Amendment_0001_(SF30)_to_16-223-SOL-00036.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE PAGE OF PAGES

1 6

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

0001 10/28/2016

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

CODE

FDA/OO/OFBA/OAGS/DAP

SUZANNE MARTELLA

3900 NCTR ROAD

BUILDING 50, RM 430, HFT-320

JEFFERSON AR 72079

Same as Block 6

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, county, State and ZIP: Code) (X) 9A. AMENDMENT OF SOLICITATION NO.

ALL OFFERORS

16-223-SOL-00036

9B. DATED (SEE ITEM 11)

10/18/2016

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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.

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 one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram 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 DATA 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

IT MODIFIES THE CONTRACT/ORDER NO. 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 NO. IN

ITEM 10A.

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

E. IMPORTANT: Contractor is not, is required to sign this document and return __1_ copies to the issuing office.

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

The purpose of this Amendment is to:

1) Change specific solicitation language (Section 1). A revised SF1449 with Continuation Pages (Solicitation Revision 1) supersedes the Solicitation posted on Oct 18, 2016. Offerors shall use only Solicitation Revision 1 and are advised to understand the Summary of Changes outlined in the attached pages.

2) Address Questions and Answers (Section 2).

3) Change language regarding Inhalation Exposure Facility. Summary of Changes Section 3 highlights the language change to the paragraph found on Page 18 of the PWS. A revised PWS Page 18 is provided for Offerors to remove and replace the affected Page. This is not mandatory if Offerors can amend the paragraph in their own copy.

SEE THE FOLLOWING SF30 CONTINUATION PAGES

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

Jerry Martin, Contracting Officer

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY _____________________________________________

(Signature of Contracting Officer)

NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.243

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION 1 – SF1449 CONTINUATION PAGE(S) CHANGES

The following changes are made to the SF1449 and Continuation pages. Changes in the updated SF1449 are highlighted by a bold black line in the left margin of the document and are summarized below. Offerors, as of the date in Block 3 of this SF30, shall use only the Solicitation Revision 1 document:

1. SF1449 Page 1, top right block, change Page numbering FROM: “Page 1 of 35” TO: “Page 1 of 34”.

2. SF1449 Page 4, Section B, Paragraph B.2.2 under the Pricing Table, “NOTE:” is changed TO “NOTE 1:”

3. SF1449 Page 5, Section B, Paragraph B.2.2 under NOTE 1:, “NOTE 2:” is added as follows:

“NOTE 2: For the purpose of a balanced evaluation, Offerors are to insert the price of $25,000 in each of the Travel CLINs (0003, 1002, 2002, 3002 and 4002) in the Pricing Table above.”

4. SF1449 Page 5, Section B, Paragraph B.2.5 Sub-paragraph a., second sentence is changed to read:

FROM: “If at a future date the Government does require one or more Contractor employees to travel (training, conferences, etc.)…” TO: “If at a future date the Government does require one or more Contractor employees to travel (training, conferences, national/local AALAS, etc.)…”

5. SF1449 Page 8, Section B, Paragraph B.4.3, Paragraph Title is changed:

FROM: “Occupational Health & Safety and Employee Medical Examinations” TO: “Occupational Health & Safety”

6. SF1449 Page 2, Table of Contents, Paragraph B.4.3 Title is changed:

FROM: “Occupational Health & Safety and Employee Medical Examinations” TO: “Occupational Health & Safety”

7. SF1449 Page 17, Section E, Table of FAR Clauses, make the following changes:

DELETE the following FAR Clauses:

FAR 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions, Sept 2007.

52.222-22, Previous Contracts and Compliance Records, Feb 1999 52.222-25, Affirmative Action Compliance, Apr 1984

8. SF1449 Page 17, Section E, Table of FAR Clauses, the fill-in information has been added to the following FAR Clause:

FAR NUMBER TITLE DATE

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony

Conviction under any Federal Law “(b)(1) It is is not a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is is not a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.”

Feb 2016

*NOTE FOR CLAUSE FILL-IN: Offerors need only submit the fill-in using the updated SF1449 (Solicitation). There is no need to check the boxes on this Amendment document.

9. F1449 Page 17, Section E, Table of FAR Clauses, the following FAR clause is added:

FAR NUMBER TITLE DATE

52.237-10 Identification of Uncompensated Overtime Mar 2015

10. SF1449 Page 19, Section E, Paragraph E.3, Sub-paragraph E.3.1.1.e.1, first sentence in the paragraph is changed to read:

FROM: “1. All Volumes submitted in response to this RFP shall be placed in 3-ring binders, presented on 8.5 x 11 inch paper with standard one-inch margins on each border, single-spaced using a minimum of 12-point font size, printed front and back, and furnished in the number of copies stated below.”

TO: “1. All Volumes submitted in response to this RFP shall be placed in 3-ring binders, presented on

8.5 x 11 inch paper with standard one-inch margins on each border, single-spaced using a minimum of 12-point body text font size (table and graph font may be smaller, but must be clearly legible), printed front and back, and furnished in the number of copies stated below.”

11. SF1449 Page 21, Paragraph E.3.1.3 Volume II – Past Performance Instructions, Subparagraph 3 is changed to add a sentence at the end. Paragraph is changed to read:

FROM: “Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers. Recent is defined as within the last three (3) years. Relevant is defined as work similar in terms of type, scope, complexity, and size of the work described in the PWS.”

TO: “Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial customers. Recent is defined as within the last three (3) years. Relevant is defined as work similar in terms of type, scope, complexity, and size of the work described in the PWS. Offerors that are newly formed entities without prior contracts should list contracts and subcontracts as required above for all key personnel. Indicate which contracts are within a reasonable degree equal in size, scope and complexity to the current requirement.”

12. SF1449 Page 21, Paragraph E.3.1.3 Volume II – Past Performance Instructions, Subparagraph 4 is deleted in its entirety.

13. SF1449 Page 21, Section E, Paragraph E.3.1.4, 4th bullet is changed to read:

FROM: “Representations and Certifications.”

TO: “Representations and Certifications and other Clauses with required fill-in information.”

14. SF1449 Page 22, Section E, Paragraph E.3.3 entitled “Proposal Disqualification,” first sentence in the paragraph is changed to read:

FROM: “Failure to address the information required by the instructions provided herein will result in technical disqualification and will not be evaluated further.”

TO: “Failure to adequately address the information required by the instructions provided herein may result in technical disqualification whereby the proposal will not be evaluated further.”

(End of SF1449 changes)

SECTION 2 – QUESTIONS AND ANSWERS

The following are the questions submitted prior to receipt of proposals and their corresponding answers.

Question 1: RFP Page 21, Paragraph E.3.1.3 Volume II – Past Performance Instructions, Subparagraph 4 states: “Past performance is for the prime contractor or joint venture partners. Unless a newly formed joint venture on or after the 6th of October, 2016 pre-solicitation notice for this requirement, past performance will be based on recent and relevant work performed by the joint venture entity and not the individual members of the joint venture. For a newly formed joint venture on or after pre-solicitation notice with no past performance record as a joint venture entity, past performance will not be given a positive or negative rating, but will be given a “neutral” rating.” Considering the period for recency of past performance is limited to three years, request the government revise the solicitation’s past performance criteria to allow for the inclusion and evaluation of relevant experience of proposed key personnel as per FAR Part 15?

Answer 1: As provided by FAR 15.305(a)(2)(iii), sub-paragraph 3 language has been changed to allow the government to evaluate recent and relevant past performance of key personnel. Sub-paragraph 4 has been deleted in its entirety.

Question 2: RFP Page 18 under Volume Preparation, it states, “….using a minimum of 12-point font size.” This font size is fine for proposal body text but is very restrictive for graphical notations, diagrams, tables and similar graphics. Will the government modify this font requirement to allow smaller fonts for tables and graphics?

Answer 2: Yes. Language is updated to reference 12-point font for body text only size (table and graph font may be smaller, but must be clearly legible). See updated language in the updated SF1449.

Question 3: Section E.3.1.1 General Instructions, e.(1) Volume Preparation Instructions Page 18:

“All Volumes submitted in response to this RFP shall be placed in 3-ring binders, presented on 8.5 x 11 inch paper with standard one-inch margins on each border, single-spaced using a minimum of 12-point font size.” For tables and graphics will the Government accept 11 x 17 inch paper and a 10-point font size for tables and graphics?

Q3a: If so would the 11 x 17 inch paper be considered one or as two pages?

Answer 3: Language is updated to reference 12-point font for body text only size (table and graph font may be smaller, but must be clearly legible). See updated language in the updated SF1449.

A3a: The government will accept 11 x 17 inch paper, which will be considered as two pages of the total proposal page count.

Question 4: Can we submit a response to the opportunity if we are capable of only providing partial services?

Answer 4: No. The FDA, as outlined by the RFP, has a complete requirement for animal husbandry, care and technical support services. See SF1449 page 22, Section E, paragraph E.3.3 entitled “Proposal Disqualification.”

Question 5: Is it permissible to collaborate with any of the interested vendors for the opportunity listed on FBO website?

Answer 5: Yes. Pay particular attention to the information outlined in the SF1449 as it relates to a “Joint Venture” (Page 23) and Past Performance as it relates to a Joint Venture (Page 21).

Question 6: Attachment 1, PWS page 18, Section 4.1.20. Building 53 – Conventional Rodent Facility and Zebrafish Facility (Room 53C-106), states: “When construction on 53A is completed the 53A facility will contain 11 animal rooms, 2 rodent surgery rooms, and 3 specialized procedure rooms.” Is there a projected date for contractor support of the renovated space?

Answer 6: Projected date is on or about May of 2017.

Question 7: Attachment 1, PWS page 18-19, Section 4.1.20 Inhalation Exposure Facility (53B and -111) paragraph states: “The contract personnel are involved in the inhalation chamber use in toxicology studies only to the extent of routine animal husbandry including recording weights and observations, loading and unloading the rats or mice into special exposure tubes, and processing of decontaminated exposure tubes (the Government is responsible for operation of equipment and decontamination of the exposure tubes).”

This inhalation program has been very labor intensive in the past as contractor personnel conducted timed serial blood collection and other highly technical procedures. Will these highly technical procedures be required of the contractor or performed by the government on the new contract?

Answer 7: To clarify, Contractor personnel are responsible for the following activities within the inhalation facility itself: loading and unloading the rats or mice into special exposure tubes, and processing of decontaminated exposure tubes (the Government is responsible for operation of equipment and decontamination of the exposure tubes). Standard study support activities such as animal husbandry, recording weights and observations, blood and or urine collection could be performed as part of an inhalation study, but not inside the inhalation facility.

PWS paragraph has been updated and a Revised Page 18 with the new Paragraph is included at the end of this SF30.

Question 8: Attachment 1, PWS, Appendix 1: Historical and Estimated Workload, Table 5. Overtime Worked September 2011 to December 2015, page 9. There is a dramatic increase in NHP overtime hours and Sunday premium hours in the 5-year period listed. What is this attributed to?

Answer 8: Overtime increases were attributed to a combination of factors: 1) minimal staffing, 2) expansion of the environmental enrichment program and 3) the addition of squirrel monkeys since the beginning of the Program. The Government expects the Contractor to staff appropriately to cover the required 7 day per week work requirement in order to prevent the necessity for overtime.

(End of Questions and Answers)

SECTION 3 – Performance Work Statement (PWS) CHANGE

1. PWS, Page 18, Paragraph entitled “Inhalational Exposure Facility (53B-106 and -111)” is hereby changed to read:

FROM: “The contract personnel are involved in the inhalation chamber use in toxicology studies only to the extent of routine animal husbandry including recording weights and observations, loading and unloading the rats or mice into special exposure tubes, and processing of decontaminated exposure tubes (the Government is responsible for operation of equipment and decontamination of the exposure tubes).”

TO: “Contractor personnel are responsible for the following activities within the inhalation facility itself:

loading and unloading the rats or mice into special exposure tubes and processing of decontaminated exposure tubes (the Government is responsible for operation of equipment and decontamination of the exposure tubes). Standard study support activities such as animal husbandry, recording weights and observations, blood and or urine collection could be performed as part of an inhalation study, but not inside the inhalation facility.”

As noted in Block 14, Page 18 of the NCTR Animal Care PWS includes a revision to the entire Paragraph entitled “Inhalational Exposure Facility (53B-106 and -111).” A Revised PWS Page 18 is provided on the following page for Offerors to remove and replace the affected Page. Offerors are not mandated to use the revised page if they can amend the paragraph in their own copy.

(End of PWS Changes)

16-223-SOL-00036 ATTACHMENT 1

18 (Revision 1) provided camera system to record any skin lesions on the mice. Animal husbandry also includes washing racks and cages 1X/ week. Washing racks and cages is quite involved. Doors to cages and pans must be removed from the rack. Cages must be removed from rack and turned upside down and placed back on the rack. Next the rack and cages are washed using spray from facility water and allowed to drain. The racks with cages are placed into the rack washer and run through a wash cycle. Then racks are connected to an Edstrom Chlori-Flush Station to decontaminate the automatic watering system and flush with hypochlorite solution for 2 minutes. During the 2 minute flush each lixit must be activated to ensure the hypochlorite solution is present in the lixit assembly. The rack is then disconnected from the flush station and, after 30 minutes, is reconnected to the Edstrom Chlori-Flush Station and flushed with rinse water for 2 minutes. During the 2 minute rinse flush each lixit must be activated to ensure the hypochlorite solution is removed from the lixit assembly. Also required is the sanitization of the Room Automatic Watering Distribution System weekly with hypochlorite solution (flush, soak for 30 minutes and flush).

4.1.20. Building 53 – Conventional Rodent Facility and Zebrafish Facility (Room 53C-106). This is the largest animal facility on campus divided into 4 sections (A, B, C, & D). When construction on 53A is completed the 53A facility will contain 11 animal rooms, 2 rodent surgery rooms, and 3 specialized procedure rooms. It is anticipated that one of the specialized procedure rooms will house 40 operant testing chambers for rats. The 53B facility contains 2 rooms dedicated to inhalation studies (containing 6 inhalation chambers), 6 animal rooms, and 3 specialized procedure rooms. The 53C facility contains 22 animal rooms, 1 Zebrafish room, 1 Zebrafish support room, 2 procedure rooms, and 3 behavioral testing rooms. The 53D facility contains 4 behavioral testing rooms. Building 53 contains a clean and dirty cage wash processing area sized to support all activities in this facility. This facility will be under renovation in 2016-2017, requiring use of the building 5A processing area during that time-frame.

The types of technical procedures in mice or rats expected in this area are: oral gavage, topical dosing, dosed diet, or dosed water studies, studies involving date-mating rats, studies involving injection by IP, IV, or SQ route, blood collection, and daily behavior testing. Dosing intervals are defined by each protocol and may occur monthly, weekly or daily, usually Monday – Friday but may be 7 days/week with the trend at this facility moving toward dosing 7 days/week. Contractor participation in behavior testing procedures involves transferring animals to the testing rooms, placing animals in testing devices, monitoring animals during testing, and returning animals to the home cage at the conclusion of testing. IV dosing and blood collection may be required on mice as young as postnatal day 3. The 40 operant testing chambers in 53A are predicted to support 36 rats per hour for 6 hours per day. Behavior tests include running wheel performance, maze exploration, open field testing, emergence testing, acoustic startle response, rotarod, avoidance testing, play behavior, and pre-weaning behaviors. Normally, no more than three of these tests are performed each day and testing takes no more than 5 hours per day. Testing on weekends is minimal.

Participation in other protocol-specified testing procedures may be required in future studies.

Occasionally rodents may be brought in from sources that require rodent quarantine. All rodents received from non-commercial sources undergo quarantine for 10-14 days but may be held longer if pathogens are isolated from the animals. All rodents are quarantined in ventilated caging systems. During quarantine, animals receive routine care and samples are taken for microbial testing upon the receipt of animals and after 5 days individual water samples are analyzed by the Government for Pseudomonas aeruginosa. All equipment and all supplies used for support during quarantine must be autoclaved. It is estimated that 5 shipments will be received at NCTR and undergo a 10-14 day quarantine period each year of the contract.

Inhalational Exposure Facility (53B-106 and -111) – Contractor personnel are responsible for the following activities within the inhalation facility itself: loading and unloading the rats or mice into special exposure tubes and processing of decontaminated exposure tubes (the Government is responsible for operation of equipment and decontamination of the exposure tubes). Standard study support activities such as animal husbandry, recording weights and observations, blood and or urine collection could be performed as part of an inhalation study, but not inside the inhalation facility.

Zebrafish Facility (Room 53C-106) - This room houses a zebrafish breeding colony which produces embryos for use in research protocols. Two racks hold 144 3-liter tanks each. All tanks will be occupied and an average daily census of ~600 adults is expected throughout the contract period.

4.1.21. Building 62 – Conventional Rodent Facility. There are two (2) conventional rodent housing rooms in this facility. The types of technical procedures in mice or rats expected in this area are: oral gavage, (dosing Monday

– Friday usually, but may be 7 days/week), studies involving injection by IP, IV, or SQ route (dosing monthly, weekly or daily usually Monday – Friday but may be 7 days/week), blood collection, use of operant test chambers, and transfer to the MRI or MicroPET rooms.