Amendment_000001_Questions_and_Answers.pdf

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 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 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.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

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.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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

IT MODIFIES THE CONTRACT/ORDER NUMBER 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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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)

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.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

000001

Margo Katzper, Contracting Officer

NCI answers to questions received from the Offerors as of 12:30 pm on July 24, 2017, in response to the Solicitation number stated in 9A. above.

Offerors must include a signed copy of this Amendment in their Business Proposal.

National Cancer Institute Office of Acquisitions 9609, Medical Center Drive Rockville, MD 20850

N02CM71017-38

1 3

07/24/2017

07/17/2017

Solicitation Number: N02CM71017-38 Amendment: 000001 Date: July 24, 2017

Solicitation No.: N02CM-71017-38 Title: Storage and Distribution of Clinical Agents

Questions and Answers

Q.1. Is this a new requirement?

A.1. No.

Q.2. If this is not a new requirement who is the incumbent?

A.2. Fisher BioServices Inc.

Q.3. What is the minimum required sq footage or storage area requirements?

A.3. There is no minimum square footage requirement. Please see item k. on Page 2 of the Attachment 14-Additional Business Proposal Instructions at the end of the RFP for further guidance.

Q.4. How many products are currently in inventory?

A.4. The inventory on hand fluctuates. For proposal preparation purposes, refer to Option A on Page 2 of Attachment 14-Additional Business Proposal Instructions at the end of the RFP.

Q.5. The estimated inventory should increase each year by 25%, so should the facility be able to store the max amount immediately?

A.5. Offerors should consider their options for managing the increased capacity of the contract and consider this as part of their response to their approach.

Q.6. Will the NIH be responsible for shipping costs?

A.6. See item e. on Page 1 of Attachment 14-Additional Business Proposal Instructions at the end of the RFP.

Q.7. Can an extension be given for the proposal submission date? A number of our critical proposal resources will be on vacation.

A.7. The Government is unable to grant an extension for the proposal submission date.

Q.8. Will there be a pre-proposal conference?

A.8. The Government does not plan to hold a pre-proposal conference.

Q.9. We have a cGMP process where our QA group signs off on inbound and out bound materials and clinical packaging operations. Is a Pharmacist an absolute requirement? (Att. 3- Statement of Work, Pg. 5, paragraph b.)

A.9. For the work described in attachment 3, page 5, paragraph b, the activities performed are preparation of patient-specific prescriptions for dispensing purposes and must be performed by a licensed pharmacist.

Q.10. Given that the facility will be 100% dedicated to the NCI, will NCI allow offerors time to acquire additional capacity? Or is it the NCIs expectation that this capacity will exist and is currently idle? (Att. 3 Statement of Work, Pg. 9, paragraph 22.b.)

Solicitation Number: N02CM71017-38 Amendment: 000001 Date: July 24, 2017

A.10. The request for proposals does not require the facility to be 100% dedicated to the contract (See paragraph a. on page 1 of the Attachment 6-Additional Proposal Instructions). Offerors should consider their options for managing the increased capacity needs of the contract and consider this as part of their response to their approach.

Q.11. Does an individual with 30+ years of clinical trial supply experience at a senior level, suffice for " familiarity with strategies for packaging and labeling agents" (Att. 6- Additional Technical Proposal Instructions, Pg. 5, paragraph ii) A.11. The offerors should make their own decision in considering this as part of their response to their approach.

Q.12. Is there a site or listing of where the NIH Hazardous Chemical Waste Disposal Service Contractors are located? (Att. 14-Additional Business Proposal Instructions, Pg. 2, paragraph i.)

A.12. They are located on the National Institutes of Health campus; Bethesda, MD.

Q.13. What is the estimated size, weight and volume of the estimated 15 boxes of Medical Pathological Waste? (Att. 14-Additional Business Proposal Instructions, Pg. 2, paragraph j.)

A.13. Weight will vary based on the contents, but are estimated at approximately 50 lbs. per box with a volume of approximately 30 gallons.

Q.14. Is the cubic feet estimate, initial quantity to be transferred to the offeror or the estimated quantity at the phase out? (Att. 14-Additional Business Proposal Instructions, Pg. 2, paragraph k.)

A.14. The information provided in Attachment 14-Additional Business Proposal Instructions, Pg.

2, paragraph k. provides approximate space specifications based on the current facility. It does not refer to inventory being transferred to the offeror or the estimated quantity at the phase out.

Q.15. Is the Phase in volume cubic feet requirement (by condition) the same as the cubic volume in letter k. above? (Att. 14-Additional Business Proposal Instructions, Pg.

2, paragraph l.)

A.15. Item l. of the referenced section provides approximate number of agent samples and unit packages of agent. It does not refer to space.

Q.16. Is the 25% increase in desired capacity based on 400,000 units referenced in letter d.

or the 265,000 units referenced in letter l.? (Att. 14-Additional Business Proposal Instructions, Pg. 3, paragraph n.)

A.16. The 25% is based on the 265,000 units.

Q.17. Please provide current estimate for Phase out from the existing contract currently in place. (Att. 14-Additional Business Proposal Instructions, Pg. 3, paragraph m.)

A.17. Refer to Item 1., Page 2, ttachment 14-Additional Business Proposal Instructions.

Q.18. Is there a way to translate units into cubic feet?

A.18. No.