VA770-17-R-0417-00001000.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

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10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

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1. CONTRACT ID CODE

FACILITY CODE

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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:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication 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 is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, 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.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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

D. OTHER

BY

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

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

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) National CMOP 00001 01-19-2018 none 36C770 Department of Veterans Affairs National CMOP 3450 S. 4th St. Trafficway Leavenworth

KS

66048-5581 36C770 Department of Veterans Affairs National CMOP 3450 S. 4th St. Trafficway Leavenworth

KS

66048-5581 To all Offerors/Bidders

VA770-17-R-0417

X X X X Clarify Contracts Solicitation Questions & Answers This Modification provides answers to questions asked regarding this solicition.

This modification is issued to revise Section C- Contract Period page #6 "The implementation/transition period shall be no more than thirty (30) calendar days from date of contract award."

SHALL now read "The implementation/transition period shall be no more than sixty (60) calendar days from date of contract of award."

ALL other Terms of this Soliciation remain unchanged.

Linda Bayer Contract Officer

Please find the following questions for clarification in regards to solicitation VA770-17-R-0417:

1. Can you elaborate and specify dates for DSCSA serialization and/or aggregation requirements? Our interpretation is to have serialization implemented by November 2018. (PG 14, J. PRODUCT CHARACTERISTIC REQUIREMENTS CMOP Response: DSCSA serialization requirements can be found on the FDA website. It is the Offerors responsibility to monitor the site for changes that may impact requirement deadlines.

2. Considering DSCSA requirements, please clarify who will be responsible for providing and storing serial numbers, also who will maintain EPCIS reports?

CMOP Response: The contractor shall be responsible for complying with DSCSA Regulations regarding the Repacking of pharmaceuticals.

3. To help determine capacities, product mix, and sku complexity, can you provide a 6-month history of specific products (SKUs), with specific counts, ordered under this contract previously?

CMOP Response: CMOP estimates that 200 non- controlled drugs are sent for repacking. The drug name and specific pack size (NDC’s) can increase or decrease month by month due to manufacturer back orders, changes drug usage and CMOP inventory levels.

CMOP Response: Controlled drugs are only dispensed out of two CMOPs however these drugs experience the same unpredictability as mentioned for non-controlled drugs.

4. Can you provide clarification (historical data gathered) on average lot size per SKU/count? Page 7, D. GENERAL REQUIREMENTS #6 &7 CMOP Response: The contract items listed above refer to items # 6 and #7

6. Historical data shows an average of 12 pallets of controlled bulk product is sent to the repacker each week equating to an average of 30 pallets of finished product that is shipped to CMOP.

7. Historical data for the past year shows that there was an average of thirty (30) shipments per month, from the repacker to the CMOP facilities. The question is vague but CMOP will make every attempt to minimize the amount of lot numbers for each drug sent to the Repacker.

5. Confirm if no topserts or additional product information sheets are required to be provided by packager? PG 16, M. PRODUCT HANDLING CMOP Response: Not required

6. Can you provide current approved component specifications/vendors to ensure consistency of sourcing (closures, bottles)?

CMOP Response: CMOP cannot supply this information. This information will be available from any prospective supplier.

7. The contract states a transition period of 30 days, in light of insufficient information to fully evaluate SKU mix/complexity and please provide additional information to put forth a formal transition plan (ramp-up/down period, validation requirements, set-up, component procurements, scheduling, etc.) PG 6, #2 C. CONTRACT PERIOD CMOP Response CMOP does not believe there is insufficient information to evaluate the complexity. The Transition Plan is stated in the Evaluation Criteria, General Information (d.). “The contractor shall provide a written transition plan to minimize any decreases in productivity and to prevent possible negative impact on service. This plan shall include but is not limited to the identification and establishment of new processing facilities and locations, the hiring, and training of staff prior to the start date, and obtaining NDC approvals, and establish point of contacts . The Transition Plan shall be included in proposal and shall be incorporated in the contract award.” The statement “shall include but is not limited to” allows the Offeror to add more information to include the topics listed in the Offerors question.

8. Do the CMOPS have a preference on shipper pack out – bundled or loose packed? PG 16, M. PRODUCT HANDLING CMOP Response: Packaging will be according to good business practices and industry standards. See Section M Product Handling.

9. Do any of the products require special handling (ex. Hormonal, penicillin products, etc.)

CMOP Response: Special handling may be required for hazardous and controlled drugs.

10. Can you identify the current contract holder and expiration date of current contract?

CMOP Response: The current contract holder is Aphena Pharma Solutions. All contract information can be found on fbo.gov and other internet sources.

11. Do you have a targeted award date for the new contract?

CMOP Response: The solicitation closes on 1/29/2018, we are unable to completely predict the award date at this time, it is estimated that CMOP may award sometime in July.

12. Is there a specific list of the Drugs to be Repackaged?

CMOP Response: There is not a specific list however CMOP estimates that 200 non- controlled drugs will be sent for repacking. The drug name and specific pack size (NDC’s) can vary due to manufacturer back orders, changes in drug usage and CMOP inventory levels.

13. What sizes (count) is the bulk product shipped to the repacker?

CMOP Response: Bulk size may vary due to the manufacturer of the drug. CMOP will make every attempt to send the Repacker the largest pack size available from the drug supplier however limited drug availability and other factors may not make this possible.

14. What proposal volume does Factor 5 SDVOSB or VOSB participation belong?

CMOP Response: CMOP does not understand the question, if this is in reference to what Volume the The offeror shall submit information describing the extent of opportunities to be provided to: Service Disabled Veteran-Owned small businesses and Veteran-Owned small businesses. That should be submitted in the Business Proposal.

15. What information is required for past performance? Page 103 of the solicitation states:

“The offeror must submit the following information on past performance for all current and completed contracts for the past five years. Solicitation Attachment 3 has been provided for this purpose. All information requested in Attachment 3, where applicable, must be provided.”

Are we to provide past performance information within the business volume of what we feel to be applicable from the past performance questionnaires that we send out to our clients?

CMOP Response: Please review the FAR Clause 52.212-1, Instructions to Offerors and Evaluation Criteria Past Performance (c.) to further clarify please read Attachment 3 for instructions.

16. Where is the proposal delivery address?

CMOP Response: The delivery address can be found in the Submission Instructions Section of the solicitation. Page 102

17. The due date on the PPQ appears to be incorrect. Please provide the correct date.

CMOP Response: If the Offeror is referring to “RFQ” the Offer Due Date/Local time is in box #8 of the Standard Form 1449 in the solicitation.

18. Does the VA require child resistant caps and the subsequent testing/certification for the 1,000cc, 2,000cc, 3,000cc and 4,000cc bottles?

CMOP Response: Section J Product Characteristic Requirements states that child resistant cap requirements do not apply to bulk sized bottles. See J.2.h.

19. Will the VA accept 950cc or 1250cc bottles in lieu of the 1,000cc bottles?

CMOP Response: See Section J Product Characteristic Requirements.

20. What are the current contacted repackaging fees/rates?

CMOP Response: Current repacking fee/rates can be requested under Freedom of Information Act (FOIA).

21. The previous VA repackaging contract issued by the NAC allowed for a 75 day implementation period. Will the VA consider revising this requirement to allow an implementation period greater than the stated 30 days?

CMOP Response: The NAC repacking contract is different from the CMOP repacking contract therefore CMOP does have different requirements, the implementation period will be adjusted to 60 day implementation period.

The contract will now read , “. The implementation/transition period shall be no more than sixty (60) calendar days from date of contract award.

22. Does the VA require that offerors include Bar Code 128 labeling with the samples submitted or does the VA require the 2D (Q//R) labeling to be provided with the samples?

CMOP Response: Offerors shall include Bar Code 128 labeling with their samples. The solicitation states “At the time of solicitation Bar Code 128 is required. The government requirement for bar code shall change during the base year of the contract. The implementation of the 2D (Q/R) type automated information data carrier shall be incorporated by the contractor on the date required by the DSCSA.” See Section J.5.d. Product Characteristic Requirements.