Amendment 2- 75N91021R00003.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

Randall Tiqui Contracting Officer

Purpose: 1) To answer offerors' questions; and 2)Update Attachment 5- Section K- Representations, Certifications, and Other Statements of Offerors.

National Institutes of Health National Cancer Institute Frederick, MD 21701

TO ALL CONTRACTORS

75N91021R00003

1 5

12/21/2020

12/21/2020

RFP: 75N91020R00003 2

Amendment No: 0002 Date: 12/21/2020

This amendment answers questions received regarding Solicitation 75N91020R00003 and updates Attachment 5- Section K- Representations, Certifications, and Other Statements of Offerors.

1. We are a control analytical chemistry testing laboratory that partner with other laboratories/vivariums with bioanalytical testing. We have reviewed the testing you outlined, and the problem is that we don’t have one laboratory that can do all of the in vivo/in vitro analysis. Would it be acceptable to submit an application with [COMPANY NAME REDACTED] and multiple other laboratories that we are partners with to cover all the requirements?

Yes, your proposal would be evaluated in accordance with the Technical Evaluation Factors of the solicitation.

2. If we are only able to perform a subset of the protocols, do we still qualify? (We can do the rat studies, but not the dog studies).

Your proposal would be evaluated in accordance with the Technical Evaluation Factors of the solicitation.

3. We are currently putting GLP conditions in place at [COMPANY NAME REDACTED] and we should have all required documentation by Mid-February. Are we still eligible to submit a proposal?

In accordance with the Mandatory Qualification Criteria outlined in Section M. 4., GLP Compliance must be documented with the most recent FDA Establishment Inspection Report demonstrating that the facility is currently in compliance with FDA GLP regulations, i.e. is not currently disqualified at the time of receipt of Final Proposal Revisions.

4. On Page 76 of the RFP 75N91021R00003, under section L subsection d Level of effort, it appears that the cost proposal for this RFP should include a cost estimate for the number of Labor hours provided for each category within the table provided in this section. This appears to be supported by the statement provided in Attachment 17 under Section 4 (Options) where it states: “Provide separate budgets covering all costs associated with carrying out functions for (A) the Base and (B) Option Periods. The Government’s base requirement for the work set forth in the Statement of Work (SOW) of this solicitation is 4,791 labor hours per contract year.” Also, In Attachment 17, under Section 2, the RFP states: “The business proposal must include a cumulative cost summary for the studies (overall total) identified in Section 3 below and separate cost summaries should be provided for each individual study as supporting documentation”. We would appreciate a response to the following questions:

a. Should the Business proposal include a separate estimated cost for the Level of effort as shown in the table under Section L sub-section d, as well as a separate cost for the studies identified in Section 3?

RFP: 75N91020R00003 3

Date: 12/21/2020

Yes. It is estimated six studies will be required each contract year. A separate cost summary should be provided for each of the six studies identified in Attachment 17- Section 3. In addition, a cumulative cost summary should be provided showing the cumulative total of the six studies. The cumulative total will be used to establish the contract ceiling for each contract year. Offerors should provide this information for the Base Period and each Option Period.

b. Based on the information provided under Attachment 17 section 2, we have listed our understanding of the RFP below. Please address our questions or confirm our assumptions below:

i. The business proposal must include a cost summary for each individual study in which the cost of each study is presented as Base Year and each Option Year with an overall Total. Is our assumption correct?

See response to question 2.a. above.

ii. The business proposal must also include a base period total overall cost which is the sum of 6 studies requested and this same cost should also be calculated for all option years. Is our assumption correct?

Yes

iii. Does NCI anticipate that the combined number of hours in the 6 sample tasks is not to exceed the RFP proposed LOE of 4791 hours? Please provide clarification.

Yes. The combined hours between the six sample studies should total the 4,791 hours identified in the solicitation.

iv. In the Level of Effort Table provided, who are considered to be Administrative? Should we assume that these individuals are those who are involved in management of the contract such as, project managers, PI, Associate PI and so on?

The Principal Investigator and Associate Principal Investigator should be included under the “Principal Investigator” category. Examples of “Professional” category may include Veterinarian, Study Director (Project Manager), and Lead Analytical Chemist. Examples of “Technical Support” may include Toxicology Technician, Chemical Technician, Medical Technologist, and Animal Care Technician. Examples of “Administrative” category may include Project Manager, Administrative Support, Report Writing, Quality Assurance Auditing, Quality Control Auditing.

RFP: 75N91020R00003 4

5. Attachment 17 of the RFP 75N91021R00003 under Section 3 subsection 2 (Travel) states the contract should assume that the PI and one key personnel, will travel 6 times per year.

a. Are these number of instances of travel per year accurate?

Yes

b. Should three local and three international travel be included?

Offerors should estimate travel to six domestic conferences only.

c. Since there is no administrative task, should the cost of this travel be included in each study? Or should we include a separate Administrative task?

Yes, travel should be included with each study. It is estimated after the completion of each study, the PI and one Key Personnel will be required to present results from the studies.

6. In Attachment 3 of RFP 75N91021R00003, under sections 3a and b, several Administrative requirements have been requested which includes but not limited to: meetings (for technical discussions, discussion of anticipated problems/obstacles) which are to be attended by PI and other individuals, and travel to a COR and CO specified meetings to present scientific information or attend conferences. Please state:

a. How should the contractors capture the cost of such activities?

Labor costs for attending technical meetings and travel to present study findings should be included with each study cost summary.

b. Should an Administrative Task be included?

No, please see response to Question 6.a.

c. For the purpose of cost estimation, how many project meetings per month should be assumed?

Offerors should assume that for each project, 4 hours will be required during the first month after project initiation for discussions with the PI and/or Study Director to plan and fine tune the study. After which assume 0.5 hour discussions for monthly updates.

d. Should travel be included in this administrative task?

Please see responses to Questions 5.c. and 6.a. above related to proposing travel costs.

RFP: 75N91020R00003 5

e. Are the number of hours for this administrative task in addition to the Level of effort specified?

No.

7. Under Section J, Attachment 5- Section K- Representations, Certifications, and Other

Statements of Offerors, is replaced.