC Issuance of Infant Formula

How many children are currently receiving rebated infant formula? Please provide this as a monthly average for the last 3-4 months.

The actual number of children (ages one (1) through five (5)) that received and redeemed WIC checks for rebated eligible infant formula are:

Month (2017)

Total Amount of Children

April 36

May 30

June 26

July 30

Average of four (4) Month total 30.5

*Note: The above data does not include infants in age group 0 to 12 months.

https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeticActFDCAct/default.htm https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeticActFDCAct/default.htm

Reference

Question (Bolded) and Answer

Section 1.2.2 WIC Issuance of Infant Formula

What percentage (estimate) of participants require a Kosher or Halal infant formula?

During the past year, Halal compliant Non-Rebate-Eligible formulas (milk and soy) were added to the NJ WIC approved formulas. Approximately 1,201 (3%) of WIC infants currently receive approved Halal formulas.

Since the current standard Rebate-Eligible formulas currently provided to the WIC program meet Kosher standards, the State is unable to distinguish the percentage of Participants who specifically require Kosher formula. However, it is noted that there is a growing need for Participants in the State to have access to Halal and Kosher compliant formula.

Section 1.2.2 WIC Issuance of Infant Formula

What are the minimum stocking requirements for each infant formula product expected to be authorized (or currently authorized)? Please provide the minimum stocking requirements for all three forms of formula in each of the two types (milk and soy). Do these requirements vary by retail vendor categories?

The current minimum stock requirement for all of NJ’s WIC vendors is listed below:

Food Item Requirements

Brand/ Variety Container Size Minimum Stock of

Each Container Size

Infant Formula Enfamil Premium Infant

13-ounce Concentrate

32 Each

Infant Formula Enfamil Prosobee 13-ounce Concentrate

12 Each

Infant Formula Enfamil Premium Infant

12.5-ounce Powder 24 Each

Infant Formula Enfamil Gentlease 12.4-ounce Powder 18 Each

Infant Formula Enfamil Prosobee 12.9-ounce Powder 12 Each

Note: Minimum stock is per Retailer location.

WIC Issuance of Infant Formula

WIC Services cannot guarantee that all vouchers sent to program Participants will be Redeemed. Currently 10% of all WIC Services vouchers are not Redeemed by program Participants.

A. Please explain the State's partial redemption process.

Once a Participant receives their WIC checks and leaves the clinic, they have the freedom to use/cash all or none of their checks. For the period of February 1, 2017 through July 31, 2017 the percentage of WIC checks issued to participants in New Jersey and not redeemed was 14-15%. Please reference pages 5-8 of the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised RFP 11/3/17.”

B. Also, confirm that the contracted manufacturer will not be paying rebates on the vouchers that are not redeemed by participants.

The State confirms that the Vendor {Contractor} will not pay rebates on checks that are not redeemed by Participants. Please reference page 10 of the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised RFP 11/3/17.”

Section 1.2.3 Notification of Rebate Infant

Formula

The transition period for a new contract is an important, material provision of this solicitation and the resulting contract. We therefore request the State outline the transition process it will utilize if there is a new supplier of infant formula. We request a response to the following questions:

A. Will participants entering the WIC clinic (or certified) on or after January 2, 2018 receive Food Instruments for January, February, and March that include the existing Vendor's products, or will only the January and February Food Instruments cover the existing Vendor's products and the March Food Instrument cover the new Vendor's

Reference products?

Upon the successful award of the Blanket P.O. {Contract} resulting from this Bid Solicitation {RFP}, there will be a period of time where the State is contracted with the Vendor {Contractor} awarded under this Bid Solicitation {RFP}, but there are still active checks with the prior infant formula provider. WIC Services issues Participants benefit checks on a three

(3) month basis The new Vendor {Contractor} will in no way be responsible to rebate another manufacturer’s product. Conversely, the outgoing infant formula provider will still provide a rebate on its own formula products that have already been issued. During this period of transition, the newly awarded Vendor’s {Contractor’s} products will be made available.

B. Are participants required to visit the clinic in order to receive additional Food Instruments? Please provide general information on participant requirements for visiting the clinic during the first year in which an infant receives WIC benefits. c) Please provide more details on the Food Instrument issuance process to be used during the contract transition.

Participants are required to visit the clinic to receive food instruments. DOH currently has a 6-month certification period for all WIC statuses, and most Participants receive three (3) months of checks at each visit. During the transition period, Participants will continue to receive the current contractor’s formula until the new Blanket P.O. {Contract} goes into effect. For example, based on a Participant’s check pick-up cycle, a Participant may receive two (2) months of current contract formula and receive the new Blanket P.O. {Contract} formula for the third month.

Notification of Rebate Infant

Formula

When does the State anticipate providing notification to health care providers, local WIC agencies, participants, and retailers? We request the State agree to provide such notification at least 75 days prior to the start of the new contract. Will the State agree to this notification requirement?

The State will notify health care providers, local WIC agencies, Participants, and retailers of the Infant Formulas to be provided under the Blanket P.O. {Contract} after Blanket P.O. {Contract} award and prior to the transition period. Please reference the answer to question #27 of this Bid Amendment {Addendum} for additional information regarding the transition.

Notification of Rebate Infant

Formula

Will the State provide a timeline when it intends to notify the health care providers, Local WIC Agencies, Participants and WIC Retailers of the Infant Formulas to be provided under this Contract, along with official notification of any changes to the Infant Formulas being provided during the term of this Contract. a. If there is a change in the manufacturer, we request the State to notify its authorized vendors 90 days prior to the start date of the contract to ensure adequate time for vendors to place orders for the new contract formulas?

Please reference the answer to questions #27 and 28, of this Bid Amendment {Addendum}.

Section 1.2.4 Database of WIC

Retailers

A. How many WIC over 50% vendors are authorized in New Jersey?

As specified in Bid Solicitation {RFP} Section 1.2.4, Database of WIC Retailers, “it is the policy of WIC Services to not allow into the WIC Program, retailers that would derive 50% or more of its business from WIC Participants.”

B. Please provide the WIC vendors’ minimum stocking requirements per peer group.

Please reference the answer to question #25, of this Bid Amendment {Addendum}.

C. What are the top 5 retail chains within the State?

In July 2017, data provided by the Department of Health (DOH) demonstrated that the top five (5) State retail chains that accept WIC checks are:

Reference

Question (Bolded) and Answer

1. ShopRite;

2. Stop & Shop;

3. Acme;

4. Walmart; and

5. Target.

Database of WIC

Retailers

What are the top five (5) WIC retailers measured by the percentage of WIC food volume (i.e., redeemed food instruments).

In September 2017, data provided by the Department of Health (DOH) that the top five (5) WIC retailers, when measured by the percentage of WIC Food Volume are:

1. Kollel Food Store;

2. Fine Fare Supermarket;

3. SLG Store Inc.;

4. NPGS Jackson; and

5. Twin City Supermarket.

Database of WIC

Retailers

How many authorized [retail] vendors have been disqualified for fraud or other serious violations of its retail agreement in each of the last five years?

There were no Retailors disqualified for fraud in the past five (5) years. The number of Retailors disqualified for serious violations are listed below:

Year # of Vendors

Disqualified for Serious Violations

2013 9

2014 8

2015 3

2016 14

2017 14 (to date)

Database of WIC

Retailers

Have there been any documented instances of trafficking or other fraud involving infant formula, or instances in which fraudulent transactions involving authorized WIC vendors have been identified during the last five years?

No, there have not been any documented instances of trafficking or other fraud involving infant formula, or instances in which fraudulent transactions involving authorized WIC vendors have been identified during the last five (5) years.

Section 1.2.5 Monthly Infant

Formula Rebate

Will the State include Issuance versus redemption data on the invoices broken into issuance months and redemption months?

Infant Formula Rebate Invoices include the number of:

A. Formula units sold;

B. WIC checks redeemed; and C. WIC participants that received the formula for each type of rebated formula (see attached invoices) by issue month.

Since rebates are only billed for units sold, and not issued, the State will not include issuance data on the invoices.

Section 1.3.1

Electronic Please confirm the questions and answers will be incorporated and made a part of the final contract resulting from this bid solicitation.

Reference

Question (Bolded) and Answer

Question & Answer Period

Yes, answers to questions posed during the Electronic Question & Answer (eQ&A) period and any subsequent revisions to the Bid Solicitation {RFP} are made a part of the final Blanket P.O.

{Contract} resulting from this Bid Solicitation {RFP}.

Section 1.3.1 Electronic

Question & Answer Period

Please provide the date when the State will provide or post answers to Bidder's questions. We would like to confirm that we may maintain contact during the bid period with the New Jersey WIC's Nutrition and/or Vendor staff for matters relating to infant cereal or baby food. Any communication would not involve the current infant formula bid.

The State will post the answers to questions asked during the Electronic Question and Answer period at least seven (7) business days prior to bid opening. Additionally, WIC Services may maintain communication with Vendors regarding all matters not related to this Bid Solicitation

{RFP}.

Electronic

Question & Answer Period

Because of the amount of analysis and approvals required for a contract of this size, please confirm the State will allow 10 business days between the day responses to questions are published and the bid due/opening date. If answers are not provided 10 business days prior to the scheduled bid due date, please revise the bid due date to be 10 business days after answers are posted.

The State will allow at least seven (7) business days from the time of advertisement of the Bid

Amendment addressing questions posed during the eQ&A period and the opening of the Bid Solicitation {RFP}.

Electronic

Question & Answer Period

A. Please confirm that all prospective bidders will receive all questions submitted, along with the responses from the State, from all bidders that have submitted questions.

All prospective Vendors {Bidders} will have access to the Bid Amendment {Addendum} outlining all questions submitted and all answers via NJSTART.

B. Please also confirm that the answers to the questions will be posted online via an addendum and will thus become part of the contract.

Yes, answers to questions received will be posted via a Bid Amendment {Addendum}.

Additionally, any Bid Amendment {Addendum} to this Bid Solicitation {RFP} will become part of this Bid Solicitation {RFP} and part of any Blanket P.O. {Contract} awarded as a result of this Bid Solicitation {RFP}.

C. Also, what document takes precedence if there is a discrepancy between what is reflected in the IFB and Q&A responses?

Answers to Q&A responses that require an amendment to the Bid Solicitation {RFP} are incorporated into the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised RFP 11/3/17.” In the event that there is a discrepancy between the Bid Solicitation {RFP} and the Q&A responses, the response will take precedence. Additionally, please refer to Bid Soliciation {RFP} Section 5.1, Precedence of Special Contractual Terms and Conditions.

Section 1.3.1.1 Exceptions to the

State of NJ Standard Terms and Conditions

What are the mandatory requirements referenced in this section? Please specify which provisions are considered mandatory requirements.

In accordance with Bid Solicitation {RFP} Section 2.2, General Definitions, the State's use of the words "shall" and "must" in this Bid Solicitation {“RFP}, denotes that which is a mandatory requirement. Additionally, please reference Bid Solicitation {RFP} Section 9.0, State of NJ Standard Terms and Conditions. Vendors {Bidders} are cautioned to review all parts of the Bid Solicitation {RFP} and its attachments to ensure compliance with all mandatory submissions and requirements.

Section 1.3.2 Submission of

Quotes

This section states bid may be submitted electronically or via hard copy. According to the Federal Regulation §246.16a - "Infant formula and authorized foods cost containment" section (c)(ii) in a single-supplier competitive bid system for infant formula rebate

Reference

Question (Bolded) and Answer contracts, the State Agency must "Publically open and read all bids aloud on the day the bids are due."

Please advise how NJ WIC will comply with Federal Regulations and "publically open" electronic bid submissions. Also, please identify everyone who has access to bids once they have been submitted on-line, prior to the official bid submission deadline. Please explain the steps taken to restrict access to bids to those persons identified in response to the question above.

Please be advised that the bid opening process is independently completed by the Department of the Treasury, Division of Purchase & Property (Division), Proposal Review Unit. It is noted that the State's eProcurement system, NJSTART, restricts access to submitted electronic Quotes {Proposals} until the actual Bid Opening date/time.

Section 1.3.2 Submission of

Quotes

Please provide a name, phone number, and email address of an individual that will be contacted to be certain that a bid package has been received.

Vendors {Bidders} submitting a hard copy Quote {Proposal} via an independent carrier should request a delivery confirmation from the carrier. In the event that the Vendor {Bidder} cannot confirm delivery via its selected carrier. Vendor {Bidder} can contact the Division’s receptionist at 609.292.4700, Monday –Friday, between the hours of 9:00 am and 5:00 pm (ET). It is solely the Vendor’s {Bidder’s] responsibility to ensure Quotes {Proposals} are delivered at or prior to the deadline.

Section 1.4.1 Bid Amendment

{Addenda}:

Revisions to this Bid Solicitation

{RFP}

If any addenda are issued, will they be required to be signed and submitted with a bid proposal?

The Vendor {Bidder} will not be required to sign and/or submit any Bid Amendment {Addenda} posted as a result of this Bid Solicitation {RFP}. However, it is noted that it is the sole responsibility of the Vendor {Bidder} to be knowledgeable of all of the additions, deletions, clarifications, and modifications to the Bid Solicitation {RFP} and/or the SSTC relative to this Bid Solicitation {RFP}, as set forth in all Bid Amendments {Addenda}.

Section 1.4.4 Contents of

Proposal

In the last paragraph of this section it states the pricing information for this bid solicitation "must be made public to allow all eligible purchasing entities access to the pricing information." Please confirm NJ WIC Services is the only entity that will be seeking infant formula under the terms of this solicitation. Please further confirm the provision on page 19 of this RFP (Using Agency[ies]) is not applicable to this WIC rebate contract.

By definition (Reference Section 2.2 of the Bid Solicitation {RFP} (p.19)), NJ WIC Services is a Using Agency and as such the term is applicable to this procurement. However, WIC Services will be the only Using Agency eligible to utilize the services provided under the terms of this Bid Solicitation {RFP} and its resulting Blanket P.O. {Contract}. Additionally, it is noted that submitted pricing will still be viewable by other Using Agencies.

Section 1.4.5 Announcement of Quote {Proposal}

Information

This section states on the date and time Quotes are due all information submitted may be publically announced. According to the Federal Regulation §246.16a - "Infant formula and authorized foods cost containment" section (c)(ii) in a single-supplier competitive bid system for infant formula rebate contracts, the State Agency must "Publically open and read all bids aloud on the day the bids are due."

A. Please confirm bids will be opened publically in front of representatives that are attending the public bid opening.

Yes, submitted Quotes {Proposals} will be opened publically in front of representatives that are attending the public bid opening. Please reference page 14 of the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised RFP 11/3/17.”

B. Also, please provide the room location for the bid opening and a call-in number where bidders can call into listen to the public bid opening.

The Bid Opening will be held at:

Bid Opening Room – 9TH FLOOR

DIVISION OF PURCHASE AND PROPERTY

DEPARTMENT OF THE TREASURY

33 WEST STATE STREET, P.O. BOX 230

TRENTON, NJ 08625-0230

It is noted that a call-in number is not available. Prospective Vendors {Bidders} may attend the public bid opening in person.

Announcement of Quote {Proposal}

Information

Please provide the address and room number for the bid opening. Would the State be willing to provide a call-in number for those bidders who are unable to attend the bid opening in person? Lastly, please confirm the State will read aloud the relevant information from the bid sheets, including the product name being bid, unit size, Reconstituted ounce per unit, wholesale price per unit, rebate per unit, net cost per unit, percentage rebate (discount), the Total Net Cost for each product form, and the Total Net Cost per Month.

Please reference the answer to question #44 of this Bid Amendment {Addendum}. Additionally, all information provided on the Vendor’s {Bidder’s} submitted Infant Formula Rebate Tabulation Sheet (Price Schedule) will be read during the bid opening.

Announcement of Quote {Proposal}

Information

Please confirm the following information will be read from the Price Schedule at the public bid opening: Vendor Name, Product Name Being Bid, Unit Size, Reconstituted Ounce per Unit, Lowest Wholesale Full Truckload Price Per Unit, Rebate Bid Per Unit, Net Cost, Percent Rebate and Total Net Cost Per Month (from page 2 of 2).

Please reference the answer to question #45 of this Bid Amendment {Addendum}.

Announcement of Quote {Proposal}

Information

A. Per Federal Regulations, "The State agency must publicly open and read all bids aloud on the day the bids are due." Please confirm that there will be a public opening.

Please supply the date, time, and location of the public opening.

Yes, the State will open and publically read the submitted Quotes {Proposals} on the day they are due. As referenced on the cover page of the Bid Solicitation {RFP}, the Quote {Proposal} Submission Date (bid opening) is November 30, 2017, at 2:00 pm (ET).

B. Please confirm the state will read aloud company name, product brand name, unit size, reconstituted ounces per unit, wholesale price per unit, rebate bid per unit, net cost per unit, percent rebate, and total monthly net cost.

Please reference the answer to question # 44 for additional information.

C. In the event of a tie, how will the state determine the RFP winner?

In the event of a tie, the State will first rely on the provisions set forth in the Bid Solicitation {RFP}. Additionally, please reference the answers to questions 119-120 of this Bid Amendment. It is noted that the Infant Formula Rebate Tab Sheet (Price Schedule) is formatted to three (3) decimal places decreasing, if not eliminating the chance of a tie.

D. In case of a protest, what is the procedure and the appropriate timeframe for submitting a protest? Also, please confirm that all bidders will be notified in the event of a bid protest.

In the event that an individual would like to challenge the intended award of a Blanket P.O.

{Contract}, it should submit a formal request in accordance with the Division’s Administrative Regulations, N.J.A.C. 17:12-3.3., within the allotted protest period, as demonstrated within the Bid Solicitation's {RFP’s} Notice of Intent to Award. Letters of Protest must be received by the protest period end date and may be submitted to the following three (3) addresses

Reference

Question (Bolded) and Answer

ONLY: (1) email at dpp.protest@treas.nj.gov; (2) facsimile at 609-984-2575; or (3) mail or courier to:

Attn: Hearing Unit, Division of Purchase and Property 33 West State St.

P.O. Box 039, Trenton, NJ 08625-0039.

The Bureau does not notify all Vendors {Bidders} when a protest is submitted.

Announcement of Quote {Proposal}

Information

This section states "all information concerning the proposals submitted may be publicly announced and shall be available for inspection and copying." Please describe the process required to inspect and /or copy proposal information.

In the event that a Vendor {Bidder} would like to inspect and /or copy Quote {Proposal} information, it would be able to do so after the issuance of the Notice of Intent to Award (Notice).

Upon receipt of the Notice, the Vendor {Bidder} could submit a written/email request to the Bureau utilizing the instructions included in the Notice.

Section 1.4.5(B) Announcement of Quote {Proposal}

Information

A. Please confirm negotiation is not being contemplated for this WIC Infant Formula Bid.

If unable to confirm, please explain what is meant by "negotiation." What terms and conditions might be negotiated?

The State confirms that negotiation is not applicable to this procurement. Please reference page 14 of the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised RFP 11/3/17.”

B. Please confirm rebate pricing will not be negotiated after bids are submitted.

C. Please confirm that the contract award will go to the manufacturer providing the state the lowest total monthly net cost as indicated on the price schedule.

Please reference the answer to question #3 of this Bid Amendment {Addendum}.

Section 3.1 Essential

Requirements

Does the State intend to continue issuing non-contract, non-exempt formulas during the duration of this contract?

The State intends to continue issuing non-rebate, non-exempt formulas if there is a child tolerance issue (with medical justification) or religious practice.

Section 3.3

Infant Formula

Would the State consider limiting authorized products to powder and ready-to-feed forms? Powdered infant formula is more cost-effective and the RTF form is available to those who have issues with water quality.

The State does not accept the proposed modification to the Bid Solicitation {RFP}.

Section 3.3.1 Infant Formula Specifications

A. Please confirm that the State is aware that the USDA has made a correction to regulations that provides for non-exempt formulas that are less than 20 kcal fl. oz. to be provided and rebated through the WIC program with a prescriber's authorization.

The State is aware of the USDA’s modification.

B. Abbott produces several non-exempt alternates to the primary contracted formulas that are ~19 kcal/fl. oz. that are widely used and rebated in states where Abbott holds the contract. Should Abbott be the successful bidder on this contract, please confirm that these ~19 kcal/fl. oz. formulas would be allowable and utilized ahead of non-contract non-exempt, or exempt formulas.

Reference

Question (Bolded) and Answer

The State confirms that the referenced formula would be allowable and would be considered ahead of non-contract, non-exempt, or exempt formulas.

Section 3.3.1 Infant Formula Specifications

Please confirm the State will only issue infant formulas that meet all the requirements specified in this section. There are currently several infant formulas on the market that do not meet the minimum WIC requirements specified in Table 4 at 7 CFR 246.10(e).

The State confirms. Additionally, please reference the answer to question #22, of this Bid Amendment {Addendum}.

Section 3.5 Reformulation/

Product Substitutions/

Changes in Labeling and

Packing

A. Under what circumstances might WIC Services withhold approval of a Vendor's new primary contract infant formula or other infant formula products? Infant formula is the most heavily regulated product on the market and must meet stringent nutrition and manufacturing requirements.

If the new Rebate-Eligible Infant formula (primary) or other infant formula products are USDA and FDA approved and meet the definition of Rebate-Eligible formula, WIC Services does not anticipate any circumstances where it would withhold approval, if notified in a timely manner. However, the time frame necessary to implement the new formula distribution (revise in computer system, retailer notification, revising and printing forms and Participant flyers, clinic training, etc.) may cause a delay. The State emphasizes the importance of the awarded Vendor {Contractor} communicating new product launches in a timely manner to prevent these delays.

B. Please confirm the State will not unreasonably withhold approval of any new primary contract brand infant formula that meets all of USDA's minimum WIC requirements, including the requirements specified in Table 4 of USDA's regulations at 7 CFR 246.10(e).

Reformulation/

Product Substitutions/

Changes in Labeling and

Packing

On what basis would the State deny an infant formula that was reformulated? Since manufacturers are not making product solely for the State, to allow the State to have "sole right to make final determination of what constitutes an acceptable change, replacement, substitution, or alternative" is not practical. Manufacturing a product formulated for and distributed only in the State could dramatically affect a manufacturer's ability to execute the requirements of this contract. Please remove this provision. If not removed, please provide the reasons that the State feels that this provision is in the best interest of the Department, the State, WIC infant participants and the contractor.

The State would deny a reformulation if it failed to meet the minimum requirements set forth by the USDA WIC program. The provision of the 90 calendar days advance written notification prior to implementation of any product substitutions, changes in formulation of Infant Formulas, as well as changes in packaging, unit size, and labeling is in the best interest of all involved as it provides an opportunity for the State and the Vendor {Contractor} to discuss the proposed changes and ensure that they are in accordance with USDA regulations. The State recognizes customary industry practice; however, WIC Services has the responsibility of providing benefits to its Participants and needs to be involved in the decision making process. Although the State has the “sole right to make final determination...,” if it will offer the Vendor’s {Contractor’s} awarded product, that determination is made in collaboration with the awarded Vendor {Contractor}.

Reformulation/

Product Substitutions/

Changes in Labeling and

Packing

A. Please increase the notification period to 120 days.

The awarded Vendor {Contractor} may provide an increased notification period of 120 calendar days. The Bid Solicitation {RFP} has been modified to demonstrate, “at least 90 calendar days”. Please reference the revised Bid Solicitation {RFP} titled, "T1057 WIC Rebate Revised RFP 11/3/17.”

B. Since manufacturers are not making product solely for the State, to have "sole right to make final determination of what constitutes an acceptable change, replacement, Reference

Question (Bolded) and Answer substitution, or alternative Infant Formula as part of the WIC Program," is not practical. Manufacturing a product formulated for and distributed only in the State could dramatically affect a manufacturer's ability to execute the requirements of this contract. Please remove this section.

Please reference the answer to question # 55 of this Bid Amendment {Addendum}.

C. Please provide the reasons that the State feels that this provision is needed. Infant formulas sold in the US must meet the requirements of the Infant Formula Act as outlined and managed by the FDA.

Please reference the answer to question # 55 of this Bid Amendment {Addendum}.

Additionally, the State is aware that Infant formula must meet the requirements of the Infant Formula Act as outlined and managed by the FDA; however, the State, as the vehicle in which the WIC Program is administered in NJ, has additional requirements that take into account the needs and concerns of the Participants in the NJ WIC Program.

Section 3.5.1 Product

Substitution

Will the State agree to first substitute an alternate brand or product of the Vendor's formula in instances of potential product shortages prior to substituting with a non-contract brand?

In accordance with Bid Solicitation {RFP] Section 3.5.1, Product Substitution, in the event that the Vendor {Contractor} needs to substitute a formula due to a shortage or mandatory/voluntary recall, the Vendor’s {Contractor’s} substitute of first order shall be a different physical form of its unavailable formula (e.g. powder versus liquid concentrate). The Blanket P.O. {Contract} resulting from this Bid Solicitation {RFP} requires that specific formulas be available, if the contractor does not have an alternate physical form of the recalled, discontinues, or formula currently in shortage, it is the State’s right to seek a non -contract brand. Due to the nutritional requirements of the WIC Program in NJ, the State cannot and will not substitute an alternate brand or product in the Vendor’s {Contractor’s} lineup of products, and will seek another manufacturer to provide the specific formula needed. All provisions set forth within the Bid Solicitation {RFP} will stand. Please review the above referenced section for additional information.

Product

Substitution

Please confirm that the State would substitute an appropriate alternate brand of the Contractor's product line prior to issuing a non-contract brand.

Please reference the answer to question #57 of this Bid Amendment {Addendum}.

If not confirmed, please list all of the reasons why the state will not substitute an appropriate alternate brand of the contracted infant formula prior to issuing a non-contract brand.

Product

Substitution

Please confirm that should there be a shortage or recall of products, the state will first issue a different physical form of the contractor's formula, secondly, consider issuing another sub brand of rebate eligible formula…