Amendment_Two__RFP_N01CN77019-18.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

Purpose: To clarify both the period of performance and ordering and delivery periods, as well as to answer offerors' questions.

National Institutes of Health National Cancer Institute Frederick, MD 21701

TO ALL POTENTIAL OFFERORS

N01CN77019-18

1 3

06/01/2018

Nicole M. Belanger -S Digitally signed by Nicole M. Belanger - S Date: 2018.06.01 13:31:51 -04'00'

6/1/2018

RFP No. N01CN77019-18 2

Amendment Two

This amendment clarifies the estimated period of performance, clarifies the ordering and delivery periods under the applicable FAR clauses, and answers questions received regarding Solicitation N01CN77019-18.

1. For this solicitation, the period of performance listed under Articles B.3.b., F.1 and I.4.a.3(a) is tentatively 11/21/2018 – 11/20/2023. Under article I.4.a.5(d), the last day of the ordering period will be on/about 11/20/2028 and under Section L.1.c(1), the anticipated award date will be on/about 11/21/2018.

2. I have noticed that the Amendment to the Solicitation does not contain “Additional Business Proposal Instructions” the way it contains “Additional Technical Proposal Instructions”. Should we follow the Business Proposal Instructions from the Solicitation page 91, or do you anticipate that “Additional Business Proposal Instructions” will be published?

Yes, please follow the Business Proposal Instructions from page 91 of the Solicitation.

3. Under the proposed cost of work in the business proposal, what should we budget for? We are instructed to respond to two sample task orders under the Efficacy Pool. Do we include these two budgets under the business proposal? Do we need to describe any other costs not related to the two task orders in the business proposal?

For both the Efficacy and Pharmacology/Toxicology pools, offerors are instructed to propose on either sample task order or both sample task orders. Offerors should submit a separate budget for all proposed sample task orders, as well as describe any additional anticipated costs in the business proposal that are not covered in the sample task orders.

4. How many “Breakdown of Proposed Estimated Costs” Excel files do we need to submit, two (one for each sample task order) or one combined document?

Please submit a separate “Breakdown of Proposed Estimated Costs” Excel file for each submitted sample task order and one for the Task Order 1, Kick Off Meeting.

5. Do we budget for the kick off meeting separately or include the travel into the Breakdown of Proposed Estimated Costs?

Yes, please budget for the kick off meeting separately.

6. Toward the performance of in vivo efficacy studies, our animal facility is GLP certified and experienced in routine performance of GLP studies. For the present sample task orders, the efficacy and immunogenicity assessments are exploratory in nature and will not be performed in the context of formal IND-enabling toxicity / biodistribution studies. It is our recommendation that the proposed in vivo studies in mice do not need to follow GLP

RFP No. N01CN77019-18 3

Amendment Two conditions at this stage. Does the NCI agree with our interpretation of the studies to be performed and with our recommendation?

The Efficacy studies are exploratory and do not need to be performed in the context of IND-enabling studies, nor do they need to follow the regulatory requirements for GLP. NCI would expect that all studies follow good documentation practices to assure that methods, results, and data interpretation are properly recorded and easily retrievable.

7. Our laboratories are well equipped to perform the assays relevant to the sample task orders.

We routinely develop assays based on our technological platforms and can offer various levels of assay characterization, based on specific needs. What parameters does NCI want assessed for proposed studies in sample task orders 1 and 2, i.e. sensitivity, etc.? As a follow up question, we typically provide full qualification and validation services for immunological monitoring of clinical studies, not preclinical studies. For the proposed preclinical studies, we recommend that assays be developed and potentially qualified but not fully validated. Full validation may be performed at the stage of clinical use of the proposed interventions. Does the NCI concur with our recommendation?

The specific assays required for the Efficacy pool can be general assays for tumor development or growth (i.e. Ki-67 immunohistochemical assays for tumor proliferation), compound specific assays to determine the pharmacodynamic effects of the agents and potential mechanisms of action (i.e. if the compound is a receptor inhibitor, then inhibition of the receptor and/or a downstream target of the receptor), and/or pharmacokinetic studies (i.e. drug plasma levels, half live, etc.) depending on what is specifically requested in the Statement of Work.

Unless otherwise called for in the Statement of Work, the assays are generally well documented in the literature and have been utilized in prior scientific studies as documented in the biomedical literature.

8. The Evaluation Criteria state the need for “[d]ocumented utilization and adherence to quality assurance and control procedures in implementing research studies to determine efficacy…” Our laboratories routinely run a broad variety of immunological assessment assays on both preclinical and clinical samples. As a GCLP-certified laboratory with extensive Quality Assurance oversight, a number of studies we conduct are performed under GCLP conditions.

Considering the preclinical nature of the proposed studies, it is our recommendation that the performance of the proposed assays does not need to be done under GxP conditions with full quality oversight. However, good documentation practices (GDP) could be utilized to ensure clear, consistent, and traceable record keeping of the studies performed. Could the NCI clarify the level of documentation and quality oversight required for both the task areas as well as the Sample Task Orders?

Good documentation practices are sufficient for the Efficacy pool.